Professional Documents
Culture Documents
Expl Ained &: Expanded
Expl Ained &: Expanded
E XP L A I NE D &
EXPANDED
Making Your Quality Management
System Sustainable
Charles A. Cianfrani
John E. “Jack” West
ISO 9001:2008
Explained and
Expanded
Charles A. Cianfrani
John E. (Jack) West
Epilogue . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 137
Appendix Questions an Assessor Can Consider
in Planning and Conducting a
Self‑Assessment to the Contents of
ISO 9004:2009 . . . . . . . . . . . . . . . . . . . 139
Index. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 151
ix
S
urvival and sustainability are the key topics of this
book. It is intended to encourage quality professionals
to examine the structure and deployment of the quality
management system (QMS) of an organization—to expand its
breadth, depth, and objectives beyond mere compliance with
the requirements of a standard (even a very good standard) and
to aspire to world-class performance levels. While this book
addresses what an organization can do to meet the intent of
ISO 9001, its purpose is to discuss the importance of how the
requirements are met and what activities may be appropriate
beyond just meeting minimum requirements. While it dis-
cusses why an organization should consider compliance with
ISO 9001 and what needs to be done to pass an audit, most
of the book addresses activities that need to be considered for
sustainability. Many of these activities are beyond the scope of
ISO 9001 but are critical for survival and sustainability. Also
included are a chapter that considers the future of quality from
the perspective of both quality experts and CEOs, and a chap-
ter of activities to encourage the ongoing revitalization of the
organization’s QMS.
Since its initial release in 1987, the ISO 9001 standard has
been embraced by a wide range of organizations—large and
small, for profit and n ot-for-profit, regulated and not regulated,
and in many different industries throughout the world. Why
xi
Charlie Cianfrani
Jack West
May 2013
T
his book is intended to provide users of ISO 9001:2008
Explained1 with guidance that can help an organization
build a robust, sustainable QMS that focuses on achiev-
ing sustained success over time. But you need not have used
that book or even been certified to ISO 9001 to derive benefit
from this book. Figure I.1 provides a model for the contents of
this book. There are several categories of potential users of this
book:
• Users whose organizations are not yet certified to ISO
9001:2008 but need to be can benefit from using this
book along with ISO 9001:2008 Explained as they imple-
ment their QMS (see Chapters 1–4)
• Users who do not need certification but want a more
robust and efficient QMS can use this book without refer-
ence to ISO 9001:2008 Explained (see Chapters 3–6)
• Users already certified to or compliant with ISO
9001:2008 can gain greater QMS efficiency and organi-
zational sustainability by using this book along with ISO
9004:2009, Quality management systems—Managing for
the sustained success of an organization2 and Unlocking
the Power of Your QMS: Keys to Business Performance
Improvement 3 (see Chapters 4–7)
xv
The future
of quality
Why? (1) (5)
Need to continually
revitalize the QMS (7)
Figure I.1 M
odel for the content of ISO 9001:2008 Explained and
Expanded.
Notes
1. C. A. Cianfrani, J. J. Tsiakals, and J. West, ISO 9001:2008
Explained, 3rd ed. (Milwaukee, WI: ASQ Quality Press, 2009).
2. ISO 9004:2009, Quality management systems—Managing for
the sustained success of an organization (ISO/TC 176/SC 2,
2009).
3. J. West and C. A. Cianfrani, Unlocking the Power of Your QMS:
Keys to Business Performance Improvement (Milwaukee, WI:
ASQ Quality Press, 2004).
W
hy should an organization want to ensure effective
conformity with ISO 9001? Over the past 25 years
the answer to this question has become clear:
• ISO 9001 has been embraced as an international model
for quality management system (QMS) requirements,
with over 1 million certified user organizations in over
100 countries!
• ISO 9001 has morphed from a set of requirements that
focused on procedures and documents to one that focuses
on system output through process management. It is the
output of the system that matters.
• An ISO 9001–conforming system has the potential of
yielding output to delight customers.
• Customers do care whether an organization can demon-
strate conformity with ISO 9001 requirements, but they
care more about the output! Figure 1.1 illustrates this
concept.
• Conformity with ISO 9001 requirements has demon-
strated an ability to improve operating effectiveness and
even efficiency, as long as the organization honors the
intent of the requirements rather than just making a mini-
mum effort to pass an audit.
Chapter One
Context of the
organization
QMS improvement
Customer requirements
Customer satisfaction
and resource management
Performance evaluation
and feedback
Continual Improvement—
Both Incremental and Breakthrough
The importance of intense attention to deploying processes
to address the principle of continual improvement cannot be
overstressed. Process improvements that result in achieving
conforming output from nonconforming processes or improv-
ing the efficiency of compliant processes can enhance both
organizational performance and customer satisfaction, thereby
contributing to organizational sustainability. Remember, an
organization that is not getting better is getting worse!
Table 1.1 C
haracteristics of incremental and breakthrough
improvements.
Incremental Breakthrough
improvement improvement
Breakthrough target:
Be 5% better than
Benchmark: benchmark in 18 months
Best-in-class
performance
Incremental
Operating under UP
controlled conditions is Breakthrough
good in 18 months
5 years 18
months
Change Management
Mergers, acquisitions, s pin-offs, downsizing, outsourcing, and
restructuring are a contemporary reality. ISO 9001 includes
a rather simplistic requirement to maintain the integrity of
the QMS when changes are planned and implemented. This
is much easier said than done. We recommend an aggressive
Summary
We started this chapter with a question: Why should an orga-
nization want to ensure effective conformity with ISO 9001?
In the contemporary marketplace the answer to this question is
clear: Conformity may not be mandatory, but lack of conformity
can be a competitive disadvantage. Further, while conformity
Notes
1. J. West and C. A. Cianfrani, Unlocking the Power of Your QMS:
Keys to Business Performance Improvement (Milwaukee, WI:
ASQ Quality Press, 2004), chapter 1.
2. C. A. Cianfrani, J. J. Tsiakals, and J. West, ISO 9001:2008
Explained, 3rd ed. (Milwaukee, WI: ASQ Quality Press, 2009).
M
any organizations that adopt a QMS take a “trust
the people” approach. Portions of the system are
assigned to individuals who become the key players
in the operation of the system. They are often the only people
who understand its secret magic in achieving results. In other
words, these key people have become the system. And, this
works. For a time, there might be gains in quality and massive
cost reductions. The authors have seen organizations exist in
this state for a number of years. But then those key individuals
retire or leave. Or, the team moves on to other activities after
the initial push, the system becomes stale, and top managers
begin to ask, “What has this system stuff done for me lately?”
After a few years, the system withers and dies. What hap-
pened? First, there was really no system at all. Instead, there
were good people with great intentions and a bit of authority
to make things happen. Often in such situations, there was an
inadequate understanding of the process approach. The prac-
tices adopted by the team belonged only to the team and did
not reflect c ross-functional processes that could stand the test
of time.
Why do we continue to make this mistake? Often it is
because we misunderstand the nature of people empowerment.
We tend to prefer giving individuals power over their situation
19
Chapter Two
Controls
Resources
H1446_Cianfrani_pi_000.indd 23
and delivery times and delivery times and requirements
Adjustments
Source: Reproduced from C. A. Cianfrani, J. J. Tsiakals, and J. West, The ASQ ISO 9000:2000 Handbook (Milwaukee, WI:
23
11/2/13 11:43 AM
24 Chapter Two
Process Process
Focused Objectives Customers
• Work–life balance
• Natural resources
Excellence models also emphasize results achieved in areas
such as customers, people, society, and strategic key indicators.
Other Observations
Future of Quality studies conducted by the American Society
for Quality (ASQ) and the last several Conference Board CEO
Challenge studies offer some insight into additional process
needs for organizations to consider (see Chapter 6). Pertinent
issues include:
• Globalization. We all know that innovation, commerce,
marketing, sales, and staffing are global issues for many,
Organization’s Organization’s
system leading to sustained success
environment environment
H1446_Cianfrani_pi_000.indd 27
Interested ISO 9004 Interested
parties Clause 4 parties
Managing for the
ISO 9004 sustained success of ISO 9004
Needs Clause 5 an organization Clause 9
and Strategy and Improvement,
expectations policy ISO 9001 innovation,
Clause 5 and learning
Management
responsibility
ISO 9004
ISO 9004
Clause 7
Process
management
Key
Value-adding activities
Foundation: Quality management principles (ISO 9000)
Building Your Quality Management System
Information flow
27
11/2/13 11:43 AM
28 Chapter Two
Summary
This chapter has explored the basics of process management as
a fundamental for developing and maintaining a QMS. It also
Notes
1. For more on this topic, see J. West and C. A. Cianfrani, Unlock-
ing the Power of Your QMS: Keys to Business Performance
Improvement (Milwaukee, WI: ASQ Quality Press, 2004).
2. C. A. Cianfrani, J. J. Tsiakals, and J. West, ISO 9001:2008
Explained, 3rd ed. (Milwaukee, WI: ASQ Quality Press, 2009),
5–7.
3. Ibid., 40–63.
4. Ibid., 66–81.
5. Ibid., 84–154.
6. Ibid., 122–130.
7. Ibid., 139–142.
8. Ibid., 12–13.
9. Ibid., 156–212.
T
here are several different types of management system
audits. Examples include quality, financial, environ-
mental, information system, and sector-specific audits
(e.g., automotive, aerospace, telecommunications, medical
devices). This chapter addresses auditing related to QMSs.
There are three basic audit categories:
• First-party audits: internal audits an organization per-
forms on its own system
• Second-party audits: audits that customers perform on
their suppliers
• Third-party audits: audits performed by registrars or other
interested parties such as regulators
One reason QMS auditing is important is that it is a require-
ment of ISO 9001 (clause 8.2.2). It also impacts the ability of
the organization to operate in conformity with many of its prin-
ciples and core values. Even if auditing were not an ISO 9001
requirement, having an effective audit process would make
sense. Auditing provides confidence that processes and con-
trols are being implemented in accordance with all organiza-
tional and regulatory requirements as applicable. No reputable
organization would believe it could operate without periodic
financial controls and audits of its processes. Why shouldn’t a
31
Chapter Three
Report
Prepare Conduct
the results
for the audit the audit
of the audit
Interview
people
Form
conclusions
Conduct
Observe Analyze
opening
activities data
meeting
Conduct
closing
meeting
Examine
records
• Provide resources
• Review results
• Use results
Management
• Information
• Time
• Trained personnel
Figure 3.3 A
udit inputs and outputs, resources required, and
management role.
——Improvement
——Feedback loops
——Results
The organization can emulate an outside audit by performing an
internal audit of all processes of the QMS to ensure compliance
with internal requirements as well as ISO 9001 requirements,
with particular attention to the above process characteristics
and implementing appropriate corrective action where noncon-
formity is evident.
For details on the kinds of questions to ask during such an
internal audit, see our book titled ISO 9001:2008 Explained.
For every clause and subclause of ISO 9001:2008 there is an
explanation of what the requirement is, what it means, tips on
implementation of compliant processes, considerations for
documentation, and questions to ask to assess conformity.
Summary
It is vital that organizations embrace QMS auditing as a pow-
erful tool to ensure the understanding, deployment, control,
measurement, and improvement of processes. Auditing pro-
vides confidence to the organization and its customers that its
processes and controls are being implemented in accordance
with all organizational and regulatory requirements and that
Notes
1. ISO 9000:2005 Quality management systems—Fundamentals
and vocabulary; ISO 19011:2011 Guidelines for auditing man-
agement systems.
2. D. R. Arter, C. A. Cianfrani, and J. West, How to Audit the
Process-Based QMS, 2nd ed. (Milwaukee, WI: ASQ Quality
Press, 2012).
3. C. A. Cianfrani, J. J. Tsiakals, and J. West, ISO 9001:2008
Explained, 3rd ed. (Milwaukee, WI: ASQ Quality Press, 2009),
5–7.
4. A full discussion of the Cost of Quality concept is beyond the
scope of this book, but a number of other books provide a good
starting point, particularly D. C. Wood, ed., Principles of Qual-
ity Costs: Financial Measures for Strategic Implementation of
Quality Management, 4th ed. (Milwaukee, WI: ASQ Quality
Press, 2013).
I
n this chapter we identify some of the ISO 9001:2008
requirements that are necessary but often are not done
well, and we offer suggestions for improvement in those
areas. We also recommend certain system elements that are not
required by ISO 9001:2008 but that may be critical to success
in many organizations. You need to think about these things
and exercise all this against your own principles, mission,
vision, objectives, and situation. Chapter 5 will provide guid-
ance on how to select system elements to add or improve. Used
together, Chapters 4 and 5 can help you determine which ele-
ments to attack and in what order.
Addressing Effectiveness
(Capability and Capacity) and
Efficiency (Waste Elimination)
In Chapter 1 we discussed the distinction between process
effectiveness and process efficiency, making the point that we
should strive for both. In the narrowest of senses effective-
ness is meeting the requirements, but true effectiveness can be
thought of as effectiveness on steroids. To sustain effectiveness
we must be capable of meeting requirements, but we must also
have the capacity to meet requirements over time and when
demand for our product changes.
47
Chapter Four
Figure 4.1 V
alidation that product designs meet customer
requirements—summary of requirements.
Source: ANSI/ISO/ASQ (E) Q9001-2008.
Design verification
Design
Customer Design process Design
Product
needs inputs phases and outputs
reviews
Design validation
Tactics
Mission Vision Objectives (Ys) to meet Measures (Xs)
objectives
Etc.
Outputs
Action items:
• Changes
• Mid-course corrections
• Reallocation of resources
• Affirmation or change of objectives
y = f(x) + ∑
∑ = random variation
y
Figure 4.5 M
easure process parameters that drive process output
results.
with top managers, who work out their picture of the organiza-
tion’s future and share it with the employees. Their objective
should be to get employees to understand the top management’s
vision so everyone in the organization is heading in the same
direction and has the same idea of the ultimate destination.
An organization’s vision of the future may be quite different
from its current situation. The organization may have a vision
of becoming something very different from what is described
in its current mission statement. For example, the organization
may have the vision of abandoning its current lines of business
in favor of growth in other areas.
These notions are often given little real emphasis, and the
creation of mission and vision statements is sometimes an iso-
lated, idealistic exercise that brings little benefit to most mem-
bers of the organization. This is often because there is a lack of
honest dialogue on the real purpose and vision of top manag-
ers. It leads to such things as quality policies that have no direct
linkage to the organization’s real reasons for existing. This is
where the formal management system built around ISO 9001
or ISO 14001 comes in. It is in the proper development of the
quality objectives that the quality professional has the opportu-
nity to facilitate such honest dialogue.
In establishing objectives, an organization needs to consider
both its mission and its vision. If an organization has a vision
of becoming very different in the future, its long-term objec-
tives will be very different from its n ear-term goals. And both
long- and near-term objectives must be met. Setting goals with
the long term in mind without having adequate emphasis on
sustaining n ear-term performance is a prescription for failure.
In some cases, mission and vision can be developed inde-
pendently of one another. Often they are interrelated. They
should be the foundation for all that happens in the organiza-
tion. They should be reflected in strategies and in all of the
organization’s policies, including quality policy and objectives
looked for the best overall results rather than just grabbing the
quick money and hoping there were no resulting problems.
When we focus on processes, we tend to focus on details.
However, we must understand how the whole system works
rather than search for direct cause- and-effect relationships.
Managers must understand what will happen if they make an
uncoordinated process change. It is this big-picture coordina-
tion that makes system management “magic.” In our example,
the interrelationship among the cost reduction process, the
quality improvement process, and the financial accounting pro-
cess needed attention.
Some techniques that can help with such big-picture think-
ing include:
• When your people work on improving one process, it is
the manager’s job to make certain other processes and
interactions are considered.
• “Think globally” and understand how the system’s vari-
ous processes work together to achieve the specified
results and the organization’s objectives. An organization
has one management system, but it has many compo-
nents. In addition to quality, it might include processes to
manage finance, investor relations, and so on. All parts of
the system must work together to produce results.
• Provide a simplified, graphic illustration of how your
organization’s key processes interact. Use care in under-
standing and describing these interactions. Keep in mind
that ISO 9001 requires that a quality manual include a
description of the interactions.
During the development of ISO 9001:2000, there was discus-
sion on whether to emphasize the process approach or the sys-
tems approach to management. Both principles are important,
but the principle underlying the process approach won out. It is
Optimizing Documentation
We hear people say that ISO 9001 requires unnecessary doc-
umentation or that the documentation is too restrictive for
Summary
The concept of effectively meeting requirements in an efficient
manner is often more complex than meets the eye. First, the
system must be developed to provide a design that will meet
the needs of ultimate users at a price the customer is willing
to pay. The design, production, and delivery processes must be
verified and validated to meet customer needs. Notions such as
correction, corrective action, and preventive action need to be
assimilated into the organization’s culture. Top managers must
work hard to achieve alignment of goals with all in the organi-
zation. Leaders need to manage by facts supported by credible
data. Top leaders must always keep their eye on the overall
system to avoid suboptimization. And all this needs to be done
in as simple a manner as can be developed.
Notes
1. S. Shingo, A Study of the Toyota Production System from an
Industrial Engineering Viewpoint (Cambridge, MA: Productiv-
ity Press, 1989).
2. C. A. Cianfrani and J. West, Cracking the Case of ISO 9001:2008
for Manufacturing (Milwaukee, WI: ASQ Quality Press, 2009),
162–165.
3. A. De Meyer, C. H. Loch, and M. T. Pich, “Managing Project
Uncertainty: From Variation to Chaos,” MIT Sloan Manage-
ment Review, Winter 2002: 60–67; J. West and C. A. Cianfrani,
Unlocking the Power of Your QMS: Keys to Business Perfor-
mance Improvement (Milwaukee, WI: ASQ Quality Press,
2004), chapter 5.
4. For an informative discussion of this subject, see Frank Hous-
ton, “Measurement of Software Processes and Products,” in
C. A. Cianfrani, J. J. Tsiakals, and J. E. West, eds., ASQ ISO
9000:2000 Handbook (Milwaukee, WI: ASQ Quality Press,
2002), 427–444.
A
powerful method for deciding where it is of value
to go beyond the requirements of ISO 9001:2008 to
improve the effectiveness and efficiency of a QMS is
to develop and deploy a s elf-assessment process.
What is a self-assessment? In Chapter 3 we discussed the
differences between internal audit and self- assessment. An
important distinction is that internal audit is a requirement of
ISO 9001 (clause 8.2.2) and s elf-assessment is not.
Internal audits provide confidence that processes are con-
tinuing to perform as intended and would provide evidence of
prudent judgment if issues of liability were ever to arise. Audits
are also a valuable source of input to the corrective action, pre-
ventive action, and continual improvement processes of an
organization. The value of the audit process is further enhanced
when it is integrated with management review.
Self-assessment is different. It is performed by, or at the
direction of, the organization’s own management and goes
beyond determining conformity with detailed requirements. It
is intended to evaluate the effectiveness and efficiency of the
organization and the maturity of its QMS processes. The output
of s elf-assessment can indicate:
• The conformity of processes to requirements
• The maturity level of the QMS processes
81
Chapter Five
How to Conduct a
Self‑Assessment: A Primer
There are many models for conducting self-assessment of a
QMS. The most recognized of these are national and regional
quality award models, also referred to as organizational excel-
lence models. Examples include the Baldrige Performance
Excellence Program and the European Foundation for Quality
Management (EFQM) Excellence Model. A common theme in
Conducting a S
elf-Assessment: A S
tep-by-Step Model
As an example of how a s elf-assessment could be performed,
consider the following scenario:
1. An organization’s management decides to assess the
organization’s management system maturity for the
processes included in ISO 9004:2009.
Self-Assessment Reports
There are many possible ways to format a self-assessment
report. One reasonable approach is to state (or paraphrase)
H1446_Cianfrani_pi_000.indd 89
Table 5.2 Example of reporting self-assessment results.
Improvement actions
Subclause Question Actual performance observation Rating to consider
6.3 Are there processes in place We have job descriptions but they 3 Consider asking HR to
to identify the professional do not articulate the experience or work with operations
and personal competences education required. This has resulted to improve our job
the organization needs in in hiring staff that are not fully description and candidate
the short and long term? competent to do the required work. screening processes
8.3 In addition to internal We have no formal process for this 1 Consider structuring a
audits is there a self- item. process to address this
assessment process activity—by whom, by
defined, documented, and when, and how?
deployed?
8.3 Are there effective Our process is better than any other 5 None required
processes established and process in the world for this item.
deployed for monitoring,
measurement, and
recording of process
variables and product
Go Beyond Where It Matters
characteristics?
89
11/2/13 12:39 PM
90 Chapter Five
Summary—Conducting a Self-Assessment
A self-assessment process may seem cumbersome to put into
practice, but once the front end is structured, the actual perfor-
mance of s elf-assessments is routine. Assessors make a plan,
ask questions, obtain responses, make maturity judgments, and
report results to management. Management decides where the
greatest value can be obtained by implementing improvements,
sets priorities, and allocates required resources.
The time required to perform a s elf-assessment depends on
its scope. Including preparation, performing the self-assessment,
and preparing a report, the time required can range from one
day to several days.
The data obtained from the self-assessment process are
much richer than audit report data and can provide the input
necessary to ensure productive deployment of both human and
financial resources.
Self-assessment can point the way to migrating a QMS
beyond mere compliance with ISO 9001:2008 requirements to
a QMS that can be a stepping stone to world-class performance.
Summary
“Go beyond” where it will have a favorable impact on the
organization and its customers. ISO 9001 is a good starting
point, but in most organizations there are system elements that
need to be more robust than what is required by ISO 9001.
Use an assessment technique like the one given in this chap-
ter to find those areas that can benefit from expansion of the
breadth and depth of your QMS, then set priorities and lead
improvement projects—as many as the available resources will
accommodate.
• Adopt a self-
assessment technique and conduct self-
assessments on all or selected parts of the QMS
• Review the alignment of vision, mission, strategies, goals,
QMPs, and process measures to ensure compatibility
Notes
1. J. M. Juran, ed., A History of Managing for Quality (Milwaukee,
WI: ASQC Quality Press, 1995).
2. J. M. Juran, Juran on Quality by Design (New York: Free Press,
1992); J. M. Juran, Managerial Breakthrough (New York:
McGraw-Hill, 1995).
3. W. E. Deming, Out of the Crisis (Cambridge, MA: MIT Center
for Advanced Engineering Study, 1986), 18–96.
4. P. B. Crosby, Quality Is Free: The Art of Making Quality Certain
(New York: Mentor, 1980).
I
n the previous chapters we examined the QMS from the
standpoint of activities that must be done to meet minimum
requirements as well as actions that can be considered to
expand the scope and depth of an existing QMS.
In this chapter we challenge quality professionals to adopt
an expanded view of their role. They should attack the more
philosophical aspects of our profession. These include closing
the communication gap that is often bemoaned by the quality
community and planning how the quality system will contrib-
ute to addressing the significant challenges to be faced in the
next several years.
We mentioned that there is a communication gap between
quality practitioners and staff in other areas of the organization
(e.g., engineering, marketing, finance, senior management). If
an objective is to expand the scope and depth of quality man-
agement in an organization, it seems rational to address the
question of how to bridge the communication gap.
It is also important for a quality professional to identify
the most significant strategic and tactical challenges the orga-
nization will confront in the future and think about how such
challenges present opportunities for the quality process to
play an integral role in the management of the organization. A
107
• UCL
• AQL
• FMEA
• DOE
• QFD
• CAPA
Each of these acronyms is understood and used by quality pro-
fessionals in most organizations, but it would be surprising if a
senior executive could participate in an in-depth conversation
including many of these terms.
We believe that a gulf exists between how executives (the
individuals who control the allocation of resources and set pri-
orities) think and make decisions and how quality profession-
als think and make decisions. In order for the quality discipline
to become recognized and respected in an organization, this
gulf needs to be bridged.
Table 6.1 C
onference Board CEO Challenge 2012: Synopsis of survey
results.
Rank
United
Challenge Global States Europe Asia
Innovation 1 3 2 1
Human capital 2 4 7 2
Government regulation 4 1 3 7
Global expansion 5 7 4T 3T
Cost optimization 6 5 4T 6
Customer relationships 7 6 6 8
Sustainability 8 9 9 3T
Investor relations 10 10 10 10
Innovation
It is becoming clear that innovation is increasingly the lifeblood
of an organization. With today’s rate of change increasing, no
organization can assure its future without the ability to bring
innovation to customers. Apple is a sterling example of relying
on innovation to create and dominate a market.
To foster innovation in an organization, the quality function
can:
• Ensure documentation and deployment of a formal inno-
vation process that identifies responsibilities and timelines
• Identify customers with whom alliances can be formalized
• Develop personnel through training on innovation skills
• Use customer feedback to identify wants, needs, and
requirements by implementing a voice of the customer
process
Human Capital
Many factors combine to make the management of human
resources a priority, including an aging workforce, a multi-
generational workplace, an imbalance of skills and competen-
cies to meet current needs, changing technology, increased
customer expectations, and pressures to keep the workforce
current. Addressing these challenges will be a major area of
emphasis in the future.
Activities that QA can consider deploying to mitigate nega-
tive impact include:
• Focus HR processes on hiring competent staff that meet
minimum position requirements (vs. keeping the organi-
zation out of court)
• Promote internal training to maintain and improve skills
• Provide performance metrics to identify acceptable and
subpar performance (i.e., measure competence)
• Provide information to HR that enhances the organization
brand as a way to attract targeted talent
• Establish controls for work performed offshore or at alter-
native work locations (e.g., w
ork-from-home employees,
work performed via the internet in multiple geographic
locations)
Processes to ensure the continuing availability of competent
staff at all levels of the organization will require active partici-
pation and contribution from QA to ensure these processes are
Global Expansion
Many organizations are involved in global commerce, which
presents a variety of challenges. Examples include (1) commu-
nication, (2) understanding customer requirements, (3) stabil-
ity of financial arrangements, (4) internet security, (5) variable
environmental regulations, (6) domestic and international labor
relations, (7) export/import regulations, (8) cultural awareness
and sensitivity, and (9) supply chain management. Even oper-
ating from several different locations within the United States
involves some (or all) of these challenges. And these challenges
will be exacerbated as organizations undergo both domestic
and international expansion.
Addressing these and other challenges in a way that main-
tains efficient and effective control of products while maintain-
ing profit (where applicable) will not be easy. Expansion of
the breadth and scope of the QMS will be required, as well as
a measure of luck and the ability to forecast and anticipate the
changes that are certain to occur.
To be effective in developing and implementing processes
to cope with global expansion of operations, activities such as
the following can be considered:
• Deployment of processes that require appropriate and
unambiguous specification of product requirements
• Review and enforcement of customer contract review
processes for international customers independent of the
source of the product
• Institution of projects to achieve compliance with organi-
zation- and customer-required registrations (for example,
ISO 14001, ISO 9001)
Cost Optimization
Cost optimization, when looking forward, is more than just cost
containment. It will require attention to all aspects of processes,
from customer requests to delivery and customer support, and
even to processes to ensure effective product p hase-out.
The quality function should shine when addressing such
challenges. Examples of processes that can be considered for
implementation (or expansion of scope if already implemented)
include:
• Institutionalizing lean and Six Sigma methodology to
eliminate waste and n on-value-adding activities
• Ensuring alignment of processes with mission, vision,
and objectives
• Implementing value stream mapping, process mapping,
and benchmarking
• Promoting FMEA to mitigate risk and minimize the Cost
of Quality
• Managing a Cost of Quality process to quantify, under-
stand, communicate, and lower costs
Attention to these activities as well as many similar ones is
well within the capability of contemporary quality profession-
als and can be technically easy to apply and even expand to
face future cost optimization challenges. But often their appli-
cation is dependent on the cultural base of the organization.
The technical stuff is easy, but hard work and time are needed
Customer Relationships
The very first QMP is customer focus. If an organization does
not have and maintain a customer focus, its sustainability is in
question. Customer focus is intended to encompass all aspects
of the relationship with customers.
In the past the most effective way of maintaining excel-
lent customer relationships was somewhat simplistic: deliver-
ing products that met customer requirements on time and at a
competitive price. In today’s marketplace, that approach is not
enough to ensure sustainability. The advent of the internet and
social media has complicated the processes required to main-
tain favorable customer relationships. Competition is arising
from new sources—for example, BRIC organizations (those
from Brazil, Russia, India, and China)—seeking new business
in the global marketplace. Product and service delivery issues
or problems receive rapid and wide publication (for example,
the Costa Concordia disaster in Italy, the BP oil spill, Bank
of America debit card fees) and can have a significant impact
on brand reputation, even if they are addressed as quickly and
skillfully as possible. Needless to say, organizations need a
contingency plan for such possible incidents.
In addition to continuing to deploy existing processes to
maintain and improve customer relationships, quality profes-
sionals can participate in developing new processes to address
the evolving marketplace realities. Activities that can be con-
sidered include developing and deploying processes for:
• Fast response to customer complaints from any source,
formal or informal
• Monitoring of social network sites for negative brand
postings and establishing defined responsibility for quick
response
Summary
This chapter explored a few areas where the quality function can
assume an expanded role in an organization. We probed ideas
for bridging the communication gap between quality, top man-
agement, and other areas of the organization, a long-standing
complaint of quality professionals. Although both sides of
the communication gap contribute to imperfect communica-
tion, quality professionals should consider what they can do to
improve this real or perceived situation. We discussed several
approaches to explore.
We also explored the future of the quality function, using
studies to identify the areas where quality can assume an
C
hapter 1 dealt with the question of why you would
want to conform to ISO 9001. This chapter deals with
a different but related topic. Organizations, like people,
go through cycles. There is the dynamic startup, a period of
growth, then periods of stability, and a return to a period of
growth. It is that last transition that is dangerous. Organizations
can get to the point where they are too stable, unable to even
picture what a new growth cycle might look like. For some, the
answer becomes the sale of the business. New products can be
a key to revitalization; so can adoption of technological pro-
cess changes. But we need to be able to see the need for such
changes. Often the formal management system does not pro-
vide the tools to identify needed changes.
123
Chapter Seven
H1446_Cianfrani_pi_000.indd 126
organizational
organization?
Threats Strategic planning model OK?
s
Ideas
Issues
126 Chapter Seven
tunitie
external Vision statement and objectives
assessments
Oppor
Principles Alignment
Objectives
Prepare People
Innovation
workforce
Improvement
for change
Learning
Audit
Corrective and
preventive action Identify key
Do we need a processes
new system?
Figure 7.1 C
onsiderations for sustaining growth.
11/2/13 12:53 PM
Revitalizing Your Quality Management System 127
Satisfying Customers
To understand customer satisfaction we need to recognize that
there is almost always a difference between our internal mea-
sures of quality and the perceptions of our customers. The fact
may be that your organization has provided a great product or
service, but the customer may not perceive it the same way.
Everyone needs to understand the importance of looking at the
product or service from the point of view of the customer.
Improving Performance
We should assume that our competitors are trying to improve—
improve service delivery, improve designs, lower costs, improve
efficiencies, and so forth. If we do not do the same, sooner or
to find the key changes that will make the system more effec-
tive and efficient if you focus all of your attention on individual
products and processes. Continual work to improve products
and processes is important. But it is not the secret. Instead, the
key is finding the innovative changes that will make a positive
impact on the whole system. Sometimes these changes are big,
but often they are small. What matters is that they are critical
to the organization’s survival. It is very difficult to find such
innovative changes unless you know a lot about the organiza-
tion, and it is almost impossible to get sufficient focus on such
critical changes if top managers are not engaged in finding and
making them. Innovation is an essential element of improve-
ment, and it does not happen by chance.
What does this business reality have to do with standards?
Management system standards like ISO 9001:2008 and ISO
14001:2004 contain requirements to use the formal manage-
ment system itself to determine the need for and make the
needed changes. They also contain a crucial requirement for
a management review process. It is the job of top managers to
perform the reviews and plan the changes to the system that
are needed in order for the organization to prosper (see ISO
9001:2008 clause 5.6).
Management review can be approached as an activity that
is necessary to maintain the ISO certificate for the organization
(not an uncommon approach), executed by way of an agenda
and a meeting that address nothing but mandated items. Or it
can be viewed as an opportunity to take a hard look at how the
organization is operating to meet both s hort-term and long-term
needs. The opportunity for quality professionals is to make cer-
tain the management review process is structured and operated
in a way that will enable top managers to determine what needs
to be changed, and to monitor the planning and execution of
those changes to ensure they are effective.
The management review process must be set up so that it
brings to the surface issues requiring near-term action to make
the organization is and steering the course for the future. But
setting objectives and measuring progress is not sufficient as a
driver of dynamic change. Everyone in the organization needs
to be involved and doing their part to achieve objectives. To
make this happen, we need alignment.
Shared Vision
We must have used the words mission and vision a hundred
times in this book. We make no apology for that. We believe
organizational excellence and sustainability are dependent on
these concepts more than any others. Your objective should
be to achieve a state where each member of the organization
has a mission and vision that are aligned with, and perhaps
a part of, the organization’s mission and vision. This is often
referred to as “shared vision.” Imagine an organization where
an employee at any level who is presented with a choice makes
the same decision the CEO would make. In this example, the
employee has the same knowledge and data about the situation
that the CEO has. But the employee also has the same basic
value set as the CEO. It is hard to believe that shared vision is
attainable until you see it in a real organization. But the authors
have seen it in organizations big and small.
Summary
Strong management systems are very helpful in identifying
a need to change. They detect disruptive changes both within
and outside of the organization and enable leaders to see future
directions so that the organization, not its competitors, drives
the marketplace.
I
SO 9001 contains a set of minimum requirements for the
QMS of an organization, but it is far from being a perfect
model. In fact, no system model can provide a complete
structure that will be successful in all situations! Remember, all
models are wrong but some are useful.
This book has addressed why and how ISO 9001 can be
useful to any organization. We discussed its minimum require-
ments and how to ensure processes are designed and deployed
to meet those requirements. We also probed many areas where it
makes good business sense to consider going beyond minimum
requirements to enhance effectiveness, efficiency, and cus-
tomer satisfaction. We provided many examples of processes
that should be considered to achieve these enhancements.
We also briefly discussed the interaction of the QMS with
the culture of an organization. Without the right culture, no
QMS will enjoy l ong-term sustainability. But there are no reci-
pes for culture management. Each organization must find its
own way. This concept may appear philosophical and intrac-
table, but if you want success, it cannot be ignored, even if it
is not clear where to start. Self-assessment is an essential tool
that can be used to guide the setting of priorities and deciding
what to do first.
It could be argued that quality systems work related to
short- and long-term survival cannot be pursued until cultural
137
Epilogue
139
Appendix
8.2 Monitoring
• How does the organization monitor its operational envi-
ronment and collect and manage the information that is
necessary for understanding present and future needs and
expectations?
• Are there effective processes established and deployed
for monitoring and recording process variables, outputs,
and product characteristics?
• How does the organization collect and manage the infor-
mation that is necessary for determining the need for
alternative, competitive, or new product offerings?
• How does the organization collect and manage the infor-
mation that is necessary to anticipate current and expected
changes in statutory and regulatory requirements?
• How does the organization collect and manage the infor-
mation that is necessary to assess current organizational
and process capabilities?
8.3 Measurement
• Are there effective processes established and deployed
for measuring and recording process variables, outputs,
and product characteristics?
9.4 Learning
• Does the organization promote and encourage improve-
ment and innovation through learning?
• Do formal processes exist throughout the organization to
encourage learning and the sharing of knowledge?
• Do formal processes exist for recognizing, supporting,
and rewarding the improvement of people’s competence?
Note: Page numbers followed by f refer to figures; those followed by t refer to tables.
151
J P
Juran, Joseph, 97, 102 partner development, 8
people
L organization and, 8
leadership, providing, 7 process use by, 20, 21f
lean, 97 quality management system and,
learning, continual, 8 127–129
performance, improving, 128–129
M plan-do-check-act (PDCA), 61
prevention, 59, 98, 111, 119
“magical” solutions, 96–98
preventive action, 59–61, 61f, 104
Malcolm Baldrige National Quality
developing, during planning
Award, 25
process, 60–61
management, systems approach to,
ISO 9001:2008 references to, 59
69–74
problems, causes of, 62
benefits of, 71–72
processes
big-picture thinking techniques, 71
change management, 15–16
complexity and, 72–73
continual improvement, 13–15,
described, 69–70
14t, 15f
processes and, 70–71
control mechanisms of, 21, 21f
simplicity, steps to encourage,
defined, 20, 20f
73–74
derived from excellence models,
management responsibility (clause 5),
25–26
24, 27f
effectiveness, 12–13, 47–48
management review, 36
efficiency, 12–13, 47–48
role of, in quality management
from ISO 9004:2009, 26–29, 27f
system, 129–131
resources people use within, 20,
management systems, integrating,
21f
28–29
support of, 21f
managers, top
well-managed example of, 24f
ISO 9001:2008 conformity and, 3
process management. See also
mission/vision statements and,
processes
10–11
basics of, 20–21, 20f, 21f
quality professional and, 9
ISO 9001:2008 needs of, 22,
tasks of, 9
24–25
measurement process (clause 8), 25, 27f
quality management system and,
mission statements
19–30
alignment and, 67, 69
system management and, 21–22,
revising, 10–11
23f, 24f
product and process validation, ISO
N 9001:2008, 49–56, 51f, 52f
nonconformity, cost of, 42, 43–44 elements of, 54–55
product design
O review, 52–53, 52f
objectives, alignment of, 7 validation, 52f, 53
organizational excellence models. verification, 52f, 53
See quality award models, product development, 53, 94, 105
self-assessment
product realization (clause 7), 24, 27f, quality management system (QMS),
50, 51f, 53–54, 94 future of
purpose, providing, 7 actions to consider from report
data for, 114–115
Q ASQ 2011 study on, 113–114,
QMS. See quality management 114f
system (QMS) communication challenge,
quality 108–112
business relationship of, 99–100 Conference Board and, 112–113,
ISO 9000:2005 definition of, 128 113t
working definition of, 128 cost optimization and, 118–119
quality assurance personnel customer relationships and,
executive management language 119–120
and, 100 global expansion and, 117–118
strategic planning and, 99 human capital and, 116–117
quality auditing. See auditing innovation and, 115–116
quality audits, internal, 33–34 overview, 107–108
quality award models, self- planning for, 112–120
assessment, 82–90 quality management system (QMS),
conducting phase tasks of, 84, 90 revitalization of
examples of, 82 changing conditions and, 93,
initiating, 83 124–127, 126f
maturity levels and, 85, 86t employee’s role and, 132–134
planning phase tasks of, 83 management review role and,
reporting phase tasks of, 84–85, 129–131
87–89, 89t people and, 127–129
step-by-step model of, 85–87 setting the bar and, 131–132
quality management principles shared vision and, 134–135
(QMPs), 6–10, 103 stable state and, 123–124
quality management system (QMS). quality professional
See also process management capabilities of, 101
auditing, 31–45 communication challenges of,
building, 19–30 108–112
creating sustainable, xv-xvi, xvif, concepts of, 102
5–12
current system, understanding, 5–6 R
future of (see quality management registration/regulatory compliance
system [QMS], future of) audits, 34
mission/vision statements and, resource management (clause 6), 24,
10–11 27f
processes for, 11–12 results, focus on, 7
quality management principles right-first-time (RFT), 61
and, 6–10
revitalization of (see quality S
management system [QMS], second-party audits, 31
revitalization of) sector-specific standards, auditing
structure and deployment of, 5–12 and, 42–43
U
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