Why Quality Is Important and How

It Applies in Diverse Business and

Social Environments, Volume I
Why Quality Is Important and How
It Applies in Diverse Business and
Social Environments, Volume I

Paul Hayes
Why Quality Is Important and How It Applies in Diverse Business and Social
Environments, Volume I
Copyright © Business Expert Press, LLC, 2021.

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 Description
These two volumes are about understanding—why—and application—
how—with the aim of providing guidance and introduction to both.
Quality is the consistent achievement of the user’s expectations of a product
or service. The achievement needs to be “The right thing, right first time,
every time, in time.” Beginning with manufacturing and services, it also
includes professional, personal, and spiritual dimensions.
Variation does not sit happily with consistency and skill in handling
risk and opportunity requires competence in the use of statistics, prob-
ability, and uncertainty; and needs to complement the critically essential
soft dimensions of quality and the overarching and underpinning pri-
macy of personal relationships.
There are no clear boundaries to the applicability of quality and the
related processes and procedures expressed in management systems, and
this is why it matters so much to show “how it applies in diverse business
and social environments.” Increasingly, the acceptability of boundaries
that are drawn depends on their effect on the user and the achievement
of quality, and the latest standards on quality management are explicit on
this key point.
Quality is everyone’s business, and there is no single professional dis-
cipline that can properly express this. Insights, knowledge, experience,
best practice, tools, and techniques need to be shared across all kinds of
organizational and professional boundaries, and there is no departmental
boundary that can stand apart from the organization-wide commitment
to quality achievement.

Keywords
quality; management; systems; uncertainty; statistics; probability; humil-
ity; arrogance; love; attunement; mastery; ascendancy; holiness
 Contents
Acknowledgments....................................................................................xi

Chapter 1 Introduction......................................................................1
What Is Quality and What Does It Entail?.........................1
Who Is the Publication Aimed at and
How Could It Be Used?..................................................5
Chapter 2 Quality and Manufacturing Industries...............................7
The Role of the Specification..............................................7
System Approaches to Conformance to Specifications........7
Scope and Boundaries of Quality.......................................8
Central Role of the Specification........................................9
Circular Economy............................................................12
Eco-Parks and a New Industrial Revolution.....................14
Technology Verification....................................................16
Life-Cycle Perspective and Analysis..................................18
Industry 4.0.....................................................................19
Chapter 3 Quality and Service Industries..........................................25
What Is a Service Business or Organization?.....................25
Internal and External Customers......................................26
Going the Extra Mile and the Importance of Family........26
Chapter 4 Quality, Risk, Opportunity, and Improvement.................27
Consistency and Variation................................................27
Coefficients of Variation...................................................31
Risk as Likelihood............................................................35
Making Inferences............................................................40
Distributions....................................................................40
Sampling..........................................................................40
Process Stability...............................................................42
Risk as Likelihood and Consequence...............................43
Uncertainty and Risk and Opportunity............................44
Risk Management and Risk-Based Thinking....................45
viii CONTENTS

Limits to Risk Management—Adulteration and

Corruption...................................................................57
Improvement...................................................................57
Plan-Do-Check-Act.........................................................59
Chapter 5 Quality and the Individual...............................................65
Leadership and the Individual..........................................75
Shame and Guilt, Is and Ought.......................................77
Personal Change and Improvement..................................77
Chapter 6 Quality and the Team.......................................................79
Pulling Together in the Same Direction............................79
Profiles and Team Roles....................................................80
Chapter 7 Quality and the Community............................................83
Interested Parties, Stakeholders, and People......................83
Corporate Social Responsibility........................................83
Triple Bottom Line..........................................................84
Taguchi and Loss to Society.............................................85
Community and Quality..................................................86
Building Capabilities and Releasing Vision......................87
Chapter 8 Quality, Health and Safety, and the Environment............91
Standalone or Integrated?.................................................91
Quality, Safety and Environment Go Together.................93
Annex SL and Management System Integration...............97
Society Imperatives..........................................................98
Chapter 9 Quality and Information Technology...............................99
Software for QA and QC.................................................99
Software Quality............................................................103
Information Technology.................................................113
Chapter 10 Tools and Techniques for Quality...................................121
Standards and Specifications...........................................121
Standards and Best Practice............................................121
Quality Assurance and Control......................................123
Audit..............................................................................124
Process Management......................................................124
Statistics.........................................................................127
The Systems Approach...................................................132
 CONTENTS
ix

Chapter 11 Deployment for Quality.................................................135

Quality Function Deployment (QFD)...........................135
Benchmarking................................................................139
Maturity Grids...............................................................140
Management Systems.....................................................147
Statistical Quality and Process Control...........................149
Process Management......................................................152
Business Process Engineering and Reengineering............156
Chapter 12 Quality Management.....................................................159
Responsibility................................................................159
Accountability, Transparency..........................................160
Triple Bottom Line, Internal Values, and
Management of Behavior, Corruption........................161
Role and Effect of Standards..........................................163
Accreditation and certification.......................................173
Total Quality Management, Companywide Quality
Control.......................................................................176
Quality in the Supply Chain..........................................177
Appendices
Abbreviations..................................................................181
Key Addresses...................................................................183
Probability Distribution Functions...................................185
Examples of Opportunity and Risk Management
Approaches and Their Main Uses.................................188
Example Process Flowchart...............................................190
Example Section of Data Flow Diagram for
PowerApps Documentation..........................................194
Example TOWS Analysis.................................................195
Case Studies....................................................................198
References............................................................................................201
About the Author.................................................................................245
Index..................................................................................................247
 Acknowledgments
The opportunity for this book came from an invitation to write some-
thing for Business Expert Press. The, somewhat pretentious, title I offered
was changed to this wider scope and gave me the opportunity to share the
experience and understandings from a varied career.
After starting in Aluminium Chemicals research, I moved into tech-
nical paper-making with Wiggins Teape, which was then owned by BAT
(formerly British American Tobacco) and is now Arjo Wiggins Appleton.
I started at Glory Mill near High Wycombe in Buckinghamshire and the
graduate intake scheme I was fortunate to join introduced me to their
very mature leading-edge approach to quality management. Experience at
Stoneywood Mill in Aberdeen and then the paper-converting operation
at Dyce as a quality manager provided a base in the best practice in qual-
ity assurance and quality control well before there were international stan-
dards to support it. My mentor throughout those years and for a number
afterward was Peter Daisley, and I would like to acknowledge that deep
debt of gratitude for all his support and particularly the direction to the
statistical disciplines that are such an important part of quality.
Dental Chemicals, with the very wide range of materials science in-
volved, and testing laboratory supervision introduced me to Pharmaceu-
ticals and the Orange Guide as some of the chemicals claimed therapeutic
benefits.
This was followed by quality management in a medical devices com-
pany making single-use sterile and reusable Class II anesthetic and sterile
single-use class III blood circulation devices and device sets. This also in-
volved regulatory responsibilities setting up registration and all the device
forms with the U.S. FDA and hosting one of the early Good Manufac-
turing Practice inspections in the UK. The quality management systems
developed used local access to computer bureaux for the documenta-
tion. The work also involved national and some international standards
experience.
xii ACKNOWLEDGMENTS

In both experiences I was deeply indebted to the very able and experi-
enced team members and have many happy memories of the individuals.
The next steps involved training in use of the emerging business mi-
crocomputers and software to develop quality management system, and
this interest has been a constant theme beginning with the help of Roger
Chambers in Aberdeen, who worked in the NHS on the IT side and is
now a long-term family friend and fellow believer.
Quality management in computer and software manufacturing
brought invaluable experience in this area followed by the first exposure
to quality consultancy using the new, at the time, UK government grant
scheme for development of basic quality management systems (QMS)
but also included development of QMS software for gauge control and
hospital ward management.
Contacts made in the time with Wiggins Teape resulted in a move
into pre-clinical trial testing of chemicals and pharmaceutical testing with
responsibilities in training and quality improvement. The experience of
developing trainers and resources, and then delivering the programs, was
a rich development time and contact with the four key original directors
of the organization and the key QA and human resources staff a great joy.
I am deeply indebted to Geoff Cox of New Directions for all the vital
input to our quality and management training in the pre-clinical chemi-
cals and pharmaceuticals organization and particularly for the pointer to
the work of Roger Harrison that forms such a key foundation of the later
chapters of this work.
Experience of independent auditing for the UK Competent body for
medical devices just prior to the passing of the first EU Medical Devices
legislation was accompanied by a large team project work on the estab-
lishment of an early ISO 9000 QMS preparatory to the floatation of a
major Scottish government building management organization and also
experience in delivery of auditor training for the major UK standards and
quality training and consultancy body.
Working in ISO 9000 and then TQM Quality Consultancy for
the Renault Institute of Quality Management was founded on very
well-developed training materials, which were a joy to deliver. This work
also included IT support network creation and support for the team of
 ACKNOWLEDGMENTS
xiii

consultants in the days when ISDN was the preferred, and the only really
feasible, option for Wide Area Networks for staff teams.
Recent years have seen specialization in test laboratory and calibration
systems in the Marine Energy Renewables sector, long-term indwelling
sterile Class III Medical Device specification and prequalification with
major international agencies, authorized representative role with the same
medical device, inspection body, and Innovative Environment Technol-
ogy Verification (ETV) assessment, and work as an EU expert arising
from this, quite apart from keeping the professional competence up to
date in ISO 9001 certification.
The support from John Griffiths and the whole team at EMEC, in-
cluding Lesley Bews, Chris White, and Neil Kermode, and those that I
have worked there over the years has been key over the past decade and
more, along with the EU ETV colleagues arising from this association.
The very rewarding long-term association with EMEC sprang from
a membership of the UK Chartered Quality Institute (CQI), which was
then the Institute for Quality Assurance (IQA). The consultants register
for this body led to long-term associations with Ian Dalling, John Jeffery,
and Roger Horne and others, and many opportunities for enjoyably wid-
ening, deepening, and maintaining quality management competences.
The understanding, support, and learning from Dr Bill Potter of Sta-
pleford Scientific Services, and John Hurll of Hurll Technical Services
have been rich friendships and have been invaluable in many important
connections and particularly the statistical and scientific dimensions and
connections.
Andy Taylor worked with me on eLearning and with his authoring
of training material and with the science and quality background, his
encouragement on reading the first draft was crucial. The help from my
daughter Fenella Hayes throughout and in preparing the document for
copy editing was greatly appreciated.
But without the long-term support of my wife Maureen and family, of
which two of my three children have worked with me in my business for
differing times before moving into their own careers, none of this would
have happened. And we are both so grateful for the overarching care and
leading that we both depend on in life.
 CHAPTER 1

Introduction

This is about understanding—why and application—how.

The aim is to provide guidance and introduction to both.
The book is in two volumes, with the first ending with
Chapter 12, Quality Management.

What Is Quality and What Does It Entail?

Consistency and Variation

Quality is the consistent achievement of the user’s expectations of a prod-

uct or service. The achievement needs to be “The right thing, right first
time, every time, in time.”1 We begin by looking at manufacturing and
service industry and we wrap up by looking at the professions.
Immediately we can see that variation is not going to sit happily with
consistency and that we must consider risk, and its converse—opportu-
nity, likelihood, and probability and understand and use statistics. There
are common and special causes of variability and with each we need to
apply the related statistical techniques.
Products, even if produced by robotic machines, still involve human
agency individually and in teams at key points throughout production
and then in the use and service phases even more so. We need to be con-
fident that we can deliver to the standards required and this needs to be
established by a whole range of means.

1
Phil Crosby “Do it right first time, every time” amended according to R.G. Boznak.
July 1994."When Doing It Right First Time Is Not Enough,” Quality Progress,
pp. 74-78.
2 WHY QUALITY IS IMPORTANT, VOLUME I

Processes, Procedures, Best Practice, and Their Expression

The creation and delivery of products and services depends on processes,

and more detailed procedures when necessary, within and across organi-
zations of all kinds. Processes are assembled, established, and maintained
in management systems inside and across organizational boundaries. We
are going to need to describe these processes and communicate them
within and across organizational boundaries.
Best practice that is known to enable and assure consistent achieve-
ment of user’s expectations must be captured and shared and leads to
standards, specifications, and many related documents, which increas-
ingly are created and shared, sometimes exclusively, within virtual infor-
mation technology environments. There is a natural flow from statements
of objectives, with their associated measures of achievements, through
policies on how they will be achieved in different areas, to the enabling
processes and procedures for the use of those individuals responsible for
their operation.
A record of how processes and procedures are operated, and the out-
comes are documented also needs to be captured, stored, and shared.

Scope and Boundaries

There is no clear boundary to the applicability of quality and the related

processes and procedures expressed in management systems, and this is
the main reason for this work and its stated aim to show “how it applies in
diverse business and social environments.” Increasingly the acceptability
of boundaries that are drawn depends on their effect on the user and the
achievement of quality, and the latest standard on quality management is
explicit on this key point.2
Quality is everyone’s business and there is no one professional dis-
cipline that can properly express this. Insights, knowledge, experience,
best practice, tools, and techniques need to be shared across all kinds of
organizational and professional boundaries, and there is no departmental

2
See ISO 9001:2015, “Quality Management Systems—Requirements.”
 Introduction 3

boundary that can stand apart from the organization wide commitment
to quality achievement.

Foundations of Society

In early society, weights and measures were the basis of trade and interna-
tional collaboration, and the ethics of honest accurate traceable measures
is reflected in their reference in the law codes and spiritual reference works
of the day.
Modern science is based on the higher and higher discriminations and
the lower and lower uncertainty in measurements that permit testing of
the most revealing, and often counterintuitive and disturbing hypotheses
and current findings of modern science.3

Health and Safety

Quality failures have consequences, and these can be extreme, so this

topic has traction well outside the immediately obvious scope.

Improvement and PDCA

Quality is a journey and continual improvement is a driver and motiva-

tion, goal, objective, aim, and expression and will be central to everything
we say about achievement of quality. Not only is this a truism we used
heavily in the 1970s and 1980s, but it reflects the widely accepted belief
that achievement and maintenance of quality is central to business and
organizational success.
Continual or Continuous Improvement is a process with four very
well-established steps PLAN, DO, CHECK or STUDY, and ACT
(PDC[S]A), that have clear links to the scientific method (Figure 1.1)
which it probably even predates.4

3
See Nova, “Einstein’s Quantum Riddle”, https://www.pbs.org/wgbh/nova/video/
einsteins-quantum-riddle/ and https://www.youtube.com/watch?v=Mn4AwineA5o
4
See R. Moen and C. Norman. “Evolution of the PDCA Cycle.” http://www.idem-
ployee.id.tue.nl/g.w.m.rauterberg/lecturenotes/DG000%20DRP-R/references/
Moen-Norman-2009.pdf.
4 WHY QUALITY IS IMPORTANT, VOLUME I

Figure 1.1  Evolution of the scientific method5

The very largely accepted standard for management systems—ISO

9001 (now version 2015)—has this statement “The PDCA cycle enables
an organization to ensure that its processes are adequately resourced and
managed, and that opportunities for improvement are determined and
acted on.” The open source Management System Standard6 describes
it as “Plan–Do–Check–Act” (PDCA) is a cycle that individual people
naturally follow to varying degrees of competence. PLAN is the prepara-
tion for doing something. DO is the execution of the PLAN. CHECK is
monitoring to confirm the PLAN is being properly followed during DO
and that nothing unexpected occurs. Finally during ACT, a review of
PLAN, DO, and CHECK processes is conducted to see if the approach
used can be improved the next time around plus agreeing actions to make
it happen.
PDCA is therefore a natural potentially universal cycle of continual
learning and continual improvement applicable to organization strategy,
tactics, and operations. The fourth element ACT can also be conducted
proactively to ensure that the organization remains aligned with future
stakeholder needs and expectations by trying to anticipate future likely
innovation and change.”7

5
Ibid.
6
See “Management System Specification and Guidance MSS 1000:2014,” CQI Inte-
grated Management SIG. https://www.integratedmanagement.info/mss-1000.
7
“Management System Specification and Guidance MSS 1000:2014,” CQI Integrated
Management SIG. https://www.integratedmanagement.info/mss-1000.
 Introduction 5

“Check” is sometimes replaced with “Study” for non-native English

speakers if “Check” has negative connotations of “holding back.” It is also
conceived as applying more explicitly to improvement.8 This gives rise to
the equivalent PDSA cycle.

Excellence, the Destination

The journey has a goal, and this is explored in several ways. Excellence is
a common aim. It is expressed in many ways as follows:

• Customer delight—see “Going the extra mile and the importance

of family”
• Total Quality Management—see “Total Quality Management,
Company Wide Quality Control”
• Personal Mastery9—See “Personal Quality and Mastery”

Touching Lives

Quality is all about relationships and the motivation and values ex-
pressed. It is concerned with building values and community and express-
ing the highest ideals—see Quality, Life, and Service and the concluding
Chapter 24—Quality, Faith, and Transcendent Values.

Who Is the Publication Aimed at and

How Could It Be Used?
This is an introduction to quality to assist those responsible for the prod-
uct or service they provide in many diverse situations and organizations
to help them see the common issues they face and find the support, ref-
erences, and links to take their exploration and understanding forward.
To handle the many issues we all face, and which we touch on in
Volume 2, it is important to at least review and be confident in the basics
we cover in Volume 1.
8
An Introduction to the PDCA Cycle Webcast, Part 1. http://asq.org/2011/07/­
continuous-improvement/intro-to-pdca-1.html.
9
See D. Kachoui. April 2018. “Personal Improvement—Becoming A Master—Do
you have what it takes to achieve mastery?” Quality Progress, pp. 38-43. http://asq.org/
quality-progress/2018/04/career-development/becoming-a-master.pdf.
 Index
Accelerating change—from biology to
technology, 14
Accountability, transparency, 160–161
Accreditation and certification,
173–176
Additive manufacturing, 20
Adelphia Communications Corp.,
162
Adulteration and corruption, 57
Agile, 107
AI. See Appreciative inquiry
AI. See Artificial intelligence
Aim of control, 151
Alexander the Great 356 BC, logistics
and supply chain, 177–178
American Productivity & Quality
Center (APQC), 140
American Society for Quality (ASQ),
99, 139, 140, 150
Appreciative inquiry (AI), 74–75
APQC. See American Productivity &
Quality Center
AR. See Augmented reality
Arthur Andersen, 162
Artificial intelligence (AI), 20, 23, 65,
103
ASQ Future of Quality Report 2015,
21
ASQ. See American Society for
Quality
Audit, 124
Augmented reality (AR), 20
Authorization to Work, 70
Automated code repair, 113
Automation, 20, 21, 23, 65
Baldrige models, 133
Benchmarking, 139–140
Beveridge, Sir William, 88
Big data, 20, 101–102
Blockchain, 20
BS 5750, 124
Build useful apps without writing
codes, 101
Building capabilities and releasing
vision, 87–90
Business philanthropy, 83
Business process engineering and
reengineering, 156–158
Capability maturity model (CMM), 144
Castka, P., 166
Central limit theorem, 131–132
Central product, 104
Circular economy, 12–14
Closed loop production system, 14
Cloud computing, 20
CMM. See Capability maturity model
COBIT. See Control Objectives for
Information and related
Technology
Cochrane review, 10
Coefficients of variation, 31–35
Command and control vs system
thinking, 165, 166
Common cause, 126
Communication, 172
Community and quality, 86–87
Community Benefit Societies, 87
Community Development Trusts, 87
Companywide quality control
(CWQC), 176–177
Competency, 66–71
Cone and quartering, 40
Conner Peripherals, 176
Consistency and variation, 1, 27–31
Context Of The Organization
(COTO), 167, 168
Continual
and continuous improvement,
common dictionary
definitions of, 58–59
improvement, 59
continuous Improvement, 3
248 INDEX

Continuous improvement, Eco-parks/new industrial revolution,

58–59 14–16
Control Objectives for Information Elkington, John, 84
and related Technology Ellen McArthur Foundation, 15–16
(COBIT), 116 Enron Corp., 162
Copper T 380A intrauterine Environment Technology Verification
contraceptive device, 9 (ETV), 16
Corbett, C.J., 166 ETV. See Environment Technology
Core competencies, 67 Verification
Coronavirus. See COVID-19 EU ETV General Verification
Corporate social responsibility (CSR), Protocol, 17
83–84, 85, 86 EU ETV pilot program phases, 17,
Correlation coefficient, 130, 131 42, 45
Corruption, 161–163 Evolution of Deming, 73, 77
COTO. See Context Of The Expert systems, 103
Organization
COVID-19, 87 Failure mode and effects analysis
Crosby, Phil, 140 (FMEA), 53
Cryptocurrency, 117 Faithfulness, 28
CSR. See Corporate social FMEA. See Failure mode and effects
responsibility analysis
Customer going the extra mile/ Foreseeable risk, 53
importance of family, 26 Framework, relationship between the
CuT380A, 10 components of, 52
CWQC. See Companywide quality Functional competencies, 67, 70
control
Cyber-physical systems, 20 Gaussian. See Normal distribution
Generic risk model with key risk
Daily ‘Standup’ Meetings, 107 factors, 115
Deficiency-based versus capability Global Reporting Initiative (GRI),
growth approaches, 89 162
Deming, W. Edwards, 72 Google, 162
Design of experiments, 138–139 GRI. See Global Reporting Initiative
Design, quality, 111–112
Developing apps, key components Hammer, Michael, 156
for, 101 Health and Safety Executive
DevOps, 112–113 (HSE), 95
Diagramming and definition, 110 HOQ. See House of Quality
Digital House of Quality (HOQ), 136,
age evolution, 179 137, 140
computing, 21 HPLC testing. See Pressure liquid
economy, 113 chromatography
technology, 19 HSE. See Health and Safety Executive
transformation, 20, 21 Human agency, 25
Distributions, 40 Human resources, 65
DJSI. See Dow Jones Sustainability
Indexes Ideal and typical OC curves,
Dow Jones Sustainability Indexes 37, 38
(DJSI), 162 Improvement, 57–59
 INDEX
249
IMS. See Integrated Management
System
Incremental and breakthrough, 58
Independent assessment, 18
Industrial revolution, 20, 21
Industry 4.0, 19–24, 178
nine technologies of, 23
Industry and quality approaches,
changes in, 19
Information security management
systems and cybersecurity,
114–115
Information technology (IT),
8, 113–120
Informed mindful safety leadership,
171
Input—process—output cross-
functional flowchart–
vertical, 155
Inputs, outputs, and accountability,
155–156
Integrated environmental strategies, 13
Integrated Management System
(IMS), 45, 91, 92
Interested parties/stakeholders/
people, 83
Internal and external customers, 26
Internal values, 161–163
International Standards Organization
(ISO), 43, 44, 97, 98, 105,
108, 114, 139, 140
Internet of Things (IoT), 20
Internet Protocol Version 6 (IPv6), 20
Interrelated matrices, 138
IoT. See Internet of Things
IPv6. See Internet Protocol Version 6
Ishikawa, Kaoru Dr., 150
ISO 13485, 9, 11
ISO 14034, 16–17
ISO 17025, 175, 176
ISO 31000, 50, 51
ISO 7439, 9
ISO 9000, 147
ISO 9001, 9, 11, 106, 148, 175
ISO 9001:1994, 165, 176
ISO 9001:2008, 55, 160, 172
ISO 9001:2015, 76, 124, 159, 160,
165, 166, 172
ISO 9004, 143
ISO. See International Standards
Organization
IT. See Information technology
JIT. See Just In Time
Juran trilogy planning/control/
improvement, 62–63
Just In Time (JIT), 138, 178
Knowledge, 172–173
Leadership, 75–76, 170–171
Leadership seen through ISO
9001:2015, 170
Left and right skew and symmetric
normal distributions, 128
Life cycle perspective, 45
and analysis, 18–19
Linear vs circular economy, 12
LinkedIn, 54
Linking of processes to the standard, 169
Lot Tolerance Percent Defective
(LTPD), 38
LTPD. See Lot Tolerance Percent
Defective
Machine learning (ML), 20
Making inferences, 39
Management
of behavior, 161–163
representative, 159
systems, 2, 4, 8, 12, 13, 14, 23, 91,
147–149, 154, 169
Maturity grids, 140–147
MIL-Q-9859, 124
Mitsubishi Heavy Industries Ltd,
Kobe Shipyard of, 135
ML. See Machine learning
Modern science, 3
Month and zip code, homes sold in a
US city by, 129
Motorola, 132, 133
MSS 1000, 91, 148
NEC Corp., 162
Normal distribution, 28–30, 30–31
coverage of 1–3 standard
deviations of, 31
Normal/Gaussian distribution, 127
250 INDEX
Object orientation, 154
Objectives, 172
ODA. See Olympic Delivery
Authority
Olympic Delivery Authority (ODA),
94, 95, 96
Olympics construction fatalities, 95
1–3 standard deviations, 68–95–97
rule of, 30
One/two/three peaks, 129
Order and delivery, 154
Organization, context of, 169
Out-of-control signal, 43
PAR. See Prognosis and assessment
of risk scales
Paris, Christopher, 167
PAS 99 standard, 91
PDCA cycle, representation of the
structure of ISO 9001,
148
PDCA. See Plan–Do–Check–Act
Performance appraisal, 72–74, 89
Personal
change and improvement,
77–78
quality, 65
strengths and weaknesses, 80
Piper alpha factor sequence, 97
Plan–Do–Check–Act (PDCA), 3–5,
50, 59–63, 77, 124
Policy management, 171
Population Council specification, 9
Power User, 100
Pre-existing tools, 14
Pressure liquid chromatography
(HPLC) testing, 57
Process
capability, 28
indices of, 32–35
plot showing cp for varying
process widths, 34
specification range reject
likelihood, 35
flow with blockchain,
119
management, 124–127, 147,
152–156
sequence and its interactions,
example of, 149
stability, 42–43
Procter & Gamble Co., 162
Product life cycles, 12, 13, 16
Product or service, life-cycle
perspective of, 18
Prognosis and assessment of risk scales
(PAR), 53
QA. See Quality assurance
QC. See Quality control
QFD. See Quality Function
Deployment
QHSE. See Quality Health Safety
Environment
Qualitative risk matrix, 49
Quantitative risk matrix, 49
Quality
and the community
building capabilities and releasing
vision, 87–90
community and quality,
86–87
CSR, 83–84
interested parties/stakeholders/
people, 83
society, taguchi and loss to,
85–86
TBL, 84–85
consistency and variation, 1
deployment for
benchmarking, 139–140
business process engineering and
reengineering, 156–158
management systems, 147–149
maturity grids, 140–147
process management,
152–156
QFD, 135–139
SPC and SQC, 149–152
excellence, the destination, 5
foundations of society, 3
health/safety/environment
annex sl and management system
integration, 97–98
society imperatives, 98
standalone/integrated, 91–93
 INDEX
251
and the individual
appreciative inquiry, 74–75
competency, 66–71
leadership, 75–76
performance appraisal, 72–74
personal change and
improvement, 77–78
personal quality, 65
shame and guilt, is and ought, 77
training and ensuring
opportunity, identifying the
need for, 71–72
improvement and PDCA, 3–5
and information technology
QA and QC, software for,
99–103
software quality, 103–113
introduction to, 5
manufacturing industries
central role of specification, 9–12
circular economy, 12–14
eco-parks/new industrial
revolution, 14–16
Industry 4.0, 19–24
life-cycle perspective and analysis,
18–19
quality, scope and boundaries
of, 8
role of specification, 7
system approaches, 7–8
technology verification, 16–18
processes, procedures, best practice,
and their expression, 2
quality management
accountability, transparency,
160–161
accreditation and certification,
173–176
corruption, 161–163
CWQC, 176–177
internal values, 161–163
management of behavior,
161–163
responsibility, 159–160
standards, role and effect of,
163–173
supply chain, 177–180
TBL, 161–163
TQM, 176–177
risk/opportunity/improvement
adulteration and corruption, 57
coefficients of variation, 31–35
consistency and variation, 27–31
distributions, 40
improvement, 57–59
likelihood, risk, 35–39
making inferences, 39
plan-do-check-act, 59–63
process stability, 42–43
risk management, 45–57
risk-based thinking, 45–56
sampling, 40–42
uncertainty/risk/opportunity,
44–45
scope and boundaries of, 2–3, 8
and service industries
customer going the extra mile/
importance of family, 26
internal and external customers,
26
service business/organization,
25–26
and the team
profiles and team roles, 80–81
pulling together in the same
direction, 79
tools and techniques for
audit, 124
process management, 124–127
quality assurance and control,
123–124
standards and best practice,
121–123
standards and specifications, 121
statistics, 127–132
systems approach, 132–133
touching lives, 5
Quality assurance (QA), 7, 12, 99–
103, 123–124
software for, 99–103
Quality attributes, 108
Quality control (QC), 63, 99–103,
123–124
software for, 99–103
Quality Function Deployment
(QFD), 112, 135–139
252 INDEX
Quality Health Safety Environment
(QHSE), 92, 98
Quality management, 2, 8, 9, 12,
100, 124, 147, 152–153
maturity grid, 141, 142
Quality of life, 87
Quality requirements and evaluation,
109
RAD. See Rapid application
development
Radziwill, N., 20, 22
Rapid application development
(RAD), 107
Responsibility, 25–26, 83, 159–160
Right skewness, 129
Risk
assessment cycle, 51
assessment methodology, 116
avoidance, 53–54
-based thinking, 18, 45–56, 161
likelihood/consequence, 30–31,
35–39, 43–44
acceptance sampling and
hypothesis testing, 35
analogy between judge’s decisions
and statistical tests, 39
ideal and typical OC curves, 38
varying sample size and reject
number for a given AQL and
LQ, 38
management, 18, 44, 45–57, 114
matrix, 47–49
Robotics, 65
Robust parameter design, 85
Rosin-Rammler distribution, 29
Sampling, 40–42
SAS Institute, 162
Schein, Edgar, 163
Scientific management, 126
Scientific method, evolution of, 4
Scrum methodology, 107
SDLCs. See Software development
life cycles
Secure profitable future, 79
Seddon, J., 164, 165
SEI CMMI—the three critical
dimensions, 146
Self-assessment
elements and criteria related to
maturity levels, generic model
for, 143
of the detailed elements of 5.2, 145
Service business/organization, 25–26
Shame and guilt, is and ought, 77
Shell Oil Co., 162
Shewhart, Walter, 125
Single process, schematic
representation of the elements
of, 147
Six Sigma, 133
Society, taguchi and loss to, 85–86
Software
characteristics and sub
characteristics, 109
lifecycle processes, 106–108
quality, 103–113
Software development life cycles
(SDLCs), 106, 109, 114
integrating risk, 110–111
SPC and SQC. See Statistical quality
and process control
Special causes, 125, 126
Specification
role of, 7
central role of, 9–12
system approaches to conformance,
7–8
Spiral SDLC, 107
Sprint ‘Kickoff’ Meeting, 107
Stakeholders/interested parties and
issues/requirements, 169
Standard normal distribution, 28–30
Standards
and best practice, 121–123
and specifications, 121
role and effect of, 163–173
Statistics, 127–132
control, 42
engineering, 102–103
quality and process control (SPC
and SQC), 149–152
Supply chain, 177–180
SustainAbility, 84
Sustainable manufacturing concepts
and practices OECD,
evolution of, 15
 INDEX
253
SWOT analysis, 55
System of profound knowledge,
components of, 174
Systems approach, 132–133
Taguchi, Genichi, 85, 138
Taylor, Frederik W, 126–127
TBL. See Triple bottom line
Technical/scientific credibility
competencies, 68, 69
Technology
landscape, 20
verification, 16–18
Testing, 17
Three-sigma limits, 43
Total Quality Control (TQC),
138
Total quality management (TQM),
176–177
Tows analysis, 54–56
TOWS
matrix to Volkswagen, application
of, 56
strategic alternatives matrix, 55
TQC. See Total Quality Control
TQM. See Total quality management
Traceability and blockchain,
117–120
Training and ensuring opportunity,
identifying the need for,
71–72
Triple bottom line (TBL), 84–85,
161–163
Tyco International, 162
UKAS. See United Kingdom
Accreditation Service
UML. See Unified Modelling
Language
Uncertainty/risk/opportunity, 44–45
Unified Modelling Language (UML),
110, 112, 153
United Kingdom Accreditation
Service (UKAS), 175
Use cases, 110
Variability, 28
Variation, understanding sources of,
151
Virtual information technology
environments, 2
Virtual reality (VR), 20
Visual representation of a blockchain,
119
VOC. See Voice of the Customer
Voice of the Customer (VOC), 136,
139–140
Voice of the Stakeholder (VOS), 140
VOS. See Voice of the Stakeholder
VR. See Virtual reality
Waterfall and V linear SDLCs, 106
Watson, Greg, 24
WEF. See World Economic Forum
Weihrich approach, 55
Western Electric Handbook, 43
World Economic Forum (WEF), 21
World War II, 7, 21, 62, 72, 135
WorldCom Inc., 162
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