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1 TQM application has its limitations Do you agree with this statement Justify your answer giving examples
The past decade has seen many firms focusing on Total Quality Management (TQM) as a means of
improving profits market share and competitiveness Although TQM is a proven approach for success in
manufacturing services and the public sector several organizations failed in their campaigns because of
its
The main limitation of TQM can be summarized as follows
1 Attitude of management
For an effective implementation of TQM it is important to have management commitment However in
India implementation of TQM is difficult due to the conservative attitude of the management
2 Lack of initiatives
In order to introduce TQM we need a participative management style
3 SlowProcess
TQM is a slow process A total change in the outlook of the management and employees is required and
the results of TQM can be seen in long run
4 Practically Difficult
The success of TQM depends upon team work participative management and total commitment to
quality on the part of management and employees is required which is practically very difficult
However TQM also leads to a synergy of benefits to the firm
1 A philosophy that improves business from top to bottom [everybody in the organization is
involved towards the same objective]
2 2A focused systematic and structured approach to enhancing customers satisfaction [helps to
increase sales profit of the organization ]
3 Process improvement methods that reduce or eliminate problems ie non conformance costs
[improves the efficiency of the process and better results]
4 Tools and techniques for improvement - quality operating system [improved working methods
for improves results ]
5 Delivering what the customer wants in terms of service product and the whole experience [helps
to tailor the productservice to match customer requirements and the customer satisfaction]
1
6 Intrinsic motivation and improved attitudes throughout the workforce
[improved work conditions means employees are motivated to perform better]
7 Workforce is proactive - prevention orientated [it helps to prevent accidents quality rejects
etc ]
8 Enhanced communication [it encourages discussion among employees between managers
and employees]
9 Reduction in waste and rework [continual discussion continual improvements proactive
attitude helps to prevent waste rework reduces rejects]
10 Increase in process ownership- employee involvement and empowerment [setting of quality
circles problem solving teams improves the employee involvement and empowers employee
to make decisions]
11 Everyone from top to bottom educated [TQM involves continual training at all levels which
helps the development of the individuals ]
12 Improved customersupplier relationships (internally amp external) [TQM takes the system across
all working units including all departments internally and external stakeholders integration]
13 Market competitiveness[TQM helps to improve the customer servicing and helps
the competitive positioning of the company in the market]
14 TQM through education management and staff are given the tools to achieve all the above
Education provides for guided innovation from all levels Training which is a cost shows a
commitment by management
15 15 TQM helps Individual staff self improvement which is a motivator
Thus staff will collectively provide continual improvement of company systems By working together
communicationdepartmental barriers will be broken down The standard of service can be set
maintained and then improved Suppliers will be working with rather than working for the company
The standard of staff and management will improve through education
Direct benefits of TQM are as follows
bull Increased pride of workmanship among individual workers
bull Increased readiness
bull Improved sustainability caused by extended time between equipment failures
bull Greater mission survivability
bull Better justification for budgets because of more efficient operations
bull Streamlined maintenance and production processes
The bottom line of TQM is ldquomore bang for the buckrdquo The Concept of Quality Management The concept
2
behind quality management revolves around a change from management by results to management by
process (quality) improvement Managers are tasked with continuously improving each and every process
in their organization That means combining quantitative methods and human resource management
techniques to improve customer-supplier
The overall benefits of an TQM ISO 9000 quality management system are the following
Increase Revenue
1 Access wider geographic markets by complying with a globally recognised standard
2 New customers who require ISO 9000 compliance
Preserve Existing Revenue
1 Reduce customer rejection of productsservices because of poor quality
2 Improve customer loyalty
Reduce Costs
1 Reduce or eliminate repetition of work
2 Reduce warranty and customer support costs
3 Reduce management time spent on ldquoputting out firesrdquo
4 Improve productivity by ldquodoing it right the first timerdquo
3
3 Discuss in brief the philosophies of Deming and Juran and do the comparative assessment of the two
Broadly the following considerations are taken into account for the Deming Application Prize
The emphasis of examination is on the implementation of TQM The actual implementation of TQM
practices is appreciated Usage of advanced statistical methods is not the basis for success appreciation
and implementation of statistical methodology are more important
Similar patterns of evaluation are adopted for both manufacturing and non-manufacturing companies
Examination viewpoint criteria are not a check-list for assessment These provide an overall picture of
TQM
Examiners judge features that have been applied by the company The Examination Viewpoint includes
bull Top Management Leadership Vision Strategies
bull TQM Frameworks
bull Quality Assurance Systems
bull Management Systems for Business Elements
bull Human Resource Development
bull Effective Utilisation of Information
bull TQM Concepts and Values
bull Scientific Methods
bull Organisational Powers (Core Technology Speed Vitality)
bull Contribution to Realisation of Corporate Objectives
Successful companies should score
bull 70 points or higher in the Executive Session
bull 70 points or higher as the company average excluding the Executive Session
bull 50 points or higher for any examined unit of the company
According to Juran the selected individual must serve as a role model for any one or more of the following
ten criteria
1 Demonstration of outstanding leadership in establishing customer-driven quality
2 Demonstration of outstanding leadership in combining statistical thinking and management which
results in high quality of products and services
4
3 Demonstration of outstanding leadership in improving the supplier aspects of quality
4 Demonstration of outstanding leadership in improving the human aspects of quality
5 Evidence of effective quality management training andor consulting in the manufacturing service
and small business sectors
6 Evidence of successful design development and marketing of quality management publications
books and instruction systems
7 Evidence of substantial original research on the processes tools and techniques for quality
management
8 Evidence of substantial original quality management research that has social significance
9 Evidence of furtherance of quality awareness through articles conventions and other means
10 Evidence of distinct philanthropy dedicated to the promotions of quality management
The common outcome the two concept are seeking are delivery of ever-improving value improvement of
overall organizational effectiveness and capabilities and finally organizational and personal learning
The following are the common criteria for the two concepts
1 Leadership
2 Strategic Planning
3 Customer and Market Focus
4 Emphasis on Measurement Analysis and Knowledge Management
5 Workforce Focus
6 Effective Process Management
7 Towards Results
5
3 Explain giving examples as to how ISO standards can benefit the society
ISO (International Organization for Standardization) is the worlds largest and foremost developer and
publisher of international standards Because the organization is present globally and the name
International Organization for Standardization would be abbreviated differently in different countries the
founders chose the name ISO derived from the Greek term isos which means equal ISO is a non-
governmental organization headquartered in Geneva Switzerland and networks the regional standards
institutes and regulatory bodies of 163 countries
The ISO structure with one member institute per country bridges the gap between the public and private
sectors and facilitates exchange of information between regulators and businesses In many countries
the member institute is a governmental entity whereas in other countries the member institute is a
private entity This part public-part private structure in different parts of the world enables ISO to develop
standards and solutions that benefit both the business sector and society as a whole making sure that
one entitys interests are not prioritized over another
The ISO official site contends that Standards make an enormous and positive contribution to most
aspects of our lives The importance of standards may be better appreciated when considering what
would happen in its absence when a product is made according to predefined standards and meets
customer expectations it is often taken for granted However in an environment without standards
people would very likely voice concerns about poor quality and unsafe products Whether a business
manufactures goods or provides serviceswhen it meets standards relevant to its industry it ensures that
positive characteristics such as quality durability efficiency safety and environmental friendliness are
reinforced
ISO standards benefit to society by safeguarding their interests and by ensuring that the products and
services they purchase are safe and reliable The standards also help to reduce environmental impact of
business operations by publishing accepted levels of gas and radiation emission and controlling the
quality of water air and soil In addition ISO standards drive the move toward sustainable productions
processes ISO synchronizes and aligns businesses to cleaner and safer production methods by laying
down operational guidelines for different industries
The ISO 9000 and ISO 14000 families are among ISOs most widely known standards ever The vast
majority of ISO standards are highly specific to a particular product material or process However the
standards that have earned the ISO 9000 and ISO 14000 families a worldwide reputation are known as
generic management system standards Generic means that the same standards can be applied to
any organization large or small whatever its product ndash including whether its product is actually a
service ndash in any sector of activity and whether it is a business enterprise a public administration or a
government department Management system refers to what the organization does to manage its
processes or activities
6
Generic also signifies that no matter what the organization is or does if it wants to establish a quality
management system or an environmental management system then such a system has a number of
essential features which are spelled out in the relevant standards of the ISO 9000 or ISO 14000 families
ISO 9000 is concerned with quality management This means what the organization does to enhance
customer satisfaction by meeting customer and applicable regulatory requirements and continually to
improve its performance in this regard ISO 14000 is primarily concerned with environmental
management This means what the organization does to minimize harmful effects on the environment
caused by its activities and continually to improve its environmental performance
7
4 List out the conventional seven quality control tools Explain any two in brief
1 Histograms
A histogram is a bar graph that shows frequency data Histograms provide the easiest way
to evaluate the distribution of data
A histogram is a graphical display of tabular frequencies shown as adjacent rectangles Each
rectangle is erected over an interval with an area equal to the frequency of the observations in the
interval The height of a rectangle is also equal to the frequency density of the interval ie the frequency
divided by the width of the interval The total area of the histogram is equal to the number of data A
histogram may also be based on relative frequencies It then shows the proportion of cases that fall into
each of several categories with the total area equaling The categories are usually specified as
consecutive non-overlapping intervals of a variable The categories (intervals) must be adjacent and
often are chosen to be of the same size
Histograms are used to plot density of data and often for density estimation estimating the probability
density function of the underlying variable The total area of a histogram used for probability density is
always normalized to 1 If the length of the intervals on the x-axis is all 1 then a histogram is identical to
a relative frequency plot
2 Pareto Chart
Pareto charts are used to identify and prioritize problems to be solved They are actually
histograms aided by the 8020 rule adapted by Joseph Juran (80 of the problems are created by
approximately 20 of the causes)
3 Cause and Effect Diagram
The cause and effect diagram is also called the Ishikawa diagram or the fishbone diagram It
is a tool for discovering all the possible causes for a particular effect The major purpose of
this diagram is to act as a first step in problem solving by creating a list of possible causes
4 Scatter Diagrams
Scatter Diagrams are used to study and identify the possible relationship between the changes observed
in two different sets of variables
5 Flow Charts
A flow chart is a pictorial representation showing all of the steps of a process
8
6 Run Charts
Run charts are used to analyze processes according to ti me or order Run charts are useful
in discovering patterns or significant events that occur during a time period
7 Control Charts
Control charts are used to determine whether a process will produce a product or service with consistent
measurable properties
A control chart consists of
Points representing a statistic (eg a mean range proportion) of measurements of a quality
characteristic in samples taken from the process at different times [the data]
The mean of this statistic using all the samples is calculated (eg the mean of the means mean
of the ranges mean of the proportions)
A center line is drawn at the value of the mean of the statistic
The standard error (eg standard deviationsqrt(n) for the mean) of the statistic is also calculated
using all the samples
Upper and lower control limits (sometimes called natural process limits) that indicate the
threshold at which the process output is considered statistically unlikely are drawn typically at 3
standard errors from the center line
The chart may have other optional features including
Upper and lower warning limits drawn as separate lines typically two standard errors above and
below the center line
Division into zones with the addition of rules governing frequencies of observations in each zone
Annotation with events of interest as determined by the Quality Engineer in charge of the
processs quality
Chart usage
If the process is in control all points will plot within the control limits Any observations outside the limits
or systematic patterns within suggest the introduction of a new (and likely unanticipated) source of
variation known as a special cause variation Since increased variation means increased quality costs
a control chart signaling the presence of a special-cause requires immediate investigation This makes
the control limits very important decision aids The control limits tell us about process behavior and have
no intrinsic relationship to any specification targets or engineering tolerance In practice the process
mean (and hence the center line) may not coincide with the specified value (or target) of the quality
9
characteristic because the process design simply cant deliver the process characteristic at the desired
level
Control charts limit specification or targets because of the tendency of those involved with the process
(eg machine operators) to focus on performing to specification when in fact the least-cost course of
action is to keep process variation as low as possible Attempting to make a process whose natural center
is not the same as the target perform to target specification increases process variability and increases
costs significantly and is the cause of much inefficiency in operations process capability studies do
examine the relationship between the natural process limits (the control limits) and specifications
however The purpose of control charts is to allow simple detection of events that are indicative of actual
process change This simple decision can be difficult where the process characteristic is continuously
varying the control chart provides statistically objective criteria of change When change is detected and
considered good its cause should be identified and possibly become the new way of working where the
change is bad then its cause should be identified and eliminated
The purpose in adding warning limits or subdividing the control chart into zones is to provide early
notification if something is amiss Instead of immediately launching a process improvement effort to
determine whether special causes are present the Quality Engineer may temporarily increase the rate at
which samples are taken from the process output until its clear that the process is truly in control Note
that with three sigma limits one expects to be signaled approximately once out of every 370 points on
average
10
5 Suppose that you are working in an organization which wants to develop an effective implementation methodology for ISO 9000 Quality Management System How will you help your organization in developing an effective implementation methodology
Implementation of TQMISO 9000 affects the entire organization right from the start If pursued with total
dedication it results in cultural transition to an atmosphere of continuous improvement
The process of implementing ISO 9000 depends on
The sophistication of your existing quality program
The size of your organization and
The complexity of your process
The 14 essential steps briefly described below are to be followed through in order to implement ISO
9000 quality management system successfully
Step 1 Top Management Commitment
The top management (managing director or chief executive) should demonstrate a commitment and a
determination to implement an ISO 9000 quality management system in the organization Without top
management commitment no quality initiative can succeed Top management must be convinced that
registration and certification will enable the organization to demonstrate to its customers a visible
commitment to quality It should realize that a quality management system would improve overall
business efficiency by elimination of wasteful duplication in management system
The top management should provide evidence of its commitment to the development and implementation
of the quality management system and continually improve its effectiveness by
1 Communicating to the organization the importance of meeting customer as well as statutory and
regulatory requirements
2 Defining the organizations quality policy and make this known to every employee
3 Ensuring that quality objectives are established at all levels and functions
4 Ensuring the availability of resources required for the development and implementation of the
quality management system
5 Appointing a management representative to coordinate quality management system activities
and
6 Conducting management review
The top management should also consider actions such as
Leading the organization by example
Participating in improvement projects
11
Creating an environment that encourages the involvement of people
This type of top management commitment may be driven by
Direct marketplace pressure requirements of crucial customers or parent conglomerates
Indirect marketplace pressure increased quality levels and visibility among competitors
Growth ambitions desire to exploit market opportunities
Personal belief in the value of quality as a goal and quality management systems as a means of
reaching that goal
The top management should identify the goals to be achieved through the quality management system
Typical goals may be
Be more efficient and profitable
Produce products and services that consistently meet customers needs and expectations
Achieve customers satisfaction
Increase market share
Improve communications and morale in the organization
Reduce costs and liabilities
Increase confidence in the production system
Step 2 Establish Implementation Team
ISO 9000 is implemented by people The first phase of implementation calls for the commitment of top
management - the CEO and perhaps a handful of other key people The next step is to establish
implementation team and appoint a Management Representative (MR) as its coordinator to plan and
oversee implementation Its members should include representatives of all functions of the organization -
Marketing Design and development Planning Production Quality control etc In the context of the
standard the MR is the person within the Organization who acts as interface between organization
management and the ISO 9000 registrar His role is in fact much broader than that The MR should also
act as the organizationrsquos quality management system champion and must be a person with
Total backing from the CEO
Genuine and passionate commitment to quality in general and the ISO 9000 quality
management system in particular
The dignity - resulting from rank seniority or both - to influence managers and others of all levels
and functions
Detailed knowledge of quality methods in general and ISO 9000 in particular
The members of the implementation team should also be trained on ISO 9000 quality
management systems by a professional training organization
12
Step 3 Start ISO 9000 Awareness Programs
ISO 9000 awareness programs should be conducted to communicate to the employees the aim of the
ISO 9000 quality management system the advantage it offers to employees customers and the
organization how it will work and their roles and responsibilities within the system Suppliers of materials
and components should also participate in these programs
The awareness program should emphasize the benefits that the organization expects to realize through
its ISO 9000 quality management system The program should also stress the higher levels of
participation and self-direction that the quality management system renders to employees Such a focus
will go far to enlist employee support and commitment The programs could be run either by the
implementation team or by experts hired to talk to different levels of employees
Step 4 Provide Training
Since the ISO 9000 quality management system affects all the areas and all personnel in the
organization training programs should be structured for different categories of employees - senior
managers middle-level managers supervisors and workers The ISO 9000 implementation plan should
make provision for this training The training should cover the basic concepts of quality management
systems and the standard and their overall impact on the strategic goals of the organization the changed
processes
and the likely work culture implications of the system In addition initial training may also be necessary on
writing quality manuals procedures and work instruction auditing principles techniques of laboratory
management calibration testing procedures etc When in-house capacity to carry out such training is not
available it may be necessary to participate in external training courses run by professional training
organizations
Alternatively an external training institution could be invited to conduct in-house training courses
Step 5 Conduct Initial Status Survey
ISO 9000 does not require duplication of effort or redundant system The goal of ISO 9000 is to create a
quality management system that conforms to the standard This does not preclude incorporating
adapting and adding onto quality programs already in place So the next step in the implementation
process is to compare the organizationrsquos existing quality management system if there is one -- with the
requirements of the standard (ISO 90012000)
For this purpose an organization flow chart showing how information actually flows (not what should be
done) from order placement by the customer to delivery to this customer should be drawn up From this
13
over-all flow chart a flow chart of activities in each department should be prepared With the aid of the
flow charts a record of existing quality management system should be established A significant number
of written procedures may already be in place Unless they are very much out of date these documents
should not be discarded Rather they should be incorporated into the new quality management system
Documents requiring modification or elaboration should be identified and listed This exercise is some
times referred to as gap analysis During these review processes wide consultation with executives
and representatives of various unions and associations within the organization is required to enlist their
active cooperation
In the review process documents should be collected studied and registered for further use possibly
after they have been revised Before developing new quality management system documentation we
need to consider with which quality requirements or department we should start The best is to select an
area where processes are fairly well organized running effectively and functioning satisfactorily
The basic approach is to determine and record how a process is currently carried out We can do this by
identifying the people involved and obtaining information from them during individual interviews
Unfortunately it often happens that different people will give different contradicting versions of a process
Each one may refer to oral instructions that are not accurate or clear This is why the facts are often not
described correctly the first time around and have to be revised several times Once it has been agreed
how to describe the current process this process has to be adapted supplemented and implemented
according to the requirements of the quality standard (ISO 90012000) This requires organizational
arrangements the drawing up of additional documents and possible removal of existing documentation
(eg procedures inspectiontest plans inspectiontest instructions) and records (eg inspectiontest
reports inspectiontest certificates)
In introducing a quality management system the emphasis is on the improvement of the existing
processes or the re-organization of processes In general the steps to follow are the following
Ascertain and establish the following What is the present operationprocess What already
exists
Analyze the relevant sections of the quality standard - ISO 90012000 What is actually required
If necessary supplement and change operational arrangements in accordance with the standard
develop documents and records and describe operationsprocesses What is the desired
operationprocess
Step 6 Create a Documented Implementation Plan
14
Once the organization has obtained a clear picture of how its quality management system compares with
the ISO 90012000 standard all non-conformances must be addressed with a documented
implementation plan Usually the plan calls for identifying and describing processes to make the
organizationrsquos quality management system fully in compliance with the standard
The implementation plan should be thorough and specific detailing
Quality documentation to be developed
Objective of the system
Pertinent ISO 90012000 section
Person or team responsible
Approval required
Training required
Resources required
Estimated completion date
These elements should be organized into a detailed chart to be reviewed and approved The plan should
define the responsibilities of different departments and personnel and set target dates for the completion
of activities Once approved the Management Representative should control review and update the plan
as the implementation process proceeds
Step 7 Develop Quality Management System Documentation
Documentation is the most common area of non-conformance among organizations wishing to implement
ISO 9000 quality management systems As one company pointed out When we started our
implementation we found that documentation was inadequate Even absent in some areas Take
calibration Obviously its necessary and obviously we do it but it wasnt being documented Another
area was inspection and testing We inspect and test practically every item that leaves
here but our documentation was inadequate
Documentation of the quality management system should include
Documented statements of a quality policy and quality objectives
A quality manual
Documented procedures and records required by the standard ISO 90012000
and
15
Documents needed by the organization to ensure the effective planning operation
and control of its processes Quality documentation is generally prepared in the three levels
indicated in the box that follows
Level A Quality manual
States the scope of the quality management system including exclusions and details of their justification
and describes the processes of the quality management system and their interaction Generally gives an
organization profile presents the organizational relationships and responsibilities of persons whose work
affects quality and outlines the main procedures It may also describe organizations quality policy and
quality objectives
Level B Quality management system procedures
Describes the activities of individual departments how quality is controlled in each department and the
checks that are carried out
Level C Quality documents (forms reports work instructions etc)
Work instructions describe in detail how specific tasks are performed include drawing standards
methods of tests customers specifications etc
Presents forms to be used for recording observations etc
In small companies the above levels of documentation could be presented in one manual otherwise
separate manuals should be prepared A list of the documents to be prepared should be drawn up and
the responsibility for writing the documents should be assigned to the persons concerned in various
functional departments They should be advised to prepare the drafts within a specific time frame
Step 8 Document Control
Once the necessary quality management system documentation has been generated a documented
system must be created to control it Control is simply a means of managing the creation approval
distribution revision storage and disposal of the various types of documentation Document control
systems should be as simple and as easy to operate as possible -- sufficient to meet ISO 90012000
requirements and that is all
Document control should include
Approval for adequacy by authorized person (s) before issue
16
Review updating and re-approval of documents by authorized person (s)
Identification of changes and of the revision status of documents
Availability of relevant versions of documents at points of use
Identification and control of documents of external origin
Assurance of legibility and identifability of documents and
Prevention of unintended use of obsolete documents
The principle of ISO 9000 document control is that employees should have access to the documentation
and records needed to fulfil their responsibilities
Step 9 Implementation
It is good practice to implement the quality management system being documented as the documentation
is developed although this may be more effective in larger firms In smaller companies the quality
management system is often implemented all at once throughout the organization Where phased
implementation takes place the effectiveness of the system in selected areas can be evaluated It would
be a good idea initially to evaluate areas where the chances of a positive evaluation are high to maintain
the confidence of both management and staff in the merits of implementing the quality management
system
The implementation progress should be monitored to ensure that the quality management system is
effective and conforms to the standard These activities include internal quality audit formal corrective
action and management review
Step 10 Internal Quality Audit
As the system is being installed its effectiveness should be checked by regular internal quality audits
Internal quality audits are conducted to verify that the installed quality management system
Conform to the planned arrangements to the requirements of the standard (ISO 90012000) and
to the quality management system requirements established by your organization and
Is effectively implemented and maintained Even after the system stabilizes and starts
functioning internal audits should be planned and performed as part of an ongoing strategy A
few staff members should be trained to carry out internal auditing Use ISO 19011 for guidance in
auditing auditor qualification and programmes
17
Step 11 Management Review
When the installed quality management system has been operating for three to six months an internal
audit and management review should be conducted and corrective actions implemented The
management reviews are conducted to ensure the continuing suitability adequacy and effectiveness of
the quality management system1048578 The review should include assessing opportunities for improvement
and the need for changes to the quality management system including the quality policy and quality
objectives The input to management review should include information on
Results of audits
Customer feed back
Process performance and product conformity
Status of preventive and corrective actions
Follow-up actions from previous management reviews
Changes that could affect the quality management system and
Recommendations for improvements
Management reviews should also address the pitfalls to effective implementation including lack of CEO
commitment failure to involve everyone in the process and failure to monitor progress and enforce
deadlines
Step 12 Pre-assessment Audit
When system deficiencies are no longer visible it is normally time to apply for certification However
before doing so a pre-assessment audit should be arranged with an independent and qualified auditor
Sometimes certification bodies provide this service for a nominal charge The pre-assessment audit would
provide a degree of confidence for formally going ahead with an application for certification
Step 13 Certification and Registration
Once the quality management system has been in operation for a few months and has stabilized a formal
application for certification could be made to a selected certification agency The certification agency first
carries out an audit of the documents (referred to as an adequacy audit) If the documents conform to
18
the requirements of the quality standard then on-site audit is carried out If the certification body finds the
system to be working satisfactorily it awards the organization a certificate generally for a period of three
years During this three-year period it will carry out periodic surveillance audits to ensure that the system
is continuing to operate satisfactorily
Step 14 Continual Improvement
Certification to ISO 9000 should not be an end We should continually seek to improve the effectiveness
and suitability of the quality management system through the use of
Quality policy
Quality objectives
Audit results
Analysis of data
Corrective and preventive actions
Management review
ISO 90042000 provides a methodology for continual improvement
19
6 Intrinsic motivation and improved attitudes throughout the workforce
[improved work conditions means employees are motivated to perform better]
7 Workforce is proactive - prevention orientated [it helps to prevent accidents quality rejects
etc ]
8 Enhanced communication [it encourages discussion among employees between managers
and employees]
9 Reduction in waste and rework [continual discussion continual improvements proactive
attitude helps to prevent waste rework reduces rejects]
10 Increase in process ownership- employee involvement and empowerment [setting of quality
circles problem solving teams improves the employee involvement and empowers employee
to make decisions]
11 Everyone from top to bottom educated [TQM involves continual training at all levels which
helps the development of the individuals ]
12 Improved customersupplier relationships (internally amp external) [TQM takes the system across
all working units including all departments internally and external stakeholders integration]
13 Market competitiveness[TQM helps to improve the customer servicing and helps
the competitive positioning of the company in the market]
14 TQM through education management and staff are given the tools to achieve all the above
Education provides for guided innovation from all levels Training which is a cost shows a
commitment by management
15 15 TQM helps Individual staff self improvement which is a motivator
Thus staff will collectively provide continual improvement of company systems By working together
communicationdepartmental barriers will be broken down The standard of service can be set
maintained and then improved Suppliers will be working with rather than working for the company
The standard of staff and management will improve through education
Direct benefits of TQM are as follows
bull Increased pride of workmanship among individual workers
bull Increased readiness
bull Improved sustainability caused by extended time between equipment failures
bull Greater mission survivability
bull Better justification for budgets because of more efficient operations
bull Streamlined maintenance and production processes
The bottom line of TQM is ldquomore bang for the buckrdquo The Concept of Quality Management The concept
2
behind quality management revolves around a change from management by results to management by
process (quality) improvement Managers are tasked with continuously improving each and every process
in their organization That means combining quantitative methods and human resource management
techniques to improve customer-supplier
The overall benefits of an TQM ISO 9000 quality management system are the following
Increase Revenue
1 Access wider geographic markets by complying with a globally recognised standard
2 New customers who require ISO 9000 compliance
Preserve Existing Revenue
1 Reduce customer rejection of productsservices because of poor quality
2 Improve customer loyalty
Reduce Costs
1 Reduce or eliminate repetition of work
2 Reduce warranty and customer support costs
3 Reduce management time spent on ldquoputting out firesrdquo
4 Improve productivity by ldquodoing it right the first timerdquo
3
3 Discuss in brief the philosophies of Deming and Juran and do the comparative assessment of the two
Broadly the following considerations are taken into account for the Deming Application Prize
The emphasis of examination is on the implementation of TQM The actual implementation of TQM
practices is appreciated Usage of advanced statistical methods is not the basis for success appreciation
and implementation of statistical methodology are more important
Similar patterns of evaluation are adopted for both manufacturing and non-manufacturing companies
Examination viewpoint criteria are not a check-list for assessment These provide an overall picture of
TQM
Examiners judge features that have been applied by the company The Examination Viewpoint includes
bull Top Management Leadership Vision Strategies
bull TQM Frameworks
bull Quality Assurance Systems
bull Management Systems for Business Elements
bull Human Resource Development
bull Effective Utilisation of Information
bull TQM Concepts and Values
bull Scientific Methods
bull Organisational Powers (Core Technology Speed Vitality)
bull Contribution to Realisation of Corporate Objectives
Successful companies should score
bull 70 points or higher in the Executive Session
bull 70 points or higher as the company average excluding the Executive Session
bull 50 points or higher for any examined unit of the company
According to Juran the selected individual must serve as a role model for any one or more of the following
ten criteria
1 Demonstration of outstanding leadership in establishing customer-driven quality
2 Demonstration of outstanding leadership in combining statistical thinking and management which
results in high quality of products and services
4
3 Demonstration of outstanding leadership in improving the supplier aspects of quality
4 Demonstration of outstanding leadership in improving the human aspects of quality
5 Evidence of effective quality management training andor consulting in the manufacturing service
and small business sectors
6 Evidence of successful design development and marketing of quality management publications
books and instruction systems
7 Evidence of substantial original research on the processes tools and techniques for quality
management
8 Evidence of substantial original quality management research that has social significance
9 Evidence of furtherance of quality awareness through articles conventions and other means
10 Evidence of distinct philanthropy dedicated to the promotions of quality management
The common outcome the two concept are seeking are delivery of ever-improving value improvement of
overall organizational effectiveness and capabilities and finally organizational and personal learning
The following are the common criteria for the two concepts
1 Leadership
2 Strategic Planning
3 Customer and Market Focus
4 Emphasis on Measurement Analysis and Knowledge Management
5 Workforce Focus
6 Effective Process Management
7 Towards Results
5
3 Explain giving examples as to how ISO standards can benefit the society
ISO (International Organization for Standardization) is the worlds largest and foremost developer and
publisher of international standards Because the organization is present globally and the name
International Organization for Standardization would be abbreviated differently in different countries the
founders chose the name ISO derived from the Greek term isos which means equal ISO is a non-
governmental organization headquartered in Geneva Switzerland and networks the regional standards
institutes and regulatory bodies of 163 countries
The ISO structure with one member institute per country bridges the gap between the public and private
sectors and facilitates exchange of information between regulators and businesses In many countries
the member institute is a governmental entity whereas in other countries the member institute is a
private entity This part public-part private structure in different parts of the world enables ISO to develop
standards and solutions that benefit both the business sector and society as a whole making sure that
one entitys interests are not prioritized over another
The ISO official site contends that Standards make an enormous and positive contribution to most
aspects of our lives The importance of standards may be better appreciated when considering what
would happen in its absence when a product is made according to predefined standards and meets
customer expectations it is often taken for granted However in an environment without standards
people would very likely voice concerns about poor quality and unsafe products Whether a business
manufactures goods or provides serviceswhen it meets standards relevant to its industry it ensures that
positive characteristics such as quality durability efficiency safety and environmental friendliness are
reinforced
ISO standards benefit to society by safeguarding their interests and by ensuring that the products and
services they purchase are safe and reliable The standards also help to reduce environmental impact of
business operations by publishing accepted levels of gas and radiation emission and controlling the
quality of water air and soil In addition ISO standards drive the move toward sustainable productions
processes ISO synchronizes and aligns businesses to cleaner and safer production methods by laying
down operational guidelines for different industries
The ISO 9000 and ISO 14000 families are among ISOs most widely known standards ever The vast
majority of ISO standards are highly specific to a particular product material or process However the
standards that have earned the ISO 9000 and ISO 14000 families a worldwide reputation are known as
generic management system standards Generic means that the same standards can be applied to
any organization large or small whatever its product ndash including whether its product is actually a
service ndash in any sector of activity and whether it is a business enterprise a public administration or a
government department Management system refers to what the organization does to manage its
processes or activities
6
Generic also signifies that no matter what the organization is or does if it wants to establish a quality
management system or an environmental management system then such a system has a number of
essential features which are spelled out in the relevant standards of the ISO 9000 or ISO 14000 families
ISO 9000 is concerned with quality management This means what the organization does to enhance
customer satisfaction by meeting customer and applicable regulatory requirements and continually to
improve its performance in this regard ISO 14000 is primarily concerned with environmental
management This means what the organization does to minimize harmful effects on the environment
caused by its activities and continually to improve its environmental performance
7
4 List out the conventional seven quality control tools Explain any two in brief
1 Histograms
A histogram is a bar graph that shows frequency data Histograms provide the easiest way
to evaluate the distribution of data
A histogram is a graphical display of tabular frequencies shown as adjacent rectangles Each
rectangle is erected over an interval with an area equal to the frequency of the observations in the
interval The height of a rectangle is also equal to the frequency density of the interval ie the frequency
divided by the width of the interval The total area of the histogram is equal to the number of data A
histogram may also be based on relative frequencies It then shows the proportion of cases that fall into
each of several categories with the total area equaling The categories are usually specified as
consecutive non-overlapping intervals of a variable The categories (intervals) must be adjacent and
often are chosen to be of the same size
Histograms are used to plot density of data and often for density estimation estimating the probability
density function of the underlying variable The total area of a histogram used for probability density is
always normalized to 1 If the length of the intervals on the x-axis is all 1 then a histogram is identical to
a relative frequency plot
2 Pareto Chart
Pareto charts are used to identify and prioritize problems to be solved They are actually
histograms aided by the 8020 rule adapted by Joseph Juran (80 of the problems are created by
approximately 20 of the causes)
3 Cause and Effect Diagram
The cause and effect diagram is also called the Ishikawa diagram or the fishbone diagram It
is a tool for discovering all the possible causes for a particular effect The major purpose of
this diagram is to act as a first step in problem solving by creating a list of possible causes
4 Scatter Diagrams
Scatter Diagrams are used to study and identify the possible relationship between the changes observed
in two different sets of variables
5 Flow Charts
A flow chart is a pictorial representation showing all of the steps of a process
8
6 Run Charts
Run charts are used to analyze processes according to ti me or order Run charts are useful
in discovering patterns or significant events that occur during a time period
7 Control Charts
Control charts are used to determine whether a process will produce a product or service with consistent
measurable properties
A control chart consists of
Points representing a statistic (eg a mean range proportion) of measurements of a quality
characteristic in samples taken from the process at different times [the data]
The mean of this statistic using all the samples is calculated (eg the mean of the means mean
of the ranges mean of the proportions)
A center line is drawn at the value of the mean of the statistic
The standard error (eg standard deviationsqrt(n) for the mean) of the statistic is also calculated
using all the samples
Upper and lower control limits (sometimes called natural process limits) that indicate the
threshold at which the process output is considered statistically unlikely are drawn typically at 3
standard errors from the center line
The chart may have other optional features including
Upper and lower warning limits drawn as separate lines typically two standard errors above and
below the center line
Division into zones with the addition of rules governing frequencies of observations in each zone
Annotation with events of interest as determined by the Quality Engineer in charge of the
processs quality
Chart usage
If the process is in control all points will plot within the control limits Any observations outside the limits
or systematic patterns within suggest the introduction of a new (and likely unanticipated) source of
variation known as a special cause variation Since increased variation means increased quality costs
a control chart signaling the presence of a special-cause requires immediate investigation This makes
the control limits very important decision aids The control limits tell us about process behavior and have
no intrinsic relationship to any specification targets or engineering tolerance In practice the process
mean (and hence the center line) may not coincide with the specified value (or target) of the quality
9
characteristic because the process design simply cant deliver the process characteristic at the desired
level
Control charts limit specification or targets because of the tendency of those involved with the process
(eg machine operators) to focus on performing to specification when in fact the least-cost course of
action is to keep process variation as low as possible Attempting to make a process whose natural center
is not the same as the target perform to target specification increases process variability and increases
costs significantly and is the cause of much inefficiency in operations process capability studies do
examine the relationship between the natural process limits (the control limits) and specifications
however The purpose of control charts is to allow simple detection of events that are indicative of actual
process change This simple decision can be difficult where the process characteristic is continuously
varying the control chart provides statistically objective criteria of change When change is detected and
considered good its cause should be identified and possibly become the new way of working where the
change is bad then its cause should be identified and eliminated
The purpose in adding warning limits or subdividing the control chart into zones is to provide early
notification if something is amiss Instead of immediately launching a process improvement effort to
determine whether special causes are present the Quality Engineer may temporarily increase the rate at
which samples are taken from the process output until its clear that the process is truly in control Note
that with three sigma limits one expects to be signaled approximately once out of every 370 points on
average
10
5 Suppose that you are working in an organization which wants to develop an effective implementation methodology for ISO 9000 Quality Management System How will you help your organization in developing an effective implementation methodology
Implementation of TQMISO 9000 affects the entire organization right from the start If pursued with total
dedication it results in cultural transition to an atmosphere of continuous improvement
The process of implementing ISO 9000 depends on
The sophistication of your existing quality program
The size of your organization and
The complexity of your process
The 14 essential steps briefly described below are to be followed through in order to implement ISO
9000 quality management system successfully
Step 1 Top Management Commitment
The top management (managing director or chief executive) should demonstrate a commitment and a
determination to implement an ISO 9000 quality management system in the organization Without top
management commitment no quality initiative can succeed Top management must be convinced that
registration and certification will enable the organization to demonstrate to its customers a visible
commitment to quality It should realize that a quality management system would improve overall
business efficiency by elimination of wasteful duplication in management system
The top management should provide evidence of its commitment to the development and implementation
of the quality management system and continually improve its effectiveness by
1 Communicating to the organization the importance of meeting customer as well as statutory and
regulatory requirements
2 Defining the organizations quality policy and make this known to every employee
3 Ensuring that quality objectives are established at all levels and functions
4 Ensuring the availability of resources required for the development and implementation of the
quality management system
5 Appointing a management representative to coordinate quality management system activities
and
6 Conducting management review
The top management should also consider actions such as
Leading the organization by example
Participating in improvement projects
11
Creating an environment that encourages the involvement of people
This type of top management commitment may be driven by
Direct marketplace pressure requirements of crucial customers or parent conglomerates
Indirect marketplace pressure increased quality levels and visibility among competitors
Growth ambitions desire to exploit market opportunities
Personal belief in the value of quality as a goal and quality management systems as a means of
reaching that goal
The top management should identify the goals to be achieved through the quality management system
Typical goals may be
Be more efficient and profitable
Produce products and services that consistently meet customers needs and expectations
Achieve customers satisfaction
Increase market share
Improve communications and morale in the organization
Reduce costs and liabilities
Increase confidence in the production system
Step 2 Establish Implementation Team
ISO 9000 is implemented by people The first phase of implementation calls for the commitment of top
management - the CEO and perhaps a handful of other key people The next step is to establish
implementation team and appoint a Management Representative (MR) as its coordinator to plan and
oversee implementation Its members should include representatives of all functions of the organization -
Marketing Design and development Planning Production Quality control etc In the context of the
standard the MR is the person within the Organization who acts as interface between organization
management and the ISO 9000 registrar His role is in fact much broader than that The MR should also
act as the organizationrsquos quality management system champion and must be a person with
Total backing from the CEO
Genuine and passionate commitment to quality in general and the ISO 9000 quality
management system in particular
The dignity - resulting from rank seniority or both - to influence managers and others of all levels
and functions
Detailed knowledge of quality methods in general and ISO 9000 in particular
The members of the implementation team should also be trained on ISO 9000 quality
management systems by a professional training organization
12
Step 3 Start ISO 9000 Awareness Programs
ISO 9000 awareness programs should be conducted to communicate to the employees the aim of the
ISO 9000 quality management system the advantage it offers to employees customers and the
organization how it will work and their roles and responsibilities within the system Suppliers of materials
and components should also participate in these programs
The awareness program should emphasize the benefits that the organization expects to realize through
its ISO 9000 quality management system The program should also stress the higher levels of
participation and self-direction that the quality management system renders to employees Such a focus
will go far to enlist employee support and commitment The programs could be run either by the
implementation team or by experts hired to talk to different levels of employees
Step 4 Provide Training
Since the ISO 9000 quality management system affects all the areas and all personnel in the
organization training programs should be structured for different categories of employees - senior
managers middle-level managers supervisors and workers The ISO 9000 implementation plan should
make provision for this training The training should cover the basic concepts of quality management
systems and the standard and their overall impact on the strategic goals of the organization the changed
processes
and the likely work culture implications of the system In addition initial training may also be necessary on
writing quality manuals procedures and work instruction auditing principles techniques of laboratory
management calibration testing procedures etc When in-house capacity to carry out such training is not
available it may be necessary to participate in external training courses run by professional training
organizations
Alternatively an external training institution could be invited to conduct in-house training courses
Step 5 Conduct Initial Status Survey
ISO 9000 does not require duplication of effort or redundant system The goal of ISO 9000 is to create a
quality management system that conforms to the standard This does not preclude incorporating
adapting and adding onto quality programs already in place So the next step in the implementation
process is to compare the organizationrsquos existing quality management system if there is one -- with the
requirements of the standard (ISO 90012000)
For this purpose an organization flow chart showing how information actually flows (not what should be
done) from order placement by the customer to delivery to this customer should be drawn up From this
13
over-all flow chart a flow chart of activities in each department should be prepared With the aid of the
flow charts a record of existing quality management system should be established A significant number
of written procedures may already be in place Unless they are very much out of date these documents
should not be discarded Rather they should be incorporated into the new quality management system
Documents requiring modification or elaboration should be identified and listed This exercise is some
times referred to as gap analysis During these review processes wide consultation with executives
and representatives of various unions and associations within the organization is required to enlist their
active cooperation
In the review process documents should be collected studied and registered for further use possibly
after they have been revised Before developing new quality management system documentation we
need to consider with which quality requirements or department we should start The best is to select an
area where processes are fairly well organized running effectively and functioning satisfactorily
The basic approach is to determine and record how a process is currently carried out We can do this by
identifying the people involved and obtaining information from them during individual interviews
Unfortunately it often happens that different people will give different contradicting versions of a process
Each one may refer to oral instructions that are not accurate or clear This is why the facts are often not
described correctly the first time around and have to be revised several times Once it has been agreed
how to describe the current process this process has to be adapted supplemented and implemented
according to the requirements of the quality standard (ISO 90012000) This requires organizational
arrangements the drawing up of additional documents and possible removal of existing documentation
(eg procedures inspectiontest plans inspectiontest instructions) and records (eg inspectiontest
reports inspectiontest certificates)
In introducing a quality management system the emphasis is on the improvement of the existing
processes or the re-organization of processes In general the steps to follow are the following
Ascertain and establish the following What is the present operationprocess What already
exists
Analyze the relevant sections of the quality standard - ISO 90012000 What is actually required
If necessary supplement and change operational arrangements in accordance with the standard
develop documents and records and describe operationsprocesses What is the desired
operationprocess
Step 6 Create a Documented Implementation Plan
14
Once the organization has obtained a clear picture of how its quality management system compares with
the ISO 90012000 standard all non-conformances must be addressed with a documented
implementation plan Usually the plan calls for identifying and describing processes to make the
organizationrsquos quality management system fully in compliance with the standard
The implementation plan should be thorough and specific detailing
Quality documentation to be developed
Objective of the system
Pertinent ISO 90012000 section
Person or team responsible
Approval required
Training required
Resources required
Estimated completion date
These elements should be organized into a detailed chart to be reviewed and approved The plan should
define the responsibilities of different departments and personnel and set target dates for the completion
of activities Once approved the Management Representative should control review and update the plan
as the implementation process proceeds
Step 7 Develop Quality Management System Documentation
Documentation is the most common area of non-conformance among organizations wishing to implement
ISO 9000 quality management systems As one company pointed out When we started our
implementation we found that documentation was inadequate Even absent in some areas Take
calibration Obviously its necessary and obviously we do it but it wasnt being documented Another
area was inspection and testing We inspect and test practically every item that leaves
here but our documentation was inadequate
Documentation of the quality management system should include
Documented statements of a quality policy and quality objectives
A quality manual
Documented procedures and records required by the standard ISO 90012000
and
15
Documents needed by the organization to ensure the effective planning operation
and control of its processes Quality documentation is generally prepared in the three levels
indicated in the box that follows
Level A Quality manual
States the scope of the quality management system including exclusions and details of their justification
and describes the processes of the quality management system and their interaction Generally gives an
organization profile presents the organizational relationships and responsibilities of persons whose work
affects quality and outlines the main procedures It may also describe organizations quality policy and
quality objectives
Level B Quality management system procedures
Describes the activities of individual departments how quality is controlled in each department and the
checks that are carried out
Level C Quality documents (forms reports work instructions etc)
Work instructions describe in detail how specific tasks are performed include drawing standards
methods of tests customers specifications etc
Presents forms to be used for recording observations etc
In small companies the above levels of documentation could be presented in one manual otherwise
separate manuals should be prepared A list of the documents to be prepared should be drawn up and
the responsibility for writing the documents should be assigned to the persons concerned in various
functional departments They should be advised to prepare the drafts within a specific time frame
Step 8 Document Control
Once the necessary quality management system documentation has been generated a documented
system must be created to control it Control is simply a means of managing the creation approval
distribution revision storage and disposal of the various types of documentation Document control
systems should be as simple and as easy to operate as possible -- sufficient to meet ISO 90012000
requirements and that is all
Document control should include
Approval for adequacy by authorized person (s) before issue
16
Review updating and re-approval of documents by authorized person (s)
Identification of changes and of the revision status of documents
Availability of relevant versions of documents at points of use
Identification and control of documents of external origin
Assurance of legibility and identifability of documents and
Prevention of unintended use of obsolete documents
The principle of ISO 9000 document control is that employees should have access to the documentation
and records needed to fulfil their responsibilities
Step 9 Implementation
It is good practice to implement the quality management system being documented as the documentation
is developed although this may be more effective in larger firms In smaller companies the quality
management system is often implemented all at once throughout the organization Where phased
implementation takes place the effectiveness of the system in selected areas can be evaluated It would
be a good idea initially to evaluate areas where the chances of a positive evaluation are high to maintain
the confidence of both management and staff in the merits of implementing the quality management
system
The implementation progress should be monitored to ensure that the quality management system is
effective and conforms to the standard These activities include internal quality audit formal corrective
action and management review
Step 10 Internal Quality Audit
As the system is being installed its effectiveness should be checked by regular internal quality audits
Internal quality audits are conducted to verify that the installed quality management system
Conform to the planned arrangements to the requirements of the standard (ISO 90012000) and
to the quality management system requirements established by your organization and
Is effectively implemented and maintained Even after the system stabilizes and starts
functioning internal audits should be planned and performed as part of an ongoing strategy A
few staff members should be trained to carry out internal auditing Use ISO 19011 for guidance in
auditing auditor qualification and programmes
17
Step 11 Management Review
When the installed quality management system has been operating for three to six months an internal
audit and management review should be conducted and corrective actions implemented The
management reviews are conducted to ensure the continuing suitability adequacy and effectiveness of
the quality management system1048578 The review should include assessing opportunities for improvement
and the need for changes to the quality management system including the quality policy and quality
objectives The input to management review should include information on
Results of audits
Customer feed back
Process performance and product conformity
Status of preventive and corrective actions
Follow-up actions from previous management reviews
Changes that could affect the quality management system and
Recommendations for improvements
Management reviews should also address the pitfalls to effective implementation including lack of CEO
commitment failure to involve everyone in the process and failure to monitor progress and enforce
deadlines
Step 12 Pre-assessment Audit
When system deficiencies are no longer visible it is normally time to apply for certification However
before doing so a pre-assessment audit should be arranged with an independent and qualified auditor
Sometimes certification bodies provide this service for a nominal charge The pre-assessment audit would
provide a degree of confidence for formally going ahead with an application for certification
Step 13 Certification and Registration
Once the quality management system has been in operation for a few months and has stabilized a formal
application for certification could be made to a selected certification agency The certification agency first
carries out an audit of the documents (referred to as an adequacy audit) If the documents conform to
18
the requirements of the quality standard then on-site audit is carried out If the certification body finds the
system to be working satisfactorily it awards the organization a certificate generally for a period of three
years During this three-year period it will carry out periodic surveillance audits to ensure that the system
is continuing to operate satisfactorily
Step 14 Continual Improvement
Certification to ISO 9000 should not be an end We should continually seek to improve the effectiveness
and suitability of the quality management system through the use of
Quality policy
Quality objectives
Audit results
Analysis of data
Corrective and preventive actions
Management review
ISO 90042000 provides a methodology for continual improvement
19
behind quality management revolves around a change from management by results to management by
process (quality) improvement Managers are tasked with continuously improving each and every process
in their organization That means combining quantitative methods and human resource management
techniques to improve customer-supplier
The overall benefits of an TQM ISO 9000 quality management system are the following
Increase Revenue
1 Access wider geographic markets by complying with a globally recognised standard
2 New customers who require ISO 9000 compliance
Preserve Existing Revenue
1 Reduce customer rejection of productsservices because of poor quality
2 Improve customer loyalty
Reduce Costs
1 Reduce or eliminate repetition of work
2 Reduce warranty and customer support costs
3 Reduce management time spent on ldquoputting out firesrdquo
4 Improve productivity by ldquodoing it right the first timerdquo
3
3 Discuss in brief the philosophies of Deming and Juran and do the comparative assessment of the two
Broadly the following considerations are taken into account for the Deming Application Prize
The emphasis of examination is on the implementation of TQM The actual implementation of TQM
practices is appreciated Usage of advanced statistical methods is not the basis for success appreciation
and implementation of statistical methodology are more important
Similar patterns of evaluation are adopted for both manufacturing and non-manufacturing companies
Examination viewpoint criteria are not a check-list for assessment These provide an overall picture of
TQM
Examiners judge features that have been applied by the company The Examination Viewpoint includes
bull Top Management Leadership Vision Strategies
bull TQM Frameworks
bull Quality Assurance Systems
bull Management Systems for Business Elements
bull Human Resource Development
bull Effective Utilisation of Information
bull TQM Concepts and Values
bull Scientific Methods
bull Organisational Powers (Core Technology Speed Vitality)
bull Contribution to Realisation of Corporate Objectives
Successful companies should score
bull 70 points or higher in the Executive Session
bull 70 points or higher as the company average excluding the Executive Session
bull 50 points or higher for any examined unit of the company
According to Juran the selected individual must serve as a role model for any one or more of the following
ten criteria
1 Demonstration of outstanding leadership in establishing customer-driven quality
2 Demonstration of outstanding leadership in combining statistical thinking and management which
results in high quality of products and services
4
3 Demonstration of outstanding leadership in improving the supplier aspects of quality
4 Demonstration of outstanding leadership in improving the human aspects of quality
5 Evidence of effective quality management training andor consulting in the manufacturing service
and small business sectors
6 Evidence of successful design development and marketing of quality management publications
books and instruction systems
7 Evidence of substantial original research on the processes tools and techniques for quality
management
8 Evidence of substantial original quality management research that has social significance
9 Evidence of furtherance of quality awareness through articles conventions and other means
10 Evidence of distinct philanthropy dedicated to the promotions of quality management
The common outcome the two concept are seeking are delivery of ever-improving value improvement of
overall organizational effectiveness and capabilities and finally organizational and personal learning
The following are the common criteria for the two concepts
1 Leadership
2 Strategic Planning
3 Customer and Market Focus
4 Emphasis on Measurement Analysis and Knowledge Management
5 Workforce Focus
6 Effective Process Management
7 Towards Results
5
3 Explain giving examples as to how ISO standards can benefit the society
ISO (International Organization for Standardization) is the worlds largest and foremost developer and
publisher of international standards Because the organization is present globally and the name
International Organization for Standardization would be abbreviated differently in different countries the
founders chose the name ISO derived from the Greek term isos which means equal ISO is a non-
governmental organization headquartered in Geneva Switzerland and networks the regional standards
institutes and regulatory bodies of 163 countries
The ISO structure with one member institute per country bridges the gap between the public and private
sectors and facilitates exchange of information between regulators and businesses In many countries
the member institute is a governmental entity whereas in other countries the member institute is a
private entity This part public-part private structure in different parts of the world enables ISO to develop
standards and solutions that benefit both the business sector and society as a whole making sure that
one entitys interests are not prioritized over another
The ISO official site contends that Standards make an enormous and positive contribution to most
aspects of our lives The importance of standards may be better appreciated when considering what
would happen in its absence when a product is made according to predefined standards and meets
customer expectations it is often taken for granted However in an environment without standards
people would very likely voice concerns about poor quality and unsafe products Whether a business
manufactures goods or provides serviceswhen it meets standards relevant to its industry it ensures that
positive characteristics such as quality durability efficiency safety and environmental friendliness are
reinforced
ISO standards benefit to society by safeguarding their interests and by ensuring that the products and
services they purchase are safe and reliable The standards also help to reduce environmental impact of
business operations by publishing accepted levels of gas and radiation emission and controlling the
quality of water air and soil In addition ISO standards drive the move toward sustainable productions
processes ISO synchronizes and aligns businesses to cleaner and safer production methods by laying
down operational guidelines for different industries
The ISO 9000 and ISO 14000 families are among ISOs most widely known standards ever The vast
majority of ISO standards are highly specific to a particular product material or process However the
standards that have earned the ISO 9000 and ISO 14000 families a worldwide reputation are known as
generic management system standards Generic means that the same standards can be applied to
any organization large or small whatever its product ndash including whether its product is actually a
service ndash in any sector of activity and whether it is a business enterprise a public administration or a
government department Management system refers to what the organization does to manage its
processes or activities
6
Generic also signifies that no matter what the organization is or does if it wants to establish a quality
management system or an environmental management system then such a system has a number of
essential features which are spelled out in the relevant standards of the ISO 9000 or ISO 14000 families
ISO 9000 is concerned with quality management This means what the organization does to enhance
customer satisfaction by meeting customer and applicable regulatory requirements and continually to
improve its performance in this regard ISO 14000 is primarily concerned with environmental
management This means what the organization does to minimize harmful effects on the environment
caused by its activities and continually to improve its environmental performance
7
4 List out the conventional seven quality control tools Explain any two in brief
1 Histograms
A histogram is a bar graph that shows frequency data Histograms provide the easiest way
to evaluate the distribution of data
A histogram is a graphical display of tabular frequencies shown as adjacent rectangles Each
rectangle is erected over an interval with an area equal to the frequency of the observations in the
interval The height of a rectangle is also equal to the frequency density of the interval ie the frequency
divided by the width of the interval The total area of the histogram is equal to the number of data A
histogram may also be based on relative frequencies It then shows the proportion of cases that fall into
each of several categories with the total area equaling The categories are usually specified as
consecutive non-overlapping intervals of a variable The categories (intervals) must be adjacent and
often are chosen to be of the same size
Histograms are used to plot density of data and often for density estimation estimating the probability
density function of the underlying variable The total area of a histogram used for probability density is
always normalized to 1 If the length of the intervals on the x-axis is all 1 then a histogram is identical to
a relative frequency plot
2 Pareto Chart
Pareto charts are used to identify and prioritize problems to be solved They are actually
histograms aided by the 8020 rule adapted by Joseph Juran (80 of the problems are created by
approximately 20 of the causes)
3 Cause and Effect Diagram
The cause and effect diagram is also called the Ishikawa diagram or the fishbone diagram It
is a tool for discovering all the possible causes for a particular effect The major purpose of
this diagram is to act as a first step in problem solving by creating a list of possible causes
4 Scatter Diagrams
Scatter Diagrams are used to study and identify the possible relationship between the changes observed
in two different sets of variables
5 Flow Charts
A flow chart is a pictorial representation showing all of the steps of a process
8
6 Run Charts
Run charts are used to analyze processes according to ti me or order Run charts are useful
in discovering patterns or significant events that occur during a time period
7 Control Charts
Control charts are used to determine whether a process will produce a product or service with consistent
measurable properties
A control chart consists of
Points representing a statistic (eg a mean range proportion) of measurements of a quality
characteristic in samples taken from the process at different times [the data]
The mean of this statistic using all the samples is calculated (eg the mean of the means mean
of the ranges mean of the proportions)
A center line is drawn at the value of the mean of the statistic
The standard error (eg standard deviationsqrt(n) for the mean) of the statistic is also calculated
using all the samples
Upper and lower control limits (sometimes called natural process limits) that indicate the
threshold at which the process output is considered statistically unlikely are drawn typically at 3
standard errors from the center line
The chart may have other optional features including
Upper and lower warning limits drawn as separate lines typically two standard errors above and
below the center line
Division into zones with the addition of rules governing frequencies of observations in each zone
Annotation with events of interest as determined by the Quality Engineer in charge of the
processs quality
Chart usage
If the process is in control all points will plot within the control limits Any observations outside the limits
or systematic patterns within suggest the introduction of a new (and likely unanticipated) source of
variation known as a special cause variation Since increased variation means increased quality costs
a control chart signaling the presence of a special-cause requires immediate investigation This makes
the control limits very important decision aids The control limits tell us about process behavior and have
no intrinsic relationship to any specification targets or engineering tolerance In practice the process
mean (and hence the center line) may not coincide with the specified value (or target) of the quality
9
characteristic because the process design simply cant deliver the process characteristic at the desired
level
Control charts limit specification or targets because of the tendency of those involved with the process
(eg machine operators) to focus on performing to specification when in fact the least-cost course of
action is to keep process variation as low as possible Attempting to make a process whose natural center
is not the same as the target perform to target specification increases process variability and increases
costs significantly and is the cause of much inefficiency in operations process capability studies do
examine the relationship between the natural process limits (the control limits) and specifications
however The purpose of control charts is to allow simple detection of events that are indicative of actual
process change This simple decision can be difficult where the process characteristic is continuously
varying the control chart provides statistically objective criteria of change When change is detected and
considered good its cause should be identified and possibly become the new way of working where the
change is bad then its cause should be identified and eliminated
The purpose in adding warning limits or subdividing the control chart into zones is to provide early
notification if something is amiss Instead of immediately launching a process improvement effort to
determine whether special causes are present the Quality Engineer may temporarily increase the rate at
which samples are taken from the process output until its clear that the process is truly in control Note
that with three sigma limits one expects to be signaled approximately once out of every 370 points on
average
10
5 Suppose that you are working in an organization which wants to develop an effective implementation methodology for ISO 9000 Quality Management System How will you help your organization in developing an effective implementation methodology
Implementation of TQMISO 9000 affects the entire organization right from the start If pursued with total
dedication it results in cultural transition to an atmosphere of continuous improvement
The process of implementing ISO 9000 depends on
The sophistication of your existing quality program
The size of your organization and
The complexity of your process
The 14 essential steps briefly described below are to be followed through in order to implement ISO
9000 quality management system successfully
Step 1 Top Management Commitment
The top management (managing director or chief executive) should demonstrate a commitment and a
determination to implement an ISO 9000 quality management system in the organization Without top
management commitment no quality initiative can succeed Top management must be convinced that
registration and certification will enable the organization to demonstrate to its customers a visible
commitment to quality It should realize that a quality management system would improve overall
business efficiency by elimination of wasteful duplication in management system
The top management should provide evidence of its commitment to the development and implementation
of the quality management system and continually improve its effectiveness by
1 Communicating to the organization the importance of meeting customer as well as statutory and
regulatory requirements
2 Defining the organizations quality policy and make this known to every employee
3 Ensuring that quality objectives are established at all levels and functions
4 Ensuring the availability of resources required for the development and implementation of the
quality management system
5 Appointing a management representative to coordinate quality management system activities
and
6 Conducting management review
The top management should also consider actions such as
Leading the organization by example
Participating in improvement projects
11
Creating an environment that encourages the involvement of people
This type of top management commitment may be driven by
Direct marketplace pressure requirements of crucial customers or parent conglomerates
Indirect marketplace pressure increased quality levels and visibility among competitors
Growth ambitions desire to exploit market opportunities
Personal belief in the value of quality as a goal and quality management systems as a means of
reaching that goal
The top management should identify the goals to be achieved through the quality management system
Typical goals may be
Be more efficient and profitable
Produce products and services that consistently meet customers needs and expectations
Achieve customers satisfaction
Increase market share
Improve communications and morale in the organization
Reduce costs and liabilities
Increase confidence in the production system
Step 2 Establish Implementation Team
ISO 9000 is implemented by people The first phase of implementation calls for the commitment of top
management - the CEO and perhaps a handful of other key people The next step is to establish
implementation team and appoint a Management Representative (MR) as its coordinator to plan and
oversee implementation Its members should include representatives of all functions of the organization -
Marketing Design and development Planning Production Quality control etc In the context of the
standard the MR is the person within the Organization who acts as interface between organization
management and the ISO 9000 registrar His role is in fact much broader than that The MR should also
act as the organizationrsquos quality management system champion and must be a person with
Total backing from the CEO
Genuine and passionate commitment to quality in general and the ISO 9000 quality
management system in particular
The dignity - resulting from rank seniority or both - to influence managers and others of all levels
and functions
Detailed knowledge of quality methods in general and ISO 9000 in particular
The members of the implementation team should also be trained on ISO 9000 quality
management systems by a professional training organization
12
Step 3 Start ISO 9000 Awareness Programs
ISO 9000 awareness programs should be conducted to communicate to the employees the aim of the
ISO 9000 quality management system the advantage it offers to employees customers and the
organization how it will work and their roles and responsibilities within the system Suppliers of materials
and components should also participate in these programs
The awareness program should emphasize the benefits that the organization expects to realize through
its ISO 9000 quality management system The program should also stress the higher levels of
participation and self-direction that the quality management system renders to employees Such a focus
will go far to enlist employee support and commitment The programs could be run either by the
implementation team or by experts hired to talk to different levels of employees
Step 4 Provide Training
Since the ISO 9000 quality management system affects all the areas and all personnel in the
organization training programs should be structured for different categories of employees - senior
managers middle-level managers supervisors and workers The ISO 9000 implementation plan should
make provision for this training The training should cover the basic concepts of quality management
systems and the standard and their overall impact on the strategic goals of the organization the changed
processes
and the likely work culture implications of the system In addition initial training may also be necessary on
writing quality manuals procedures and work instruction auditing principles techniques of laboratory
management calibration testing procedures etc When in-house capacity to carry out such training is not
available it may be necessary to participate in external training courses run by professional training
organizations
Alternatively an external training institution could be invited to conduct in-house training courses
Step 5 Conduct Initial Status Survey
ISO 9000 does not require duplication of effort or redundant system The goal of ISO 9000 is to create a
quality management system that conforms to the standard This does not preclude incorporating
adapting and adding onto quality programs already in place So the next step in the implementation
process is to compare the organizationrsquos existing quality management system if there is one -- with the
requirements of the standard (ISO 90012000)
For this purpose an organization flow chart showing how information actually flows (not what should be
done) from order placement by the customer to delivery to this customer should be drawn up From this
13
over-all flow chart a flow chart of activities in each department should be prepared With the aid of the
flow charts a record of existing quality management system should be established A significant number
of written procedures may already be in place Unless they are very much out of date these documents
should not be discarded Rather they should be incorporated into the new quality management system
Documents requiring modification or elaboration should be identified and listed This exercise is some
times referred to as gap analysis During these review processes wide consultation with executives
and representatives of various unions and associations within the organization is required to enlist their
active cooperation
In the review process documents should be collected studied and registered for further use possibly
after they have been revised Before developing new quality management system documentation we
need to consider with which quality requirements or department we should start The best is to select an
area where processes are fairly well organized running effectively and functioning satisfactorily
The basic approach is to determine and record how a process is currently carried out We can do this by
identifying the people involved and obtaining information from them during individual interviews
Unfortunately it often happens that different people will give different contradicting versions of a process
Each one may refer to oral instructions that are not accurate or clear This is why the facts are often not
described correctly the first time around and have to be revised several times Once it has been agreed
how to describe the current process this process has to be adapted supplemented and implemented
according to the requirements of the quality standard (ISO 90012000) This requires organizational
arrangements the drawing up of additional documents and possible removal of existing documentation
(eg procedures inspectiontest plans inspectiontest instructions) and records (eg inspectiontest
reports inspectiontest certificates)
In introducing a quality management system the emphasis is on the improvement of the existing
processes or the re-organization of processes In general the steps to follow are the following
Ascertain and establish the following What is the present operationprocess What already
exists
Analyze the relevant sections of the quality standard - ISO 90012000 What is actually required
If necessary supplement and change operational arrangements in accordance with the standard
develop documents and records and describe operationsprocesses What is the desired
operationprocess
Step 6 Create a Documented Implementation Plan
14
Once the organization has obtained a clear picture of how its quality management system compares with
the ISO 90012000 standard all non-conformances must be addressed with a documented
implementation plan Usually the plan calls for identifying and describing processes to make the
organizationrsquos quality management system fully in compliance with the standard
The implementation plan should be thorough and specific detailing
Quality documentation to be developed
Objective of the system
Pertinent ISO 90012000 section
Person or team responsible
Approval required
Training required
Resources required
Estimated completion date
These elements should be organized into a detailed chart to be reviewed and approved The plan should
define the responsibilities of different departments and personnel and set target dates for the completion
of activities Once approved the Management Representative should control review and update the plan
as the implementation process proceeds
Step 7 Develop Quality Management System Documentation
Documentation is the most common area of non-conformance among organizations wishing to implement
ISO 9000 quality management systems As one company pointed out When we started our
implementation we found that documentation was inadequate Even absent in some areas Take
calibration Obviously its necessary and obviously we do it but it wasnt being documented Another
area was inspection and testing We inspect and test practically every item that leaves
here but our documentation was inadequate
Documentation of the quality management system should include
Documented statements of a quality policy and quality objectives
A quality manual
Documented procedures and records required by the standard ISO 90012000
and
15
Documents needed by the organization to ensure the effective planning operation
and control of its processes Quality documentation is generally prepared in the three levels
indicated in the box that follows
Level A Quality manual
States the scope of the quality management system including exclusions and details of their justification
and describes the processes of the quality management system and their interaction Generally gives an
organization profile presents the organizational relationships and responsibilities of persons whose work
affects quality and outlines the main procedures It may also describe organizations quality policy and
quality objectives
Level B Quality management system procedures
Describes the activities of individual departments how quality is controlled in each department and the
checks that are carried out
Level C Quality documents (forms reports work instructions etc)
Work instructions describe in detail how specific tasks are performed include drawing standards
methods of tests customers specifications etc
Presents forms to be used for recording observations etc
In small companies the above levels of documentation could be presented in one manual otherwise
separate manuals should be prepared A list of the documents to be prepared should be drawn up and
the responsibility for writing the documents should be assigned to the persons concerned in various
functional departments They should be advised to prepare the drafts within a specific time frame
Step 8 Document Control
Once the necessary quality management system documentation has been generated a documented
system must be created to control it Control is simply a means of managing the creation approval
distribution revision storage and disposal of the various types of documentation Document control
systems should be as simple and as easy to operate as possible -- sufficient to meet ISO 90012000
requirements and that is all
Document control should include
Approval for adequacy by authorized person (s) before issue
16
Review updating and re-approval of documents by authorized person (s)
Identification of changes and of the revision status of documents
Availability of relevant versions of documents at points of use
Identification and control of documents of external origin
Assurance of legibility and identifability of documents and
Prevention of unintended use of obsolete documents
The principle of ISO 9000 document control is that employees should have access to the documentation
and records needed to fulfil their responsibilities
Step 9 Implementation
It is good practice to implement the quality management system being documented as the documentation
is developed although this may be more effective in larger firms In smaller companies the quality
management system is often implemented all at once throughout the organization Where phased
implementation takes place the effectiveness of the system in selected areas can be evaluated It would
be a good idea initially to evaluate areas where the chances of a positive evaluation are high to maintain
the confidence of both management and staff in the merits of implementing the quality management
system
The implementation progress should be monitored to ensure that the quality management system is
effective and conforms to the standard These activities include internal quality audit formal corrective
action and management review
Step 10 Internal Quality Audit
As the system is being installed its effectiveness should be checked by regular internal quality audits
Internal quality audits are conducted to verify that the installed quality management system
Conform to the planned arrangements to the requirements of the standard (ISO 90012000) and
to the quality management system requirements established by your organization and
Is effectively implemented and maintained Even after the system stabilizes and starts
functioning internal audits should be planned and performed as part of an ongoing strategy A
few staff members should be trained to carry out internal auditing Use ISO 19011 for guidance in
auditing auditor qualification and programmes
17
Step 11 Management Review
When the installed quality management system has been operating for three to six months an internal
audit and management review should be conducted and corrective actions implemented The
management reviews are conducted to ensure the continuing suitability adequacy and effectiveness of
the quality management system1048578 The review should include assessing opportunities for improvement
and the need for changes to the quality management system including the quality policy and quality
objectives The input to management review should include information on
Results of audits
Customer feed back
Process performance and product conformity
Status of preventive and corrective actions
Follow-up actions from previous management reviews
Changes that could affect the quality management system and
Recommendations for improvements
Management reviews should also address the pitfalls to effective implementation including lack of CEO
commitment failure to involve everyone in the process and failure to monitor progress and enforce
deadlines
Step 12 Pre-assessment Audit
When system deficiencies are no longer visible it is normally time to apply for certification However
before doing so a pre-assessment audit should be arranged with an independent and qualified auditor
Sometimes certification bodies provide this service for a nominal charge The pre-assessment audit would
provide a degree of confidence for formally going ahead with an application for certification
Step 13 Certification and Registration
Once the quality management system has been in operation for a few months and has stabilized a formal
application for certification could be made to a selected certification agency The certification agency first
carries out an audit of the documents (referred to as an adequacy audit) If the documents conform to
18
the requirements of the quality standard then on-site audit is carried out If the certification body finds the
system to be working satisfactorily it awards the organization a certificate generally for a period of three
years During this three-year period it will carry out periodic surveillance audits to ensure that the system
is continuing to operate satisfactorily
Step 14 Continual Improvement
Certification to ISO 9000 should not be an end We should continually seek to improve the effectiveness
and suitability of the quality management system through the use of
Quality policy
Quality objectives
Audit results
Analysis of data
Corrective and preventive actions
Management review
ISO 90042000 provides a methodology for continual improvement
19
3 Discuss in brief the philosophies of Deming and Juran and do the comparative assessment of the two
Broadly the following considerations are taken into account for the Deming Application Prize
The emphasis of examination is on the implementation of TQM The actual implementation of TQM
practices is appreciated Usage of advanced statistical methods is not the basis for success appreciation
and implementation of statistical methodology are more important
Similar patterns of evaluation are adopted for both manufacturing and non-manufacturing companies
Examination viewpoint criteria are not a check-list for assessment These provide an overall picture of
TQM
Examiners judge features that have been applied by the company The Examination Viewpoint includes
bull Top Management Leadership Vision Strategies
bull TQM Frameworks
bull Quality Assurance Systems
bull Management Systems for Business Elements
bull Human Resource Development
bull Effective Utilisation of Information
bull TQM Concepts and Values
bull Scientific Methods
bull Organisational Powers (Core Technology Speed Vitality)
bull Contribution to Realisation of Corporate Objectives
Successful companies should score
bull 70 points or higher in the Executive Session
bull 70 points or higher as the company average excluding the Executive Session
bull 50 points or higher for any examined unit of the company
According to Juran the selected individual must serve as a role model for any one or more of the following
ten criteria
1 Demonstration of outstanding leadership in establishing customer-driven quality
2 Demonstration of outstanding leadership in combining statistical thinking and management which
results in high quality of products and services
4
3 Demonstration of outstanding leadership in improving the supplier aspects of quality
4 Demonstration of outstanding leadership in improving the human aspects of quality
5 Evidence of effective quality management training andor consulting in the manufacturing service
and small business sectors
6 Evidence of successful design development and marketing of quality management publications
books and instruction systems
7 Evidence of substantial original research on the processes tools and techniques for quality
management
8 Evidence of substantial original quality management research that has social significance
9 Evidence of furtherance of quality awareness through articles conventions and other means
10 Evidence of distinct philanthropy dedicated to the promotions of quality management
The common outcome the two concept are seeking are delivery of ever-improving value improvement of
overall organizational effectiveness and capabilities and finally organizational and personal learning
The following are the common criteria for the two concepts
1 Leadership
2 Strategic Planning
3 Customer and Market Focus
4 Emphasis on Measurement Analysis and Knowledge Management
5 Workforce Focus
6 Effective Process Management
7 Towards Results
5
3 Explain giving examples as to how ISO standards can benefit the society
ISO (International Organization for Standardization) is the worlds largest and foremost developer and
publisher of international standards Because the organization is present globally and the name
International Organization for Standardization would be abbreviated differently in different countries the
founders chose the name ISO derived from the Greek term isos which means equal ISO is a non-
governmental organization headquartered in Geneva Switzerland and networks the regional standards
institutes and regulatory bodies of 163 countries
The ISO structure with one member institute per country bridges the gap between the public and private
sectors and facilitates exchange of information between regulators and businesses In many countries
the member institute is a governmental entity whereas in other countries the member institute is a
private entity This part public-part private structure in different parts of the world enables ISO to develop
standards and solutions that benefit both the business sector and society as a whole making sure that
one entitys interests are not prioritized over another
The ISO official site contends that Standards make an enormous and positive contribution to most
aspects of our lives The importance of standards may be better appreciated when considering what
would happen in its absence when a product is made according to predefined standards and meets
customer expectations it is often taken for granted However in an environment without standards
people would very likely voice concerns about poor quality and unsafe products Whether a business
manufactures goods or provides serviceswhen it meets standards relevant to its industry it ensures that
positive characteristics such as quality durability efficiency safety and environmental friendliness are
reinforced
ISO standards benefit to society by safeguarding their interests and by ensuring that the products and
services they purchase are safe and reliable The standards also help to reduce environmental impact of
business operations by publishing accepted levels of gas and radiation emission and controlling the
quality of water air and soil In addition ISO standards drive the move toward sustainable productions
processes ISO synchronizes and aligns businesses to cleaner and safer production methods by laying
down operational guidelines for different industries
The ISO 9000 and ISO 14000 families are among ISOs most widely known standards ever The vast
majority of ISO standards are highly specific to a particular product material or process However the
standards that have earned the ISO 9000 and ISO 14000 families a worldwide reputation are known as
generic management system standards Generic means that the same standards can be applied to
any organization large or small whatever its product ndash including whether its product is actually a
service ndash in any sector of activity and whether it is a business enterprise a public administration or a
government department Management system refers to what the organization does to manage its
processes or activities
6
Generic also signifies that no matter what the organization is or does if it wants to establish a quality
management system or an environmental management system then such a system has a number of
essential features which are spelled out in the relevant standards of the ISO 9000 or ISO 14000 families
ISO 9000 is concerned with quality management This means what the organization does to enhance
customer satisfaction by meeting customer and applicable regulatory requirements and continually to
improve its performance in this regard ISO 14000 is primarily concerned with environmental
management This means what the organization does to minimize harmful effects on the environment
caused by its activities and continually to improve its environmental performance
7
4 List out the conventional seven quality control tools Explain any two in brief
1 Histograms
A histogram is a bar graph that shows frequency data Histograms provide the easiest way
to evaluate the distribution of data
A histogram is a graphical display of tabular frequencies shown as adjacent rectangles Each
rectangle is erected over an interval with an area equal to the frequency of the observations in the
interval The height of a rectangle is also equal to the frequency density of the interval ie the frequency
divided by the width of the interval The total area of the histogram is equal to the number of data A
histogram may also be based on relative frequencies It then shows the proportion of cases that fall into
each of several categories with the total area equaling The categories are usually specified as
consecutive non-overlapping intervals of a variable The categories (intervals) must be adjacent and
often are chosen to be of the same size
Histograms are used to plot density of data and often for density estimation estimating the probability
density function of the underlying variable The total area of a histogram used for probability density is
always normalized to 1 If the length of the intervals on the x-axis is all 1 then a histogram is identical to
a relative frequency plot
2 Pareto Chart
Pareto charts are used to identify and prioritize problems to be solved They are actually
histograms aided by the 8020 rule adapted by Joseph Juran (80 of the problems are created by
approximately 20 of the causes)
3 Cause and Effect Diagram
The cause and effect diagram is also called the Ishikawa diagram or the fishbone diagram It
is a tool for discovering all the possible causes for a particular effect The major purpose of
this diagram is to act as a first step in problem solving by creating a list of possible causes
4 Scatter Diagrams
Scatter Diagrams are used to study and identify the possible relationship between the changes observed
in two different sets of variables
5 Flow Charts
A flow chart is a pictorial representation showing all of the steps of a process
8
6 Run Charts
Run charts are used to analyze processes according to ti me or order Run charts are useful
in discovering patterns or significant events that occur during a time period
7 Control Charts
Control charts are used to determine whether a process will produce a product or service with consistent
measurable properties
A control chart consists of
Points representing a statistic (eg a mean range proportion) of measurements of a quality
characteristic in samples taken from the process at different times [the data]
The mean of this statistic using all the samples is calculated (eg the mean of the means mean
of the ranges mean of the proportions)
A center line is drawn at the value of the mean of the statistic
The standard error (eg standard deviationsqrt(n) for the mean) of the statistic is also calculated
using all the samples
Upper and lower control limits (sometimes called natural process limits) that indicate the
threshold at which the process output is considered statistically unlikely are drawn typically at 3
standard errors from the center line
The chart may have other optional features including
Upper and lower warning limits drawn as separate lines typically two standard errors above and
below the center line
Division into zones with the addition of rules governing frequencies of observations in each zone
Annotation with events of interest as determined by the Quality Engineer in charge of the
processs quality
Chart usage
If the process is in control all points will plot within the control limits Any observations outside the limits
or systematic patterns within suggest the introduction of a new (and likely unanticipated) source of
variation known as a special cause variation Since increased variation means increased quality costs
a control chart signaling the presence of a special-cause requires immediate investigation This makes
the control limits very important decision aids The control limits tell us about process behavior and have
no intrinsic relationship to any specification targets or engineering tolerance In practice the process
mean (and hence the center line) may not coincide with the specified value (or target) of the quality
9
characteristic because the process design simply cant deliver the process characteristic at the desired
level
Control charts limit specification or targets because of the tendency of those involved with the process
(eg machine operators) to focus on performing to specification when in fact the least-cost course of
action is to keep process variation as low as possible Attempting to make a process whose natural center
is not the same as the target perform to target specification increases process variability and increases
costs significantly and is the cause of much inefficiency in operations process capability studies do
examine the relationship between the natural process limits (the control limits) and specifications
however The purpose of control charts is to allow simple detection of events that are indicative of actual
process change This simple decision can be difficult where the process characteristic is continuously
varying the control chart provides statistically objective criteria of change When change is detected and
considered good its cause should be identified and possibly become the new way of working where the
change is bad then its cause should be identified and eliminated
The purpose in adding warning limits or subdividing the control chart into zones is to provide early
notification if something is amiss Instead of immediately launching a process improvement effort to
determine whether special causes are present the Quality Engineer may temporarily increase the rate at
which samples are taken from the process output until its clear that the process is truly in control Note
that with three sigma limits one expects to be signaled approximately once out of every 370 points on
average
10
5 Suppose that you are working in an organization which wants to develop an effective implementation methodology for ISO 9000 Quality Management System How will you help your organization in developing an effective implementation methodology
Implementation of TQMISO 9000 affects the entire organization right from the start If pursued with total
dedication it results in cultural transition to an atmosphere of continuous improvement
The process of implementing ISO 9000 depends on
The sophistication of your existing quality program
The size of your organization and
The complexity of your process
The 14 essential steps briefly described below are to be followed through in order to implement ISO
9000 quality management system successfully
Step 1 Top Management Commitment
The top management (managing director or chief executive) should demonstrate a commitment and a
determination to implement an ISO 9000 quality management system in the organization Without top
management commitment no quality initiative can succeed Top management must be convinced that
registration and certification will enable the organization to demonstrate to its customers a visible
commitment to quality It should realize that a quality management system would improve overall
business efficiency by elimination of wasteful duplication in management system
The top management should provide evidence of its commitment to the development and implementation
of the quality management system and continually improve its effectiveness by
1 Communicating to the organization the importance of meeting customer as well as statutory and
regulatory requirements
2 Defining the organizations quality policy and make this known to every employee
3 Ensuring that quality objectives are established at all levels and functions
4 Ensuring the availability of resources required for the development and implementation of the
quality management system
5 Appointing a management representative to coordinate quality management system activities
and
6 Conducting management review
The top management should also consider actions such as
Leading the organization by example
Participating in improvement projects
11
Creating an environment that encourages the involvement of people
This type of top management commitment may be driven by
Direct marketplace pressure requirements of crucial customers or parent conglomerates
Indirect marketplace pressure increased quality levels and visibility among competitors
Growth ambitions desire to exploit market opportunities
Personal belief in the value of quality as a goal and quality management systems as a means of
reaching that goal
The top management should identify the goals to be achieved through the quality management system
Typical goals may be
Be more efficient and profitable
Produce products and services that consistently meet customers needs and expectations
Achieve customers satisfaction
Increase market share
Improve communications and morale in the organization
Reduce costs and liabilities
Increase confidence in the production system
Step 2 Establish Implementation Team
ISO 9000 is implemented by people The first phase of implementation calls for the commitment of top
management - the CEO and perhaps a handful of other key people The next step is to establish
implementation team and appoint a Management Representative (MR) as its coordinator to plan and
oversee implementation Its members should include representatives of all functions of the organization -
Marketing Design and development Planning Production Quality control etc In the context of the
standard the MR is the person within the Organization who acts as interface between organization
management and the ISO 9000 registrar His role is in fact much broader than that The MR should also
act as the organizationrsquos quality management system champion and must be a person with
Total backing from the CEO
Genuine and passionate commitment to quality in general and the ISO 9000 quality
management system in particular
The dignity - resulting from rank seniority or both - to influence managers and others of all levels
and functions
Detailed knowledge of quality methods in general and ISO 9000 in particular
The members of the implementation team should also be trained on ISO 9000 quality
management systems by a professional training organization
12
Step 3 Start ISO 9000 Awareness Programs
ISO 9000 awareness programs should be conducted to communicate to the employees the aim of the
ISO 9000 quality management system the advantage it offers to employees customers and the
organization how it will work and their roles and responsibilities within the system Suppliers of materials
and components should also participate in these programs
The awareness program should emphasize the benefits that the organization expects to realize through
its ISO 9000 quality management system The program should also stress the higher levels of
participation and self-direction that the quality management system renders to employees Such a focus
will go far to enlist employee support and commitment The programs could be run either by the
implementation team or by experts hired to talk to different levels of employees
Step 4 Provide Training
Since the ISO 9000 quality management system affects all the areas and all personnel in the
organization training programs should be structured for different categories of employees - senior
managers middle-level managers supervisors and workers The ISO 9000 implementation plan should
make provision for this training The training should cover the basic concepts of quality management
systems and the standard and their overall impact on the strategic goals of the organization the changed
processes
and the likely work culture implications of the system In addition initial training may also be necessary on
writing quality manuals procedures and work instruction auditing principles techniques of laboratory
management calibration testing procedures etc When in-house capacity to carry out such training is not
available it may be necessary to participate in external training courses run by professional training
organizations
Alternatively an external training institution could be invited to conduct in-house training courses
Step 5 Conduct Initial Status Survey
ISO 9000 does not require duplication of effort or redundant system The goal of ISO 9000 is to create a
quality management system that conforms to the standard This does not preclude incorporating
adapting and adding onto quality programs already in place So the next step in the implementation
process is to compare the organizationrsquos existing quality management system if there is one -- with the
requirements of the standard (ISO 90012000)
For this purpose an organization flow chart showing how information actually flows (not what should be
done) from order placement by the customer to delivery to this customer should be drawn up From this
13
over-all flow chart a flow chart of activities in each department should be prepared With the aid of the
flow charts a record of existing quality management system should be established A significant number
of written procedures may already be in place Unless they are very much out of date these documents
should not be discarded Rather they should be incorporated into the new quality management system
Documents requiring modification or elaboration should be identified and listed This exercise is some
times referred to as gap analysis During these review processes wide consultation with executives
and representatives of various unions and associations within the organization is required to enlist their
active cooperation
In the review process documents should be collected studied and registered for further use possibly
after they have been revised Before developing new quality management system documentation we
need to consider with which quality requirements or department we should start The best is to select an
area where processes are fairly well organized running effectively and functioning satisfactorily
The basic approach is to determine and record how a process is currently carried out We can do this by
identifying the people involved and obtaining information from them during individual interviews
Unfortunately it often happens that different people will give different contradicting versions of a process
Each one may refer to oral instructions that are not accurate or clear This is why the facts are often not
described correctly the first time around and have to be revised several times Once it has been agreed
how to describe the current process this process has to be adapted supplemented and implemented
according to the requirements of the quality standard (ISO 90012000) This requires organizational
arrangements the drawing up of additional documents and possible removal of existing documentation
(eg procedures inspectiontest plans inspectiontest instructions) and records (eg inspectiontest
reports inspectiontest certificates)
In introducing a quality management system the emphasis is on the improvement of the existing
processes or the re-organization of processes In general the steps to follow are the following
Ascertain and establish the following What is the present operationprocess What already
exists
Analyze the relevant sections of the quality standard - ISO 90012000 What is actually required
If necessary supplement and change operational arrangements in accordance with the standard
develop documents and records and describe operationsprocesses What is the desired
operationprocess
Step 6 Create a Documented Implementation Plan
14
Once the organization has obtained a clear picture of how its quality management system compares with
the ISO 90012000 standard all non-conformances must be addressed with a documented
implementation plan Usually the plan calls for identifying and describing processes to make the
organizationrsquos quality management system fully in compliance with the standard
The implementation plan should be thorough and specific detailing
Quality documentation to be developed
Objective of the system
Pertinent ISO 90012000 section
Person or team responsible
Approval required
Training required
Resources required
Estimated completion date
These elements should be organized into a detailed chart to be reviewed and approved The plan should
define the responsibilities of different departments and personnel and set target dates for the completion
of activities Once approved the Management Representative should control review and update the plan
as the implementation process proceeds
Step 7 Develop Quality Management System Documentation
Documentation is the most common area of non-conformance among organizations wishing to implement
ISO 9000 quality management systems As one company pointed out When we started our
implementation we found that documentation was inadequate Even absent in some areas Take
calibration Obviously its necessary and obviously we do it but it wasnt being documented Another
area was inspection and testing We inspect and test practically every item that leaves
here but our documentation was inadequate
Documentation of the quality management system should include
Documented statements of a quality policy and quality objectives
A quality manual
Documented procedures and records required by the standard ISO 90012000
and
15
Documents needed by the organization to ensure the effective planning operation
and control of its processes Quality documentation is generally prepared in the three levels
indicated in the box that follows
Level A Quality manual
States the scope of the quality management system including exclusions and details of their justification
and describes the processes of the quality management system and their interaction Generally gives an
organization profile presents the organizational relationships and responsibilities of persons whose work
affects quality and outlines the main procedures It may also describe organizations quality policy and
quality objectives
Level B Quality management system procedures
Describes the activities of individual departments how quality is controlled in each department and the
checks that are carried out
Level C Quality documents (forms reports work instructions etc)
Work instructions describe in detail how specific tasks are performed include drawing standards
methods of tests customers specifications etc
Presents forms to be used for recording observations etc
In small companies the above levels of documentation could be presented in one manual otherwise
separate manuals should be prepared A list of the documents to be prepared should be drawn up and
the responsibility for writing the documents should be assigned to the persons concerned in various
functional departments They should be advised to prepare the drafts within a specific time frame
Step 8 Document Control
Once the necessary quality management system documentation has been generated a documented
system must be created to control it Control is simply a means of managing the creation approval
distribution revision storage and disposal of the various types of documentation Document control
systems should be as simple and as easy to operate as possible -- sufficient to meet ISO 90012000
requirements and that is all
Document control should include
Approval for adequacy by authorized person (s) before issue
16
Review updating and re-approval of documents by authorized person (s)
Identification of changes and of the revision status of documents
Availability of relevant versions of documents at points of use
Identification and control of documents of external origin
Assurance of legibility and identifability of documents and
Prevention of unintended use of obsolete documents
The principle of ISO 9000 document control is that employees should have access to the documentation
and records needed to fulfil their responsibilities
Step 9 Implementation
It is good practice to implement the quality management system being documented as the documentation
is developed although this may be more effective in larger firms In smaller companies the quality
management system is often implemented all at once throughout the organization Where phased
implementation takes place the effectiveness of the system in selected areas can be evaluated It would
be a good idea initially to evaluate areas where the chances of a positive evaluation are high to maintain
the confidence of both management and staff in the merits of implementing the quality management
system
The implementation progress should be monitored to ensure that the quality management system is
effective and conforms to the standard These activities include internal quality audit formal corrective
action and management review
Step 10 Internal Quality Audit
As the system is being installed its effectiveness should be checked by regular internal quality audits
Internal quality audits are conducted to verify that the installed quality management system
Conform to the planned arrangements to the requirements of the standard (ISO 90012000) and
to the quality management system requirements established by your organization and
Is effectively implemented and maintained Even after the system stabilizes and starts
functioning internal audits should be planned and performed as part of an ongoing strategy A
few staff members should be trained to carry out internal auditing Use ISO 19011 for guidance in
auditing auditor qualification and programmes
17
Step 11 Management Review
When the installed quality management system has been operating for three to six months an internal
audit and management review should be conducted and corrective actions implemented The
management reviews are conducted to ensure the continuing suitability adequacy and effectiveness of
the quality management system1048578 The review should include assessing opportunities for improvement
and the need for changes to the quality management system including the quality policy and quality
objectives The input to management review should include information on
Results of audits
Customer feed back
Process performance and product conformity
Status of preventive and corrective actions
Follow-up actions from previous management reviews
Changes that could affect the quality management system and
Recommendations for improvements
Management reviews should also address the pitfalls to effective implementation including lack of CEO
commitment failure to involve everyone in the process and failure to monitor progress and enforce
deadlines
Step 12 Pre-assessment Audit
When system deficiencies are no longer visible it is normally time to apply for certification However
before doing so a pre-assessment audit should be arranged with an independent and qualified auditor
Sometimes certification bodies provide this service for a nominal charge The pre-assessment audit would
provide a degree of confidence for formally going ahead with an application for certification
Step 13 Certification and Registration
Once the quality management system has been in operation for a few months and has stabilized a formal
application for certification could be made to a selected certification agency The certification agency first
carries out an audit of the documents (referred to as an adequacy audit) If the documents conform to
18
the requirements of the quality standard then on-site audit is carried out If the certification body finds the
system to be working satisfactorily it awards the organization a certificate generally for a period of three
years During this three-year period it will carry out periodic surveillance audits to ensure that the system
is continuing to operate satisfactorily
Step 14 Continual Improvement
Certification to ISO 9000 should not be an end We should continually seek to improve the effectiveness
and suitability of the quality management system through the use of
Quality policy
Quality objectives
Audit results
Analysis of data
Corrective and preventive actions
Management review
ISO 90042000 provides a methodology for continual improvement
19
3 Demonstration of outstanding leadership in improving the supplier aspects of quality
4 Demonstration of outstanding leadership in improving the human aspects of quality
5 Evidence of effective quality management training andor consulting in the manufacturing service
and small business sectors
6 Evidence of successful design development and marketing of quality management publications
books and instruction systems
7 Evidence of substantial original research on the processes tools and techniques for quality
management
8 Evidence of substantial original quality management research that has social significance
9 Evidence of furtherance of quality awareness through articles conventions and other means
10 Evidence of distinct philanthropy dedicated to the promotions of quality management
The common outcome the two concept are seeking are delivery of ever-improving value improvement of
overall organizational effectiveness and capabilities and finally organizational and personal learning
The following are the common criteria for the two concepts
1 Leadership
2 Strategic Planning
3 Customer and Market Focus
4 Emphasis on Measurement Analysis and Knowledge Management
5 Workforce Focus
6 Effective Process Management
7 Towards Results
5
3 Explain giving examples as to how ISO standards can benefit the society
ISO (International Organization for Standardization) is the worlds largest and foremost developer and
publisher of international standards Because the organization is present globally and the name
International Organization for Standardization would be abbreviated differently in different countries the
founders chose the name ISO derived from the Greek term isos which means equal ISO is a non-
governmental organization headquartered in Geneva Switzerland and networks the regional standards
institutes and regulatory bodies of 163 countries
The ISO structure with one member institute per country bridges the gap between the public and private
sectors and facilitates exchange of information between regulators and businesses In many countries
the member institute is a governmental entity whereas in other countries the member institute is a
private entity This part public-part private structure in different parts of the world enables ISO to develop
standards and solutions that benefit both the business sector and society as a whole making sure that
one entitys interests are not prioritized over another
The ISO official site contends that Standards make an enormous and positive contribution to most
aspects of our lives The importance of standards may be better appreciated when considering what
would happen in its absence when a product is made according to predefined standards and meets
customer expectations it is often taken for granted However in an environment without standards
people would very likely voice concerns about poor quality and unsafe products Whether a business
manufactures goods or provides serviceswhen it meets standards relevant to its industry it ensures that
positive characteristics such as quality durability efficiency safety and environmental friendliness are
reinforced
ISO standards benefit to society by safeguarding their interests and by ensuring that the products and
services they purchase are safe and reliable The standards also help to reduce environmental impact of
business operations by publishing accepted levels of gas and radiation emission and controlling the
quality of water air and soil In addition ISO standards drive the move toward sustainable productions
processes ISO synchronizes and aligns businesses to cleaner and safer production methods by laying
down operational guidelines for different industries
The ISO 9000 and ISO 14000 families are among ISOs most widely known standards ever The vast
majority of ISO standards are highly specific to a particular product material or process However the
standards that have earned the ISO 9000 and ISO 14000 families a worldwide reputation are known as
generic management system standards Generic means that the same standards can be applied to
any organization large or small whatever its product ndash including whether its product is actually a
service ndash in any sector of activity and whether it is a business enterprise a public administration or a
government department Management system refers to what the organization does to manage its
processes or activities
6
Generic also signifies that no matter what the organization is or does if it wants to establish a quality
management system or an environmental management system then such a system has a number of
essential features which are spelled out in the relevant standards of the ISO 9000 or ISO 14000 families
ISO 9000 is concerned with quality management This means what the organization does to enhance
customer satisfaction by meeting customer and applicable regulatory requirements and continually to
improve its performance in this regard ISO 14000 is primarily concerned with environmental
management This means what the organization does to minimize harmful effects on the environment
caused by its activities and continually to improve its environmental performance
7
4 List out the conventional seven quality control tools Explain any two in brief
1 Histograms
A histogram is a bar graph that shows frequency data Histograms provide the easiest way
to evaluate the distribution of data
A histogram is a graphical display of tabular frequencies shown as adjacent rectangles Each
rectangle is erected over an interval with an area equal to the frequency of the observations in the
interval The height of a rectangle is also equal to the frequency density of the interval ie the frequency
divided by the width of the interval The total area of the histogram is equal to the number of data A
histogram may also be based on relative frequencies It then shows the proportion of cases that fall into
each of several categories with the total area equaling The categories are usually specified as
consecutive non-overlapping intervals of a variable The categories (intervals) must be adjacent and
often are chosen to be of the same size
Histograms are used to plot density of data and often for density estimation estimating the probability
density function of the underlying variable The total area of a histogram used for probability density is
always normalized to 1 If the length of the intervals on the x-axis is all 1 then a histogram is identical to
a relative frequency plot
2 Pareto Chart
Pareto charts are used to identify and prioritize problems to be solved They are actually
histograms aided by the 8020 rule adapted by Joseph Juran (80 of the problems are created by
approximately 20 of the causes)
3 Cause and Effect Diagram
The cause and effect diagram is also called the Ishikawa diagram or the fishbone diagram It
is a tool for discovering all the possible causes for a particular effect The major purpose of
this diagram is to act as a first step in problem solving by creating a list of possible causes
4 Scatter Diagrams
Scatter Diagrams are used to study and identify the possible relationship between the changes observed
in two different sets of variables
5 Flow Charts
A flow chart is a pictorial representation showing all of the steps of a process
8
6 Run Charts
Run charts are used to analyze processes according to ti me or order Run charts are useful
in discovering patterns or significant events that occur during a time period
7 Control Charts
Control charts are used to determine whether a process will produce a product or service with consistent
measurable properties
A control chart consists of
Points representing a statistic (eg a mean range proportion) of measurements of a quality
characteristic in samples taken from the process at different times [the data]
The mean of this statistic using all the samples is calculated (eg the mean of the means mean
of the ranges mean of the proportions)
A center line is drawn at the value of the mean of the statistic
The standard error (eg standard deviationsqrt(n) for the mean) of the statistic is also calculated
using all the samples
Upper and lower control limits (sometimes called natural process limits) that indicate the
threshold at which the process output is considered statistically unlikely are drawn typically at 3
standard errors from the center line
The chart may have other optional features including
Upper and lower warning limits drawn as separate lines typically two standard errors above and
below the center line
Division into zones with the addition of rules governing frequencies of observations in each zone
Annotation with events of interest as determined by the Quality Engineer in charge of the
processs quality
Chart usage
If the process is in control all points will plot within the control limits Any observations outside the limits
or systematic patterns within suggest the introduction of a new (and likely unanticipated) source of
variation known as a special cause variation Since increased variation means increased quality costs
a control chart signaling the presence of a special-cause requires immediate investigation This makes
the control limits very important decision aids The control limits tell us about process behavior and have
no intrinsic relationship to any specification targets or engineering tolerance In practice the process
mean (and hence the center line) may not coincide with the specified value (or target) of the quality
9
characteristic because the process design simply cant deliver the process characteristic at the desired
level
Control charts limit specification or targets because of the tendency of those involved with the process
(eg machine operators) to focus on performing to specification when in fact the least-cost course of
action is to keep process variation as low as possible Attempting to make a process whose natural center
is not the same as the target perform to target specification increases process variability and increases
costs significantly and is the cause of much inefficiency in operations process capability studies do
examine the relationship between the natural process limits (the control limits) and specifications
however The purpose of control charts is to allow simple detection of events that are indicative of actual
process change This simple decision can be difficult where the process characteristic is continuously
varying the control chart provides statistically objective criteria of change When change is detected and
considered good its cause should be identified and possibly become the new way of working where the
change is bad then its cause should be identified and eliminated
The purpose in adding warning limits or subdividing the control chart into zones is to provide early
notification if something is amiss Instead of immediately launching a process improvement effort to
determine whether special causes are present the Quality Engineer may temporarily increase the rate at
which samples are taken from the process output until its clear that the process is truly in control Note
that with three sigma limits one expects to be signaled approximately once out of every 370 points on
average
10
5 Suppose that you are working in an organization which wants to develop an effective implementation methodology for ISO 9000 Quality Management System How will you help your organization in developing an effective implementation methodology
Implementation of TQMISO 9000 affects the entire organization right from the start If pursued with total
dedication it results in cultural transition to an atmosphere of continuous improvement
The process of implementing ISO 9000 depends on
The sophistication of your existing quality program
The size of your organization and
The complexity of your process
The 14 essential steps briefly described below are to be followed through in order to implement ISO
9000 quality management system successfully
Step 1 Top Management Commitment
The top management (managing director or chief executive) should demonstrate a commitment and a
determination to implement an ISO 9000 quality management system in the organization Without top
management commitment no quality initiative can succeed Top management must be convinced that
registration and certification will enable the organization to demonstrate to its customers a visible
commitment to quality It should realize that a quality management system would improve overall
business efficiency by elimination of wasteful duplication in management system
The top management should provide evidence of its commitment to the development and implementation
of the quality management system and continually improve its effectiveness by
1 Communicating to the organization the importance of meeting customer as well as statutory and
regulatory requirements
2 Defining the organizations quality policy and make this known to every employee
3 Ensuring that quality objectives are established at all levels and functions
4 Ensuring the availability of resources required for the development and implementation of the
quality management system
5 Appointing a management representative to coordinate quality management system activities
and
6 Conducting management review
The top management should also consider actions such as
Leading the organization by example
Participating in improvement projects
11
Creating an environment that encourages the involvement of people
This type of top management commitment may be driven by
Direct marketplace pressure requirements of crucial customers or parent conglomerates
Indirect marketplace pressure increased quality levels and visibility among competitors
Growth ambitions desire to exploit market opportunities
Personal belief in the value of quality as a goal and quality management systems as a means of
reaching that goal
The top management should identify the goals to be achieved through the quality management system
Typical goals may be
Be more efficient and profitable
Produce products and services that consistently meet customers needs and expectations
Achieve customers satisfaction
Increase market share
Improve communications and morale in the organization
Reduce costs and liabilities
Increase confidence in the production system
Step 2 Establish Implementation Team
ISO 9000 is implemented by people The first phase of implementation calls for the commitment of top
management - the CEO and perhaps a handful of other key people The next step is to establish
implementation team and appoint a Management Representative (MR) as its coordinator to plan and
oversee implementation Its members should include representatives of all functions of the organization -
Marketing Design and development Planning Production Quality control etc In the context of the
standard the MR is the person within the Organization who acts as interface between organization
management and the ISO 9000 registrar His role is in fact much broader than that The MR should also
act as the organizationrsquos quality management system champion and must be a person with
Total backing from the CEO
Genuine and passionate commitment to quality in general and the ISO 9000 quality
management system in particular
The dignity - resulting from rank seniority or both - to influence managers and others of all levels
and functions
Detailed knowledge of quality methods in general and ISO 9000 in particular
The members of the implementation team should also be trained on ISO 9000 quality
management systems by a professional training organization
12
Step 3 Start ISO 9000 Awareness Programs
ISO 9000 awareness programs should be conducted to communicate to the employees the aim of the
ISO 9000 quality management system the advantage it offers to employees customers and the
organization how it will work and their roles and responsibilities within the system Suppliers of materials
and components should also participate in these programs
The awareness program should emphasize the benefits that the organization expects to realize through
its ISO 9000 quality management system The program should also stress the higher levels of
participation and self-direction that the quality management system renders to employees Such a focus
will go far to enlist employee support and commitment The programs could be run either by the
implementation team or by experts hired to talk to different levels of employees
Step 4 Provide Training
Since the ISO 9000 quality management system affects all the areas and all personnel in the
organization training programs should be structured for different categories of employees - senior
managers middle-level managers supervisors and workers The ISO 9000 implementation plan should
make provision for this training The training should cover the basic concepts of quality management
systems and the standard and their overall impact on the strategic goals of the organization the changed
processes
and the likely work culture implications of the system In addition initial training may also be necessary on
writing quality manuals procedures and work instruction auditing principles techniques of laboratory
management calibration testing procedures etc When in-house capacity to carry out such training is not
available it may be necessary to participate in external training courses run by professional training
organizations
Alternatively an external training institution could be invited to conduct in-house training courses
Step 5 Conduct Initial Status Survey
ISO 9000 does not require duplication of effort or redundant system The goal of ISO 9000 is to create a
quality management system that conforms to the standard This does not preclude incorporating
adapting and adding onto quality programs already in place So the next step in the implementation
process is to compare the organizationrsquos existing quality management system if there is one -- with the
requirements of the standard (ISO 90012000)
For this purpose an organization flow chart showing how information actually flows (not what should be
done) from order placement by the customer to delivery to this customer should be drawn up From this
13
over-all flow chart a flow chart of activities in each department should be prepared With the aid of the
flow charts a record of existing quality management system should be established A significant number
of written procedures may already be in place Unless they are very much out of date these documents
should not be discarded Rather they should be incorporated into the new quality management system
Documents requiring modification or elaboration should be identified and listed This exercise is some
times referred to as gap analysis During these review processes wide consultation with executives
and representatives of various unions and associations within the organization is required to enlist their
active cooperation
In the review process documents should be collected studied and registered for further use possibly
after they have been revised Before developing new quality management system documentation we
need to consider with which quality requirements or department we should start The best is to select an
area where processes are fairly well organized running effectively and functioning satisfactorily
The basic approach is to determine and record how a process is currently carried out We can do this by
identifying the people involved and obtaining information from them during individual interviews
Unfortunately it often happens that different people will give different contradicting versions of a process
Each one may refer to oral instructions that are not accurate or clear This is why the facts are often not
described correctly the first time around and have to be revised several times Once it has been agreed
how to describe the current process this process has to be adapted supplemented and implemented
according to the requirements of the quality standard (ISO 90012000) This requires organizational
arrangements the drawing up of additional documents and possible removal of existing documentation
(eg procedures inspectiontest plans inspectiontest instructions) and records (eg inspectiontest
reports inspectiontest certificates)
In introducing a quality management system the emphasis is on the improvement of the existing
processes or the re-organization of processes In general the steps to follow are the following
Ascertain and establish the following What is the present operationprocess What already
exists
Analyze the relevant sections of the quality standard - ISO 90012000 What is actually required
If necessary supplement and change operational arrangements in accordance with the standard
develop documents and records and describe operationsprocesses What is the desired
operationprocess
Step 6 Create a Documented Implementation Plan
14
Once the organization has obtained a clear picture of how its quality management system compares with
the ISO 90012000 standard all non-conformances must be addressed with a documented
implementation plan Usually the plan calls for identifying and describing processes to make the
organizationrsquos quality management system fully in compliance with the standard
The implementation plan should be thorough and specific detailing
Quality documentation to be developed
Objective of the system
Pertinent ISO 90012000 section
Person or team responsible
Approval required
Training required
Resources required
Estimated completion date
These elements should be organized into a detailed chart to be reviewed and approved The plan should
define the responsibilities of different departments and personnel and set target dates for the completion
of activities Once approved the Management Representative should control review and update the plan
as the implementation process proceeds
Step 7 Develop Quality Management System Documentation
Documentation is the most common area of non-conformance among organizations wishing to implement
ISO 9000 quality management systems As one company pointed out When we started our
implementation we found that documentation was inadequate Even absent in some areas Take
calibration Obviously its necessary and obviously we do it but it wasnt being documented Another
area was inspection and testing We inspect and test practically every item that leaves
here but our documentation was inadequate
Documentation of the quality management system should include
Documented statements of a quality policy and quality objectives
A quality manual
Documented procedures and records required by the standard ISO 90012000
and
15
Documents needed by the organization to ensure the effective planning operation
and control of its processes Quality documentation is generally prepared in the three levels
indicated in the box that follows
Level A Quality manual
States the scope of the quality management system including exclusions and details of their justification
and describes the processes of the quality management system and their interaction Generally gives an
organization profile presents the organizational relationships and responsibilities of persons whose work
affects quality and outlines the main procedures It may also describe organizations quality policy and
quality objectives
Level B Quality management system procedures
Describes the activities of individual departments how quality is controlled in each department and the
checks that are carried out
Level C Quality documents (forms reports work instructions etc)
Work instructions describe in detail how specific tasks are performed include drawing standards
methods of tests customers specifications etc
Presents forms to be used for recording observations etc
In small companies the above levels of documentation could be presented in one manual otherwise
separate manuals should be prepared A list of the documents to be prepared should be drawn up and
the responsibility for writing the documents should be assigned to the persons concerned in various
functional departments They should be advised to prepare the drafts within a specific time frame
Step 8 Document Control
Once the necessary quality management system documentation has been generated a documented
system must be created to control it Control is simply a means of managing the creation approval
distribution revision storage and disposal of the various types of documentation Document control
systems should be as simple and as easy to operate as possible -- sufficient to meet ISO 90012000
requirements and that is all
Document control should include
Approval for adequacy by authorized person (s) before issue
16
Review updating and re-approval of documents by authorized person (s)
Identification of changes and of the revision status of documents
Availability of relevant versions of documents at points of use
Identification and control of documents of external origin
Assurance of legibility and identifability of documents and
Prevention of unintended use of obsolete documents
The principle of ISO 9000 document control is that employees should have access to the documentation
and records needed to fulfil their responsibilities
Step 9 Implementation
It is good practice to implement the quality management system being documented as the documentation
is developed although this may be more effective in larger firms In smaller companies the quality
management system is often implemented all at once throughout the organization Where phased
implementation takes place the effectiveness of the system in selected areas can be evaluated It would
be a good idea initially to evaluate areas where the chances of a positive evaluation are high to maintain
the confidence of both management and staff in the merits of implementing the quality management
system
The implementation progress should be monitored to ensure that the quality management system is
effective and conforms to the standard These activities include internal quality audit formal corrective
action and management review
Step 10 Internal Quality Audit
As the system is being installed its effectiveness should be checked by regular internal quality audits
Internal quality audits are conducted to verify that the installed quality management system
Conform to the planned arrangements to the requirements of the standard (ISO 90012000) and
to the quality management system requirements established by your organization and
Is effectively implemented and maintained Even after the system stabilizes and starts
functioning internal audits should be planned and performed as part of an ongoing strategy A
few staff members should be trained to carry out internal auditing Use ISO 19011 for guidance in
auditing auditor qualification and programmes
17
Step 11 Management Review
When the installed quality management system has been operating for three to six months an internal
audit and management review should be conducted and corrective actions implemented The
management reviews are conducted to ensure the continuing suitability adequacy and effectiveness of
the quality management system1048578 The review should include assessing opportunities for improvement
and the need for changes to the quality management system including the quality policy and quality
objectives The input to management review should include information on
Results of audits
Customer feed back
Process performance and product conformity
Status of preventive and corrective actions
Follow-up actions from previous management reviews
Changes that could affect the quality management system and
Recommendations for improvements
Management reviews should also address the pitfalls to effective implementation including lack of CEO
commitment failure to involve everyone in the process and failure to monitor progress and enforce
deadlines
Step 12 Pre-assessment Audit
When system deficiencies are no longer visible it is normally time to apply for certification However
before doing so a pre-assessment audit should be arranged with an independent and qualified auditor
Sometimes certification bodies provide this service for a nominal charge The pre-assessment audit would
provide a degree of confidence for formally going ahead with an application for certification
Step 13 Certification and Registration
Once the quality management system has been in operation for a few months and has stabilized a formal
application for certification could be made to a selected certification agency The certification agency first
carries out an audit of the documents (referred to as an adequacy audit) If the documents conform to
18
the requirements of the quality standard then on-site audit is carried out If the certification body finds the
system to be working satisfactorily it awards the organization a certificate generally for a period of three
years During this three-year period it will carry out periodic surveillance audits to ensure that the system
is continuing to operate satisfactorily
Step 14 Continual Improvement
Certification to ISO 9000 should not be an end We should continually seek to improve the effectiveness
and suitability of the quality management system through the use of
Quality policy
Quality objectives
Audit results
Analysis of data
Corrective and preventive actions
Management review
ISO 90042000 provides a methodology for continual improvement
19
3 Explain giving examples as to how ISO standards can benefit the society
ISO (International Organization for Standardization) is the worlds largest and foremost developer and
publisher of international standards Because the organization is present globally and the name
International Organization for Standardization would be abbreviated differently in different countries the
founders chose the name ISO derived from the Greek term isos which means equal ISO is a non-
governmental organization headquartered in Geneva Switzerland and networks the regional standards
institutes and regulatory bodies of 163 countries
The ISO structure with one member institute per country bridges the gap between the public and private
sectors and facilitates exchange of information between regulators and businesses In many countries
the member institute is a governmental entity whereas in other countries the member institute is a
private entity This part public-part private structure in different parts of the world enables ISO to develop
standards and solutions that benefit both the business sector and society as a whole making sure that
one entitys interests are not prioritized over another
The ISO official site contends that Standards make an enormous and positive contribution to most
aspects of our lives The importance of standards may be better appreciated when considering what
would happen in its absence when a product is made according to predefined standards and meets
customer expectations it is often taken for granted However in an environment without standards
people would very likely voice concerns about poor quality and unsafe products Whether a business
manufactures goods or provides serviceswhen it meets standards relevant to its industry it ensures that
positive characteristics such as quality durability efficiency safety and environmental friendliness are
reinforced
ISO standards benefit to society by safeguarding their interests and by ensuring that the products and
services they purchase are safe and reliable The standards also help to reduce environmental impact of
business operations by publishing accepted levels of gas and radiation emission and controlling the
quality of water air and soil In addition ISO standards drive the move toward sustainable productions
processes ISO synchronizes and aligns businesses to cleaner and safer production methods by laying
down operational guidelines for different industries
The ISO 9000 and ISO 14000 families are among ISOs most widely known standards ever The vast
majority of ISO standards are highly specific to a particular product material or process However the
standards that have earned the ISO 9000 and ISO 14000 families a worldwide reputation are known as
generic management system standards Generic means that the same standards can be applied to
any organization large or small whatever its product ndash including whether its product is actually a
service ndash in any sector of activity and whether it is a business enterprise a public administration or a
government department Management system refers to what the organization does to manage its
processes or activities
6
Generic also signifies that no matter what the organization is or does if it wants to establish a quality
management system or an environmental management system then such a system has a number of
essential features which are spelled out in the relevant standards of the ISO 9000 or ISO 14000 families
ISO 9000 is concerned with quality management This means what the organization does to enhance
customer satisfaction by meeting customer and applicable regulatory requirements and continually to
improve its performance in this regard ISO 14000 is primarily concerned with environmental
management This means what the organization does to minimize harmful effects on the environment
caused by its activities and continually to improve its environmental performance
7
4 List out the conventional seven quality control tools Explain any two in brief
1 Histograms
A histogram is a bar graph that shows frequency data Histograms provide the easiest way
to evaluate the distribution of data
A histogram is a graphical display of tabular frequencies shown as adjacent rectangles Each
rectangle is erected over an interval with an area equal to the frequency of the observations in the
interval The height of a rectangle is also equal to the frequency density of the interval ie the frequency
divided by the width of the interval The total area of the histogram is equal to the number of data A
histogram may also be based on relative frequencies It then shows the proportion of cases that fall into
each of several categories with the total area equaling The categories are usually specified as
consecutive non-overlapping intervals of a variable The categories (intervals) must be adjacent and
often are chosen to be of the same size
Histograms are used to plot density of data and often for density estimation estimating the probability
density function of the underlying variable The total area of a histogram used for probability density is
always normalized to 1 If the length of the intervals on the x-axis is all 1 then a histogram is identical to
a relative frequency plot
2 Pareto Chart
Pareto charts are used to identify and prioritize problems to be solved They are actually
histograms aided by the 8020 rule adapted by Joseph Juran (80 of the problems are created by
approximately 20 of the causes)
3 Cause and Effect Diagram
The cause and effect diagram is also called the Ishikawa diagram or the fishbone diagram It
is a tool for discovering all the possible causes for a particular effect The major purpose of
this diagram is to act as a first step in problem solving by creating a list of possible causes
4 Scatter Diagrams
Scatter Diagrams are used to study and identify the possible relationship between the changes observed
in two different sets of variables
5 Flow Charts
A flow chart is a pictorial representation showing all of the steps of a process
8
6 Run Charts
Run charts are used to analyze processes according to ti me or order Run charts are useful
in discovering patterns or significant events that occur during a time period
7 Control Charts
Control charts are used to determine whether a process will produce a product or service with consistent
measurable properties
A control chart consists of
Points representing a statistic (eg a mean range proportion) of measurements of a quality
characteristic in samples taken from the process at different times [the data]
The mean of this statistic using all the samples is calculated (eg the mean of the means mean
of the ranges mean of the proportions)
A center line is drawn at the value of the mean of the statistic
The standard error (eg standard deviationsqrt(n) for the mean) of the statistic is also calculated
using all the samples
Upper and lower control limits (sometimes called natural process limits) that indicate the
threshold at which the process output is considered statistically unlikely are drawn typically at 3
standard errors from the center line
The chart may have other optional features including
Upper and lower warning limits drawn as separate lines typically two standard errors above and
below the center line
Division into zones with the addition of rules governing frequencies of observations in each zone
Annotation with events of interest as determined by the Quality Engineer in charge of the
processs quality
Chart usage
If the process is in control all points will plot within the control limits Any observations outside the limits
or systematic patterns within suggest the introduction of a new (and likely unanticipated) source of
variation known as a special cause variation Since increased variation means increased quality costs
a control chart signaling the presence of a special-cause requires immediate investigation This makes
the control limits very important decision aids The control limits tell us about process behavior and have
no intrinsic relationship to any specification targets or engineering tolerance In practice the process
mean (and hence the center line) may not coincide with the specified value (or target) of the quality
9
characteristic because the process design simply cant deliver the process characteristic at the desired
level
Control charts limit specification or targets because of the tendency of those involved with the process
(eg machine operators) to focus on performing to specification when in fact the least-cost course of
action is to keep process variation as low as possible Attempting to make a process whose natural center
is not the same as the target perform to target specification increases process variability and increases
costs significantly and is the cause of much inefficiency in operations process capability studies do
examine the relationship between the natural process limits (the control limits) and specifications
however The purpose of control charts is to allow simple detection of events that are indicative of actual
process change This simple decision can be difficult where the process characteristic is continuously
varying the control chart provides statistically objective criteria of change When change is detected and
considered good its cause should be identified and possibly become the new way of working where the
change is bad then its cause should be identified and eliminated
The purpose in adding warning limits or subdividing the control chart into zones is to provide early
notification if something is amiss Instead of immediately launching a process improvement effort to
determine whether special causes are present the Quality Engineer may temporarily increase the rate at
which samples are taken from the process output until its clear that the process is truly in control Note
that with three sigma limits one expects to be signaled approximately once out of every 370 points on
average
10
5 Suppose that you are working in an organization which wants to develop an effective implementation methodology for ISO 9000 Quality Management System How will you help your organization in developing an effective implementation methodology
Implementation of TQMISO 9000 affects the entire organization right from the start If pursued with total
dedication it results in cultural transition to an atmosphere of continuous improvement
The process of implementing ISO 9000 depends on
The sophistication of your existing quality program
The size of your organization and
The complexity of your process
The 14 essential steps briefly described below are to be followed through in order to implement ISO
9000 quality management system successfully
Step 1 Top Management Commitment
The top management (managing director or chief executive) should demonstrate a commitment and a
determination to implement an ISO 9000 quality management system in the organization Without top
management commitment no quality initiative can succeed Top management must be convinced that
registration and certification will enable the organization to demonstrate to its customers a visible
commitment to quality It should realize that a quality management system would improve overall
business efficiency by elimination of wasteful duplication in management system
The top management should provide evidence of its commitment to the development and implementation
of the quality management system and continually improve its effectiveness by
1 Communicating to the organization the importance of meeting customer as well as statutory and
regulatory requirements
2 Defining the organizations quality policy and make this known to every employee
3 Ensuring that quality objectives are established at all levels and functions
4 Ensuring the availability of resources required for the development and implementation of the
quality management system
5 Appointing a management representative to coordinate quality management system activities
and
6 Conducting management review
The top management should also consider actions such as
Leading the organization by example
Participating in improvement projects
11
Creating an environment that encourages the involvement of people
This type of top management commitment may be driven by
Direct marketplace pressure requirements of crucial customers or parent conglomerates
Indirect marketplace pressure increased quality levels and visibility among competitors
Growth ambitions desire to exploit market opportunities
Personal belief in the value of quality as a goal and quality management systems as a means of
reaching that goal
The top management should identify the goals to be achieved through the quality management system
Typical goals may be
Be more efficient and profitable
Produce products and services that consistently meet customers needs and expectations
Achieve customers satisfaction
Increase market share
Improve communications and morale in the organization
Reduce costs and liabilities
Increase confidence in the production system
Step 2 Establish Implementation Team
ISO 9000 is implemented by people The first phase of implementation calls for the commitment of top
management - the CEO and perhaps a handful of other key people The next step is to establish
implementation team and appoint a Management Representative (MR) as its coordinator to plan and
oversee implementation Its members should include representatives of all functions of the organization -
Marketing Design and development Planning Production Quality control etc In the context of the
standard the MR is the person within the Organization who acts as interface between organization
management and the ISO 9000 registrar His role is in fact much broader than that The MR should also
act as the organizationrsquos quality management system champion and must be a person with
Total backing from the CEO
Genuine and passionate commitment to quality in general and the ISO 9000 quality
management system in particular
The dignity - resulting from rank seniority or both - to influence managers and others of all levels
and functions
Detailed knowledge of quality methods in general and ISO 9000 in particular
The members of the implementation team should also be trained on ISO 9000 quality
management systems by a professional training organization
12
Step 3 Start ISO 9000 Awareness Programs
ISO 9000 awareness programs should be conducted to communicate to the employees the aim of the
ISO 9000 quality management system the advantage it offers to employees customers and the
organization how it will work and their roles and responsibilities within the system Suppliers of materials
and components should also participate in these programs
The awareness program should emphasize the benefits that the organization expects to realize through
its ISO 9000 quality management system The program should also stress the higher levels of
participation and self-direction that the quality management system renders to employees Such a focus
will go far to enlist employee support and commitment The programs could be run either by the
implementation team or by experts hired to talk to different levels of employees
Step 4 Provide Training
Since the ISO 9000 quality management system affects all the areas and all personnel in the
organization training programs should be structured for different categories of employees - senior
managers middle-level managers supervisors and workers The ISO 9000 implementation plan should
make provision for this training The training should cover the basic concepts of quality management
systems and the standard and their overall impact on the strategic goals of the organization the changed
processes
and the likely work culture implications of the system In addition initial training may also be necessary on
writing quality manuals procedures and work instruction auditing principles techniques of laboratory
management calibration testing procedures etc When in-house capacity to carry out such training is not
available it may be necessary to participate in external training courses run by professional training
organizations
Alternatively an external training institution could be invited to conduct in-house training courses
Step 5 Conduct Initial Status Survey
ISO 9000 does not require duplication of effort or redundant system The goal of ISO 9000 is to create a
quality management system that conforms to the standard This does not preclude incorporating
adapting and adding onto quality programs already in place So the next step in the implementation
process is to compare the organizationrsquos existing quality management system if there is one -- with the
requirements of the standard (ISO 90012000)
For this purpose an organization flow chart showing how information actually flows (not what should be
done) from order placement by the customer to delivery to this customer should be drawn up From this
13
over-all flow chart a flow chart of activities in each department should be prepared With the aid of the
flow charts a record of existing quality management system should be established A significant number
of written procedures may already be in place Unless they are very much out of date these documents
should not be discarded Rather they should be incorporated into the new quality management system
Documents requiring modification or elaboration should be identified and listed This exercise is some
times referred to as gap analysis During these review processes wide consultation with executives
and representatives of various unions and associations within the organization is required to enlist their
active cooperation
In the review process documents should be collected studied and registered for further use possibly
after they have been revised Before developing new quality management system documentation we
need to consider with which quality requirements or department we should start The best is to select an
area where processes are fairly well organized running effectively and functioning satisfactorily
The basic approach is to determine and record how a process is currently carried out We can do this by
identifying the people involved and obtaining information from them during individual interviews
Unfortunately it often happens that different people will give different contradicting versions of a process
Each one may refer to oral instructions that are not accurate or clear This is why the facts are often not
described correctly the first time around and have to be revised several times Once it has been agreed
how to describe the current process this process has to be adapted supplemented and implemented
according to the requirements of the quality standard (ISO 90012000) This requires organizational
arrangements the drawing up of additional documents and possible removal of existing documentation
(eg procedures inspectiontest plans inspectiontest instructions) and records (eg inspectiontest
reports inspectiontest certificates)
In introducing a quality management system the emphasis is on the improvement of the existing
processes or the re-organization of processes In general the steps to follow are the following
Ascertain and establish the following What is the present operationprocess What already
exists
Analyze the relevant sections of the quality standard - ISO 90012000 What is actually required
If necessary supplement and change operational arrangements in accordance with the standard
develop documents and records and describe operationsprocesses What is the desired
operationprocess
Step 6 Create a Documented Implementation Plan
14
Once the organization has obtained a clear picture of how its quality management system compares with
the ISO 90012000 standard all non-conformances must be addressed with a documented
implementation plan Usually the plan calls for identifying and describing processes to make the
organizationrsquos quality management system fully in compliance with the standard
The implementation plan should be thorough and specific detailing
Quality documentation to be developed
Objective of the system
Pertinent ISO 90012000 section
Person or team responsible
Approval required
Training required
Resources required
Estimated completion date
These elements should be organized into a detailed chart to be reviewed and approved The plan should
define the responsibilities of different departments and personnel and set target dates for the completion
of activities Once approved the Management Representative should control review and update the plan
as the implementation process proceeds
Step 7 Develop Quality Management System Documentation
Documentation is the most common area of non-conformance among organizations wishing to implement
ISO 9000 quality management systems As one company pointed out When we started our
implementation we found that documentation was inadequate Even absent in some areas Take
calibration Obviously its necessary and obviously we do it but it wasnt being documented Another
area was inspection and testing We inspect and test practically every item that leaves
here but our documentation was inadequate
Documentation of the quality management system should include
Documented statements of a quality policy and quality objectives
A quality manual
Documented procedures and records required by the standard ISO 90012000
and
15
Documents needed by the organization to ensure the effective planning operation
and control of its processes Quality documentation is generally prepared in the three levels
indicated in the box that follows
Level A Quality manual
States the scope of the quality management system including exclusions and details of their justification
and describes the processes of the quality management system and their interaction Generally gives an
organization profile presents the organizational relationships and responsibilities of persons whose work
affects quality and outlines the main procedures It may also describe organizations quality policy and
quality objectives
Level B Quality management system procedures
Describes the activities of individual departments how quality is controlled in each department and the
checks that are carried out
Level C Quality documents (forms reports work instructions etc)
Work instructions describe in detail how specific tasks are performed include drawing standards
methods of tests customers specifications etc
Presents forms to be used for recording observations etc
In small companies the above levels of documentation could be presented in one manual otherwise
separate manuals should be prepared A list of the documents to be prepared should be drawn up and
the responsibility for writing the documents should be assigned to the persons concerned in various
functional departments They should be advised to prepare the drafts within a specific time frame
Step 8 Document Control
Once the necessary quality management system documentation has been generated a documented
system must be created to control it Control is simply a means of managing the creation approval
distribution revision storage and disposal of the various types of documentation Document control
systems should be as simple and as easy to operate as possible -- sufficient to meet ISO 90012000
requirements and that is all
Document control should include
Approval for adequacy by authorized person (s) before issue
16
Review updating and re-approval of documents by authorized person (s)
Identification of changes and of the revision status of documents
Availability of relevant versions of documents at points of use
Identification and control of documents of external origin
Assurance of legibility and identifability of documents and
Prevention of unintended use of obsolete documents
The principle of ISO 9000 document control is that employees should have access to the documentation
and records needed to fulfil their responsibilities
Step 9 Implementation
It is good practice to implement the quality management system being documented as the documentation
is developed although this may be more effective in larger firms In smaller companies the quality
management system is often implemented all at once throughout the organization Where phased
implementation takes place the effectiveness of the system in selected areas can be evaluated It would
be a good idea initially to evaluate areas where the chances of a positive evaluation are high to maintain
the confidence of both management and staff in the merits of implementing the quality management
system
The implementation progress should be monitored to ensure that the quality management system is
effective and conforms to the standard These activities include internal quality audit formal corrective
action and management review
Step 10 Internal Quality Audit
As the system is being installed its effectiveness should be checked by regular internal quality audits
Internal quality audits are conducted to verify that the installed quality management system
Conform to the planned arrangements to the requirements of the standard (ISO 90012000) and
to the quality management system requirements established by your organization and
Is effectively implemented and maintained Even after the system stabilizes and starts
functioning internal audits should be planned and performed as part of an ongoing strategy A
few staff members should be trained to carry out internal auditing Use ISO 19011 for guidance in
auditing auditor qualification and programmes
17
Step 11 Management Review
When the installed quality management system has been operating for three to six months an internal
audit and management review should be conducted and corrective actions implemented The
management reviews are conducted to ensure the continuing suitability adequacy and effectiveness of
the quality management system1048578 The review should include assessing opportunities for improvement
and the need for changes to the quality management system including the quality policy and quality
objectives The input to management review should include information on
Results of audits
Customer feed back
Process performance and product conformity
Status of preventive and corrective actions
Follow-up actions from previous management reviews
Changes that could affect the quality management system and
Recommendations for improvements
Management reviews should also address the pitfalls to effective implementation including lack of CEO
commitment failure to involve everyone in the process and failure to monitor progress and enforce
deadlines
Step 12 Pre-assessment Audit
When system deficiencies are no longer visible it is normally time to apply for certification However
before doing so a pre-assessment audit should be arranged with an independent and qualified auditor
Sometimes certification bodies provide this service for a nominal charge The pre-assessment audit would
provide a degree of confidence for formally going ahead with an application for certification
Step 13 Certification and Registration
Once the quality management system has been in operation for a few months and has stabilized a formal
application for certification could be made to a selected certification agency The certification agency first
carries out an audit of the documents (referred to as an adequacy audit) If the documents conform to
18
the requirements of the quality standard then on-site audit is carried out If the certification body finds the
system to be working satisfactorily it awards the organization a certificate generally for a period of three
years During this three-year period it will carry out periodic surveillance audits to ensure that the system
is continuing to operate satisfactorily
Step 14 Continual Improvement
Certification to ISO 9000 should not be an end We should continually seek to improve the effectiveness
and suitability of the quality management system through the use of
Quality policy
Quality objectives
Audit results
Analysis of data
Corrective and preventive actions
Management review
ISO 90042000 provides a methodology for continual improvement
19
Generic also signifies that no matter what the organization is or does if it wants to establish a quality
management system or an environmental management system then such a system has a number of
essential features which are spelled out in the relevant standards of the ISO 9000 or ISO 14000 families
ISO 9000 is concerned with quality management This means what the organization does to enhance
customer satisfaction by meeting customer and applicable regulatory requirements and continually to
improve its performance in this regard ISO 14000 is primarily concerned with environmental
management This means what the organization does to minimize harmful effects on the environment
caused by its activities and continually to improve its environmental performance
7
4 List out the conventional seven quality control tools Explain any two in brief
1 Histograms
A histogram is a bar graph that shows frequency data Histograms provide the easiest way
to evaluate the distribution of data
A histogram is a graphical display of tabular frequencies shown as adjacent rectangles Each
rectangle is erected over an interval with an area equal to the frequency of the observations in the
interval The height of a rectangle is also equal to the frequency density of the interval ie the frequency
divided by the width of the interval The total area of the histogram is equal to the number of data A
histogram may also be based on relative frequencies It then shows the proportion of cases that fall into
each of several categories with the total area equaling The categories are usually specified as
consecutive non-overlapping intervals of a variable The categories (intervals) must be adjacent and
often are chosen to be of the same size
Histograms are used to plot density of data and often for density estimation estimating the probability
density function of the underlying variable The total area of a histogram used for probability density is
always normalized to 1 If the length of the intervals on the x-axis is all 1 then a histogram is identical to
a relative frequency plot
2 Pareto Chart
Pareto charts are used to identify and prioritize problems to be solved They are actually
histograms aided by the 8020 rule adapted by Joseph Juran (80 of the problems are created by
approximately 20 of the causes)
3 Cause and Effect Diagram
The cause and effect diagram is also called the Ishikawa diagram or the fishbone diagram It
is a tool for discovering all the possible causes for a particular effect The major purpose of
this diagram is to act as a first step in problem solving by creating a list of possible causes
4 Scatter Diagrams
Scatter Diagrams are used to study and identify the possible relationship between the changes observed
in two different sets of variables
5 Flow Charts
A flow chart is a pictorial representation showing all of the steps of a process
8
6 Run Charts
Run charts are used to analyze processes according to ti me or order Run charts are useful
in discovering patterns or significant events that occur during a time period
7 Control Charts
Control charts are used to determine whether a process will produce a product or service with consistent
measurable properties
A control chart consists of
Points representing a statistic (eg a mean range proportion) of measurements of a quality
characteristic in samples taken from the process at different times [the data]
The mean of this statistic using all the samples is calculated (eg the mean of the means mean
of the ranges mean of the proportions)
A center line is drawn at the value of the mean of the statistic
The standard error (eg standard deviationsqrt(n) for the mean) of the statistic is also calculated
using all the samples
Upper and lower control limits (sometimes called natural process limits) that indicate the
threshold at which the process output is considered statistically unlikely are drawn typically at 3
standard errors from the center line
The chart may have other optional features including
Upper and lower warning limits drawn as separate lines typically two standard errors above and
below the center line
Division into zones with the addition of rules governing frequencies of observations in each zone
Annotation with events of interest as determined by the Quality Engineer in charge of the
processs quality
Chart usage
If the process is in control all points will plot within the control limits Any observations outside the limits
or systematic patterns within suggest the introduction of a new (and likely unanticipated) source of
variation known as a special cause variation Since increased variation means increased quality costs
a control chart signaling the presence of a special-cause requires immediate investigation This makes
the control limits very important decision aids The control limits tell us about process behavior and have
no intrinsic relationship to any specification targets or engineering tolerance In practice the process
mean (and hence the center line) may not coincide with the specified value (or target) of the quality
9
characteristic because the process design simply cant deliver the process characteristic at the desired
level
Control charts limit specification or targets because of the tendency of those involved with the process
(eg machine operators) to focus on performing to specification when in fact the least-cost course of
action is to keep process variation as low as possible Attempting to make a process whose natural center
is not the same as the target perform to target specification increases process variability and increases
costs significantly and is the cause of much inefficiency in operations process capability studies do
examine the relationship between the natural process limits (the control limits) and specifications
however The purpose of control charts is to allow simple detection of events that are indicative of actual
process change This simple decision can be difficult where the process characteristic is continuously
varying the control chart provides statistically objective criteria of change When change is detected and
considered good its cause should be identified and possibly become the new way of working where the
change is bad then its cause should be identified and eliminated
The purpose in adding warning limits or subdividing the control chart into zones is to provide early
notification if something is amiss Instead of immediately launching a process improvement effort to
determine whether special causes are present the Quality Engineer may temporarily increase the rate at
which samples are taken from the process output until its clear that the process is truly in control Note
that with three sigma limits one expects to be signaled approximately once out of every 370 points on
average
10
5 Suppose that you are working in an organization which wants to develop an effective implementation methodology for ISO 9000 Quality Management System How will you help your organization in developing an effective implementation methodology
Implementation of TQMISO 9000 affects the entire organization right from the start If pursued with total
dedication it results in cultural transition to an atmosphere of continuous improvement
The process of implementing ISO 9000 depends on
The sophistication of your existing quality program
The size of your organization and
The complexity of your process
The 14 essential steps briefly described below are to be followed through in order to implement ISO
9000 quality management system successfully
Step 1 Top Management Commitment
The top management (managing director or chief executive) should demonstrate a commitment and a
determination to implement an ISO 9000 quality management system in the organization Without top
management commitment no quality initiative can succeed Top management must be convinced that
registration and certification will enable the organization to demonstrate to its customers a visible
commitment to quality It should realize that a quality management system would improve overall
business efficiency by elimination of wasteful duplication in management system
The top management should provide evidence of its commitment to the development and implementation
of the quality management system and continually improve its effectiveness by
1 Communicating to the organization the importance of meeting customer as well as statutory and
regulatory requirements
2 Defining the organizations quality policy and make this known to every employee
3 Ensuring that quality objectives are established at all levels and functions
4 Ensuring the availability of resources required for the development and implementation of the
quality management system
5 Appointing a management representative to coordinate quality management system activities
and
6 Conducting management review
The top management should also consider actions such as
Leading the organization by example
Participating in improvement projects
11
Creating an environment that encourages the involvement of people
This type of top management commitment may be driven by
Direct marketplace pressure requirements of crucial customers or parent conglomerates
Indirect marketplace pressure increased quality levels and visibility among competitors
Growth ambitions desire to exploit market opportunities
Personal belief in the value of quality as a goal and quality management systems as a means of
reaching that goal
The top management should identify the goals to be achieved through the quality management system
Typical goals may be
Be more efficient and profitable
Produce products and services that consistently meet customers needs and expectations
Achieve customers satisfaction
Increase market share
Improve communications and morale in the organization
Reduce costs and liabilities
Increase confidence in the production system
Step 2 Establish Implementation Team
ISO 9000 is implemented by people The first phase of implementation calls for the commitment of top
management - the CEO and perhaps a handful of other key people The next step is to establish
implementation team and appoint a Management Representative (MR) as its coordinator to plan and
oversee implementation Its members should include representatives of all functions of the organization -
Marketing Design and development Planning Production Quality control etc In the context of the
standard the MR is the person within the Organization who acts as interface between organization
management and the ISO 9000 registrar His role is in fact much broader than that The MR should also
act as the organizationrsquos quality management system champion and must be a person with
Total backing from the CEO
Genuine and passionate commitment to quality in general and the ISO 9000 quality
management system in particular
The dignity - resulting from rank seniority or both - to influence managers and others of all levels
and functions
Detailed knowledge of quality methods in general and ISO 9000 in particular
The members of the implementation team should also be trained on ISO 9000 quality
management systems by a professional training organization
12
Step 3 Start ISO 9000 Awareness Programs
ISO 9000 awareness programs should be conducted to communicate to the employees the aim of the
ISO 9000 quality management system the advantage it offers to employees customers and the
organization how it will work and their roles and responsibilities within the system Suppliers of materials
and components should also participate in these programs
The awareness program should emphasize the benefits that the organization expects to realize through
its ISO 9000 quality management system The program should also stress the higher levels of
participation and self-direction that the quality management system renders to employees Such a focus
will go far to enlist employee support and commitment The programs could be run either by the
implementation team or by experts hired to talk to different levels of employees
Step 4 Provide Training
Since the ISO 9000 quality management system affects all the areas and all personnel in the
organization training programs should be structured for different categories of employees - senior
managers middle-level managers supervisors and workers The ISO 9000 implementation plan should
make provision for this training The training should cover the basic concepts of quality management
systems and the standard and their overall impact on the strategic goals of the organization the changed
processes
and the likely work culture implications of the system In addition initial training may also be necessary on
writing quality manuals procedures and work instruction auditing principles techniques of laboratory
management calibration testing procedures etc When in-house capacity to carry out such training is not
available it may be necessary to participate in external training courses run by professional training
organizations
Alternatively an external training institution could be invited to conduct in-house training courses
Step 5 Conduct Initial Status Survey
ISO 9000 does not require duplication of effort or redundant system The goal of ISO 9000 is to create a
quality management system that conforms to the standard This does not preclude incorporating
adapting and adding onto quality programs already in place So the next step in the implementation
process is to compare the organizationrsquos existing quality management system if there is one -- with the
requirements of the standard (ISO 90012000)
For this purpose an organization flow chart showing how information actually flows (not what should be
done) from order placement by the customer to delivery to this customer should be drawn up From this
13
over-all flow chart a flow chart of activities in each department should be prepared With the aid of the
flow charts a record of existing quality management system should be established A significant number
of written procedures may already be in place Unless they are very much out of date these documents
should not be discarded Rather they should be incorporated into the new quality management system
Documents requiring modification or elaboration should be identified and listed This exercise is some
times referred to as gap analysis During these review processes wide consultation with executives
and representatives of various unions and associations within the organization is required to enlist their
active cooperation
In the review process documents should be collected studied and registered for further use possibly
after they have been revised Before developing new quality management system documentation we
need to consider with which quality requirements or department we should start The best is to select an
area where processes are fairly well organized running effectively and functioning satisfactorily
The basic approach is to determine and record how a process is currently carried out We can do this by
identifying the people involved and obtaining information from them during individual interviews
Unfortunately it often happens that different people will give different contradicting versions of a process
Each one may refer to oral instructions that are not accurate or clear This is why the facts are often not
described correctly the first time around and have to be revised several times Once it has been agreed
how to describe the current process this process has to be adapted supplemented and implemented
according to the requirements of the quality standard (ISO 90012000) This requires organizational
arrangements the drawing up of additional documents and possible removal of existing documentation
(eg procedures inspectiontest plans inspectiontest instructions) and records (eg inspectiontest
reports inspectiontest certificates)
In introducing a quality management system the emphasis is on the improvement of the existing
processes or the re-organization of processes In general the steps to follow are the following
Ascertain and establish the following What is the present operationprocess What already
exists
Analyze the relevant sections of the quality standard - ISO 90012000 What is actually required
If necessary supplement and change operational arrangements in accordance with the standard
develop documents and records and describe operationsprocesses What is the desired
operationprocess
Step 6 Create a Documented Implementation Plan
14
Once the organization has obtained a clear picture of how its quality management system compares with
the ISO 90012000 standard all non-conformances must be addressed with a documented
implementation plan Usually the plan calls for identifying and describing processes to make the
organizationrsquos quality management system fully in compliance with the standard
The implementation plan should be thorough and specific detailing
Quality documentation to be developed
Objective of the system
Pertinent ISO 90012000 section
Person or team responsible
Approval required
Training required
Resources required
Estimated completion date
These elements should be organized into a detailed chart to be reviewed and approved The plan should
define the responsibilities of different departments and personnel and set target dates for the completion
of activities Once approved the Management Representative should control review and update the plan
as the implementation process proceeds
Step 7 Develop Quality Management System Documentation
Documentation is the most common area of non-conformance among organizations wishing to implement
ISO 9000 quality management systems As one company pointed out When we started our
implementation we found that documentation was inadequate Even absent in some areas Take
calibration Obviously its necessary and obviously we do it but it wasnt being documented Another
area was inspection and testing We inspect and test practically every item that leaves
here but our documentation was inadequate
Documentation of the quality management system should include
Documented statements of a quality policy and quality objectives
A quality manual
Documented procedures and records required by the standard ISO 90012000
and
15
Documents needed by the organization to ensure the effective planning operation
and control of its processes Quality documentation is generally prepared in the three levels
indicated in the box that follows
Level A Quality manual
States the scope of the quality management system including exclusions and details of their justification
and describes the processes of the quality management system and their interaction Generally gives an
organization profile presents the organizational relationships and responsibilities of persons whose work
affects quality and outlines the main procedures It may also describe organizations quality policy and
quality objectives
Level B Quality management system procedures
Describes the activities of individual departments how quality is controlled in each department and the
checks that are carried out
Level C Quality documents (forms reports work instructions etc)
Work instructions describe in detail how specific tasks are performed include drawing standards
methods of tests customers specifications etc
Presents forms to be used for recording observations etc
In small companies the above levels of documentation could be presented in one manual otherwise
separate manuals should be prepared A list of the documents to be prepared should be drawn up and
the responsibility for writing the documents should be assigned to the persons concerned in various
functional departments They should be advised to prepare the drafts within a specific time frame
Step 8 Document Control
Once the necessary quality management system documentation has been generated a documented
system must be created to control it Control is simply a means of managing the creation approval
distribution revision storage and disposal of the various types of documentation Document control
systems should be as simple and as easy to operate as possible -- sufficient to meet ISO 90012000
requirements and that is all
Document control should include
Approval for adequacy by authorized person (s) before issue
16
Review updating and re-approval of documents by authorized person (s)
Identification of changes and of the revision status of documents
Availability of relevant versions of documents at points of use
Identification and control of documents of external origin
Assurance of legibility and identifability of documents and
Prevention of unintended use of obsolete documents
The principle of ISO 9000 document control is that employees should have access to the documentation
and records needed to fulfil their responsibilities
Step 9 Implementation
It is good practice to implement the quality management system being documented as the documentation
is developed although this may be more effective in larger firms In smaller companies the quality
management system is often implemented all at once throughout the organization Where phased
implementation takes place the effectiveness of the system in selected areas can be evaluated It would
be a good idea initially to evaluate areas where the chances of a positive evaluation are high to maintain
the confidence of both management and staff in the merits of implementing the quality management
system
The implementation progress should be monitored to ensure that the quality management system is
effective and conforms to the standard These activities include internal quality audit formal corrective
action and management review
Step 10 Internal Quality Audit
As the system is being installed its effectiveness should be checked by regular internal quality audits
Internal quality audits are conducted to verify that the installed quality management system
Conform to the planned arrangements to the requirements of the standard (ISO 90012000) and
to the quality management system requirements established by your organization and
Is effectively implemented and maintained Even after the system stabilizes and starts
functioning internal audits should be planned and performed as part of an ongoing strategy A
few staff members should be trained to carry out internal auditing Use ISO 19011 for guidance in
auditing auditor qualification and programmes
17
Step 11 Management Review
When the installed quality management system has been operating for three to six months an internal
audit and management review should be conducted and corrective actions implemented The
management reviews are conducted to ensure the continuing suitability adequacy and effectiveness of
the quality management system1048578 The review should include assessing opportunities for improvement
and the need for changes to the quality management system including the quality policy and quality
objectives The input to management review should include information on
Results of audits
Customer feed back
Process performance and product conformity
Status of preventive and corrective actions
Follow-up actions from previous management reviews
Changes that could affect the quality management system and
Recommendations for improvements
Management reviews should also address the pitfalls to effective implementation including lack of CEO
commitment failure to involve everyone in the process and failure to monitor progress and enforce
deadlines
Step 12 Pre-assessment Audit
When system deficiencies are no longer visible it is normally time to apply for certification However
before doing so a pre-assessment audit should be arranged with an independent and qualified auditor
Sometimes certification bodies provide this service for a nominal charge The pre-assessment audit would
provide a degree of confidence for formally going ahead with an application for certification
Step 13 Certification and Registration
Once the quality management system has been in operation for a few months and has stabilized a formal
application for certification could be made to a selected certification agency The certification agency first
carries out an audit of the documents (referred to as an adequacy audit) If the documents conform to
18
the requirements of the quality standard then on-site audit is carried out If the certification body finds the
system to be working satisfactorily it awards the organization a certificate generally for a period of three
years During this three-year period it will carry out periodic surveillance audits to ensure that the system
is continuing to operate satisfactorily
Step 14 Continual Improvement
Certification to ISO 9000 should not be an end We should continually seek to improve the effectiveness
and suitability of the quality management system through the use of
Quality policy
Quality objectives
Audit results
Analysis of data
Corrective and preventive actions
Management review
ISO 90042000 provides a methodology for continual improvement
19
4 List out the conventional seven quality control tools Explain any two in brief
1 Histograms
A histogram is a bar graph that shows frequency data Histograms provide the easiest way
to evaluate the distribution of data
A histogram is a graphical display of tabular frequencies shown as adjacent rectangles Each
rectangle is erected over an interval with an area equal to the frequency of the observations in the
interval The height of a rectangle is also equal to the frequency density of the interval ie the frequency
divided by the width of the interval The total area of the histogram is equal to the number of data A
histogram may also be based on relative frequencies It then shows the proportion of cases that fall into
each of several categories with the total area equaling The categories are usually specified as
consecutive non-overlapping intervals of a variable The categories (intervals) must be adjacent and
often are chosen to be of the same size
Histograms are used to plot density of data and often for density estimation estimating the probability
density function of the underlying variable The total area of a histogram used for probability density is
always normalized to 1 If the length of the intervals on the x-axis is all 1 then a histogram is identical to
a relative frequency plot
2 Pareto Chart
Pareto charts are used to identify and prioritize problems to be solved They are actually
histograms aided by the 8020 rule adapted by Joseph Juran (80 of the problems are created by
approximately 20 of the causes)
3 Cause and Effect Diagram
The cause and effect diagram is also called the Ishikawa diagram or the fishbone diagram It
is a tool for discovering all the possible causes for a particular effect The major purpose of
this diagram is to act as a first step in problem solving by creating a list of possible causes
4 Scatter Diagrams
Scatter Diagrams are used to study and identify the possible relationship between the changes observed
in two different sets of variables
5 Flow Charts
A flow chart is a pictorial representation showing all of the steps of a process
8
6 Run Charts
Run charts are used to analyze processes according to ti me or order Run charts are useful
in discovering patterns or significant events that occur during a time period
7 Control Charts
Control charts are used to determine whether a process will produce a product or service with consistent
measurable properties
A control chart consists of
Points representing a statistic (eg a mean range proportion) of measurements of a quality
characteristic in samples taken from the process at different times [the data]
The mean of this statistic using all the samples is calculated (eg the mean of the means mean
of the ranges mean of the proportions)
A center line is drawn at the value of the mean of the statistic
The standard error (eg standard deviationsqrt(n) for the mean) of the statistic is also calculated
using all the samples
Upper and lower control limits (sometimes called natural process limits) that indicate the
threshold at which the process output is considered statistically unlikely are drawn typically at 3
standard errors from the center line
The chart may have other optional features including
Upper and lower warning limits drawn as separate lines typically two standard errors above and
below the center line
Division into zones with the addition of rules governing frequencies of observations in each zone
Annotation with events of interest as determined by the Quality Engineer in charge of the
processs quality
Chart usage
If the process is in control all points will plot within the control limits Any observations outside the limits
or systematic patterns within suggest the introduction of a new (and likely unanticipated) source of
variation known as a special cause variation Since increased variation means increased quality costs
a control chart signaling the presence of a special-cause requires immediate investigation This makes
the control limits very important decision aids The control limits tell us about process behavior and have
no intrinsic relationship to any specification targets or engineering tolerance In practice the process
mean (and hence the center line) may not coincide with the specified value (or target) of the quality
9
characteristic because the process design simply cant deliver the process characteristic at the desired
level
Control charts limit specification or targets because of the tendency of those involved with the process
(eg machine operators) to focus on performing to specification when in fact the least-cost course of
action is to keep process variation as low as possible Attempting to make a process whose natural center
is not the same as the target perform to target specification increases process variability and increases
costs significantly and is the cause of much inefficiency in operations process capability studies do
examine the relationship between the natural process limits (the control limits) and specifications
however The purpose of control charts is to allow simple detection of events that are indicative of actual
process change This simple decision can be difficult where the process characteristic is continuously
varying the control chart provides statistically objective criteria of change When change is detected and
considered good its cause should be identified and possibly become the new way of working where the
change is bad then its cause should be identified and eliminated
The purpose in adding warning limits or subdividing the control chart into zones is to provide early
notification if something is amiss Instead of immediately launching a process improvement effort to
determine whether special causes are present the Quality Engineer may temporarily increase the rate at
which samples are taken from the process output until its clear that the process is truly in control Note
that with three sigma limits one expects to be signaled approximately once out of every 370 points on
average
10
5 Suppose that you are working in an organization which wants to develop an effective implementation methodology for ISO 9000 Quality Management System How will you help your organization in developing an effective implementation methodology
Implementation of TQMISO 9000 affects the entire organization right from the start If pursued with total
dedication it results in cultural transition to an atmosphere of continuous improvement
The process of implementing ISO 9000 depends on
The sophistication of your existing quality program
The size of your organization and
The complexity of your process
The 14 essential steps briefly described below are to be followed through in order to implement ISO
9000 quality management system successfully
Step 1 Top Management Commitment
The top management (managing director or chief executive) should demonstrate a commitment and a
determination to implement an ISO 9000 quality management system in the organization Without top
management commitment no quality initiative can succeed Top management must be convinced that
registration and certification will enable the organization to demonstrate to its customers a visible
commitment to quality It should realize that a quality management system would improve overall
business efficiency by elimination of wasteful duplication in management system
The top management should provide evidence of its commitment to the development and implementation
of the quality management system and continually improve its effectiveness by
1 Communicating to the organization the importance of meeting customer as well as statutory and
regulatory requirements
2 Defining the organizations quality policy and make this known to every employee
3 Ensuring that quality objectives are established at all levels and functions
4 Ensuring the availability of resources required for the development and implementation of the
quality management system
5 Appointing a management representative to coordinate quality management system activities
and
6 Conducting management review
The top management should also consider actions such as
Leading the organization by example
Participating in improvement projects
11
Creating an environment that encourages the involvement of people
This type of top management commitment may be driven by
Direct marketplace pressure requirements of crucial customers or parent conglomerates
Indirect marketplace pressure increased quality levels and visibility among competitors
Growth ambitions desire to exploit market opportunities
Personal belief in the value of quality as a goal and quality management systems as a means of
reaching that goal
The top management should identify the goals to be achieved through the quality management system
Typical goals may be
Be more efficient and profitable
Produce products and services that consistently meet customers needs and expectations
Achieve customers satisfaction
Increase market share
Improve communications and morale in the organization
Reduce costs and liabilities
Increase confidence in the production system
Step 2 Establish Implementation Team
ISO 9000 is implemented by people The first phase of implementation calls for the commitment of top
management - the CEO and perhaps a handful of other key people The next step is to establish
implementation team and appoint a Management Representative (MR) as its coordinator to plan and
oversee implementation Its members should include representatives of all functions of the organization -
Marketing Design and development Planning Production Quality control etc In the context of the
standard the MR is the person within the Organization who acts as interface between organization
management and the ISO 9000 registrar His role is in fact much broader than that The MR should also
act as the organizationrsquos quality management system champion and must be a person with
Total backing from the CEO
Genuine and passionate commitment to quality in general and the ISO 9000 quality
management system in particular
The dignity - resulting from rank seniority or both - to influence managers and others of all levels
and functions
Detailed knowledge of quality methods in general and ISO 9000 in particular
The members of the implementation team should also be trained on ISO 9000 quality
management systems by a professional training organization
12
Step 3 Start ISO 9000 Awareness Programs
ISO 9000 awareness programs should be conducted to communicate to the employees the aim of the
ISO 9000 quality management system the advantage it offers to employees customers and the
organization how it will work and their roles and responsibilities within the system Suppliers of materials
and components should also participate in these programs
The awareness program should emphasize the benefits that the organization expects to realize through
its ISO 9000 quality management system The program should also stress the higher levels of
participation and self-direction that the quality management system renders to employees Such a focus
will go far to enlist employee support and commitment The programs could be run either by the
implementation team or by experts hired to talk to different levels of employees
Step 4 Provide Training
Since the ISO 9000 quality management system affects all the areas and all personnel in the
organization training programs should be structured for different categories of employees - senior
managers middle-level managers supervisors and workers The ISO 9000 implementation plan should
make provision for this training The training should cover the basic concepts of quality management
systems and the standard and their overall impact on the strategic goals of the organization the changed
processes
and the likely work culture implications of the system In addition initial training may also be necessary on
writing quality manuals procedures and work instruction auditing principles techniques of laboratory
management calibration testing procedures etc When in-house capacity to carry out such training is not
available it may be necessary to participate in external training courses run by professional training
organizations
Alternatively an external training institution could be invited to conduct in-house training courses
Step 5 Conduct Initial Status Survey
ISO 9000 does not require duplication of effort or redundant system The goal of ISO 9000 is to create a
quality management system that conforms to the standard This does not preclude incorporating
adapting and adding onto quality programs already in place So the next step in the implementation
process is to compare the organizationrsquos existing quality management system if there is one -- with the
requirements of the standard (ISO 90012000)
For this purpose an organization flow chart showing how information actually flows (not what should be
done) from order placement by the customer to delivery to this customer should be drawn up From this
13
over-all flow chart a flow chart of activities in each department should be prepared With the aid of the
flow charts a record of existing quality management system should be established A significant number
of written procedures may already be in place Unless they are very much out of date these documents
should not be discarded Rather they should be incorporated into the new quality management system
Documents requiring modification or elaboration should be identified and listed This exercise is some
times referred to as gap analysis During these review processes wide consultation with executives
and representatives of various unions and associations within the organization is required to enlist their
active cooperation
In the review process documents should be collected studied and registered for further use possibly
after they have been revised Before developing new quality management system documentation we
need to consider with which quality requirements or department we should start The best is to select an
area where processes are fairly well organized running effectively and functioning satisfactorily
The basic approach is to determine and record how a process is currently carried out We can do this by
identifying the people involved and obtaining information from them during individual interviews
Unfortunately it often happens that different people will give different contradicting versions of a process
Each one may refer to oral instructions that are not accurate or clear This is why the facts are often not
described correctly the first time around and have to be revised several times Once it has been agreed
how to describe the current process this process has to be adapted supplemented and implemented
according to the requirements of the quality standard (ISO 90012000) This requires organizational
arrangements the drawing up of additional documents and possible removal of existing documentation
(eg procedures inspectiontest plans inspectiontest instructions) and records (eg inspectiontest
reports inspectiontest certificates)
In introducing a quality management system the emphasis is on the improvement of the existing
processes or the re-organization of processes In general the steps to follow are the following
Ascertain and establish the following What is the present operationprocess What already
exists
Analyze the relevant sections of the quality standard - ISO 90012000 What is actually required
If necessary supplement and change operational arrangements in accordance with the standard
develop documents and records and describe operationsprocesses What is the desired
operationprocess
Step 6 Create a Documented Implementation Plan
14
Once the organization has obtained a clear picture of how its quality management system compares with
the ISO 90012000 standard all non-conformances must be addressed with a documented
implementation plan Usually the plan calls for identifying and describing processes to make the
organizationrsquos quality management system fully in compliance with the standard
The implementation plan should be thorough and specific detailing
Quality documentation to be developed
Objective of the system
Pertinent ISO 90012000 section
Person or team responsible
Approval required
Training required
Resources required
Estimated completion date
These elements should be organized into a detailed chart to be reviewed and approved The plan should
define the responsibilities of different departments and personnel and set target dates for the completion
of activities Once approved the Management Representative should control review and update the plan
as the implementation process proceeds
Step 7 Develop Quality Management System Documentation
Documentation is the most common area of non-conformance among organizations wishing to implement
ISO 9000 quality management systems As one company pointed out When we started our
implementation we found that documentation was inadequate Even absent in some areas Take
calibration Obviously its necessary and obviously we do it but it wasnt being documented Another
area was inspection and testing We inspect and test practically every item that leaves
here but our documentation was inadequate
Documentation of the quality management system should include
Documented statements of a quality policy and quality objectives
A quality manual
Documented procedures and records required by the standard ISO 90012000
and
15
Documents needed by the organization to ensure the effective planning operation
and control of its processes Quality documentation is generally prepared in the three levels
indicated in the box that follows
Level A Quality manual
States the scope of the quality management system including exclusions and details of their justification
and describes the processes of the quality management system and their interaction Generally gives an
organization profile presents the organizational relationships and responsibilities of persons whose work
affects quality and outlines the main procedures It may also describe organizations quality policy and
quality objectives
Level B Quality management system procedures
Describes the activities of individual departments how quality is controlled in each department and the
checks that are carried out
Level C Quality documents (forms reports work instructions etc)
Work instructions describe in detail how specific tasks are performed include drawing standards
methods of tests customers specifications etc
Presents forms to be used for recording observations etc
In small companies the above levels of documentation could be presented in one manual otherwise
separate manuals should be prepared A list of the documents to be prepared should be drawn up and
the responsibility for writing the documents should be assigned to the persons concerned in various
functional departments They should be advised to prepare the drafts within a specific time frame
Step 8 Document Control
Once the necessary quality management system documentation has been generated a documented
system must be created to control it Control is simply a means of managing the creation approval
distribution revision storage and disposal of the various types of documentation Document control
systems should be as simple and as easy to operate as possible -- sufficient to meet ISO 90012000
requirements and that is all
Document control should include
Approval for adequacy by authorized person (s) before issue
16
Review updating and re-approval of documents by authorized person (s)
Identification of changes and of the revision status of documents
Availability of relevant versions of documents at points of use
Identification and control of documents of external origin
Assurance of legibility and identifability of documents and
Prevention of unintended use of obsolete documents
The principle of ISO 9000 document control is that employees should have access to the documentation
and records needed to fulfil their responsibilities
Step 9 Implementation
It is good practice to implement the quality management system being documented as the documentation
is developed although this may be more effective in larger firms In smaller companies the quality
management system is often implemented all at once throughout the organization Where phased
implementation takes place the effectiveness of the system in selected areas can be evaluated It would
be a good idea initially to evaluate areas where the chances of a positive evaluation are high to maintain
the confidence of both management and staff in the merits of implementing the quality management
system
The implementation progress should be monitored to ensure that the quality management system is
effective and conforms to the standard These activities include internal quality audit formal corrective
action and management review
Step 10 Internal Quality Audit
As the system is being installed its effectiveness should be checked by regular internal quality audits
Internal quality audits are conducted to verify that the installed quality management system
Conform to the planned arrangements to the requirements of the standard (ISO 90012000) and
to the quality management system requirements established by your organization and
Is effectively implemented and maintained Even after the system stabilizes and starts
functioning internal audits should be planned and performed as part of an ongoing strategy A
few staff members should be trained to carry out internal auditing Use ISO 19011 for guidance in
auditing auditor qualification and programmes
17
Step 11 Management Review
When the installed quality management system has been operating for three to six months an internal
audit and management review should be conducted and corrective actions implemented The
management reviews are conducted to ensure the continuing suitability adequacy and effectiveness of
the quality management system1048578 The review should include assessing opportunities for improvement
and the need for changes to the quality management system including the quality policy and quality
objectives The input to management review should include information on
Results of audits
Customer feed back
Process performance and product conformity
Status of preventive and corrective actions
Follow-up actions from previous management reviews
Changes that could affect the quality management system and
Recommendations for improvements
Management reviews should also address the pitfalls to effective implementation including lack of CEO
commitment failure to involve everyone in the process and failure to monitor progress and enforce
deadlines
Step 12 Pre-assessment Audit
When system deficiencies are no longer visible it is normally time to apply for certification However
before doing so a pre-assessment audit should be arranged with an independent and qualified auditor
Sometimes certification bodies provide this service for a nominal charge The pre-assessment audit would
provide a degree of confidence for formally going ahead with an application for certification
Step 13 Certification and Registration
Once the quality management system has been in operation for a few months and has stabilized a formal
application for certification could be made to a selected certification agency The certification agency first
carries out an audit of the documents (referred to as an adequacy audit) If the documents conform to
18
the requirements of the quality standard then on-site audit is carried out If the certification body finds the
system to be working satisfactorily it awards the organization a certificate generally for a period of three
years During this three-year period it will carry out periodic surveillance audits to ensure that the system
is continuing to operate satisfactorily
Step 14 Continual Improvement
Certification to ISO 9000 should not be an end We should continually seek to improve the effectiveness
and suitability of the quality management system through the use of
Quality policy
Quality objectives
Audit results
Analysis of data
Corrective and preventive actions
Management review
ISO 90042000 provides a methodology for continual improvement
19
6 Run Charts
Run charts are used to analyze processes according to ti me or order Run charts are useful
in discovering patterns or significant events that occur during a time period
7 Control Charts
Control charts are used to determine whether a process will produce a product or service with consistent
measurable properties
A control chart consists of
Points representing a statistic (eg a mean range proportion) of measurements of a quality
characteristic in samples taken from the process at different times [the data]
The mean of this statistic using all the samples is calculated (eg the mean of the means mean
of the ranges mean of the proportions)
A center line is drawn at the value of the mean of the statistic
The standard error (eg standard deviationsqrt(n) for the mean) of the statistic is also calculated
using all the samples
Upper and lower control limits (sometimes called natural process limits) that indicate the
threshold at which the process output is considered statistically unlikely are drawn typically at 3
standard errors from the center line
The chart may have other optional features including
Upper and lower warning limits drawn as separate lines typically two standard errors above and
below the center line
Division into zones with the addition of rules governing frequencies of observations in each zone
Annotation with events of interest as determined by the Quality Engineer in charge of the
processs quality
Chart usage
If the process is in control all points will plot within the control limits Any observations outside the limits
or systematic patterns within suggest the introduction of a new (and likely unanticipated) source of
variation known as a special cause variation Since increased variation means increased quality costs
a control chart signaling the presence of a special-cause requires immediate investigation This makes
the control limits very important decision aids The control limits tell us about process behavior and have
no intrinsic relationship to any specification targets or engineering tolerance In practice the process
mean (and hence the center line) may not coincide with the specified value (or target) of the quality
9
characteristic because the process design simply cant deliver the process characteristic at the desired
level
Control charts limit specification or targets because of the tendency of those involved with the process
(eg machine operators) to focus on performing to specification when in fact the least-cost course of
action is to keep process variation as low as possible Attempting to make a process whose natural center
is not the same as the target perform to target specification increases process variability and increases
costs significantly and is the cause of much inefficiency in operations process capability studies do
examine the relationship between the natural process limits (the control limits) and specifications
however The purpose of control charts is to allow simple detection of events that are indicative of actual
process change This simple decision can be difficult where the process characteristic is continuously
varying the control chart provides statistically objective criteria of change When change is detected and
considered good its cause should be identified and possibly become the new way of working where the
change is bad then its cause should be identified and eliminated
The purpose in adding warning limits or subdividing the control chart into zones is to provide early
notification if something is amiss Instead of immediately launching a process improvement effort to
determine whether special causes are present the Quality Engineer may temporarily increase the rate at
which samples are taken from the process output until its clear that the process is truly in control Note
that with three sigma limits one expects to be signaled approximately once out of every 370 points on
average
10
5 Suppose that you are working in an organization which wants to develop an effective implementation methodology for ISO 9000 Quality Management System How will you help your organization in developing an effective implementation methodology
Implementation of TQMISO 9000 affects the entire organization right from the start If pursued with total
dedication it results in cultural transition to an atmosphere of continuous improvement
The process of implementing ISO 9000 depends on
The sophistication of your existing quality program
The size of your organization and
The complexity of your process
The 14 essential steps briefly described below are to be followed through in order to implement ISO
9000 quality management system successfully
Step 1 Top Management Commitment
The top management (managing director or chief executive) should demonstrate a commitment and a
determination to implement an ISO 9000 quality management system in the organization Without top
management commitment no quality initiative can succeed Top management must be convinced that
registration and certification will enable the organization to demonstrate to its customers a visible
commitment to quality It should realize that a quality management system would improve overall
business efficiency by elimination of wasteful duplication in management system
The top management should provide evidence of its commitment to the development and implementation
of the quality management system and continually improve its effectiveness by
1 Communicating to the organization the importance of meeting customer as well as statutory and
regulatory requirements
2 Defining the organizations quality policy and make this known to every employee
3 Ensuring that quality objectives are established at all levels and functions
4 Ensuring the availability of resources required for the development and implementation of the
quality management system
5 Appointing a management representative to coordinate quality management system activities
and
6 Conducting management review
The top management should also consider actions such as
Leading the organization by example
Participating in improvement projects
11
Creating an environment that encourages the involvement of people
This type of top management commitment may be driven by
Direct marketplace pressure requirements of crucial customers or parent conglomerates
Indirect marketplace pressure increased quality levels and visibility among competitors
Growth ambitions desire to exploit market opportunities
Personal belief in the value of quality as a goal and quality management systems as a means of
reaching that goal
The top management should identify the goals to be achieved through the quality management system
Typical goals may be
Be more efficient and profitable
Produce products and services that consistently meet customers needs and expectations
Achieve customers satisfaction
Increase market share
Improve communications and morale in the organization
Reduce costs and liabilities
Increase confidence in the production system
Step 2 Establish Implementation Team
ISO 9000 is implemented by people The first phase of implementation calls for the commitment of top
management - the CEO and perhaps a handful of other key people The next step is to establish
implementation team and appoint a Management Representative (MR) as its coordinator to plan and
oversee implementation Its members should include representatives of all functions of the organization -
Marketing Design and development Planning Production Quality control etc In the context of the
standard the MR is the person within the Organization who acts as interface between organization
management and the ISO 9000 registrar His role is in fact much broader than that The MR should also
act as the organizationrsquos quality management system champion and must be a person with
Total backing from the CEO
Genuine and passionate commitment to quality in general and the ISO 9000 quality
management system in particular
The dignity - resulting from rank seniority or both - to influence managers and others of all levels
and functions
Detailed knowledge of quality methods in general and ISO 9000 in particular
The members of the implementation team should also be trained on ISO 9000 quality
management systems by a professional training organization
12
Step 3 Start ISO 9000 Awareness Programs
ISO 9000 awareness programs should be conducted to communicate to the employees the aim of the
ISO 9000 quality management system the advantage it offers to employees customers and the
organization how it will work and their roles and responsibilities within the system Suppliers of materials
and components should also participate in these programs
The awareness program should emphasize the benefits that the organization expects to realize through
its ISO 9000 quality management system The program should also stress the higher levels of
participation and self-direction that the quality management system renders to employees Such a focus
will go far to enlist employee support and commitment The programs could be run either by the
implementation team or by experts hired to talk to different levels of employees
Step 4 Provide Training
Since the ISO 9000 quality management system affects all the areas and all personnel in the
organization training programs should be structured for different categories of employees - senior
managers middle-level managers supervisors and workers The ISO 9000 implementation plan should
make provision for this training The training should cover the basic concepts of quality management
systems and the standard and their overall impact on the strategic goals of the organization the changed
processes
and the likely work culture implications of the system In addition initial training may also be necessary on
writing quality manuals procedures and work instruction auditing principles techniques of laboratory
management calibration testing procedures etc When in-house capacity to carry out such training is not
available it may be necessary to participate in external training courses run by professional training
organizations
Alternatively an external training institution could be invited to conduct in-house training courses
Step 5 Conduct Initial Status Survey
ISO 9000 does not require duplication of effort or redundant system The goal of ISO 9000 is to create a
quality management system that conforms to the standard This does not preclude incorporating
adapting and adding onto quality programs already in place So the next step in the implementation
process is to compare the organizationrsquos existing quality management system if there is one -- with the
requirements of the standard (ISO 90012000)
For this purpose an organization flow chart showing how information actually flows (not what should be
done) from order placement by the customer to delivery to this customer should be drawn up From this
13
over-all flow chart a flow chart of activities in each department should be prepared With the aid of the
flow charts a record of existing quality management system should be established A significant number
of written procedures may already be in place Unless they are very much out of date these documents
should not be discarded Rather they should be incorporated into the new quality management system
Documents requiring modification or elaboration should be identified and listed This exercise is some
times referred to as gap analysis During these review processes wide consultation with executives
and representatives of various unions and associations within the organization is required to enlist their
active cooperation
In the review process documents should be collected studied and registered for further use possibly
after they have been revised Before developing new quality management system documentation we
need to consider with which quality requirements or department we should start The best is to select an
area where processes are fairly well organized running effectively and functioning satisfactorily
The basic approach is to determine and record how a process is currently carried out We can do this by
identifying the people involved and obtaining information from them during individual interviews
Unfortunately it often happens that different people will give different contradicting versions of a process
Each one may refer to oral instructions that are not accurate or clear This is why the facts are often not
described correctly the first time around and have to be revised several times Once it has been agreed
how to describe the current process this process has to be adapted supplemented and implemented
according to the requirements of the quality standard (ISO 90012000) This requires organizational
arrangements the drawing up of additional documents and possible removal of existing documentation
(eg procedures inspectiontest plans inspectiontest instructions) and records (eg inspectiontest
reports inspectiontest certificates)
In introducing a quality management system the emphasis is on the improvement of the existing
processes or the re-organization of processes In general the steps to follow are the following
Ascertain and establish the following What is the present operationprocess What already
exists
Analyze the relevant sections of the quality standard - ISO 90012000 What is actually required
If necessary supplement and change operational arrangements in accordance with the standard
develop documents and records and describe operationsprocesses What is the desired
operationprocess
Step 6 Create a Documented Implementation Plan
14
Once the organization has obtained a clear picture of how its quality management system compares with
the ISO 90012000 standard all non-conformances must be addressed with a documented
implementation plan Usually the plan calls for identifying and describing processes to make the
organizationrsquos quality management system fully in compliance with the standard
The implementation plan should be thorough and specific detailing
Quality documentation to be developed
Objective of the system
Pertinent ISO 90012000 section
Person or team responsible
Approval required
Training required
Resources required
Estimated completion date
These elements should be organized into a detailed chart to be reviewed and approved The plan should
define the responsibilities of different departments and personnel and set target dates for the completion
of activities Once approved the Management Representative should control review and update the plan
as the implementation process proceeds
Step 7 Develop Quality Management System Documentation
Documentation is the most common area of non-conformance among organizations wishing to implement
ISO 9000 quality management systems As one company pointed out When we started our
implementation we found that documentation was inadequate Even absent in some areas Take
calibration Obviously its necessary and obviously we do it but it wasnt being documented Another
area was inspection and testing We inspect and test practically every item that leaves
here but our documentation was inadequate
Documentation of the quality management system should include
Documented statements of a quality policy and quality objectives
A quality manual
Documented procedures and records required by the standard ISO 90012000
and
15
Documents needed by the organization to ensure the effective planning operation
and control of its processes Quality documentation is generally prepared in the three levels
indicated in the box that follows
Level A Quality manual
States the scope of the quality management system including exclusions and details of their justification
and describes the processes of the quality management system and their interaction Generally gives an
organization profile presents the organizational relationships and responsibilities of persons whose work
affects quality and outlines the main procedures It may also describe organizations quality policy and
quality objectives
Level B Quality management system procedures
Describes the activities of individual departments how quality is controlled in each department and the
checks that are carried out
Level C Quality documents (forms reports work instructions etc)
Work instructions describe in detail how specific tasks are performed include drawing standards
methods of tests customers specifications etc
Presents forms to be used for recording observations etc
In small companies the above levels of documentation could be presented in one manual otherwise
separate manuals should be prepared A list of the documents to be prepared should be drawn up and
the responsibility for writing the documents should be assigned to the persons concerned in various
functional departments They should be advised to prepare the drafts within a specific time frame
Step 8 Document Control
Once the necessary quality management system documentation has been generated a documented
system must be created to control it Control is simply a means of managing the creation approval
distribution revision storage and disposal of the various types of documentation Document control
systems should be as simple and as easy to operate as possible -- sufficient to meet ISO 90012000
requirements and that is all
Document control should include
Approval for adequacy by authorized person (s) before issue
16
Review updating and re-approval of documents by authorized person (s)
Identification of changes and of the revision status of documents
Availability of relevant versions of documents at points of use
Identification and control of documents of external origin
Assurance of legibility and identifability of documents and
Prevention of unintended use of obsolete documents
The principle of ISO 9000 document control is that employees should have access to the documentation
and records needed to fulfil their responsibilities
Step 9 Implementation
It is good practice to implement the quality management system being documented as the documentation
is developed although this may be more effective in larger firms In smaller companies the quality
management system is often implemented all at once throughout the organization Where phased
implementation takes place the effectiveness of the system in selected areas can be evaluated It would
be a good idea initially to evaluate areas where the chances of a positive evaluation are high to maintain
the confidence of both management and staff in the merits of implementing the quality management
system
The implementation progress should be monitored to ensure that the quality management system is
effective and conforms to the standard These activities include internal quality audit formal corrective
action and management review
Step 10 Internal Quality Audit
As the system is being installed its effectiveness should be checked by regular internal quality audits
Internal quality audits are conducted to verify that the installed quality management system
Conform to the planned arrangements to the requirements of the standard (ISO 90012000) and
to the quality management system requirements established by your organization and
Is effectively implemented and maintained Even after the system stabilizes and starts
functioning internal audits should be planned and performed as part of an ongoing strategy A
few staff members should be trained to carry out internal auditing Use ISO 19011 for guidance in
auditing auditor qualification and programmes
17
Step 11 Management Review
When the installed quality management system has been operating for three to six months an internal
audit and management review should be conducted and corrective actions implemented The
management reviews are conducted to ensure the continuing suitability adequacy and effectiveness of
the quality management system1048578 The review should include assessing opportunities for improvement
and the need for changes to the quality management system including the quality policy and quality
objectives The input to management review should include information on
Results of audits
Customer feed back
Process performance and product conformity
Status of preventive and corrective actions
Follow-up actions from previous management reviews
Changes that could affect the quality management system and
Recommendations for improvements
Management reviews should also address the pitfalls to effective implementation including lack of CEO
commitment failure to involve everyone in the process and failure to monitor progress and enforce
deadlines
Step 12 Pre-assessment Audit
When system deficiencies are no longer visible it is normally time to apply for certification However
before doing so a pre-assessment audit should be arranged with an independent and qualified auditor
Sometimes certification bodies provide this service for a nominal charge The pre-assessment audit would
provide a degree of confidence for formally going ahead with an application for certification
Step 13 Certification and Registration
Once the quality management system has been in operation for a few months and has stabilized a formal
application for certification could be made to a selected certification agency The certification agency first
carries out an audit of the documents (referred to as an adequacy audit) If the documents conform to
18
the requirements of the quality standard then on-site audit is carried out If the certification body finds the
system to be working satisfactorily it awards the organization a certificate generally for a period of three
years During this three-year period it will carry out periodic surveillance audits to ensure that the system
is continuing to operate satisfactorily
Step 14 Continual Improvement
Certification to ISO 9000 should not be an end We should continually seek to improve the effectiveness
and suitability of the quality management system through the use of
Quality policy
Quality objectives
Audit results
Analysis of data
Corrective and preventive actions
Management review
ISO 90042000 provides a methodology for continual improvement
19
characteristic because the process design simply cant deliver the process characteristic at the desired
level
Control charts limit specification or targets because of the tendency of those involved with the process
(eg machine operators) to focus on performing to specification when in fact the least-cost course of
action is to keep process variation as low as possible Attempting to make a process whose natural center
is not the same as the target perform to target specification increases process variability and increases
costs significantly and is the cause of much inefficiency in operations process capability studies do
examine the relationship between the natural process limits (the control limits) and specifications
however The purpose of control charts is to allow simple detection of events that are indicative of actual
process change This simple decision can be difficult where the process characteristic is continuously
varying the control chart provides statistically objective criteria of change When change is detected and
considered good its cause should be identified and possibly become the new way of working where the
change is bad then its cause should be identified and eliminated
The purpose in adding warning limits or subdividing the control chart into zones is to provide early
notification if something is amiss Instead of immediately launching a process improvement effort to
determine whether special causes are present the Quality Engineer may temporarily increase the rate at
which samples are taken from the process output until its clear that the process is truly in control Note
that with three sigma limits one expects to be signaled approximately once out of every 370 points on
average
10
5 Suppose that you are working in an organization which wants to develop an effective implementation methodology for ISO 9000 Quality Management System How will you help your organization in developing an effective implementation methodology
Implementation of TQMISO 9000 affects the entire organization right from the start If pursued with total
dedication it results in cultural transition to an atmosphere of continuous improvement
The process of implementing ISO 9000 depends on
The sophistication of your existing quality program
The size of your organization and
The complexity of your process
The 14 essential steps briefly described below are to be followed through in order to implement ISO
9000 quality management system successfully
Step 1 Top Management Commitment
The top management (managing director or chief executive) should demonstrate a commitment and a
determination to implement an ISO 9000 quality management system in the organization Without top
management commitment no quality initiative can succeed Top management must be convinced that
registration and certification will enable the organization to demonstrate to its customers a visible
commitment to quality It should realize that a quality management system would improve overall
business efficiency by elimination of wasteful duplication in management system
The top management should provide evidence of its commitment to the development and implementation
of the quality management system and continually improve its effectiveness by
1 Communicating to the organization the importance of meeting customer as well as statutory and
regulatory requirements
2 Defining the organizations quality policy and make this known to every employee
3 Ensuring that quality objectives are established at all levels and functions
4 Ensuring the availability of resources required for the development and implementation of the
quality management system
5 Appointing a management representative to coordinate quality management system activities
and
6 Conducting management review
The top management should also consider actions such as
Leading the organization by example
Participating in improvement projects
11
Creating an environment that encourages the involvement of people
This type of top management commitment may be driven by
Direct marketplace pressure requirements of crucial customers or parent conglomerates
Indirect marketplace pressure increased quality levels and visibility among competitors
Growth ambitions desire to exploit market opportunities
Personal belief in the value of quality as a goal and quality management systems as a means of
reaching that goal
The top management should identify the goals to be achieved through the quality management system
Typical goals may be
Be more efficient and profitable
Produce products and services that consistently meet customers needs and expectations
Achieve customers satisfaction
Increase market share
Improve communications and morale in the organization
Reduce costs and liabilities
Increase confidence in the production system
Step 2 Establish Implementation Team
ISO 9000 is implemented by people The first phase of implementation calls for the commitment of top
management - the CEO and perhaps a handful of other key people The next step is to establish
implementation team and appoint a Management Representative (MR) as its coordinator to plan and
oversee implementation Its members should include representatives of all functions of the organization -
Marketing Design and development Planning Production Quality control etc In the context of the
standard the MR is the person within the Organization who acts as interface between organization
management and the ISO 9000 registrar His role is in fact much broader than that The MR should also
act as the organizationrsquos quality management system champion and must be a person with
Total backing from the CEO
Genuine and passionate commitment to quality in general and the ISO 9000 quality
management system in particular
The dignity - resulting from rank seniority or both - to influence managers and others of all levels
and functions
Detailed knowledge of quality methods in general and ISO 9000 in particular
The members of the implementation team should also be trained on ISO 9000 quality
management systems by a professional training organization
12
Step 3 Start ISO 9000 Awareness Programs
ISO 9000 awareness programs should be conducted to communicate to the employees the aim of the
ISO 9000 quality management system the advantage it offers to employees customers and the
organization how it will work and their roles and responsibilities within the system Suppliers of materials
and components should also participate in these programs
The awareness program should emphasize the benefits that the organization expects to realize through
its ISO 9000 quality management system The program should also stress the higher levels of
participation and self-direction that the quality management system renders to employees Such a focus
will go far to enlist employee support and commitment The programs could be run either by the
implementation team or by experts hired to talk to different levels of employees
Step 4 Provide Training
Since the ISO 9000 quality management system affects all the areas and all personnel in the
organization training programs should be structured for different categories of employees - senior
managers middle-level managers supervisors and workers The ISO 9000 implementation plan should
make provision for this training The training should cover the basic concepts of quality management
systems and the standard and their overall impact on the strategic goals of the organization the changed
processes
and the likely work culture implications of the system In addition initial training may also be necessary on
writing quality manuals procedures and work instruction auditing principles techniques of laboratory
management calibration testing procedures etc When in-house capacity to carry out such training is not
available it may be necessary to participate in external training courses run by professional training
organizations
Alternatively an external training institution could be invited to conduct in-house training courses
Step 5 Conduct Initial Status Survey
ISO 9000 does not require duplication of effort or redundant system The goal of ISO 9000 is to create a
quality management system that conforms to the standard This does not preclude incorporating
adapting and adding onto quality programs already in place So the next step in the implementation
process is to compare the organizationrsquos existing quality management system if there is one -- with the
requirements of the standard (ISO 90012000)
For this purpose an organization flow chart showing how information actually flows (not what should be
done) from order placement by the customer to delivery to this customer should be drawn up From this
13
over-all flow chart a flow chart of activities in each department should be prepared With the aid of the
flow charts a record of existing quality management system should be established A significant number
of written procedures may already be in place Unless they are very much out of date these documents
should not be discarded Rather they should be incorporated into the new quality management system
Documents requiring modification or elaboration should be identified and listed This exercise is some
times referred to as gap analysis During these review processes wide consultation with executives
and representatives of various unions and associations within the organization is required to enlist their
active cooperation
In the review process documents should be collected studied and registered for further use possibly
after they have been revised Before developing new quality management system documentation we
need to consider with which quality requirements or department we should start The best is to select an
area where processes are fairly well organized running effectively and functioning satisfactorily
The basic approach is to determine and record how a process is currently carried out We can do this by
identifying the people involved and obtaining information from them during individual interviews
Unfortunately it often happens that different people will give different contradicting versions of a process
Each one may refer to oral instructions that are not accurate or clear This is why the facts are often not
described correctly the first time around and have to be revised several times Once it has been agreed
how to describe the current process this process has to be adapted supplemented and implemented
according to the requirements of the quality standard (ISO 90012000) This requires organizational
arrangements the drawing up of additional documents and possible removal of existing documentation
(eg procedures inspectiontest plans inspectiontest instructions) and records (eg inspectiontest
reports inspectiontest certificates)
In introducing a quality management system the emphasis is on the improvement of the existing
processes or the re-organization of processes In general the steps to follow are the following
Ascertain and establish the following What is the present operationprocess What already
exists
Analyze the relevant sections of the quality standard - ISO 90012000 What is actually required
If necessary supplement and change operational arrangements in accordance with the standard
develop documents and records and describe operationsprocesses What is the desired
operationprocess
Step 6 Create a Documented Implementation Plan
14
Once the organization has obtained a clear picture of how its quality management system compares with
the ISO 90012000 standard all non-conformances must be addressed with a documented
implementation plan Usually the plan calls for identifying and describing processes to make the
organizationrsquos quality management system fully in compliance with the standard
The implementation plan should be thorough and specific detailing
Quality documentation to be developed
Objective of the system
Pertinent ISO 90012000 section
Person or team responsible
Approval required
Training required
Resources required
Estimated completion date
These elements should be organized into a detailed chart to be reviewed and approved The plan should
define the responsibilities of different departments and personnel and set target dates for the completion
of activities Once approved the Management Representative should control review and update the plan
as the implementation process proceeds
Step 7 Develop Quality Management System Documentation
Documentation is the most common area of non-conformance among organizations wishing to implement
ISO 9000 quality management systems As one company pointed out When we started our
implementation we found that documentation was inadequate Even absent in some areas Take
calibration Obviously its necessary and obviously we do it but it wasnt being documented Another
area was inspection and testing We inspect and test practically every item that leaves
here but our documentation was inadequate
Documentation of the quality management system should include
Documented statements of a quality policy and quality objectives
A quality manual
Documented procedures and records required by the standard ISO 90012000
and
15
Documents needed by the organization to ensure the effective planning operation
and control of its processes Quality documentation is generally prepared in the three levels
indicated in the box that follows
Level A Quality manual
States the scope of the quality management system including exclusions and details of their justification
and describes the processes of the quality management system and their interaction Generally gives an
organization profile presents the organizational relationships and responsibilities of persons whose work
affects quality and outlines the main procedures It may also describe organizations quality policy and
quality objectives
Level B Quality management system procedures
Describes the activities of individual departments how quality is controlled in each department and the
checks that are carried out
Level C Quality documents (forms reports work instructions etc)
Work instructions describe in detail how specific tasks are performed include drawing standards
methods of tests customers specifications etc
Presents forms to be used for recording observations etc
In small companies the above levels of documentation could be presented in one manual otherwise
separate manuals should be prepared A list of the documents to be prepared should be drawn up and
the responsibility for writing the documents should be assigned to the persons concerned in various
functional departments They should be advised to prepare the drafts within a specific time frame
Step 8 Document Control
Once the necessary quality management system documentation has been generated a documented
system must be created to control it Control is simply a means of managing the creation approval
distribution revision storage and disposal of the various types of documentation Document control
systems should be as simple and as easy to operate as possible -- sufficient to meet ISO 90012000
requirements and that is all
Document control should include
Approval for adequacy by authorized person (s) before issue
16
Review updating and re-approval of documents by authorized person (s)
Identification of changes and of the revision status of documents
Availability of relevant versions of documents at points of use
Identification and control of documents of external origin
Assurance of legibility and identifability of documents and
Prevention of unintended use of obsolete documents
The principle of ISO 9000 document control is that employees should have access to the documentation
and records needed to fulfil their responsibilities
Step 9 Implementation
It is good practice to implement the quality management system being documented as the documentation
is developed although this may be more effective in larger firms In smaller companies the quality
management system is often implemented all at once throughout the organization Where phased
implementation takes place the effectiveness of the system in selected areas can be evaluated It would
be a good idea initially to evaluate areas where the chances of a positive evaluation are high to maintain
the confidence of both management and staff in the merits of implementing the quality management
system
The implementation progress should be monitored to ensure that the quality management system is
effective and conforms to the standard These activities include internal quality audit formal corrective
action and management review
Step 10 Internal Quality Audit
As the system is being installed its effectiveness should be checked by regular internal quality audits
Internal quality audits are conducted to verify that the installed quality management system
Conform to the planned arrangements to the requirements of the standard (ISO 90012000) and
to the quality management system requirements established by your organization and
Is effectively implemented and maintained Even after the system stabilizes and starts
functioning internal audits should be planned and performed as part of an ongoing strategy A
few staff members should be trained to carry out internal auditing Use ISO 19011 for guidance in
auditing auditor qualification and programmes
17
Step 11 Management Review
When the installed quality management system has been operating for three to six months an internal
audit and management review should be conducted and corrective actions implemented The
management reviews are conducted to ensure the continuing suitability adequacy and effectiveness of
the quality management system1048578 The review should include assessing opportunities for improvement
and the need for changes to the quality management system including the quality policy and quality
objectives The input to management review should include information on
Results of audits
Customer feed back
Process performance and product conformity
Status of preventive and corrective actions
Follow-up actions from previous management reviews
Changes that could affect the quality management system and
Recommendations for improvements
Management reviews should also address the pitfalls to effective implementation including lack of CEO
commitment failure to involve everyone in the process and failure to monitor progress and enforce
deadlines
Step 12 Pre-assessment Audit
When system deficiencies are no longer visible it is normally time to apply for certification However
before doing so a pre-assessment audit should be arranged with an independent and qualified auditor
Sometimes certification bodies provide this service for a nominal charge The pre-assessment audit would
provide a degree of confidence for formally going ahead with an application for certification
Step 13 Certification and Registration
Once the quality management system has been in operation for a few months and has stabilized a formal
application for certification could be made to a selected certification agency The certification agency first
carries out an audit of the documents (referred to as an adequacy audit) If the documents conform to
18
the requirements of the quality standard then on-site audit is carried out If the certification body finds the
system to be working satisfactorily it awards the organization a certificate generally for a period of three
years During this three-year period it will carry out periodic surveillance audits to ensure that the system
is continuing to operate satisfactorily
Step 14 Continual Improvement
Certification to ISO 9000 should not be an end We should continually seek to improve the effectiveness
and suitability of the quality management system through the use of
Quality policy
Quality objectives
Audit results
Analysis of data
Corrective and preventive actions
Management review
ISO 90042000 provides a methodology for continual improvement
19
5 Suppose that you are working in an organization which wants to develop an effective implementation methodology for ISO 9000 Quality Management System How will you help your organization in developing an effective implementation methodology
Implementation of TQMISO 9000 affects the entire organization right from the start If pursued with total
dedication it results in cultural transition to an atmosphere of continuous improvement
The process of implementing ISO 9000 depends on
The sophistication of your existing quality program
The size of your organization and
The complexity of your process
The 14 essential steps briefly described below are to be followed through in order to implement ISO
9000 quality management system successfully
Step 1 Top Management Commitment
The top management (managing director or chief executive) should demonstrate a commitment and a
determination to implement an ISO 9000 quality management system in the organization Without top
management commitment no quality initiative can succeed Top management must be convinced that
registration and certification will enable the organization to demonstrate to its customers a visible
commitment to quality It should realize that a quality management system would improve overall
business efficiency by elimination of wasteful duplication in management system
The top management should provide evidence of its commitment to the development and implementation
of the quality management system and continually improve its effectiveness by
1 Communicating to the organization the importance of meeting customer as well as statutory and
regulatory requirements
2 Defining the organizations quality policy and make this known to every employee
3 Ensuring that quality objectives are established at all levels and functions
4 Ensuring the availability of resources required for the development and implementation of the
quality management system
5 Appointing a management representative to coordinate quality management system activities
and
6 Conducting management review
The top management should also consider actions such as
Leading the organization by example
Participating in improvement projects
11
Creating an environment that encourages the involvement of people
This type of top management commitment may be driven by
Direct marketplace pressure requirements of crucial customers or parent conglomerates
Indirect marketplace pressure increased quality levels and visibility among competitors
Growth ambitions desire to exploit market opportunities
Personal belief in the value of quality as a goal and quality management systems as a means of
reaching that goal
The top management should identify the goals to be achieved through the quality management system
Typical goals may be
Be more efficient and profitable
Produce products and services that consistently meet customers needs and expectations
Achieve customers satisfaction
Increase market share
Improve communications and morale in the organization
Reduce costs and liabilities
Increase confidence in the production system
Step 2 Establish Implementation Team
ISO 9000 is implemented by people The first phase of implementation calls for the commitment of top
management - the CEO and perhaps a handful of other key people The next step is to establish
implementation team and appoint a Management Representative (MR) as its coordinator to plan and
oversee implementation Its members should include representatives of all functions of the organization -
Marketing Design and development Planning Production Quality control etc In the context of the
standard the MR is the person within the Organization who acts as interface between organization
management and the ISO 9000 registrar His role is in fact much broader than that The MR should also
act as the organizationrsquos quality management system champion and must be a person with
Total backing from the CEO
Genuine and passionate commitment to quality in general and the ISO 9000 quality
management system in particular
The dignity - resulting from rank seniority or both - to influence managers and others of all levels
and functions
Detailed knowledge of quality methods in general and ISO 9000 in particular
The members of the implementation team should also be trained on ISO 9000 quality
management systems by a professional training organization
12
Step 3 Start ISO 9000 Awareness Programs
ISO 9000 awareness programs should be conducted to communicate to the employees the aim of the
ISO 9000 quality management system the advantage it offers to employees customers and the
organization how it will work and their roles and responsibilities within the system Suppliers of materials
and components should also participate in these programs
The awareness program should emphasize the benefits that the organization expects to realize through
its ISO 9000 quality management system The program should also stress the higher levels of
participation and self-direction that the quality management system renders to employees Such a focus
will go far to enlist employee support and commitment The programs could be run either by the
implementation team or by experts hired to talk to different levels of employees
Step 4 Provide Training
Since the ISO 9000 quality management system affects all the areas and all personnel in the
organization training programs should be structured for different categories of employees - senior
managers middle-level managers supervisors and workers The ISO 9000 implementation plan should
make provision for this training The training should cover the basic concepts of quality management
systems and the standard and their overall impact on the strategic goals of the organization the changed
processes
and the likely work culture implications of the system In addition initial training may also be necessary on
writing quality manuals procedures and work instruction auditing principles techniques of laboratory
management calibration testing procedures etc When in-house capacity to carry out such training is not
available it may be necessary to participate in external training courses run by professional training
organizations
Alternatively an external training institution could be invited to conduct in-house training courses
Step 5 Conduct Initial Status Survey
ISO 9000 does not require duplication of effort or redundant system The goal of ISO 9000 is to create a
quality management system that conforms to the standard This does not preclude incorporating
adapting and adding onto quality programs already in place So the next step in the implementation
process is to compare the organizationrsquos existing quality management system if there is one -- with the
requirements of the standard (ISO 90012000)
For this purpose an organization flow chart showing how information actually flows (not what should be
done) from order placement by the customer to delivery to this customer should be drawn up From this
13
over-all flow chart a flow chart of activities in each department should be prepared With the aid of the
flow charts a record of existing quality management system should be established A significant number
of written procedures may already be in place Unless they are very much out of date these documents
should not be discarded Rather they should be incorporated into the new quality management system
Documents requiring modification or elaboration should be identified and listed This exercise is some
times referred to as gap analysis During these review processes wide consultation with executives
and representatives of various unions and associations within the organization is required to enlist their
active cooperation
In the review process documents should be collected studied and registered for further use possibly
after they have been revised Before developing new quality management system documentation we
need to consider with which quality requirements or department we should start The best is to select an
area where processes are fairly well organized running effectively and functioning satisfactorily
The basic approach is to determine and record how a process is currently carried out We can do this by
identifying the people involved and obtaining information from them during individual interviews
Unfortunately it often happens that different people will give different contradicting versions of a process
Each one may refer to oral instructions that are not accurate or clear This is why the facts are often not
described correctly the first time around and have to be revised several times Once it has been agreed
how to describe the current process this process has to be adapted supplemented and implemented
according to the requirements of the quality standard (ISO 90012000) This requires organizational
arrangements the drawing up of additional documents and possible removal of existing documentation
(eg procedures inspectiontest plans inspectiontest instructions) and records (eg inspectiontest
reports inspectiontest certificates)
In introducing a quality management system the emphasis is on the improvement of the existing
processes or the re-organization of processes In general the steps to follow are the following
Ascertain and establish the following What is the present operationprocess What already
exists
Analyze the relevant sections of the quality standard - ISO 90012000 What is actually required
If necessary supplement and change operational arrangements in accordance with the standard
develop documents and records and describe operationsprocesses What is the desired
operationprocess
Step 6 Create a Documented Implementation Plan
14
Once the organization has obtained a clear picture of how its quality management system compares with
the ISO 90012000 standard all non-conformances must be addressed with a documented
implementation plan Usually the plan calls for identifying and describing processes to make the
organizationrsquos quality management system fully in compliance with the standard
The implementation plan should be thorough and specific detailing
Quality documentation to be developed
Objective of the system
Pertinent ISO 90012000 section
Person or team responsible
Approval required
Training required
Resources required
Estimated completion date
These elements should be organized into a detailed chart to be reviewed and approved The plan should
define the responsibilities of different departments and personnel and set target dates for the completion
of activities Once approved the Management Representative should control review and update the plan
as the implementation process proceeds
Step 7 Develop Quality Management System Documentation
Documentation is the most common area of non-conformance among organizations wishing to implement
ISO 9000 quality management systems As one company pointed out When we started our
implementation we found that documentation was inadequate Even absent in some areas Take
calibration Obviously its necessary and obviously we do it but it wasnt being documented Another
area was inspection and testing We inspect and test practically every item that leaves
here but our documentation was inadequate
Documentation of the quality management system should include
Documented statements of a quality policy and quality objectives
A quality manual
Documented procedures and records required by the standard ISO 90012000
and
15
Documents needed by the organization to ensure the effective planning operation
and control of its processes Quality documentation is generally prepared in the three levels
indicated in the box that follows
Level A Quality manual
States the scope of the quality management system including exclusions and details of their justification
and describes the processes of the quality management system and their interaction Generally gives an
organization profile presents the organizational relationships and responsibilities of persons whose work
affects quality and outlines the main procedures It may also describe organizations quality policy and
quality objectives
Level B Quality management system procedures
Describes the activities of individual departments how quality is controlled in each department and the
checks that are carried out
Level C Quality documents (forms reports work instructions etc)
Work instructions describe in detail how specific tasks are performed include drawing standards
methods of tests customers specifications etc
Presents forms to be used for recording observations etc
In small companies the above levels of documentation could be presented in one manual otherwise
separate manuals should be prepared A list of the documents to be prepared should be drawn up and
the responsibility for writing the documents should be assigned to the persons concerned in various
functional departments They should be advised to prepare the drafts within a specific time frame
Step 8 Document Control
Once the necessary quality management system documentation has been generated a documented
system must be created to control it Control is simply a means of managing the creation approval
distribution revision storage and disposal of the various types of documentation Document control
systems should be as simple and as easy to operate as possible -- sufficient to meet ISO 90012000
requirements and that is all
Document control should include
Approval for adequacy by authorized person (s) before issue
16
Review updating and re-approval of documents by authorized person (s)
Identification of changes and of the revision status of documents
Availability of relevant versions of documents at points of use
Identification and control of documents of external origin
Assurance of legibility and identifability of documents and
Prevention of unintended use of obsolete documents
The principle of ISO 9000 document control is that employees should have access to the documentation
and records needed to fulfil their responsibilities
Step 9 Implementation
It is good practice to implement the quality management system being documented as the documentation
is developed although this may be more effective in larger firms In smaller companies the quality
management system is often implemented all at once throughout the organization Where phased
implementation takes place the effectiveness of the system in selected areas can be evaluated It would
be a good idea initially to evaluate areas where the chances of a positive evaluation are high to maintain
the confidence of both management and staff in the merits of implementing the quality management
system
The implementation progress should be monitored to ensure that the quality management system is
effective and conforms to the standard These activities include internal quality audit formal corrective
action and management review
Step 10 Internal Quality Audit
As the system is being installed its effectiveness should be checked by regular internal quality audits
Internal quality audits are conducted to verify that the installed quality management system
Conform to the planned arrangements to the requirements of the standard (ISO 90012000) and
to the quality management system requirements established by your organization and
Is effectively implemented and maintained Even after the system stabilizes and starts
functioning internal audits should be planned and performed as part of an ongoing strategy A
few staff members should be trained to carry out internal auditing Use ISO 19011 for guidance in
auditing auditor qualification and programmes
17
Step 11 Management Review
When the installed quality management system has been operating for three to six months an internal
audit and management review should be conducted and corrective actions implemented The
management reviews are conducted to ensure the continuing suitability adequacy and effectiveness of
the quality management system1048578 The review should include assessing opportunities for improvement
and the need for changes to the quality management system including the quality policy and quality
objectives The input to management review should include information on
Results of audits
Customer feed back
Process performance and product conformity
Status of preventive and corrective actions
Follow-up actions from previous management reviews
Changes that could affect the quality management system and
Recommendations for improvements
Management reviews should also address the pitfalls to effective implementation including lack of CEO
commitment failure to involve everyone in the process and failure to monitor progress and enforce
deadlines
Step 12 Pre-assessment Audit
When system deficiencies are no longer visible it is normally time to apply for certification However
before doing so a pre-assessment audit should be arranged with an independent and qualified auditor
Sometimes certification bodies provide this service for a nominal charge The pre-assessment audit would
provide a degree of confidence for formally going ahead with an application for certification
Step 13 Certification and Registration
Once the quality management system has been in operation for a few months and has stabilized a formal
application for certification could be made to a selected certification agency The certification agency first
carries out an audit of the documents (referred to as an adequacy audit) If the documents conform to
18
the requirements of the quality standard then on-site audit is carried out If the certification body finds the
system to be working satisfactorily it awards the organization a certificate generally for a period of three
years During this three-year period it will carry out periodic surveillance audits to ensure that the system
is continuing to operate satisfactorily
Step 14 Continual Improvement
Certification to ISO 9000 should not be an end We should continually seek to improve the effectiveness
and suitability of the quality management system through the use of
Quality policy
Quality objectives
Audit results
Analysis of data
Corrective and preventive actions
Management review
ISO 90042000 provides a methodology for continual improvement
19
Creating an environment that encourages the involvement of people
This type of top management commitment may be driven by
Direct marketplace pressure requirements of crucial customers or parent conglomerates
Indirect marketplace pressure increased quality levels and visibility among competitors
Growth ambitions desire to exploit market opportunities
Personal belief in the value of quality as a goal and quality management systems as a means of
reaching that goal
The top management should identify the goals to be achieved through the quality management system
Typical goals may be
Be more efficient and profitable
Produce products and services that consistently meet customers needs and expectations
Achieve customers satisfaction
Increase market share
Improve communications and morale in the organization
Reduce costs and liabilities
Increase confidence in the production system
Step 2 Establish Implementation Team
ISO 9000 is implemented by people The first phase of implementation calls for the commitment of top
management - the CEO and perhaps a handful of other key people The next step is to establish
implementation team and appoint a Management Representative (MR) as its coordinator to plan and
oversee implementation Its members should include representatives of all functions of the organization -
Marketing Design and development Planning Production Quality control etc In the context of the
standard the MR is the person within the Organization who acts as interface between organization
management and the ISO 9000 registrar His role is in fact much broader than that The MR should also
act as the organizationrsquos quality management system champion and must be a person with
Total backing from the CEO
Genuine and passionate commitment to quality in general and the ISO 9000 quality
management system in particular
The dignity - resulting from rank seniority or both - to influence managers and others of all levels
and functions
Detailed knowledge of quality methods in general and ISO 9000 in particular
The members of the implementation team should also be trained on ISO 9000 quality
management systems by a professional training organization
12
Step 3 Start ISO 9000 Awareness Programs
ISO 9000 awareness programs should be conducted to communicate to the employees the aim of the
ISO 9000 quality management system the advantage it offers to employees customers and the
organization how it will work and their roles and responsibilities within the system Suppliers of materials
and components should also participate in these programs
The awareness program should emphasize the benefits that the organization expects to realize through
its ISO 9000 quality management system The program should also stress the higher levels of
participation and self-direction that the quality management system renders to employees Such a focus
will go far to enlist employee support and commitment The programs could be run either by the
implementation team or by experts hired to talk to different levels of employees
Step 4 Provide Training
Since the ISO 9000 quality management system affects all the areas and all personnel in the
organization training programs should be structured for different categories of employees - senior
managers middle-level managers supervisors and workers The ISO 9000 implementation plan should
make provision for this training The training should cover the basic concepts of quality management
systems and the standard and their overall impact on the strategic goals of the organization the changed
processes
and the likely work culture implications of the system In addition initial training may also be necessary on
writing quality manuals procedures and work instruction auditing principles techniques of laboratory
management calibration testing procedures etc When in-house capacity to carry out such training is not
available it may be necessary to participate in external training courses run by professional training
organizations
Alternatively an external training institution could be invited to conduct in-house training courses
Step 5 Conduct Initial Status Survey
ISO 9000 does not require duplication of effort or redundant system The goal of ISO 9000 is to create a
quality management system that conforms to the standard This does not preclude incorporating
adapting and adding onto quality programs already in place So the next step in the implementation
process is to compare the organizationrsquos existing quality management system if there is one -- with the
requirements of the standard (ISO 90012000)
For this purpose an organization flow chart showing how information actually flows (not what should be
done) from order placement by the customer to delivery to this customer should be drawn up From this
13
over-all flow chart a flow chart of activities in each department should be prepared With the aid of the
flow charts a record of existing quality management system should be established A significant number
of written procedures may already be in place Unless they are very much out of date these documents
should not be discarded Rather they should be incorporated into the new quality management system
Documents requiring modification or elaboration should be identified and listed This exercise is some
times referred to as gap analysis During these review processes wide consultation with executives
and representatives of various unions and associations within the organization is required to enlist their
active cooperation
In the review process documents should be collected studied and registered for further use possibly
after they have been revised Before developing new quality management system documentation we
need to consider with which quality requirements or department we should start The best is to select an
area where processes are fairly well organized running effectively and functioning satisfactorily
The basic approach is to determine and record how a process is currently carried out We can do this by
identifying the people involved and obtaining information from them during individual interviews
Unfortunately it often happens that different people will give different contradicting versions of a process
Each one may refer to oral instructions that are not accurate or clear This is why the facts are often not
described correctly the first time around and have to be revised several times Once it has been agreed
how to describe the current process this process has to be adapted supplemented and implemented
according to the requirements of the quality standard (ISO 90012000) This requires organizational
arrangements the drawing up of additional documents and possible removal of existing documentation
(eg procedures inspectiontest plans inspectiontest instructions) and records (eg inspectiontest
reports inspectiontest certificates)
In introducing a quality management system the emphasis is on the improvement of the existing
processes or the re-organization of processes In general the steps to follow are the following
Ascertain and establish the following What is the present operationprocess What already
exists
Analyze the relevant sections of the quality standard - ISO 90012000 What is actually required
If necessary supplement and change operational arrangements in accordance with the standard
develop documents and records and describe operationsprocesses What is the desired
operationprocess
Step 6 Create a Documented Implementation Plan
14
Once the organization has obtained a clear picture of how its quality management system compares with
the ISO 90012000 standard all non-conformances must be addressed with a documented
implementation plan Usually the plan calls for identifying and describing processes to make the
organizationrsquos quality management system fully in compliance with the standard
The implementation plan should be thorough and specific detailing
Quality documentation to be developed
Objective of the system
Pertinent ISO 90012000 section
Person or team responsible
Approval required
Training required
Resources required
Estimated completion date
These elements should be organized into a detailed chart to be reviewed and approved The plan should
define the responsibilities of different departments and personnel and set target dates for the completion
of activities Once approved the Management Representative should control review and update the plan
as the implementation process proceeds
Step 7 Develop Quality Management System Documentation
Documentation is the most common area of non-conformance among organizations wishing to implement
ISO 9000 quality management systems As one company pointed out When we started our
implementation we found that documentation was inadequate Even absent in some areas Take
calibration Obviously its necessary and obviously we do it but it wasnt being documented Another
area was inspection and testing We inspect and test practically every item that leaves
here but our documentation was inadequate
Documentation of the quality management system should include
Documented statements of a quality policy and quality objectives
A quality manual
Documented procedures and records required by the standard ISO 90012000
and
15
Documents needed by the organization to ensure the effective planning operation
and control of its processes Quality documentation is generally prepared in the three levels
indicated in the box that follows
Level A Quality manual
States the scope of the quality management system including exclusions and details of their justification
and describes the processes of the quality management system and their interaction Generally gives an
organization profile presents the organizational relationships and responsibilities of persons whose work
affects quality and outlines the main procedures It may also describe organizations quality policy and
quality objectives
Level B Quality management system procedures
Describes the activities of individual departments how quality is controlled in each department and the
checks that are carried out
Level C Quality documents (forms reports work instructions etc)
Work instructions describe in detail how specific tasks are performed include drawing standards
methods of tests customers specifications etc
Presents forms to be used for recording observations etc
In small companies the above levels of documentation could be presented in one manual otherwise
separate manuals should be prepared A list of the documents to be prepared should be drawn up and
the responsibility for writing the documents should be assigned to the persons concerned in various
functional departments They should be advised to prepare the drafts within a specific time frame
Step 8 Document Control
Once the necessary quality management system documentation has been generated a documented
system must be created to control it Control is simply a means of managing the creation approval
distribution revision storage and disposal of the various types of documentation Document control
systems should be as simple and as easy to operate as possible -- sufficient to meet ISO 90012000
requirements and that is all
Document control should include
Approval for adequacy by authorized person (s) before issue
16
Review updating and re-approval of documents by authorized person (s)
Identification of changes and of the revision status of documents
Availability of relevant versions of documents at points of use
Identification and control of documents of external origin
Assurance of legibility and identifability of documents and
Prevention of unintended use of obsolete documents
The principle of ISO 9000 document control is that employees should have access to the documentation
and records needed to fulfil their responsibilities
Step 9 Implementation
It is good practice to implement the quality management system being documented as the documentation
is developed although this may be more effective in larger firms In smaller companies the quality
management system is often implemented all at once throughout the organization Where phased
implementation takes place the effectiveness of the system in selected areas can be evaluated It would
be a good idea initially to evaluate areas where the chances of a positive evaluation are high to maintain
the confidence of both management and staff in the merits of implementing the quality management
system
The implementation progress should be monitored to ensure that the quality management system is
effective and conforms to the standard These activities include internal quality audit formal corrective
action and management review
Step 10 Internal Quality Audit
As the system is being installed its effectiveness should be checked by regular internal quality audits
Internal quality audits are conducted to verify that the installed quality management system
Conform to the planned arrangements to the requirements of the standard (ISO 90012000) and
to the quality management system requirements established by your organization and
Is effectively implemented and maintained Even after the system stabilizes and starts
functioning internal audits should be planned and performed as part of an ongoing strategy A
few staff members should be trained to carry out internal auditing Use ISO 19011 for guidance in
auditing auditor qualification and programmes
17
Step 11 Management Review
When the installed quality management system has been operating for three to six months an internal
audit and management review should be conducted and corrective actions implemented The
management reviews are conducted to ensure the continuing suitability adequacy and effectiveness of
the quality management system1048578 The review should include assessing opportunities for improvement
and the need for changes to the quality management system including the quality policy and quality
objectives The input to management review should include information on
Results of audits
Customer feed back
Process performance and product conformity
Status of preventive and corrective actions
Follow-up actions from previous management reviews
Changes that could affect the quality management system and
Recommendations for improvements
Management reviews should also address the pitfalls to effective implementation including lack of CEO
commitment failure to involve everyone in the process and failure to monitor progress and enforce
deadlines
Step 12 Pre-assessment Audit
When system deficiencies are no longer visible it is normally time to apply for certification However
before doing so a pre-assessment audit should be arranged with an independent and qualified auditor
Sometimes certification bodies provide this service for a nominal charge The pre-assessment audit would
provide a degree of confidence for formally going ahead with an application for certification
Step 13 Certification and Registration
Once the quality management system has been in operation for a few months and has stabilized a formal
application for certification could be made to a selected certification agency The certification agency first
carries out an audit of the documents (referred to as an adequacy audit) If the documents conform to
18
the requirements of the quality standard then on-site audit is carried out If the certification body finds the
system to be working satisfactorily it awards the organization a certificate generally for a period of three
years During this three-year period it will carry out periodic surveillance audits to ensure that the system
is continuing to operate satisfactorily
Step 14 Continual Improvement
Certification to ISO 9000 should not be an end We should continually seek to improve the effectiveness
and suitability of the quality management system through the use of
Quality policy
Quality objectives
Audit results
Analysis of data
Corrective and preventive actions
Management review
ISO 90042000 provides a methodology for continual improvement
19
Step 3 Start ISO 9000 Awareness Programs
ISO 9000 awareness programs should be conducted to communicate to the employees the aim of the
ISO 9000 quality management system the advantage it offers to employees customers and the
organization how it will work and their roles and responsibilities within the system Suppliers of materials
and components should also participate in these programs
The awareness program should emphasize the benefits that the organization expects to realize through
its ISO 9000 quality management system The program should also stress the higher levels of
participation and self-direction that the quality management system renders to employees Such a focus
will go far to enlist employee support and commitment The programs could be run either by the
implementation team or by experts hired to talk to different levels of employees
Step 4 Provide Training
Since the ISO 9000 quality management system affects all the areas and all personnel in the
organization training programs should be structured for different categories of employees - senior
managers middle-level managers supervisors and workers The ISO 9000 implementation plan should
make provision for this training The training should cover the basic concepts of quality management
systems and the standard and their overall impact on the strategic goals of the organization the changed
processes
and the likely work culture implications of the system In addition initial training may also be necessary on
writing quality manuals procedures and work instruction auditing principles techniques of laboratory
management calibration testing procedures etc When in-house capacity to carry out such training is not
available it may be necessary to participate in external training courses run by professional training
organizations
Alternatively an external training institution could be invited to conduct in-house training courses
Step 5 Conduct Initial Status Survey
ISO 9000 does not require duplication of effort or redundant system The goal of ISO 9000 is to create a
quality management system that conforms to the standard This does not preclude incorporating
adapting and adding onto quality programs already in place So the next step in the implementation
process is to compare the organizationrsquos existing quality management system if there is one -- with the
requirements of the standard (ISO 90012000)
For this purpose an organization flow chart showing how information actually flows (not what should be
done) from order placement by the customer to delivery to this customer should be drawn up From this
13
over-all flow chart a flow chart of activities in each department should be prepared With the aid of the
flow charts a record of existing quality management system should be established A significant number
of written procedures may already be in place Unless they are very much out of date these documents
should not be discarded Rather they should be incorporated into the new quality management system
Documents requiring modification or elaboration should be identified and listed This exercise is some
times referred to as gap analysis During these review processes wide consultation with executives
and representatives of various unions and associations within the organization is required to enlist their
active cooperation
In the review process documents should be collected studied and registered for further use possibly
after they have been revised Before developing new quality management system documentation we
need to consider with which quality requirements or department we should start The best is to select an
area where processes are fairly well organized running effectively and functioning satisfactorily
The basic approach is to determine and record how a process is currently carried out We can do this by
identifying the people involved and obtaining information from them during individual interviews
Unfortunately it often happens that different people will give different contradicting versions of a process
Each one may refer to oral instructions that are not accurate or clear This is why the facts are often not
described correctly the first time around and have to be revised several times Once it has been agreed
how to describe the current process this process has to be adapted supplemented and implemented
according to the requirements of the quality standard (ISO 90012000) This requires organizational
arrangements the drawing up of additional documents and possible removal of existing documentation
(eg procedures inspectiontest plans inspectiontest instructions) and records (eg inspectiontest
reports inspectiontest certificates)
In introducing a quality management system the emphasis is on the improvement of the existing
processes or the re-organization of processes In general the steps to follow are the following
Ascertain and establish the following What is the present operationprocess What already
exists
Analyze the relevant sections of the quality standard - ISO 90012000 What is actually required
If necessary supplement and change operational arrangements in accordance with the standard
develop documents and records and describe operationsprocesses What is the desired
operationprocess
Step 6 Create a Documented Implementation Plan
14
Once the organization has obtained a clear picture of how its quality management system compares with
the ISO 90012000 standard all non-conformances must be addressed with a documented
implementation plan Usually the plan calls for identifying and describing processes to make the
organizationrsquos quality management system fully in compliance with the standard
The implementation plan should be thorough and specific detailing
Quality documentation to be developed
Objective of the system
Pertinent ISO 90012000 section
Person or team responsible
Approval required
Training required
Resources required
Estimated completion date
These elements should be organized into a detailed chart to be reviewed and approved The plan should
define the responsibilities of different departments and personnel and set target dates for the completion
of activities Once approved the Management Representative should control review and update the plan
as the implementation process proceeds
Step 7 Develop Quality Management System Documentation
Documentation is the most common area of non-conformance among organizations wishing to implement
ISO 9000 quality management systems As one company pointed out When we started our
implementation we found that documentation was inadequate Even absent in some areas Take
calibration Obviously its necessary and obviously we do it but it wasnt being documented Another
area was inspection and testing We inspect and test practically every item that leaves
here but our documentation was inadequate
Documentation of the quality management system should include
Documented statements of a quality policy and quality objectives
A quality manual
Documented procedures and records required by the standard ISO 90012000
and
15
Documents needed by the organization to ensure the effective planning operation
and control of its processes Quality documentation is generally prepared in the three levels
indicated in the box that follows
Level A Quality manual
States the scope of the quality management system including exclusions and details of their justification
and describes the processes of the quality management system and their interaction Generally gives an
organization profile presents the organizational relationships and responsibilities of persons whose work
affects quality and outlines the main procedures It may also describe organizations quality policy and
quality objectives
Level B Quality management system procedures
Describes the activities of individual departments how quality is controlled in each department and the
checks that are carried out
Level C Quality documents (forms reports work instructions etc)
Work instructions describe in detail how specific tasks are performed include drawing standards
methods of tests customers specifications etc
Presents forms to be used for recording observations etc
In small companies the above levels of documentation could be presented in one manual otherwise
separate manuals should be prepared A list of the documents to be prepared should be drawn up and
the responsibility for writing the documents should be assigned to the persons concerned in various
functional departments They should be advised to prepare the drafts within a specific time frame
Step 8 Document Control
Once the necessary quality management system documentation has been generated a documented
system must be created to control it Control is simply a means of managing the creation approval
distribution revision storage and disposal of the various types of documentation Document control
systems should be as simple and as easy to operate as possible -- sufficient to meet ISO 90012000
requirements and that is all
Document control should include
Approval for adequacy by authorized person (s) before issue
16
Review updating and re-approval of documents by authorized person (s)
Identification of changes and of the revision status of documents
Availability of relevant versions of documents at points of use
Identification and control of documents of external origin
Assurance of legibility and identifability of documents and
Prevention of unintended use of obsolete documents
The principle of ISO 9000 document control is that employees should have access to the documentation
and records needed to fulfil their responsibilities
Step 9 Implementation
It is good practice to implement the quality management system being documented as the documentation
is developed although this may be more effective in larger firms In smaller companies the quality
management system is often implemented all at once throughout the organization Where phased
implementation takes place the effectiveness of the system in selected areas can be evaluated It would
be a good idea initially to evaluate areas where the chances of a positive evaluation are high to maintain
the confidence of both management and staff in the merits of implementing the quality management
system
The implementation progress should be monitored to ensure that the quality management system is
effective and conforms to the standard These activities include internal quality audit formal corrective
action and management review
Step 10 Internal Quality Audit
As the system is being installed its effectiveness should be checked by regular internal quality audits
Internal quality audits are conducted to verify that the installed quality management system
Conform to the planned arrangements to the requirements of the standard (ISO 90012000) and
to the quality management system requirements established by your organization and
Is effectively implemented and maintained Even after the system stabilizes and starts
functioning internal audits should be planned and performed as part of an ongoing strategy A
few staff members should be trained to carry out internal auditing Use ISO 19011 for guidance in
auditing auditor qualification and programmes
17
Step 11 Management Review
When the installed quality management system has been operating for three to six months an internal
audit and management review should be conducted and corrective actions implemented The
management reviews are conducted to ensure the continuing suitability adequacy and effectiveness of
the quality management system1048578 The review should include assessing opportunities for improvement
and the need for changes to the quality management system including the quality policy and quality
objectives The input to management review should include information on
Results of audits
Customer feed back
Process performance and product conformity
Status of preventive and corrective actions
Follow-up actions from previous management reviews
Changes that could affect the quality management system and
Recommendations for improvements
Management reviews should also address the pitfalls to effective implementation including lack of CEO
commitment failure to involve everyone in the process and failure to monitor progress and enforce
deadlines
Step 12 Pre-assessment Audit
When system deficiencies are no longer visible it is normally time to apply for certification However
before doing so a pre-assessment audit should be arranged with an independent and qualified auditor
Sometimes certification bodies provide this service for a nominal charge The pre-assessment audit would
provide a degree of confidence for formally going ahead with an application for certification
Step 13 Certification and Registration
Once the quality management system has been in operation for a few months and has stabilized a formal
application for certification could be made to a selected certification agency The certification agency first
carries out an audit of the documents (referred to as an adequacy audit) If the documents conform to
18
the requirements of the quality standard then on-site audit is carried out If the certification body finds the
system to be working satisfactorily it awards the organization a certificate generally for a period of three
years During this three-year period it will carry out periodic surveillance audits to ensure that the system
is continuing to operate satisfactorily
Step 14 Continual Improvement
Certification to ISO 9000 should not be an end We should continually seek to improve the effectiveness
and suitability of the quality management system through the use of
Quality policy
Quality objectives
Audit results
Analysis of data
Corrective and preventive actions
Management review
ISO 90042000 provides a methodology for continual improvement
19
over-all flow chart a flow chart of activities in each department should be prepared With the aid of the
flow charts a record of existing quality management system should be established A significant number
of written procedures may already be in place Unless they are very much out of date these documents
should not be discarded Rather they should be incorporated into the new quality management system
Documents requiring modification or elaboration should be identified and listed This exercise is some
times referred to as gap analysis During these review processes wide consultation with executives
and representatives of various unions and associations within the organization is required to enlist their
active cooperation
In the review process documents should be collected studied and registered for further use possibly
after they have been revised Before developing new quality management system documentation we
need to consider with which quality requirements or department we should start The best is to select an
area where processes are fairly well organized running effectively and functioning satisfactorily
The basic approach is to determine and record how a process is currently carried out We can do this by
identifying the people involved and obtaining information from them during individual interviews
Unfortunately it often happens that different people will give different contradicting versions of a process
Each one may refer to oral instructions that are not accurate or clear This is why the facts are often not
described correctly the first time around and have to be revised several times Once it has been agreed
how to describe the current process this process has to be adapted supplemented and implemented
according to the requirements of the quality standard (ISO 90012000) This requires organizational
arrangements the drawing up of additional documents and possible removal of existing documentation
(eg procedures inspectiontest plans inspectiontest instructions) and records (eg inspectiontest
reports inspectiontest certificates)
In introducing a quality management system the emphasis is on the improvement of the existing
processes or the re-organization of processes In general the steps to follow are the following
Ascertain and establish the following What is the present operationprocess What already
exists
Analyze the relevant sections of the quality standard - ISO 90012000 What is actually required
If necessary supplement and change operational arrangements in accordance with the standard
develop documents and records and describe operationsprocesses What is the desired
operationprocess
Step 6 Create a Documented Implementation Plan
14
Once the organization has obtained a clear picture of how its quality management system compares with
the ISO 90012000 standard all non-conformances must be addressed with a documented
implementation plan Usually the plan calls for identifying and describing processes to make the
organizationrsquos quality management system fully in compliance with the standard
The implementation plan should be thorough and specific detailing
Quality documentation to be developed
Objective of the system
Pertinent ISO 90012000 section
Person or team responsible
Approval required
Training required
Resources required
Estimated completion date
These elements should be organized into a detailed chart to be reviewed and approved The plan should
define the responsibilities of different departments and personnel and set target dates for the completion
of activities Once approved the Management Representative should control review and update the plan
as the implementation process proceeds
Step 7 Develop Quality Management System Documentation
Documentation is the most common area of non-conformance among organizations wishing to implement
ISO 9000 quality management systems As one company pointed out When we started our
implementation we found that documentation was inadequate Even absent in some areas Take
calibration Obviously its necessary and obviously we do it but it wasnt being documented Another
area was inspection and testing We inspect and test practically every item that leaves
here but our documentation was inadequate
Documentation of the quality management system should include
Documented statements of a quality policy and quality objectives
A quality manual
Documented procedures and records required by the standard ISO 90012000
and
15
Documents needed by the organization to ensure the effective planning operation
and control of its processes Quality documentation is generally prepared in the three levels
indicated in the box that follows
Level A Quality manual
States the scope of the quality management system including exclusions and details of their justification
and describes the processes of the quality management system and their interaction Generally gives an
organization profile presents the organizational relationships and responsibilities of persons whose work
affects quality and outlines the main procedures It may also describe organizations quality policy and
quality objectives
Level B Quality management system procedures
Describes the activities of individual departments how quality is controlled in each department and the
checks that are carried out
Level C Quality documents (forms reports work instructions etc)
Work instructions describe in detail how specific tasks are performed include drawing standards
methods of tests customers specifications etc
Presents forms to be used for recording observations etc
In small companies the above levels of documentation could be presented in one manual otherwise
separate manuals should be prepared A list of the documents to be prepared should be drawn up and
the responsibility for writing the documents should be assigned to the persons concerned in various
functional departments They should be advised to prepare the drafts within a specific time frame
Step 8 Document Control
Once the necessary quality management system documentation has been generated a documented
system must be created to control it Control is simply a means of managing the creation approval
distribution revision storage and disposal of the various types of documentation Document control
systems should be as simple and as easy to operate as possible -- sufficient to meet ISO 90012000
requirements and that is all
Document control should include
Approval for adequacy by authorized person (s) before issue
16
Review updating and re-approval of documents by authorized person (s)
Identification of changes and of the revision status of documents
Availability of relevant versions of documents at points of use
Identification and control of documents of external origin
Assurance of legibility and identifability of documents and
Prevention of unintended use of obsolete documents
The principle of ISO 9000 document control is that employees should have access to the documentation
and records needed to fulfil their responsibilities
Step 9 Implementation
It is good practice to implement the quality management system being documented as the documentation
is developed although this may be more effective in larger firms In smaller companies the quality
management system is often implemented all at once throughout the organization Where phased
implementation takes place the effectiveness of the system in selected areas can be evaluated It would
be a good idea initially to evaluate areas where the chances of a positive evaluation are high to maintain
the confidence of both management and staff in the merits of implementing the quality management
system
The implementation progress should be monitored to ensure that the quality management system is
effective and conforms to the standard These activities include internal quality audit formal corrective
action and management review
Step 10 Internal Quality Audit
As the system is being installed its effectiveness should be checked by regular internal quality audits
Internal quality audits are conducted to verify that the installed quality management system
Conform to the planned arrangements to the requirements of the standard (ISO 90012000) and
to the quality management system requirements established by your organization and
Is effectively implemented and maintained Even after the system stabilizes and starts
functioning internal audits should be planned and performed as part of an ongoing strategy A
few staff members should be trained to carry out internal auditing Use ISO 19011 for guidance in
auditing auditor qualification and programmes
17
Step 11 Management Review
When the installed quality management system has been operating for three to six months an internal
audit and management review should be conducted and corrective actions implemented The
management reviews are conducted to ensure the continuing suitability adequacy and effectiveness of
the quality management system1048578 The review should include assessing opportunities for improvement
and the need for changes to the quality management system including the quality policy and quality
objectives The input to management review should include information on
Results of audits
Customer feed back
Process performance and product conformity
Status of preventive and corrective actions
Follow-up actions from previous management reviews
Changes that could affect the quality management system and
Recommendations for improvements
Management reviews should also address the pitfalls to effective implementation including lack of CEO
commitment failure to involve everyone in the process and failure to monitor progress and enforce
deadlines
Step 12 Pre-assessment Audit
When system deficiencies are no longer visible it is normally time to apply for certification However
before doing so a pre-assessment audit should be arranged with an independent and qualified auditor
Sometimes certification bodies provide this service for a nominal charge The pre-assessment audit would
provide a degree of confidence for formally going ahead with an application for certification
Step 13 Certification and Registration
Once the quality management system has been in operation for a few months and has stabilized a formal
application for certification could be made to a selected certification agency The certification agency first
carries out an audit of the documents (referred to as an adequacy audit) If the documents conform to
18
the requirements of the quality standard then on-site audit is carried out If the certification body finds the
system to be working satisfactorily it awards the organization a certificate generally for a period of three
years During this three-year period it will carry out periodic surveillance audits to ensure that the system
is continuing to operate satisfactorily
Step 14 Continual Improvement
Certification to ISO 9000 should not be an end We should continually seek to improve the effectiveness
and suitability of the quality management system through the use of
Quality policy
Quality objectives
Audit results
Analysis of data
Corrective and preventive actions
Management review
ISO 90042000 provides a methodology for continual improvement
19
Once the organization has obtained a clear picture of how its quality management system compares with
the ISO 90012000 standard all non-conformances must be addressed with a documented
implementation plan Usually the plan calls for identifying and describing processes to make the
organizationrsquos quality management system fully in compliance with the standard
The implementation plan should be thorough and specific detailing
Quality documentation to be developed
Objective of the system
Pertinent ISO 90012000 section
Person or team responsible
Approval required
Training required
Resources required
Estimated completion date
These elements should be organized into a detailed chart to be reviewed and approved The plan should
define the responsibilities of different departments and personnel and set target dates for the completion
of activities Once approved the Management Representative should control review and update the plan
as the implementation process proceeds
Step 7 Develop Quality Management System Documentation
Documentation is the most common area of non-conformance among organizations wishing to implement
ISO 9000 quality management systems As one company pointed out When we started our
implementation we found that documentation was inadequate Even absent in some areas Take
calibration Obviously its necessary and obviously we do it but it wasnt being documented Another
area was inspection and testing We inspect and test practically every item that leaves
here but our documentation was inadequate
Documentation of the quality management system should include
Documented statements of a quality policy and quality objectives
A quality manual
Documented procedures and records required by the standard ISO 90012000
and
15
Documents needed by the organization to ensure the effective planning operation
and control of its processes Quality documentation is generally prepared in the three levels
indicated in the box that follows
Level A Quality manual
States the scope of the quality management system including exclusions and details of their justification
and describes the processes of the quality management system and their interaction Generally gives an
organization profile presents the organizational relationships and responsibilities of persons whose work
affects quality and outlines the main procedures It may also describe organizations quality policy and
quality objectives
Level B Quality management system procedures
Describes the activities of individual departments how quality is controlled in each department and the
checks that are carried out
Level C Quality documents (forms reports work instructions etc)
Work instructions describe in detail how specific tasks are performed include drawing standards
methods of tests customers specifications etc
Presents forms to be used for recording observations etc
In small companies the above levels of documentation could be presented in one manual otherwise
separate manuals should be prepared A list of the documents to be prepared should be drawn up and
the responsibility for writing the documents should be assigned to the persons concerned in various
functional departments They should be advised to prepare the drafts within a specific time frame
Step 8 Document Control
Once the necessary quality management system documentation has been generated a documented
system must be created to control it Control is simply a means of managing the creation approval
distribution revision storage and disposal of the various types of documentation Document control
systems should be as simple and as easy to operate as possible -- sufficient to meet ISO 90012000
requirements and that is all
Document control should include
Approval for adequacy by authorized person (s) before issue
16
Review updating and re-approval of documents by authorized person (s)
Identification of changes and of the revision status of documents
Availability of relevant versions of documents at points of use
Identification and control of documents of external origin
Assurance of legibility and identifability of documents and
Prevention of unintended use of obsolete documents
The principle of ISO 9000 document control is that employees should have access to the documentation
and records needed to fulfil their responsibilities
Step 9 Implementation
It is good practice to implement the quality management system being documented as the documentation
is developed although this may be more effective in larger firms In smaller companies the quality
management system is often implemented all at once throughout the organization Where phased
implementation takes place the effectiveness of the system in selected areas can be evaluated It would
be a good idea initially to evaluate areas where the chances of a positive evaluation are high to maintain
the confidence of both management and staff in the merits of implementing the quality management
system
The implementation progress should be monitored to ensure that the quality management system is
effective and conforms to the standard These activities include internal quality audit formal corrective
action and management review
Step 10 Internal Quality Audit
As the system is being installed its effectiveness should be checked by regular internal quality audits
Internal quality audits are conducted to verify that the installed quality management system
Conform to the planned arrangements to the requirements of the standard (ISO 90012000) and
to the quality management system requirements established by your organization and
Is effectively implemented and maintained Even after the system stabilizes and starts
functioning internal audits should be planned and performed as part of an ongoing strategy A
few staff members should be trained to carry out internal auditing Use ISO 19011 for guidance in
auditing auditor qualification and programmes
17
Step 11 Management Review
When the installed quality management system has been operating for three to six months an internal
audit and management review should be conducted and corrective actions implemented The
management reviews are conducted to ensure the continuing suitability adequacy and effectiveness of
the quality management system1048578 The review should include assessing opportunities for improvement
and the need for changes to the quality management system including the quality policy and quality
objectives The input to management review should include information on
Results of audits
Customer feed back
Process performance and product conformity
Status of preventive and corrective actions
Follow-up actions from previous management reviews
Changes that could affect the quality management system and
Recommendations for improvements
Management reviews should also address the pitfalls to effective implementation including lack of CEO
commitment failure to involve everyone in the process and failure to monitor progress and enforce
deadlines
Step 12 Pre-assessment Audit
When system deficiencies are no longer visible it is normally time to apply for certification However
before doing so a pre-assessment audit should be arranged with an independent and qualified auditor
Sometimes certification bodies provide this service for a nominal charge The pre-assessment audit would
provide a degree of confidence for formally going ahead with an application for certification
Step 13 Certification and Registration
Once the quality management system has been in operation for a few months and has stabilized a formal
application for certification could be made to a selected certification agency The certification agency first
carries out an audit of the documents (referred to as an adequacy audit) If the documents conform to
18
the requirements of the quality standard then on-site audit is carried out If the certification body finds the
system to be working satisfactorily it awards the organization a certificate generally for a period of three
years During this three-year period it will carry out periodic surveillance audits to ensure that the system
is continuing to operate satisfactorily
Step 14 Continual Improvement
Certification to ISO 9000 should not be an end We should continually seek to improve the effectiveness
and suitability of the quality management system through the use of
Quality policy
Quality objectives
Audit results
Analysis of data
Corrective and preventive actions
Management review
ISO 90042000 provides a methodology for continual improvement
19
Documents needed by the organization to ensure the effective planning operation
and control of its processes Quality documentation is generally prepared in the three levels
indicated in the box that follows
Level A Quality manual
States the scope of the quality management system including exclusions and details of their justification
and describes the processes of the quality management system and their interaction Generally gives an
organization profile presents the organizational relationships and responsibilities of persons whose work
affects quality and outlines the main procedures It may also describe organizations quality policy and
quality objectives
Level B Quality management system procedures
Describes the activities of individual departments how quality is controlled in each department and the
checks that are carried out
Level C Quality documents (forms reports work instructions etc)
Work instructions describe in detail how specific tasks are performed include drawing standards
methods of tests customers specifications etc
Presents forms to be used for recording observations etc
In small companies the above levels of documentation could be presented in one manual otherwise
separate manuals should be prepared A list of the documents to be prepared should be drawn up and
the responsibility for writing the documents should be assigned to the persons concerned in various
functional departments They should be advised to prepare the drafts within a specific time frame
Step 8 Document Control
Once the necessary quality management system documentation has been generated a documented
system must be created to control it Control is simply a means of managing the creation approval
distribution revision storage and disposal of the various types of documentation Document control
systems should be as simple and as easy to operate as possible -- sufficient to meet ISO 90012000
requirements and that is all
Document control should include
Approval for adequacy by authorized person (s) before issue
16
Review updating and re-approval of documents by authorized person (s)
Identification of changes and of the revision status of documents
Availability of relevant versions of documents at points of use
Identification and control of documents of external origin
Assurance of legibility and identifability of documents and
Prevention of unintended use of obsolete documents
The principle of ISO 9000 document control is that employees should have access to the documentation
and records needed to fulfil their responsibilities
Step 9 Implementation
It is good practice to implement the quality management system being documented as the documentation
is developed although this may be more effective in larger firms In smaller companies the quality
management system is often implemented all at once throughout the organization Where phased
implementation takes place the effectiveness of the system in selected areas can be evaluated It would
be a good idea initially to evaluate areas where the chances of a positive evaluation are high to maintain
the confidence of both management and staff in the merits of implementing the quality management
system
The implementation progress should be monitored to ensure that the quality management system is
effective and conforms to the standard These activities include internal quality audit formal corrective
action and management review
Step 10 Internal Quality Audit
As the system is being installed its effectiveness should be checked by regular internal quality audits
Internal quality audits are conducted to verify that the installed quality management system
Conform to the planned arrangements to the requirements of the standard (ISO 90012000) and
to the quality management system requirements established by your organization and
Is effectively implemented and maintained Even after the system stabilizes and starts
functioning internal audits should be planned and performed as part of an ongoing strategy A
few staff members should be trained to carry out internal auditing Use ISO 19011 for guidance in
auditing auditor qualification and programmes
17
Step 11 Management Review
When the installed quality management system has been operating for three to six months an internal
audit and management review should be conducted and corrective actions implemented The
management reviews are conducted to ensure the continuing suitability adequacy and effectiveness of
the quality management system1048578 The review should include assessing opportunities for improvement
and the need for changes to the quality management system including the quality policy and quality
objectives The input to management review should include information on
Results of audits
Customer feed back
Process performance and product conformity
Status of preventive and corrective actions
Follow-up actions from previous management reviews
Changes that could affect the quality management system and
Recommendations for improvements
Management reviews should also address the pitfalls to effective implementation including lack of CEO
commitment failure to involve everyone in the process and failure to monitor progress and enforce
deadlines
Step 12 Pre-assessment Audit
When system deficiencies are no longer visible it is normally time to apply for certification However
before doing so a pre-assessment audit should be arranged with an independent and qualified auditor
Sometimes certification bodies provide this service for a nominal charge The pre-assessment audit would
provide a degree of confidence for formally going ahead with an application for certification
Step 13 Certification and Registration
Once the quality management system has been in operation for a few months and has stabilized a formal
application for certification could be made to a selected certification agency The certification agency first
carries out an audit of the documents (referred to as an adequacy audit) If the documents conform to
18
the requirements of the quality standard then on-site audit is carried out If the certification body finds the
system to be working satisfactorily it awards the organization a certificate generally for a period of three
years During this three-year period it will carry out periodic surveillance audits to ensure that the system
is continuing to operate satisfactorily
Step 14 Continual Improvement
Certification to ISO 9000 should not be an end We should continually seek to improve the effectiveness
and suitability of the quality management system through the use of
Quality policy
Quality objectives
Audit results
Analysis of data
Corrective and preventive actions
Management review
ISO 90042000 provides a methodology for continual improvement
19
Review updating and re-approval of documents by authorized person (s)
Identification of changes and of the revision status of documents
Availability of relevant versions of documents at points of use
Identification and control of documents of external origin
Assurance of legibility and identifability of documents and
Prevention of unintended use of obsolete documents
The principle of ISO 9000 document control is that employees should have access to the documentation
and records needed to fulfil their responsibilities
Step 9 Implementation
It is good practice to implement the quality management system being documented as the documentation
is developed although this may be more effective in larger firms In smaller companies the quality
management system is often implemented all at once throughout the organization Where phased
implementation takes place the effectiveness of the system in selected areas can be evaluated It would
be a good idea initially to evaluate areas where the chances of a positive evaluation are high to maintain
the confidence of both management and staff in the merits of implementing the quality management
system
The implementation progress should be monitored to ensure that the quality management system is
effective and conforms to the standard These activities include internal quality audit formal corrective
action and management review
Step 10 Internal Quality Audit
As the system is being installed its effectiveness should be checked by regular internal quality audits
Internal quality audits are conducted to verify that the installed quality management system
Conform to the planned arrangements to the requirements of the standard (ISO 90012000) and
to the quality management system requirements established by your organization and
Is effectively implemented and maintained Even after the system stabilizes and starts
functioning internal audits should be planned and performed as part of an ongoing strategy A
few staff members should be trained to carry out internal auditing Use ISO 19011 for guidance in
auditing auditor qualification and programmes
17
Step 11 Management Review
When the installed quality management system has been operating for three to six months an internal
audit and management review should be conducted and corrective actions implemented The
management reviews are conducted to ensure the continuing suitability adequacy and effectiveness of
the quality management system1048578 The review should include assessing opportunities for improvement
and the need for changes to the quality management system including the quality policy and quality
objectives The input to management review should include information on
Results of audits
Customer feed back
Process performance and product conformity
Status of preventive and corrective actions
Follow-up actions from previous management reviews
Changes that could affect the quality management system and
Recommendations for improvements
Management reviews should also address the pitfalls to effective implementation including lack of CEO
commitment failure to involve everyone in the process and failure to monitor progress and enforce
deadlines
Step 12 Pre-assessment Audit
When system deficiencies are no longer visible it is normally time to apply for certification However
before doing so a pre-assessment audit should be arranged with an independent and qualified auditor
Sometimes certification bodies provide this service for a nominal charge The pre-assessment audit would
provide a degree of confidence for formally going ahead with an application for certification
Step 13 Certification and Registration
Once the quality management system has been in operation for a few months and has stabilized a formal
application for certification could be made to a selected certification agency The certification agency first
carries out an audit of the documents (referred to as an adequacy audit) If the documents conform to
18
the requirements of the quality standard then on-site audit is carried out If the certification body finds the
system to be working satisfactorily it awards the organization a certificate generally for a period of three
years During this three-year period it will carry out periodic surveillance audits to ensure that the system
is continuing to operate satisfactorily
Step 14 Continual Improvement
Certification to ISO 9000 should not be an end We should continually seek to improve the effectiveness
and suitability of the quality management system through the use of
Quality policy
Quality objectives
Audit results
Analysis of data
Corrective and preventive actions
Management review
ISO 90042000 provides a methodology for continual improvement
19
Step 11 Management Review
When the installed quality management system has been operating for three to six months an internal
audit and management review should be conducted and corrective actions implemented The
management reviews are conducted to ensure the continuing suitability adequacy and effectiveness of
the quality management system1048578 The review should include assessing opportunities for improvement
and the need for changes to the quality management system including the quality policy and quality
objectives The input to management review should include information on
Results of audits
Customer feed back
Process performance and product conformity
Status of preventive and corrective actions
Follow-up actions from previous management reviews
Changes that could affect the quality management system and
Recommendations for improvements
Management reviews should also address the pitfalls to effective implementation including lack of CEO
commitment failure to involve everyone in the process and failure to monitor progress and enforce
deadlines
Step 12 Pre-assessment Audit
When system deficiencies are no longer visible it is normally time to apply for certification However
before doing so a pre-assessment audit should be arranged with an independent and qualified auditor
Sometimes certification bodies provide this service for a nominal charge The pre-assessment audit would
provide a degree of confidence for formally going ahead with an application for certification
Step 13 Certification and Registration
Once the quality management system has been in operation for a few months and has stabilized a formal
application for certification could be made to a selected certification agency The certification agency first
carries out an audit of the documents (referred to as an adequacy audit) If the documents conform to
18
the requirements of the quality standard then on-site audit is carried out If the certification body finds the
system to be working satisfactorily it awards the organization a certificate generally for a period of three
years During this three-year period it will carry out periodic surveillance audits to ensure that the system
is continuing to operate satisfactorily
Step 14 Continual Improvement
Certification to ISO 9000 should not be an end We should continually seek to improve the effectiveness
and suitability of the quality management system through the use of
Quality policy
Quality objectives
Audit results
Analysis of data
Corrective and preventive actions
Management review
ISO 90042000 provides a methodology for continual improvement
19
the requirements of the quality standard then on-site audit is carried out If the certification body finds the
system to be working satisfactorily it awards the organization a certificate generally for a period of three
years During this three-year period it will carry out periodic surveillance audits to ensure that the system
is continuing to operate satisfactorily
Step 14 Continual Improvement
Certification to ISO 9000 should not be an end We should continually seek to improve the effectiveness
and suitability of the quality management system through the use of
Quality policy
Quality objectives
Audit results
Analysis of data
Corrective and preventive actions
Management review
ISO 90042000 provides a methodology for continual improvement
19