The basics of FMEA

Library	Item Barcode	Call Number	Material Type	Item Category 1	Status
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Summary

Demonstrates How To Perform FMEAs Step-by-Step

Originally designed to address safety concerns, Failure Mode and Effect Analysis (FMEA) is now used throughout the industry to prevent a wide range of process and product problems. Useful in both product design and manufacturing, FMEA can identify improvements early when product and process changes are relatively easy and inexpensive to make.

Updated to include changes reflected in ISO/TX-16949:2002 standards and 2008 AIAG guidelines, The Basics of FMEA, Second Edition continues to provide the expert advice needed to help shorten the learning curve for FMEA teams to conduct effective and efficient FMEAs, even if it is their very first one.

Includes Ready-to-Use Worksheet Templates

Using a manufacturing case study, readers learn step-by-step how to use FMEAs to assess, evaluate, and prioritize areas of risk, and then to implement the actions needed to reduce risks to an acceptable level. It shows the steps needed to ferret out potential problems and prevent making inferior products that could endanger public and worker safety and compromise profits as well as the future of all stakeholders.

Although engineers have typically analyzed processes and products for potential failures, the FMEA process standardizes the approach and establishes a common language that nontechnical as well as technical employees can use at all levels. Unlike other improvement tools, FMEA does not require complicated statistics. However, they require a full commitment to quality and a willingness to take a team approach that involves all stakeholders.

Introduction	p. ix
Chapter 1 What Is an FMEA?	p. 1
The History of FMEAs	p. 1
Chapter 2 What Is the Purpose of an FMEA?	p. 3
Part of a Comprehensive Quality System	p. 3
FMEAs and Bottom-Line Results	p. 4
Example 1	p. 4
Example 2	p. 4
Example 3	p. 5
Chapter 3 ISO 9000, ISO/TS 16949, and FMEAs	p. 7
Chapter 4 The FMEA Process	p. 9
Evaluating the Risk of Failure	p. 10
Assessing the Risk Priority Number	p. 10
Chapter 5 The FMEA Team	p. 11
FMEA Team Size	p. 11
FMEA Team Membership	p. 12
FMEA Team Leader	p. 12
The Role of the Process Expert	p. 12
Training the FMEA Team	p. 13
Chapter 6 FMEA Boundaries of Freedom	p. 15
FMEA Scope	p. 16
FMEA Start-Up Worksheet	p. 17
Chapter 7 Product/Design versus Process FMEAs	p. 19
Product/Design	p. 19
Process	p. 20
Chapter 8 Ten Steps for an FMEA	p. 23
The FMEA Worksheet	p. 23
Step 1 Review the Process or Product	p. 25
Step 2 Brainstorm Potential Failure Modes	p. 25
Step 3 List Potential Effects for Each Failure Mode	p. 26
Steps 4-6 Assigning Severity, Occurrence, and Detection Rankings	p. 26
Step 4 Assign a Severity Ranking for Each Effect	p. 31
Step 5 Assign an Occurrence Ranking for Each Failure Mode	p. 36
Step 6 Assign a Detection Ranking for Each Failure Mode and/or Effect	p. 36
Step 7 Calculate the Risk Priority Number for Each Failure Mode	p. 36
Step 8 Prioritize the Failure Modes for Action	p. 37
Step 9 Take Action to Eliminate or Reduce the High-Risk Failure Modes	p. 38
Step 10 Calculate the Resulting RPN as the Failure Modes Are Reduced	p. 38
Chapter 9 FMEA Case Study	p. 41
Case Study Step 1 Review the Process	p. 41
Case Study Step 2 Brainstorm Potential Failure Modes	p. 42
Case Study Step 3 List Potential Effects of Each Failure Mode	p. 42
Case Study Step 4 Assign a Severity Ranking for Each Effect	p. 46
Case Study Step 5 Assign an Occurrence Ranking for Each Failure Mode	p. 46
Case Study Step 6 Assign a Detection Ranking for Each Failure Mode and/or Effect	p. 46
Case Study Step 7 Calculate the Risk Priority Number for Each Failure Mode	p. 46
Case Study Step 8 Prioritize the Failure Modes for Action	p. 47
Case Study Step 9 Take Action to Eliminate or Reduce the High-Risk Failure Modes	p. 47
Case Study Step 10 Calculate the Resulting RPN as the Failure Modes Are Reduced or Eliminated	p. 47
Chapter 10 When and Where to Use FMEAs	p. 49
Safety	p. 49
Accounting/Finance	p. 50
Software Design	p. 50
Information Systems/Technology	p. 50
Marketing	p. 51
Human Resources	p. 51
Purchasing	p. 51
Appendix 1 Creating a Process Flowchart	p. 53
Appendix 2 Brainstorming	p. 57
Brainstorming Rules	p. 57
Appendix 3 Reaching Consensus on Severity, Occurrence, and Detection Rankings	p. 59
Team Voting	p. 59
Get the Process Expert Involved	p. 60
Defer to One of the Team Members	p. 60
Rank Failures and Effects within a Ranking Category	p. 60
Talking It Out	p. 61
Use the Higher Ranking	p. 61
Appendix 4 Examples of Custom Ranking Scales	p. 63
Appendix 5 Process Improvement Techniques	p. 73
Mistake Proofing	p. 73
Design of Experiments	p. 74
Statistical Process Control	p. 74
Team Problem Solving Using CI Tools	p. 75
Appendix 6 ISO/TS 16949 Requirements Referencing FMEAs	p. 77
Appendix 7 Alternative FMEA Worksheets	p. 81
FMEA Glossary of Terms	p. 85
Index	p. 87

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Summary

Table of Contents