McDermott • Mikulak • Beauregard

THE
THEBASICS
BASICSOF
OF

FMEA
FMEA
The Basics of FMEA , Second Edition

2nd
2ndEdition
Edition
Robin
RobinE. E.McDermott
McDermott
Raymond
RaymondJ. J.Mikulak
Mikulak
Michael
MichaelR.R.Beauregard
Beauregard
THE BASICS OF

FMEA
THE BASICS OF

FMEA
2nd Edition

Robin E. McDermott
Raymond J. Mikulak
Michael R. Beauregard
CRC Press
Taylor & Francis Group
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Contents

Introduction............................................................................................ ix
Chapter 1 What Is an FMEA?................................................................ 1
The History of FMEAs............................................................................ 1
Chapter 2 What Is the Purpose of an FMEA?........................................ 3
Part of a Comprehensive Quality System................................................. 3
FMEAs and Bottom-Line Results............................................................ 4
Example 1........................................................................................... 4
Example 2........................................................................................... 4
Example 3........................................................................................... 5
Chapter 3 ISO 9000, ISO/TS 16949, and FMEAs.................................. 7
Chapter 4 The FMEA Process................................................................ 9
Evaluating the Risk of Failure................................................................ 10
Assessing the Risk Priority Number....................................................... 10
Chapter 5 The FMEA Team................................................................. 11
FMEA Team Size.................................................................................. 11
FMEA Team Membership..................................................................... 12
FMEA Team Leader.............................................................................. 12
The Role of the Process Expert............................................................... 12
Training the FMEA Team..................................................................... 13
Chapter 6 FMEA Boundaries of Freedom............................................ 15
FMEA Scope......................................................................................... 16
FMEA Start-Up Worksheet................................................................... 17
Chapter 7 Product/Design versus Process FMEAs.............................. 19
Product/Design...................................................................................... 19
Process................................................................................................... 20

v
vi  ◾ Contents

Chapter 8 Ten Steps for an FMEA....................................................... 23

The FMEA Worksheet........................................................................... 23
Step 1: Review the Process or Product................................................. 25
Step 2: Brainstorm Potential Failure Modes......................................... 25
Step 3: List Potential Effects for Each Failure Mode............................ 26
Steps 4–6: Assigning Severity, Occurrence, and Detection Rankings...... 26
Step 4: Assign a Severity Ranking for Each Effect............................ 31
Step 5: Assign an Occurrence Ranking for Each Failure Mode........ 36
Step 6: Assign a Detection Ranking for Each Failure Mode
and/or Effect........................................................................ 36
Step 7: Calculate the Risk Priority Number for Each
Failure Mode............................................................................ 36
Step 8: Prioritize the Failure Modes for Action.................................... 37
Step 9: Take Action to Eliminate or Reduce the High-Risk
Failure Modes.......................................................................... 38
Step 10: Calculate the Resulting RPN as the Failure Modes
Are Reduced............................................................................. 38
Chapter 9 FMEA Case Study............................................................... 41
Case Study Step 1: Review the Process................................................ 41
Case Study Step 2: Brainstorm Potential Failure Modes......................42
Case Study Step 3: List Potential Effects of Each Failure Mode..........42
Case Study Step 4: Assign a Severity Ranking for Each Effect............46
Case Study Step 5: Assign an Occurrence Ranking for Each
Failure Mode.........................................................46
Case Study Step 6: Assign a Detection Ranking for Each Failure
Mode and/or Effect...............................................46
Case Study Step 7: Calculate the Risk Priority Number for Each
Failure Mode.........................................................46
Case Study Step 8: Prioritize the Failure Modes for Action................. 47
Case Study Step 9: Take Action to Eliminate or Reduce the
High-Risk Failure Modes...................................... 47
Case Study Step 10: Calculate the Resulting RPN as the Failure
Modes Are Reduced or Eliminated....................... 47
Chapter 10 When and Where to Use FMEAs........................................ 49
Safety..................................................................................................... 49
Accounting/Finance.............................................................................. 50
Software Design.................................................................................... 50
Information Systems/Technology.......................................................... 50
Marketing.............................................................................................. 51
Human Resources.................................................................................. 51
Purchasing............................................................................................. 51
 Contents  ◾  vii

Appendix 1 Creating a Process Flowchart........................................... 53

Appendix 2 Brainstorming.................................................................. 57
Brainstorming Rules.............................................................................. 57
Appendix 3 Reaching Consensus on Severity, Occurrence, and
Detection Rankings......................................................... 59
Team Voting.......................................................................................... 59
Get the Process Expert Involved............................................................60
Defer to One of the Team Members......................................................60
Rank Failures and Effects within a Ranking Category..........................60
Talking It Out....................................................................................... 61
Use the Higher Ranking........................................................................ 61
Appendix 4 Examples of Custom Ranking Scales............................... 63
Appendix 5 Process Improvement Techniques.................................... 73
Mistake Proofing................................................................................... 73
Design of Experiments........................................................................... 74
Statistical Process Control..................................................................... 74
Team Problem Solving Using CI Tools.................................................. 75
Appendix 6 ISO/TS 16949 Requirements Referencing FMEAs.......... 77
Appendix 7 Alternative FMEA Worksheets......................................... 81
FMEA Glossary of Terms.................................................................... 85
Introduction

Failure Mode and Effect Analysis (FMEA) techniques have been around for over
40 years. It was only in the late twentieth century, however, that FMEAs gained
widespread appeal outside the safety arena. This was thanks in large part to
the U.S. automotive industry with its QS-9000 supplier requirements that were
established in 1996 and global efforts by the International Automotive Task
Force (IATF) to build on QS-9000 (and other international quality standards)
with the development of ISO/TS 16949.
The 2002 revision of ISO/TS 16949 incorporates ISO 9001:2000 and defines
the quality system requirements (and application of ISO 9001) for automotive
production and relevant service part organizations.
The ISO/TS 16949 standard requires that suppliers to the automotive indus-
try conduct product/design and process FMEAs in an effort to prevent failures
before they happen.
Unlike many quality improvement tools, FMEAs do not require compli-
cated statistics, yet they can yield significant savings for a company while at the
same time reducing the potential costly liability of a process or product that does
not perform as promised.
FMEAs do take time and people resources. Because FMEAs are team based,
several people need to be involved in the process. The foundation of FMEAs
is the FMEA team members and their input during the FMEA process. Com-
panies must be prepared to allow the team enough time to do a thorough
job. Effective FMEAs cannot be done by one person alone sitting in an office
filling­out the FMEA forms. Automotive customers and ISO auditors today
can easily spot an FMEA that was done just to appease the customer and fulfill
standards requirements.
This booklet was designed to help shorten the learning curve for FMEA
teams and to help them conduct effective and efficient FMEAs, even if it is their
very first FMEA. The book’s easy-to-use reference format makes it an invaluable
resource for FMEA teams.

ix
Chapter 1

What Is an FMEA?

An FMEA (Failure Mode and Effect Analysis) is a systematic method of identi-

fying and preventing product and process problems before they occur. FMEAs
are focused on preventing defects, enhancing safety, and increasing customer
satisfaction. Ideally, FMEAs are conducted in the product design or process
devel­opment stages, although conducting an FMEA on existing products and
processes can also yield substantial benefits.

The History of FMEAs

The first formal FMEAs were conducted in the aerospace industry in the mid-1960s
and were specifically focused on safety issues. Before long, FMEAs became a key
tool for improving safety, especially in the chemical process industries. The goal
with safety FMEAs was, and remains today, to prevent safety accidents and inci-
dents from occurring.
While engineers have always analyzed processes and products for potential
failures, the FMEA process standardizes the approach and establishes a common
language that can be used both within and between companies. It can also be
used by nontechnical as well as technical employees of all levels.
The automotive industry adapted the FMEA technique for use as a quality
improvement tool.