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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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First published in 2021 by


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Business Expert Press Supply and Operations Management Collection

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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 Build useful apps without writing
technology, 14 codes, 101
Accountability, transparency, 160–161 Building capabilities and releasing
Accreditation and certification, vision, 87–90
173–176 Business philanthropy, 83
Additive manufacturing, 20 Business process engineering and
Adelphia Communications Corp., reengineering, 156–158
162
Adulteration and corruption, 57 Capability maturity model (CMM), 144
Agile, 107 Castka, P., 166
AI. See Appreciative inquiry Central limit theorem, 131–132
AI. See Artificial intelligence Central product, 104
Aim of control, 151 Circular economy, 12–14
Alexander the Great 356 BC, logistics Closed loop production system, 14
and supply chain, 177–178 Cloud computing, 20
American Productivity & Quality CMM. See Capability maturity model
Center (APQC), 140 COBIT. See Control Objectives for
American Society for Quality (ASQ), Information and related
99, 139, 140, 150 Technology
Appreciative inquiry (AI), 74–75 Cochrane review, 10
APQC. See American Productivity & Coefficients of variation, 31–35
Quality Center Command and control vs system
AR. See Augmented reality thinking, 165, 166
Arthur Andersen, 162 Common cause, 126
Artificial intelligence (AI), 20, 23, 65, Communication, 172
103 Community and quality, 86–87
ASQ Future of Quality Report 2015, Community Benefit Societies, 87
21 Community Development Trusts, 87
ASQ. See American Society for Companywide quality control
Quality (CWQC), 176–177
Audit, 124 Competency, 66–71
Augmented reality (AR), 20 Cone and quartering, 40
Authorization to Work, 70 Conner Peripherals, 176
Automated code repair, 113 Consistency and variation, 1, 27–31
Automation, 20, 21, 23, 65 Context Of The Organization
(COTO), 167, 168
Baldrige models, 133 Continual
Benchmarking, 139–140 and continuous improvement,
Beveridge, Sir William, 88 common dictionary
Big data, 20, 101–102 definitions of, 58–59
Blockchain, 20 improvement, 59
BS 5750, 124 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 ISO. See International Standards


System Organization
Incremental and breakthrough, 58 IT. See Information technology
Independent assessment, 18
Industrial revolution, 20, 21 JIT. See Just In Time
Industry 4.0, 19–24, 178 Juran trilogy planning/control/
nine technologies of, 23 improvement, 62–63
Industry and quality approaches, Just In Time (JIT), 138, 178
changes in, 19
Information security management Knowledge, 172–173
systems and cybersecurity,
114–115 Leadership, 75–76, 170–171
Information technology (IT), Leadership seen through ISO
8, 113–120 9001:2015, 170
Informed mindful safety leadership, Left and right skew and symmetric
171 normal distributions, 128
Input—process—output cross- Life cycle perspective, 45
functional flowchart– and analysis, 18–19
vertical, 155 Linear vs circular economy, 12
Inputs, outputs, and accountability, LinkedIn, 54
155–156 Linking of processes to the standard, 169
Integrated environmental strategies, 13 Lot Tolerance Percent Defective
Integrated Management System (LTPD), 38
(IMS), 45, 91, 92 LTPD. See Lot Tolerance Percent
Interested parties/stakeholders/ Defective
people, 83
Internal and external customers, 26 Machine learning (ML), 20
Internal values, 161–163 Making inferences, 39
International Standards Organization Management
(ISO), 43, 44, 97, 98, 105, of behavior, 161–163
108, 114, 139, 140 representative, 159
Internet of Things (IoT), 20 systems, 2, 4, 8, 12, 13, 14, 23, 91,
Internet Protocol Version 6 (IPv6), 20 147–149, 154, 169
Interrelated matrices, 138 Maturity grids, 140–147
IoT. See Internet of Things MIL-Q-9859, 124
IPv6. See Internet Protocol Version 6 Mitsubishi Heavy Industries Ltd,
Ishikawa, Kaoru Dr., 150 Kobe Shipyard of, 135
ISO 13485, 9, 11 ML. See Machine learning
ISO 14034, 16–17 Modern science, 3
ISO 17025, 175, 176 Month and zip code, homes sold in a
ISO 31000, 50, 51 US city by, 129
ISO 7439, 9 Motorola, 132, 133
ISO 9000, 147 MSS 1000, 91, 148
ISO 9001, 9, 11, 106, 148, 175
ISO 9001:1994, 165, 176 NEC Corp., 162
ISO 9001:2008, 55, 160, 172 Normal distribution, 28–30, 30–31
ISO 9001:2015, 76, 124, 159, 160, coverage of 1–3 standard
165, 166, 172 deviations of, 31
ISO 9004, 143 Normal/Gaussian distribution, 127
250 INDEX

Object orientation, 154 sequence and its interactions,


Objectives, 172 example of, 149
ODA. See Olympic Delivery stability, 42–43
Authority Procter & Gamble Co., 162
Olympic Delivery Authority (ODA), Product life cycles, 12, 13, 16
94, 95, 96 Product or service, life-cycle
Olympics construction fatalities, 95 perspective of, 18
1–3 standard deviations, 68–95–97 Prognosis and assessment of risk scales
rule of, 30 (PAR), 53
One/two/three peaks, 129
Order and delivery, 154 QA. See Quality assurance
Organization, context of, 169 QC. See Quality control
Out-of-control signal, 43 QFD. See Quality Function
Deployment
PAR. See Prognosis and assessment QHSE. See Quality Health Safety
of risk scales Environment
Paris, Christopher, 167 Qualitative risk matrix, 49
PAS 99 standard, 91 Quantitative risk matrix, 49
PDCA cycle, representation of the Quality
structure of ISO 9001, and the community
148 building capabilities and releasing
PDCA. See Plan–Do–Check–Act vision, 87–90
Performance appraisal, 72–74, 89 community and quality,
Personal 86–87
change and improvement, CSR, 83–84
77–78 interested parties/stakeholders/
quality, 65 people, 83
strengths and weaknesses, 80 society, taguchi and loss to,
Piper alpha factor sequence, 97 85–86
Plan–Do–Check–Act (PDCA), 3–5, TBL, 84–85
50, 59–63, 77, 124 consistency and variation, 1
Policy management, 171 deployment for
Population Council specification, 9 benchmarking, 139–140
Power User, 100 business process engineering and
Pre-existing tools, 14 reengineering, 156–158
Pressure liquid chromatography management systems, 147–149
(HPLC) testing, 57 maturity grids, 140–147
Process process management,
capability, 28 152–156
indices of, 32–35 QFD, 135–139
plot showing cp for varying SPC and SQC, 149–152
process widths, 34 excellence, the destination, 5
specification range reject foundations of society, 3
likelihood, 35 health/safety/environment
flow with blockchain, annex sl and management system
119 integration, 97–98
management, 124–127, 147, society imperatives, 98
152–156 standalone/integrated, 91–93
INDEX
251

and the individual TQM, 176–177


appreciative inquiry, 74–75 risk/opportunity/improvement
competency, 66–71 adulteration and corruption, 57
leadership, 75–76 coefficients of variation, 31–35
performance appraisal, 72–74 consistency and variation, 27–31
personal change and distributions, 40
improvement, 77–78 improvement, 57–59
personal quality, 65 likelihood, risk, 35–39
shame and guilt, is and ought, 77 making inferences, 39
training and ensuring plan-do-check-act, 59–63
opportunity, identifying the process stability, 42–43
need for, 71–72 risk management, 45–57
improvement and PDCA, 3–5 risk-based thinking, 45–56
and information technology sampling, 40–42
QA and QC, software for, uncertainty/risk/opportunity,
99–103 44–45
software quality, 103–113 scope and boundaries of, 2–3, 8
introduction to, 5 and service industries
manufacturing industries customer going the extra mile/
central role of specification, 9–12 importance of family, 26
circular economy, 12–14 internal and external customers,
eco-parks/new industrial 26
revolution, 14–16 service business/organization,
Industry 4.0, 19–24 25–26
life-cycle perspective and analysis, and the team
18–19 profiles and team roles, 80–81
quality, scope and boundaries pulling together in the same
of, 8 direction, 79
role of specification, 7 tools and techniques for
system approaches, 7–8 audit, 124
technology verification, 16–18 process management, 124–127
processes, procedures, best practice, quality assurance and control,
and their expression, 2 123–124
quality management standards and best practice,
accountability, transparency, 121–123
160–161 standards and specifications, 121
accreditation and certification, statistics, 127–132
173–176 systems approach, 132–133
corruption, 161–163 touching lives, 5
CWQC, 176–177 Quality assurance (QA), 7, 12, 99–
internal values, 161–163 103, 123–124
management of behavior, software for, 99–103
161–163 Quality attributes, 108
responsibility, 159–160 Quality control (QC), 63, 99–103,
standards, role and effect of, 123–124
163–173 software for, 99–103
supply chain, 177–180 Quality Function Deployment
TBL, 161–163 (QFD), 112, 135–139
252 INDEX

Quality Health Safety Environment Self-assessment


(QHSE), 92, 98 elements and criteria related to
Quality management, 2, 8, 9, 12, maturity levels, generic model
100, 124, 147, 152–153 for, 143
maturity grid, 141, 142 of the detailed elements of 5.2, 145
Quality of life, 87 Service business/organization, 25–26
Quality requirements and evaluation, Shame and guilt, is and ought, 77
109 Shell Oil Co., 162
Shewhart, Walter, 125
RAD. See Rapid application Single process, schematic
development representation of the elements
Radziwill, N., 20, 22 of, 147
Rapid application development Six Sigma, 133
(RAD), 107 Society, taguchi and loss to, 85–86
Responsibility, 25–26, 83, 159–160 Software
Right skewness, 129 characteristics and sub
Risk characteristics, 109
assessment cycle, 51 lifecycle processes, 106–108
assessment methodology, 116 quality, 103–113
avoidance, 53–54 Software development life cycles
-based thinking, 18, 45–56, 161 (SDLCs), 106, 109, 114
likelihood/consequence, 30–31, integrating risk, 110–111
35–39, 43–44 SPC and SQC. See Statistical quality
acceptance sampling and and process control
hypothesis testing, 35 Special causes, 125, 126
analogy between judge’s decisions Specification
and statistical tests, 39 role of, 7
ideal and typical OC curves, 38 central role of, 9–12
varying sample size and reject system approaches to conformance,
number for a given AQL and 7–8
LQ, 38 Spiral SDLC, 107
management, 18, 44, 45–57, 114 Sprint ‘Kickoff’ Meeting, 107
matrix, 47–49 Stakeholders/interested parties and
Robotics, 65 issues/requirements, 169
Robust parameter design, 85 Standard normal distribution, 28–30
Rosin-Rammler distribution, 29 Standards
and best practice, 121–123
Sampling, 40–42 and specifications, 121
SAS Institute, 162 role and effect of, 163–173
Schein, Edgar, 163 Statistics, 127–132
Scientific management, 126 control, 42
Scientific method, evolution of, 4 engineering, 102–103
Scrum methodology, 107 quality and process control (SPC
SDLCs. See Software development and SQC), 149–152
life cycles Supply chain, 177–180
Secure profitable future, 79 SustainAbility, 84
Seddon, J., 164, 165 Sustainable manufacturing concepts
SEI CMMI—the three critical and practices OECD,
dimensions, 146 evolution of, 15
INDEX
253

SWOT analysis, 55 UKAS. See United Kingdom


System of profound knowledge, Accreditation Service
components of, 174 UML. See Unified Modelling
Systems approach, 132–133 Language
Uncertainty/risk/opportunity, 44–45
Taguchi, Genichi, 85, 138 Unified Modelling Language (UML),
Taylor, Frederik W, 126–127 110, 112, 153
TBL. See Triple bottom line United Kingdom Accreditation
Technical/scientific credibility Service (UKAS), 175
competencies, 68, 69 Use cases, 110
Technology
landscape, 20 Variability, 28
verification, 16–18 Variation, understanding sources of,
Testing, 17 151
Three-sigma limits, 43 Virtual information technology
Total Quality Control (TQC), environments, 2
138 Virtual reality (VR), 20
Total quality management (TQM), Visual representation of a blockchain,
176–177 119
Tows analysis, 54–56 VOC. See Voice of the Customer
TOWS Voice of the Customer (VOC), 136,
matrix to Volkswagen, application 139–140
of, 56 Voice of the Stakeholder (VOS), 140
strategic alternatives matrix, 55 VOS. See Voice of the Stakeholder
TQC. See Total Quality Control VR. See Virtual reality
TQM. See Total quality management
Traceability and blockchain, Waterfall and V linear SDLCs, 106
117–120 Watson, Greg, 24
Training and ensuring opportunity, WEF. See World Economic Forum
identifying the need for, Weihrich approach, 55
71–72 Western Electric Handbook, 43
Triple bottom line (TBL), 84–85, World Economic Forum (WEF), 21
161–163 World War II, 7, 21, 62, 72, 135
Tyco International, 162 WorldCom Inc., 162
OTHER TITLES IN OUR SUPPLY AND OPERATIONS
MANAGEMENT COLLECTION
Joy M. Field, Boston College, Editor
• The Barn Door Is Open: Frameworks and Tools for Success and Fulfillment in the
Workplace by Serge Alfonse
• Operations Management in China by Craig Seidelson
• Logistics Management: An Analytics-Based Approach by Tan Miller and
Matthew J. Liberatore
• The Practical Guide to Transforming Your Company by Daniel Plung and Connie Krull
• Leading and Managing Strategic Suppliers by Richard Moxham
• Moving the Chains: An Operational Solution for Embracing Complexity in the Digital Age
by Domenico LePore
• The New Age Urban Transportation Systems, Volume I: Cases from Asian Economies
by Sundaravalli Narayanaswami
• The New Age Urban Transportation Systems, Volume II: Cases from Asian Economies
by Sundaravalli Narayanaswami
• Optimizing the Supply Chain by Jay E. Fortenberry
• Sustain: Extending Improvement in the Modern Enterprise by W. Scott Culberson
• Managing Using the Diamond Principle: Innovating to Effect Organizational Process
Improvement by Mark W. Johnson
• Insightful Quality, Second Edition: Beyond Continuous Improvement
by Victor E. Sower and Frank K. Fair
• The Global Supply Chain and Risk Management by Stuart Rosenberg
• Moving into the Express Lane: How to Rapidly Increase the Value of Your Business
by Rick Pay
• The Effect of Supply Chain Management on Business Performance by Milan Frankl

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