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- Herausgeber: John Wiley & Sons
- Kategorie: Wissenschaft und neue Technologien
- Serie: Wiley Series in Quality and Reliability Engineering
- Sprache: Englisch
Outlines the correct procedures for doing FMEAs and how to successfully apply them in design, development, manufacturing, and service applications
There are a myriad of quality and reliability tools available to corporations worldwide, but the one that shows up consistently in company after company is Failure Mode and Effects Analysis (FMEA). Effective FMEAs takes the best practices from hundreds of companies and thousands of FMEA applications and presents streamlined procedures for veteran FMEA practitioners, novices, and everyone in between.
Written from an applications viewpoint—with many examples, detailed case studies, study problems, and tips included—the book covers the most common types of FMEAs, including System FMEAs, Design FMEAs, Process FMEAs, Maintenance FMEAs, Software FMEAs, and others. It also presents chapters on Fault Tree Analysis, Design Review Based on Failure Mode (DRBFM), Reliability-Centered Maintenance (RCM), Hazard Analysis, and FMECA (which adds criticality analysis to FMEA).
With extensive study problems and a companion Solutions Manual, this book is an ideal resource for academic curricula, as well as for applications in industry. In addition, Effective FMEAs covers:
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The basics of FMEAs and risk assessment
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How to apply key factors for effective FMEAs and prevent the most common errors
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What is needed to provide excellent FMEA facilitation
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Implementing a "best practice" FMEA process
Everyone wants to support the accomplishment of safe and trouble-free products and processes while generating happy and loyal customers. This book will show readers how to use FMEA to anticipate and prevent problems, reduce costs, shorten product development times, and achieve safe and highly reliable products and processes.
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Seitenzahl: 657
Veröffentlichungsjahr: 2012
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Table of Contents
Cover
Wiley Series in Quality & Reliability Engineering and Related Titles
Title page
Copyright page
Dedication
Series Editor’s Foreword
Copyrights and Permissions
Acknowledgments
Introduction
MY PERSONAL PHILOSOPHY REGARDING FMEAs
END OF CHAPTER PROBLEMS
MY PLEDGE TO READERS
Chapter 1: The Case for Failure Mode and Effects Analysis
IN THIS CHAPTER
1.1 THE NEED FOR EFFECTIVE FMEAs
1.2 FMEA APPLICATION BY INDUSTRY
1.3 THE FACTOR OF 10 RULE
1.4 FMEA SUCCESSES
1.5 BRIEF HISTORY OF FMEA
1.6 FMEA STANDARDS AND GUIDELINES
1.7 HOW TO USE THIS BOOK
1.8 WEB COMPANION TO EFFECTIVE FMEAs
1.9 END OF CHAPTER PROBLEMS
Chapter 2: The Philosophy and Guiding Principles for Effective FMEAs
IN THIS CHAPTER
2.1 WHAT IS PHILOSOPHY AND WHY DOES IT MATTER TO FMEAs?
2.2 GUIDING PRINCIPLES FOR EFFECTIVE FMEAs
2.3 THE ROLE OF FMEA IN DESIGN FOR RELIABILITY
2.4 YOU CAN’T ANTICIPATE EVERYTHING
2.5 END OF CHAPTER PROBLEMS
Chapter 3: Understanding the Fundamental Definitions and Concepts of FMEAs
IN THIS CHAPTER
3.1 DEFINITION OF FMEA
3.2 PRIMARY OBJECTIVE OF FMEA
3.3 DEFINITION OF FAILURE MODE EFFECTS AND CRITICALITY ANALYSIS
3.4 TYPES OF FMEAs
3.5 FMEA DEFINITIONS AND EXAMPLES
3.6 IS IT A FAILURE MODE, EFFECT, OR CAUSE?
3.7 FMEA GLOSSARY
3.8 WEB COMPANION TO EFFECTIVE FMEAs
3.9 END OF CHAPTER PROBLEMS
Chapter 4: Selection and Timing of FMEA Projects
IN THIS CHAPTER
4.1 GUIDELINES FOR WHEN TO DO FMEAs
4.2 FMEA PROJECT SELECTION CRITERIA
4.3 PRELIMINARY RISK ASSESSMENT
4.4 WHEN TO DO DIFFERENT TYPES OF FMEAs
4.5 RESPONSIBILITY FOR FMEAs BETWEEN OEMs AND SUPPLIERS
4.6 INTRODUCING THE ALL-TERRAIN BICYCLE CASE STUDY
4.7 END OF CHAPTER PROBLEMS
Chapter 5: How to Perform an FMEA Project: Preparation
IN THIS CHAPTER
USE OF THE BICYCLE EXAMPLES IN THE CHAPTER
5.1 THE SUBJECT OF FMEA PREPARATION
5.2 PREPARATION TASKS DONE ONCE FOR ALL FMEA PROJECTS
5.3 PREPARATION TASKS FOR EACH NEW FMEA PROJECT
5.4 END OF CHAPTER PROBLEMS
Chapter 6: How to Perform an FMEA Project: Procedure
IN THIS CHAPTER
USE OF THE BICYCLE EXAMPLES IN THE CHAPTER
6.1 FMEA PROCEDURE SEQUENCE OF STEPS
6.2 BASIC FMEA PROCEDURE
6.3 FMEA LINKAGES
6.4 END OF CHAPTER PROBLEMS
Chapter 7: How to Develop and Execute Effective Risk Reduction Actions
IN THIS CHAPTER
USE OF THE BICYCLE EXAMPLES IN THE CHAPTER
7.1 PRIORITIZE ISSUES FOR CORRECTIVE ACTION
7.2 DEVELOP EFFECTIVE RECOMMENDED ACTIONS
7.3 ACTION STRATEGIES TO REDUCE RISK
7.4 EXAMPLES OF RECOMMENDED ACTIONS
7.5 FMEA EXECUTION ENABLERS
7.6 THE ESSENCE OF EXECUTION
7.7 DOCUMENTING ACTIONS TAKEN
7.8 ENSURING RISK IS REDUCED TO AN ACCEPTABLE LEVEL
7.9 END OF CHAPTER PROBLEMS
Chapter 8: Case Studies
IN THIS CHAPTER
8.1 CASE STUDY: SHOCK ABSORBER ASSEMBLY
8.2 CASE STUDY: STRUDEL PASTRY MANUFACTURING
8.3 CASE STUDY: MOTOROLA SOLUTIONS “PRESS-TO-TALK” FEATURE
8.4 CASE STUDY: FLASHLIGHT
8.5 CASE STUDY: DC-10 CARGO DOOR FAILURE
8.6 CASE STUDY: SPACE SHUTTLE CHALLENGER O-RING FAILURE
8.7 CASE STUDY: PROJECTOR LAMP
8.8 CASE STUDY: ALL-TERRAIN BICYCLE
8.9 CASE STUDY: RESIN LEVER
8.10 CASE STUDY: POWER STEERING
8.11 OTHER CASE STUDIES AND EXAMPLES
8.12 WEB COMPANION TO EFFECTIVE FMEAs
8.13 END OF CHAPTER PROBLEMS
Chapter 9: Lessons Learned for Effective FMEAs
IN THIS CHAPTER
9.1 THE MOST COMMON FMEA MISTAKES: HOW TO AVOID THEM AND AUDIT THEM
9.2 SUMMARY OF FMEA QUALITY OBJECTIVES
9.3 FMEA QUALITY AUDIT PROCEDURE
9.4 END OF CHAPTER PROBLEMS
Chapter 10: How to Facilitate Successful FMEA Projects
IN THIS CHAPTER
10.1 FMEA FACILITATION
10.2 EFFECTIVE MEETINGS
10.3 PRIMARY FMEA FACILITATION SKILLS
10.4 UNLEASHING TEAM CREATIVITY
10.5 FMEA FACILITATION ROLES AND RESPONSIBILITIES
10.6 HOW TO REDUCE FMEA IN-MEETING TIME
10.7 DIFFICULTY GETTING CONSENSUS ON COMPETING IDEAS
10.8 END OF CHAPTER PROBLEMS
Chapter 11: Implementing an Effective Company-Wide FMEA Process
IN THIS CHAPTER
11.1 WHAT IS A COMPANY-WIDE FMEA PROCESS AND WHY IS IT IMPORTANT?
11.2 MANAGEMENT ROLES AND RESPONSIBILITIES
11.3 EFFECTIVE FMEA PROCESS
11.4 LESSONS LEARNED IN IMPLEMENTING A COMPANY-WIDE FMEA PROCESS
11.5 COMPANY CLIMATE FOR SHARING FAILURE INFORMATION
11.6 END OF CHAPTER PROBLEMS
Chapter 12: Failure Mode Effects and Criticality Analysis (FMECA)
IN THIS CHAPTER
12.1 INTRODUCTION TO FMECA
12.2 WHEN TO USE FMECA
12.3 BRIEF HISTORY OF FMECA
12.4 TYPES OF FMECA
12.5 QUANTITATIVE CRITICALITY ANALYSIS
12.6 QUALITATIVE CRITICALITY ANALYSIS
12.7 FMECA CRITICALITY MATRIX
12.8 FMECA WORKSHEET
12.9 SUMMARY OUTPUT OF FMECA
12.10 END OF CHAPTER PROBLEMS
Chapter 13: Introduction to Design Review Based on Failure Mode (DRBFM)
IN THIS CHAPTER
13.1 WHAT IS DRBFM?
13.2 CHANGE POINT ANALYSIS
13.3 CONDUCTING DRBFM PROJECTS
13.4 HOW DRBFM INTEGRATES WITH FMEA
13.5 DRBFM WORKSHEET
13.6 DRBFM EXAMPLES AND CASE STUDIES
13.7 DESIGN REVIEW BASED ON TEST RESULTS
13.8 DRBFM GLOSSARY
13.9 DRBFM RESOURCES FOR FURTHER STUDY
13.10 END OF CHAPTER PROBLEMS
Chapter 14: Introduction to Fault Tree Analysis (FTA)
IN THIS CHAPTER
14.1 WHAT IS FAULT TREE ANALYSIS?
14.2 FTA AND FMEA
14.3 BRIEF HISTORY OF FTA
14.4 MODELS
14.5 EVENTS AND GATES
14.6 FTA EXAMPLE
14.7 FTA GLOSSARY
14.8 FTA PROCEDURE
14.9 FTA HANDBOOKS AND STANDARDS
14.10 USE OF FTA ON SOFTWARE
14.11 FTA BENEFITS AND LIMITATIONS
14.12 END OF CHAPTER PROBLEMS
Chapter 15: Other FMEA Applications
IN THIS CHAPTER
15.1 RELIABILITY-CENTERED MAINTENANCE
15.2 HAZARD ANALYSIS
15.3 CONCEPT FMEA
15.4 SOFTWARE FMEA
15.5 FAILURE MODES, MECHANISMS, AND EFFECTS ANALYSIS
15.6 FAILURE MODES, EFFECTS, AND DIAGNOSTIC ANALYSIS
15.7 END OF CHAPTER PROBLEMS
Chapter 16: Selecting the Right FMEA Software
IN THIS CHAPTER
16.1 CHARACTERISTICS OF EXCELLENT FMEA SOFTWARE
16.2 WHY NOT JUST USE SPREADSHEET SOFTWARE?
16.3 ADVANTAGES OF RELATIONAL DATABASE
16.4 USING THE CRITERIA FOR SELECTING RELATIONAL DATABASE SOFTWARE
16.5 END OF CHAPTER PROBLEMS
Appendices
APPENDIX A: FMEA SCALES
APPENDIX B: FMEA WORKSHEET FORMS
APPENDIX C: ALL-TERRAIN BICYCLE DOCUMENTS
APPENDIX D: LISTS AND CHECKLISTS
APPENDIX E: FMEA GLOSSARY
Index
Wiley Series in Quality & Reliability Engineering and Related Titles
Copyright © 2012 by John Wiley & Sons, Inc. All rights reserved
Published by John Wiley & Sons, Inc., Hoboken, New Jersey
Published simultaneously in Canada
No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form or by any means, electronic, mechanical, photocopying, recording, scanning, or otherwise, except as permitted under Section 107 or 108 of the 1976 United States Copyright Act, without either the prior written permission of the Publisher, or authorization through payment of the appropriate per-copy fee to the Copyright Clearance Center, Inc., 222 Rosewood Drive, Danvers, MA 01923, (978) 750-8400, fax (978) 750-4470, or on the web at www.copyright.com. Requests to the Publisher for permission should be addressed to the Permissions Department, John Wiley & Sons, Inc., 111 River Street, Hoboken, NJ 07030, (201) 748-6011, fax (201) 748-6008, or online at http://www.wiley.com/go/permissions.
Limit of Liability/Disclaimer of Warranty: While the publisher and author have used their best efforts in preparing this book, they make no representations or warranties with respect to the accuracy or completeness of the contents of this book and specifically disclaim any implied warranties of merchantability or fitness for a particular purpose. No warranty may be created or extended by sales representatives or written sales materials. The advice and strategies contained herein may not be suitable for your situation. You should consult with a professional where appropriate. Neither the publisher nor author shall be liable for any loss of profit or any other commercial damages, including but not limited to special, incidental, consequential, or other damages.
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Library of Congress Cataloging-in-Publication Data
Carlson, Carl (Carl Seymour)
Effective FMEAs : achieving safe, reliable, and economical products and processes using failure mode and effects analysis / by Carl Carlson.
p. cm. – (Quality and reliability engineering series ; 1)
Includes bibliographical references.
ISBN 978-1-118-00743-3 (hardback)
1. Failure mode and effects analysis. 2. Manufacturing processes–Quality control. 3. Quality of products. I. Title.
TA169.5.C37 2012
658.5'62–dc23
2012010946
In memory of my parents, for their unwavering support and guidance, which continues to inspire my life.
Series Editor’s Foreword
by Dr. Andre Kleyner
Editor of the Wiley Series in Quality & Reliability Engineering
The importance of quality and reliability to a system can hardly be disputed. Product failures in the field inevitably lead to losses in the form of repair cost, warranty claims, customer dissatisfaction, product recalls, loss of sale, and, in extreme cases, loss of life. Thus quality and reliability plays a critical role in the modern science and engineering and as such sees various opportunities and faces a number of challenges.
As quality and reliability science evolves, it reflects the trends and transformations of the technologies it supports. A device utilizing a new technology, whether it be a solar power panel, a stealth aircraft, or a state-of-the-art medical device, needs to function properly and without failure throughout its mission life. New technologies bring about new failure mechanisms (chemical, electrical, physical, mechanical, structural, etc.), new failure sites, and new failure modes. Therefore, continuous advancement of the physics of failure combined with a multidisciplinary approach is essential to our ability to address those challenges in the future.
In addition to the transformations associated with changes in technology, the field of quality and reliability engineering has been going through its own evolution, developing new techniques and methodologies aimed at process improvement and reduction of the number of design- and manufacturing-related failures.
The concepts of Design for Reliability (DfR) have been gaining popularity in recent years, and their development is expected to continue for years to come. DfR methods shift the focus from reliability demonstration and the outdated “Test–Analyze–Fix” philosophy to designing reliability into products and processes using the best available science-based methods. The important part of the DfR process is Failure Mode and Effects Analysis (FMEA).
FMEA helps to transform past design experience into the ability to foresee future problems and to avoid or mitigate them at the early stages of the design, thus effectively translating the old expression “Forewarned is forearmed” into a powerful engineering practice. Properly done, FMEA can anticipate and prevent problems, reduce costs, shorten product development times, and achieve safe and highly reliable products and processes.
The book you are about to read presents the foundation and a step-by-step procedure for an efficient and cost-effective FMEA. It offers an excellent mix of theory, practice, applications, and common-sense engineering. This book also demonstrates the extensions of FMEA concepts, such as Failure Mode, Effects, and Criticality Analysis (FMECA), Fault Tree Analysis (FTA), Design Review Based on Failure Modes (DRBFM), and their applications to various engineering fields.
As a process, DfR often transforms the role of the reliability engineer from being primarily focused on product test and analysis to being a mentor to the design team, who is responsible for finding and applying the best design methods to achieve reliability. Properly applied DfR process along with FMEA ensures that pursuit of reliability is an enterprise-wide activity.
Several other emerging and continuing trends in quality and reliability engineering are also worth mentioning here. For an increasing number of applications, risk assessment will enhance reliability analysis, addressing not only the probability of failure, but also the quantitative consequences of that failure. Life-cycle engineering concepts are expected to find wider applications to reduce life-cycle risks and minimize the combined cost of design, manufacturing, quality, warranty, and service.
Additionally, continuous globalization and outsourcing affect most industries and complicate the work of quality and reliability professionals. Having various engineering functions distributed around the globe adds a layer of complexity to design coordination and logistics. Also moving design and production into regions with little knowledge depth regarding design and manufacturing processes, with a less robust quality system in place, and where low cost is often the primary driver of product development, affects a company’s ability to produce reliable and defect-free parts.
Despite its obvious importance, quality and reliability education is paradoxically missing in today’s engineering curriculum. Few engineering schools offer degree programs or even a sufficient variety of courses in quality or reliability methods. Therefore, a majority of the quality and reliability practitioners receive their professional training from colleagues, professional seminars, publications, and technical books. The lack of formal education opportunities in this field greatly emphasizes the importance of technical publications for professional development.
The main objective of the Wiley Series in Quality & Reliability Engineering is to provide a solid educational foundation for both practitioners and researchers in quality and reliability and to expand the reader’s knowledge base to include the latest developments in this field. This series continues Wiley’s tradition of excellence in technical publishing and provides a lasting and positive contribution to the teaching and practice of engineering.
Copyrights and Permissions
There are many excerpts in the book that come from published papers, journals or books. These are each cited adjacent to the textual material, and the numbered reference is placed in the Reference section at the end of each chapter. In addition to the above manner of referencing, the following sources are acknowledged for allowing excerpts to be used in the book.
Page 85, from Quality Planning and Analysis, 3rd Edition, by J.M. Juran. Copyright © The McGraw-Hill Companies, Inc. McGraw-Hill makes no representation or warranties as to the accuracy of any information contained in the McGraw-Hill Material, including any warranties of merchantability or fitness for a particular purpose. In no event shall McGraw-Hill have any liability to any party for special, incidental, tort, or consequential damages arising out of or in connection with the McGraw-Hill Material, even if McGraw-Hill has been advised of the possibility of such damages.
Pages 190–193, from “A conjoint study of quantitative and semi-quantitative assessment of failure in a strudel manufacturing plant by means of FMEA and HACCP, Cause and Effect and Pareto diagram.” International Journal of Food Science and Technology. Reprinted with permission of John Wiley & Sons, Inc.
Pages 193 and 195–199 present a case study of the press-to-talk feature of a mobile 2-way radio developed by Motorola Solutions. MOTOROLA, MOTO, MOTOROLA SOLUTIONS and the Stylized M Logo are trademarks or registered trademarks of Motorola Trademark Holdings, LLC and are used under license. All other trademarks are the property of their respective owners. © 2011 Motorola Solutions, Inc. All rights reserved.
Pages 200–201 and 203–205 from Inviting Disaster: Lessons from the Edge of Technology. Brief quotes from pp. 74, 87, 88, 123, 125 (522 words in total) from Inviting Disaster: Lessons from the Edge of Technology by James R. Chiles, copyright © 2001 by James R. Chiles, reprinted by permission of HarperCollins Publishers.
Pages 242–244 and 246–248, from Facilitating with Ease!, by Ingrid Bens. Copyright © 2000 Jossey-Bass Inc. Reprinted with permission of John Wiley & Sons, Inc.
Page 252, from Your Creative Brain: Seven Steps to Maximize Imagination, Productivity, and Innovation in Your Life, by Shelley Carson. Copyright © 2010 by Harvard University. Reprinted with permission of John Wiley & Sons, Inc.
Page 287, from SAE ARP5580: Recommended Failure Mode and Effects Analysis (FMEA) Practices for Non-Automotive Applications. Reprinted with permission from SAE, © 2001 SAE International.
Pages 301 and 303, from SAE 2003-01-2887 Reliability Problem Prevention Method for Automotive Components. Reprinted with permission from SAE, © 2003 SAE International.
Pages 317, 318, and 320 from the article Fault Tree Analysis: An Overview of Basic Concepts, part of Weibull.com Reliability Engineering Resources. Copyright © 1992–2012 ReliaSoft Corporation. All Rights Reserved.
Page 330, from SAE JA1012: A Guide to the Reliability-Centered Maintenance (RCM) Standard. Reprinted with permission from SAE, © 2002 SAE International.
Pages 350–353, from the proceedings of the annual Reliability and Maintainability Symposium entitled “Software FMEA Techniques,” by Peter L. Goddard. © 2000 IEEE.
Pages 352–353, from SAE 2005-01-0817 “Software FMEA: A Missing Link in Design for Robustness,” by Dev Raheja. Reprinted with permission from SAE, © 2005 SAE International.
Pages 356–358, from the proceedings of the IEEE workshop on Accelerated Testing & Reliability “Identification and Utilization of Failure Mechanisms to Enhance FMEA and FMECA,” by Michael G. Pecht, et al. © 2005 IEEE.
Page 356, from Transactions of the Institute of Measurement and Control entitled “Physics-of-Failure-Based Prognostics for Electronic Products,” by Michael G. Pecht and Jie Gu. Reprinted by permission of SAGE.
Pages 396–399, from Failure of Materials in Mechanical Design: Analysis, Prediction, Prevention, by Jack A. Collins. Reprinted with permission of John Wiley & Sons, Inc.
Acknowledgments
Many colleagues and friends have offered advice, counsel, and support during this book-writing odyssey. It has been a broad team effort and for this support, I am very appreciative.
I am deeply indebted to my wife Holly. She consistently encouraged me to stay true to my experiences and reach as many students and practitioners as possible with the topics of the book. She sat through my Failure Mode and Effects Analysis (FMEA) class in order to be able to review and edit the content with a high degree of reality. Her relentless adherence to proper grammar and simplicity of communication enhanced the quality of the book immeasurably. Moreover, her feedback on each chapter helped to ensure the book offers the best possible gradients of learning for new and experienced readers.
I am grateful for my colleagues who provided support in my search for the very best publisher, including Dr. John Bowles, Rajesh Karki, John McKenzie, Joe Michalek, Patrick O’Connor, Dev Raheja, and George Sarakakis.
I wish to thank the many friends and colleagues who reviewed portions of the book and provided candid and meaningful feedback to improve the content, including Dustin Carlson, Thanasis Gerokostopoulos, Jennifer Hiebel, Joe Michalek, and Dev Raheja.
My colleagues and friends at ReliaSoft have been exceedingly supportive and helpful. They have provided a team-based platform for developing innovative reliability and FMEA tools with clients, and for sharing successful applications at symposiums around the world. They have allowed me to use the full resources of ReliaSoft Web sites, course materials, and software for research and inclusion in the book. Most of the FMEAs used in the student exercises were developed with the use of ReliaSoft’s Xfmea software. Many of the fault tree examples were developed with BlockSim software. I am especially grateful to Chris Carpenter, David Groebel, Kyriacos Kyriacou, Thanasis Gerokostopoulos, Lisa Hacker, Doug Ogden, Andreas Periclos, and Pantelis Vassiliou.
ReliaSoft allowed the use of its client database for a survey of industry professional and academic faculty to obtain feedback on priority and depth of book topics that helped ensure the book met industry and academic needs. I am grateful for the support for this survey and for the hundreds of industry professionals and academic faculty who took the time to provide meaningful responses. The book was improved to meet the needs of industry professionals and academic faculty.
Diana Gialo and Simone Taylor, who are my contacts at John Wiley & Sons, have coached me on the process of writing a technical book, and maintained a professional relationship throughout the process. They supported each stage of book development, offered helpful advice, and made available the resources of John Wiley & and Sons for research and material.
Many professional colleagues have provided insights, content, and case studies on FMEA, Design Review Based on Failure Mode (DRBFM), Fault Tree Analysis, Hazard Analysis, Failure Mode Effects and Criticality Analysis (FMECA), Reliability-Centered Maintenance (RCM), Software FMEA, and Failure Mode, Mechanism, and Effects Analysis (FMMEA). For this help, I am grateful to Lisa Allan, Dr. John Bowles, Sornchai Buakaew, James Davis, Clif Ericson, Dr. William Goble, Shri Gupta, Bill Haughey, Brandon Johnson, Joe Michalek, Dr. Michael Pecht, and Dev Raheja.
I am indebted to many FMEA subject-matter experts who have pioneered innovative ways to display and teach FMEA. For example, Michael Schubert, Rhonda Brender, David Mann, and Patrick Schreiner worked together as a collaborative team to creatively develop, display, and link Process Flow Diagrams, Process FMEAs, and Process Control Plans. Bill Haughey added to these innovations in a positive way. The idea for using a familiar item like a bicycle came from them. I benefited from knowing and working with these colleagues. I am grateful for their contributions.
I wish to acknowledge the many people who graciously granted permission for me to use material from their books, articles, Web sites, journals, and other publications. In addition, I received help from many employees who work for professional societies and publications in my quest for permissions. I wish to especially thank Jeanette Brooks (Inderscience Enterprises Limited), Terri Kelly (Society of Automotive Engineers [SAE] International), Jacqueline Hansson (Institute of Electrical and Electronics Engineers, IEEE), and Lora Price (Automotive Industry Action Group, AIAG) for their kind support.
The journey on my personal path of professional development has included interaction with countless people who provided insight and knowledge. My knowledge of the subject matter of this book has benefited from every conversation, meeting, committee, and project while working at General Motors, while supporting ReliaSoft Corporation as a consultant and trainer with clients all over the world, and with colleagues from Reliability and Maintainability Symposium, Applied Reliability Symposium, the SAE, and the American Society of Quality.
Finally, my parents taught me the values of education, perseverance, diligence, humility, respect for a diversity of ideas, and that no one person has all the answers to any subject. Those values have been an immense help in writing this book, for which I am exceedingly grateful.
C. S. C.
Introduction
Anything that can possibly go wrong, does.
—Ancient mountaineering adage
Some call it the fourth law of thermodynamics. Some call it an ancient mountaineering adage. The most common ascription is Murphy’s Law: “If anything can go wrong, it will.” Whatever the source, it pays to anticipate problems and solve them before they entangle customers, or worse, become catastrophic.
Across the globe, development times are becoming shorter, cost concerns more acute, and customers are demanding and expecting absolute safety and high reliability. Companies need to rethink how they achieve these objectives. While it may have been sufficient in the past to focus on testing and analysis as the primary methods of ensuring high reliability, this is no longer sufficient because test-and-fix can take too long and is too costly. It is essential to ensure high design quality and reliability during the early development stages in order to shorten development times and stay within budgets. To do this, it is necessary to focus first on problem prevention, rather than merely problem solving, anticipating the factors that can lead to failure and ensuring designs are robust. Failure Mode and Effects Analysis (FMEA) can anticipate and prevent problems and help companies achieve high reliability in products and processes within considerably shorter development times, and within budget.
During my 30-year career in reliability engineering and management, I have had the pleasure of working with thousands of engineers and managers and hundreds of companies. I have never met a single person who does not want to contribute to a successful team effort to develop trouble-free products or processes. Whether part of a design team, manufacturing, management, or a support activity, we all want to see our efforts make a difference in the quality and reliability of the products or services we support. There is a natural passion and energy of employees to achieve trouble-free products. Failure Mode and Effects Analysis is a key tool for accomplishing this objective.
The plain truth is FMEA has the potential to be a very powerful tool to achieve high reliability in products and processes, and when done well, it is remarkably effective. Yet in practice, FMEA does not always achieve the expected results, and can lose effectiveness.
While working in the fields of aerospace, vehicle engineering, and reliability consulting, I have supervised or performed over 2,000 FMEAs. During this time, I have seen just about every possible way to do FMEAs incorrectly, and discovered simple strategies to learn from these mistakes and turn them into quality objectives. The purpose of this book is to share these best practices for doing FMEAs effectively.
One of the objectives of the book is to teach by example. Many case studies are discussed and examined, including industry-specific applications, two well-known catastrophes (the space shuttle Challenger and the McDonnell Douglas DC-10 cargo door blowout), and an FMEA case study on an all-terrain bicycle. Other case studies and stories about FMEA application are interspersed throughout the book. At the end of each chapter is a set of problems that can be useful in learning the fundamentals of FMEA and how FMEA can be applied to many different activities and industries.
To get good results from FMEAs, it is necessary to learn and apply the correct procedures. To get uniformly outstanding results with each and every FMEA, it is essential to learn and apply a set of simple strategies. This book teaches these strategies.
FMEA has been around for many decades and has a long history as a method to support product designs, manufacturing processes, service, and maintenance. There is a wide range of applications and types of FMEAs. This book is for anyone who wants to learn about FMEAs and how to do them effectively and efficiently regardless of job discipline or prior FMEA experience.
Whether you are involved in product designs, manufacturing, service, maintenance, management, quality, or any other discipline that supports product development and operations, FMEA can be a valuable tool to dramatically increase reliability and ensure safety of equipment, personnel, processes, or services. What is important is to learn from mistakes, follow the simple strategies covered in this book, and do the procedure correctly.
MY PERSONAL PHILOSOPHY REGARDING FMEAs
Through the synergy engendered by the right team of experts, and by implementing correct and proven methods and procedures, problems can be anticipated and prevented, resulting in safe and trouble-free products and processes, with the inherent risk in any system or process reduced to a very low level.
END OF CHAPTER PROBLEMS
Beginning with Chapter 2, there is a Problems section at the end of the each chapter to support the learning process of the chapter content. The Problems range from relatively easy to more challenging, including evaluation of actual FMEA case studies. The solutions to the Problems can be found in the Solutions Manual, which will be available to instructors and industry professionals, at no additional charge. The ordering information can be found at the following web site: http://www.wiley.com/go/effectivefmeas.
This web site will also have additional resources, as they become available, including more examples of FMEA definitions, case studies, related FMEA material, illustrations, and useful links.
MY PLEDGE TO READERS
Humility, that low, sweet root, from which all heavenly virtues shoot.
—Thomas More
FMEA is a broad subject, with a wide variety of standards, procedures, and applications. There is no shortage of opinions and ideas from practitioners, both new and experienced. It is impossible to fully satisfy everyone, from every level of experience and every industry and application. However, I encourage feedback, and I will carefully listen to all comments, concerns, criticisms, and suggestions. I will stay engaged and find ways to share comments, suggestions, and knowledge about the subject of FMEA with students, readers, and industry practitioners. In the words of a great teacher, “learning is not a spectator sport.” No one person has all of the answers, and by sharing our experience and knowledge, we can learn from each other.
I sincerely wish you the best in your quest to support safe and trouble-free products and processes.
CARL S. CARLSON
Chapter 1
The Case for Failure Mode and Effects Analysis
I haven’t failed; I’ve found ten thousand ways that don’t work.
—Thomas Edison
IN THIS CHAPTER
Companies and industries across the globe are cutting costs and shortening development times. Yet high reliability and impeccable safety are essential to customer satisfaction and financial viability. This chapter introduces Failure Mode and Effects Analysis (FMEA), highlights FMEA successes, and illustrates how FMEA improves reliability and safety while reducing warranty costs in a variety of industries. This chapter makes the case for FMEA.
1.1 THE NEED FOR EFFECTIVE FMEAs
One only has to look at past news headlines to see the huge cost of product failures for businesses.
Headline in CNET News:
Microsoft to Extend Xbox 360 Warranty, Take $1 Billion HitMicrosoft said … it will take a $1 billion charge as it extends the warranty on the Xbox 360, after an investigation showed the game console can be prone to hardware failures.[1]
U.S. Consumer Product Safety Commission:
PC Notebook Computer Batteries Recalled Due to Fire and Burn HazardName of Product: Lithium-Ion Batteries used in Hewlett-Packard, Toshiba and Dell Notebook Computers. Hazard: These lithium-ion batteries can overheat, posing a fire and burn hazard to consumers.[2]
Headline in CNN Money:
Firestone Tires RecalledBridgestone Corp. … recalled 6.5 million of its Firestone-brand tires—the second largest tire recall in U.S. history—in response to complaints the tires may be linked to fatal crashes involving sport utility vehicles.[3]
U.S. Consumer Product Safety Commission:
Yamaha Recalls Snowmobiles Due to Loss of Steering ControlName of Product: 2009 Model Year FX10 Snowmobiles. Hazard: A bolt in the right front A arm can loosen in the suspension/steering system, resulting in the sudden loss of steering control. This poses a risk of injury or death to riders.[4]
Product recalls, in-service warranty problems, and safety issues can ruin the reputation of companies and put them out of business, in addition to the potential harm or loss to consumers. At minimum, they place a huge financial burden on the bottom line. Can FMEA prevent product failures such as these? The answer is “Yes.” FMEAs, when properly performed on the correct parts with the correct procedure during the correct time frame with the correct team, can prevent costly failures before products enter the marketplace. It is far less costly to prevent problems through the proper use of FMEA than to pay for expensive field problems or expensive litigation, and suffer from loss of reputation. Once lost, reputation is very difficult to earn back.
Today, companies face unprecedented worldwide competition through three ever-present challenges: the mandate to reduce costs, faster development times, and high customer expectations for the reliability of products and processes. One of the most powerful tools to meet all three of these challenges is FMEA. Properly done, FMEA will reduce costs by making products more reliable, thus lowering warranty costs and the costs associated with product failures. FMEA will shorten product development times by addressing problems early in the process thus reducing the costly, and time-consuming, test-and-fix treadmill. FMEA will help companies meet customer high expectations for reliability by eliminating or mitigating failures before users or consumers discover them.
Companies already using FMEAs know their value and understand the necessity of doing them. The question is, are the FMEAs being done correctly, with the highest possible quality, and are the powerful results of which they are capable being achieved? Are product designs and manufacturing processes uniformly improving through use of FMEAs? Is field warranty going down? Is rock solid safety being achieved? In business terms, what is the return on investment? This book will enhance the effectiveness of FMEAs where currently in use, and reinforce correct application.
Companies not yet doing FMEAs or that are having questionable results from FMEA programs should take a hard look at the cost of quality and reliability failures. Both should seriously consider implementing effective FMEAs as part of their product development process or quality improvement systems. Those having questionable results need to modify their approach and conduct their FMEAs more effectively, which this book is meant to facilitate.
Most corporate and military applications require some form of FMEA, yet questions persist about the overall effectiveness of FMEA as applied in many companies and organizations today. Today, with good reason, results in FMEA applications are mixed. Few reliability tools elicit stronger responses from quality and reliability professionals than FMEA. As for reactions to FMEA around the virtual water cooler, one may hear comments like “waste of time,” “lack of support,” and “don’t want anything to do with it,” at one end, to “powerful tool,” “effective way to prevent problems,” and “needs to be done across the board,” at the other end. So why is there so much variation in the application of a tool that has been around for many decades? How can results be achieved more uniformly and successfully?
The purpose of this book is to teach clearly and simply the entire subject of FMEAs, including the best practice procedures for doing FMEA projects, the pitfalls, the lessons learned to make FMEAs more effective, and how to implement an effective FMEA process in any company or industry.
Take the analysis Figure 1.1, which shows the cost of warranty servicing at Hewlett-Packard from 2003 to 2010. The chart is based on actual warranty expenses, which is lost revenue and demonstrates one of the costs of product failures and customer dissatisfaction. As can be seen from the chart, billions of dollars per year were spent servicing warranty claims, averaging over 3% of total sales.[5]
FIGURE 1.1 Hewlett-Packard warranty claims and accruals 2003–2010.
(Source: Warranty Week from SEC data.)
Figure 1.2 shows the warranty costs at the top 20 U.S.-based companies.[6]
FIGURE 1.2 Top 20 U.S.-based warranty providers: 2010 annual warranty costs and accrual rates (in $ millions and as a percent of sales).
(Source: Warranty Week from SEC data.)
It is easily seen that many companies are spending huge amounts of money servicing warranty claims, money that could be much better spent designing higher quality products that result in higher customer satisfaction. FMEA used properly is a highly effective tool for accomplishing this objective. The potential cost savings is enormous.
Well-done FMEAs improve reliability, ensure safety, and reduce risk to organizations. They are an essential part of doing business.
1.2 FMEA APPLICATION BY INDUSTRY
FMEA is a vital task supporting reliability programs in nearly every industry worldwide. Based on a survey of approximately 500 reliability professionals across the globe, FMEA is the most important task in their reliability programs.[7]
The American Society of Quality (ASQ) certifies Six Sigma Black Belt candidates. One of the primary topics in ASQ’s published Six Sigma Certification Body of Knowledge is FMEA.[8]
The automotive industry uses the International Organization for Standardization Technical Specification (ISO/TS 16949:2009) as the quality standard for its suppliers. This standard specifies the precise quality system requirements for suppliers in the automotive sector. FMEA plays a central role in the implementation of this standard.[9]
Advanced Product Quality Planning (APQP) is a framework of procedures and techniques used to develop products in industry, particularly the automotive industry. According to the Automotive Industry Action Group (AIAG), the purpose of APQP is “to produce a product quality plan which will support development of a product or service that will satisfy the customer.” FMEA is a key requirement of APQP.[10]
The Joint Commission Resources (JCR) is a not-for-profit affiliate of the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) and has as its mission “to continuously improve the safety and quality of care in the United States and in the international community through the provision of education and consultation services and international services.” The Joint Commission and JCR were named as the first World Health Organization Collaborating Centre for Patient Safety Solutions. In the JCR publication titled Failure Mode and Effects Analysis in Health Care: Proactive Risk Reduction, it says “FMEA can improve the safety for individuals receiving care by helping to identify failures and near misses and by protecting individuals from harm when, despite an organizations best efforts, failures do occur.” The publication goes on to say, “It can narrow or eliminate gaps in quality and performance and yield improved outcomes. It is easy to learn and enhances organization-wide collaboration and understanding. Simply stated, its use is good business practice.”[11]
A type of FMEA called Hazard Analysis plays a central role in the risk assessment approach required in ISO 14971:2007 for medical devices.[12]
Reliability-Centered Maintenance (RCM) is the analytical process used by most companies to determine preventive maintenance (PM) requirements and ensure safe and cost-effective operations of any system. The core of an RCM project is an FMEA on selected manufacturing or operational equipment.
All branches of the military require FMEAs for joint programs and supplied parts. The type of FMEA often required by the military is Failure Mode Effects and Criticality Analysis (FMECA), which is covered in Chapter 12 of this book.[13, 14]
Regardless of what industry one is involved in—aerospace, medical, appliances, electronics, automotive, chemical, energy, services, information, and so on—FMEA is a key tool that supports high reliability, ensures safety, and achieves customer satisfaction.
1.3 THE FACTOR OF 10 RULE
Figure 1.3 describes the increasing costs of finding and fixing problems depending on when the problems are discovered. The later problems are found in the product development process, the more it costs to fix them, symbolized by factors of 10.[15]
FIGURE 1.3 Factor of 10 rule.
What can be learned from the “Factor of 10 Rule” about how FMEA supports product improvement?
FMEAs can assess which designs are best from a feasibility standpoint.
FMEAs can ensure designs are safe, robust, and have inherently high reliability.
FMEAs can support streamlined development of products and anticipate problems before being discovered in testing.
FMEAs can improve the effectiveness of testing to ensure no problems are conveyed to the customer.
FMEAs can ensure the manufacturing process is stable and in control.
FMEAs can ensure operation of equipment is safe and cost-effective.
If a company budget cannot support reliability improvement during product development, how can the company expect to budget for the costs of warranty, recalls, and other expensive corrective actions?
In practice, there are a number of sound business reasons to implement an effective FMEA process. A well-done FMEA is a proven tool to reduce life cycle warranty costs. Well-done FMEAs will reduce the number of “oops” during product development. It is far less expensive to prevent problems early in product development than to fix problems after launch. FMEAs can identify and address safety issues before a potential catastrophe.
Figure 1.4 illustrates how FMEA shifts problem discovery to much earlier in the Product Development Process timeline.
FIGURE 1.4 FMEA shifts problem discovery earlier in the product development process.
1.4 FMEA SUCCESSES
Many companies have had great benefits from the use of FMEAs. The following are brief synopses of five company successes, minus specific details in order to protect confidentiality. Chapter 8 gives detailed case studies and other case studies are interspersed throughout the book.
FMEA Case Study 1
Cooling systems are an important part of vehicles and residential and commercial buildings. In this example, an FMEA was done on the cooling system of a complex vehicle system. The FMEA team discovered 24 safety-related failure modes with the potential for high frequency in service. If these failure modes were not properly addressed, they could have been dangerous to the customer and catastrophic to the company. All of the safety-related failure modes were addressed with actions recommended by the FMEA team. One example of a failure mode discovered by this FMEA team was a radiator leak caused by corrosion, which was almost certain to occur. The cause of the problem was resolved when the FMEA team recommended changing the design of the radiator using a new corrosion-resistant material.
FMEA Case Study 2
An exercise company was developing a new product with considerable innovation and new technology. The company wanted to ensure their equipment was both safe and reliable. In this example, a System FMEA was conducted on the new exercise equipment. The FMEA team discovered nine failure modes with potential to cause injury to the user. All of these potential failure modes were addressed with specific corrective actions. One of the failure modes had the potential to cause injury to the user due to improper stride length limits. This was resolved by redesigning the stride length feature, making it safe for all users.
FMEA Case Study 3
A company performed a System FMEA on new equipment that uses food products. Particular attention was paid to ensure there were no safety problems due to contamination. The FMEA team uncovered 20 failure modes with potential for bacterial harm to customers. All of them were addressed with adequate action plans. An example was a potential failure mode of a valve leaking due to high pressure in the system. A valve redesign resolved the problem.
FMEA Case Study 4
A company that makes small electronic devices was developing a new product that utilized a tiny speaker. A Design FMEA was done on the speaker subsystem. In this example, seven failure modes were discovered that could potentially result in complete loss of performance, and the FMEA team believed they were very likely to occur. All of these potential failure modes were addressed with specific actions. One example was a diaphragm that was too stiff due to a narrow racetrack. The racetrack was redesigned with better stiffness parameters, resolving this problem.
FMEA Case Study 5
A Process FMEA was done on a vehicle door hanging operation, where the door assembly is bolted onto the vehicle in the assembly plant. At the time of this FMEA, door fit was not possible within specifications without using an unusual and expensive adjustment procedure. The FMEA team raised this issue to management for review and correction, resulting in a new robust door opening design that no longer required the expensive in-plant adjustment.
In the first four of these case studies, actions were taken to eliminate or mitigate the failures before testing was begun, ensuring the products were safe and reliable, and generating considerable cost savings. When FMEAs are done this way, testing can be done with the objective of confirmation rather than initial discovery. In the fifth case study, an expensive plant operation was eliminated.
1.5 BRIEF HISTORY OF FMEA
FMEA was formalized in 1949 by the U.S. Armed Forces by the introduction of Military Procedures document (MIL-P)-1629, “Procedures for Performing a Failure Mode Effect and Criticality Analysis.” The objective was to classify failures “according to their impact on mission success and personnel/equipment safety.”[16] It was later adopted in the Apollo space program to mitigate risk due to small sample sizes. The use of FMEA gained momentum during the 1960s, with the push to put a man on the moon and return him safely to earth. In the late 1970s, the Ford Motor Company introduced FMEA to the automotive industry for safety and regulatory consideration after the Pinto affair. They also used it to improve production and design. “In the 1980s, the automotive industry began implementing FMEA by standardizing the structure and methods through the Automotive Industry Action Group. Although developed by the military, the FMEA method is now extensively used in a variety of industries including semiconductor processing, foodservice, plastics, software, automotive, and healthcare to name a few.”[17]
1.6 FMEA STANDARDS AND GUIDELINES
There are many standards and guidelines published that cover the scope and general procedure for doing FMEAs or FMECAs.* Some of the more common and relevant guidelines are:
Society of Automotive Engineers (SAE) J1739,
Potential Failure Mode and Effects Analysis in Design (Design FMEA), Potential Failure Mode and Effects Analysis in Manufacturing and Assembly Processes (Process FMEA)
[2009]
AIAG,
Potential
Failure Mode and Effects Analysis
(
FMEA
) Reference Manual Fourth Edition
[2008]
Military Standard (MIL-STD)-1629A,
Procedures for Performing a Failure Mode Effects and Criticality Analysis
(cited for cancellation in 1994, but still used in some military and other applications)
SAE ARP5580,
Recommended Failure Modes and Effects Analysis (FMEA) Practices for Non-Automobile Applications
[2001]
International Electrotechnical Commission (IEC) 60812,
Analysis techniques for system reliability—Procedure for failure mode and effects analysis (FMEA)
[2006]
Many other standards and guidelines promote or mandate the use of FMEA. These will be referenced when relevant to the topics covered in this book.
1.7 HOW TO USE THIS BOOK
Most people will benefit from reading the entire book in sequence, chapter by chapter. However, understanding the limited availability of time in people’s lives, here are a few suggestions to accommodate those whose scope of application is limited.
Chapter numbers and titles are recapped here for ease in reviewing the section below.
Students who are using the book to learn the fundamentals of FMEA as part of a course of study such as engineering should read at least through Chapter 9 and further, depending on the individual course of study and its unique objectives. The student should perform the end of chapter problems.
In academia, teachers who would like to integrate FMEA into engineering or other curricula should utilize the material in the book at least through Chapter 9. Instructors may want to add other applications, such as FMEA facilitation, RCM, DRBFM, and so on, as per individual course of study needs. However, it is important to ensure the student understands the basics and applications of FMEA up through Chapter 9, as the unique application chapters build on the foundation established in those chapters.
Industry professionals and practitioners who wish to learn how to perform FMEAs, if new to the subject, or want to improve their results if already experienced with the subject matter, should read at least through Chapter 10. End of chapter problems are optional. Later chapters cover unique applications such as FMECA, FTA, DRBFM, RCM, Hazard Analysis, and so on, and build on the knowledge base of the earlier chapters up through Chapter 10. Therefore, it is important to understand the material from the first 10 chapters, regardless of one’s focus on a unique application.
The application of FMEAs to product designs is usually called System or Design FMEAs. The application of FMEAs to manufacturing or assembly processes is called Process FMEAs. These applications share many of the same definitions, concepts, and procedures. Therefore, material relating to both System/Design FMEAs and Process FMEA applications is integrated into each of the chapters in the book. However, wherever there are unique definitions, concepts, or procedures between System/Design FMEAs and Process FMEAs, these are clearly identified.
Managers or executives who will be involved in implementing FMEA processes should read Chapters 2, 4, 9, 10, and 11. Chapters 3 and 5 through 8 are optional, depending on how deeply the manager wishes to learn the fundamentals of FMEA. It is the author’s opinion, based on managing engineering and reliability groups for many years, that managers are well served to understand the fundamentals of FMEA as part of implementing a successful FMEA process. However, as mentioned in the beginning of this section, time is limited, and the above chapters are the minimum required for good understanding and application.
1.8 WEB COMPANION TO EFFECTIVE FMEAs
There is a companion web site to this book. Students and practitioners are encouraged to visit http://www.wiley.com/go/effectivefmeas. Additional resources will be posted on this web site as they become available, including more examples of FMEA definitions, case studies, related FMEA material, illustrations, and useful links.
1.9 END OF CHAPTER PROBLEMS
Beginning with Chapter 2, end of chapter problems are included to support FMEA application knowledge.
Note
* Throughout this book, there will be many references to the acronyms FMEA and FMECA. The grammatical convention used will be to refer to an FMEA, and a FMECA. The reason for this is most practitioners say “ef-em-ee-ae” when referring to FMEA; however, most practitioners say “fah-mee-kah” when referring to FMECA. Therefore, the convention will be to refer to an FMEA and a FMECA.
REFERENCES
1. Fried, Ina. Microsoft to Extend Xbox 360 Warranty, Take 1$ Billion Hit [Online] 2007. Available at http://news.cnet.com/Microsoft-to-extend-Xbox-360-warranty%2C-take-1-billion-hit/2100-1014_3-6195058.html?tag=contentMain;contentBody;1n, Article date July 5, 2007 CNET News.
2. PC Notebook Computer Batteries Recalled Due to Fire and Burn Hazard. Available at http://www.cpsc.gov/cpscpub/prerel/prhtml09/09035.html, Bulletin date October 30, 2008; Release #09-035, U.S. Consumer Product Safety Commission.
3. Firestone Tires Recalled. [Online] 2000. Available at http://money.cnn.com/2000/08/09/news/firestone_recall/, Article date August 9, 2000, CNN Money.
4. Yamaha Recalls Snowmobiles Due to Loss of Steering Control. Available at http://www.cpsc.gov/cpscpub/prerel/prhtml10/10719.html, Bulletin date January 27, 2010; Alert #10-719, U.S. Consumer Product Safety Commission.
5. Computer Warranty Claims and Accruals. Product Warranty Series [Online] 2010. Available at http://www.warrantyweek.com/archive/ww20100916.html, Warranty Week, based on SEC data.
6. Warranty Claims & Accruals in Financial Statements. [Online] 2011. Available at http://www.warrantyweek.com/, Warranty Week, based on SEC data.
7. Carlson, Carl, Georgios Sarakakis, David Groebel, and Adamantios Mettas, 2010, Best Practices for Effective Reliability Program Plans, in Reliability and Maintainability Symposium.
8. ASQ. Six Sigma Black Belt Certification Certification [Online] 2011 [cited 2011]. Available at http://asq.org/certification/six-sigma/bok.html.
9. ISO, 2009, ISO/TS 16949 Quality Management Systems—Particular Requirements for the Application of ISO 9001:2008 for Automotive Production and Relevant Service Part Organizations.
10. AIAG, 2008, Advanced Product Quality Planning and Control Plan (APQP), AIAG.
11. JCR, Failure Mode and Effects Analysis in Health Care: Proactive Risk Reduction, 3rd ed. Joint Commission Resources, 2010.
12. ISO, 2007, ISO 14791 Medical devices—Application of Risk Management to Medical Devices.
13. Military, United States, 1980, MIL-STD-1629A: Procedures for Performing A Failure Mode Effects And Criticality Analysis, Department of Defense.
14. SAE, 2001, SAE ARP5580: Recommended Failure Mode and Effects Analysis (FMEA) Practices for Non-Automotive Applications, copyright 2001 SAE International.
15. DFR Fundamentals: An Introduction to Design for Reliability. 2007. ReliaSoft Corporation.RS 560 DFR Fundamentals, Copyright ReliaSoft Corporation.
16. Military, United States, 1949, Mil-P 1629 Procedures for Performing a Failure Mode Effect and Criticality Analysis.
17. Fadlovich, Erik. Performing Failure Mode and Effect Analysis [Online] 2007 [cited 2010]. Available at http://www.embeddedtechmag.com/component/content/article/6134, Embedded Technology.
Chapter 2
The Philosophy and Guiding Principles for Effective FMEAs
In matters of style, swim with the current; in matters of principle, stand like a rock.
—Thomas Jefferson
IN THIS CHAPTER
One of the keys to effective Failure Mode and Effects Analyses (FMEAs) is for the entire FMEA process to be driven by the correct philosophy, meaning that the approach is based on the vital few guiding principles that support achieving high reliability in today’s competitive environment. This chapter lays out the primary focus areas for doing timely FMEAs effectively. The remaining chapters in this book build on these guiding principles.
2.1 WHAT IS PHILOSOPHY AND WHY DOES IT MATTER TO FMEAs?
We are boxed in by the boundary conditions of our thinking.
—Albert Einstein
Philosophy is a theory or attitude that guides one’s behavior. FMEA is a tool that exists in the larger framework of quality and reliability processes. If one’s approach to achieving quality and reliability is sound, then it will properly guide the use of the FMEA tool. Basing one’s approach to FMEAs on wrong principles, such as fixing existing problems rather than anticipating and preventing them, or on incorrect objectives, such as “to fill out a form” or “to comply with a mandate,” will reap unsatisfactory results.
The guiding principles below originate from the overall philosophy of FMEA as communicated in the Introduction to this book. Again:
Through the synergy engendered by the right team of experts, and by implementing correct and proven methods and procedures, problems can be anticipated and prevented resulting in safe and trouble-free products and processes, with the inherent risk in any system or process reduced to a very low level.
2.2 GUIDING PRINCIPLES FOR EFFECTIVE FMEAs
Each of the following is an important guiding principle, applicable to any type of FMEA, which should direct the FMEA process and FMEA practitioners. The remainder of this book embraces these principles.
2.2.1 Having the Right Objectives
If you don’t know where you are going, you will wind up somewhere else.
—Yogi Berra
Focus on Problem Prevention
Preventing problems saves money and improves products. Fixing problems is necessary when they occur, but is substantially more expensive than problem prevention. There is a different mindset in an organization that focuses on problem prevention, and the tools and timing are different. FMEA is a key tool to prevent problems before designs reach testing or processes reach the plant floor, and to improve tests and controls to be sure problems do not reach consumers. The emphasis for this entire book is problem prevention.
Focus on Design and Process Improvements
In order to achieve safe and reliable product and process designs in a timely manner, it is essential for FMEAs to drive design and process improvements as the primary objective. Safe and trouble-free designs and stable, capable, and error-proof manufacturing processes must be the primary goal. FMEAs need to drive action strategies that improve designs and processes. Chapter 7 describes many action strategies that can be employed to improve designs and processes, and reduce risk to a very low level.
Leverage FMEAs to Improve Test Plans and Process Controls
Effective product testing and manufacturing process controls are essential elements of successful product development. Tests and process controls must accurately detect all possible failures and their causes based on the entire range of operating profiles and customers usages. FMEAs can and should improve test plans and process controls. Chapter 6 shows how FMEAs link to design verification and process controls.
Select FMEA Projects Based on Preliminary Risk Assessment
FMEAs take time and cost money. It is not possible to perform FMEAs on every subsystem and component. A company should use the FMEA tool for projects that present a threshold level of risk based on a preliminary risk assessment. Chapter 4, Section 4.2, explains how to select FMEA projects.
Keep It Simple
Some FMEA practitioners complicate FMEAs with extraneous and nonvalue information. Columns can be added to FMEAs that may seem like a good idea, but add time without corresponding value. Risk ranking scales can have too many ranking levels and complex criteria that lack clarity. Each and every worksheet column, scale, preparation task, and procedure step must pass this simple test: does it add sufficient value to justify the time that is expended? One of the overriding principles of effective FMEAs is to keep to the essential elements. This book intends to empower FMEA practitioners with knowledge about all aspects of FMEAs so they can make the right choices at each stage and keep the procedure as simple as possible.
2.2.2 Having the Right Resources
When every physical and mental resource is focused, one’s power to solve a problem multiplies tremendously.
—Norman Vincent Peale
FMEA Is a Team-Based Activity
To be successful, FMEAs need the right team of subject matter experts. Even the best engineers have blind spots and only a team composed of the right disciplines can provide the necessary input and discussion to ensure all concerns are surfaced and addressed. FMEAs should not be performed by one or two individuals, or with the wrong team composition. Chapter 5, Section 5.3.4, provides guidance in establishing the correct FMEA team and ensuring they are properly trained.
Fully Understand the Basics of FMEAs
There is no shortcut to understanding the definitions and concepts of FMEAs. Knowing the basics of FMEAs, such as key definitions and concepts, is essential for learning the proper application of FMEAs to achieve safe, reliable, and economical products and processes. FMEA teams need to be well trained on the fundamentals of FMEA and the correct procedures. Chapter 3 covers all of the key definitions, with many real-world examples.
Provide Skilled FMEA Facilitation and Unleash FMEA Team Creativity
The skill set needed to perform FMEAs is not the same as the skill set needed to facilitate FMEA projects. Good facilitation is crucial for attaining the best results from FMEA teams, shortening FMEA in-meeting time, and maximizing the contributions from subject matter experts. Chapter 10 outlines and explains the unique skills for facilitating successful FMEA projects.
Albert Einstein said, “I am enough of an artist to draw freely upon my imagination. Imagination is more important than knowledge. Knowledge is limited. Imagination encircles the world.” When he said that, he certainly did not mean knowledge is not important. What he meant is that creativity and imagination play significant roles in developing new technology, new products, and new solutions. Many high-risk problems require thinking “outside the box,” and the FMEA team can solve very difficult problems when a skilled facilitator energizes its power of creativity. Chapter 10 covers how to facilitate productive FMEA meetings, unleash creativity, and move the team through the FMEA process to excellent results in a timely manner.
Benefit from Real-World Lessons Learned
FMEA has been around for over 50 years and there have been many important lessons learned. Based on the knowledge from thousands of FMEAs and hundreds of companies, certain mistakes are seen to occur repeatedly. FMEA practitioners should not keep repeating these same mistakes. Chapter 9 reveals the most common FMEA mistakes and tells how to translate them into FMEA quality objectives so that results are uniformly exceptional. This chapter also describes an FMEA audit process based upon the FMEA quality objectives.
Another part of lessons learned is the field problems discovered after an FMEA analysis has been completed. No company has ever introduced products with no field problems or failures. An effective process must be in place to capture the test and field failures missed by FMEAs and provide these as input to future FMEA teams.
Management Plays a Key Role in Establishing and Supporting an Effective FMEA Process
Individual FMEA practitioners can do their very best to perform FMEAs correctly, but there are certain vital activities that are the proper role of management to implement an effective FMEA process. Without these management-supported steps, FMEAs can flounder and miss the mark. These include establishing the strategy, providing the resources, implementing reviews of high-risk issues, supplier management, FMEA quality audits, integrating FMEAs with other businesses process, and providing the right FMEA software. Chapter 11 outlines the best practices of successful companies in achieving uniformly great results with FMEAs and explains some of the common FMEA implementation mistakes and how to avoid them. Chapter 16 shows how to select the right FMEA software that optimizes FMEA team effectiveness.
