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Q M
UALITY ANAGEMENT
S H
YSTEM ANDBOOK
for
P D
RODUCT EVELOPMENT
C
OMPANIES
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Q M
UALITY ANAGEMENT
S H
YSTEM ANDBOOK
for
P D
RODUCT EVELOPMENT
C
OMPANIES
Vivek Nanda
CRC PR ESS
Boca Raton London New York Washington, D.C.
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Library of Congress Cataloging-in-Publication Data
Nanda, Vivek.
Quality management system handbook for product development companies
/ Vivek (Vic) Nanda.
p. cm.
Includes bibliographical references and index.
ISBN 1-57444-352-6
1. Quality control—Automation. 2. Manufacturing resource planning. 3. Production.
planning—Data processing. I. Title.
TS156.N25 2005
658.4'013'011—dc22
2004058345
This book contains information obtained from authentic and highly regarded sources. Reprinted material
is quoted with permission, and sources are indicated. A wide variety of references are listed. Reasonable
efforts have been made to publish reliable data and information, but the author and the publisher cannot
assume responsibility for the validity of all materials or for the consequences of their use.
Neither this book nor any part may be reproduced or transmitted in any form or by any means, electronic
or mechanical, including photocopying, microfilming, and recording, or by any information storage or
retrieval system, without prior permission in writing from the publisher.
The consent of CRC Press does not extend to copying for general distribution, for promotion, for creating
new works, or for resale. Specific permission must be obtained in writing from CRC Press for such
copying.
Direct all inquiries to CRC Press, 2000 N.W. Corporate Blvd., Boca Raton, Florida 33431.
Trademark Notice: Product or corporate names may be trademarks or registered trademarks, and are
used only for identification and explanation, without intent to infringe.
Visit the CRC Press Web site at www.crcpress.com
© 2005 by CRC Press
No claim to original U.S. Government works
International Standard Book Number 1-57444-352-6
Library of Congress Card Number 2004058345
Printed in the United States of America 1 2 3 4 5 6 7 8 9 0
Printed on acid-free paper
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To my pride and joy — my son, Hersh Rahul Nanda.
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PREFACE
You probably picked this book up because your company has recently
launched or is considering launching a program to institute a quality
management system (QMS). Or perhaps you are just curious about what
it means to implement a quality management system in a company, what
such an implementation entails, and what benefits it offers. This book
describes a systematic approach for quality management and continuous
improvement in a product development company by means of a formal
quality management system.
The QMS implementation approach described in this book is centered
on a high-level process for defining a QMS — from identification of
essential prerequisites for a successful QMS implementation to mechanisms
for continuous improvement. The QMS implementation process steps
through the following five major phases:
(cid:1) QMS implementation planning
(cid:1) QMS definition
(cid:1) QMS refinement
(cid:1) QMS deployment
(cid:1) Continuous improvement
The primary objective of this book is to provide pertinent information
that a product development company would need to implement a QMS
from scratch. Because this is intended to be a nuts-and-bolts book, it drills
down deeper into each of the five phases. In addition to describing the
high-level QMS implementation process and explaining what the elements
of a sound QMS are, it also provides guidance on how to define, deploy,
and continually improve a QMS. Implementation guidance is provided for
all functional areas of a typical product development company, and
without bias toward any particular industry or QMS standard. Several
vii
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viii (cid:1) Quality Management System Handbook
examples of QMS documentation are provided in the appendices to serve
as ready reference to assist companies in defining their own QMS docu-
mentation.
Fundamentally, this book embraces the widely accepted view* that
because much of the work in today’s companies is accomplished by
executing business processes, one must improve the business processes
and supporting process management infrastructure in order to improve
quality of products and services. Process management infrastructure
includes but is not limited to organizational processes (including process
documentation), standards, employee competencies, resources, and tools
that support process management.
A process-oriented view of companies differs from the traditional
function or line view of companies, wherein line managers are interested
primarily in optimizing and improving their respective functions, as
opposed to business processes (which typically span multiple functions).
That is, improvements are driven vertically in each function of the com-
pany, as opposed to horizontally across the company. Exclusively focusing
on optimization at a functional level generally leads to suboptimization
at the organizational level, as each function focuses expressly on achieving
its objectives. For example, if sales personnel focus solely on achieving
their sales targets and make unrealistic commitments to customers to
secure sales wins, then it will only result in customer dissatisfaction and
long-term harm to the company’s reputation.
It is important to recognize that product and service delivery are an
outcome of interplay of cross-functional business processes. A process-
oriented view of a company facilitates a better understanding of the various
stakeholders involved in business processes and provides insight into how
each function contributes to the quality of the final output. Such a view
helps better manage the interfaces between various functions. Conversely,
lack of process orientation causes the quality of products and services to
fall victim to struggles between different functions that often operate with
competing objectives. Such a situation is exacerbated if there are rigid
personalities in key decision-making positions who ignore larger organi-
zational objectives for the sake of personal ones. Personnel in such
companies fail to see (or intentionally ignore) the big picture — the role
various functions play in each process, and the value and contribution of
each role in delivering a quality product or service.
For this reason, in recent years, the view has gained wide acceptance
that the route to quality is via process management and process improve-
ment. Companies have begun to realize that they must complement their
* It is acknowledged that Rummler and Brache were among the first advocates of such
a view of organizations [RuB95].
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Preface (cid:1) ix
functional view of business operations with a horizontal (or process) view
of business operations. The restructuring and release of the most widely
recognized QMS standard, ISO 9001:2000, founded on a process-based
approach to quality improvement, is proof of the wider acceptance of the
process view. Due to the increasing relevance of this process paradigm,
this book takes a process-oriented approach to the establishment of a
QMS, and describes quality practices that are relevant to typical processes
in product development companies.
Finally, it is recognized that no two companies are alike. Companies
differ with regards to:
(cid:1) The industry they belong to
(cid:1) Market segment (and product space) within the industry in which
they operate
(cid:1) Organizational structure
(cid:1) Business processes they use
(cid:1) Time to market (time from the conception of a product until its
delivery to customers)
(cid:1) Competency level of personnel
(cid:1) Customer perception of quality
(cid:1) Quality requirements placed on them as a result of customer or
market demand
Therefore, the processes and related quality practices described in this
book may not be applicable as is to all companies. One size does not fit
all. Each company should examine the guidance provided in this book
in the context of its operations and tailor it for its use, such that the
established QMS is relevant to the company’s operations. In addition,
different companies will have different needs with regards to maturity and
sophistication of their QMS and quality practices. For example, companies
that develop mission-critical products or products that place human life
at risk have the most stringent quality expectations and requirements.
Therefore, when appropriate, companies should build upon the essential
elements of a QMS presented in this book. Such enhancement should be
as per organizational need and commensurate with applicable quality,
regulatory, and customer requirements.
Vivek (Vic) Nanda, CSQE, CQA
