Feature

Demings 14 Principles
Background
Recent changes in regulatory
requirements for clinical trials pose
considerable challenges for the clinical
research community. The clinical research
Quality Assurance (QA) profession as a whole
has not historically utilised quality management
tools, and QA professionals may have little to
no formal training in continuous improvement
methods, to be aware of their value in assessing
and improving the impact and value of the QA
department to any organisation. This article will
present Demings 14 Principles for Management,
paraphrasing them to demonstrate how easily they
can apply to the clinical trial project management,
Contract Research Organisation (CRO) and clinical
department management.
Demings 14 Principles
Dr. William Edwards Deming is known as the father of the
Japanese post-war industrial revival and was regarded by
many as the leading quality guru in the United States.
Deming created 14 Principles for Management that
summarised his business philosophy. The principles became
a basis for transformation of industry. The 14 principles apply
anywhere, from small organisations to large ones, to the
service industry as well as to manufacturing. They apply to
any division within a company.

1. Create Constancy of Purpose Towards Improvement

Replace short-term reaction with long-term planning.
Approaching a new clinical trial project, keep in mind that it
must be better performed and with a lower budget than the
previous ones.
Having the above in mind, analyse previous pitfalls, difficulties,
problems, obstacles and identify the current and anticipated
problems. Hint: findings from system and clinical trials audits
may be a good source of such information. Can these recur?
Most probably yes, unless you take measures to prevent or, at
least, to mitigate them. Hence start with planning and allocate
resources for training and education, based on what youve
learned from your past experience, and make risk analysis
and contingency plans. Acting this way you can constantly
improve your service.
10 Quasar

2. Adopt the New Philosophy

Management should actually adopt the quality philosophy,
rather than merely expect the workforce to do so.
When the new clinical trial project is thoroughly planned
and the quality matters are carefully embedded into it by
the study management, while creating the atmosphere of
striving for the best performance, it will penetrate into the
study team at all levels, both in-house and at sites.
When the management looks forward, not at the
competitors, but at the customers, that will be the moment
of major change.

3. Cease Dependence on Inspection

Quality does not come from inspection; mass inspection is
unreliable, costly and ineffective.
Of course, we can never cede the monitoring, however
quality embedded projects will allow us to reduce the level
of scrutiny over clinical sites without giving up on the quality
of deliverables (i.e. clinical data), genuinely improving costeffectiveness.
The data collected by monitoring, i.e. inspection, should be
used for better process control.

4. Move Towards a Single Supplier for any One Item

Work toward a single source and long term relationship.
If youre a pharmaceutical company, invest your time
in finding the one and only CRO. It will not necessarily
be a single one, but if you create a solid group of CROs
delivering up to your standards, nurture the relationships,
establish a mutual trust and reliance between purchaser
and vendor, make them feel like partners, this will benefit
you immeasurably. When outsourcing your activities, always
remember that price alone has no meaning. Change focus
from lowest initial cost to lowest total cost.
If youre a CRO strive to be a part of such a group. Working
with the same customers over time will make your operation
more efficient, meaning lower prices and higher profits.

Feature
5. Improve Constantly and Forever
Quality starts with the intent of management. Management is
obligated to continually look for ways to improve quality.
First of all, teamwork in clinical trial project planning is
fundamental. Second, we must remember that chronic
problems have chronic causes. Treating the symptoms does not
solve the problem. Putting out fires is not improvement of the
process. Improvement efforts must shift focus from improving the
personnel to improving the processes.
We must identify the systemic policies, practices, belief systems
etc. that are dysfunctional and change them. As long as these
systemic causes remain, the resulting systemic problems will
remain. One of the most efficient tools to reveal the causes
is quality audit followed by corrective actions that include
investigation, a.k.a. root cause analysis. Clinical trial audits and
system audits may open our eyes and indicate the process
deficiencies and flaws. Appropriate handling of the latest will
inevitably lead to improvement.

6. Institute Training
If people are inadequately trained, they will not all work the same
way, and this will introduce variation.
In our business, every new project calls for study specific training,
even when very experienced personnel are involved, both
in-house and at site. The more we invest in the development
of an extensive and comprehensive training programme, the
more field, office and site staff are trained, training effectiveness
evaluated and re-training carried out when the need is
identified, the more uniformity in results, meaning statistically we
will achieve valid clinical data.
Management must remove the inhibitors to good work and
provide the setting where workers can be successful.

7. Institute Leadership
Deming makes a distinction between leadership and mere
supervision.
First of all managers, or should we say leaders, must know the
work they supervise. That will assist them to know the difference
between special and common cause of variation, or in other
words to distinguish between a mere mistake and a weakness of
a process.
CRA Managers or Study Managers are not policemen, neither
are QA personnel. We all have a common goal to complete our
clinical trial in time, at the lowest possible cost, with scientifically
valid results, while strengthening the relationships with
investigators and subcontractors/clients. Its everyones job and
everyones responsibility. When the management message, not
verbal but though action devoted to quality, it will make its way
to the field personnel, also reaching to the sites staff.

8. Drive Out Fear

Deming sees management by fear as counter- productive in
the long term, because it prevents workers from acting in the
organisations best interests.
Theres no better way to make personnel feel that every single
one of them is responsible for improvement than to allow a free
discussion of any subject at any point of time. Attentiveness and
responsiveness of the Study Management to the field personnel
requests, open door policy, willing to assist and support, fast
troubleshooting, backup in case of conflicts and trust, will not
only encourage the personnel to report the problems, or to
admit their own mistakes, but also will create an atmosphere of
partnership which is the most favourable for the project success.

9. Break Down Barriers Between Departments

The concept of the internal customer means that
each department serves not the management,
but the other departments that use its outputs.
Often a companys departments or units are
competing with each other or have goals that
conflict. They do not work as a team; therefore
they cannot solve or foresee problems. Even worse,
one departments goal may cause trouble for
another.
There is no better example of the involvement of a
multi-disciplinary team than a clinical trial project:
data management and clinical supplies, laboratory
personnel, logistics, operations, administration,
and the site personnel. So, first know your internal
suppliers and customers. Integration, co-operation,
open communication lines, mutual understanding
and support are necessary pre-requisites for the
success of the project.
We can easily depict interrelations within the team
as customer-supplier relationships: operations as
customer of clinical supplies, data management
as customer of operations, etc.
From the very beginning of the quality
embedded clinical project, all parties involved
shall have a perception of the common goal and
comprehension of success as a result of teamwork;
therefore promote the teamwork. This is the only
environment in which continual improvement
is possible in. Every department shall make its
contribution, presenting its needs and expectations
on the one hand as a customer, on the other hand
meeting needs and delivering expectations as a
service provider.

Moreover, remember that the more information, both positive

and negative we have, the better we can manage not only the
current project, but also the future ones.
Quasar 11

Feature

10. Eliminate Slogans

Its not people who make the most mistakes - its the process they are working
within. Harassing the workforce without improving the processes they use, is
counter-productive.
Eliminate slogans, exhortations and numerical targets for the workforce. These
never help anybody do a good job.
Facing problems and obstacles raised by audit non-conformities, study
management must not think of penalties, replacement, rebuke, or any
other person-orientated actions as these have proved ineffective in terms of
contributing to improvement measures, but rather look carefully at the process,
analyse it, understand its strengths and weaknesses, consider the possible
resolutions, and only then act. Following this approach, study management
will most probably find out that the measures, i.e. corrective actions rather
than mere corrections, are process-oriented, and therefore, target-oriented.
Moreover, once implemented, corrective actions will improve the entire process
as a result, preventing the study team from making additional mistakes.

11. Eliminate Management by Objectives

Deming saw production targets as encouraging the delivery of poor-quality goods.
Have you participated in competitive recruitment to a clinical study? Im sure
you have. Have you ever analysed the number of protocol violations, damage
to relationships with site personnel, CRAs frustration, illegible data for statistical
analysis data as a result of such a process?
Quotas only take into account numbers, not quality or methods.
A person, in order to hold a job, will try to meet a quota at any cost, including
doing damage to their company.
Initiate a seasonal project when fast recruitment is crucial, encourage your
teams by creating the best foundations for the most efficient implementation,
i.e. all administrative and regulatory issues resolved, study teams trained
appropriately, logistics and clinical supplies standing by. Then set measurable
and realistic (!) objectives of performance and make sure they are understood.
This way the importance of timely and prompt execution will be perceived as
the natural course of things and the employees and the site teams will be proud
in their workmanship.

12. Remove Barriers to Pride of Workmanship

People are eager to do a good job and distressed when they cannot. Too
often, misguided supervisors, faulty equipment and defective materials stand
in the way of good performance. These barriers must be removed.
When the CRA encourages the recruitment, but the site is running out of
clinical supplies that for some reason couldnt be delivered in time, or hasty
allocation of resources makes the field personnel struggle through more work
than they are able to handle appropriately, when the site personnel are
inadequately trained or communication in an electronically managed trial
constantly fails, what pride can people possibly take of their workmanship?

12 Quasar

Its not people who make

most mistakes - its the
process they are working
within. Harassing the
workforce without
improving the processes they
use is counter-productive.

Author Biog
13. Institute Education and Self-improvement
Invest in the education of your work forces (including sub-contractors), encourage
self-education and introduce training programmes, worship knowledge and
professionalism. This is the only recipe for commitment to lifelong employment and
business success.
As the CRA (that does not necessarily have a clinical background) aquires more
knowledge, of the therapeutic area of the study protocol, the better the CRO
team is trained on the internal sponsors processes (SOPs, internal communication
lines, etc.), as the site staff have more understanding in regulations, the more study
management is educated in the topics like teamwork, statistical techniques, risk
management, project management and, of course, quality tools, the more chances
that our mission - to complete our clinical trial in time, at the lowest possible cost,
with scientifically valid results while strengthening the relationships with investigators
and sub-contractors/clients will be successfully accomplished.

14. The Transformation is Everyones Job

It will require a special top management team with a plan of action to carry out
the quality mission. The critical mass of people should be included in the change.
Workers cannot do it on their own, nor can managers.
The leadership model must replace the bureaucratic model of the boss deciding on
what and how everyone else must change. Once consensus is reached, it is feasible
to focus collective energy, intellect, experience, etc. on priorities for improvement.

Summary
Deming preached that to achieve the highest level of performance requires
more than a good philosophy the organisation must change its behaviour and
adopt new ways of doing business. Indeed, his 14 Principles pose a challenge for
many companies to figure out how to apply them in a meaningful way; however
CRO or clinical departments will benefit immeasurably by finding this way and
implementation of the principles in the management practice.

Rita Gabay
Rita is currently owner and manager of QA INSIGHT
- a company providing independent QA, GCP and
ISO 13845 consultancy and audit services.
With a clinical background, and a MSc in Quality
Assurance and Reliability, Rita has over 20
years of experience in marketing, Clinical Quality
Assurance, and management of Quality Systems
compliant with ISO 9001:2008 and 13485:2003.
She served as QA Manager and Auditor in
pharmaceutical, medical devices and in-vitro
diagnostic companies.

Demings Fourteen Points of Management

1
2

Create constancy of purpose for

improvement of product and service
Adopt the new philosophy

8
9

Drive out fear

Break down barriers between staff areas

Cease dependence on mass

inspections

10

End the practice of awarding business

on the basis of price tags alone

11

Improve constantly and forever the

system of production and service

12

Remove barriers that rob people of

pride of workmanship

13

Encourage education and selfimprovement for everyone

14

Take action to accomplish the

transformation

Institute training
Adopt and institute leadership

Rita is a certified auditor. She holds the Certificate

of International Register of Certified Auditors, and
the Health Canada Certificate of CMDCAS Auditor
Qualification Programme.

Eliminate slogans, exhortations, and

targets for the work force

She lectures at the professional and educational

forums on GCP, ISO and Medical Devices regulations

Eliminate numerical quotas

Quasar 13

Quality Engineering, 20:390401, 2008

Copyright # Taylor & Francis Group, LLC
ISSN: 0898-2112 print=1532-4222 online
DOI: 10.1080/08982110802317398

Quality Management and Jurans Legacy

Soren Bisgaard
Eugene M. Isenberg School of
Management, University of
Massachusetts Amherst,
Massachusetts, and Institute for
Business and Industrial Statistics,
University of Amsterdam,
The Netherlands

ABSTRACT Quality management provides the framework for the industrial

application of statistical quality control, design of experiments, quality
improvement, and reliability methods. It is therefore helpful for quality
engineers and statisticians to be familiar with basic quality management
principles. In this article we discuss Dr. Joseph M. Jurans important contributions to modern quality management concepts, principles, and models.
Many people have contributed to modern quality management. However,
through his extensive writings covering more than six decades, Juran has
managed to distill and synthesize the subject. He has provided us with a
coherent framework and terminology and anticipated many of the principles that subsequently became incorporated under the Six Sigma umbrella.
We briefly outline Jurans framework and discuss a number of key contributions he has made to the subject of managing for quality.
KEYWORDS Design for Six Sigma, quality engineering, Six Sigma

INTRODUCTION

Address correspondence to Soren

Bisgaard, Eugene M. Isenberg School
of Management, 121 Presidents
Drive, Amherst, MA 01003. E-mail:
Bisgaard@som.umass.edu

Quality management provides the framework within which modern

statistical quality control, quality improvement, and reliability operate. Only
when imbedded within a managerial framework do statistical tools and techniques become fully operational and effective. Quality management provides
the structure, policies, and organizational environment in which statisticians
and quality professionals can get work done. However, quality engineers and
statisticians are often primarily focused on tools and techniques. They are
typically not well versed in the managerial aspects related to how quality
activities are effectively organized and managed within an organization.
Indeed, Six Sigma advocates seem at times preoccupied with statistical tools
and road maps and pay less attention to the larger managerial framework.
Besides possessing the necessary technical skills, it is useful for quality
professionals to supplement their knowledge base with a basic understanding of quality management principles. One of the most prolific contributors
to modern quality management was Dr. Joseph M. Juran. In this article we
review Jurans legacy. Many have obviously contributed to quality management. However, Juran, more than anyone else, unified the concepts and
brought them together as a system. In our estimation, he was the
quintessential synthesizer of the field. His concept of managing for quality,
comprehensively outlined in his book Juran on Leadership for Quality,
390

( Juran, 1989), is a generic system that we expect will

have a long lasting universality. It has provided the
blueprint for the subsequent Six Sigma movement.
Indeed, some of Jurans ideas have yet to be adopted
by Six Sigma for that approach to be a comprehensive quality management system.
The purpose of this article is twofold: (a) to describe
Jurans comprehensive quality management framework and (b) to highlight some of Jurans most important contributions to modern quality management. In
doing so, we hope to assist quality professionals primarily familiar with statistical tools and techniques, to
gain a better understanding of Jurans management
framework as well as developing an interest in studying
Jurans many books and publications.

A BRIEF HISTORICAL BACKGROUND

Quality management as we know it today has
evolved over the past century from an early embryonic set of ideas to a comprehensive framework for
managing all aspects of quality in an organization,
private or public, for profit or not, manufacturing
or service. Early contributions began before World
War I. For example, the textile business that played
a pivotal role in the industrial revolution was an early
proving ground for many quality related ideas. However, if we seek a formal birth date, it seems fair to
assert that the publication of Dr. Walter Shewharts
seminal 1931 book, The Economic Control of Quality
of Manufactured Product, heralded the beginning of
modern statistically based quality management.
During the 1920s it was recognized that statistical
principles were needed to guide the development
and evaluation of sample inspection procedures.
Further, it was recognized that random variation
needed to be accounted for in the monitoring and
control of production processes. Much of the early
statistical work took place within the Bell Telephone
Company. For example, Shewhart is credited for having invented the control chart in 1924 and H. F.
Dodge and H. G. Romig developed early acceptance
sampling theory. They all worked for Bell Labs; see
Millman (1984). Further, after graduating as an electrical engineer, in 1924 Joseph M. Juran assumed a
position in the inspection department of Western
Electric Company, the production division of the Bell
System, responsible for producing communications
hardware; see Juran (2004).
391

Although Shewhart primarily focused on statistical

issues relevant to quality control, he also discussed
managerial issues. However, most of his managerial
emphasis was on organizing and managing the
inspection function. Jurans first book, Management,
of Inspection and Quality Control (Juran, 1945),
published in 1945, right after he left Western Electric
to venture into consulting and teaching, had a similar
focus.
Quality management in the modern sense was not
discussed in the literature until after World War II.
Even then, the field only evolved slowly over the
following decades. In the early 1950s both Dr. W. E.
Deming and Dr. J. M. Juran were invited to consult
for the Japanese industry about the implementation of quality control. Both based their advice to
Japanese executives on their experience before and
during WWII in United States implementing industrial quality control. Both had been frustrated about
the ineffectiveness of quality control when (a) upper
management only exhibited a passing and superficial
interest in managing the quality function and (b) systems were based primarily on inspection. Both came
to the conclusion that to be effective, efforts should
have strong top management leadership and should
include activities aimed at finding and eliminating
root causes for poor quality, not just passive inspection. Indeed, both came to the conviction during the
1950s that a comprehensive system for managing
quality was critical. Demings focus was primarily
philosophical and strategic. His main contribution
has been to educate upper management in the critical strategic role played by quality in a competitive
economy. His writing is mostly focused on quality
concepts, paradigms and philosophies. Demings
work is essentially setting the stage for initiating
quality efforts in an organization and as such essential. However, his writing is not particularly specific
in his advice about how quality should be implemented and organized in a company. Juran, on the other
hand, while not silent on strategic issues was more
hands-on, prescriptive, and developed comprehensive and detailed practical guidelines for the
development and implementation of a quality management system. His ideas clearly evolved over the
years, but the fundamental concepts were already
evident in the first edition of his quality handbook ( Juran, 1951). A side-by-side comparison of
Demings (1986) book Out of the Crisis with Jurans
Quality Management and Jurans Legacy

(1989) Juran on Leadership for Quality brings out

these differences. However, it should also be noted
that these two scholars works are complementary,
not antithetical. It is not an issue about which book
is better or whose theory is superior. Both Deming
and Juran have made valuable contributions. Both
were giants in the field. Each emphasized different
issues. Indeed, there are few essential disagreements
between them. Among statisticians Deming is better
known, but Juran deserves equal recognition.
Demings and Jurans teachings to Japanese executives, managers, and engineers were not one-way
communications. Both seemed to have learned from
their work in Japan. Both brought back many good
ideas. Surely the Japanese applied the ideas they
learned from their American teachers. But they also
made significant contributions themselves. By applying what they learned, the Japanese saw what
worked, what did not work, what shortcomings
existing approaches had, and came up with whole
new ideas of their own. Thus, many Japanese industrialists, engineers, and scholars such as K. Ishikawa,
S. Toyoda, T. Ohno, S. Mizuno, H. Kume, N. Kano,
and G. Taguchi have made valuable contributions
to the body of knowledge. For an overview of
the history of modern quality management, see
Garvin (1988, chapter 1) and Juran (1995).

JURANS CONTRIBUTIONS TO
QUALITY MANAGEMENT
Although his 1945 book discussed management
issues, Jurans serious entry into the field of quality
management was the publication in 1951 of the first
edition of the Quality Control Handbook. This seminal book, edited by Juran with numerous chapters
written by him, propelled Juran to the forefront of
the field and caught the attention of Japanese industrialists. Although there is a clear evolution and maturing of the field over the years, the combined content
of the five editions of the Juran Quality Handbook
(Juran, 1962; 1947; 1988b) issued roughly every 10
years since 1951 constitute an essential source for
Jurans thinking about quality management and for
the entire field. All five editions are significantly different. Each contains different materials. All are worthwhile reviewing. As indicated above, Juran did not
write everything himself. However, he supposedly
exercised strong editorial control and was very
S. Bisgaard

hands-on in the development of these monumental

books. The general trend from the first to the fifth
edition is a gradual change of focus from a technical
to a managerial. His book Managerial Breakthrough
( Juran, 1964) is also important. However, for a
modern presentation of his evolving view of what
he seemed to prefer to call managing for quality
we recommend Juran on Leadership for Quality
( Juran, 1989). Other important books are Juran on
Quality by Design ( Juran, 1992) and Juran on Planning for Quality ( Juran, 1988a). His autobiography
( Juran, 2004) is also interesting but primarily about
his Horatio Algerlike personal life, struggles, and
successes. His book with longtime partner Dr. Frank
Gryna ( Juran and Gryna, 1993) constitutes a solid university course textbook. Later, new or revised editions
of books organized by the Juran Institute but published after Juran himself withdrew from daily
involvement seemed to have compromised the clarity
of Jurans vision. Some of this seemed to have been in
an effort to keep up with the Six Sigma movement.
However, to us it seems that Six Sigma only borrowed parts of Jurans trilogy, to be discussed below.
Thus, we find that the best expression of Jurans
mature views on quality management are to be found
in Juran (1989) or Juran and Godfrey (1999).
Jurans main contribution to modern quality management was his concept of what is known as the
Juran Trilogy. This is a conceptualization of managing for quality consisting of three main functions:
quality planning, quality control, and quality
improvement. To fully appreciate this concept, we
first discuss Jurans work on defining quality, related
economic models for quality, and his economic
perspective on the societal importance of quality.
We then discuss his management trilogy. We also
review his insight to how to implement quality
improvement at the top management level. Finally,
we discuss Jurans work on developing precise
definitions, terminology and concepts, something
fundamental to any field of study.

Jurans Definitions of Quality

Without well-defined terminology, discussions
about quality and quality management easily get
confused. Juran recognized that the word quality
is not easily defined. Dictionaries provide many definitions, most of which are too vague or philosophical
392

for technical use. However, Jurans definition of

quality as fitness for use is widely recognized today
as one of the more useful. To appreciate the subtleties of this seemingly awkward definition, consider
the following example. If a busy business traveler
needs a simple, clean, and safe accommodation for
the night, an expensive five-star hotel room may
not constitute fitness for use despite its luxury
delivered to perfection. However, the same person
may come back the next week for a vacation with
the family and find the same hotel a perfect fit
for that use and therefore now be delighted with
the quality. In other words, it is the customer, not
the provider, who defines quality. Further, quality
depends on the circumstances and it is not more
is better but fitness for use that is the key issue.
Quality is a bundle of attributes timely delivered to
satisfaction that solves the customers problem. In
economic terms, quality is a nonprice competitive
market signal. Quality does not thrive in monopolistic circumstances. Rather, in a competitive economy, customers have choices. There are typically
multiple alternative market offerings, but ultimately
customers will vote with their pocketbooks based
on a trade-off between cost and quality. Quality is
what appears appealing and fit to the customer
relative to alternative market offerings.
Older definitions of quality such as conformance
to specifications are no longer adequate at the highest conceptual level. Specifications may be useful
surrogates at lower conceptual levelsintrafirm
and operationallybut cannot serve as the predominant definition. Quality must be defined relative to
the customers needs and expectations.
Although fitness for use is the predominant
definition, Juran realized a need for further subsidiary
definitions, chiefly for economic reasons. On the one
hand, some people may argue that high quality obviously will be more costly and expensive. Advocates of
that viewpoint implicitly think of quality in terms of
more features. On the other hand, others may argue
that high quality is cheaper. This may seem contradictory but is not. Advocates of that viewpoint consider
the cost of defects, delays, rework, and waste, or, more
broadly, deficiencies associated with poor quality.
They understand that first doing things incorrectly
and then having to fix it inevitably is expensive. Reducing deficiencies therefore reduces costs. Permanently
removing the causes of deficiencies is even better.
393

FIGURE 1 Quality defined by Juran as fitness for use and his

two subsidiary definitions as features and deficiencies.

Clearly both viewpoints have merit. Juran resolved

the quandary by providing two subsidiary definitions
to quality: (a) features and (b) freedom from deficiencies as illustrated in Figure 1. Features have to
do with the design of the product, process, or service. It is what we intend to deliver. Deficiencies
have to do with the actual delivery. This profound
distinction is only slowly gaining popularity but is
important, especially in the context of Design for
Six Sigma. More importantly, the distinction is key
to understanding the economic reasons for pursuing
quality as a strategic objective, something Toyota
Motor Company, for example, consistently has done
with extraordinary success.
Admittedly, we have not been able to come up
with a better definition to replace Jurans fitness
for use. However, Jurans features and freedom
from deficiencies terminology may perhaps today
seem somewhat obsolete. Although we will continue
to use Jurans terminology in this article devoted to a
discussion of his contributions, we find that design
quality and delivery quality better capture the
two subsidiary notions. Others may prefer to use
quality of design and quality of conformance.
The word design connotes what is desired and
something more general, strategic and important
than features. This term also seems better suited
when applied relative to a general market offering
whether a product or a service. Also, rather than
freedom from deficiencies we find the word
delivery more generally applicable to products
and services and more appealing than the authoritarian-sounding word conformance.

Jurans Economic Perspective

We are concerned about quality not necessarily
because we aspire to win quality awards. The real
reason is because striving for superior quality is
Quality Management and Jurans Legacy

sound business economics. As Drucker (1973, p. 60)

noted, Profit is not the explanation, cause, or rationale of business behavior and business decisions, but
the test of their validity. Milton Friedman has put it
more bluntly: The business of business is business.
In todays competitive business environment, quality
initiatives must justify themselves economically.
Quality is important because it delivers competitive
advantage and measurable, tangible economic benefits in terms of reduced costs, better customer satisfaction and improved bottom line profitability. The
opening chapter of the first edition of Jurans Quality
Control Handbook is entitled The Economics of
Quality. In other words, in 1951 Juran was already
keen on the economic aspects of quality. Below
we discuss a firm-specific as well as a more global
societal perspective of the economics of quality.

Economic Model
Jurans definition of quality and the two subsidiary
definitions as features and deficiencies provide the
basis for understanding the business economics of
quality. Typically, improving (design) quality in
terms of features will increase the cost of producing
a product or service. However, it will also allow the
company to charge a higher price and may increase
sales volume. In accounting parlance, added or
improved features have a beneficial top-line effect.
On the other hand, improving (delivery) quality by
reducing the number of errors and deficiencies will
usually dramatically reduce costs. Thus, it has a

middle line cost-saving impact that immediately

trickles down to the bottom line as increased
profit. In the long run, reducing deficiencies will also
improve a companys market reputation and its
brand. Therefore, reduced deficiencies may allow
for charging a premium price, increase the market
share or both. Figure 2 provides a graphical summary
of the economic relations. Given these simple economic relations, it can be seen that the common but
nave perception that high quality costs more is
not necessarily true. In fact, when it comes to deficiencies the contrary is usually the case: high quality
costs less! This is why top executives ought to be
keenly interested in quality.

Cost of Poor Quality

Juran is credited for having developed most of the
fundamental concepts and theory behind what is call
cost-of-poor-quality (COPQ). Feigenbaum (1961)
and Crosby (1980) have also made important contributions in this conceptual area, but Jurans efforts
were early, comprehensive, and have had lasting
impact. Rather than the confusing notion of cost
of quality, used by many authors, Juran defined
the concept of cost of poor quality (COPQ) as
the sum of all costs that would disappear if there
were no quality problems. Cost-of-poor-quality
concepts are accounting tools adapted to assess the
economic consequences of poor quality; that is, deficiencies. Juran recognized that upper management
primarily understands and deals with money-related
issues. Thus, for communication reasons, he noted
that it makes sense to try to communicate in monetary terms the impact of poor quality and use these
concepts to justify quality programs, select projects
and account for actual results. For more on this,
see Campanella (1990) and Bisgaard and Freiesleben
(2000).

Societal Impact of Quality

FIGURE 2 A graphical summary of the economic relations of

quality defined as features and deficiencies. Improving features
primarily impact the top line. Reducing deficiencies impacts
the middle lines. Both contribute to improving the bottom
line.
S. Bisgaard

Juran has also addressed the larger societal

perspective of the importance of quality. Several editions of Jurans Quality Handbook elaborate on these
themes. However, we briefly mention that Juran
pointed out that in an increasingly sophisticated
industrialized society, quality in a general sense is
imperative. We have all become dependent on
reliable products, services, and systems. We have
394

concerns about protection against power outages,

clean water, environmental catastrophes, safe drugs,
safe products and services in general, safe medical
care, reliable communication channels, healthy food,
etc. As Juran explained, like the Dutch who have
reclaimed so much land from the sea, we secure
the benefits of technology. However, we need protective dikes in the form of good quality to shield
society against service interruptions and to guard
against disasters. Juran calls this life behind the
quality dikes. Quality assurance is important from
a societal perspective even if rarely yet discussed
by economists.

A Unified Quality Management

Framework: The Juran Trilogy
One of the key contributions by Juran is his unified concept of the Juran Trilogy, a comprehensive
framework and set of principles for organizing quality within an organization. This concept was first
articulated in Juran (1986). Based on his experience
at the Hawthorne Works of the Western Electric
Company, Juran rejected the notion early that quality
was only an inspection function; see Juran (1993).
He further objected to the notion that quality should
be the sole responsibility of the quality inspection
department. In his view, the responsibility should
remain with the operating departments; those that
make the defects have the responsibility for them,
not the inspectors. Any other allocation of responsibility will have disastrous consequences for quality
and operational costs. Moreover, he was keen on
breaking down institutional barriers that prevented
quality improvement initiatives. As he learned as a
young engineer, in a traditional management
environment, production was the job of one unit,
quality of another unit, and no one was in charge
of process improvement; see Juran (1993, p. 40).
Juran suggested that the financial function provides a useful managerial model to emulate for the
quality function both in terms of job description
and organization. It is the operating departments
responsibility to produce financial results, not the
finance departments. Likewise, it should be the quality functions responsibly to coordinate activities relevant to quality. Continuing the analogy, Juran
pointed out that the financial management function
consists of (a) budgeting, (b) budget control, and
395

(c) cost reduction. In generic terms, these three functions are concerned with (a) planning, (b) control,
and (c) improvement. Juran suggested that quality
management likewise should be organized into three
equally important functions, (a) quality planning, (b)
quality control, and (c) quality improvement. Table 1,
based on Juran (1989) but adapted and modified,
outlines the tasks and responsibilities of these three
functions.
It may seem logical to implement quality planning
before engaging in quality control and quality
improvement. However, Juran suggested that it is
more pragmatic to start with quality improvement.
Any existing organization will be able to make substantial improvements right away with a small
upfront investment. This will help establish quick
wins and early employee buy-in. This is psychologically important for any change management program; see Kotter (1995). Nevertheless, we discuss
below Jurans Trilogy in the logical order of
planning, control, and improvement.

Quality Planning
To stay competitive, we must do more than just
remove deficiencies. We must develop new products
and services with new features that appeal to an
evolving customer taste and continue to be better
than the competitors offerings. Moreover, we must
do so without repeating the mistakes of the past
and without designing deficiencies into the product
(i.e., a product can also be a service or process).
Juran motivated this, by the analogy of an alligator
hatchery. If we are up to our waist in alligators, it
is not enough to kill the alligators around us. We
must also go after the production of new alligators,
the alligator hatchery. In other words, at the product
design stage we must proactively try to prevent the
need for subsequent quality improvement.
Quality planning is the process of preparing the
launch of new competitive products, services, and
processes that meet customers needs and expectations, minimize product and service dissatisfaction,
avoid costly deficiencies, optimize company performance, and provide participation from those
affected by the product or service. Quality planning
is essentially a marriage of the traditional marketing
function with the research and development or
engineering design function assisted by the quality
Quality Management and Jurans Legacy

TABLE 1 The Juran Trilogy Consisting of the Three Functions of Quality Planning, Quality Control and Quality Improvement. This Table
is Based on Juran (1989, p. 22) but Modified and Adapted
Quality management: Jurans Trilogy
Quality planning
Determine who the customers are;
classify customer segments
Determine what the needs of each
customer segment are
Design products with features and
specifications that satisfy the needs
of the customer segments
Develop products and processes that are
capable of delivering the product or
service
Develop metrics and control mechanisms
for monitoring and control
Provide training in the delivery processes

Quality control
Planning for control:
Develop an understanding of
what needs to be controlled
relative to customer needs
Develop a process flow diagram
Choose what and where to
control; control points
Establish measures
Establish goals and standards of
performance
Executing control:
Evaluate actual outcomes
Compare actual outcome to goals
Take action on the difference

function to provide tools, formal standards, measurements, and data on performance. In this view, Juran
is even today at the cutting edge if not ahead of modern thinking relative to innovation and commercialization of new products; see, for example, Kotler
(2003).
Typically, quality planning involves developing
new or updating existing products to meet evolving
market demands or take advantage of new or emerging technologies. Table 1 as well as Figure 3 summarize the steps of the quality planning processes.

Quality improvement
Establish infrastructure for
improvement
Identify improvement projects
Establish improvement teams
Provide teams with resources,
training, and motivation:
Diagnose root causes
Find remedies; improve
Establish controls to institutionalize
and hold on to the gains
Disband the team

Quality planning starts with establishing a team project. Next, the cross-functional team needs to identify
the customers, discover the customers needs,
develop the product or service, develop the process
for the delivery of the product or service, develop
the controls, and transfer to operations. Upper
management must take responsibility for initiating,
supporting, provide resources and monitor the
quality planning process.

Quality Control: Managing the Control

Function

FIGURE 3 Jurans quality planning roadmap. Adapted and

modified from Juran (1992, p. 20).
S. Bisgaard

The second function of Jurans Trilogy is quality

control. Although control is related to the original
inspection function and widely discussed in the statistical literature since Shewhart (1931), Juran has contributed profound managerial ideas to this area that
we now review. The basic tasks of the control function are summarized in the center column of Table 1.
Figure 4 provides a systems diagram of the universal control function. A sensor evaluates actual
performance. The actual performance is reported
back to the umpire. The umpire compares the actual
performance to the target (goal). If the difference is
significant (i.e., larger than noise), the umpire orders
a control action. The actuator makes the necessary
changes to bring the process back on target (goal).
This idea is applied universally at all levels of
396

FIGURE 4 The concept of process control.

management. All employees, from the shop floor

worker to the CEO, exercise control. The difference
is the subject and scope of control. Workers typically
control product and process features. Executives
control budgets, sales, etc.
The above concepts are basic engineering control
theory. Nothing new here! Jurans contribution has to
do with the management of the control function, the
distribution of authority, and responsibility, a topic
rarely discussed in the statistical process control
literature. We already mentioned that traditional
quality control by inspection carried out by a separate inspection department tends to develop an
unhealthy transfer of the responsibility from the
producer to the inspector. That approach has proven
ineffective. The issue of separation of authority from
responsibility however applies more generally, not
just to the shop floor inspection function. Juran
pointed out that necessary criteria for what he
termed controllability of a process are (1) knowing
what the goals are; (2) the ability to know what the

FIGURE 5 A graphical depiction of the Juran trilogy, adapted

from Juran (1989).

397

actual performance is; and (3) having means for

and authority to change the performance when the
process does not conform to goals or standards.
Without these three criteria fulfilled, a person cannot
fairly be said to be in control. Ideally, responsibility
for control should be assigned to individuals and
combined with authority. Indeed, to hold someone
responsible in the absence of controllability is bad
management. A test for completeness of planning
for control is to check whether the three criteria for
controllability are met.
It is interesting to note that Jurans principle for
controllability is parallel to management expert
Peter Druckers notion of self-control; see Drucker
(1954, pp. 130132). Drucker explains that control
can mean (1) ability to direct oneself and ones
work or (2) domination of one person by another.
The objective of management control should be
the ability to direct oneself and ones work! Drucker
claims that it is a major objective of modern management to substitute management by domination
with management by self-control. However, to
make management by self-control a reality requires
more than saying that it is desirable. It requires new
tools and far-reaching changes in traditional thinking and practices. A manager needs to know his
goals, be able to measure his performance and
results against goals, and have the authority to
make changes. Each manager should have the
information needed for control and receive it soon
enough to be able to make necessary changes for
achieving the necessary results. The information
should go to the manager himself, not to his
superior. Measurements should be a means of
self-control, not a tool of control from above. If
information technology is abused to impose control
on managers from above, it will inflict harm by
demoralizing management and by lowering the
effectiveness of managers. Enlightened management
will primarily rely on self-control and personal
responsibility. Thus, Druckers notion of self-control
is parallel to Jurans controllability.
It is also interesting to note that the idea of
controllability is related to Shewharts and Demings
notions of special causes and common or systems
causes. Special causes are those the operator can
control, is responsible for, and have the authority
to change. Systems causes are causes inherent to
the system that only management can control and
Quality Management and Jurans Legacy

have the authority to change. Hence, systems problems should be the responsibility of upper management, not lower level workers. Anything else is
unfair, unreasonable, and counterproductive; see
Deming (1986).

Quality Improvement
We now consider Jurans insight to how to organize and implement quality improvement. In Juran
(1993), he explained how he personally came to realize that quality control without quality improvement
was ineffective, if not futile. He related the story
about a Western Electric production process of a certain circuit breaker produced in large volume where
the defect rate was 15%. A statistical investigation
revealed that the copper wire exhibited excessive
variability from coil to coil, causing many out of spec
products. A remedy was subsequently developed to
compensate for the excessive variability. Eventually
this problem was permanently removed and the
defect rate reduced virtually to zero. Thus, rather
than a chronic waste of 15% of labor cost, materials,
and costly inspection, the cost of poor quality was
essentially permanently eliminated. Guided by this
watershed experience, in 1954 Juran explained to
Japanese executives that if they were serious about
quality, they should not just rely on inspection and
quality control. Rather, they should aggressively
pursue a strategy of quality improvement by
permanently removing chronic problems and waste.
Such a strategy would have an extraordinary return
on the investment, he promised. However, it would
require the executives to be involved, make quality
a strategic issue, break down barriers between
departments, and make quality a company-wide
effort.
It is likely that Juran was not the first to
recognize that quality improvement needs to be
done via special projects. However, his declaration
that Quality is improved project-by-project and in
no other way sums up his point. He has more
succinctly than anyone formulated the basic principles for how to implement and organize for quality
improvement.
Juran outlined a universal roadmap for quality
improvement that is analogous to detective work.
The initial steps are first to gather information on
needs, for example, on a cost-of-poor-quality basis,
S. Bisgaard

then proceed to identify potential projects and select

projects, for example, based on a cost-of-poorquality ranking, and finally organize project teams.
Once the project teams are formed, they are required
to follow a six-step road map: (1) review that the
chosen project is important, (2) define the project
mission and objective, (3) diagnose root cause(s),
(4) develop a remedy and verify its effectiveness,
(5) deal with organizational resistance to change,
and (6) institute controls to hold the gains. Anyone
familiar with Six Sigma will recognize this as a
generic version of the Define, Measure, Analyze,
Improve, and Control (DMAIC) framework.

Upper Management Responsibilities

Like many other consultants in quality management, Juran no doubt repeatedly experienced that
unless upper management were fully involved and
onboard, any long-term effort is futile. For executives
to just pronounce support and walk away is not
enough. Upper management must be thoroughly
engaged throughout the journey. But what does that
mean? Unlike many quality consultants who just
voiced frustration, Juran proceeded to be prescriptive and explain in detail what top management
involvement ought to mean.
The first step is to establish a quality council. A
quality council is a group of top executives and
upper managers that develops the quality strategy
and guides and supports the implementation. The
responsibility of the quality council is to launch,
coordinate, and institutionalize annual quality
improvement goals and plans. The council formulates policies and improvement priorities, establishes
metrics, establishes a project nomination and selection process, establishes a team selection process,
provides resources, assures implementation,
establishes needed benchmarks to gauge progress,
establishes a progress review process, faces up
to employee apprehension from workers made
superfluous, retrains or reassigns workers, provides
recognition, and revises the reward system to accommodate for quality.
Councils may be established at several organizational levels. Large companies may establish councils
on division as well as at corporate levels. At any
level, the membership should consist of upper managers from line and staff. Members of higher levels
398

often chair lower level councils. Senior manager

membership is a must. Otherwise, only useful
many type problems are solved, not the vital
few that produce the greatest return.
According to Juran, the chairperson of the councils should be the manager with overall responsibility
and authority for the unit. One member of the council should be the director of quality. However, this
structure, although logically sound, may need modification. For example, General Electric (GE) has
found that senior managers may not necessarily have
sufficient skills and background in quality management to effectively head a quality council. Instead,
GE has successfully experimented with having professionally trained quality leaders head the councils.
However, the senior managers membership, presence, and support on the council were found to be
critical for success. This modified structure is not
unlike what is common practice in financial management where it is typically the CFO and not the CEO
who heads up the finance committee.

Terminology
A more subtle but important contribution to quality management is Jurans work on definitions and
terminology. Any scientific field requires its own
precise and well-defined terminology. Terminology
and definitions are fundamental to any science. Without it, confusion prevails. For example, a lay person
will not be particularly careful about using heat
and temperature synonymously. However, a
well-trained physicist, chemist, or engineer would
be abhorred. For them these terms have precise
and very different meanings.
In the honorable scientific tradition of the French
chemist Lavoisier and the English physicist Faraday,
Juran recognized that for the nascent science of
quality management to become on a sound footing,
he needed to develop terms and define new concepts. For example, as we already alluded to Juran
pointed out that cost of quality was an ambiguous
term. The cost-of-quality concept is too confusing
and difficult to narrow down. It fails to distinguish
between the cost of providing quality features and
the cost of deficiencies. Cost of poor quality, on the
other hand, can be precisely defined as the sum of
all costs that will disappear if the deficiencies are
removed.
399

We already discussed Jurans definition of quality

and its two subsidiary definitions. However, he
defined many other important terms. For example,
he defined the meaning of customers, processors,
and suppliers and explained how these three combined play a universal role in any process. Thus,
he called this triple role Triprol. For more, see
Juran and Godfrey (1999).

CONCLUSION: AN APPRECIATION OF
JURANS IMPACT NOW AND IN THE
FUTURE
According to the economist Schumpeter (1950),
in a free market, economic reality is distinguished
by competition from new commodities, new
technologies, new sources of supply, new types of
organizationcompetition that commands a decisive cost or quality advantage. Innovation-based
competition is extremely effective and strikes not
at the margins of existing firms but at their foundations and threatens their survival. New innovations
render older innovations obsolete. Schumpeter
(1950) referred to this as the perennial gale of
creative destruction.
Quality is about innovationinnovation of better
products, better services, better processes, and better
organizational structures. We used to think of quality
as only related to deficiencies and only related to
production floor problems. Modern quality management defines quality more broadly as fitness for
use with the subsidiary meaning of features and
deficiencies. This expanded definition puts the customer front and center and implies the need for
developing innovative ways to retain existing and
attract new customers with competitive market offerings. Improvements aimed at eliminating chronic
sources of deficiencies from products and processes
are innovations that reduce cost and improve our
competitive position. But we cannot only rely on
reducing deficiencies. We must also compete on product innovations that involve new featuresdesign
and develop new products or services that provide
better value to the customersmarket offerings that
better solve the customers problems. Juran (1989)
called the process of innovating new market offerings quality planning. In Six Sigma terminology
this is called Design for Six Sigma (DFSS), but the
Quality Management and Jurans Legacy

concept is the same. From this perspective, quality

management is a systematic and well-organized
approach to managing the process of designing
and developing process and product innovations.
Rather than hoping for haphazard occurrences, quality management puts innovation on a schedule and
provides the organizational framework for managing
innovations, large and small.
Jurans Trilogy is a system for managing not just
quality but more general for managing innovation.
His teaching provides us with a practical and comprehensive framework for managing innovations.
Juran tells us what to do. His writing provides
hands-on operational information about how to go
about organizing and implementing a quality
management program within an organization. In
many aspects, Juran was ahead of his time.
If we should be critical of Juran it would be
relative to his impact. Many of his ideas are still
seldom used and are waiting to be discovered.
Although he wrote many books and publications,
we attribute his lack of widespread popularity
and impact especially among managers to his
somewhat arduous engineering style of writing.
Juran is not easy reading, but patience makes it
highly rewarding. The irony is that what has made
his contributions to quality management so important, namely his precise and detailed writing style,
has perhaps also turned off the larger population
of managers for whom quality management is so
essential. We even suspect that few Six Sigma practitioners are familiar with his work. Indeed, in
some areas, Six Sigma is still trying to catch up
with or reinvent Jurans ideas. For example, Six
Sigma does not yet adequately account for the
quality control function. Jurans concept of quality
planning also appears to be much more comprehensive than the current design for Six Sigma concept. Moreover, we find that in most areas of
quality management Juran is far better articulated
about fundamental principles.
Another criticism that arguably may not be widely
share is that Juran never took a strong position
relative to the ISO 9000 standardization movement.
We share with Juran a sincere appreciation for the
importance of standardization in general. We also
appreciate that in his role as the Nestor of the
quality movement, he may not have wanted to be
perceived as causing dissention. We also feel
S. Bisgaard

confident that ISO 9000 initially was well intended.

However, in our judgment the effect has been a
diversion away from a forward looking business
focusimproving quality and satisfy customers
to a defensive focus on satisfying self-appointed
quality auditors to pass a certification with what
sometimes more looked like Potemkin village
contrivances. Indeed, we feel that ISO 9000 has
had a corrupting effect on the quality movement,
especially in Europe.
In fairness Juran (1995, p. 595) did write that:
The ISO standards have a degree of merit. The criteria
define a comprehensive quality control system. The certification process may well get rid of the plague of multiple
assessments which have burdened suppliers in the past.
However, the criteria fail to include some of the essentials
needed to attain world-class quality, such as personal
leadership by the upper managers; training the hierarchy
in managing for quality; quality goals in the business plan;
maintaining a revolutionary rate of quality improvement;
participation and empowerment of the workforce.
All in all, there is a risk that European companies are in
for a massive let down. They are getting certified to ISO
9000, but this alone will not enable them to attain quality
leadership.

We wish Juran would have been willing to be

more outspoken and publicly against ISO 9000 from
the start. It will take time to recover. Six Sigma, with
its business focus, is a good start. Lean Six Sigma is
perhaps what will help the quality movement regain
credibility among upper managers especially in
Europe.
To sum up, quality engineers and statisticians
involved with quality will be more effective if they
also concern themselves with the managerial
environment in which they operate and apply their
tools. There may be alternative systems for quality
management, but Jurans trilogy is in our opinion
comprehensive and effective. Moreover, his handon advice about going about organizing the quality
function and how to involve upper management is
unsurpassed. We hope this article will inspire
quality professionals to revisit the extensive Juran
literature.

ACKNOWLEDGMENTS
The author thanks Professor Xavier Tort and two
anonymous referees for very useful comments that
helped improve this article. The work on this article
400

was supported by the Isenberg Program for Technology Management, the Isenberg School of
Management, University of Massachusetts Amherst.

ABOUT THE AUTHOR

Dr. Sren Bisgaard is the Eugene M. Isenberg
Professor of techonology management at the University of Massachusetts, Amherst, and Professor of
business and industrial statistics at the University of
Amsterdam, The Netherlands. He is a fellow of the
American Society for Quality and of the American
Statistical Association and has received numerous
awards, including the Shewhart Medal, the Wilcoxon
Prize, the Shewell Award and the Brumbaugh Award.
He serves on the editorial board for the Journal of
Quality Technology, Quality Engineering and is on
the management board of Technometrics.

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Feigenbaum, A. V. (1951). Total Quality Control. New York: McGraw-Hill.

401

Garvin, D. (1988). Managing Quality. New York: The Free Press.

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Quality Management and Jurans Legacy

Control (design + material + product -h process)

^ Costs (inspection + rejects)
X CustoiTier satisfaction

TOTAL
QUALITY
CONTROL
By Armand V. Feigenbaum
To design, process, and sell products competitively in the 1956 market place, American
businessmen must take full account of these
crucial trends;
e Customers both industrial and consumer
have been increasing their quality requirements
very sharply in recent years. This tendency is
likely to be greatly amplified by the intense competition that seems inevitable in the near future.
For example, the electrical relay that could command the lion's share of the 1950 industrial market is no longer acceptable for 1956 operating
needs. Consumers are progressively more minute
in their examination of the finish of appliances,
or in their judgment of the tone of a radio or television set. Even for military products on which
quality has always been the major consideration
e.g., jet engines, airborne electronics, and ordnance
specifications are continually being made more
rigorous.

t As a result of this i^icreased customer demand

for higher quality products, present in-plant quality practices and techniques are now, or soon will
be, outmoded.
Thus, the machined part that could once be
checked with a pocket scale or a pair of micrometers
must now be carefully measured with an air
^auge; and material that could once be visually
iccepted if it were "reddish brown and shiny"
nust now be carefully analyzed both chemically

and physically to assure that it is beryllium copper instead of phosphor bronze. At the same time,
automation, in which rapid quality evaluation is a
pivotal point, has magnified the need for mechanization of inspection and test equipment much
of which is now in the hand-tool stage. Indeed,
the qualit}' control content of the manufacturing
equipment investment dollar may well double in
the next decade to purchase the benefit of this
mechanization.
Quality costs have become very high. For
many companies they may he much too high if
these companies are to maintain and improve their
competitive position over the long run.
In fact, quality costs (inspection, testing, laboratory checks, scrap, rework, customer complaints,
and similar expenses) have crept up to become a
multimillion-dollar item. For many businesses they
are comparable in degree with total direct labor
dollars, with distribution dollars, or with purchased
material dollars! While I can find no documented
research on the subject, evidence points strongly
to the fact that many businesses have quality-cost
expenditures representing 7 % , 8 % , 10%, and
even more of their cost of sales!
e Taken together, these three trends spell out
the twin quality objective that 1956 competitive
conditions present to American business management: (a) considerable improvement in the quality
of many products and many quality practices, and,
at the same time, (b) substantial reductions in the
over-all costs of maintainijtg quality.

93

94

Harvard Business Review

Under these conditions, if quahty must be not

only maintained but upgraded, the wave of the
future looks like an expensive one to ride. How
many of the frailer business craft will be able to
avoid getting swamped?

Broad Scope
Fortunately, there is a way out of the dilemma imposed on businessmen by increasingly
demanding customers and by ever-spiraling costs
of quality. This "way out" seems to lie in a new
kind of quality control, which might be called
"total quality control."
The underlying principle of this total quality
view and its basic difference from all other
concepts is that, to provide genuine effectiveness, control must start with the design of the
product and end only when the product has
been placed in the hands of a customer who remains satisfied.
The reason for this breadth of scope is that
the quality of any product is affected at many
stages of the industrial cycle:
(1) Marketing evaluates the level of quality
which customers want and for which they are willing to pay.
(2) Engineering reduces this marketing evaluation to exact specifications.
(3) Purchasing chooses, contracts with, and retains vendors for parts and materials.
(4) Manufacturing engineering selects the jigs,
tools, and processes for relay production.
(5) Manufacturing supervision and shop operators exert a major quality influence during parts
making, subassembly, and final assembly.
(6) Mechanical inspection and functional test
check conformance to specifications.
(7) Shipping influences the caliber of the packaging and transportation.
In other words, the determination both of
quality and of quality cost actually takes place
throughout the entire industrial cycle. This is
the reason why real quality control cannot be
accomplished by concentrating on inspection
alone, or design alone, or reject trouble-shooting
alone, or operator education alone, or statistical
analysis alone important as each of these individual elements is.
The breadth of the job makes quality control
a new and important business management
function. Just as the theme of the historical inspection activity was "they (i.e., bad parts) shall

not pass," the theme of this new approach is

"make them right the first time." Emphasis is
on defect prevention so that routine inspection
will not be needed to as large an extent. The
burden of quality proof rests, not with inspection, but with the makers of the part machinist, assembly foreman, vendor, as the case
may be.
Like traditional inspection, the quality control
function in this total quality view is still responsible for assurance of the quality of products shipped, but its broader scope places a major
addition on this responsibility. Quality control
becomes responsible for quality assurance at optiiiiuni qziality costs.
The total quality view sees the prototype quality control man, not as an inspector, but as a
quality control engineer with an adequate
background of the applicable product technology and with training in statistical methods, in
inspection techniques, and in other useful tools
for improving and controlling product quality.
Compared With Other Views
It may serve further to clarify the character
of the total quality view if we compare it with
other quality control concepts. Actually, there
have been and are today a great many different
concepts both of the meaning of the term "quality control" and of what the principal elements
of the quality control activity are. The two most
widely accepted of these concepts may be described as the "modern inspection view" and the
"statistical view."
Historically, quality control meant nothing
more than the activity of traditional factory inspection, which was intended to protect the customer by screening bad material from good
prior to shipment. In the modem inspection
view, quality control means this traditional inspection function updated and made more efficient by the use of certain statistical methods
and work-in-process inspection routines. Thus:
e Statistically verified sampling plans assure the
quality of outgoing lots better and more economically than do the older ioo% inspection or hitor-miss spot check procedures.
C In-process sampling inspections detect quality
errors before too many bad parts have been produced, and are consequently more effective than
concentration on final inspection with its risk of
producing a large number of bad parts.
An impressive weight of dollars-and-cents evidence demonstrates that such techniques repre-

Total Quality Control 95

sent a great improvement over old-fashioned
practices. Probably most systems of quality control in American business today are examples of
this modern inspection point of view. That is,
they see the prototype quality control man as a
well-grounded inspection specialist who has bad
training in useful statistical methods.
The statistical view, in turn, reflects the major
and increasing contributions which probability
methods are making to the improvement of industrial decision making. It is a view that predominates both in the literature of quality control and in professional meetings on the subject.
It sees the prototype quality control man as an
industrial statistician, who works on problems
ranging from the design of laboratory experiments, through the establishment of control
charts for production processes, on to the analysis of manufacturing rejects. It sees him, in
other words, as capable of making contributions
in fields not directly connected with product
quality, such as time study and safety.
These modern inspection and statistical concepts of quality control have been and are highly
useful in the areas of product quality which
they cover. But, compared with total quality
control, their scope is much too limited; they are
able to provide only a partial grasp of the over-all
quality problem that faces American businessmen. They simply are not geared to the fact
that quality considerations are involved in every
phase of industrial activity, and are not equipped
to keep over-all costs of quality at a minimum.
Effect of Cost Accounting
If the burden and sharp upward trend of
these quality costs and the need for genuinely broad quality control effort are only
now becoming recognized in some businesses,
part of the reason must be ascribed to traditional
industrial cost accounting practices. Cost accounting methods often have not identified and
grouped quality costs in a form suitable for the
development of adequate controls. The magnitude of the quality cost sum has tended to be
obscured by the piecemeal identification of certain individual quality cost elements: for example, scrap and spoilage, or field complaint expense. Most often, quality cost has been conceived as tbe cost of the company inspection activity actually just a fraction of over-all qualjl-y (.Q5(and controls have been established
on tbis fragmentary basis, ^ ^ ^ ^ ^
Regardless of the source of the fault, the only

clear answer to the quality cost problem seems

to lie in the new concept of total quality control.
Operation of the Function
The work of this total quality control function may be classified into four broad categories,
as follows (see EXHIBIT I for elaboration):
1. New design control, or the planning of controls
for new or modified products prior to the start
of production.
2. Incoming material control, or the control of
incoming purchased parts and materials.
3. Product control, or the shop floor control of
materials, parts, and batches from machines,
processes, and assembly lines.
4. Special process studies, or the conducting of
special analyses of factory and processing
problems.
In this work, the two basic responsibilities of
the quality control function are: (i) to provide
quality assurance for the company's product
i.e,, simply, to be sure that the products shipped
are right; and (2) to assist in assuring optimum
quality costs for those products. It fulfills these
responsibilities through its suhfunctions: quality control engineering, inspection, and test,
which operate a continuous feedback cycle:
(1) Quality control engineering does quality
planning; this establishes the basic framework of
the quality control system for the firm's products.
(2) Inspection and test do quality measuring;
this determines, in accordance with the quality
plan, the conformance and performance of parts
and products with engineering specifications,
(3) There is rapid feedback to quality control
engineering for quality analysis, which results in
new quality planning, thus completing the cycle.
(This analysis also fosters corrective action for
product quality deviations.)

Engineering Component
The true nerve center of the total quality
control function is the engineering component.
Its activities in each of the four broad quality
control jobs deserve examination in some detail.
New Design Control
In this area, quality control engineering provides three main activities:
1. Preproduction service to design engineering and inannfacturing engineering in analyzing

96

Harvard Business Review

EXHIBIT I. QUALITY CONTROL IN THE QUALITY ACTIVITY CYCLE

ACTIVITIES

Rectivinq a Inapc1inq
Quality Moteriot

INCOMING MATERIAL CONTROL

Manufacturing Quality
Por)8 a Productj
Infptctinq BTntlnq
Ouaftty Product

PRODUCT CONTROL

Ouoljty
Producti'

SPECIAL PROCESS STUDIES

the quality-ability of new products and production processes, and in de-bugging quality problems This assures a product which will be as
defeet-free as possible prior to the start of production. Among the new technical tools which
the quality control engineer brings to this effort
are process quality capability studies, tolerance
analysis technique, pilot run practice, and a
wide variety of statistical methods.
2. Planning of inspections and tests to be
carried on when production is under way on the
new product This is to establish continuous
control of in-process quality. It involves determining the following:
Dimensions and characteristics of the parts
to be checked.
Degree to which they are to be checked.
In-process and final production points at which
checks are required.
Methods and procedures to be used including statistical sampling plans, control charts,
and so on.
Personnel who will make the checks that
is, production operators or people from the
inspection and test subfunctions.
3. Design of genuinely modern inspection
and testing equipment, which, to the fullest possible extent, is physically integrated with manufacturing equipment to permit the viachine to

check its own work The aim of this activity

is economical investment expenditures, maximum equipment utilization, and fullest practical
mechanization and automation both of operations and of quality control paper work.
Incoming Material Control
In this area, quality control engineering must
assist in the establishment of good quality relationships with suppliers. It contributes to this
objective in the following ways:
By planning the periodic rating of the quality
performance of present suppliers, it provides facts
which assist the purchasing function in quickly
bringing satisfactory or unsatisfactory quality performance to the attention of vendors.
C By evaluating the quality capabihty of potential suppliers, it provides facts which assist purchasing to select good quality vendors.
e By working with the vendors, it assists them
in understanding the quality control requirements
of the purchase contracts they have won.
e By establishing quality certification programs,
it places the burden of quality proof on the vendor
rather than on an extensive, expensive in-plant incoming inspection effort.

Product Control
In this area, quality control engineering carries on the cost measurement and quality cost
reduction project activity required for over-all

Total Quality Control 97

quality cost control and reduction, and it works
closely with the inspection and test subfunctions
which perform the actual measuring work. It
also performs process quality capability studies
to determine the quality limits within which a
machine or process may be expected to operate.
The aim is to make sure that parts will be routed
to equipment which is capable of economically
maintaining engineering specifications.
Special Process Studies
In this area, the job of quality control engineering is to analyze complex, in-process quality
problems which have been fed back to it by inspection and test. These studies are directed
both to the elimination of defects and to the development of possible improvements in present
quality levels.

Specialized Activity
Certain elements of this quality control engineering work have previously been performed
on a sporadic or divided basis. But the quality
control engineer himself is something new under
the sun. For quality control engineering is not
merely a new label for the inspection planning
package, nor a fresh designation for the test
equipment engineer, nor yet a technologically
fiavored title for the industrial statistician. It
is, instead, a specialized activity with a character all its own, calling for a unique combination
of skills.
Quality control engineering work is the product of the cross-fertilization of modern developments in several fields in statistical methodology, in fast-response high-precision inspection
and testing equipment, in management understanding of the nature of the control function
in modern business. Altogether, it has the attributes of a genuinely new sector of the engineering profession.
In experience, education, aptitude, and attitude, the man entering quality control engineering work today is, in fact, not very different from
the man entering other longer established major
technical fields as, for example, product engineering or manufacturing engineering. He must
possess, or have the capacity to acquire, the
necessary product and process background. He
must have the personal characteristics to work
effectively in a dynamic atmosphere with people
of diverse interests. He must possess the technical background which will enable him to ac-

quire, if he does not already have it, a growing

body of quality control engineering knowledge.
Finally, he needs the analytical ability to use
this knowledge in solving new and different
quality problems.
Inspection & Test
The planning and analysis work of the quality control engineer makes a new, more positive
type of inspection and test both possible and
necessary in the modern quality control function. Instead of policing the manufacturing
process, this type of inspection and test becomes
a direct part of that process by assisting in the
production of good quality products.
Thus, during incoming material control and
product control, the inspection and test subfunctions are responsible not only for fully establishing that the materials received and the products in-process and shipped are of the specified
quality, but also for thoroughly and promptly
feeding back facts for preventing the purchase
and production of poor quality material in the
future.
This positive quality measuring requires only
a very minimum of routine hand-sorting inspection and test. In product control. For example,
this result is made possible through a continuous sequence of engineering work to assure that
with the facilities provided production operators
can make parts right the first time, know that
they can, and have the necessary equipment and
gauges to check their own work. On this basis,
then, inspection and test can provide genuine
assistance in the production of the right quality by:
Becoming auditors of the good quality practices that have been established.
Providing as much as possible on-the-spot,
shop floor analysis of defects.
Feeding back facts about these defects for
corrective analysis and action elsewhere.
Such quality assurance efFort has been termed
controhaudit inspection and test. Inevitably it
means the upgrading of traditional inspection
and test; it requires considerably fewer but much
more highly qualified and more specialized personnel those who have genuine ability to be
helpful in making the right quality. An instance in point is the arc-welding inspector who
now not only knows whether or not weld penetration on a part is satisfactory but also, in the
case of defective welds, may be able to counsel

98

Harvard Business Review

the shop on the reasons why the penetration has

been unsatisfactory.

Organizational Problem
In organizing a modern quality control function, the first principle to recognize is that quality is everybody's job.
In defiance of this principle, there have been
many business experiments over the years which
have attempted to make the quality activity
cycle less of a decentralized, Tinkers-to-Eversto-Chance sequence. Often these attempts have
taken the form of centralizing all quality responsibility by organizing a component whose
job was handsomely described as "responsibilit)'
for all factors affecting product quality."
These experiments have had a life span of as
long as six months when the job incumbent
had the advantage of a strong stomach, a rhinoceros hide, and a well-spent and sober boyhood. Others not similarly endowed did not
last even that long.
The simple fact of the matter is that the
marketing man is in the best position to evaluate adequately customer's quality preferences;
the design engineer is the only man who can
effectively establish specification quality levels;
the shop supervisor is the individual who can
best concentrate on the building of quality.
Total quality control programs therefore require,
as a first step, top management's re-emphasis
on the responsibility and accountability of all
company employees in new design control, incoming material control, product control, and
special process studies.
The second principle of total quality control
organization is a corollary to the first one. It is
that because quality is everybody's job, it may
become nobody's job. Thus the second major
step required in total quality programs becomes
clear. Top management must recognize that
the many individual responsibilities for quality
will be exercised most effectively when they are
buttressed and serviced by a well-organized,
genuinely modern management function whose
only area of specialization is product quality,
and whose only area of operation is in the quality control job.
Location of the Function
In view of these two organizational principles,
where should the quality control function be
placed in the larger structure of company or-

ganization? Should it be part of marketing, of

engineering, of manufacturing? Should it report direct to general management?
While these are crucial questions, they are not
susceptible to categorical answers. Certainly,
quality control in any company should report
high enough so that it can implement its responsibilities for quality assurance at optimum costs.
Certainly, also, it should be close enough to the
firing line so that it will be able to fulfill its
technological role. However, companies vary
widely in their objectives, their character, their
philosophy of organization structure, and their
technology. The answer to the question of
where to locate quality control will necessarily
vary also.
It may be worthwhile, however, to report one
firm's approach to this issue. In the General
Electric Company's product departments, each
of which operates as a decentralized business
with profit and loss accountability reposing with
the department general manager, the cycle of
basic quality responsibility is as follows:
The marketing component is responsible for
evaluating customers' quality preferences and determining the prices these customers are willing
to pay for the various quality levels.
e The engineering component is responsible for
translating marketing's requirements into exact
drawings and specifications.
e The manufacturing component is responsible
for building products to these drawings, and for
knowing that it has done so.
Within this structure of responsibility, quality control clearly emerges as a manufacturing
function. Thus, in the General Electric product
department, the quality control manager reports
to the chief manufacturing executive in that department the manufacturing manager and
operates at the same organization level as the
production superintendents, the managers of
materials, and the managers of manufacturing
engineering.

The Results
Experience in an increasing number of companies shows that operation of a total quality
control program has paid off in six ways:
1. Improved product quality.
2. Reduced scrap, complaint, inspection, and
other quality costs.

Total Quality Control 99

3.
4.
5.
6.

Better product design.

Ehmination of many production bottlenecks.
improved processing methods.
Development of a greater spirit of qualitymindedness on the production shop floor.

Certainly our experience with this program

has been highly satisfactory in the Ceneral Electric Company, where we have been developing
the concept and procedure for some years.
Total quality control has thus, in actual practice, been successful in meeting the dual objective of better quality at lower quality costs. The
reason for the satisfactory better-quality result
is fairly clear from the very nature of the prevention-centered, step-by-step, technically thorough program. But the explanation may not
be nearly so obvious for the accompanying byproduct of lower over-all quality cost. This
needs to be spelled out, especially since it includes, in the long run, lower expenses for the
quality control activities themselves as compared
with the costs of traditional inspection and test.
Costs of Quality
The reason for the favorable cost result of
total quality control is that it cuts the two major
cost segments of quality (which might be called
failure and appraisal costs) by means of much
smaller increases in the third and smallest segment (prevention costs). Why this is possible
can be seen as soon as the character of these
three categories is considered:
(1) Eailure costs are caused by defective materials and products that do not meet company quality specifications. They include such loss elements
as scrap, spoilage, rework, field complaints, etc.
(2) Appraisal costs include the expenses for
maintaining company quality levels by means of
formal evaluations of product quality. This involves such cost elements as inspection, test, quality audits, laboratory acceptance examinations, and
outside endorsements.
(3) Prevention costs are for the purpose of
keeping defects from occurring in the first place.
Included here are such costs as quality control engineering, employee quality training, and the quality maintenance of patterns and tools.
In the absence of formal nationwide studies
of quality costs in various businesses, it is impossible to generalize with any authority about
the relative magnitude of these three elements
of quality cost. However, I believe it would not

be far wrong to assert that failure costs may

represent from one-half to three-quarters of
total quality costs, while appraisal costs probably range in the neighborhood of one-quarter
of this total. Prevention costs, on the other
hand, probably do not exceed one-tenth of the
quality cost total in most businesses. Out of this
i o % , usually S%-g% are directed into such
traditional channels as pattern and tool maintenance and the specification-changing or interpreting work of product engineering. This leaves
only 1% or 2% that is spent for elements of
quality control engineering work.
It is a significant fact that, historically, under
the traditional inspection function, failure and
appraisal costs have tended to move upward together, and it has been difficult to pull them
down once they have started to rise. The reason
for this relationship is that:
C As defects increase thus pushing up failure
costs the number of inspectors has been increased to maintain the "they shall not pass" screen
to protect the customer. This, in turn, has pushed
up appraisal costs.
C For the reasons mentioned earlier in this article, screening inspection does not have much
effect in eliminating the defects, nor can it completely prevent some of the defective products from
leaving the plant and going into the hands of complaining customers.
Appraisal costs thus stay up as long as failure
costs remain high. In fact, the higher these failure and appraisal costs go, the higher they are
likely to go without successful preventive activity.
Once these two main elements of quality cost
have started to rise as they seem to have
throughout industry generally today the one
best hope for pulling them to earth again seems
to be spending more on the third and smallest
element, namely, prevention cost. The i o %
now spent may well need to be doubled, much
of the increase going for quality control engineering as well as for improved methods of inspection and test equipment automation.
At first glance such increases in prevention
costs may not seem to be in the interest of quality cost improvement, but this objection is rapidly dispelled as soon as results are considered.
Translated into quality cost terms, the operation
of total quality control has the following sequence of results:
(1) A substantial cut in failure costs which
has the highest cost reduction potential of all qual-

100

Harvard Business Review

ity cost elements occurs because of the reduced

number of defects and the improvements in product quality brought about by modern quality control practice.
(2) Fewer defects mean somewhat less need for
routine inspection and test, causing a reduction in
appraisal costs.
(3) Better inspection and test equipment and
practices, and the replacement of many routine
operators by less numerous but more effective control audit inspectors and testers, bring about additional reductions in appraisal costs,
(4) Because the new cojitrol-andit inspection
and test is effective in preventing defects, appraisal
dollars for the first time begin to exercise a positive downward pull on failure costs.
The ultimate end result is that total quality
control brings about a sizable reduction in overall quality costs, and a major alteration in the
proportions of the three cost segments. No
large, long-term increase in the size of the quality control function is required as a necessary
condition for quality cost improvement. Instead,
quality control expense, as a proportion of total
company expense, will be down in the long run.
Improvements of one-third or more in over-all
quality costs are not unusual.
Quality Dollar Budgeting
It is worth noting that this identification and
analysis of quality costs permits a major forward
step in the business budgeting process. That is,
it makes feasible determining the dollars needed
for quality control, not on the basis of historical
inspection cost experience, but on the basis of
current company objectives in product quality
and quality costs.
Quality needs and problems differ so mucb
from company to company that it is not realistic
to generalize about the specific mix of quality
costs that should be budgeted under total quality control. But the direction of budgetary
trends may be suggested by an example, which
embodies current industrial experience in tbis

area. EXHIBIT II shows how one company expects to cut its quality costs by switching from
a mild version of the inspection view to total
quality control. The company anticipates that
total quality expenses will drop from the current
high of 7% of sales to 5%, with declines
achieved both in failure and appraisal costs
while prevention costs increase from only 0.70%
of sales to a still modest 1.25%. In this example, the cost savings budgeted are rather moderate, owing to the presence of complicating
factors such as the following:
An anticipated 50% increase in sales over the
next five years from $50 million to $75
million.
Planned additions to a product line that is
already highly technical and diversified, hence
accompanied by major quality problems.
Such a planned 30% improvement in quality
cost ratios is feasible, indeed conservative, with
a successful total quality control program
even with a 50% business expansion and even
with counterbalancing quality eost increases
brought about by the introduction of new produets. While the company in the example may
not be typical (probably there is no such thing
as a typical business enterprise), it is at least
illustrative of the good results that can be
achieved even when circumstances pose unusual difficulties.

Conclusion
Total quality control thus represents another
forward step in management science. Its integration of design-througb-shipment control of
the many elements in the quahty picture makes
it much more effective than the unlinked fragmentary controls of the past. As a major new
business management activity, it provides professional effort in meeting the objective of assured product quality at minimum quality cost.
With this concept, inspection and test have

EXHIBIT I I . BUDGETED QUALITY COSTS AND SAVINGS UNDER TOTAL QUALITY CONTROL

(Assuming sales increase from $50 million to $75 million)

Quality
cost element

Failure
Appraisal
Prevention
Total

Total dollars

Per cent of total

quality cost

Per cent of sales

Present

S-year goal

Present

S-year goal

$ 2 ,275,000
875,000
350,000

$2,062,500
750,000
937.500

4-55%
1-75

65%

55%

0.70

2.75%
1.00
1.25

25
10

20
25

$ 3 ,500,000

$3,750,000

7.00%

5.00%

roo%

100%

Present

S-year goal

Total Quality Control 101

a chance to develop in the direction that conscientious inspectors and testers have always
sought; that is, into an activity with a positive
role in assisting other members of the manufacturing, engineering, and marketing team toward
quality improvement and quality cost control.
No longer are inspection and test confined to
essentially a negative, fist-shaking role in sorting
had parts from good, a role placing them continually on the defensive and evoking the hostility of other managers.
Further, those tools of statistical methodology
that have proved practical and useful can now
be brought to their fullest effectiveness. With
the quality control engineers as tool builders,
and the control audit inspectors as tool users,
statistical techniques can be put to work in a
down-to-earth fashion that welds them into regular day-by-day controls. No longer will these
techniques be treated as too often in the past
merely as curiosities, to he employed in special situations on a pinch-hitting basis.
With equipment for inspection and test a
direct and major responsibility of the quality

control function, more use can he made of

equipment specialists who wish to concentrate
their skills on the great needs, opportunities, and
unique complexities of today's quality control
equipment field.
Total quality control thus welds this new
technology into a strong yet flexible weapon,
capable of successfully coming to grips with the
three major quality problems that modern business must face and solve: the upward customer
pressure on quality levels, the resulting rapid obsolescence of quality praetices, the very high
level of quality costs.
M^hile delivery and other factors may sell a
product the first time, it is usually quahty which
keeps the product sold and which keeps the customer coming back a second and a third time.
Quality cost perhaps 8% or more of eost of
sales is one of the major elements of product
cost that must be made right to permit the setting of the right price to the customer. Helping
to assure this right quality at this right quality
cost is the way the new total tjuality control can
serve its company in the years ahead.

OREMEN recognized that in the last analysis quality performance is a matter of attitudes, of both the individual worker and the group as a whole.
Foremen who were prone to consider a lack of interest in quality as some
innate attribute of workers were also likely to be the ones who tried to dictate
a "you-do-it-this-way-or-else" policy. Those foremen who assumed that the
average man wanted to do a good job, who gave careful training to the new
operator, and who helped outfall of their operators when they needed it were
more likely to he rewarded with good quality work.
The present study lends support to the administrative principle of delegating responsibility to hourly wage earners and especially to utility men. Those
foremen most highly thought of by management were those who freely admitted that they could not possibly check on all the quality problems throughout the workin'a day. It was their conviction that a foreman must depend
upon his whole"team his utility man and his other operators to speak
up on quality problems and so prevent bad work from going through to the
inspector Quality consciousness, it may be inferred, is not somethmg developed solely between a foreman and the individual worker. The men must
take on a self-disciplinary s,roiip responsibility for doing a good )ob and doing
it for a foreman who is their leader in fact as well as m tttle.
Charles R. Walker, Robert H. Guest, and Arthur N. Turner, The Foreman
on tke Assembly Line
, ,, .
. ^
/Cambridge, Harvard University Press, 1956, p. 75.


er

Knowing the cause

is half the battle
Symptoms can be signposts on the route to curing problems

^ A ^ V ^ ^ ^ V hen we come across a probThis exercise stirs the thought processes of

^^m ^^m 1cm, smedmes we know
the group's members and extracts core process
^W
^ W more about the problem
knowledge to identify likely contributing facitself than we do about the cause of the probtors. Along the way, each person in the group
lem. In manu facruring, there may be many
asks and answers questions about possible
variables and contributing factors. The more
relationships of the five M categories.
complex the production process, the more
Other tools may also be used in order to
difficult it may be to sort out the problem's
test causes and provide solutions. Check sheets
cause.
may be used to determine fretjuency of various
Our mission needs to be to find and
cause occurrences. But how do we use a list or
cure the causes using the symptoms as signcheck sheet to capture information?
posts. Luckily, we have
Seven Quality Tools in
Defect 1:
Defect 2:
ID (Dace
Defect 3:
Defect 4:
Defect 5:
aborted cycle bad stock
other
( iir "quaiit)' toolbox" to or part tt) too short too long
liL-lp us identify causes.
3
4
3
1
0
1/1/08
The cause and effect
1/2/08
2
2
3
3
1
Jnii;ram was developed
1/3/08
1
S
3
0
2
i)\ Kaoru lshikawa to
Figure 2-Check Sheet for Part Defects
sorr out possible causes
associated with producdon problems.
For example, what if we examining a pile
This method is commonly referred to as
of defective parts? We found that there were
:i iishbone diagram because of how the
several key defects. This check sheet allows us
sordng process is illustrated.
to capture that informadon and quantify the
The diagram is best constructed by a
frequency of these defects.
group
that is knowledgeable about the
We can total the frequency of each defect
E/izahel/i Mazc-Eiuerv
process at hand. The group starts with
and generate a picture of the greatest defect
the fishbone framework composed of the five
problem. In this exampie, we use the data colATs: Materials, Machines, Measurements, Man,
lected on the check sheet by plotting the totals
and Methods. The group brainstorms what
in descending order of occurrence. This is the
variables in each category may contribute to
Pareto chart shown in Figure 3.
the current problem.
Pareto charts, histograms, and control
12
\ . Materials

\ ^ Machines

Measurements

10

\
\
\

Effect
or
Problem

Frequency

8
6
4
2

Man^/

^/Methods

Figure I-Diagram of Five M's Cause Categories and

Resulting Effect
28

November/December 2008

Defect 2;

Defect 3:

too long

aborted
cycle

Defect 1:
too short

Defect 4:

Defect 5:

bad stock

other

Figure 3-Pareto Chart of Part Defects

www.ToolingAndProduction.com

quality
Upper Control Limit

Machine Parts Process Flow

Drawing
Review

Lower Control Limit

Machine
Setup

Figure 6-Controt Chart

Stock
Inspection

Machine
Parts

Defective
Check
Sheet

Good

Figure 4Flowcharts

chart use may also point to signiricant

causes. Flowcharts can help map the
process to establish where factors are
introduced.
Parts & Size 1 2 3 4 5 6 7 8
0.90
0.91
0.92
0.93
0.94
0.95
0,96
0.97
0.98
0.99
1.00
1.01
1.02
1.03
1.04
1.05
1.06
1.07
1.08
1.09
1.10

What is a histogram? How does that

tool work? It works by showing the
relative bel] curve of data distribution.
Figure 5 is an example. The part size
is to be 1.0". An inspector at the end
of the process has collected data.
Once key contributing factors have
been identified, causes and possible
solutions can be reviewed for feasibility, tested for validitj', and posted as
troubleshooting fixes.
The control chart helps to identify out-of-control points and assignable causes. First something must be
known about the normal in-specification manufacturing process. The process average, or in-specification mean,
is plotted as the centerline. Upper and
lower control limits can be calculated
and plotted.
This process average can be considered the centerline of a road and the
control limits the edges of
the toad that we must stay
9
11 12 between to avoid running
off the road surface. Bv

plotting new data within these limits,

we can monitor and respond to trends
or out'Of-control conditions.
A scatter diagram shows nonlinear
reiationships that result in scattered
data piots. If variables have relationships, these will show clear correlations. This scatter diagram is from
Wikipedia, and indicates the relationship between duration of an eruption
of Old Faithful geyser and the length
between eruptions.
The discipline of total quality' control uses Seven Quality Tools to identify focus for continuous improvement efforts in manufacturing. Over
the years, c|ualit)' experts realized that
many quality-related problems could
be solved with the above tools.

Elii^abeth Ma^e-Emery is a quality professional from Di/yton, OH. For more information iihout quality tools or related topics,
e-mail her at ema^eemery@jiu. edu.

Old Faithful Eruptions

o

f[

Figure 5-Histogram
www.ToolingAndProduction.com

O)

- -

i"

OD

o
CD

Eruption Duration (Min)

\
1.5

I
2.0

i
2.5

I
3.0

1
3.5

I
4.0

1
4.5

r
5.0

Figure 7-Scatter Diagram

November/December 2008

IStiri5