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.

Introduction	p. ix
What Is an FMEA?	p. 1
The History of FMEAs	p. 1
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
ISO 9000, ISO/TS 16949, and FMEAs	p. 7
The FMEA Process	p. 9
Evaluating the Risk of Failure	p. 10
Assessing the Risk Priority Number	p. 10
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
FMEA Boundaries of Freedom	p. 15
FMEA Scope	p. 16
FMEA Start-Up Worksheet	p. 17
Product/Design versus Process FMEAs	p. 19
Product/Design	p. 19
Process	p. 20
Ten Steps for an FMEA	p. 23
The FMEA Worksheet	p. 23
Review the Process or Product	p. 25
Brainstorm Potential Failure Modes	p. 25
List Potential Effects for Each Failure Mode	p. 26
Assigning Severity, Occurrence, and Detection Rankings	p. 26
Assign a Severity Ranking for Each Effect	p. 31
Assign an Occurrence Ranking for Each Failure Mode	p. 36
Assign a Detection Ranking for Each Failure Mode and/or Effect	p. 36
Calculate the Risk Priority Number for Each Failure Mode	p. 36
Prioritize the Failure Modes for Action	p. 37
Take Action to Eliminate or Reduce the High-Risk Failure Modes	p. 38
Calculate the Resulting RPN as the Failure Modes Are Reduced	p. 38
FMEA Case Study	p. 41
Review the Process	p. 41
Brainstorm Potential Failure Modes	p. 42
List Potential Effects of Each Failure Mode	p. 42
Assign a Severity Ranking for Each Effect	p. 46
Assign an Occurrence Ranking for Each Failure Mode	p. 46
Assign a Detection Ranking for Each Failure Mode and/or Effect	p. 46
Calculate the Risk Priority Number for Each Failure Mode	p. 46
Prioritize the Failure Modes for Action	p. 47
Take Action to Eliminate or Reduce the High-Risk Failure Modes	p. 47
Calculate the Resulting RPN as the Failure Modes Are Reduced or Eliminated	p. 47
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
Creating a Process Flowchart	p. 53
Brainstorming	p. 57
Brainstorming Rules	p. 57
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
Examples of Custom Ranking Scales	p. 63
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
ISO/TS 16949 Requirements Referencing FMEAs	p. 77
Alternative FMEA Worksheets	p. 81
FMEA Glossary of Terms	p. 85
Index	p. 87
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