Some thoughts on quality

DOI: 10.1002/qaj.313

Some Thoughts on Quality

Paul C. Constant Jr.*

Midwest Research Institute, 425 Volker Boulevard, Kansas City, Missouri 64110, USA

Summary

A view of quality is given from inside an independent contract research organization(CRO) that undertakes regulated studies as well as unregulated studies and has as itsprimary focus on ‘the project’. Focusing on the project brings into play dependency,which means that the success of the project is dependent on the company’s Board, itsmanagement, and its technical and support staffs. Dependency is a factor that needsto be considered when talking quality. Some project, company, and clientdependencies are given. Quality assurance and quality control play important rolesin quality operations, but there is more.Quality needs to be a built-in aspect, which here is termed ‘quality inherency’, andnot an add-on. Quality should be seen as a quality permeation system powered fromthe top management position; and as a quality operational system that comprises alltechnical and business processes, their sub-processes and interfaces, or linkages.Quality needs to be functional and regularly improved and maintained. Eight majoractivities are discussed that are needed to achieve quality inherency. Ten processes,their sub-processes and linkages are presented in a systems diagram as well assummarized in words. The article describes what success means to the client, theresearch organization’s management, the project team member, and the projectleader and ends with conclusions. Copyright # 2005 John Wiley & Sons, Ltd.

Key Words: quality; quality inherency; quality permeation system; quality management

Introduction

All levels of management should recognize that

when a company is out of quality it is out of

business. Therefore, management should ensure

that quality is built into the operations and is not

considered an add-on feature. This underlying

thesis is explained from the viewpoint of the

operation of an organization involved with

regulated and non-regulated studies. A few tools

are given that can help with establishing quality

systems; these may significantly enhance the

assurance that quality requirements will be met,

whether they are for the design of a product,

formulation of a new material, development of a

new method, the establishment of a new

business operation, or improvement in an

operation. These tools are a quality permeation

system, a quality operations system, and quality

inherency, each of which can be used by a chief

executive officer (CEO) in deciding, for exam-

ple, whether a consultant has a needed skill or

when determining how managers can increase

their skills to enhance the quality of their

operations. These tools, likewise, can be useful

to consultants or others who want to increase

their skills. Before discussing these tools, some

background information is given that can benefit

the management of a company, projects, or tasks

in many ways.

*Correspondence to: P.C. Constant Jr., Midwest ResearchInstitute, 425 Volker Boulevard, Kansas City, Missouri,64110, USA.E-mail: [email protected]

Copyright r 2005 John Wiley & Sons, Ltd. Qual Assur J 2005; 9, 108–119.

Background

The organization is involved in the business of

contract research and has the project as its

primary focus, as depicted in Figure 1. The four

principal entities shown, the Board of Directors,

the company’s management, and the staff (both

technical and support) bring to bear what is

needed to ensure that projects are successfully

completed to the client’s and company’s (con-

tractor’s) satisfaction.

There needs to be total staff commitment to

ensure company longevity as well, and this

longevity will come naturally when there is the

appropriate quality of operation for all company

processes (see Figure 2).

Crosby has said that there is no cost to

quality, quality is free [1], and as a result of this,

there can be considerable profit – monetary,

image, self-satisfaction, etc. With total staff

commitment illustrated in Figure 1 (by the

arrows directed toward the project) and assum-

ing the company has the proper staff and

management, the cost of quality can be low.

This is mainly because of synergy that is

established, which leads to increased effective-

ness and, therefore, efficiency of operations that

lower operational costs, such as, the need for

rework or by anticipating problems and estab-

lishing or taking preventive measures. Although

a significant business cost is the cost of

inadequate quality, in some organizations things

are not always done properly. Non-conformities

result, thereby driving up the cost of doing

work. The cost of ‘bad’ quality comes from not

doing things right the first time. Some companies

go bankrupt because of the excessive number of

warranties that have to be fulfilled or because of

rework, such as having to rerun the analyses of

samples because an instrument was not properly

calibrated. For staff members, not doing their

job right the first time could mean losing his or

her job or it could impede one’s professional

growth.

The focus of Figure 1 brings to play depen-

dency, which is considered to be associated with

quality. Actually, some items of dependency can

be considered requirements, such as client

requirements (specifications, schedule, security,

conflict of interest, and cost), company opera-

tional requirements, and regulatory require-

ments. Others can be considered guides, such

as company policies and procedures, standards,

and client requirements (see Figure 2). An

extension of the aspect of dependency shown

in Figure 1 relates to two additional entities: the

company and the client. Success for each of

these entities also depends on a population of

factors, just as the project does. The factors

shown in Figure 3 do not necessarily constitute

complete populations. Insofar as contract work

is concerned, the company’s success is client

driven and is dependent on client satisfac-

tion, financial viability, image, security, con-

tinuous improvement, safety, new business,

and repeat business, to mention a few. The

client is usually looking for quality, timeliness,

value added, and cost control. Depending

on the type of work or other issues, the client

could be interested in additional factors, such

as intellectual property, confidentiality, safety,

security, etc.

Three good tools to consider using in quality

management are a quality operations system

shown in Figure 2, a quality permeation

system shown in Figure 4, and quality

inherency.Figure 1. Company R&D focus – the project

Some Thoughts on Quality 109


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110 PC Constant Jr.


Quality Permeation System

Perhaps the quality permeation system should be

called ‘Follow the Leader’, because this is a

significant factor, if not the most important

factor, in ensuring that quality is an inherent

(embedded) characteristic or attribute of a

company’s operation. Good results will be more

rapidly achieved if the emphasis for quality

emanates from the company’s top manager

rather than from the bottom up via a champion

of the cause. The latter approach can take years

and years of hard work and the steadfastness of

the individual who is the prime mover, notwith-

standing that the individual needs to remain

employed by the company for most of these

many, many years.

Figure 4 shows six important elements of the

quality permeation system. First and foremost is

the person leading the company, e.g. the

president or the CEO. This person is responsible

for the orchestration of quality throughout the

organization. This responsibility cannot be

delegated. This person ensures that the company

has a mission statement, a quality policy and

quality objectives. These should be well docu-

mented, communicated throughout the organi-

zation, and maintained. The president must also

ensure that the quality assurance (QA) staff/unit

is independent from technical operations. The

president interfaces with senior management

(second element). In turn, senior management

interfaces with the company’s staff. It is im-

portant to mention that the president not only

communicates with senior management, but

directly with the staff when it is believed to be

necessary. The staff is composed of two units:

the technical staff (third element) that leads and

performs project work and that staff’s support

help (fourth element). The fifth element is QA

staff that is independent of the technical staff,

reporting to the president or a senior manage-

ment person who is not directly responsible for

technical operations or the technical staff. The

QA staff is knowledgeable of company policies

and procedures and is thoroughly trained and

experienced in external regulations pertinent to

the company’s operation, such as good labora-

tory practice (GLP), good clinical practice

(GCP), and current good manufacturing practice

(cGMP) regulatory requirements. The QA staff

interfaces with the technical and support units,

senior management, and the client by appro-

priate means, e.g. meetings, telephone, written

communiqu!es, etc. The sixth element, and

certainly not the least important, is the client,

or customer who communicates with the rele-

vant CRO counterparts. Communication chan-

nels between the CRO and the client should be

established before project work commences. The

negotiated contract between the client and the

CRO usually outlines the requirements by which

the work is to be undertaken. However, some-

times certain requirements are not forthcoming

until the project is underway for a variety of

Figure 3. Dependency

Figure 4. Quality permeation system



reasons: they were not known at the time of

proposal preparation or contract negotiations;

neither party thought of the requirement(s); new

requirements were established, etc.

It is important to mention that the client not

only interfaces with different units within the

CRO organization but with appropriate func-

tions within its own organization as well. The

CRO’s external interface can be with many

different third parties, such as suppliers, regula-

tory bodies, competitors, and the business and

technical communities. This external interface

helps the CRO obtain input for evaluating and

benchmarking their own services.

Quality Operations System

There are a number of quality management

systems for use by organizations of all types and

sizes. Some of the better known ones are: ISO

9001:2000 [2,3], ISO 17 025 [4], ISO 14 000

[5], Baldrige National Quality Program [6], Six

Sigma [7], and Balanced Score Card [8].

Although a company need not base its quality

system on one of the foregoing, it must have a

quality system in place, and each element of the

system must be carefully monitored and main-

tained. An illustration of a quality system is

given in Figure 2. This system comprises ten

major processes that cover technical and busi-

ness processes.y

1. Management system and businessprocesses

Process 1 is the system of technical and business

processes and their sub-process and interfaces,

or linkages, that help enable processes 2 through

10 and the enablers to be effective and efficient.

Process 1 covers activities/sub-processes man-

agement, executes its responsibilities to ensure

the company remains financially viable, satisfies

client needs, maintains its image, realizes con-

tinuous improvement in operations, and realizes

professional staff growth in pursuing its mission

and achieving its objectives. These activities

include business planning, management review,

internal auditing, handling client complaints,

corrective and preventive action, process plan-

ning and evaluation, training, record keeping,

and document control.

2. Marketing

Process 2 is a continuous, relentless process

directed toward selling the company’s services

with the intent of obtaining contracts to under-

take projects. This process interacts with pro-

cesses 1, 3, 5–8, and 10. Process 2’s activities

include seeking relevant intelligence, assessing

this information, and determining and evaluat-

ing market and sales opportunities. Additionally,

the activities include establishing opportunities

for new business areas as well as obtaining sales

in existing areas, building the company’s overall

image, promoting technical capabilities, assist-

ing in deciding on whether to bid on a job, and

any other activities relating to clients and

prospective clients.

3. Proposal

Process 3 covers proposal preparation, costing,

review, submission, and follow-up activities.

This process interacts with processes 1, 2, 4–6,

and 10. Once the decision has been made in

Process 2 to bid on a job, a proposal team (e.g.

comprising management, technical, support,

contract, and legal) designs and prepares the

proposal. Appropriate reviews are made, the

proposal is submitted, and appropriate follow-

up activities are undertaken in a coordinated

manner at the proper times.

4. Contract

Process 4 is where the contract unit interfaces

with processes 1, 3, 5, 6, 8, and 10 at all levels of

yTo increase the clarity of Figure 2, not all interactionsdiscussed in the manuscript are indicated in the figure.

112 PC Constant Jr.


the company in support of winning new work

and assuring the successful completion of

current projects. The unit’s principal activities

include assisting in bid/no bid decisions, advis-

ing on contractual matters, preparing the busi-

ness portion of a proposal, and pricing labor,

materials, and other items. Additionally, activ-

ities include assisting in establishing proposed

budgets, reviewing the entire proposal, prepar-

ing and negotiating contracts and their modifi-

cations, and handling sub-contracts and

consulting agreements.

5. Document control

Process 5 covers the systematic control of all

documents used in the operation of the quality

control (QC) system. This process interacts with

processes 3, 4, 6, 7, and 10. Process 5 covers

receipt of internal and external quality docu-

ments, storing hardcopies of the documents,

entering these documents into and maintaining

an electronic database, and keeping a master list

or the equivalent of quality documents. Addi-

tionally, it includes the review and updating of

documents, approvals by appropriate managers,

and distribution of quality documents under a

control system, disposal of obsolete documents,

and maintenance of any satellite repositories for

current and historical documents. The document

control office interacts with most operational

units, such as the technical staff, contracts,

human resources, safety, and security.

6. Project operation

Process 6 interacts with all the other processes.

Process 6 covers anticipating and satisfying

needs and problem areas, planning and schedul-

ing work, performing work according to plans

and schedules, designing products/methods,

monitoring activities (technical, financial, and

administrative), and measuring key parameters.

The project leader, line management, certain

project staff, and market interact with the client,

as required. The project team leader and staff

interact appropriately with enablers noted in

Figure 2: the client, management, quality assur-

ance, project staff, security, safety and support

staff. There is interaction when needed with

other units of the contractor’s organization that

may not be identified in Figure 2. These include

marketing, contracts, accounting, purchasing,

property, quality assurance, human resources,

instrument services, document control, and

records center.

7. Evaluation

Process 7 interacts with processes 1, 2, 5, 6, 8–

10. This process covers the evaluation of

company project-related operations, such as

purchasing, contracts, property, and shipping

and receiving, with respect to their involvement

in project operations. In addition, the process

requires appropriate follow-through on the

actions being taken to ensure there is closure

to an issue and all activities have been well

documented and the necessary critiques have

been undertaken. It also covers the evaluation of

third-party assistance, such as, sub-contractors’

and consultants’ work. The process also makes

certain that project products are evaluated by

appropriate means, such as, product/method/

model verification and product validation using

appropriate statistical designs, test instruments

and procedures, data processing and analysis

techniques (resolute, statistical, or both). Mon-

itoring and measurement results from Process 6

are evaluated to determine if any corrective

actions need to be taken, and if so, what they

are, how they will be done, and who will

undertake them, as well as their cost and target

dates for their completion. Vital factors of

Process 7 are the activities of the corporate

independent QA unit. Guides, shown in Figure

2, are client requirements, balanced score card

(a management personnel evaluation tool), and

standards.

8. Client satisfaction

Process 8 focuses on satisfying client require-

ments, a positive evaluation by the client, and



repeat business from the client. Client satisfac-

tion covers the following activities: learning

from and listening to the client and reacting

appropriately in a timely manner, accepting the

client as part of the team (if acceptable by the

client), keeping the client informed, building

trust, seeking help from the client when it is

needed, and documenting pertinent information.

Process 8 interacts with processes 1, 2, 4–7, 9,

and 10. Telephone calls, teleconferences, video

conferences, field visits, written communiqu!es,

and personnel visits are means by which the

client is contacted for an assessment of the

contractor’s work as well as for reporting.

Timely performance feedback from the client

via a quantitative client survey questionnaire

administered at the completion of a project by

the appropriate office, such as the corporate

marketing group, can be quite useful for deter-

mining potential improvements to be made for

both project and company operations. All

results from the survey are well documented

and communicated to appropriate people, such

as, division management, senior management (if

warranted), project leader, contract department,

and project team members.

9. Corrective and preventive actions(adjustments)

Process 9 interacts with processes 1, 4, 6, 8, and

10. These cover both project and company

operation, with ensuing improvements made as

effectively and rapidly as deemed necessary or

practical. Principal activities of Process 9 are:

identifying problems and determining their

causes, evaluating the impact the problem has

or may have on project and company objectives,

planning corrective actions, undertaking the

plan of actions and validating the results of the

actions taken, and documenting all pertinent

information. Management, project staff, and the

staff in general identify areas where preventive

actions should be considered. Preventive actions

are reviewed by management of the organiza-

tional unit(s) concerned and, in turn, discussed

with staff affected by the actions, staff that made

the suggestion/request, or both. Approval of the

action is made by the responsible division

director, or midlevel division manager, the

project leader, or senior management, depending

on the issue. (The approval process is usually

covered by a company policy.) Then appropriate

actions are taken, if such are warranted. Client

complaints are reported to the project leader, his

or her supervisors, and other appropriate levels

of management. Appropriate resolution is

sought and appropriately resolved, bringing

closure to the complaint. The complaint case is

well documented from its receipt through its

closure. The client is properly informed through-

out the complaint resolution period according to

a client complaint communication plan. Appro-

priate critiques are held with appropriate

company personnel for operational improve-

ment considerations and to minimize the chance

of the problem arising again.

10. Continual improvement

Process 10 activities include determining im-

provements; assessing their authenticity and

value; undertaking the improvements and mon-

itoring the improvements through their comple-

tion; and communicating and documenting

pertinent results and the activities that were

undertaken. Process 10 interacts with processes

1–9. Any staff member can suggest an improve-

ment. However, there should be appropriate

justification accompanying the request. For

example, an engineer may need an acoustic

anechoic chamber to effectively test equipment

that is being developed. He or she does not

simply request this facility, the request must

include justification for the need, such as the

testing rate of units would be increased 100%,

rejects would be lowered by 20%, and the

operation would eliminate the need of one

technician, thereby realizing a cost savings of

X dollars/month. Management assesses and

approves the actions to be taken to implement

the improvement.

Each process of the quality system is critiqued

by its own staff as well as by management,

114 PC Constant Jr.


periodically, for its effectiveness and any im-

provements that should be made.

Quality Inherency

Quality has no bounds. Quality encompasses all

company processes. It also encompasses the

increase in the effectiveness and efficiency of

operations with continuous improvement and

client satisfaction in mind and helps the company

remain financially viable. It is indeed more.

Quality covers more than just QA and quality

control (QC) on projects. The most critical factor

in achieving quality in an effective and efficient

manner is the individual – the employee. This

person should not have to ‘think’ about quality.

Quality should come naturally. Quality needs to

be inherent in a person’s own operations.

Inherency can be simply exemplified by an

infielder in baseball when a ball is hit and driven

in his direction. The professional ballplayer

usually does not have time to think of what he

is going to do. He has the ability – talent and

proper emotional attributes – and is so well

trained and experienced that he reacts instinc-

tively. The infielder properly positions himself to

field the ball and automatically throws it to the

proper base in time for the out.

It is not to be inferred here that a person

should not ‘think’. Rather, a person should have

the proper educational background and emo-

tional attributes, know the relevant policies and

procedures, and be so well trained to effectively

carry out his or her responsibilities so that he or

she simply does things the way they should be

done – this is in effect quality.

Now that this human characteristic of quality

inherency is known to be quite important, how

is it achieved? There are eight major activities

that are paramount for success in attaining

inherency, factors in ensuring that quality comes

naturally:

* Select the right employees.* Train employees well.* Provide proper tools.* Provide proper work environment.* Provide proper maintenance.

* Monitor performance.* Reward good performance.* Discipline when necessary for wrong doings.

Select the right employees

To meet specifications in producing a product,

the proper materials must be used. This may not

always be easy. For example, the material

ordered may meet specifications on paper, but

in reality faults in the material are not readily

apparent. A test may be required to uncover the

faults. If a test is not undertaken and the

material is accepted by a visual inspection, the

quality of the material is not necessarily known.

The quality will become evident after the

product has been made and put into use. This

point is also true in recruiting new employees.

Recruitment is not a simple task because of

ghost factors (certain attributes, characteristics,

etc. of the applicant) that are not apparent

during an interview. These ghost factors only

become evident under certain conditions or

circumstances to the non-professional. Selecting

a current staff member for the correct person-to-

job match is not as difficult because the

company has knowledge of the employees’ past

performance at the company.

Ghost factors include an individual’s intellect

and will, which are his or her controlling

mechanisms. Consequently, they are important

to know and understand in establishing the

inherent quality in an individual, because these

ghost factors, if known, could prevent the hiring

of someone who is not suited for the position.

Therefore, it may be prudent to consider

psychological testing as part of the hiring

qualifying procedure. What is needed is a person

with the proper attributes or potential to do

what is required, which include the right

attitude and behavior for the position to be

filled.

Training for quality inherency is more than

training on regulatory requirements, of compa-

ny’s policies and procedures, working with

people, operational processes, accountability,

ethics and professionalism. It is for placing



value on doing things correctly the first time in

an effective way for oneself, the client, and the

company as well as being responsible for one’s

performance. The latter point brings into con-

sideration a person’s attitude and behavior and

why they are who they are. To achieve quality

inherency in an individual, understanding the

meaning of attitude and behavior and knowing

how to effect the proper change in these

characteristics is needed. Attitude and/or beha-

vior change is not necessarily easily achieved,

but necessary, if needed, to ensure quality

operations. To effectively deal with unwanted

attitudes and behavior may require the assis-

tance of professionals in this field. Attitudes are

feelings or emotions. Attitudes are important to

know and difficult to measure. Someone wrote,

‘Attitude is a little thing that can make a big

difference’. Behavior is attitudes put into action–

human conduct.

Train employees well

A prerequisite for quality is education and

training and re-education and re-training for

everyone in the company. If a good selection of

employees is made, training becomes simpler.

However, there can be hurdles to overcome,

such as, establishing the training program,

selecting or acquiring the proper trainers, the

cost of training, and time to do it correctly.

Training is a continuous venture.

It must be recognized that there are differ-

ences in people. Therefore, the means to be used

to train people can vary depending on the

characteristics of individuals. Consequently,

establishing the appropriate training program

and curriculum can become complex and time

consuming as well as costly. Training needs to be

done on a continuing basis because changes in

operating practices, especially procedures and

improvements, may require an emotional accep-

tance.

There are many means to train: traditional

instructor-led, on-the-job, mentoring, internal

and external specialized courses, e-training, self-

training, and any combination thereof. The

advantages and disadvantages of each method

need to be considered in establishing the training

program. In addition, there are many factors to

be considered, such as the trainee’s educational

background, experience, and aptitude, notwith-

standing outside influences and emotional char-

acteristics – attitude and behavior – as well as

intellect and will. Incorporating all these factors

into a training program may require the

assistance of professionals from the field of

education/training.

Validation of the training program should not

be forgotten. Means of evaluation include

observation or monitoring of work habits and

performance, checking the person’s work, writ-

ten examination, client comments, and other

employees’ opinions.

Provide proper tools

Management must be aware of the resources a

person needs to help ensure they are achieving

the desired quality of work. The employee has

the responsibility of informing management

when a required resource is needed, for provid-

ing appropriate justification for the need of the

resource, and the consequences if the resource is

not obtained when needed. Lack of having the

proper tools can bring about poor attitude or

behavior, or both, and hinder the development

of inherency. The mature, strong-willed, profes-

sional and ethical person will not lose his/her

quality inherency. They will always find ways to

seek and obtain the needed resource.

Provide proper environment

Providing the proper environment in which to

work can be as important as management

providing the proper tools. The environment in

which a person works can have a large influence

on a person’s behavior at work, and this

behavior may be carried to places external to

the workplace and vice versa. The culture of a

company sets the environment to which people

will respond and exposure to this environment

can affect a person’s attitude. The appropriate

environmental and health conditions, as well as

a safe work environment, should prevail.

116 PC Constant Jr.


Proper maintenance

This covers people, equipment, facilities, mate-

rials, and work environment. It also covers

policies, procedures, protocol, plans, etc. that

need to be reviewed, updated and approved on a

scheduled and as needed basis.

Monitor performance

An effective management monitoring program –

follow-up and follow-through – is required to

ensure operations are going according to plans.

Follow-up means that things are being mon-

itored properly in a timely manner and there is

appropriate documentation of objective evi-

dence. Follow-through means taking appropri-

ate action on results of the monitoring and it

includes evaluating the results appropriately and

then taking the necessary corrective actions. A

follow-through on the corrective actions needs

to be taken to ensure that the corrective actions

have been successfully completed. Performance

monitoring should be well documented for the

benefit of the employee as well as the company.

Reward good performance

It is important to reward a person for good and

exceptional performance. It is equally important

to hold people accountable for poor perfor-

mance. The particular reward depends on the

accomplishment, its value, company policy, and

the impact it has made for the client, the

company, society, etc. The justification for the

reward unquestionably needs to be correct and

proper with no politics or friendship involved. A

reward must be based on merit, and contribu-

tions of others must be a considering factor.

There should be no hesitation in recognizing a

person more than once, if the case warrants it.

Everyone appreciates being recognized for the

contributions he or she has made, and being

rewarded can be a valuable tool for helping

maintain quality operations. An unidentified

person wrote, ‘To accept oneself positively and

live creatively is the road to success, but to deny

and reject one’s attributes is the road to failure’.

Discipline as required for wrong doings

Discipline is an act of caring for those who

receive it.

Although taking disciplinary actions when

they are needed is not an easy or relished task

for most people, appropriate actions must be

taken when they are needed. They must not be

delayed or postponed. If appropriate actions are

not taken, there is a high probability that the

quality of work will not improve. It will

probably degrade. The person being disciplined

must be presented all the objective evidence in a

professional manner and be given the opportu-

nity to explain his or her side of the issue. If

disciplinary action is warranted, it must be fair

and just.

Success Means Quality Achieved

David T. Kearns wrote, ‘In a race for quality,

there is no finish line’. Everyone wants success

for the client, the company, and him or herself.

However, how many people want to run the race

for quality? How many are prepared? Quality

inherent in peoples’ performance will be a

paramount factor in ensuring successful results.

The successful project ends with a satisfied

client/customer, a satisfied staff member, satis-

fied management, and a satisfied project leader.

The client/customer is satisfied by:

* Work completed on schedule with the desired

level of quality and the cost within budget.* Technical contributions made that contribute

to the client’ increase in earnings and image.* Client personnel being assisted in their jobs.

Project team members gain satisfaction

through:

* Their contributions to the project’s success.* Recognition for their personal contributions.* Increased knowledge and capability.* Support received when needed.

The contractor’s management is satisfied by:

* A satisfied client.* A satisfied staff member.



* Increased purview of its image and image

enhancement.* Technical contributions provided to the mar-

ketplace and community in general.* Increased staff knowledge and capabilities.* Receiving a significant fee (profit).* Receiving additional work from the client

and/or others.* New/additional business areas opened.

The leader of a project is satisfied by knowing

he or she served others well.

Robert J. Eaton said, ‘All by itself, good

quality won’t determine winners, but poor

quality will certainly determine the losers’.

Conclusion

When a company is out of quality, it is out of

business. Quality must be built-in characteristics

of an employee as well as the company’s

operation. The cost of quality is what it costs

to do things wrong – not doing things right the

first time. Quality can be considered confor-

mance to requirements or the absence of non-

conformities.

Desire for quality must come from the

individual employee – be built-in, inherent –

and employees must receive encouragement for

quality performance from the highest level of the

organization. The employees must be given the

proper tools to do their job. The permeation

source for quality in an organization lies with

the company’s highest official.

An organization must have a quality manage-

ment system, which is a set of interrelated or

interacting processes. The system must be

company-suitable, and it must be effective,

auditable, documented, maintained, and fol-

lowed. It is essential that the system be main-

tained, which includes internal and external

audits and an internal continuous, documented

and followed improvement plan.

A company’s senior management sets opera-

tional policies and procedures, permeates qual-

ity, and establishes the authorities and

responsibilities of each organizational division.

Division management ensures:

* Proper resources are available when needed.* Corrective actions are appropriate and have

been taken.* Requirements are met.* Operations are safe.* Staff is appropriately trained for tasks they

are given.* Feedback is obtained from clients.* Appropriate corrective actions to non-con-

formities are noted in audit reports.

In a quality organization, staff members will be

kept current in their areas of expertise working

at all times to reach their next level of

excellence. They will foster the highest standard

of ethical and professional conducts and work

diligently to meet client requirements. They will

adhere to company policies and procedures,

applicable client policies and procedures, applic-

able laws, and business and government require-

ments and regulations. They will ‘master their

minds and bodies’ so as to benefit the client,

their management, their fellow employees, and

others directly or indirectly, while not losing the

human touch. The staff and management are

partners in progress.

References

1. Crosby PB. Quality is Free. McGraw-Hill Book Com-

pany: New York, 1980.

2. Hart J. ISO 9000:2000 The Route to Registration. (1st

edn), 3rd Printing. BSi Management Systems and BSi

CEEM: Reston, VA, 2002.

3. ISO 9001:2000. Quality Management Systems –

Requirements. International Standards Organization,

2000, available at http://www.iso.org [16 November

2004].

4. ISO 17025:1999. General Requirements for the

Competence of Testing and Calibration Labora-

tories. International Standards Organization, 2000,

available at http://www.iso.org [16 November

2004].

5. ISO 14000. Environmental Management Systems.

International Standards Organization, 2000,

118 PC Constant Jr.


available at http://www.iso.org [16 November

2004].

6. Criteria for Performance Excellence. Baldrige Na-

tional Quality System: NIST, Administration Building,

100 Bureau Drive, Stop 1020, Gaitherburg, MD 20800,

2004.

7. Stamatis DH. Six Sigma Fundamentals. Productivity

Press: New York, NY 10016, 2004.

8. Kaplan RS, Norton DP. The Balanced Score Card:

Translating Strategy into Action. Harvard Business

School Press: Boston, MA, 2002.



Documents

Some thoughts on quality