Table Of ContentA
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A GUIDE TO LIABILITY PREVENTION F
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E.F. “BUD” GOOKINS A
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This book is designed to be an easy read, high-level guide to R
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inform the executive management and staff support functions of L
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an organization how critical it is to develop a Product Liability A
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Prevention System and the steps needed to establish an effective L
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Product Safety Plan. It was created to inspirer the reader to be aware
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that the product safety criteria must be a subset of the organization’s R
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structure and built into the operation’s strategic plan.
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Gookins walks the reader though a series of product systems and C A GUIDE TO LIABILITY PREVENTION
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design concepts that will enable the manufacturer and service A
organizations to establish a product safety and product liability GU
prevention process that can be integrated into an existing structure. ID
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It discusses the key elements of a sound operational process, quality TO
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assurance, and reliability system approach to product safety. It will IA
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address product liability prevention initiatives, the salient points IL
involved in justifying a product recall, and how to navigate though the ITY
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recall of a defective product that reaches R
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the fi eld. VE
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About the Author: E.F. “Bud” Gookins is an internationally known quality consultant N
and lecturer. He is president of Gookins Technologies Ltd., a quality systems and
management consulting fi rm. Since 1962, he has developed and implemented
quality systems and conducted numerous training programs in quality and
management concepts for a diverse group of industries and service organizations. E
He has lead corporate quality initiatives for Fortune 100 companies, sat on the .F
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board of directors for several companies, lectured extensively, trained more than “
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20,000 people, and published more than 50 professional papers on human U
behavior, organizational development, and quality management systems and D
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technologies—both domestically and internationally. For more information, G
please see the “About the Author” section inside this book. O
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E.F. “BUD” GOOKINS
H1431 Printed in the United States of America
H1431 Gookins COVER.indd 1 5/22/12 8:56 AM
Achieving a Safe and
Reliable Product
Also available from ASQ Quality Press:
Product Safety Excellence: The Seven Elements Essential for Product
Liability Prevention
Timothy A. Pine
Development of FDA-Regulated Medical Products: A Translational Approach,
Second Edition
Elaine Whitmore
HALT, HASS, and HASA Explained: Accelerated Reliability Techniques,
Revised Edition
Harry W. McLean
Medical Device Design and Regulation
Carl T. DeMarco
The FDA and Worldwide Quality System Requirements Guidebook for
Medical Devices, Second Edition
Amiram Daniel and Ed Kimmelman
Quality Risk Management in the FDA-Regulated Industry
José Rodríguez-Pérez
The Power of Deduction: Failure Modes and Effects Analysis for Design
Michael A. Anleitner
Process Improvement Using Six Sigma: A DMAIC Guide
Rama Shankar
Root Cause Analysis: Simplified Tools and Techniques, Second Edition
Bjørn Andersen and Tom Fagerhaug
The Certified Manager of Quality/Organizational Excellence Handbook:
Third Edition
Russell T. Westcott, editor
To request a complimentary catalog of ASQ Quality Press publications,
call 800-248-1946, or visit our Web site at http://www.asq.org/quality-press.
Achieving a Safe and
Reliable Product
A Guide to
Liability Prevention
E.F. “Bud” Gookins
ASQ Quality Press
Milwaukee, Wisconsin
American Society for Quality, Quality Press, Milwaukee, WI 53203
© 2012 by ASQ
All rights reserved. Published 2012.
Printed in the United States of America.
18 17 16 15 14 13 12 5 4 3 2 1
Library of Congress Cataloging-in-Publication Data
Gookins, E. F.
Achieving a safe and reliable product: a guide to liability prevention/
E.F. “Bud” Gookins.
p. cm.
ISBN 978-0-87389-841-6 (hardcover: alk. paper)
1. Products liability—United States. I. Title.
KF1296.G665 2012
346.7303’8—dc23
2012013439
No part of this book may be reproduced in any form or by any means, electronic,
mechanical, photocopying, recording, or otherwise, without the prior written
permission of the publisher.
Publisher: William A. Tony
Acquisitions Editor: Matt T. Meinholz
Project Editor: Paul Daniel O’Mara
Production Administrator: Randall Benson
ASQ Mission: The American Society for Quality advances individual,
organizational, and community excellence worldwide through learning, quality
improvement, and knowledge exchange.
Attention Bookstores, Wholesalers, Schools, and Corporations: ASQ Quality
Press books, video, audio, and software are available at quantity discounts with
bulk purchases for business, educat ional, or instructional use. For information,
please contact ASQ Quality Press at 800-248-1946, or write to ASQ Quality Press,
P.O. Box 3005, Milwaukee, WI 53201-3005.
To place orders or to request ASQ membership information, call 800-248-1946.
Visit our Web site at www.asq.org/quality-press.
Printed on acid-free paper
Dedication
This book is dedicated to my wife, Sandy.
This page intentionally left blank.
Contents
Preface ..................................................... ix
Introduction ................................................ xiii
Chapter 1 Design for Product Safety . . . . . . . . . . . . . . . . . . . . . . . . 1
Conceptual Stage ....................................... 1
Pre-production Stage .................................... 5
Production Stage ........................................ 7
Post-production Stage ................................... 8
Synopsis of Life Cycle Stages ............................. 10
Chapter 2 Regulatory and Statute Laws . . . . . . . . . . . . . . . . . . . . . 13
The Food and Drug Administration – FDA (1938). . . . . . . . . . . . 14
The Occupational Safety and Health Administration –
OSHA (1970) ........................................ 15
Consumer Product Safety Commission – CPSC (1972) ........ 15
The Magnuson–Moss Warranty Federal Trade Commission
Improvement Act (1975) .............................. 16
Other Federal Laws Regarding Safety ...................... 17
Statute Law ............................................ 18
Chapter 3 Product Hazards Analysis . . . . . . . . . . . . . . . . . . . . . . . . 19
Chapter 4 Manufacturing Process Analysis . . . . . . . . . . . . . . . . . . 21
Customer Complaints ................................... 22
Chapter 5 Risk Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
What is Risk Management? ............................... 27
Risk Management – Principles and Guidelines .............. 30
Risk Assessment in the Product Cycle ...................... 33
Risk Treatment in the Product Cycle ....................... 34
Selection of the Risk Treatment Plan ....................... 35
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viii Contents
Chapter 6 Product Recall Guidelines . . . . . . . . . . . . . . . . . . . . . . . . 37
Recall Planning Procedure ................................ 38
Organization Recall Finances ............................. 40
Identification and Traceability (I&T) ....................... 41
Damage Control ........................................ 45
Chapter 7 Reliability Systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Redundancy ............................................ 52
Chapter 8 Inspection and Testing Parameters . . . . . . . . . . . . . . . . 55
Chapter 9 Operational Efficiencies . . . . . . . . . . . . . . . . . . . . . . . . . . 63
Post-production Activities ................................ 64
Chapter 10 Product Safety in the Service Sector . . . . . . . . . . . . . . 67
Chapter 11 Product Liability Lawsuits and Judgments . . . . . . . . 75
What is Class Action? .................................... 77
What is Product Liability and Does it Cost the Defendant? .... 77
Chapter 12 Type of Product Failures . . . . . . . . . . . . . . . . . . . . . . . . 81
Malfunctions Causing Failures ............................ 83
How to Perform a Product Safety Evaluation ............... 86
Design for a Fail-Safe Product ............................. 90
Chapter 13 Warnings and Cautions . . . . . . . . . . . . . . . . . . . . . . . . . 93
Warning ............................................... 93
Caution ................................................ 95
Chapter 14 Warranties . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99
The Warranty Falacy ..................................... 103
Chapter 15 Final Thoughts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107
Glossary ................................................... 111
About the Author ............................................ 117
Index ...................................................... 119
Preface
oday most manufacturers in the United States and other indus-
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trialized countries are faced with competition not only from within
the boundaries of their country but globally as well. The pressure of
higher labor cost, higher material cost, increased infrastructure cost, and
rigid regulatory and environmental requirements, issues most third world
countries do not confront, has placed many American manufacturers in a
precarious and disadvantaged position. Even companies that manufacture
all or part of the product outside of the United States are responsible for
the end use application of that product and can be sued for any injury
to the end user. A U.S. distributor that only sells a product and does not
parti ci pate in the manufacturing of that product can also be sued.
The United States leads the rest of the world in product lawsuits by
more than twenty-to-one, and this trend does not seem to be reversing. In
fact, the number of lawsuits is growing. Although some manufacturers
have been negligent and many lawsuits are justifiable, many are frivolous.
Are these frivolous lawsuits fair?
Perhaps not, but until the United States legal system is changed
American manufacturers will continue to be faced with the problems of
“deep-pocket” assault by the plaintiff’s attorneys and exposure to negative
publicity. Even if the manufacturer wins the lawsuit they will be impacted
with attorney’s fees, expert witness expenses, and oftentimes a loss of
sales revenue resulting from the negative perception of their product in
the public eye. In the United States the legal system is constructed so that
plain tiffs can hire an attorney on a contingency basis and pay nothing if
the case is adjuticated against them, but companies must pay from the
get-go to defend their case.
Clearly, this situation makes it a lot easier for plaintiffs to have their
claims adjudged without an up-front cost to them. Basically, the plain tiff
has nothing to lose and everything to gain. In other countries it is mand a-
tory that the plaintiff pay the attorney’s fee up front. Only at this time is
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