Effective FMEAs: Achieving Safe, Reliable, and Economical Products and Processes Using Failure Mode and Effects Analysis

459 Pages·2012·2.72 MB·English

by  Carl S. Carlson(auth.)

Effective FMEAs
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Effective FMEAs
Achieving Safe, Reliable, and Economical
Products and Processes Using
Failure Mode and Effects Analysis
Carl S. Carlson
A John Wiley & Sons, Inc., Publication
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Copyright © 2012 by John Wiley & Sons, Inc. All rights reserved
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Published simultaneously in Canada
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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
Printed in the United States of America
10 9 8 7 6 5 4 3 2 1
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In memory of my parents, for their unwavering support and guidance,
which continues to inspire my life.
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Contents
Series Editor’s Foreword xvii
Copyrights and Permissions xix
Acknowledgments xxi
Introduction xxiii
Chapter 1. The Case for Failure Mode and Effects Analysis 1
In This Chapter / 1
1.1 The Need for Effective FMEAs / 1
1.2 FMEA Application by Industry / 4
1.3 The Factor of 10 Rule / 5
1.4 FMEA Successes / 6
1.5 Brief History of FMEA / 8
1.6 FMEA Standards and Guidelines / 8
1.7 How to Use This Book / 9
1.8 Web Companion to Effective FMEAs / 10
1.9 End of Chapter Problems / 10
References / 11
Chapter 2. The Philosophy and Guiding Principles for Effective FMEAs 12
In This Chapter / 12
2.1 What Is Philosophy and Why Does It Matter to
FMEAs? / 12
vii
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viii CONTENTS
2.2 Guiding Principles for Effective FMEAs / 13
2.2.1 Having the Right Objectives / 13
2.2.2 Having the Right Resources / 14
2.2.3 Having the Right Procedures / 16
2.3 The Role of FMEA in Design for Reliability / 17
2.4 You Can’t Anticipate Everything / 18
2.5 End of Chapter Problems / 19
References / 20
Chapter 3. Understanding the Fundamental Defi nitions and Concepts
of FMEAs 21
In This Chapter / 21
3.1 Defi nition of FMEA / 21
3.2 Primary Objective of FMEA / 22
3.3 Defi nition of Failure Mode Effects and Criticality
Analysis / 22
3.4 Types of FMEAs / 23
3.5 FMEA Defi nitions and Examples / 25
3.5.1 Item / 26
3.5.2 Function / 27
3.5.3 Failure Mode / 28
3.5.3.1 Failure Modes at System/Subsystem
Level versus Component Level / 30
3.5.4 Effect / 32
3.5.5 Severity / 34
3.5.6 Cause / 36
3.5.7 Occurrence / 38
3.5.8 Controls / 38
3.5.9 Detection / 43
3.5.10 Risk Priority Number / 44
3.5.11 Recommended Actions / 45
3.6 Is It a Failure Mode, Effect, or Cause? / 48
3.7 FMEA Glossary / 49
3.8 Web Companion to Effective FMEAs / 51
3.9 End of Chapter Problems / 51
References / 55
Chapter 4. Selection and Timing of FMEA Projects 56
In This Chapter / 56
4.1 Guidelines for When to Do FMEAs / 56
4.2 FMEA Project Selection Criteria / 58
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CONTENTS ix
4.3 Preliminary Risk Assessment / 59
4.4 When to Do Different Types of FMEAs / 60
4.5 Responsibility for FMEAs between OEMs and
Suppliers / 62
4.6 Introducing the All-Terrain Bicycle Case Study / 63
4.7 End of Chapter Problems / 64
Chapter 5. How to Perform an FMEA Project: Preparation 66
In This Chapter / 66
Use of the Bicycle Examples in the Chapter / 66
5.1 The Subject of FMEA Preparation / 67
5.2 Preparation Tasks Done Once for All FMEA
Projects / 67
5.2.1 FMEA Software Selection / 67
5.2.2 Selecting or Modifying FMEA Worksheets
and Scales / 68
5.2.3 Identifying Roles and Responsibilities / 70
5.2.4 FMEA Team Training / 72
5.2.5 Legal Guidelines for Doing FMEAs / 72
5.2.6 Meeting Logistics / 73
5.2.7 Defi ning the System Hierarchy
(For System and Design FMEAs) / 73
5.2.8 Defi ning the Process Steps
(for Process FMEAs) / 75
5.2.9 Access to Failure Information / 76
5.3 Preparation Tasks for Each New FMEA Project / 78
5.3.1 Determine the Scope of the Analysis / 79
5.3.2 Make the Scope Visible
(for System and Design FMEAs) / 82
5.3.2.1 FMEA Block Diagram / 82
5.3.2.2 FMEA Interface Matrix / 84
5.3.2.3 Parameter Diagram (P-Diagram) / 85
5.3.2.4 Functional Block Diagram / 87
5.3.3 Make the Scope Visible
(for Process FMEAs) / 88
5.3.3.1 Process Flow Diagram (PFD) / 88
5.3.3.2 PFD Worksheet / 91
5.3.4 Assemble the Correct Team / 93
5.3.5 Establish the Ground Rules and
Assumptions / 96
5.3.6 Establish the Role of Suppliers / 98
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x CONTENTS
5.3.7 Gather and Review Relevant Information / 98
5.3.7.1 “Gather Information Checklist” (for System
and Design FMEAs) / 100
5.3.7.2 “Gather Information Checklist” (for
Process FMEAs) / 101
5.3.8 Prepare FMEA Software for First Team Meeting / 102
5.3.9 Ready-for-First-Meeting Checklist / 103
5.4 End of Chapter Problems / 103
References / 106
Chapter 6. How to Perform an FMEA Project: Procedure 107
In This Chapter / 107
Use of the Bicycle Examples in the Chapter / 107
6.1 FMEA Procedure Sequence of Steps / 108
6.2 Basic FMEA Procedure / 109
6.2.1 Items / 109
6.2.2 Functions / 111
6.2.2.1 Requirements / 113
6.2.2.2 Checklist of Function Types / 114
6.2.3 Failure Modes / 119
6.2.4 Effects / 121
6.2.5 Severity Ranking / 125
6.2.6 Classifi cation (Optional) / 127
6.2.7 Causes and Failure Mechanisms / 129
6.2.7.1 Failure Mechanisms (for System and Design
FMEAs) / 131
6.2.7.2 Five Whys / 136
6.2.8 Occurrence Ranking / 138
6.2.9 Controls / 140
6.2.9.1 Design Controls for System or Design
FMEAs / 140
6.2.9.2 Process Controls for Process FMEAs / 141
6.2.9.3 Use of Early Warning Devices and
Mitigating Controls / 142
6.2.10 Detection Ranking / 145
6.2.10.1 Detection Scale for Assessing Risk Related
to In-Service Detection Systems / 146
6.2.10.2 Limitations and Alternatives to Using
Detection Ranking / 147
6.2.11 Risk Priority Number (RPN) / 148
6.2.11.1 Limitations and Alternatives to Using
RPN / 150
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CONTENTS xi
6.3 FMEA Linkages / 152
6.3.1 System or Design FMEA Linkage to Design
Verifi cation Plan / 152
6.3.2 Process FMEA Linkage to Process Control
Plans / 153
6.3.3 Design FMEA Linkage to Process FMEA / 155
6.3.4 Relationship between System, Subsystem, and
Component FMEAs / 157
6.4 End of Chapter Problems / 158
References / 161
Chapter 7. How to Develop and Execute Effective Risk Reduction
Actions 162
In This Chapter / 162
Use of the Bicycle Examples in the Chapter / 162
7.1 Prioritize Issues for Corrective Action / 163
7.1.1 Is Action Always Required on High Severity
Issues? / 164
7.2 Develop Effective Recommended Actions / 165
7.2.1 Quality and Reliability Resources to Help
Formulate FMEA Recommended Actions / 166
7.3 Action Strategies to Reduce Risk / 166
7.3.1 Action Strategies to Reduce
Severity Risk / 167
7.3.2 Action Strategies to Reduce
Occurrence Risk / 168
7.3.3 Action Strategies to Reduce
Detection Risk / 172
7.3.4 Common Action Strategy Mistakes to Avoid / 174
7.4 Examples of Recommended Actions / 176
7.5 FMEA Execution Enablers / 176
7.6 The Essence of Execution / 182
7.7 Documenting Actions Taken / 182
7.8 Ensuring Risk Is Reduced to an Acceptable Level / 183
7.9 End of Chapter Problems / 183
References / 186
Chapter 8. Case Studies 187
In This Chapter / 187
8.1 Case Study: Shock Absorber Assembly / 188
8.2 Case Study: Strudel Pastry Manufacturing / 190
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