Block 1 MS 53 Unit 1

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Issues in Production/TQM ettorts are led by top management by involving everyone in the company with

the prime objective of satisfying the external customer. This focuses the

organizational efforts towards satisfying the internal customer with the help of a

quality management system for ' doing things right the first time. The traditional

approach of post-production detection of defects is discouraged and a prevention

philosophy is adopted to bring down the nonconformances. The organization seeks

continuous never-ending improvements which are tracked with the help of

appropriate measurement systems.

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Operations Management

In this chapter the focus will be on understanding the customer and the process andthen satisfying the customer by improving the process through total involvement of

employees. After a brief historical perspective on. TQM and its relevance to Indian

organizations (Section 3, 2), we will define the various terms relevant to quality

management (Section 3.3).

TQM organizations focus on understanding and responding to the needs of the

customer. The voice of the customer is clearly identified and then deployed

throughout the organization with minimum of distortions. In section 3.4, we will

discuss the techniques used to identify customer satisfaction and their expectations.

We will understand what Quality Function Deployment (QFD) means and what is a

house of quality.

In most organizations there are different functions which are geared towards

supporting the core manufacturing (or service) process. Functions, such as, design,

engineering, marketing, finance, systems, R&D, administration, health care and so

on. All these functions can be seen as processes which are designed to satisfy

customer needs. All processes have variations which need to be controlled and then

improved in a never ending cycle of efforts aimed at continuous improvement. In

section 3.5, we will discuss how to get into the path of continuous improvement.

Various problem solving tools will be presented. Procedures will be explained for

identifying major nonconformances and therefore the major problem areas. Since we

are aiming for continuous improvement, measurement systems for monitoring the

quality performance will be discussed. We sketch out a measurement framework for

identifying nonconformances. We will also understand what cost of quality means

and how to establish a measurement system.Even though customers are the driving force behind the process, without total

employee involvement (in terms of alignment, motivation and empowerment) and top

management leadership, the TQM efforts become futile. Methods need to be adopted

to stimulate total involvement and move toward the common goals of systematic and

continuous improvement with the ultimate aim of satisfying customers, employees

and stakeholders. These aspects will be discussed in section 3.6.

Before concluding, in section 3.7, we will introduce an International quality systems

standard called ISO 9000. Even though a TQM organization is beyond ISO 9000, the

exercise undergone for getting the quality systems certification brings in the

discipline much needed for a organization practicing TQM:

3.2 TQM: A HISTORICAL PERSPECTIVEQuality management systems have evolved through quality control (QC), quality

assurance (QA), and total quality control (TQC) systems to total quality management

(TQM) systems. We will briefly sketch out each of these systems.

Quality control is concerned with defect detection by using post-production

inspection procedures. Statistical quality control techniques are used while inspecting

the finished goods. Main focus is on the product i. co what is wrong with the product

(or part). Techniques such as acceptance sampling, control charts, control by

attributes and control by variables are typically used by the QC inspectors while

controlling the quality of goods manufactured. The extent of employee involvement

is minimal. Only few inspectors from the QC department are involved in quality

control activities. It takes a real short time (within days) to install a QC system.

However, such systems do not help identify problems.

Quality assurance systems aim to produce as per design specifications and emphasize

defect prevention. Quality is built into the system (that produces the product) by using

production and operations management principles. Statistical process control techniques

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Total Quality Managementare used to monitor the process by allowing random variations and eliminating non

random variations. Main focus is on the process -i.e., what is wrong with the process

which manufactures the product. Quality system standards (such as ISO 9000) are

adopted to assure quality in the process. ISO 9000 is an International systems

standard which shows how an organization can establish, document and maintain an

effective quality system. It helps demonstrate to the customer that the organization is

committed to quality and has the ability to meet their requirements. The employee

involvement is limited within the centralized-staff function of the QA department. It

takes between six to twelve months to install such a system. The main theme her is todocument (with well defined procedures) what you do and do what you document.

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Total quality control systems are concerned with cost reduction efforts as a drive

towards continual improvement. Here quality is organized into the system. These

systems take off once the cost of quality is calculated. Problem areas are identified

and problem solving techniques are used extensively during the continuous

improvement cycle. Performance is monitored with the help of the COQ system.

These efforts enhance the product quality. Here waste identification and removal is

an important benefit. Philip Crosby's zero defects program (Table 3.1) is a TQC

approach. So is the Taguchi methodology which emphasizes the importance of a

robust design to take care of all downstream fluctuations. In TQC systems we have

more involvement in the form of various quality circles working towards improvingthe processes. Time to install is between one to three years. It may be noted that QA

standards form the basis for a TQC or TQM approach.

Total quality management systems manage quality in. They have a strong

philosophical base that incorporates several important concepts of TQC systems.

Management efforts are oriented towards the achievement of complete customer

satisfaction. Here we find an organization wide responsibility for quality. Time to

install is three to five years. The evolution shows a culture change in the organization

which achieves customer orientation through various stages of development that

progress through a systems oriented to an improvement oriented to a prevention

oriented state.

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Issues in Production/

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Figure 3.1 and Table 3.1 show how TQM emerged over the century and who werethe quality gurus who were responsible for the status this philosophy commands

today. The progress from quality control to quality assurance to total quality control

to total quality management took almost a century of concerted efforts from quality

gurus, such as, Walter Shewhart, W. Edwards Deming, Joseph Juran, Kaoru

Ishikawa, Genichi Taguchi, Armand Feigenbaum, and Philip Crosby. The quality

movement was initiated in Japan by Deming and Juran. It was later picked up by the

Japanese who have made the quality movement a big success story. Around the 80s

Japanese companies, on a continuous cycle of never-ending improvements, surpassed

the west. They captured the markets with their consistent: quality products and have

now shifted their priorities on to satisfying customers with products having high

quality at low price.

We will take a. brief look into the Indian scenario. According to the World

Competitiveness Report (1994) Indian companies lag far behind their global

competitors in terms of customer orientation, time to innovate, time to market and, in

general, in terms of TQM practices. Under the liberalized scenario, it is more of a

concern because the global players are now entering the Indian market. We may be

having global capacities in some cases but we fail in terms of global quality For us it

is a Catch 22 with a difference-if we don't practice TQM we die; If we practice TQM

we struggle to survive (vie may not surpass but we do survive and may be succeed). I

used the word survive because our competitors are already much superior to us in

terms of quality practices. For example global players may be having component

rejection rates of I in 10,000 while Indian companies are struggling with rejection

rates of I in 100. A case in point is the US based company Motorola, which has made

the slogan six sigma quite famous by targeting 99.99997% defect free manufacturing.

According to a 1995 Business Today survey, Indian plants have trouble achieving

even 95% defect free manufacturing. In most cases the burden of high rejection is

passed on to the customer. But with liberalization becoming a reality the customer

has a choice. And companies have to listen to the voice of the customer to drive their

quality initiatives. With mass customization becoming a goal of most quality

programs, there is a lot of pressure on the Indian companies. There is a need, in most

sectors, for instant translation of new designs into finished products with no defects.

3.3 QUALITY TERMINOLOGY

In this section we will define some of' the terms which are normally used in TQM

classes. We will try to understand the meaning of quality , customer, product, quality of

design and

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Total Quality Managementquality of conformance (relationship between product and customer through quality)

quality cost, quality measurement (relationship between quality and cost), value

addition, small q, big Q, non-conformances and rework' (relationship between quality

and productivity).

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Quality: There are several definitions of CK word. For example:

"Quality is customer satisfaction"

"Quality means meeting customer requirements"

"Quality means fitness for use"

"Quality is conformance to specifications"

"Totality of features and characteristics of a product or service that bear on

its ability to satisfy stated or implied needs"

Customer: "Anyone who is impacted by the product or service". By this definition

we find that there are several customers waiting down the line when a product is

being processed through several stages in an organization before it reaches the final

consumer. Thus we have people who are impacted within the organization and also

people impacted outside the organization. Thus we have two type of customers - the

internal customers and the external customers.

External customer: One who purchases a commodity or service. External customers

are the driving forces behind an organizations business. Figure 3.2 below shows the

external customer.

Internal customer: Any individual (or group or organization) who receives and uses

what an individual (or group or organization) provides (see Figure 3.2). Should

section I meet the needs of section 2? What happens to section 2, if the section 2

requirements (in terms of quality specifications) are not met by section l? What if

section 1 is not capable of meeting section 2 needs? Should the section I work in that

case be outsourced? That would mean making section 1 redundant Taking another

example, manufacturing departments are internal customers of product design anddevelopment departments. If the design department supplies engineering designs that

are not producible by the manufacturing department then the internal supplier

customer relationship suffers. The supplier here is unable to satisfy its internal

customer. Should manufacturing somehow produce it over-riding the design

specifications? How would it affect the overall quality of the product in that case? Or

should design sensitize itself to manufacturing capabilities before developing

products intended for satisfying the external customer?

Hence, almost everyone in an organization has a customer. Satisfying the customer

(either extanal or internal) involves defining their needs and expectations and also

meeting them. Dissatisfied customers are lost opportunities. Studies have indicated

that dissatisfied customers express their dissatisfaction to other potential customers.

Moreover; developing new customers to replace dissatisfied ones is costlier than

retaining satisfied customers. Hence organizations must try their best to satisfy

customers by listening to their dissatisfaction and deploying their voice through the

organization so that the situations

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Issues in Production/causing the dissatisfaction are remedied. A proactive stance is necessary in

identifying sources of dissatisfaction because when there are no complaints it does

not necessarily mean that there are no dissatisfactions. Typical methods used are

surveys, questionnaires, follow-up phone calls and so on.

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Product: Output of any process. Classified into goods, software and services.

Quality and Customer Satisfaction: We achieve customer satisfaction with the help

of several product features. Or through products that are free from deficiencies.

Products having good features meant to attract customers are said to have good

quality of design. The various dimensions of design quality could be performance,reliability, durability, ease-of-use, serviceability, aesthetics, availability of options

(additional features and expandability), and reputation. In a service setup the

dimensions are accuracy, timeliness, completeness, friendliness, anticipating

customer needs, knowledge of server, aesthetics and reputation. Hence they have the

capabilities of commanding high price and share and therefore earning higher

revenue. On the other hand products having less deficiencies are said to have good

quality of conformance. Lower deficiencies are achieved through waste reduction

leading to lower costs thereby yielding higher profits. Freedom from deficiencies or

conformance to standards are necessary at delivery, during use and during servicing.

In addition, other supporting business processes such as sales and billing should be

free from errors. Higher conformance means fewer complaints which implies greater

customer satisfaction. The net effect of improved quality of design and conformance

is increased profits (Figure 3.3).

Quality and Productivity: The focus of productivity is now shifting. The old

factory-oriented definition of productivity is " product (or service) output per unit of

resource input". The new market-oriented concept is "salable, good quality product

(or service) output per unit of resource input." The higher the value the better is the

productivity. Figure 3 uses the new definition of productivity.

Quality and Profitability: Profitability is driven by quality.

We know, profit = revenue - cost

and revenue = price * quantity sold

⇒ Profit increases if revenue increases or cost decreases.

⇒ Revenue increases if price increases (quantity sold remaining constant)

or if quantity sold increases (price remaining fixed)

Quality and Cost: There are two debatable viewpoints regarding this relationship.

Both the views are justified depending on the frame of reference. Viewpoint 1:

Improved quality requires more expensive materials, additional labor, more precisemachines and therefore lead to higher costs. Viewpoint 2 : Improved quality is

possible through savings in rework, scrap and warranty expenses leading to decrease

in costs.

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Total Quality Management

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Value Addition: When raw material is processed in an organization, at each stage

there is a value addition taking place until it comes out as finished product (see Fig

3.2). In TQM organizations the value addition does not stop here. Rather it continues

right up to the customer. Figure 3.4 shows the definition of value.

Small q vs Big Q: The above discussions indicate a need for broadening the scope of

the quality function. The traditional approach which used to be product oriented was

based on the post-production defect detection philosophy. It used to serve well under

monopolistic situations where both the organization and the market were treated as black boxes. But the big Q focus has a much larger scope with a strong customer

orientation that enhances the product quality by improving the process. The customer

is the driving force which provides the feedback for error free product development

and production. Error prevention philosophy is adopted and there is a high degree of

organizational learning which helps the organization to satisfy customers in a highly

competitive market.

Total Quality Management: Like quality there are several definitions of TQM. A

couple of them collected, from different texts are stated below. These definitions

summarize most of what we have been discussing so far.

“TQM is the system of activities directed at achieving delightedcustomers, empowered employees, higher revenues and lower costs”.

“Total quality is performance superiority directed at delighting the customers.

The means used are people, committed to employing organizational resources

to provide value to customers, by doing the right things right the first time,

every time”

Note user-based definitions ought to be translated into product-based definitions

which are be supported by manufacturing based definitions.

Activity A

Describe how increased market share and profitability might result from improvedquality in your organisations.

.........................................................................................................................................

.........................................................................................................................................

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Issues in Production/.........................................................................................................................................

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Activity B

Select one staff department (e.g. accounting, finance, marketing services, human

resources) and describe how this department can deliver quality service to its internal

customers.

.........................................................................................................................................

.........................................................................................................................................

Activity C

How would an organisation's commitment to quality facilitate or improve the

following:

- The planning Process

- Organisation

- Control

.........................................................................................................................................

.........................................................................................................................................

.........................................................................................................................................

3.4 UNDERSTANDING THE CUSTOMER

We have seen how customers are the driving force behind big Q efforts. We also

noted that virtually everyone has a customer. Understanding the stated and implied

needs of the customer is vital for any organization practicing TQM. We have to

translate the user based definitions of quality into product-based definitions. One

method of translating the voice of the customer into design specifications of a

product is quality function deployment (QFD). In this section we try to understand

what QFD is and how it is used by TQM organizations.

Quality Function Deployment

QFD is a method used to identify critical customer attributes and to create a specific

link between customer attributes and design parameters. It helps marketing and

design to answer three primary questions:

1.

What Attributes are critical to our customers?

2.

What design parameters are important in driving those attributes?

3.

What should the design parameter targets be for the new design?

Market driven companies having a sharp customer focus produce designs that are

responsive to customer needs and expectations. Most importantly these designs must

be producible with minimum of inter-departmental conflicts. We therefore need

procedures for listening to the customer and translating them into finished product

realities. QFD provides a cross functional approach which uses a planning tool called"House of Quality" for organizing and linking the customer survey information with

the product design attributes and later deploying it in stages throughout the

organization. Customer feedback is used by the QFD team to make engineering,

marketing and design decisions. Each step in the QFD process involves building up a

section in the house of quality matrix thereby simplifying the presentation of a large

amount of data. The steps involved in building the house of quality are: (i)

identifying customer needs through market survey, (ii) identifying, customer

counterpart product characteristics, (iii) relating the customer attributes to product.

characteristics; (iv) evaluating product characteristics and developing targets, (v)

evaluating products of competitors by performing internal as well as external

comparisons, and (vi) determining which product features to deploy throughout the

production process. The matrix comprises of the following sections (see Figure 3.5):

A WHAT section•

•

A HOW section

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Issues in Production/f) Focusing on the internal assessment by filling in the engineering assessment

section. It corresponds to the how column. Here we benchmark ourselves with

our competitors.

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g)

Analyzing the matrix and choosing priority items. For example, if there is a

mismatch between the engineering assessment and the customer assessment, we

follow it up by revising the design requirements to meet the true customer

requirements. A mismatch may occur in situations where the internal assessment

puts us iii a superior position (as compared to our competitor), while the

customer assessments have rated us inferior on that particular requirement.

Several houses of quality are required in deploying-the voice of the customer. Figure

3.6 shows an example of how the voice of the customer can be deployed. QFD will be

most effective if we take a systems-approach to implementing quality practices in the

organization. Thus early involvement in the product development process with the help

of cross-functional teams is an absolute necessity to prevent problems downstream.

3.5 UNDERSTANDING AND IMPROVING TIME

PROCESS

In the previous sections we discussed who is a customer and what the voice of the

customer means to the company. In this section we will try to understand and identify

processes that can be aligned to<satisfy the customer needs. We will establish a

system to measure the performance of the process. We will present the seven QC

tools that will help us in identifying and solving major problems. We will understand

what process variability means and how to strive for continuous improvement by

reducing variability. We will then define the voice of the process by undertaking

process capability studies.

Identifying the .Process

In Section 3:3 we saw how organizational inputs are transformed through a series of

stages involving man, machine, method, materials and other resources into value added

outputs that are meant to satisfy customer needs. Figure 3.2 shows an organized series

of sequential stages representing a process that can convert a certain measurable input

into measurable outputs. The concept of a process is further defined in the Appendix

(see Fig A 1 and Fig A2). An important element here is the feedback that is essential

for process monitoring and improvement. These figures also identify the various groups

that are involved in the process namely customers suppliers and process owners. All of

them are responsible for the quality performance of the process.

In TQM we try to identify the key processes on -which the success of the

organization depends. Key processes could be (a) processes that produce the most

important products wanted by customers, (b) processes having high visibility with

customers, or (c) processes having well defined problem areas indicating a high

potential for improvement. Once the processes have been identified the ownership

has to be assigned to fix authority and responsibility for maintaining, operating and

improving the process. Quality improvement is achieved through systematic and

continuous improvement of these key processes.

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Total Quality Management A framework for measuring the process

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To know whether a system is improving or not we need to have a measurement framework

to monitor the system performance. Performance monitoring can be done by recording cost

of quality summaries. Quality costs include costs of assuring and ensuring quality- together

with the losses incurred through failures within and outside the organization. Cost of

quality can be broadly classified into cost of conformance and cost of nonconformance.

Cost of conformance includes costs of prevention and appraisal while cost of

nonconformance includes costs of internal and external failures. Appraisal costs are costs ofinspection, testing, verification and control at any stage in the process meant to ensure

acceptance of the product or process. Prevention costs involve costs of activities undertaken

to prevent or reduce the risk of nonconformity. Prevention activities include identification

of nonconformities, identification of their causes and also actions taken to remove such

causes. Thus prevention costs are incurred in getting things done right the first time.

Internal failure costs are due to defects and nonconformities that-are identified within the

organization. They include costs due to scrap, rework, repair, and re-test. External failure

costs are due to defects passing out of the organization. They include costs such as

warranty claims, loss of customer goodwill, replacement costs and so on. Refer the

recommended texts at the end of this chapter to get an exhaustive list of these quality

related costs. It has been estimated that quality costs account for 20 to 30 percent of a

company's revenue. Cutting down the cost of quality is the goal of TQM organizations. Inorganizations implementing TQM prevention costs rise in the initial stages because of

investments in systems, processes, planning and training. Appraisal costs gradually reduce

because post production inspection activities are no longer necessary. As prevention

measures start taking effect the failure costs and the total quality costs start decreasing. This

is in contrast to the traditional quality measurements processes where quality products were

supposed to be delivered at high costs, Figure 3.7 shows the difference between traditional

quality and total quality concepts. Thus having a cost of quality system in place can help a

company track improvements over time.

We can also measure and monitor a systems quality improvement program by identifyingnonconformances. A nonconformance is any deviation from measurable quality specifications

that need to be satisfied. Quality improvement programs are most effective if we identify

nonconformances in terms of quantity and cost, and systematically strive to eliminate

dominant nonconformances. Nonconformance could be in one of the following several forms:

Defects (i.e., work not to specification)

Rework (i.e., work requiring correction)

Scrap (i.e., work thrown away)

Backlogs (i.e., work behind schedule)

Late deliveries (i.e., work after due date) '

Surplus items or over-production (i.e., work not required)

We need a well defined measurement system to capture nonconformances in a database.

Next we sort the data and identify dominant nonconformances (in different sections of

the organization) to prioritize quality improvement actions appropriately. We generate

summaries of : a) nonconformance quantities and costs, (b)scrap, rework and repair

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Issues in Production/actions, (c) supplier performance, (d) product performance in the field and (e) cost of

quality. Then we undertake improvement activities to eliminate the nonconformances

as far as possible in a continuous cycle using various problem solving tools.

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Activity D

Choose a manufacturing company and a service company. Identify a key activity for

improving quality in each.

.........................................................................................................................................

..................................................................................................................................................................................................................................................................................

Activity E

Describe the elements of the TQM infrastructure.

.........................................................................................................................................

.........................................................................................................................................

.........................................................................................................................................

Organized problem solving

Problems have several viewpoint perspectives. Solving the problems in an organized

manner helps realize the maximum benefits. Organized problem solving assists

solvers to. analyze the causes thoroughly before jumping into conclusions. It helps

generate maximum ideas from members in a team.

The problem solving process involves understanding the existing process(es), and

collecting facts, figures and information to help define the problem. A problem well

defined is half solved. Data analysis is done andthe assumptions are reexamined.

Techniques are used to generate ideas for developing potential solutions. All the

alternative solutions are evaluated and the best ones are selected and implemented.

Table 3.2 shows the steps involved in creative problem solving along with the

corresponding seven quality control tools.

Table 3.2: Creative Problem Solving and Seven QC Tools

Problem-solvin Ste Useful Tools

Understanding the mess Flowcharts

Findin facts data collection Checksheets

Identif in roblems Pareto dia rams Histo rams

Generating ideas Cause-and-effect diagrams (or

Fishbone or Ishikawa diagrams)

Developing solutions Scatter diagrams

Source: The Management and Control of Quality by J. R. Evans and W.M.Lindsay

Apart from these tools we have other

basic tools, such as, brainstorming,

grouping and stratification to help guide

the problem solving process.

Brainstorming is a group process in

which group members express their ideas

in a creative atmosphere. All ideas are

acceptable. The objective is to generate a

lot of ideas which can be further defined

in stages to identify the root causes of

problems.,Grouping.

.helps in focusing the problem solving efforts. Sometime problems can be slated

in several different forms by different individuals. These can be grouped under

one key topic. This helps in summarizing rather long lists of problems into short

general categories on which problem solving efforts can be focused. Stratification

helps in breaking down data into

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Total Quality Managementlevels (for example, data collection by time, shifts, machines, stages etc.). Sometimes

it is more meaningful to analyze stratified data. Figure 3.8 shows an example where

we have a certain process consisting of three machines that are necessary for

processing a product. Suppose the final output has a wide variation in the quality

characteristic that is being measured. To identify the cause of this problem we collect

data at different stages in the production process and analyze them for variations.

33

Figure 3.9 shows simplified versions of the seven QC tools which can be applied to

almost any practical problem. Flowcharts are used to understand the larger processand how each stage affects the other. They help identify all customers, activities,

problem areas and redundant operations (if any). Critical quality characteristics that

need to be controlled at the appropriate stages are also identified. Thus flowcharts

help in identifying quality problems and areas of productivity improvement.

Checksheets help collect and report data in a systematic manner. We use special data

collection forms and use tally marks to. collect the frequency of occurrences of

characteristics that affect quality. Figure 3.9 shows a portion of a checksheet where

the frequency data is being collected for a certain quality dimension of a product.

Histograms are graphical representations of the variation in a set of data. In processes

they help identify variations and their patterns. The tally marks in the checksheet are

arranged in the form of a histogram to show the distribution of the data.

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Issues in Production/While drawing histograms samples have to be designed carefully so that they are

representative of the process (or the population). Pareto diagram is a histogram of data

(e.g. the various types of nonconformances) arranged according to their descending order

of frequencies. Pareto diagrams help segregate the major few problem areas from the

trivial many thereby short-listing potential projects for improvement. When tracked over

time they show the=results of improvement programs taking effect. Cause-and-effect

diagrams help identify causes for a certain problem (the effect) There could be various

categories of causes, such as, man, machine, material„ environment, method and so on.

Through brainstorming problem causes are listed under the various categories. Once thevarious causes have been collected, those having the biggest impact on the problem are

identified. Scatter diagrams help identify the nature of the various cause-effect

relationships. Causes having strong positive and negative correlation with the problems

arc identified for the improvement program. Control charts are graphical tools

representing the state of control of a process. Samples coming out of a process are

collected at frequent intervals, their quality characteristics measured and then plotted on

the appropriate chart for analysis. If the process is in control there is a high probability

the sample will fall between the statistically calculated upper and lower control limits.

Walter Shewhart, in the 1920s at Bell Laboratories, was the first to propose control charts

for distinguishing between common causes (or random variations) and special causes (or

non-random variations). We have control charts both for variable and attribute measures.

34


Thus organized problem solving involves defining the problem, identifying the rootcause of the problem, identifying the various solutions, selecting the best solution, and

recommending corrective action procedures for either controlling, reducing, or

eliminating problems.

Improving the process

Control means maintaining a

certain level of performance

while improvement means

achieving a higher level of

performance. Figure 3.10

shows the difference between

control and improvement. To

monitor the performance, processes must be measurable.

We use statistical process

control (SPC) techniques to

measure and analyze variations

in a process. In any process,

the process-performance

measures fluctuate randomly,

due to common causes, around a certain target value (or average value known as

process mean). However, due to some special causes we also have non-random

variations taking place. We use control charts to identify these non-random deviations

in a process caused by the sporadic problems. We get rid of these underlying causes to bring the process under control. On the other hand, to improve the process we need to

achieve higher performance levels by reducing the random chronic problems (or the

common causes of fluctuation) around new and superior target levels.

Thus we use SPC to detect special causes of process variation from common causes. A

process is said to be in a state of statistical control when the process variations are due to

the inherent, common causes only. Such processes are considered to be stable and

predictable within appropriate limits. A stable process, which also meets the product

specifications, can produce acceptable products. However, attaining stability is not an

end in itself. Rather continuously striving to reduce the random (or natural) variations

in the process is the main objective of any continuous improvement program. SPC is

implemented on the key processes where the sources of variability have been identified.

The operators are trained to gather preliminary data and prepare and use control charts.Process Capability Studies

Continuous improvement leads to process improvement which means variability

reduction through enhancement of process capability. We will try to understand what

process capability means.

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Total Quality ManagementTQM organizations that depend on outside suppliers often expect their suppliers to

provide process capability data along with the parts that are supplied. Process

capability quantifies the amount of variation inherent in the processes producing

these parts thereby helping the customer organization to determine the quality of the

parts supplied. If there is excessive variability in the process, it will have difficulty in

meeting the specifications. Thus the process capability will be low and consequently

there would be lot of defectives in the goods supplied. Similarly within the

organization itself, process capability data of the core processes are necessary

upstream for the designers in determining the design specifications and tolerances.Designers should not specify tight tolerances if the products are to be manufactured

in processes having excessive variability (i.e., low capability). On the other hand

highly capable processes should not be underutilized (or wrongly utilized) by

specifying loose tolerances.

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Figure 3.11 shows processes having

certain natural tolerances (or

variations) and how they are

performing in relation to the design

tolerances (or specifications).

Process A is a highly capable one

because it is well within the design

limits. Process B, however, hasexcessive variability and hence is

less capable of producing consistent

quality products. For process B the

natural tolerance is equal to the

design tolerance. This can be translated into .27 defects in 100 parts that are

manufactured. These are the defectives that lie outside the three sigma limits. Does not

seem that bad. But what if we are producing a million parts? It translates into having

2700 defects per million. This is not an insignificant number if the loss per defect is very

high. As some articles report, it could mean 20,000 wrong drug prescriptions a year, or

15000 babies accidentally dropped by nurses each year, or 500 incorrect surgical

operations each week and so on. . Hence having a design tolerance equal to the process

tolerance is not a good idea when we consider the three sigma limits. Now if six sigma

limits correspond with the design limits, then there is a lot of reduction in the variability

of the process. Under such situations we have a highly capable process which, if centered

on the mean, translates into having defectives of only 2 parts per billion. Motorola has

made six sigma famous by focusing on product design and process capability

improvements. Motorola's design limit of six sigma with a slight shift in the process

achieved defectives up to 3.4 parts per million (ppm). Both the processes in Figure 3A I

are centered around the mean value.

Thus, we can improve the process capability either by reducing variations in the process

(thereby changing its natural limits) or by revising the design tolerances (thereby making

changes to the design). To measure the quality of a process (and thereby its products) we

need to know two things: (a) how capable is the process (measured by C p index) and (b)how well centered it is (measured by C pk index). C p determines what the process is capable

of based on the process standard deviation and the total design tolerance.

p

ToleranceC =

6σ

where, tolerance = upper specification limit - lower specification limit

C pk determines how well the process is centered by comparing the process mean with

the nearest specification limit (NSL).

pk

mean-NSLC =

3σ

Note that when the process is centered, C p = C pk . For a six sigma company C = C pk = 2.Figure 12 shows Process X having a shift in the process average. Even though it is as

capable as Process Y, it has a greater chance of not meeting the USL. Both the processes

are, however, more capable than Process Z. If process Y has a standard deviation equal to

.7 units, and if the design tolerance is specified as 8 units, then the process capability C p=

8/11/2019 Block 1 MS 53 Unit 1


Issues in Production/8 4.2 1.9÷ = andC .

However for process X (having same

standard deviation) the C

pk 4 (3*.7) 1.9= ÷ =

pk value will be

lower than 1.9 and the C p will be equal to

1.9.

36


Before discontinuing our discussion on

specification limits and process

performance, let us briefly look at a

traditional approach. According to this

approach all product meeting design

specifications are equally good and those

just missing the design specifications are

equally bad (see Figure 3.13). This is

also known as the goal- post syndrome.

However, according to Taguchi the

target or the nominal specifications (or

the goal -posts). Hence, the farther away

we are from the target value the greater

is the loss in the quality of the part. He

has represented this loss in the form of aquadratic function. This is known as the

Tauguchi loss function.

In summary, the voice of the customer if translated properly provides the tolerance

specifications needed in satisfying customer requirements. The process control limits

for any stable process, provide the limits to the natural variation of a process. This is

the voice of the process (or the characteristic of that particular process). These natural

variations are due to common (or random) causes. The capability of this process in

meeting the customer requirements can be quantified in the form of a process

capability index (C p).

Note that higher the index the better is the process capability. It means that the

natural variations are too small and the specified tolerance is large enough for the

process to meet the customer requirements consistently. TQM organizations aim to

improve the process capability index by managing both the numerator and thedenominator of the above ratio (i.e., by making it an organization wide approach).

3.6 EMPLOYEE INVOLVEMENT AND

EMPOWERMENT

Processes cannot be improved if employees are either not fully involved or fully

empowered. Employee involvement means each employee contributes toward achieving

the organizational goals. These contributions are valued by the management and they

both recognize that the organization's success depends on total employee involvement.

Employee empowerment means authorization of employees to identify and solve

problems hindering quality efforts. Process owners need to be empowered by the

management to recognize and solve problems. We discussed how non-random variations

in the process lead to root cause identification of the underlying problem. For effective

TQM implementation, the process owners must be empowered to use organizational

resources for eliminating such problems. Similarly without employee involvement we

cannot have process control tools being effectively used for quality improvement.

8/11/2019 Block 1 MS 53 Unit 1


Total Quality ManagementTo facilitate employee involvement we need to recognize the potential value of each

individual, assign work where they can be successful, understand their motivation

and listen to them. TQM organizations can initiate formal suggestion schemes which

can help them in listening to their employees. These schemes can be used for

collecting quality improvement suggestions. Some companies give cash awards and

incentives for suggestions which get approved. Some ideas may not find approval for

implementation. However, it is important for the management to get back to the

employee with the appropriate feedback so that he knows why his ideas got turned

down. Listening to the employee suggestions and getting back to them with afeedback is a must for ensuring employee involvement.

37

Employee involvement also requires management's willingness to empower

subordinates. At the same time empowered employees who are not sensitized to the

organizational goals cannot apply their empowerment effectively. It is the

management's responsibility to define the common vision for the organization so that

empowered employees know what their roles are in achieving these objectives.

Empowered employees must be trained properly to take up organized problem

solving initiatives. Organizational resources, if necessary for implementing the

suggestions, must be provided to help them perform better. There could be

improvement concepts that cannot be approved by the management. In such cases the

management must give reasons as to why it cannot be implemented.

Thus employee involvement and empowerment are essential to tap the full potential

of the workforce in attaining organizational objectives. Discretionary efforts of

empowered employees are recognized and tapped for ensuring the success of

continuous improvement programs. Top management must be committed and

involved in setting up systems to support TQM activities. Mechanisms must be in

place so that their subordinates can take up greater responsibility.

Activity F

What effect does employee involvement have on motivation? Explain the effect in

terms of motivational theory.

.........................................................................................................................................

.........................................................................................................................................

.........................................................................................................................................

Activity G

Assume that a company has just committed to change from a traditional style of

management to one based on TQM. What topics would you include for

− Shop floor employee

− Front-line supervisors

−

Middle-level managers

.........................................................................................................................................

.........................................................................................................................................

.........................................................................................................................................

Activity H

Decribe how training in problem solving would improve

− Process control

− Employee motivation

.........................................................................................................................................

.........................................................................................................................................

.........................................................................................................................................

3.7 ISO 9000: THE INTERNATIONAL QUALITY

SYSTEM STANDARD

ISO 9000 is a series of standards agreed upon by the Geneva based International

Organization for Standardization (ISO), It was adopted in 1987. It is a set of written

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38


•

•

•

•

•

•

•

•

standards laying down a quality system. The basic elements of the system are defined

through documentation. The guidelines ensure universally recognized and uniform

quality systems that are rooted in the customer's requirements. ISO 9000 creates a

discipline required for a TQM organization.

Here are some highlights:

ISO 9000 CERTIFICATION IS ISSUED BY INDEPENDENT ISO-

CERTIFIED AUDITORS.

REGISTRATION WILL BE INCREASINGLY DRIVEN BY CUSTOMERREQUIREMENTS & COMPETITIVE PRESSURES, NOT VIA OFFICIAL OR

STATUTORY MANDATE.

CERTIFICATION ONLY VERIFIES THAT YOUR FACTORY, YOUR

LABORATORY, OR YOUR OFFICE MEETS A SET OF PREDETERMINED

(by ISO) QUALITY MANAGEMENT REQUIREMENTS.

DOCUMENTATION IS CENTRAL TO ISO 9000 REQUIREMENTS, FOR

THE PURPOSES OF PLANNING, CONTROLLING, TRAINING &

PROVIDING OBJECTIVE EVIDENCE OF COMPLIANCE.

ISO 9000 IS NOT A PRODUCT STANDARD BUT A QUALITY SYSTEM

STANDARD. IT IS DESIGNED & INTENDED TO APPLY TO VIRTUALLYANY PRODUCT OR SERVICE MADE BY ANY PROCESS ANYWHERE IN

THE WORLD.

ISO 9000 REQUIRES THAT THE QUALITY SYSTEM MONITOR

CONFORMANCE TO REQUIREMENTS.

OBLIGATES MANAGEMENT TO IMPLEMENT STATISTICAL

TECHNIQUES WHEN & AS APPROPRIATE.

ISO 9000 helps companies that market their products in the European markets. It is

essential for companies (or vendors) supplying to other companies that demand ISO

9000 certification. It is also necessary for companies whose competitors are certified

or are seeking ISO 9000 certification. Companies with geographically scatteredfacilities & global operations find it easier to convince customers about their quality

standards, if they have ISO 9000 certification. It is also meant for companies whose

transnational parents are seeking ISO 9000 certification.

ISO 9000 originated from the U.S. Department of Defense (quality) standards. The

British Standards Institute adopted these standards in 1979 for business processes and

used them as its national standard under the name of British Standard 5750. BS5750

was adopted by ISO in 1987 and called it ISO 9000 series. These series have

undergone revision in 1994.

Here are some harmonized versions of ISO 9000.

HARMONIZED VERSIONS OF ISO 9000

NATION STANDARD

AUSTRALIA AS3 900

BELGIUM NBNX50

CANADA CSAZ299

DENMARK DS/EN 29000

GERMANY DIN ISO 9000

INDIA IS 14000

SWEDEN SS ISO 9000

UK BS 5750

COMPONENTS OF THE ISO 9000 STANDARD

ISO 9000 is a misnomer. Companies do not get an ISO 9000 certification.

Instead they get either an ISO 9001, ISO 9002 or ISO 9003 certification.

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39

•

•

•

•

•

•

Quality System Models:

ISO 9001

ISO 9002

ISO 9003

for facilities seeking ISO 9000 registration for "contractual" purposes.

Quality Management Guidelines:

ISO 9004ISO 9004-2

ISO 9000-3

facilities do not register to these guidelines. These are mainly guidelines for

facilities wishing to implement ISO 9000.

Guidelines for Auditing:

Audits (or Assessments) to obtain evidence about the performance of the system

against specified requirements.

INTERNAL ASSESSMENTS (by OWN FACILITY PERSONNEL)

SECOND-PARTY ASSESSMENTS (by CUSTOMER)

THIRD-PARTY ASSESSMENTS (by an ACCREDITED THIRD PARTY)

ISO 10011 SERIES (GUIDELINES FOR AUDITING QUALITY SYSTEMS)

ISO 10011-1 (1990)"AUDITING

"

ISO 10011-2 (1990) "QUALIFICATION CRITERIA FOR QUALITY

SYSTEMS AUDITING"

ISO 10011-3 (1990) "MGMNT OF AUDIT PROGRAMS"

Guidelines for Measuring Equipment:

For many facilities monitoring means taking measurements.

ISO 10012-1 (1992) "QUALITY ASSURANCE REQUIREMENTS FORMEASURING EQUIPMENT" (guidance docu)

Supporting Documents:

ISO 9000 "QUALITY MANGMNT & QUALITY ASSURANCE

STANDARDS:

GUIDELINES FOR SELECTION & USE"

ISO 8402 "QUALITY VOCABULARY"

ISO 9000-2 generic guidelines for the application of the contractual

models

ISO 9000 for Quality Management Purposes:

The Guidance Documents

ISO 9004 and ISO 9004-2 provide a clearer & more graphic illustration of an

integrated quality system than do the contractual models.

ISO 9004 for MANUFACTURING & SERVICE SECTOR

ISO 9004-2 for SERVICE SECTOR

ISO 9000-3 A-SPECIALIZED SET OF GUIDELINES FOR APPLYING

ISO 9001 TO FACILITIES WHICH DEVELOP AND

MAINTAIN COMPUTER SOFTWARE

ISO 9000 for Contractual Pureposes:•

The Quality System ModelsThe following are generic models. They apply to virtually any facility producing

any product or service for virtually any market. They mostly encourage the use

of good business practices and time proven quality methods. (see Table 3.3)

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Issues in Production/ISO 9001 − most comprehensive

−

covers facilities whose process includes

−

DESIGN/DEVELOPMENT, PRODUCTION,

INSTALLATION & SERVICING

−

contains 20 sections describing various elements of

the quality system

ISO 9002 −

more limited

−

applies to facilities making products which are

designed and serviced by others

−

includes 18 of the 20 sections found in ISO 9001

ISO 9003 − most limited

−

applies only to facilities performing final inspection

& test functions

− includes 12 of the 20 sections found in ISO 9001

40


Let us summarize what we have said so far regarding ISO 9000. Stated simply ISO

9000 guides you to "document what you do and then do what you documented" It

creates an awareness and brings in the discipline much needed for continuousimprovement and TQM. ISO 9000 specifies the way a company operates along with

its quality standards, service levels, delivery performances and so on. It helps a

company to be in a customer company's short-list of supplier firms. The best

certification for a company is through a accredited third party. Certification can take

from six to twelve months or more depending on the companies existing standards,

organization culture and top management commitment.

Table 3.3: ISO 9001 - 9003 CROSS REFERENCE (Section numbers)

SECTION COVERAGE ISO 9001 ISO 9002 ISO 9003

1 Management Responsibility 4.1 4.1 4.1

2 Quality System 4.2 4.2 4.2

3 Contract Review 4.3 4.3

4 Design Control 4.4 - -

5 Document Control 4.5 4.4 4.36 Purchasing 4.6 4.5 -

7 Control of Customer-Supplied Product 4.7 4.6 -

8 Product Identification

& Traceability 4.8 4.7 4.4

9 Process Control 4.9 4.8 -

10 Inspection & Testing 4.10 4.9 4.5

11 Control of Inspection,Measuring & Test Equipment 4.11 4.10 4.6

12 Inspection & Test Status 4.12 4.11 4.7

13 Control of Nonconforming Product 4.13 4.12 4.8

14 Corrective Action 4.14 4.13 -

15 Handling, Storage,

Packaging and Delivery 4.15 4.14 4.9

16 Quality Records 4.16 4.15 4.10

17 Internal Quality Audits 4.17 4.16 -

18 Training 4.18 4.17 4.11

19 Servicin 4.19 - -20 Statistical Techniques 4.20 4.18 4.12

Note: The appendix at the end of this chapter gives some more details on ISO 9000.

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Total Quality ManagementActivity I

41

Does ISO 9000 contain product standards or standards for operation of a quality

management System? Explain the difference.

.........................................................................................................................................

.........................................................................................................................................

.........................................................................................................................................

3.8 SUMMARY

In this unit we have discussed how TQM gained its importance over the century.

How quality systems evolved from a reactionary post-production defect detection

oriented approach to a more proactive defect prevention approach. To drive TQM

efforts we realize the importance of customers and the need for understanding and

deploying their expectations through the organization. We discussed the need for

orienting our processes to be in line with the quality requirements of our customers.

Process performance measures need to be developed for monitoring improvements.

Organized problem solving techniques were discussed to identify major problem

areas. We also discussed statistical process control techniques and process capability

studies for ensuring continuous improvement. To make TQM implementation

successful. employee participation and empowerment is essential. We also discussed

the importance of ISO 9000 as an International systems standard meant for assuringquality.

3.9 SELF-ASSESMENT EXERCISES

1.

Illustrate how the TQM concept can integrate design, engineering,

manufacturing and services.

2. Explain why quality should be better by following the TQM concept them in a

system that depends on final inspection

3. What common elements or principles can you identify among (1) the Baldridge

criteria and (2) Deming, Jurian and Crosby?

4.

List the characteristics of excellent leadership for TQM

5.

Describe how leadership by top management is the driven quality.

6. Give an example of a company culture as reflected in a statement of basic

beliefs. Would such a statement help to institutionalise a quality culture? If so

how?

7.

Describe how leadership by top management is the driven of quality.

8.

Choose two functions on activities (market research, R & D, design, production

planning, procurement. human resources) and show how information can serve

to integrate them across functional lines.

9.

How does information technology affect organisational structure? Give an

example of how information technology can facilitate TQM?

10.

Why is if important for U.S. firms to comply with ISO 9000?

11. Answer the criticisms that meeting ISO standards will add to production costs.

12.

What are the benefits of ISO 9000 certification?

13.

Identify the quality cost elements associated with any of the institutions listed

below. Define each of the elements, and suggest how each might be quantified

in practice: (a) a university (b) a hospital (c) the local bus line (d) a bank (e) a

manufacturer of any of these wooden furniture, cotton cloth, men's shoe, glass

bottle casting, drugs, (f) a text book publisher.

14.

Based on your on experience, give one or two examples of situations where

pareto analysis might help improve quality or productivity.

15.

What are the steps in moving from a system of final inspection to processcontrol?

16. Choose a non-manufacturing (service) process and show how statistical quality

control would be-appropriate.

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3.9 SELF ASSESMENT EXERCISES

42


1.

Illustrate how the TQM concept can integrate design, engineering,

manufacturing and services.

2.

Explain why quality should be better by following the TQM concept than in a

system that depends on final inspection.

3.

What common elements or principles can you identify among (1) the Baldridge

criteria and (2) Deming, Juram, and Crosby?

4.

List the characteristics of excellent leadership for TQM.

5. Describe how setting targets for quality improvement helps to establish a culture

and climate.

6. Give an example of a company culture as reflected in a statement of basic

beliefs. Would such a statement help to institutionalise a quality culture? If so,

how?

3.10 FURTHER READING

Berk, J. and Berk, S. (1993) "Total Quality Management: Implementing Continuous

Improvement," Excel Books, New Delhi.

DeToro, I. J. and Teener, A. R. (1992) "Total Quality Management: Three Steps to

Continuous Improvement," Addison-Wesley Publishing Company.

Evans; J. R. and Lindsay, W. M. (1994) "The Management and Control of Quality"

Jaico Publishing House.

Johnson, P. L. (1993) "ISO 9000,"McGraw Hill

Juran, J. M. and Gryna, F. M. (1995)"Quality Planning and Analysis," Tata-McGraw

Hill Publishing Company Limited, New Delhi

Kehoe, D. K. (1996) "The Fundamentals of Quality Management," Chapman & Hall.

J. Ross, J.E. (1999) "Total Quality Management" Kogan Page Limited, London, 2nd

Edition.

3.11 APPENDIX: ISO 9000 QUALITY SYSTEM

STANDARDS

•

a)

b)

c)

•

•

ISO 9000 FAMILY:

ALL THOSE INTERNATIONAL STANDARDS PRODUCED BY THE

TECHNICAL COMMITTEE ISO/TC 176. AT PRESENT THE FAMILY

COMPRISES:

All International Standards numbered ISO 9000 through to ISO 9004,

including all parts of ISO 9000 and ISO 9004.

All International Standards numbered ISO 10001 through 10020, including

all parts; and

ISO 8402

SCOPE OF ISO 9000-1

CLARIFIES PRINCIPAL QUALITY-RELATED CONCEPTS & THE

DISTINCTIONS & INTERRELATIONSHIPS AMONG THEM:

PROVIDES GUIDANCE FOR THE SELECTION & USE OF THE ISO 9000

FAMILY OF INTERNATIONAL STANDARDS ON QUALITY MGMNT &

QUALITY ASSURANCE.

CONCEPT OF A PROCESS is defined.

SOME TERMS & DEFINITIONS TAKEN FROM ISO 8402: 1994

QUALITY: Totality of characteristics of entity that bear on its ability to satisfy

stated & implied needs.

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43

•

•

•

•

•

•

•

•

•

•

•

CONTRACTUAL ENVIRONMENT -> needs are specified

OTHER ENVIRONMENTS -> implied needs should be identified &

defined.

QUALITY POLICY: Overall intentions & directions of an organization with

regard to quality; as formally expressed by top management.

QUALITY MANAGEMENT: All activities of the overall management

function that determine the quality policy,_ objectives & responsibilities and

implement them.Implement by means such as QUALITY PLANNING, QUALITY CONTROL,

QUALITY ASSURANCE and QUALITY IMPROVEMENT within the quality

system.

QUALITY SYSTEM: Organizational structure, procedures; processes &

resources needed to implement duality management.

QUALITY CONTROL: Operational techniques & activities that are used to

fulfill requirements for quality.

QUALITY ASSURANCE: All the planned & systematic activities

implemented within the quality system, and demonstrated as needed, to provide

adequate confidence that an entity will fulfill requirements for quality.

INTERNAL QUALITY ASSURANCE -> provides confidence to mngmnt

EXTERNAL QUALITY ASSURANCE -> in contractual or other situations,

quality assurance provides confidence to the customers or others.

QUALITY IMPROVEMENT: Actions taken throughout the organization to

increase the effectiveness & efficiency of activities & processes in order to

provide added benefits to both the organization & its customers.

PRODUCT: Result of activities or processes. The general categories are

SERVICE

HARDWARE

PROCESSED MATERIALSSOFTWARE

CUSTOMER: Recipient of a product provided by the supplier.

In a CONTRACTUAL SITUATION the customer is called the "purchaser". The

customer may be for example, the ultimate consumer, user, beneficiary or

purchaser. The customer can be either external or internal to the organization.

SUPPLIER: Organization that provides a product to the customer.

In a CONTRACTUAL SITUATION, the supplier is the "contractor". The

supplier may be, for example: the producer. the distributor, importer, assembler

or service organization. Supplier can be either external or internal to the

organization.PROCESS: Set of interrelated resources & activities which transform inputs

into outputs. Resources may include PERSONNEL, FINANCE, FACILITIES,

EQUIPMENT, TECHNIQUES& METHODS.

CONCEPT OF A PROCESS:

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44


PRODUCT-RELATED & INFORMATION-RELATED FLOW

PRODUCT RELATED => Raw Math, Intermediate Products, Final Product, Sampled

Product

INFORMATION RELATED => Product Reqmnts, Product Characteristics & Status

info, Support-Function Communication, Feedback on Product Performance and

Needs, Measurement Data from Sampled Product.

EVALUATING QUALITY SYSTEMS

Three questions to be asked in relation to every process being evaluated:

a) Are the processes defined and their procedures appropriately documented?

b)

Are the processes fully deployed and implemented as documented?

c)

Are the processes effective in providing the expected results?

QUALITY SYSTEM SITUATIONS

=> guidance for quality management

=> contractual between first and second parties.

=> second party approval (undesirable if there are several customers)=> third party certification (takes care of logistics)

NOTE: FIRST PARTY AUDIT -> "internal" audit

SECOND PARTY &

THIRD PARTY AUDIT -> "external" audit

WHY DOCUMENTATION IS REQUIRED?

=> To provide permanent reference for

* implementation of Quality Systems

* maintenance of quality systems

=> To avoid differing descriptions

=> To ensure orderliness in operations

=> To train personnel

=> To provide for a system of audits

REGISTERING TO ISO 9000

A FACILITY REGISTERS TO ISO 9000 IN ORDER TO OBTAIN THIRD-PARTY

VERIFICATION THAT ITS QUALITY SYSTEM CONFORMS TO THE ISO 9000

STANDARD.

REASONS FOR REGISTERING

TO REINFORCE QUALITY PROGRAMS & COMMITMENT TO QUALITY

AS A PROACTIVE STEP TO COUNTER COMPETITION

TO SECURE NEW BUSINESS

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Total Quality ManagementIN RESPONSE TO COMPETITIVE THREAT

45

IN RESPONSE TO CUSTOMER REQUIREMENTS

IN RESPONSE TO REQUIREMENTS OF A PARENT ORGANIZATION

[NOTE: FACILITIES TEND TO RUSH INTO THE PROCESS OF APPLYING

FOR ISO 9000 BEFORE THEY ARE READY]

PREPARATORY STEPS

HAVING A QUALITY SYSTEM IN PLACE THAT MEETS THE TECHNICAL

REQUIREMENTS OF THE PART OF ISO 9000 QUALITY SYSTEMSTANDARD TO WHICH IT SEEKS REGISTRATION (ISO 9001, 9002 or 9003)

FACILITY MUST HAVE DOCUMENTED IT WITH A QUALITY MANUAL &

SUBORDINATE PROCEDURES, WORK INSTRUCTIONS, AND OTHER

MATERIALS.

FACILITY MUST HAVE OPERATED IT SUCCESSFULLY FOR 3 TO 6 MONTHS

=> ADDITIONAL STEPS:

ESTABLISH A RELATIONSHIP WITH AN ISO 9000 REGISTRAR WHOSE

SCOPE OF ACCREDITATION COVERS THE FACILITY'S FIELD OF

ACTIVITY.

FILE A FORMAL APPLICATION.UNDERGO AN ASSESSMENT OF DOCUMENTATION. UNDERGO AN ON-

SITE ASSESSMENT OF QUALITY SYSTEM.

REMEDY NON-CONFORMANCES BY COMPLETING ANY REQUIRED

CORRECTIVE ACTION REQUESTS.

REGISTRATION FOR ISO 9000

1.

Obtain management commitment.

2.

Begin training for some leaders.

3. Set up a steering team & sub-teams.

4.

Begin internal quality audit.5.

Conduct in-house training.

6. Compile quality manual.

7. Conduct ongoing quality audits & implement corrective action.

8.

Apply to third-party auditors.

9.

Adequacy audit to be conducted.

10. Pre-assessment to be conducted.

11. Implement improvements.

12.

Set the date for audit (a later date for real bad pre-audit).

13.

Provide more training.14.

Conduct frequent checks.

15.

Get plant leaders to conduct audits.

16. Share audit findings.

17. Send revised quality unanu•11 for assessment.

18.

Assessment to be conducted.

19.

Fix minor discrepancies.

20. Registration obtained,

IN SHORT, A REGISTRAR

- IS ACCREDITED BY THE NACCB OR AN EQUIVALENT BODY

- USES ASSESSORS WHOSE CREDENTIALS ARE TRACEABLE TO RBA

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46



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Compiled From:

1. ISO 9000 by Perry L. Johnson (McGraw Hill 1993 Edition)

2. ISO 9000: Concepts, Methods 4 Implementation by T.P.Bagchi (Wheeler

Publishing 1994 Edition)

3.

1994 BIS Standards (IS 14000 Series)