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Potential Failure Mode and Effects Analysis (Fmea) Reference Manual Fourth Edition (Pdfdrive)

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0% found this document useful (0 votes)

943 views150 pages

Potential Failure Mode and Effects Analysis (Fmea) Reference Manual Fourth Edition (Pdfdrive)

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Filip Moravčík

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POTENTIAL

FAILURE MODE AND

EFFECTS ANALYSIS
(FMEA)
Reference Manual
Fourth Edition

First Edition, February 1993 • Second Edition, February 1995 • Third Edition, July 2001,
Fourth Edition, June 2008
Copyright © 1993, © 1995, © 2001, © 2008
Chrysler LLC, Ford Motor Company, General Motors Corporation
ISBN: 978-1-60534-136-1
FOREWORD
4th Edition

The FMEA 4th Edition is a reference manual to be used by suppliers to Chrysler LLC, Ford Motor
Company, and General Motors Corporation as a guide to assist them in the development of both

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Design and Process FMEAs. The manual does not define requirements; it is intended to clarify

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questions concerning the technical development of FMEAs. This manual is aligned with SAE
J1739.

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Summary of Changes in the 4th edition FMEA Reference Manual

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The DFMEA and PFMEA methods described in the 4th edition FMEA Reference Manual include
those associated with design at the system, subsystem, interface, and component level and the
process at manufacturing and assembly operations.

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General Changes

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• The formatting used in the 4th edition is intended to provide easier reading.

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o An index is included.
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o Icons are used to indicate key paragraphs and visual cues are used.
• Additional examples and verbiage have been provided to improve the utility of the
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manual and to provide a closer tie into the FMEA process as it develops.
• Reinforcement of the need for management support, interest, and review of the
FMEA process and results.
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• Define and strengthen the understanding of the linkage between DFMEA and
PFMEA as well as defining the linkages to other tools.
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• Improvements to the Severity, Occurrence, Detection ranking tables so that they are
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more meaningful to real world analysis and usage.

• Alternative methods are introduced that are currently being applied in industry.
o Additional appendices which have example forms and special case application of
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FMEA.
o The focus on the “standard form” has been replaced with several options that
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represent the current application of FMEA in industry.

• The suggestion that RPN not be used as the primary means for assessing risk. The
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need for improvement has been revised including an additional method, and the use
of thresholds on RPN is clarified as a practice that is not recommended.
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Chapter I provides general FMEA guidelines, the need for management support and having a
defined process for developing and maintaining FMEAs, and the need for continuous
improvement.
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Chapter II describes the general application of the FMEA methodology, which is common
between DFMEA and PFMEA processes. This includes the planning, strategy, action plans, and
the need for management support and responsibility in FMEAs.

Chapter III focuses on DFMEA (Design Failure Mode Effects and Analysis), establishing the
scope of the analysis, use of block diagrams, various types of DFMEAs, formation of the teams,
basic procedure for analysis, action plans, and follow-up, alternatives to RPN, and connection to
PFMEAs and validation plans.

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Chapter IV focuses on PFMEA (Process Failure Mode Effects and Analysis), establishing the
scope of the analysis, use of flow diagrams, formation of teams, basic procedure for analysis,
action plans, the connection to DFMEAs and the development of control plans.

The Appendices have several examples of forms for DMFEA and PFMEA and addresses

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different applications and procedures for addressing design and process risk.

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The Supplier Quality Requirements Task Force would like to thank the following individuals, and
their companies, who have contributed their time and efforts to the development of this edition of

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the FMEA Reference Manual:

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Michael Down, General Motors Corporation
Lawrence Brozowski, General Motors Corporation
Hisham Younis, Ford Motor Company

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David Benedict, Chrysler LLC
John Feghali, Chrysler LLC
Michael Schubert, Delphi

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Rhonda Brender, Delphi

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Gregory Gruska, Omnex
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Glen Vallance, Control Planning Initiatives
Milena Krasich, Bose
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William Haughey, ReliaTrain

This manual is a copyright of Chrysler LLC, Ford Motor Company and General Motors
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Corporation, with all rights reserved. Additional copies may be obtained from AIAG @
www.aiag.org. Supply chain organizations of Chrysler LLC, Ford Motor Company or General
Motors Corporation have permission to copy forms used in this manual.
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TABLE OF CONTENTS
General Changes.................................................................................................................................. i
Chapter I......................................................................................................................................................... 1
General FMEA Guidelines ................................................................................................................ 1
Introduction ................................................................................................................................................ 2

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FMEA Process.................................................................................................................................... 2

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Purpose of Manual.................................................................................................................................. 3
Scope of Manual..................................................................................................................................... 4
Impact on Organization and Management.................................................................................................. 4

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FMEA Explained........................................................................................................................................ 5
Follow-up and Continuous Improvement ................................................................................................... 6

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Chapter II........................................................................................................................................................ 7
Overview of FMEA Strategy, Planning and Implementation............................................................. 7
Introduction ................................................................................................................................................ 8
Basic Structure ........................................................................................................................................... 8

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Approach .................................................................................................................................................... 8
Identify the Team ................................................................................................................................... 9
Define the Scope................................................................................................................................... 10

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Define the Customer............................................................................................................................. 11

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Indentify Functions, Requirements, and Specifications ....................................................................... 11
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Identify Potential Failure Modes .......................................................................................................... 12
Identify Potential Effects ...................................................................................................................... 12
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Identify Potential Causes ...................................................................................................................... 12
Identify Controls................................................................................................................................... 13
Identifying and Assessing Risk ............................................................................................................ 13
Recommended Actions and Results ..................................................................................................... 13
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Management Responsibility ..................................................................................................................... 14

Chapter III .................................................................................................................................................... 15
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DFMEA Design Failure Mode and Effects Analysis ....................................................................... 15

Introduction .............................................................................................................................................. 16
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Customer Defined................................................................................................................................. 16
Team Approach .................................................................................................................................... 17
Manufacturing, Assembly and Serviceability Considerations.............................................................. 17
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Development of a Design FMEA ............................................................................................................. 18

Prerequisites ......................................................................................................................................... 18
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Block (Boundary) Diagrams............................................................................................................. 18

Parameter (P) Diagrams.................................................................................................................... 21
Functional Requirements.................................................................................................................. 22
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Other Tools and Information Resources........................................................................................... 22

Example DFMEA................................................................................................................................. 25
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Header of the Design FMEA Form (fields A-H) .............................................................................. 25

Body of the DFMEA Form (fields a – n).......................................................................................... 29
Maintaining DFMEAs .......................................................................................................................... 64
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Leveraging DFMEAs ........................................................................................................................... 65

Linkages ............................................................................................................................................... 65
Design Verification Plan & Report (DVP&R) ................................................................................. 66
PFMEA............................................................................................................................................. 66
Chapter IV .................................................................................................................................................... 67
PFMEA Process Failure Mode and Effects Analysis ....................................................................... 67
Introduction .............................................................................................................................................. 68
Customer Defined................................................................................................................................. 69
Team Approach .................................................................................................................................... 69
Design Considerations.......................................................................................................................... 69
Development of a Process FMEA ............................................................................................................ 70

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Prerequisites ......................................................................................................................................... 70
Process Flow Diagram and linkage to PFMEA ................................................................................ 70
Other Tools and Information Sources............................................................................................... 73
Research Information ....................................................................................................................... 73
Example PFMEA Form........................................................................................................................ 75
Header of the Process FMEA Form (fields A-H) ............................................................................. 75
Body of the PFMEA Form (fields a – n) .......................................................................................... 77

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Maintaining PFMEAs......................................................................................................................... 110

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Leveraging PFMEAs .......................................................................................................................... 110
Linkages ............................................................................................................................................. 111
To DFMEA..................................................................................................................................... 111

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To Control Plan .............................................................................................................................. 112
APPENDICES............................................................................................................................................ 113

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Appendix A: Sample Forms ................................................................................................................... 114
DFMEA Forms................................................................................................................................... 114
PFMEA Forms.................................................................................................................................... 121
Appendix B: System Level FMEA......................................................................................................... 130

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Interfaces ............................................................................................................................................ 131
Interactions ......................................................................................................................................... 131
Relationships ...................................................................................................................................... 133

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Multiple Levels of Design FMEAs................................................................................................. 133

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Appendix C: Alternative Risk Assessments ........................................................................................... 135
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Alternatives to RPN............................................................................................................................ 135
Alternative: SO (S x O) .................................................................................................................. 136
Alternative: SOD, SD ..................................................................................................................... 136
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Appendix D: Alternative Analyses Techniques...................................................................................... 137
Failure Mode, Effect and Criticality Analysis (FMECA)................................................................... 137
Design Review Based on Failure Modes (DRBFM) .......................................................................... 137
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Fault Tree Analysis (FTA) ................................................................................................................. 137

References and Suggested Readings ...................................................................................................... 140
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Index....................................................................................................................................................... 141
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TABLES and FIGURES
Figure III.1a Block (Boundary) Diagram Examples .................................................................................... 19
Figures III.1b, c Block (Boundary) Diagram Examples ............................................................................... 20
Figure III.2 Example of a Parameter (P) Diagram for a Generic Catalytic Converter ................................. 21
Table III.1 Sample DFMEA Form with Minimal Information Elements & Example Entries...................... 24

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Table III.3 Example Potential Failure Modes............................................................................................... 32

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Table III.4 Example Potential Effects .......................................................................................................... 35
Table Cr1 Suggested DFMEA Severity Evaluation Criteria ........................................................................ 37
Table III.5 Example Potential Causes .......................................................................................................... 42

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Table Cr2 Suggested DFMEA Occurrence Evaluation Criteria ................................................................... 46
Table III.6 Examples of Prevention and Detection Design Controls............................................................ 51

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Table Cr3 Suggested DFMEA/PFMEA Prevention/Detection Evaluation Criteria ..................................... 54
Table III.7 Examples of Causes, Controls and Recommended Actions ....................................................... 64
Figure III.7 DFMEA Information Interrelationships Flow........................................................................... 65
Figure IV.1 High Level to Detailed Process Maps....................................................................................... 71

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Figure IV.2 Example Process Flow Diagram ............................................................................................... 72
Table IV.1 Sample PFMEA Form with Minimal Information Elements & Example Entries ...................... 74
Table IV.2 Example of Process Step/Function/Requirements Columns on PFMEA Form including Potential

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Failure Modes....................................................................................................................................... 81

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Table IV.3 Example of Effects ..................................................................................................................... 85
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Table Cr1 Suggested PFMEA Severity Evaluation Criteria......................................................................... 88
Table Cr2 Suggested PFMEA Occurrence Evaluation Criteria.................................................................... 93
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Table IV.4 Examples of Causes and Controls .............................................................................................. 96
Table Cr3 Suggested Process FMEA Detection Evaluation Criteria.......................................................... 100
Table IV.5 Examples of Causes, Controls and Actions.............................................................................. 110
Figure IV.5 PFMEA Information Interrelationship Flow........................................................................... 111
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DFMEA Form A ........................................................................................................................................ 115

DFMEA Form B......................................................................................................................................... 116
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DFMEA Form C......................................................................................................................................... 117

DFMEA Form D ........................................................................................................................................ 118
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DFMEA Form E......................................................................................................................................... 119

DFMEA Form F ......................................................................................................................................... 120
PFMEA Form A ......................................................................................................................................... 122
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PFMEA Form B ......................................................................................................................................... 123

PFMEA Form C ......................................................................................................................................... 124
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PFMEA Form D ......................................................................................................................................... 125

PFMEA Form E.......................................................................................................................................... 126
PFMEA Form F.......................................................................................................................................... 127
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PFMEA Form G ......................................................................................................................................... 128

PFMEA Form H ......................................................................................................................................... 129
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Figure B.1 Interfaces and Interactions........................................................................................................ 130

Figure B.2 Item, Functions, and Failure ..................................................................................................... 132
Figure B.3 DFMEA Effects Linkages ........................................................................................................ 134
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Table C.1 Contrast among RPN, SOD and SD........................................................................................... 136

Figure D.1 Example of DRBFM Elements................................................................................................. 138
Figure D.2 FTA Tree Structure .................................................................................................................. 139

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Chapter I General FMEA Guidelines

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Chapter I
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General FMEA
Guidelines
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1
Chapter I General FMEA Guidelines

Introduction
This manual introduces the topic of Potential Failure Mode and
Effects Analysis (FMEA) and gives general guidance in the
application of the technique.

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FMEA Process
FMEA is an analytical methodology used to ensure that potential
problems have been considered and addressed throughout the

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product and process development process (APQP – Advanced

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Product Quality Planning). Its most visible result is the
documentation of the collective knowledge of cross-functional
teams.

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Part of the evaluation and analysis is the assessment of risk. The
important point is that a discussion is conducted regarding the
design (product or process), review of the functions and any

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changes in application, and the resulting risk of potential failure.

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U ot component within the product or assembly. Critical and safety
related components or processes should be given a higher
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priority.
One of the most important factors for the successful
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implementation of an FMEA program is timeliness. It is meant

to be a “before-the-event” action, not an “after-the-fact”
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exercise. To achieve the greatest value, the FMEA must be done

before the implementation of a product or process in which the
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failure mode potential exists. Up-front time spent properly

completing an FMEA, when product/process changes can be
most easily and inexpensively implemented, will minimize late
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change crises. Actions resulting from an FMEA can reduce or

eliminate the chance of implementing a change that would create
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an even larger concern.

Ideally, the Design FMEA process should be initiated in the
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early stages of the design and the Process FMEA before tooling
or manufacturing equipment is developed and purchased. The
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FMEA evolves throughout each stage of the design and

manufacturing development process and may also be used in
problem solving.
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FMEA can also be applied to non-manufacturing areas. For

example, FMEA could be used to analyze risk in an
administration process or the evaluation of a safety system. In
general, FMEA is applied to potential failures in product design
and manufacturing processes where the benefits are clear and
potentially significant.

2
Chapter I General FMEA Guidelines

Purpose of Manual
This manual describes the basic principles and implementation
of the FMEA 1 process and how it is integrated within the
product and process development cycle. This includes the
documentation of this process and how the analyses can be

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applied for timely necessary improvement of a product or a

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process in its early and full development stage.
This manual also provides descriptions and examples of alternate
and supporting methodologies for these analyses, their specific

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advantages and limitations, guidance of how the analysis is to be

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carried out for the maximum reliability improvement or
mitigation of potential safety risks. The manual provides
guidance on how the risk can be represented, measured and
prioritized for cost effective mitigation of the failure effects.

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As a tool in risk evaluation, FMEA is considered to be a method
to identify severity of potential effects of failure and to provide

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an input to mitigating measures to reduce risk. In many

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U ot applications, FMEA also includes an estimation of the
probability of occurrence of the causes of failure and their
resultant failure modes. This broadens the analysis by providing
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a measure of the failure mode’s likelihood. To minimize risk, the
likelihood of failure occurrence is reduced which increases
product or process reliability. FMEA is a tool that is instrumental
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in reliability improvement.
There are three basic cases for which FMEA process is to be
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applied, each with a different scope or focus:

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Case 1: New designs, new technology, or new process.

The scope of the FMEA is the complete
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design, technology, or process.

Case 2: Modifications to existing design or process.

The scope of the FMEA should focus on the
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modification to design or process, possible

interactions due to the modification, and field
history. This can include changes in regulatory
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requirements.
Case 3: Use of an existing design or process in a new
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environment, location, application, or usage

profile (including duty cycle, regulatory
requirements, etc.).
The scope of the FMEA should focus on the
impact of the new environment, location, or
application usage on the existing design or
process.

1
The FMEA present herein also is known as a Failure Modes Effects and Criticality Analysis (FMECA)
since it includes a quantification of the risks.

3
Chapter I General FMEA Guidelines

Scope of Manual
The analytical methods presented in this manual are applicable
to any product or process. However, this manual will focus on
those applications prevalent within the automotive industry and
its suppliers.

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Impact on Organization and Management
FMEA is an important activity within any company. Because the

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development of an FMEA is a multi-disciplined activity

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affecting the entire product realization process, its
implementation needs to be well planned to be fully effective.
This process can take considerable time and a commitment of the
required resources is vital. Important to FMEA development is a

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process owner and senior management commitment.
Implementation approach will vary depending on the size and

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structure of the company concerned, although the principles will

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U ot be the same:
• The scope will cover FMEAs produced in house and by multi-
tier suppliers.
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• Address Design and Process FMEAs, as applicable.
• Accomplish this by having the FMEA process an integral part
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of the APQP process.

•
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Part of engineering technical reviews.

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• Part of the regular sign-off and approval of the product or

process design.
An FMEA is developed by a multi-functional (or cross-
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functional) team. The team size will depend both on the

complexity of the design and the size and organization of the
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company. Team members need relevant expertise, available time

and authority sanctioned by management.
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A comprehensive training program should be implemented

including:
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• Management Overview
• Training for users
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• Supplier Training
• Facilitator Training
Ultimately, management has the responsibility and ownership for
development and maintenance of the FMEAs.

4
Chapter I General FMEA Guidelines

FMEA Explained
FMEAs are an integral part of managing risk and supporting
continual improvement. Consequently, FMEA becomes a key
part of Product and Process development. The Advanced Product
Quality Planning (APQP) process identifies five general areas of

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focus in this development process:

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• Plan and Define Program
• Product Design and Development

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• Process Design and Development

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• Product and Process Validation
• Feedback, Assessment and Corrective Action

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The APQP Reference manual shows DFMEAs as an activity in
the Product Design and Development section of the timing chart
and PFMEAs in the Process Planning and Development section.

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The development of either DFMEA or PFMEA is a process that

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designs that meet expectations.
The FMEA analysis should not be considered a single event, but
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a long-term commitment that complements the product and
process development to ensure potential failures are evaluated
and actions are taken to reduce their risk.
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One key aspect of continual improvement is the retention of

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knowledge from past learning which often is captured in

FMEAs. It is advisable for organizations to capitalize on prior
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analyses of similar product and process designs for use as the

starting point for the next program and/or application.
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The language used in FMEAs should be as specific as possible

when describing an item (for example, failure mode, or cause)
and not extend or extrapolate beyond the team’s level of
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understanding as to what the failure effects may be.

Clear statements, concise terminology and focus on the actual

effects are key to the effective identification and mitigation of
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risk issues.
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5
Chapter I General FMEA Guidelines

Follow-up and Continuous Improvement

The need for taking effective preventive/corrective actions, with
appropriate follow-up on those actions, cannot be
overemphasized. Actions should be communicated to all affected

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activities. A thoroughly thought-out and well-developed FMEA

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will be of limited value without positive and effective
preventive/corrective actions.

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Team leadership (typically the team leader/lead engineer) is in
charge of ensuring that all recommended actions have been

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implemented or adequately addressed. The FMEA is a living
document and should always reflect the latest level, as well as
the latest relevant actions, including those occurring after the

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start of production.
The team leader/lead engineer has several means of assuring that

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recommended actions are implemented. They include, but are

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not limited to the following:
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• Reviewing designs, processes, and related records to ensure
that recommended actions have been implemented,
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• Confirming the incorporation of changes to design/assembly/
manufacturing documentation, and,
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• Reviewing Design/Process FMEAs, special FMEA

applications, and Control Plans.
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Chapter II Strategy, Planning, Implementation

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Chapter II
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Overview of FMEA
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Strategy, Planning and Implementation

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Chapter II Strategy, Planning, Implementation

Introduction
FMEA development, either design or process, uses a common
approach to address:
• Potential product or process failure to meet expectations

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• Potential consequences

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• Potential causes of the failure mode
• Application of current controls

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• Level of risk

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• Risk reduction
Before the FMEA document is started, the team must define the
scope of the project and collect existing information which is

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necessary for an effective and efficient FMEA development
process.

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Basic Structure
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The purpose of the recommended FMEA formats described in
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this manual is to organize the collection and display of relevant
FMEA information. Specific formats may vary based on the
needs of the organization and the requirements of the customer.
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Fundamentally, the format utilized should address:

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• Functions, requirements, and deliverables of the product or

process being analyzed,
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• Failure modes when functional requirements are not met,

• Effects and consequences of the failure mode,
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• Potential causes of the failure mode,

• Actions and controls to address the causes of the failure mode,

and,
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• Actions to prevent recurrence of the failure mode.

Approach
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There is no single or unique process for FMEA development;

however there are common elements as described below.

8
Chapter II Strategy, Planning, Implementation

Identify the Team

As previously mentioned, FMEA development is the
responsibility of a multi-disciplinary (or cross-functional) team
whose members encompass the necessary subject matter

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knowledge. This should include facilitation expertise and

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knowledge of the FMEA process. A team approach is
recommended to benefit the FMEA development process to
ensure input and collaboration from all affected functional areas.

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The FMEA team leader should select team members with the

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relevant experience and necessary authority. In addition to the
design and process engineers, the following are examples of
additional resources:

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FMEA development topic Relevant Resources or Expertise

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Scope Program Management, Customer, Integration responsible

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U ot individual(s)
Functions, requirements and expectations Customer, Program Management, Integration responsible
individual(s), Service Operations, Safety, Manufacturing
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and Assembly, Packaging, Logistics, Materials
Potential failure mode – the way a process or Customer, Program Management, Integration responsible
product might fail individual(s), Service Operations, Safety, Manufacturing
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and Assembly, Packaging, Logistics, Materials, Quality

Effects and consequences of the failure – to Customer, Program Management, Integration responsible
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both the organization’s processes or to a individual(s), Service Operations, Safety, Manufacturing

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downstream customer. and Assembly, Packaging, Logistics, Materials, Quality

Causes of the potential failure Customer, Manufacturing and Assembly, Packaging,
Logistics, Materials, Quality, Reliability, Engineering
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Analysis, Equipment Manufacturer, Maintenance

Frequency of occurrence of potential failure Customer, Manufacturing and Assembly, Packaging,
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Logistics, Materials, Quality, Reliability, Engineering

Analysis, Statistical Analysis, Equipment Manufacturer,
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Maintenance
Application of current controls-prevention Manufacturing and Assembly, Packaging, Logistics,
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Materials, Quality, Equipment Manufacturer, Maintenance

Application of current controls-detection Customer, Manufacturing and Assembly, Packaging,
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Logistics, Materials, Quality, Maintenance

Recommended actions required Customer, Program Management, Integration responsible
individual(s), Manufacturing and Assembly, Packaging,
Logistics, Materials, Quality, Reliability, Engineering
Analysis, Statistical Analysis, Equipment Manufacturer,
Maintenance

9
Chapter II Strategy, Planning, Implementation

Define the Scope

Scope establishes the boundary of the FMEA analysis. It defines
what is included and excluded, determined based on the type of
FMEA being developed, i.e., system, subsystem, or component.
Before the FMEA can begin, a clear understanding of what is to

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be evaluated must be determined. What to exclude can be just as

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important as what to include in the analysis. The scope needs to
be established at the start of the process to assure consistent
direction and focus.

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The following may assist the team in defining the scope of the

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FMEA:
• Function Model
• Block (Boundary) diagrams

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• Parameter (P) diagrams
•

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Interface diagrams

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U ot • Process flow diagrams
• Interrelationship matrices
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• Schematics
• Bill of Materials (BOM)
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System FMEA
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A system FMEA is made up of various subsystems. Examples of

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systems include: Chassis System, Powertrain System, or Interior

System, etc. The focus of the System FMEA is to address all
interfaces and interactions among systems, subsystems, the
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environment and the customer.

Subsystem FMEA
A Subsystem FMEA is a subset of a system FMEA. An example
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of a subsystem is the front suspension subsystem, which is a

subset of the chassis system. The focus of the Subsystem FMEA
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is to address all interfaces and interactions among the subsystem

components and interactions with other subsystems or systems.
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Component FMEA
A Component FMEA is a subset of a subsystem FMEA. For
example, a brake pad is a component of the brake assembly,
which is a subsystem of the chassis system.
NOTE: Any subsequent adjustments to the scope may require a
modification of the team structure and membership.

10
Chapter II Strategy, Planning, Implementation

Define the Customer

There are four major customers to be considered in the FMEA
process, all need to be taken into account in the FMEA analysis:
• END USER: the person or organization that will utilize the
product. The FMEA analysis affecting the End User could

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include, for example, durability.

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• OEM ASSEMBLY and MANUFACTURING CENTERS
(PLANTS): the OEM locations where manufacturing

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operations (e.g., stamping and powertrain) and vehicle
assembly take place. Addressing the interfaces between the

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product and its assembly process is critical to an effective
FMEA analysis.
• SUPPLY CHAIN MANUFACTURING: the supplier location

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where manufacturing, fabricating or assembling of production
materials or parts takes place. This includes fabricating

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production and service parts and assemblies and processes

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such as heat treating, welding, painting, plating or other
U ot finishing services. This may be any subsequent or downstream
operation or a next tier manufacturing process.
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• REGULATORS: government agencies that define
requirements and monitor compliance to safety and
environmental specifications which can impact the product or
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process.
Knowledge of these customers can help to define the functions,
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requirements and specifications more robustly as well as aid in

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determining the effects of related failure modes.

Indentify Functions,
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Requirements, and
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Specifications
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Identify and understand the functions, requirements and

specifications relevant to the defined scope. The purpose of this
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activity is to clarify the item design intent or process purpose.

This assists in the determination of the potential failure mode for
each attribute or aspect of the function.
Pr

11
Chapter II Strategy, Planning, Implementation

Identify Potential
Failure Modes
Failure mode is defined as the way or manner in which a product

y
or process could fail to meet design intent or process

an
requirements. The assumption is made that the failure could
occur but may not necessarily occur. A concise and
understandable failure definition is important since it properly

p
focuses the analysis. Potential failure modes should be described
in technical terms and not as a symptom necessarily noticeable

nl om
by the customer. A large number of failure modes identified for
a single requirement may indicate that the defined requirement is
not concise.

O C
Identify Potential

r
y
Effects

se o
U ot Potential effects of failure are defined as the effects of the failure
mode as perceived by the customer. The effects or impact of the
al M
failure are described in terms of what the customer might notice
or experience. The customer may be an internal customer as
well as the End User.
rn rd

Determining potential effects includes the analysis of the

consequences of the failures and the severity or seriousness of
te o

those consequences.
In f F

Identify Potential
Causes
o

Potential cause of failure is defined as an indication of how the

failure could occur, described in terms of something that can be

corrected or can be controlled. Potential cause of failure may be
er

an indication of a design weakness, the consequence of which is

the failure mode.
op

There is a direct relation between a cause and its resultant failure

mode (i.e., if the cause occurs, then the failure mode occurs).
Pr

Identifying the root cause(s) of the failure mode, in sufficient

detail, enables the identification of appropriate controls and
action plans. A separate potential cause analysis is performed
for each cause if there are multiple causes.

12
Chapter II Strategy, Planning, Implementation

Identify Controls
Controls are those activities that prevent or detect the cause of
the failure or failure mode. In developing controls it is important
to identify what is going wrong, why, and how to prevent or

y
detect it. Controls are applicable to product design or

an
manufacturing processes. Controls focused on prevention will
provide the greatest return.
Identifying and

p
Assessing Risk

nl om
One of the important steps in the FMEA process is the
assessment of risk. This is evaluated in three ways, severity,

O C
occurrence, and detection:
Severity is an assessment of the level of impact of a failure on

r
the customer.

y
se o
U ot Occurrence is how often the cause of a failure may occur.
Detection is an assessment of how well the product or process
controls detect the cause of the failure or the failure mode.
al M
Organizations need to understand their customer requirements
for risk assessment.
rn rd

Recommended
Actions and Results
te o
In f F

The intent of recommended actions is to reduce overall risk and

likelihood that the failure mode will occur. The recommended
actions address reduction of the severity, occurrence and
o

detection.
The following can be used to assure that the appropriate actions
ty

are taken, including but not limited to:

• Ensuring design requirements including reliability are
er

achieved,
•
op

Reviewing engineering drawings and specifications,

• Confirming incorporation in assembly/manufacturing
processes, and,
Pr

• Reviewing related FMEAs, control plans and operations

instructions.
Responsibility and timing to complete the recommended actions
should be recorded.
Once actions are completed and results captured, the updated
ratings for severity, occurrence and detection should also be
recorded.

13
Chapter II Strategy, Planning, Implementation

Management Responsibility
Management owns the FMEA process. Management has the
ultimate responsibility of selecting and applying resources and
ensuring an effective risk management process including timing.
Management responsibility also includes providing direct

y
support to the team through on-going reviews, eliminating

an
roadblocks, and incorporating lessons learned.

p
nl om
O C r
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se o
U ot
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In f F
o
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14
Chapter III Design Failure Mode and Effects Analysis

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p an
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O C r
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se o
U ot
Chapter III
al M
rn rd

DFMEA
te o

Design Failure Mode and Effects Analysis

In f F
o
ty
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15
Chapter III Design Failure Mode and Effects Analysis

Introduction
The Design Failure Mode Effects Analysis, referred to as
DFMEA, supports the design process in reducing the risk of
failures by:
• Aiding in the objective evaluation of the design, including

y
functional requirements and design alternatives,

an
• Evaluating the initial design for manufacturing, assembly,
service, and recycling requirements,

p
• Increasing the probability that potential failure modes and their

nl om
effects on system and vehicle operation have been considered
in the design/development process,
• Providing additional information to aid in the planning of

O C
thorough and efficient design, development, and validation
programs,

r
•

y
Developing a ranked list of potential failure modes according

se o
to their effect on the customer, thus establishing a priority
U ot system for design improvements, development, and validation
testing/analysis,
al M
• Providing an open issue format for recommending and
tracking risk-reducing actions, and,
•
rn rd

Providing future reference, (e.g., lessons learned), to aid in

addressing field concerns, evaluating design changes, and
developing advanced designs.
te o

The DFMEA is a living document and should:

In f F

• Be initiated before design concept finalization,

• Be updated as changes occur or additional information is
o

obtained throughout the phases of product development,

•
ty

Be fundamentally completed before the production design is

released, and,
er

• Be a source of lessons learned for future design iterations.

Customer Defined
Pr

The definition of “Customer” provided in Chapter II applies to

DFMEA. It is important to correctly identify the customer(s)
because such knowledge directs the development of the
DFMEA, including the impact of the function of the design.

16
Chapter III Design Failure Mode and Effects Analysis

Team Approach
The DFMEA is developed and maintained by a multi-
disciplinary (or cross-functional) team typically led by the design
responsible engineer from the responsible design source (e.g.,
OEM, Tier 1 supplier or Tier 2 supplier and below).

y
The responsible engineer is expected to directly and actively

an
involve representatives from all affected areas. The areas of
expertise and responsibility may include, but are not limited to,
assembly, manufacturing, design, analysis/test, reliability,

p
materials, quality, service, and suppliers, as well as the design

nl om
area responsible for the next higher or lower assembly or system,
subsystem, or component.
Manufacturing,
Assembly and

O C
Serviceability

r
y
Considerations

se o
U ot The DFMEA should include any potential failure modes and
causes that can occur during the manufacturing or assembly
al M
process which are the result of the design. Such failure modes
may be mitigated by design changes (e.g., a design feature which
prevents a part from being assembled in the wrong orientation –
rn rd

i.e., error-proofed). When not mitigated during the DFMEA

analysis (as noted in the action plan for that item), their
identification, effect, and control should be transferred to and
te o

covered by the PFMEA.

In f F

The DFMEA does not rely on process controls to overcome

potential design weaknesses, but it does take the technical and
physical limits of a manufacturing and assembly process into
o

consideration, for example:

• Necessary mold drafts

• Limited surface finish capability
er

• Assembling space (e.g., access for tooling)

• Limited hardenability of steels

• Tolerances/process capability/performance
Pr

The DFMEA can also take into consideration the technical and
physical limits of product serviceability and recycling once the
product has entered field use, for example:
• Tool access
• Diagnostic capability
• Material classification symbols (for recycling)
• Materials/chemicals used in the manufacturing processes

17
Chapter III Design Failure Mode and Effects Analysis

Development of a Design FMEA

The DFMEA focuses on the design of the product that will be
delivered to the final customer (End User). The prerequisite tasks
for an effective analysis of the product design include:

y
assembling a team, determining scope, creating block diagrams

an
or P-diagrams depicting product function and requirements. A
clear and complete definition of the desired product
characteristics better facilitates the identification of potential

p
failure modes. A DFMEA form is used to document the results
of the analysis including any recommended actions and

nl om
responsibilities (See Table III.1).
The DFMEA process can be mapped to the customer or
organization’s product development process.

O C
Prerequisites

r
y
se o
U ot A DFMEA should begin with the development of information to
understand the system, subsystem, or component being analyzed
and define their functional requirements and characteristics.
al M
In order to determine the scope of the DFMEA, the team should
consider the following as applicable to component, subsystem or
system DFMEAs:
rn rd

• What processes, mating components, or systems does the

te o

product interface with?

•
In f F

Are there functions or features of the product that affect other

components or systems?
• Are there inputs provided by other components or systems that
o

are needed to perform intended functions of the product?

•
ty

Do the product’s functions include the prevention or detection

of a possible failure mode in a linked component or system?
er

The following sections describe tools that may be applied, as

appropriate, to assist the team in developing the DFMEA.
op

Block (Boundary) Diagrams

The block diagram of the product shows the physical and logical
relationships between the components of the product. There are
different approaches and formats to the construction of a block
diagram
The block diagram indicates the interaction of components and
subsystems within the scope of the design. This interaction may
include: flow of information, energy, force, or fluid. The
objective is to understand the requirements or inputs to the

18
Chapter III Design Failure Mode and Effects Analysis

system, the activities acting on the inputs or function performed,

and the deliverables or output.
The diagram may be in the form of boxes connected by lines,
with each box corresponding to a major component of the
product or a major step of the process. The lines correspond to
how the product components are related to, or interface with

y
each other. The organization needs to decide the best approach

an
or format for the block diagram. Figure III.1a, b, and c contain
examples of block diagrams.

p
Copies of the diagrams used in DFMEA preparation should
accompany the DFMEA.

nl om
O C r
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se o
U ot
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te o
In f F
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Figure III.1a Block (Boundary) Diagram Examples

19
Chapter III Design Failure Mode and Effects Analysis

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p an
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In f F
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Figures III.1b, c Block (Boundary) Diagram Examples

20
Chapter III Design Failure Mode and Effects Analysis

Parameter (P) Diagrams

The P-Diagram is a structured tool to help the team understand
the physics related to the function(s) of the design. The team
analyzes the intended inputs (signals) and outputs (responses or
functions) for the design as well as those controlled and

y
uncontrolled factors which can impact performance.

an
The inputs to the product and outputs from the product, i.e., the
intended and unintended functions of the product, are useful in
identifying error states, noise factors, and control factors.

p
The error states correspond to the Potential Failure Modes in the

nl om
DFMEA.

O C r
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se o
U ot
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In f F
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Figure III.2 Example of a Parameter (P) Diagram for a Generic Catalytic Converter

21
Chapter III Design Failure Mode and Effects Analysis

Functional Requirements
Another step in the DFMEA process is a compilation of the
functional and interface requirements of the design. This list may
include the following categories:
• General: This category considers the purpose of the product

y
and its overall design intent

an
• Safety
• Government Regulations

p
• Reliability (Life of the Function)

nl om
• Loading and Duty Cycles: Customer product usage profile
• Quiet Operations: Noise, vibration and harshness (NVH)

O C
• Fluid Retention
• Ergonomics

r
y
•

se o
Appearance
U ot • Packaging and Shipping
• Service
al M
• Design for Assembly
• Design for Manufacturability
rn rd
te o

Other Tools and Information Resources

In f F

Other tools and resources that may help the team understand and
define the design requirements may include:
o

• Schematics, drawings, etc.

• Bill of Materials (BOM)
ty

• Interrelationship matrices
er

• Interface matrix
•
op

Quality Function Deployment (QFD)

• Quality and Reliability History
Pr

The use of these tools, supported by engineering experience and

historical information, can assist in defining a comprehensive set
of requirements and functions.
After considering these prerequisites, start filling out the form
(Table III.1 below).

22
Chapter III Design Failure Mode and Effects Analysis

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23
Pr
POTENTIAL
______ System FAILURE MODE AND EFFECTS ANALYSIS FMEA Number A
(DESIGN FMEA) Page of
______ Subsystem
op
______Component; _____________________________________
B Design Responsibility ______________________________________
C Prepared By: H
Chapter III

Model Year(s)/Program(s)_________________________________
D Key Date ________________________________________________
E FMEA Date (Orig.) F
er
Core Team G ty
Current Design Action Results
Item Potential Potential Potential Responsibility
Requirement Recommended
Failure Effect(s) of Cause(s) of Controls RPN Action Actions Taken
Controls
o & Target
RPN

Severity
Mode Failure Failure Prevention Detection Completion Date Completion Date
Severity

Function
Detection

Detection

Classification
Occurrence
Occurrence

Front Door L.H. Maintain integrity Integrity breach 5 7 105 Based on test 5 2 3 30
Corroded interior Upper edge of Design 3 Vehicle Laboratory A. Tate
H8HX-0000-A of inner door allows environ. requirements results (test no.
lower door panels protective wax durability test. accelerated Body Engineer
1481) upper edge
In f F
panel access of inner application specified (#31268) and T-118 (7) corrosion test
door panel for inner door panels best practice 0X 09 03 spec raised 125
Deteriorated life of is too low (BP 3455) 0X 09 30
door leading to:
te o
• Unsatisfactory Test results (Test 5 2 3 30
Insufficient wax Vehicle 7 105 Laboratory A. Tate
appearanc e due to Design 3 No. 1481) show
thickness specified accelerated Body Engineer
rust through paint requirements durability test.
corrosion test specified thickness
over time. (#31268) and T-118 (7) 0X 09 03 is adequate.
• Impaired function best practice
rn rd
of interior door (BP 3455) 0X 09 30
hardware Design of J. Smythe DOE shows 25% 5 2 3 30
Experiments Body Engineer variation in specified

24
(DOE) on Wax thickness is
Thickness 0X 10 18 acceptable
al M
0X 10 25

Inappropriate wax Industry 2 Physical and 5 50 None

formulation specified standard Chemical Lab
MS-1893 test - Report
No. 1265 (5)
U ot
Vehicle
durability test.
T-118 (7)
se o
Corner design 5 Design aid 7 175 Team T. Edwards Based on test: 5 1 1 5
r prevents spray equip with non- evaluation using Body Engineer 3 additional vent
from reaching all functioning production spray and Assy Ops holes provided in
areas spray head (8) equipment and affected areas
O C Vehicle specified wax 0X 11 15 (error-proofed)
durability test. 0X 12 15
T-118 (7)

Insufficient room 4 Drawing 4 80 Team Evaluation showed 5 2 4 40

Body Engineer
between panels evaluation of evaluation using adequate access
and Assy Ops
SAMPLE for spray head
nl om
spray head design aid buck
access access (4) and spray head 0X 12 15
y Vehicle
0X 11 15

durability test.
p T-118 (7)
an
a1 a2 b c de f h g h i j k l m ----n----

Table III.1 Sample DFMEA Form with Minimal Information Elements & Example Entries
Design Failure Mode and Effects Analysis

y
Chapter III Design Failure Mode and Effects Analysis

Example DFMEA
The example used with the sample form deals with a Front Door
assembly. The product has several functional requirements:
• Permit ingress to and egress from vehicle

y
• Provide occupant protection from

an
o Weather (comfort)
o Noise (comfort)

p
o Side impact (safety)

nl om
• Support anchorage for door hardware including
o Mirror

O C
o Hinges
o Latch

r
y
o Window regulator

se o • Provide proper surface for appearance items

U ot o Paint
al M
o Soft trim
• Maintain integrity of inner door panel
rn rd

The final DFMEA would include analysis of all these

requirements. The example includes part of the analysis of the
te o

requirement: “Maintain integrity of inner door panel”.

In f F

Header of the Design FMEA Form (fields A-H)

The following describes the information to be entered on the

form.
ty

The header should clearly identify the focus of the FMEA as

well as information related to the document development and

control process. This should include an FMEA number,
identification of the scope, design responsibility, completion
op

dates, etc. The header should contain the following elements 2 :

2
The letters at the end of each heading indicate the area referred to on the sample form.

25
Pr
POTENTIAL
______ System FAILURE MODE AND EFFECTS ANALYSIS FMEA Number A
(DESIGN FMEA) Page of
______ Subsystem
op
______Component; _____________________________________
B Design Responsibility ______________________________________
C Prepared By: H
Chapter III

Model Year(s)/Program(s)_________________________________
D Key Date ________________________________________________
E FMEA Date (Orig.) F
er
Core Team G
ty
Current Design Action Results
Item Potential Potential Potential Responsibility
Requirement Recommended
Failure Effect(s) of Cause(s) of Controls RPN Action Actions Taken
Controls
o & Target
RPN

Severity
Mode Failure Failure Prevention Detection Completion Date Completion Date
Severity

Function
Detection

Detection

Classification
Occurrence
Occurrence

26
(DOE) on Wax thickness is
Thickness 0X 10 18 acceptable
al M
0X 10 25

Inappropriate wax Industry 2 Physical and 5 50 None

Insufficient room 4 Drawing 4 80 Team Evaluation showed 5 2 4 40

durability test.
p T-118 (7)
an
a1 a2 b c de f h g h i j k l m ----n----

Table III.1 Sample DFMEA Form with Minimal Information Elements & Example Entries
Design Failure Mode and Effects Analysis

y
Chapter III Design Failure Mode and Effects Analysis

FMEA Number (A)

Enter an alphanumeric string which is used to identify the FMEA
document. This is used for document control.

y
System, Subsystem, or Component Name

an
and Number (B)
Enter the name and number of the system, subsystem, or

p
component which is being analyzed. (See section entitled Define

nl om
the Scope).

Design Responsibility (C)

O C
Enter the OEM, organization, and department or group who is
design responsible. Also enter the supply organization name, if

r
y
applicable.

se o
U ot
Model Year(s)/Program(s) (D)
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Enter the intended model year(s) and program(s) that will use or
be affected by the design being analyzed (if known).
rn rd

Key Date (E)

te o

Enter the initial DFMEA due date, which should not exceed the
scheduled production design release date.
In f F

FMEA Dates (F)

Enter the date the original DFMEA was completed and the latest
revision date.
ty

Core Team (G)

Enter the team members responsible for developing the DFMEA.

Contact information (e.g., name, organization, telephone

number, and email) may be included in a referenced
supplemental document.
Pr

Prepared By (H)
Enter the name and contact information including the
organization (company) of the engineer responsible for preparing
the DFMEA.

27
Pr
POTENTIAL
______ System FAILURE MODE AND EFFECTS ANALYSIS FMEA Number A
(DESIGN FMEA) Page of
______ Subsystem
op
______Component; _____________________________________
B Design Responsibility ______________________________________
C Prepared By: H
Chapter III

Model Year(s)/Program(s)_________________________________
D Key Date ________________________________________________
E FMEA Date (Orig.) F
er
Core Team G
ty
Current Design Action Results
Item Potential Potential Potential Responsibility
Requirement Recommended
Failure Effect(s) of Cause(s) of Controls RPN Action Actions Taken
Controls
o & Target
RPN

Severity
Mode Failure Failure Prevention Detection Completion Date Completion Date
Severity

Function
Detection

Detection

Classification
Occurrence
Occurrence

28
(DOE) on Wax thickness is
Thickness 0X 10 18 acceptable
al M
0X 10 25

Inappropriate wax Industry 2 Physical and 5 50 None

Insufficient room 4 Drawing 4 80 Team Evaluation showed 5 2 4 40

durability test.
p T-118 (7)
an
a1 a2 b c de f h g h i j k l m ----n----

Table III.1 Sample DFMEA Form with Minimal Information Elements & Example Entries
Design Failure Mode and Effects Analysis

y
Chapter III Design Failure Mode and Effects Analysis

Body of the DFMEA Form (fields a – n)

The body of the FMEA contains the analysis of risks related to
the potential failures, and improvement action being taken. 3

Item / Function / Requirements (a)

y
an
Item/Function can be separated into two (or more) columns or
combined into a single, bridged column which encompasses
these elements. Interfaces (as “items” of analysis) can be either

p
combined or separate. Components may be listed in the

nl om
item/function column, and an additional column may be added
containing the functions or requirements of that item. “Item”,
“Function”, and “Requirements” are described below:

O C
Item (a1)

r
Enter the items, interfaces, or parts which have been identified

y
se o
through block diagrams, P-diagrams, schematics and other
U ot drawings, and other analysis conducted by the team.
The terminology used should be consistent with customer
al M
requirements and with those used in other design development
documents and analysis to ensure traceability.
rn rd

Function (a1)
te o

Enter the function(s) of the item(s) or interface(s) being analyzed

which are necessary to meet the design intent based on customer
In f F

requirements and the team’s discussion. If the item(s) or

interface has more than one function with different potential
modes of failure, it is highly recommended that each of these
o

functions and associated failure mode(s) is listed separately.

Function becomes a2 if Item and Function are split.
ty
er

Requirements (a2)
An additional column, “Requirements”, may be added to further
op

refine the analysis of the failure mode(s). Enter the

requirement(s) for each of the functions being analyzed (based
on customer requirements and the team’s discussion; see also
Pr

Chapter II, Section: Prerequisites). If the function has more than

one requirement with different potential modes of failure, it is
highly recommended that each of the requirements and functions
are listed separately.
Requirement becomes a3 if Item and Function are split into
separate columns, e.g., a1 and a2.

3
The letters at the end of each heading indicate the area referred to on the sample form.

29
Pr
POTENTIAL
______ System FAILURE MODE AND EFFECTS ANALYSIS FMEA Number A
(DESIGN FMEA) Page of
______ Subsystem
op
______Component; _____________________________________
B Design Responsibility ______________________________________
C Prepared By: H
Chapter III

Model Year(s)/Program(s)_________________________________
D Key Date ________________________________________________
E FMEA Date (Orig.) F
er
Core Team G
ty
Current Design Action Results
Item Potential Potential Potential Responsibility
Requirement Recommended
Failure Effect(s) of Cause(s) of Controls RPN Action Actions Taken
Controls
o & Target
RPN

Severity
Mode Failure Failure Prevention Detection Completion Date Completion Date
Severity

Function
Detection

Detection

Classification
Occurrence
Occurrence

30
(DOE) on Wax thickness is
Thickness 0X 10 18 acceptable
al M
0X 10 25

Inappropriate wax Industry 2 Physical and 5 50 None

Insufficient room 4 Drawing 4 80 Team Evaluation showed 5 2 4 40

durability test.
p T-118 (7)
an
a1 a2 b c de f h g h i j k l m ----n----

Table III.1 Sample DFMEA Form with Minimal Information Elements & Example Entries
Design Failure Mode and Effects Analysis

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Chapter III Design Failure Mode and Effects Analysis

Potential Failure Mode (b)

Potential failure mode is defined as the manner in which a
component, subsystem, or system could potentially fail to meet
or deliver the intended function described in the item column.

y
Identify the potential failure mode(s) associated with the

an
function(s)/requirement(s). Potential failure modes should be
described in technical terms, and not necessarily as a symptom
noticeable by the customer.

p
Each function may have multiple failure modes. A large number

nl om
of failure modes identified for a single function may indicate that
the requirement is not well defined.
The assumption is made that the failure could occur, but may not

O C
necessarily occur, consequently the use of the word “potential”.

r
y
se o
Potential failure modes that could occur only under certain
operating conditions (i.e., hot, cold, dry, dusty, etc.) and under
U ot
certain usage conditions (i.e., above-average mileage, rough
terrain, city driving only, etc.) should be considered.
al M

After determining all the failure modes, a validation of the

rn rd

completeness of the analysis can be made through a review of

past things-gone-wrong, concerns, reports, and group
te o

brainstorming.
In f F

The potential failure mode may also be the cause of a potential

failure mode in a higher level subsystem or system, or lead to the
effect of one in a lower level component.
o

Example failure modes, as related to different requirements, are

shown in table III.3.
ty
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31
Chapter III Design Failure Mode and Effects Analysis

Item Function Requirement Failure Mode

Disk Stop vehicle on
Stop vehicle traveling Vehicle does not stop
Brake demand

y
system (considering on dry asphalt
Vehicle stops in excess of

an
environmental pavement within
conditions such specified distance specified distance
as wet, dry, etc.) within specified g’s of
Stops vehicle with more than xx

p
force
g’s of force

nl om
Activates with no demand;
Allow unimpeded Vehicle movement is partially
vehicle movement on impeded

O C
no system demand Activates with no demand
Vehicle cannot move

r
y
Brake Allows transfer Must deliver specified

se o
Rotor of force from
U ot torque resistance at axle Insufficient torque resistance
brake pads to delivered
axle
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Table III.3 Example Potential Failure Modes

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32
Chapter III Design Failure Mode and Effects Analysis

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33
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POTENTIAL
______ System FAILURE MODE AND EFFECTS ANALYSIS FMEA Number A
(DESIGN FMEA) Page of
______ Subsystem
op
______Component; _____________________________________
B Design Responsibility ______________________________________
C Prepared By: H
Chapter III

Model Year(s)/Program(s)_________________________________
D Key Date ________________________________________________
E FMEA Date (Orig.) F
er
Core Team G
ty
Current Design Action Results
Item Potential Potential Potential Responsibility
Requirement Recommended
Failure Effect(s) of Cause(s) of Controls RPN Action Actions Taken
Controls
o & Target
RPN

Severity
Mode Failure Failure Prevention Detection Completion Date Completion Date
Severity

Function
Detection

Detection

Classification
Occurrence
Occurrence

34
(DOE) on Wax thickness is
Thickness 0X 10 18 acceptable
al M
0X 10 25

Inappropriate wax Industry 2 Physical and 5 50 None

Insufficient room 4 Drawing 4 80 Team Evaluation showed 5 2 4 40

durability test.
p T-118 (7)
an
a1 a2 b c de f h g h i j k l m ----n----

Table III.1 Sample DFMEA Form with Minimal Information Elements & Example Entries
Design Failure Mode and Effects Analysis

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Chapter III Design Failure Mode and Effects Analysis

Potential Effect(s) of Failure (c)

Potential effects of failure are defined as the effects of the failure
mode on the function, as perceived by the customer(s).
Describe the effects of the failure in terms of what the customer

y
might notice or experience, remembering that the customer may

an
be an internal customer as well as the ultimate End User. State
clearly if the failure mode could impact safety or non-
compliance to regulations. The effects should always be stated in

p
terms of the specific system, subsystem, or component being

nl om
analyzed. Remember that a hierarchical relationship exists
between the component, subsystem, and system levels 4 . For
example, a part could fracture, which may cause the assembly to
vibrate, resulting in an intermittent system operation. The

O C
intermittent system operation could cause performance to
degrade and ultimately lead to customer dissatisfaction. The

r
intent is to predict the potential failure effects to the team’s level

y
se o
of knowledge.
U ot Typical failure effects should be stated in terms of product or
system performance. Table III.4 shows example effects of the
al M
failure modes from Table III.3.

Item Failure Mode Effect

rn rd

Disk Brake Vehicle does not

Vehicle control impaired; Regulatory non-compliance
te o

System stop
Vehicle stops in
In f F

excess of specified Vehicle control impaired; Regulatory non-compliance

distance
Stops vehicle with
o

more than xx g’s of Regulatory non-compliance

force
ty

Activates with no
er

demand;
Decreased pad life; diminished vehicle control
Vehicle movement is
op

partially impeded
Activates with no
demand Customer unable to drive vehicle
Pr

Vehicle cannot move

Table III.4 Example Potential Effects

4
See also Appendix B

35
Pr
POTENTIAL
______ System FAILURE MODE AND EFFECTS ANALYSIS FMEA Number A
(DESIGN FMEA) Page of
______ Subsystem
op
______Component; _____________________________________
B Design Responsibility ______________________________________
C Prepared By: H
Chapter III

Model Year(s)/Program(s)_________________________________
D Key Date ________________________________________________
E FMEA Date (Orig.) F
er
Core Team G
ty
Current Design Action Results
Item Potential Potential Potential Responsibility
Requirement Recommended
Failure Effect(s) of Cause(s) of Controls RPN Action Actions Taken
Controls
o & Target
RPN

Severity
Mode Failure Failure Prevention Detection Completion Date Completion Date
Severity

Function
Detection

Detection

Classification
Occurrence
Occurrence

36
(DOE) on Wax thickness is
Thickness 0X 10 18 acceptable
al M
0X 10 25

Inappropriate wax Industry 2 Physical and 5 50 None

Insufficient room 4 Drawing 4 80 Team Evaluation showed 5 2 4 40

durability test.
p T-118 (7)
an
a1 a2 b c de f h g h i j k l m ----n----

Table III.1 Sample DFMEA Form with Minimal Information Elements & Example Entries
Design Failure Mode and Effects Analysis

y
Chapter III Design Failure Mode and Effects Analysis

Severity (S) (d)

Severity is the value associated with the most serious effect for a
given failure mode. Severity is a relative ranking within the
scope of the individual FMEA.

y
Suggested Evaluation Criteria

an
The team should agree on evaluation criteria and a ranking
system and apply them consistently, even if modified for

p
individual process analysis. (See Table Cr1 below for criteria
guidelines.)

nl om
It is not recommended to modify criteria ranking values of 9 and
10. Failure modes with a rank of severity 1 should not be
analyzed further.

O C
Criteria:

r
Effect Rank

y
Severity of Effect on Product

se o
U ot (Customer Effect)

Failure to Potential failure mode affects safe vehicle operation and/or involves 10
noncompliance with government regulation without warning.
al M
Meet Safety
and/or
Regulatory Potential failure mode affects safe vehicle operation and/or involves
Requirements
9
rn rd

noncompliance with government regulation with warning.

Loss of primary function (vehicle inoperable, does not affect safe 8

te o

Loss or vehicle operation).

Degradation
In f F

of Primary
Degradation of primary function (vehicle operable, but at reduced 7
Function
level of performance).
o

Loss of secondary function (vehicle operable, but comfort / 6

Loss or
convenience functions inoperable).
ty

Degradation
of Secondary
Degradation of secondary function (vehicle operable, but comfort / 5
er

Function
convenience functions at reduced level of performance).
op

Appearance or Audible Noise, vehicle operable, item does not 4

conform and noticed by most customers (> 75%).
Pr

Appearance or Audible Noise, vehicle operable, item does not 3

Annoyance
conform and noticed by many customers (50%).

Appearance or Audible Noise, vehicle operable, item does not 2

conform and noticed by discriminating customers (< 25%).

No effect No discernible effect. 1

Table Cr1 Suggested DFMEA Severity Evaluation Criteria

37
Pr
POTENTIAL
______ System FAILURE MODE AND EFFECTS ANALYSIS FMEA Number A
(DESIGN FMEA) Page of
______ Subsystem
op
______Component; _____________________________________
B Design Responsibility ______________________________________
C Prepared By: H
Chapter III

Model Year(s)/Program(s)_________________________________
D Key Date ________________________________________________
E FMEA Date (Orig.) F
er
Core Team G
ty
Current Design Action Results
Item Potential Potential Potential Responsibility
Requirement Recommended
Failure Effect(s) of Cause(s) of Controls RPN Action Actions Taken
Controls
o & Target
RPN

Severity
Mode Failure Failure Prevention Detection Completion Date Completion Date
Severity

Function
Detection

Detection

Classification
Occurrence
Occurrence

38
(DOE) on Wax thickness is
Thickness 0X 10 18 acceptable
al M
0X 10 25

Inappropriate wax Industry 2 Physical and 5 50 None

Insufficient room 4 Drawing 4 80 Team Evaluation showed 5 2 4 40

durability test.
p T-118 (7)
an
a1 a2 b c de f h g h i j k l m ----n----

Table III.1 Sample DFMEA Form with Minimal Information Elements & Example Entries
Design Failure Mode and Effects Analysis

y
Chapter III Design Failure Mode and Effects Analysis

Classification (e)
This column may be used to highlight high-priority failure
modes and their associated causes.
As a result of this analysis, the team may use this information to

y
identify special characteristics.

an
Customer specific requirements may identify special product or
process characteristic symbols and their usage.

p
A characteristic designated in the design record as special
without an associated design failure mode identified in the

nl om
DFMEA is an indication of a weakness in the design process.

Potential Cause(s)/Mechanism(s) of Failure

O C
Mode (f)

r
This information can be separated into multiple columns or

y
se o
combined into a single column.
U ot
In the development of the FMEA, the identification of all
potential causes of the failure mode is key to subsequent
al M
analysis. Although varied techniques (such as brainstorming) can
be used to determine the potential cause(s) of the failure mode, it
is recommended that the team should focus on an understanding
rn rd

of the failure mechanism for each failure mode.

te o

Potential Mechanism(s) of Failure Mode (f1)

In f F

A failure mechanism is the physical, chemical, electrical,

thermal, or other process that results in the failure mode. It is
important to make the distinction that a failure mode is an
o

"observed" or "external" effect so as not to confuse failure mode

with failure mechanism, the actual physical phenomenon behind
ty

the failure mode or the process of degradation or chain of events

leading to and resulting in a particular failure mode.
er

To the extent possible, list every potential mechanism for each

failure mode. The mechanism should be listed as concisely and
op

completely as possible.
For a system, the failure mechanism is the process of error
Pr

propagation following a component failure which leads to a

system failure.
A product or process can have several failure modes which are
correlated to each other because of a common failure
mechanism behind them.
Ensure that process effects are considered as part of the
DFMEA process.

39
Pr
POTENTIAL
______ System FAILURE MODE AND EFFECTS ANALYSIS FMEA Number A
(DESIGN FMEA) Page of
______ Subsystem
op
______Component; _____________________________________
B Design Responsibility ______________________________________
C Prepared By: H
Chapter III

Model Year(s)/Program(s)_________________________________
D Key Date ________________________________________________
E FMEA Date (Orig.) F
er
Core Team G
ty
Current Design Action Results
Item Potential Potential Potential Responsibility
Requirement Recommended
Failure Effect(s) of Cause(s) of Controls RPN Action Actions Taken
Controls
o & Target
RPN

Severity
Mode Failure Failure Prevention Detection Completion Date Completion Date
Severity

Function
Detection

Detection

Classification
Occurrence
Occurrence

40
(DOE) on Wax thickness is
Thickness 0X 10 18 acceptable
al M
0X 10 25

Inappropriate wax Industry 2 Physical and 5 50 None

Insufficient room 4 Drawing 4 80 Team Evaluation showed 5 2 4 40

durability test.
p T-118 (7)
an
a1 a2 b c de f h g h i j k l m ----n----

Table III.1 Sample DFMEA Form with Minimal Information Elements & Example Entries
Design Failure Mode and Effects Analysis

y
Chapter III Design Failure Mode and Effects Analysis

Potential Cause(s) of Failure Mode (f2)

Potential cause of failure is defined as an indication of how the
design process could allow the failure to occur, described in
terms of something that can be corrected or can be controlled.

y
Potential cause of failure may be an indication of a design

an
weakness, the consequence of which is the failure mode.

p
Causes are the circumstances that induce or activate a failure
mechanism.

nl om
In identifying potential causes of failure, use concise
descriptions of the specific causes of failures, e.g., specified bolt

O C
plating allows for hydrogen embrittlement. Ambiguous phrases
such as, poor design or improper design, should not be used.

r
y
se o
Investigation of causes needs to focus on the failure mode and
not on the effect(s). In determining the cause(s), the team should
U ot
assume the existence of the cause under discussion will result in
the failure mode (i.e., the failure mode does not require multiple
al M
causes to occur).
Typically, there may be several causes each of which can result
rn rd

in the failure mode. This results in multiple lines (cause

branches) for the failure mode.
te o

To the extent possible, list every potential cause for each failure
mode/failure mechanism. The cause should be listed as concisely
In f F

and completely as possible. Separating the causes will result in a

focused analysis for each cause and may yield different
measurement, controls, and action plans.
o

Table III.5. shows sample causes for the failure modes in Table
ty

III.3. Although not required as part of the minimum FMEA form

elements, the table includes the failure mechanism to show the
er

relationships among failure mode, failure mechanism, and cause.

In preparing the DFMEA, assume that the design will be
op

manufactured and assembled to the design intent. Exceptions can

be made at the team’s discretion where historical data indicate
deficiencies in the manufacturing process.
Pr

41
Chapter III Design Failure Mode and Effects Analysis

Failure Mode Mechanism Cause

Mechanical linkage break due to inadequate corrosion

y
protection

an
No transfer of force Master cylinder vacuum lock due to seal design
Vehicle does not stop
from pedal to pads
Loss of hydraulic fluid from loose hydraulic line due to

p
incorrect connector torque specification

nl om
Loss of hydraulic fluid due to hydraulic lines
crimped/compressed, inappropriate tube material specified
Mechanical linkage joints stiff due to inappropriate
lubrication specification
Mechanical linkage joints corroded due to inadequate

O C
Reduced transfer of
Vehicle stops in excess of corrosion protection
force from pedal to
yy feet
pads
Partial loss of hydraulic fluid due to hydraulic lines

r
y
crimped, inappropriate tube material specified

se o Excessive/rapid
U ot
Stops vehicle with more
than xx g’s of force
transfer of force from
pedal to pads
Cumulative pressure build-up in master cylinder due to
seal design
al M
Activate with no demand; Corrosion or deposit build up on rails or pad ears due to
Vehicle movement is Pads do not release surface finish not promoting adequate self cleaning and
impeded corrosion protection
rn rd

Activate with no demand Hydraulic pressure

Master cylinder vacuum lock due to seal design
Vehicle cannot move does not release
te o
In f F

Table III.5 Example Potential Causes

o
ty
er
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42
Chapter III Design Failure Mode and Effects Analysis

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43
Pr
POTENTIAL
______ System FAILURE MODE AND EFFECTS ANALYSIS FMEA Number A
(DESIGN FMEA) Page of
______ Subsystem
op
______Component; _____________________________________
B Design Responsibility ______________________________________
C Prepared By: H
Chapter III

Model Year(s)/Program(s)_________________________________
D Key Date ________________________________________________
E FMEA Date (Orig.) F
er
Core Team G
ty
Current Design Action Results
Item Potential Potential Potential Responsibility
Requirement Recommended
Failure Effect(s) of Cause(s) of Controls RPN Action Actions Taken
Controls
o & Target
RPN

Severity
Mode Failure Failure Prevention Detection Completion Date Completion Date
Severity

Function
Detection

Detection

Classification
Occurrence
Occurrence

44
(DOE) on Wax thickness is
Thickness 0X 10 18 acceptable
al M
0X 10 25

Inappropriate wax Industry 2 Physical and 5 50 None

Insufficient room 4 Drawing 4 80 Team Evaluation showed 5 2 4 40

durability test.
p T-118 (7)
an
a1 a2 b c de f h g h i j k l m ----n----

Table III.1 Sample DFMEA Form with Minimal Information Elements & Example Entries
Design Failure Mode and Effects Analysis

y
Chapter III Design Failure Mode and Effects Analysis

Occurrence (O) (g)

Occurrence is the likelihood that a specific cause/mechanism
will occur resulting in the failure mode within the design life.
The likelihood of occurrence ranking number has a relative
meaning rather than an absolute value (See Table Cr2).

y
A consistent occurrence ranking system should be used to ensure

an
continuity. The occurrence number is a relative ranking within
the scope of the FMEA and may not reflect the actual likelihood
of occurrence.

p
Suggested Evaluation Criteria

nl om
The team should agree on evaluation criteria and a ranking
system and apply them consistently, even if modified for
individual process analysis. Occurrence should be estimated

O C
using a 1 to 10 scale using Table Cr2 as a guideline.
In determining this estimate, questions such as the following

r
y
should be considered:

se o
• What is the service history and field experience with similar
U ot components, subsystems, or systems?
•
al M
Is the item a carryover or similar to a previous level item?
• How significant are changes from a previous level item?
rn rd

• Is the item radically different from a previous level item?

• Is the item completely new?
te o

• What is the application or what are the environmental

In f F

changes?
• Has an engineering analysis (e.g., reliability) been used to
o

estimate the expected comparable occurrence rate for the

application?
ty

• Have preventive controls been put in place?

er
op
Pr

45
Chapter III Design Failure Mode and Effects Analysis

Criteria: Occurrence
Likelihood Criteria: Occurrence of Cause - DFMEA of Cause - DFMEA
Rank
of Failure (Design life/reliability of item/vehicle) (Incidents per
items/vehicles)

y
an
New technology/new design with no history. ≥ 100 per thousand
Very High 10
≥ 1 in 10

p
Failure is inevitable with new design, new application, or 50 per thousand
change in duty cycle/operating conditions. 9

nl om
1 in 20
Failure is likely with new design, new application, or 20 per thousand
High change in duty cycle/operating conditions. 8
1 in 50

O C
Failure is uncertain with new design, new application, or 10 per thousand
change in duty cycle/operating conditions. 7
1 in 100

r
y
se o
Frequent failures associated with similar designs or in 2 per thousand
design simulation and testing.
U ot 6
1 in 500
Occasional failures associated with similar designs or in .5 per thousand
al M
Moderate design simulation and testing. 5
1 in 2,000
Isolated failures associated with similar design or in .1 per thousand
4
rn rd

design simulation and testing.

1 in 10,000
Only isolated failures associated with almost identical .01 per thousand
te o

design or in design simulation and testing. 3

1 in 100,000
In f F

Low
No observed failures associated with almost identical ≤.001 per thousand
design or in design simulation and testing. 2
1 in 1,000,000
o

Failure is eliminated through preventive control. Failure is eliminated

Very Low through preventive 1
ty

control.
er

Table Cr2 Suggested DFMEA Occurrence Evaluation Criteria

op
Pr

46
Chapter III Design Failure Mode and Effects Analysis

This page intentionally left blank.

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47
Pr
POTENTIAL
______ System FAILURE MODE AND EFFECTS ANALYSIS FMEA Number A
(DESIGN FMEA) Page of
______ Subsystem
op
______Component; _____________________________________
B Design Responsibility ______________________________________
C Prepared By: H
Chapter III

Model Year(s)/Program(s)_________________________________
D Key Date ________________________________________________
E FMEA Date (Orig.) F
er
Core Team G
ty
Current Design Action Results
Item Potential Potential Potential Responsibility
Requirement Recommended
Failure Effect(s) of Cause(s) of Controls RPN Action Actions Taken
Controls
o & Target
RPN

Severity
Mode Failure Failure Prevention Detection Completion Date Completion Date
Severity

Function
Detection

Detection

Classification
Occurrence
Occurrence

48
(DOE) on Wax thickness is
Thickness 0X 10 18 acceptable
al M
0X 10 25

Inappropriate wax Industry 2 Physical and 5 50 None

Insufficient room 4 Drawing 4 80 Team Evaluation showed 5 2 4 40

durability test.
p T-118 (7)
an
a1 a2 b c de f h g h i j k l m ----n----

Table III.1 Sample DFMEA Form with Minimal Information Elements & Example Entries
Design Failure Mode and Effects Analysis

y
Chapter III Design Failure Mode and Effects Analysis

Current Design Controls (h)

Current Design Controls are those activities conducted as part of
the design process that have been completed or committed to and
that will assure the design adequacy for the design functional and
reliability requirements under consideration.

y
There are two types of design controls to consider:

an
Prevention:
Eliminate (prevent) the cause of the mechanism of failure or the
failure mode from occurring, or reduce its rate of occurrence.

p
Detection:

nl om
Identify (detect) the existence of a cause, the resulting
mechanism of failure or the failure mode, either by analytical or
physical methods, before the item is released for production.

O C
The preferred approach is to first use prevention controls, if

r
possible. The initial occurrence rankings will be affected by the

y
se o
prevention controls provided they are integrated as part of the
U ot design intent.
al M
Detection control should include identification of those activities
which detect the failure mode as well as those that detect the
cause.
rn rd

The team should consider analysis, testing, reviews, and other

activities that will assure the design adequacy such as:
te o

Prevention Controls
In f F

• Benchmarking studies
• Fail-safe designs
o

• Design and Material standards (internal and external)

• Documentation – records of best practices, lessons learned, etc.

from similar designs
er

• Simulation studies – analysis of concepts to establish design

requirements
op

• Error-proofing
Detection controls
Pr

• Design reviews
• Prototype testing
• Validation testing
• Simulation studies – validation of design
• Design of Experiments; including reliability testing
• Mock-up using similar parts

49
Pr
POTENTIAL
______ System FAILURE MODE AND EFFECTS ANALYSIS FMEA Number A
(DESIGN FMEA) Page of
______ Subsystem
op
______Component; _____________________________________
B Design Responsibility ______________________________________
C Prepared By: H
Chapter III

Model Year(s)/Program(s)_________________________________
D Key Date ________________________________________________
E FMEA Date (Orig.) F
er
Core Team G
ty
Current Design Action Results
Item Potential Potential Potential Responsibility
Requirement Recommended
Failure Effect(s) of Cause(s) of Controls RPN Action Actions Taken
Controls
o & Target
RPN

Severity
Mode Failure Failure Prevention Detection Completion Date Completion Date
Severity

Function
Detection

Detection

Classification
Occurrence
Occurrence

50
(DOE) on Wax thickness is
Thickness 0X 10 18 acceptable
al M
0X 10 25

Inappropriate wax Industry 2 Physical and 5 50 None

Insufficient room 4 Drawing 4 80 Team Evaluation showed 5 2 4 40

durability test.
p T-118 (7)
an
a1 a2 b c de f h g h i j k l m ----n----

Table III.1 Sample DFMEA Form with Minimal Information Elements & Example Entries
Design Failure Mode and Effects Analysis

y
Chapter III Design Failure Mode and Effects Analysis

The example Design FMEA form in this manual has two

columns for the design controls (i.e., separate columns for
Prevention Controls and Detection Controls) to assist the team in
clearly distinguishing between these two types of design
controls. This allows for a quick visual determination that both
types of design controls have been considered.

y
If a one-column (for design controls) form is used, then the

an
following prefixes should be used. For prevention controls, place
a 'P' before each prevention control listed. For detection controls,

p
place a 'D' before each detection control listed.

nl om
Preventing the causes of the failure mode through a design
change or design process change is the only way a reduction in
the occurrence ranking can be effected.

O C
Table III.6 shows example prevention and detection controls for
the causes identified in Table III.5.

r
y
se o
Failure Cause Prevention Detection
ModeU ot controls controls
Vehicle Mechanical linkage Designed per Environmental
al M
does not break due to inadequate material standard stress test 03-9963
stop corrosion protection MS-845
Master cylinder vacuum Carry-over design Pressure variability
rn rd

lock due to seal design with same duty testing – system

cycle requirements level
te o

Loss of hydraulic fluid Designed per Vibration step-

from loose hydraulic torque stress test 18-1950
In f F

line due to incorrect requirements -

connector torque 3993
specification
o

Loss of hydraulic fluid Designed per Design of

due to hydraulic lines material standard Experiments (DOE)
ty

crimped/compressed, MS-1178 – tube resiliency

inappropriate tube
er

material specified
op

Table III.6 Examples of Prevention and Detection Design Controls

51
Pr
POTENTIAL
______ System FAILURE MODE AND EFFECTS ANALYSIS FMEA Number A
(DESIGN FMEA) Page of
______ Subsystem
op
______Component; _____________________________________
B Design Responsibility ______________________________________
C Prepared By: H
Chapter III

Model Year(s)/Program(s)_________________________________
D Key Date ________________________________________________
E FMEA Date (Orig.) F
er
Core Team G
ty
Current Design Action Results
Item Potential Potential Potential Responsibility
Requirement Recommended
Failure Effect(s) of Cause(s) of Controls RPN Action Actions Taken
Controls
o & Target
RPN

Severity
Mode Failure Failure Prevention Detection Completion Date Completion Date
Severity

Function
Detection

Detection

Classification
Occurrence
Occurrence

52
(DOE) on Wax thickness is
Thickness 0X 10 18 acceptable
al M
0X 10 25

Inappropriate wax Industry 2 Physical and 5 50 None

Insufficient room 4 Drawing 4 80 Team Evaluation showed 5 2 4 40

durability test.
p T-118 (7)
an
a1 a2 b c de f h g h i j k l m ----n----

Table III.1 Sample DFMEA Form with Minimal Information Elements & Example Entries
Design Failure Mode and Effects Analysis

y
Chapter III Design Failure Mode and Effects Analysis

Detection (D) (i)

Detection is the rank associated with the best detection control
listed in the Current Design Control Detection column. When
more than one control is identified, it is recommended that the
detection ranking of each control be included as part of the

y
description of the control. Record the lowest ranking value in the
Detection column.

an
A suggested approach to Current Design Control Detection is to
assume the failure has occurred and then assess the capabilities

p
of the current design controls to detect this failure mode.

nl om
Do not automatically presume that the detection ranking is low
because the occurrence is low. It is important to assess the
capability of the design controls to detect low frequency failure
modes or reduce the risk of them going further in the design

O C
release process.
Detection is a relative ranking within the scope of the individual

r
y
FMEA. In order to achieve a lower ranking, generally the design

se o
control (analysis or verification activities) has to be improved.
U ot
al M
Suggested Evaluation Criteria
The team should agree on evaluation criteria and a ranking
system and apply them consistently, even if modified for
rn rd

individual process analysis. Detection should be estimated using

Table Cr3 as a guideline.
te o
In f F

The ranking value of one (1) is reserved for failure prevention

through proven design solutions.
o
ty
er
op
Pr

53
Chapter III Design Failure Mode and Effects Analysis

Opportunity Criteria: Likelihood

for Rank of
Detection Likelihood of Detection by Design Control Detection

No detection Almost
No current design control; Cannot detect or is not analyzed. 10

y
opportunity Impossible

an
Not likely to Design analysis/detection controls have a weak detection
Very
detect at any capability; Virtual Analysis (e.g., CAE, FEA, etc.) is not 9
stage correlated to expected actual operating conditions. Remote

p
nl om
Product verification/validation after design freeze and prior to
launch with pass/fail testing (Subsystem or system testing with
acceptance criteria such as ride and handling, shipping
8 Remote
evaluation, etc.).

O C
Post Design
Product verification/validation after design freeze and prior to

r
Freeze and

y
launch with test to failure testing (Subsystem or system testing 7 Very Low

se o
prior to launch
until failure occurs, testing of system interactions, etc.).
U ot
Product verification/validation after design freeze and prior to
al M
launch with degradation testing (Subsystem or system testing 6 Low
after durability test, e.g., function check).
rn rd

Product validation (reliability testing, development or

validation tests) prior to design freeze using pass/fail testing
5 Moderate
te o

(e.g., acceptance criteria for performance, function checks,

etc.).
In f F

Prior to Design Product validation (reliability testing, development or Moderately

Freeze validation tests) prior to design freeze using test to failure 4
o

(e.g., until leaks, yields, cracks, etc.). High

Product validation (reliability testing, development or

validation tests) prior to design freeze using degradation 3 High
er

testing (e.g., data trends, before/after values, etc.).

Design analysis/detection controls have a strong detection

Virtual
capability. Virtual analysis (e.g., CAE, FEA, etc.) is highly
Analysis - 2 Very High
Pr

correlated with actual or expected operating conditions prior

Correlated
to design freeze.

Detection not
Failure cause or failure mode can not occur because it is fully Almost
applicable;
Failure
prevented through design solutions (e.g., proven design 1
standard, best practice or common material, etc.). Certain
Prevention

Table Cr3 Suggested DFMEA/PFMEA Prevention/Detection Evaluation Criteria

54
Chapter III Design Failure Mode and Effects Analysis

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55
Pr
POTENTIAL
______ System FAILURE MODE AND EFFECTS ANALYSIS FMEA Number A
(DESIGN FMEA) Page of
______ Subsystem
op
______Component; _____________________________________
B Design Responsibility ______________________________________
C Prepared By: H
Chapter III

Model Year(s)/Program(s)_________________________________
D Key Date ________________________________________________
E FMEA Date (Orig.) F
er
Core Team G
ty
Current Design Action Results
Item Potential Potential Potential Responsibility
Requirement Recommended
Failure Effect(s) of Cause(s) of Controls RPN Action Actions Taken
Controls
o & Target
RPN

Severity
Mode Failure Failure Prevention Detection Completion Date Completion Date
Severity

Function
Detection

Detection

Classification
Occurrence
Occurrence

56
(DOE) on Wax thickness is
Thickness 0X 10 18 acceptable
al M
0X 10 25

Inappropriate wax Industry 2 Physical and 5 50 None

Insufficient room 4 Drawing 4 80 Team Evaluation showed 5 2 4 40

durability test.
p T-118 (7)
an
a1 a2 b c de f h g h i j k l m ----n----

Table III.1 Sample DFMEA Form with Minimal Information Elements & Example Entries
Design Failure Mode and Effects Analysis

y
Chapter III Design Failure Mode and Effects Analysis

Determining Action Priorities

Once the team has completed the initial identification of failure
modes and effects, causes and controls, including rankings for
severity, occurrence, and detection, they must decide if further
efforts are needed to reduce the risk. Due to the inherent

y
limitations on resources, time, technology, and other factors,
they must choose how to best prioritize these efforts.

an
The initial focus of the team should be oriented towards failure
modes with the highest severity rankings. When the severity is 9

p
or 10, it is imperative that the team must ensure that the risk is
addressed through existing design controls or recommended

nl om
actions (as documented in the FMEA).
For failure modes with severities 8 or below the team should
consider causes having highest occurrence or detection rankings.

O C
It is the team’s responsibility to look at the information
identified, decide upon an approach, and determine how to best

r
prioritize the risk reduction efforts that best serve their

y
se o
organization and customers.
U ot
Risk Evaluation;
al M
Risk Priority Number (RPN) (j)
One approach to assist in action prioritization has been to use the
rn rd

Risk Priority Number:

RPN = Severity (S) x Occurrence (O) x Detection (D)
te o

Within the scope of the individual FMEA, this value can range
In f F

between 1 and 1000.

The use of an RPN threshold is NOT a recommended practice
for determining the need for actions.
o

Applying thresholds assumes that RPNs are a measure of relative

risk (which they often are not) and that continuous improvement
is not required (which it is).
er

For example, if the customer applied an arbitrary threshold of

100 to the following, the supplier would be required to take
op

action on the characteristic B with the RPN of 112.

Item Severity Occurrence Detection RPN

A 9 2 5 90
B 7 4 4 112

57
Pr
POTENTIAL
______ System FAILURE MODE AND EFFECTS ANALYSIS FMEA Number A
(DESIGN FMEA) Page of
______ Subsystem
op
______Component; _____________________________________
B Design Responsibility ______________________________________
C Prepared By: H
Chapter III

Model Year(s)/Program(s)_________________________________
D Key Date ________________________________________________
E FMEA Date (Orig.) F
er
Core Team G
ty
Current Design Action Results
Item Potential Potential Potential Responsibility
Requirement Recommended
Failure Effect(s) of Cause(s) of Controls RPN Action Actions Taken
Controls
o & Target
RPN

Severity
Mode Failure Failure Prevention Detection Completion Date Completion Date
Severity

Function
Detection

Detection

Classification
Occurrence
Occurrence

58
(DOE) on Wax thickness is
Thickness 0X 10 18 acceptable
al M
0X 10 25

Inappropriate wax Industry 2 Physical and 5 50 None

Insufficient room 4 Drawing 4 80 Team Evaluation showed 5 2 4 40

durability test.
p T-118 (7)
an
a1 a2 b c de f h g h i j k l m ----n----

Table III.1 Sample DFMEA Form with Minimal Information Elements & Example Entries
Design Failure Mode and Effects Analysis

y
Chapter III Design Failure Mode and Effects Analysis

In this example, the RPN is higher for characteristic B, but the

priority should be to work on A with the higher severity of 9,
although the RPN is 90 which is lower and below the threshold.
Another concern with using the threshold approach is that there
is no specific RPN value that requires mandatory action.

y
Unfortunately, establishing such thresholds may promote the

an
wrong behavior causing team members to spend time trying to
justify a lower occurrence or detection ranking value to reduce
RPN. This type of behavior avoids addressing the real problem

p
that underlies the cause of the failure mode and merely keeps the

nl om
RPN below the threshold. It is important to recognize that while
determining “acceptable” risk at a particular program milestone
(e.g., vehicle launch) is desirable, it should be based on an
analysis of severity, occurrence and detection and not through

O C
the application of RPN thresholds.

r
y
Use of the RPN index in the discussions of the team can be a

se o
useful tool. The limitations of the use of RPN need to be
U ot
understood. However, the use of RPN thresholds to determine
action priority is not recommended.
al M
Recommended Action(s) (k)
rn rd

In general, prevention actions (i.e., reducing the occurrence) are

preferable to detection actions. An example of this is the use of
te o

proven design standard or best practice rather than product

verification/validation after design freeze.
In f F

The intent of recommended actions is to improve the design.

Identifying these actions should consider reducing rankings in
o

the following order: severity, occurrence, and detection.

Example approaches to reduce these are explained below:
ty

• To Reduce Severity (S) Ranking: Only a design revision can

bring about a reduction in the severity ranking.
er
op

High severity rankings can sometimes be reduced by making

design revisions that compensate or mitigate the resultant
severity of failure. For example: The requirement for a tire is to
“retain applied air pressure under use”. The severity of the effect
Pr

of the failure mode “rapid loss of air pressure” would be lower for
a “run flat” tire.

A design change, in and of itself, does not imply that the severity
will be reduced. Any design change should be reviewed by the
team to determine the effect to the product functionality and
process.

59
Pr
POTENTIAL
______ System FAILURE MODE AND EFFECTS ANALYSIS FMEA Number A
(DESIGN FMEA) Page of
______ Subsystem
op
______Component; _____________________________________
B Design Responsibility ______________________________________
C Prepared By: H
Chapter III

Model Year(s)/Program(s)_________________________________
D Key Date ________________________________________________
E FMEA Date (Orig.) F
er
Core Team G
ty
Current Design Action Results
Item Potential Potential Potential Responsibility
Requirement Recommended
Failure Effect(s) of Cause(s) of Controls RPN Action Actions Taken
Controls
o & Target
RPN

Severity
Mode Failure Failure Prevention Detection Completion Date Completion Date
Severity

Function
Detection

Detection

Classification
Occurrence
Occurrence

60
(DOE) on Wax thickness is
Thickness 0X 10 18 acceptable
al M
0X 10 25

Inappropriate wax Industry 2 Physical and 5 50 None

Insufficient room 4 Drawing 4 80 Team Evaluation showed 5 2 4 40

durability test.
p T-118 (7)
an
a1 a2 b c de f h g h i j k l m ----n----

Table III.1 Sample DFMEA Form with Minimal Information Elements & Example Entries
Design Failure Mode and Effects Analysis

y
Chapter III Design Failure Mode and Effects Analysis

For maximum effectiveness and efficiency of this approach,

changes to the product and process design should be
implemented early in the development process. For example,
alternate materials may need to be considered early in the
development cycle to eliminate corrosion severity.
• To Reduce Occurrence (O) Ranking: A reduction in the

y
occurrence ranking can be effected by removing or controlling

an
one or more of the causes or mechanisms of the failure mode
through a design revision. Actions such as, but not limited to,
the following should be considered:

p
o Error proof the design to eliminate the failure mode

nl om
o Revised design geometry and tolerances
o Revised design to lower the stresses or replace weak

O C
(high failure probability) components
o Add redundancy

r
y
o Revised material specification

se o
• To Reduce Detection (D) Ranking: The preferred method is
U ot the use of error/mistake proofing. An increase in design
validation/verification actions should result in a reduction of
al M
the detection ranking only. In some cases, a design change to a
specific part may be required to increase the likelihood of
detection (i.e., reduce the detection ranking). Additionally, the
rn rd

following should be considered:

o Design of Experiments (particularly when multiple
te o

or interactive causes of a failure mode are present)

In f F

o Revised test plan

If the assessment leads to no recommended actions for a specific
o

failure mode/cause/control combination, indicate this by entering

“None” in this column. It may be useful to also include a
ty

rationale if “None” is entered, especially in case of high severity.

For design actions consider using the following:
er

• Results of design DOE or reliability testing

• Design analysis (reliability, structural or physics of failure)

that would confirm that the solution is effective and does not
introduce new potential failure modes
Pr

• Drawing, schematics, or model to confirm physical change of

targeted feature
• Results from a design review
• Changes to a given Engineering Standard or Design Guidelines
• Reliability analysis results

61
Pr
POTENTIAL
______ System FAILURE MODE AND EFFECTS ANALYSIS FMEA Number A
(DESIGN FMEA) Page of
______ Subsystem
op
______Component; _____________________________________
B Design Responsibility ______________________________________
C Prepared By: H
Chapter III

Model Year(s)/Program(s)_________________________________
D Key Date ________________________________________________
E FMEA Date (Orig.) F
er
Core Team G
ty
Current Design Action Results
Item Potential Potential Potential Responsibility
Requirement Recommended
Failure Effect(s) of Cause(s) of Controls RPN Action Actions Taken
Controls
o & Target
RPN

Severity
Mode Failure Failure Prevention Detection Completion Date Completion Date
Severity

Function
Detection

Detection

Classification
Occurrence
Occurrence

62
(DOE) on Wax thickness is
Thickness 0X 10 18 acceptable
al M
0X 10 25

Inappropriate wax Industry 2 Physical and 5 50 None

Insufficient room 4 Drawing 4 80 Team Evaluation showed 5 2 4 40

durability test.
p T-118 (7)
an
a1 a2 b c de f h g h i j k l m ----n----

Table III.1 Sample DFMEA Form with Minimal Information Elements & Example Entries
Design Failure Mode and Effects Analysis

y
Chapter III Design Failure Mode and Effects Analysis

Table III.7 below provides an example of the application of

causes (Column f), controls (Column h) and recommended
actions (Column k).

Responsibility & Target Completion Date (l)

y
Enter the name of the individual and organization responsible for

an
completing each recommended action including the target
completion date. The design-responsible engineer/team leader is
responsible for ensuring that all actions recommended have been

p
implemented or adequately addressed.

nl om
Action Results (m-n)
This section identifies the results of any completed actions and

O C
their effect on S, O, D rankings and RPN.

r
y
Action(s) Taken and Completion Date (m)

se o
After the action has been implemented, enter a brief description
U ot
of the action taken and actual completion date.
al M
Severity, Occurrence, Detection and RPN (n)
After the preventive/corrective action has been completed,
rn rd

determine and record the resulting severity, occurrence, and

detection rankings.
te o

Calculate and record the resulting action (risk) priority indicator

In f F

(e.g., RPN).
All revised rankings should be reviewed. Actions alone do not
o

guarantee that the problem was solved (i.e., cause addressed),

thus an appropriate analysis or test should be completed as
verification. If further action is considered necessary, repeat the
ty

analysis. The focus should always be on continuous

improvement.
er
op
Pr

63
Chapter III Design Failure Mode and Effects Analysis

Item Failure Cause Prevention Detection Recommended

Mode Controls Controls Actions
Disk Vehicle Mechanical linkage Designed per Environmental stress Change material to
Brake does not break due to material test 03-9963 stainless steel
system stop inadequate corrosion standard MS-

y
protection 845

an
Master cylinder Carry-over Pressure variability Use carry-over seal
vacuum lock due to design with testing – system level design
seal design same duty cycle
requirements

p
Loss of hydraulic Designed per Vibration step-stress Modify connector

nl om
fluid from loose torque test 18-1950 from bolt-style to
hydraulic line due to requirements - quick-connect
incorrect connector 3993
torque specification
Loss of hydraulic Designed per DOE – tube Modify hose

O C
fluid due to hydraulic material resiliency design from MS-
lines standard MS- 1178 to MS-2025
crimped/compressed, 1178 to increase strength

r
y
inappropriate tube

se o
material specified
U ot
Table III.7 Examples of Causes, Controls and Recommended Actions
al M
rn rd

Maintaining DFMEAs
te o

The DFMEA is a living document and should be reviewed

In f F

whenever there is a product design change and updated, as

required. Recommended actions updates should be included into
a subsequent DFMEA along with the final results (what worked
o

and what did not work).

Another element of on-going maintenance of DFMEAs should

include a periodic review of the rankings used in the DFMEA.
er

Specific focus should be given to Occurrence and Detection

rankings. This is particularly important where improvements
have been made either through product changes or improvements
op

in design controls. Additionally, in cases where field issues have

occurred, the rankings should be revised accordingly.
Pr

64
Chapter III Design Failure Mode and Effects Analysis

Leveraging DFMEAs
If a new project or application is functionally similar to the
existing product, a single DFMEA may be used with customer
concurrence. Using a fundamentally sound baseline DFMEA as
the starting point provides the greatest opportunity to leverage

y
past experience and knowledge. If there are slight differences,

an
the team should identify and focus on the effects of these
differences.

p
Linkages

nl om
The DFMEA is not a “stand-alone” document. For example, the
output of the DFMEA can be used as input for subsequent
product development processes. It is the summary of the team’s

O C
discussions and analysis. Figure III.7 shows the linkages of
some of the commonly used documents.

r
y
se o
U ot
Boundary (Block) Diagram,
al M
P – Diagram, etc.
rn rd

DFMEA
te o
In f F

Design Verification
o

Plan & Report (DVP&R),

PFMEA, etc.
ty
er

Figure III.7 DFMEA Information Interrelationships Flow

op
Pr

65
Chapter III Design Failure Mode and Effects Analysis

Design Verification Plan & Report (DVP&R)

DFMEA and DVP&R have an important linkage. The DFMEA
identifies and documents the current design prevention and
detection controls which become input to the test description
included within the DVP&R. The DFMEA identifies “what” the

y
controls are while the DVP&R provides the “how” such as
acceptance criteria, procedure and sample size.

an
PFMEA

p
nl om
Another important linkage is between the DFMEA and PFMEA.
For example, a Process (PFMEA) failure mode or a Design
(DFMEA) failure mode can result in the same potential product
effect. In this case, the effects of the design failure mode should

O C
be reflected in the effects and severity rankings of the DFMEA
and PFMEA.

r
y
se o
U ot
al M
rn rd
te o
In f F
o
ty
er
op
Pr

66
Chapter IV Process Failure Mode and Effects Analysis

y
p an
nl om
O C r
y
se o
U ot
Chapter IV
al M
rn rd

PFMEA
te o

Process Failure Mode and Effects Analysis

In f F
o
ty
er
op
Pr

67
Chapter IV Process Failure Mode and Effects Analysis

Introduction
The process FMEA, referred to as PFMEA, supports
manufacturing process development in reducing the risk of
failures by:
• Identifying and evaluating the process functions and

y
requirements,

an
• Identifying and evaluating potential product and process-
related failure modes, and the effects of the potential failures

p
on the process and customers,

nl om
• Identifying the potential manufacturing or assembly process
causes,
• Identifying process variables on which to focus process

O C
controls for occurrence reduction or increased detection of the
failure conditions, and

r
•

y
Enabling the establishment of a priority system for

se o
preventive/corrective action and controls.
U ot The PFMEA is a living document and should:
• Be initiated before or at the feasibility stage,
al M
• Be initiated prior to tooling for production,
•
rn rd

Take into account all manufacturing operations from

individual components to assemblies, and
te o

• Include all processes within the plant that can impact the
manufacturing and assembly operations, such as shipping,
In f F

receiving, transporting of material, storage, conveyors or

labeling.
o

Early review and analysis of new or revised processes is advised

to anticipate, resolve, or monitor potential process concerns
ty

during the manufacturing planning stages of a new model or

component program.
er

The PFMEA assumes the product as designed will meet the

design intent. Potential failure modes that can occur because of a
op

design weakness may be included in a PFMEA. Their effect and

avoidance is covered by the Design FMEA.
The PFMEA does not rely on product design changes to
Pr

overcome limitations in the process. However, it does take into

consideration a product’s design characteristics relative to the
planned manufacturing or assembly process to assure that, to the
extent possible, the resultant product meets customer needs and
expectations. For example, the PFMEA development generally
assumes that the machines and equipment will meet their design
intent and therefore are excluded from the scope. Control
mechanisms for incoming parts and materials may need to be
considered based on historical data.

68
Chapter IV Process Failure Mode and Effects Analysis

Customer Defined
The definition of “Customer” for a PFMEA should normally be
the “End User.” However, the customer can also be a subsequent
or downstream manufacturing or assembly operation, a service

y
operation, or regulator. 5
Team Approach

an
The PFMEA is developed and maintained by a multi-disciplinary

p
(or cross-functional) team typically led by the responsible
engineer. During the initial development of the PFMEA, the

nl om
responsible engineer/team leader is expected to directly and
actively involve representatives from all affected areas. These
areas should include but are not limited to design, assembly,

O C
manufacturing, materials, quality, service, and suppliers, as well
as the area responsible for the next assembly. The PFMEA
should be a catalyst to stimulate the interchange of ideas between

r
y
the areas affected and thus promote a team approach.

se o
U ot
Design Considerations
al M
The team should assume the product as designed will meet the
design intent.
rn rd

During the development of a PFMEA, the team may identify

design opportunities which, if implemented, would either
te o

eliminate or reduce the occurrence of a process failure mode. For

example, adding a feature to a part and a matching feature to a
In f F

fixture will eliminate the possibility of an operator placing a part

in the wrong orientation. Such information must be provided to
the responsible design engineer as well as the tooling /
o

equipment / fixture design-responsible individual for

consideration and possible implementation.
ty
er
op
Pr

5
See discussion in Chapter II, Customer Defined

69
Chapter IV Process Failure Mode and Effects Analysis

Development of a Process FMEA

The process-responsible engineer/team leader has at his or her
disposal a number of documents that will be useful in preparing
the PFMEA. The PFMEA begins by developing a list of what the

y
process is expected to do and what it is expected not to do, i.e.,

an
the process intent.
The PFMEA should begin with a flow chart of the general

p
process. This flow chart should identify the product/process
characteristics associated with each operation. Identification of

nl om
product effects from the corresponding DFMEA should be
included. Copies of the flow chart used in the PFMEA
preparation should accompany it.

O C
In order to facilitate documentation of the analysis of potential
failures and their consequences, example PFMEA forms have
been developed and are provided in Appendix A. The minimum

r
y
se o
information content required for a PFMEA is discussed below.
U ot (Also see Table IV.1)
Prerequisites
al M
A PFMEA should begin with the development of information to
understand the manufacturing and assembly operations being
analyzed and define their requirements.
rn rd

The process flow diagram is a primary input to the PFMEA. The

flow diagram is used as a tool to help establish the scope of
te o

analysis during manufacturing system design.

In f F

Process Flow Diagram and linkage to PFMEA

A process flow diagram 6 describes the flow of the product

through the process – from incoming to outgoing. This should
ty

include each step in a manufacturing or assembly process as well

as their related outputs (product characteristics, requirements,
er

deliverables, etc.) and inputs (process characteristics, sources of

variation, etc.). The detail of the process flow depends on the
op

stage of process development discussion. The initial flow

diagram is generally considered a high level process map. It
needs more detailed analysis to identify the potential failure
Pr

modes.

6
The Process Flow Diagram is also referred to as a Process Flow Chart.

70
Chapter IV Process Failure Mode and Effects Analysis

y
p an
nl om
Figure IV.1 High Level to Detailed Process Maps

O C
The PFMEA should be consistent with the information in the

r
y
process flow diagram. The scope of the process flow diagram

se o
U ot should include all manufacturing operations from processing of
individual components to assemblies including shipping,
receiving, transportation of material, storage, conveyors,
al M
labeling, etc. A preliminary risk assessment using the process
flow diagram may be performed to identify which of these
operations or individual steps can have an impact on the product
rn rd

manufacturing and assembly and should be included in the

PFMEA.
te o

The PFMEA development continues by identifying the

In f F

requirement(s) for each process/function. Requirements are the

outputs of each operation/step and relate to the requirements for
the product. The Requirements provide a description of what
o

should be achieved at each operation/step. The Requirements

provide the team with a basis to identify potential failure modes.
ty

In order to assure continuity, it is highly recommended that the

same cross-functional team develop the Process Flow Diagram,

PFMEA, and Control Plan.
op

See Figure IV.2 for an example process flow diagram.

71
Chapter IV Process Failure Mode and Effects Analysis

y
p an
nl om
O C r
y
se o
U ot
al M
rn rd
te o
In f F
o
ty
er
op
Pr

Figure IV.2 Example Process Flow Diagram

72
Chapter IV Process Failure Mode and Effects Analysis

Other Tools and Information Sources

Other sources of information that are useful in providing the
team with ways to focus and capture discussions on the
requirements of the process include:

y
• DFMEA

an
• Drawings and design records
•

p
Bill of Process
•

nl om
Interrelationship (Characteristic) matrix
• Internal and external (customer) nonconformances (i.e., known
failure modes based on historical data)

O C
• Quality and Reliability History

r
y
se o
Research Information
U ot After establishing the scope of the analysis effort, the team
should begin by reviewing historical information. The areas to
al M
review should include:
• Lessons that have been learned from previous product and
process design implementation, and
rn rd

• Any information available that establishes best practices

te o

including items such as guidelines and standards, standard part

identification, or error-proofing methods.
In f F

Quality performance information available from similar,

previous product and process designs, including items such as:
o

process yield 7 , first time capability (both end of line and at each
operation), Parts per Million (PPM), process capability indices
ty

(Cpk and Ppk), and warranty metrics.

The information can be useful input for determination of
er

severity, occurrence and detection rankings.

After considering these prerequisites, start filling out the form
op

(Table IV.1 below).

7
First Time Quality (FTQ); First Time Through (FTT)

73
Pr
POTENTIAL
FAILURE MODE AND EFFECTS ANALYSIS FMEA Number A
(PROCESS FMEA) Page of
op
Item: _________________________________________________
B Process Responsibility ______________________________________
C Prepared By: H
Chapter IV

Model Year(s)/Program(s)_________________________________
D Key Date __________________________________________________
E FMEA Date (Orig.) F
er
Core Team G
ty
Process Current Process Action Results
Step Potential Potential Potential Responsibility
Requirement Recommended
Failure Effect(s) of Cause(s) of Controls RPN Action Actions Taken
Controls
o & Target
RPN

Severity
Mode Failure Failure Prevention Detection Completion Date Completion Date
Severity

Function
Detection

Detection

Classification
Occurrence
Occurrence

Op 70: Cover inner door, Insufficient wax Allows integrity 7 Manually inserted None 8 Variables check 5 280 Add positive Mfg Engineering Stop added, 7 2 5 70
In f F
Manual lower surfaces coverage over breach of inner spray head not for film thickness depth stop to by 0X 10 15 sprayer checked
application of with wax to specified surface door panel inserted far sprayer online
wax inside specification enough
door panel thickness Visual check
te o
Corroded interior for coverage.
lower door panels
Automate Mfg Engineering Rejected due to
spraying by 0X 12 15 complexity of
Deteriorated life of different doors on
door leading to: the same line
rn rd
• Unsatisfactory
appearanc e due to
rust through paint Spray head Test spray at 5 Variables check 5 175 Use Design of Mfg Engineering Temp and Press 7 1 5 35

74
over time. clogged start-up and for film thickness experiments by Limits were
• Impaired function - Viscosity too high after idle periods (DOE) on 0X 10 01 determined and
of interior door - Temperature too viscosity vs. limit controls have
al M
and preventative Visual check
hardware low maintenance for coverage. temperature vs. been installed-
- Pressure too low program to pressure Control charts
clean heads show process is in
control Cpk=1.85
U ot
Spray head Preventative 2 Variables check 5 70 None
deformed due to maintenance for film thickness
impact programs to
maintain heads
se o
Visual check
for coverage.
r
Spray time None 5 Operator 7 245 Install Spray Maintenance Automatic spray 7 1 7 49
O C sufficient instructions timer. XX/XX/XX timer installed-
operator starts
Lot sampling spray, timer
(visual) check controls shut-off
coverage of control charts
critical areas show process is in
control – Cpk=2.05
SAMPLE
nl om
y
Excessive wax
pcoverage over
specified surface an
a1 a2 b c de f h g h i j k l m ----n----

Table IV.1 Sample PFMEA Form with Minimal Information Elements & Example Entries
Process Failure Mode and Effects Analysis

y
Chapter IV Process Failure Mode and Effects Analysis

Example PFMEA Form

The form used in the examples in this reference manual is a
guide to document the team’s discussions and analysis of the
PFMEA elements. It contains the minimum content that is

y
normally expected by the OEMs.

an
Column order can be modified and columns can be added to this
form depending on the organization and customer needs and
expectations. In any case, any form submitted must be

p
acceptable to the customer.

nl om
Header of the Process FMEA Form (fields A-H)

O C
The following describes the information to be entered on the
form.
The PFMEA header should clearly identify the focus of the

r
y
se o
PFMEA as well as information related to the document
U ot development and control process. This should include an FMEA
number, identification of the scope, design responsibility,
completion dates, etc. The header should contain the following
al M
elements 8 :
rn rd

FMEA Number (A)

Enter an alphanumeric string which is used to identify the
te o

PFMEA document. This is used for document control.

In f F

Item (B)
o

Enter the name and number of the system, subsystem or

component for which the process is being analyzed.
ty

Process Responsibility (C)

Enter the OEM, organization, and department or group who is

process design responsible. Also enter the supply organization
op

name, if applicable.
Pr

Model Year(s)/Program(s) (D)

Enter the intended model year(s) and program(s) that will use or
be affected by the process being analyzed (if known).

8
The letters at the end of each heading indicate the area referred to on the sample form.

75
Pr
POTENTIAL
FAILURE MODE AND EFFECTS ANALYSIS FMEA Number A
(PROCESS FMEA) Page of
op
Item: _________________________________________________
B Process Responsibility ______________________________________
C Prepared By: H
Chapter IV

Severity
Mode Failure Failure Prevention Detection Completion Date Completion Date
Severity

Function
Detection

Detection

Classification
Occurrence
Occurrence

76
over time. clogged start-up and for film thickness experiments by Limits were
• Impaired function - Viscosity too high after idle periods (DOE) on 0X 10 01 determined and
of interior door - Temperature too viscosity vs. limit controls have
al M
and preventative Visual check
hardware low maintenance for coverage. temperature vs. been installed-
- Pressure too low program to pressure Control charts
clean heads show process is in
control Cpk=1.85
U ot
Spray head Preventative 2 Variables check 5 70 None
deformed due to maintenance for film thickness
impact programs to
maintain heads
se o
Visual check
for coverage.
r
Spray time None 5 Operator 7 245 Install Spray Maintenance Automatic spray 7 1 7 49
O C sufficient instructions timer. XX/XX/XX timer installed-
operator starts
Lot sampling spray, timer
(visual) check controls shut-off
coverage of control charts
critical areas show process is in
control – Cpk=2.05
SAMPLE
nl om
y
Excessive wax
pcoverage over
specified surface an
a1 a2 b c de f h g h i j k l m ----n----

Table IV.1 Sample PFMEA Form with Minimal Information Elements & Example Entries
Process Failure Mode and Effects Analysis

y
Chapter IV Process Failure Mode and Effects Analysis

Key Date (E)

Enter the initial PFMEA due date, which should not exceed the
scheduled start of production date. In case of a supply

y
organization, this date should not exceed the customer required

an
Production Part Approval Process (PPAP) submission date.

p
FMEA Date (Original) (F)

nl om
Enter the date the original PFMEA was completed and the latest
revision date.

O C
Core Team (G)
Enter the team members responsible for developing the PFMEA.

r
y
Contact information (e.g., name, organization, telephone

se o
U ot number, and email) may be included in a referenced
supplemental document.
Prepared By (H)
al M
Enter the name and contact information including the
organization (company) of the engineer/team leader responsible
rn rd

for preparing the PFMEA.

te o

Body of the PFMEA Form (fields a – n)

In f F

The body of the PFMEA contains the analysis of risks related to

the potential failures and improvement action being taken. 9
o

Process Step / Process Function /

Requirements (a)
er

Process Step/Function can be separated into two (or more)

columns or combined into a single, bridged column which
op

encompasses these elements. Process Steps may be listed in the

Process Step/Function column or additional column(s) may be
added containing the functions or requirements of that process
Pr

step. “Process Step”, “Function”, and “Requirements” are

described below:

9
The letters at the end of each heading indicate the area referred to on the sample form.

77
Pr
POTENTIAL
FAILURE MODE AND EFFECTS ANALYSIS FMEA Number A
(PROCESS FMEA) Page of
op
Item: _________________________________________________
B Process Responsibility ______________________________________
C Prepared By: H
Chapter IV

Severity
Mode Failure Failure Prevention Detection Completion Date Completion Date
Severity

Function
Detection

Detection

Classification
Occurrence
Occurrence

78
over time. clogged start-up and for film thickness experiments by Limits were
• Impaired function - Viscosity too high after idle periods (DOE) on 0X 10 01 determined and
of interior door - Temperature too viscosity vs. limit controls have
al M
and preventative Visual check
hardware low maintenance for coverage. temperature vs. been installed-
- Pressure too low program to pressure Control charts
clean heads show process is in
control Cpk=1.85
U ot
Spray head Preventative 2 Variables check 5 70 None
deformed due to maintenance for film thickness
impact programs to
maintain heads
se o
Visual check
for coverage.
r
Spray time None 5 Operator 7 245 Install Spray Maintenance Automatic spray 7 1 7 49
O C sufficient instructions timer. XX/XX/XX timer installed-
operator starts
Lot sampling spray, timer
(visual) check controls shut-off
coverage of control charts
critical areas show process is in
control – Cpk=2.05
SAMPLE
nl om
y
Excessive wax
pcoverage over
specified surface an
a1 a2 b c de f h g h i j k l m ----n----

Table IV.1 Sample PFMEA Form with Minimal Information Elements & Example Entries
Process Failure Mode and Effects Analysis

y
Chapter IV Process Failure Mode and Effects Analysis

Process Step (a1)

Enter the identification of the process step or operation being
analyzed, based on the numbering process and terminology. For
example, enter the number and identifier (e.g., name). Process

y
numbering scheme, sequencing, and terminology used should be

an
consistent with those used in the process flow diagram to ensure
traceability and relationships to other documents (Control Plans,
operator instructions, etc). Repair and rework operations should

p
also be included.

nl om
Process Function (a1)
List the process function that corresponds to each process step or

O C
operation being analyzed. The process function describes the
purpose or intent of the operation. A risk analysis is
recommended in order to limit the number of steps to be

r
y
included to only those that add value or otherwise are seen as

se o
likely to have a negative impact on the product. If there are
U ot
multiple process functions being analyzed with respect to a given
operation, each should be aligned on the form with its respective
al M
“Requirements” to aid in the development of the associated
failure modes.
rn rd

Process Function becomes a2 if Process Step and Process

te o

Function are split.

In f F

Requirements (a2)
o

List the requirements for each process function of the process

step or operation being analyzed. Requirements are the inputs to
ty

the process specified to meet design intent and other customer

requirements. If there are multiple requirements with respect to a
er

given function, each should be aligned on the form with the

respective associated failure modes in order to facilitate the
analysis.
op

Requirements become a3 if Process Step and Process Function

are split into separate columns, e.g., a1 and a2.

79
Pr
POTENTIAL
FAILURE MODE AND EFFECTS ANALYSIS FMEA Number A
(PROCESS FMEA) Page of
op
Item: _________________________________________________
B Process Responsibility ______________________________________
C Prepared By: H
Chapter IV

Severity
Mode Failure Failure Prevention Detection Completion Date Completion Date
Severity

Function
Detection

Detection

Classification
Occurrence
Occurrence

80
over time. clogged start-up and for film thickness experiments by Limits were
• Impaired function - Viscosity too high after idle periods (DOE) on 0X 10 01 determined and
of interior door - Temperature too viscosity vs. limit controls have
al M
and preventative Visual check
hardware low maintenance for coverage. temperature vs. been installed-
- Pressure too low program to pressure Control charts
clean heads show process is in
control Cpk=1.85
U ot
Spray head Preventative 2 Variables check 5 70 None
deformed due to maintenance for film thickness
impact programs to
maintain heads
se o
Visual check
for coverage.
r
Spray time None 5 Operator 7 245 Install Spray Maintenance Automatic spray 7 1 7 49
O C sufficient instructions timer. XX/XX/XX timer installed-
operator starts
Lot sampling spray, timer
(visual) check controls shut-off
coverage of control charts
critical areas show process is in
control – Cpk=2.05
SAMPLE
nl om
y
Excessive wax
pcoverage over
specified surface an
a1 a2 b c de f h g h i j k l m ----n----

Table IV.1 Sample PFMEA Form with Minimal Information Elements & Example Entries
Process Failure Mode and Effects Analysis

y
Chapter IV Process Failure Mode and Effects Analysis

Potential Failure Mode (b)

Potential failure mode is defined as the manner in which the
process could potentially fail to meet the process requirements
(including the design intent).

y
In preparing the FMEA, assume that the incoming

an
part(s)/material(s) are correct. Exceptions can be made by the
FMEA team where historical data indicate deficiencies in
incoming part quality. The team should also assume that the

p
basic design of the product is correct; however, if there are

nl om
design issues which result in process concerns, those issues
should be communicated to the design team for resolution.
List the potential failure mode(s) for the particular operation in

O C
terms of the process requirement(s) (e.g., as documented in the
process flow diagram.) Assume that the failure could occur but
may not necessarily occur. Potential failure modes should be

r
y
described in technical terms, not as a symptom noticeable by the

se o
U ot customer. See the example table below.

Process
al M
Requirement Potential Failure Mode
Step/Function
Operation 20: Four screws Fewer than four screws
rn rd

Specified screws Wrong screw used (larger dia)

Attach seat cushion
Assembly sequence: First Screw placed in any other hole
to track using a
te o

screw in right front hole

torque gun
In f F

Screws fully seated Screw not fully seated

Screws torqued to dynamic Screw torqued too high
o

torque specification Screw torqued too low

ty
er

Table IV.2 Example of Process Step/Function/Requirements Columns on PFMEA Form

including Potential Failure Modes
op

If the requirements have been well defined, then the potential

failure mode is readily identifiable by determining the condition
when a specific requirement is not met. Each requirement may
Pr

have multiple failure modes. A large number of failure modes

identified for a single requirement usually indicates that the
requirement is not well defined.
The assumption is made that the failure could occur but may not
necessarily occur – consequently the use of the word “potential”.
Verification of completeness of the potential failure modes can
be made through a review of past things-gone-wrong, concerns,

81
Pr
POTENTIAL
FAILURE MODE AND EFFECTS ANALYSIS FMEA Number A
(PROCESS FMEA) Page of
op
Item: _________________________________________________
B Process Responsibility ______________________________________
C Prepared By: H
Chapter IV

Severity
Mode Failure Failure Prevention Detection Completion Date Completion Date
Severity

Function
Detection

Detection

Classification
Occurrence
Occurrence

82
over time. clogged start-up and for film thickness experiments by Limits were
• Impaired function - Viscosity too high after idle periods (DOE) on 0X 10 01 determined and
of interior door - Temperature too viscosity vs. limit controls have
al M
and preventative Visual check
hardware low maintenance for coverage. temperature vs. been installed-
- Pressure too low program to pressure Control charts
clean heads show process is in
control Cpk=1.85
U ot
Spray head Preventative 2 Variables check 5 70 None
deformed due to maintenance for film thickness
impact programs to
maintain heads
se o
Visual check
for coverage.
r
Spray time None 5 Operator 7 245 Install Spray Maintenance Automatic spray 7 1 7 49
O C sufficient instructions timer. XX/XX/XX timer installed-
operator starts
Lot sampling spray, timer
(visual) check controls shut-off
coverage of control charts
critical areas show process is in
control – Cpk=2.05
SAMPLE
nl om
y
Excessive wax
pcoverage over
specified surface an
a1 a2 b c de f h g h i j k l m ----n----

Table IV.1 Sample PFMEA Form with Minimal Information Elements & Example Entries
Process Failure Mode and Effects Analysis

y
Chapter IV Process Failure Mode and Effects Analysis

reject or scrap reports, and group brainstorming. Sources for this

should also include a comparison of similar processes and a
review of customer (End User and subsequent operation) claims
relating to similar components.

y
Potential Effect(s) of Failure (c)

an
Potential effects of failure are defined as the effects of the failure
mode as perceived by the customer(s).

p
The effects of the failure should be described in terms of what
the customer might notice or experience, remembering that the

nl om
customer may be an internal customer as well as the ultimate
End User. The customer(s) in this context could be the next
operation, subsequent operations or locations, the dealer, and/or

O C
the vehicle owner. Each must be considered when assessing the
potential effect of a failure. The product effects in the PFMEA
should be consistent with those in the corresponding DFMEA.

r
y
se o
If the failure mode could impact safety or cause noncompliance
U ot to regulations, this should be clearly identified in the PFMEA.
For the End User, the effects should be stated in terms of product
al M
or system performance. If the customer is the next operation or
subsequent operation(s) / location(s), the effects should be stated
in terms of process / operation performance. See Table IV.3
rn rd

Example of Effects.
In order to determine the Potential Effect(s), the following
te o

questions should be asked:

In f F

1. Does the Potential Failure Mode physically prevent

downstream processing or cause potential harm to
equipment or operators?
o

This includes an inability to assemble or join to a mating

component at any subsequent customer’s facility. If so, then
ty

assess the manufacturing impact. No further analysis is required.

If not, then go to question 2. Examples could include:
er

• Unable to assemble at operation x

• Unable to attach at customer facility

• Unable to connect at customer facility
Pr

• Cannot bore at operation x

• Causes excessive tool wear at operation x
• Damages equipment at operation x
• Endangers operator at customer facility

83
Chapter IV Process Failure Mode and Effects Analysis

Note: The location, station or operation at which the effect occurs

should be identified. If at a customer’s facility, this should be
stated.

2. What is the potential impact on the End User?

y
Independent of any controls planned or implemented including

an
error or mistake-proofing, consider what the End User would
notice or experience. This information may be available within
the DFMEA. Once determined, go to question 3. Examples

p
could include:

nl om
• Noise
• High effort
• Unpleasant odor

O C
• Intermittent operation

r
•

y
Water leak

se o
• Rough idle
U ot
• Unable to adjust
al M
• Difficult to control
• Poor appearance
rn rd

3. What would happen if an effect was detected prior to

te o

reaching the End User?

In f F

The potential effect at the current or receiving locations also

needs to be considered. Examples could include:
o

• Line shutdown
• Stop shipment
ty

• Yard hold
er

• 100% of product scrapped

•
op

Decreased line speed

• Added manpower to maintain required line rate
Pr

Note: If more than one potential effect is identified when

considering questions 2 and 3, all may be listed, but for purposes
of the analysis, only consider the worst case when documenting
the resulting Severity ranking.

84
Chapter IV Process Failure Mode and Effects Analysis

Example of Effects

Requirement Failure Mode Effect

Four screws Fewer than four screws EndUuser: Loose seat

y
cushion and noise.

an
Manufacturing and
Assembly: Stop shipment
and additional sort and

p
rework due to affected

nl om
portion.
Specified screws Wrong screw used Manufacturing and
(larger dia.) Assembly: Unable to
install screw in station.

O C
Assembly sequence: Screw placed in any other Manufacturing and
First screw in right hole Assembly: Difficult to

r
y
front hole install remaining screws

se o
U ot in station.
Screws fully seated Screw not fully seated End User: Loose seat
cushion and noise.
al M
Manufacturing and
Assembly: Sort and
rework due to affected
rn rd

portion.
Screws torqued to Screw torqued too high End User: Loose seat
te o

dynamic torque cushion due to subsequent

specification fracture of screw and
In f F

noise.
Manufacturing and
Assembly: Sort and
o

rework due to affected

portion.
ty

Screw torqued too low End User: Loose seat

cushion due to gradual
er

loosening of screw and

noise.
op

Manufacturing and
Assembly: Sort and
rework due to affected
Pr

portion.

Table IV.3 Example of Effects

85
Pr
POTENTIAL
FAILURE MODE AND EFFECTS ANALYSIS FMEA Number A
(PROCESS FMEA) Page of
op
Item: _________________________________________________
B Process Responsibility ______________________________________
C Prepared By: H
Chapter IV

Severity
Mode Failure Failure Prevention Detection Completion Date Completion Date
Severity

Function
Detection

Detection

Classification
Occurrence
Occurrence

86
over time. clogged start-up and for film thickness experiments by Limits were
• Impaired function - Viscosity too high after idle periods (DOE) on 0X 10 01 determined and
of interior door - Temperature too viscosity vs. limit controls have
al M
and preventative Visual check
hardware low maintenance for coverage. temperature vs. been installed-
- Pressure too low program to pressure Control charts
clean heads show process is in
control Cpk=1.85
U ot
Spray head Preventative 2 Variables check 5 70 None
deformed due to maintenance for film thickness
impact programs to
maintain heads
se o
Visual check
for coverage.
r
Spray time None 5 Operator 7 245 Install Spray Maintenance Automatic spray 7 1 7 49
O C sufficient instructions timer. XX/XX/XX timer installed-
operator starts
Lot sampling spray, timer
(visual) check controls shut-off
coverage of control charts
critical areas show process is in
control – Cpk=2.05
SAMPLE
nl om
y
Excessive wax
pcoverage over
specified surface an
a1 a2 b c de f h g h i j k l m ----n----

Table IV.1 Sample PFMEA Form with Minimal Information Elements & Example Entries
Process Failure Mode and Effects Analysis

y
Chapter IV Process Failure Mode and Effects Analysis

Severity (S) (d)

Severity is the value associated with the most serious effect for a
given failure mode. Severity is a relative ranking within the
scope of the individual FMEA.

y
Suggested Evaluation Criteria

an
The team should agree on evaluation criteria and a ranking
system and apply them consistently, even if modified for

p
individual process analysis (See Table Cr1 for criteria
guidelines).

nl om
It is not recommended to modify criteria for ranking values 9 and

O C
10. Failure modes with a rank of 1 should not be analyzed
further.

r
y
se o
U ot
al M
rn rd
te o
In f F
o
ty
er
op
Pr

87
Pr
Criteria: Rank Criteria:
op
Effect Severity of Effect on Product Effect Severity of Effect on Process
Chapter IV

(Customer Effect) (Manufacturing/Assembly Effect)

er
Potential failure mode affects safe vehicle operation and/or 10 May endanger operator (machine or assembly) without
involves noncompliance with government regulation without warning.
Failure to Meet Failure to Meet
warning.
Safety and/or
ty Safety and/or
Regulatory Regulatory
Requirements Potential failure mode affects safe vehicle operation and/or 9 Requirements May endanger operator (machine or assembly) with
involves noncompliance with government regulation with warning.
o
warning.

Loss of primary function (vehicle inoperable, does not affect 8 100% of product may have to be scrapped. Line
Major Disruption
Loss or safe vehicle operation). shutdown or stop ship.
In f F
Degradation of
Primary Degradation of primary function (vehicle operable, but at 7 A portion of the production run may have to be
Function Significant
reduced level of performance). scrapped. Deviation from primary process including
te o
Disruption
decreased line speed or added manpower.

Loss of secondary function (vehicle operable, but comfort / 6 100% of production run may have to be reworked off
rn rd
Loss or convenience functions inoperable). Moderate line and accepted.
Degradation of Disruption
Secondary Degradation of secondary function (vehicle operable, but 5 A portion of the production run may have to be

88
Function comfort / convenience functions at reduced level of reworked off line and accepted.
performance).
al M
Appearance or Audible Noise, vehicle operable, item does 4 100% of production run may have to be reworked in
not conform and noticed by most customers (> 75%). station before it is processed.
Moderate
U ot
Appearance or Audible Noise, vehicle operable, item does 3 Disruption A portion of the production run may have to be
not conform and noticed by many customers (50%). reworked in-station before it is processed.
Annoyance
se o
r
Appearance or Audible Noise, vehicle operable, item does 2 Slight inconvenience to process, operation, or operator.
not conform and noticed by discriminating customers Minor Disruption
(< 25%).
O C
No effect No discernible effect. 1 No effect No discernible effect.

Table Cr1 Suggested PFMEA Severity Evaluation Criteria

nl om
y p an
Process Failure Mode and Effects Analysis

y
Chapter IV Process Failure Mode and Effects Analysis

This page intentionally left blank.

y
p an
nl om
O C r
y
se o
U ot
al M
rn rd
te o
In f F
o
ty
er
op
Pr

89
Pr
POTENTIAL
FAILURE MODE AND EFFECTS ANALYSIS FMEA Number A
(PROCESS FMEA) Page of
op
Item: _________________________________________________
B Process Responsibility ______________________________________
C Prepared By: H
Chapter IV

Severity
Mode Failure Failure Prevention Detection Completion Date Completion Date
Severity

Function
Detection

Detection

Classification
Occurrence
Occurrence

90
over time. clogged start-up and for film thickness experiments by Limits were
• Impaired function - Viscosity too high after idle periods (DOE) on 0X 10 01 determined and
of interior door - Temperature too viscosity vs. limit controls have
al M
and preventative Visual check
hardware low maintenance for coverage. temperature vs. been installed-
- Pressure too low program to pressure Control charts
clean heads show process is in
control Cpk=1.85
U ot
Spray head Preventative 2 Variables check 5 70 None
deformed due to maintenance for film thickness
impact programs to
maintain heads
se o
Visual check
for coverage.
r
Spray time None 5 Operator 7 245 Install Spray Maintenance Automatic spray 7 1 7 49
O C sufficient instructions timer. XX/XX/XX timer installed-
operator starts
Lot sampling spray, timer
(visual) check controls shut-off
coverage of control charts
critical areas show process is in
control – Cpk=2.05
SAMPLE
nl om
y
Excessive wax
pcoverage over
specified surface an
a1 a2 b c de f h g h i j k l m ----n----

Table IV.1 Sample PFMEA Form with Minimal Information Elements & Example Entries
Process Failure Mode and Effects Analysis

y
Chapter IV Process Failure Mode and Effects Analysis

Classification (e)

This column may be used to highlight high priority failure modes

or causes that may require additional engineering assessment.

y
This column may also be used to classify any special product or

an
process characteristics (e.g., critical, key, major, significant) for
components, subsystems, or systems that may require additional
process controls.

p
nl om
Customer specific requirements may identify special product or
process characteristic symbols and their usage.

O C
Where a special characteristic is identified with a severity of 9 or
10 in the PFMEA, the design responsible engineer should be

r
y
notified since this may affect the engineering documents.

se o
U ot Potential Cause(s) of Failure Mode (f)
al M
Potential cause of failure is defined as an indication of how the
failure could occur, and is described in terms of something that
can be corrected or can be controlled. Potential cause of failure
rn rd

may be an indication of a design or process weakness, the

consequence of which is the failure mode.
te o

To the extent possible, identify and document every potential

In f F

cause for each failure mode. The cause should be detailed as

concisely and completely as possible. Separating the causes will
result in a focused analysis for each and may yield different
o

measurement, controls, and action plans. There may be one or

more causes that can result in the failure mode being analyzed.
ty

This results in multiple lines for each cause in the table or

form. 10
er

In preparing the PFMEA, the team should assume that the

incoming part(s)/material(s) are correct. Exceptions can be
op

made at the team’s discretion where historical data indicate

deficiencies in incoming part quality.
Only specific errors or malfunctions (e.g., seal not installed or
Pr

seal installed inverted) should be listed. Ambiguous phrases

(e.g., operator error or seal mis-installed, etc.) should not be
used. See Table IV.4 Example of Causes and Controls.

10
In preparing the PFMEA, the team needs to ensure that any limitations of the design that may result in a
potential process failure mode are communicated to the design function.

91
Chapter IV Process Failure Mode and Effects Analysis

Occurrence (O) (g)

Occurrence is the likelihood that a specific cause of failure will
occur. The likelihood of occurrence ranking number has a
relative meaning rather than an absolute value (See Table Cr2).

y
Estimate the likelihood of occurrence of a potential cause of

an
failure on a 1 to 10 scale. A consistent occurrence ranking
system should be used to ensure continuity. The occurrence
ranking number is a relative ranking within the scope of the

p
FMEA and may not reflect the actual likelihood of occurrence.

nl om
The “Incident per items/vehicles” is used to indicate the number
of failures that are anticipated during the process execution. If
statistical data are available from a similar process, the data

O C
should be used to determine the occurrence ranking. In other
cases, a subjective assessment can be made by using the word
descriptions in the left hand column of the table, along with input

r
y
from the appropriate process knowledge source to estimate the

se o
ranking.
U ot
Suggested Evaluation Criteria
al M
The team should agree on evaluation criteria and a ranking
system and apply them consistently, even if modified for
individual process analysis. Occurrence should be estimated
rn rd

using a 1 to 10 scale based upon Table Cr2 as a guideline.

te o
In f F
o
ty
er
op
Pr

92
Chapter IV Process Failure Mode and Effects Analysis

Likelihood Criteria: Occurrence of Cause - PFMEA

Rank
of Failure (Incidents per items/vehicles)

y
≥ 100 per thousand

an
Very High 10
≥ 1 in 10
50 per thousand

p
9

nl om
1 in 20
20 per thousand
High 8
1 in 50

O C
10 per thousand
7

r
1 in 100

y
se o
U ot 2 per thousand
6
1 in 500
al M
.5 per thousand
Moderate 5
1 in 2,000
rn rd

.1 per thousand
4
te o

1 in 10,000
In f F

.01 per thousand

3
Low 1 in 100,000
o

≤.001 per thousand

2
1 in 1,000,000
ty

Very Low Failure is eliminated through preventive control. 1

Table Cr2 Suggested PFMEA Occurrence Evaluation Criteria

op
Pr

93
Pr
POTENTIAL
FAILURE MODE AND EFFECTS ANALYSIS FMEA Number A
(PROCESS FMEA) Page of
op
Item: _________________________________________________
B Process Responsibility ______________________________________
C Prepared By: H
Chapter IV

Severity
Mode Failure Failure Prevention Detection Completion Date Completion Date
Severity

Function
Detection

Detection

Classification
Occurrence
Occurrence

94
over time. clogged start-up and for film thickness experiments by Limits were
• Impaired function - Viscosity too high after idle periods (DOE) on 0X 10 01 determined and
of interior door - Temperature too viscosity vs. limit controls have
al M
and preventative Visual check
hardware low maintenance for coverage. temperature vs. been installed-
- Pressure too low program to pressure Control charts
clean heads show process is in
control Cpk=1.85
U ot
Spray head Preventative 2 Variables check 5 70 None
deformed due to maintenance for film thickness
impact programs to
maintain heads
se o
Visual check
for coverage.
r
Spray time None 5 Operator 7 245 Install Spray Maintenance Automatic spray 7 1 7 49
O C sufficient instructions timer. XX/XX/XX timer installed-
operator starts
Lot sampling spray, timer
(visual) check controls shut-off
coverage of control charts
critical areas show process is in
control – Cpk=2.05
SAMPLE
nl om
y
Excessive wax
pcoverage over
specified surface an
a1 a2 b c de f h g h i j k l m ----n----

Table IV.1 Sample PFMEA Form with Minimal Information Elements & Example Entries
Process Failure Mode and Effects Analysis

y
Chapter IV Process Failure Mode and Effects Analysis

Current Process Controls (h)

Current Process Controls are descriptions of the controls that can
either prevent to the extent possible, the cause of failure from
occurring or detect the failure mode or cause of failure should it

y
occur.

an
There are two types of Process Controls to consider:
Prevention:

p
Eliminate (prevent) the cause of the failure or the failure mode
from occurring, or reduce its rate of occurrence.

nl om
Detection:
Identify (detect) the cause of failure or the failure mode, leading
to the development of associated corrective action(s) or counter-

O C
measures.

r
y
se o
The preferred approach is to first use prevention controls, if
U ot possible. The initial occurrence rankings will be affected by the
prevention controls provided they are integrated as part of the
process. The initial detection rankings will be based on process
al M
controls that either detect the cause of failure, or detect the
failure mode.
Because statistical charting methods (i.e., Statistical Process
rn rd

Control) 11 typically use sampling to assess process stability and

detect out-of-control conditions they should not be considered
te o

when evaluating the effectiveness of specific Detection Controls.

SPC may, however, be considered as a Prevention Control for
In f F

specific causes whose trends are identifiable in advance of an

actual non-conformance being produced, such as tool wear.
o

The example PFMEA form in this manual has two separate

columns for Prevention Controls and Detection Controls to assist

the team in clearly distinguishing between these two types of
er

controls. This allows for a quick visual determination that both

types of process controls have been considered.
op

If a one-column (for process controls) form is used, then the

following prefixes should be used. For prevention controls, place
a 'P' before or after each prevention control listed. For detection
Pr

controls, place a 'D' before or after each detection control listed

(see Table IV.4 Example of Causes and Controls).

11
See Chrysler, Ford, GM; SPC Manual, AIAG.

95
Chapter IV Process Failure Mode and Effects Analysis

Failure Prevention
Requirement Cause Detection Control
Mode Control
Screws torqued Screw not Nut runner not Operator training Angle sensor included in nut

y
until fully seated fully seated held perpendicular runner to detect cross-threading
to work surface by not allowing part to be removed

an
operator from fixture until value is
satisfied

p
Screws torqued Screw Torque setting set Password Torque validation box included
to dynamic torqued too too high by non- protected control in set-up procedure to validate

nl om
torque high set-up personnel panel (only set-up setting prior to running
specification personnel have
access)
Torque setting set Training of set-up Torque validation box included

O C
too high by set-up personnel in set-up procedure to validate
personnel setting prior to running
Settings added to

r
y
set-up instructions

se o
U ot Screw Torque setting set Password Torque validation box included
torqued too too low by non- protected control in set-up procedure to validate
low set-up personnel panel (only set-up setting prior to running
personnel have
al M
access)

Torque setting set Training of set-up Torque validation box included

rn rd

too low by set-up personnel in set-up procedure to validate

personnel setting prior to running
Settings added to
te o

set-up instructions
In f F

Table IV.4 Examples of Causes and Controls

o
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96
Chapter IV Process Failure Mode and Effects Analysis

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97
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POTENTIAL
FAILURE MODE AND EFFECTS ANALYSIS FMEA Number A
(PROCESS FMEA) Page of
op
Item: _________________________________________________
B Process Responsibility ______________________________________
C Prepared By: H
Chapter IV

Severity
Mode Failure Failure Prevention Detection Completion Date Completion Date
Severity

Function
Detection

Detection

Classification
Occurrence
Occurrence

98
over time. clogged start-up and for film thickness experiments by Limits were
• Impaired function - Viscosity too high after idle periods (DOE) on 0X 10 01 determined and
of interior door - Temperature too viscosity vs. limit controls have
al M
and preventative Visual check
hardware low maintenance for coverage. temperature vs. been installed-
- Pressure too low program to pressure Control charts
clean heads show process is in
control Cpk=1.85
U ot
Spray head Preventative 2 Variables check 5 70 None
deformed due to maintenance for film thickness
impact programs to
maintain heads
se o
Visual check
for coverage.
r
Spray time None 5 Operator 7 245 Install Spray Maintenance Automatic spray 7 1 7 49
O C sufficient instructions timer. XX/XX/XX timer installed-
operator starts
Lot sampling spray, timer
(visual) check controls shut-off
coverage of control charts
critical areas show process is in
control – Cpk=2.05
SAMPLE
nl om
y
Excessive wax
pcoverage over
specified surface an
a1 a2 b c de f h g h i j k l m ----n----

Table IV.1 Sample PFMEA Form with Minimal Information Elements & Example Entries
Process Failure Mode and Effects Analysis

y
Chapter IV Process Failure Mode and Effects Analysis

Detection (D) (i)

Detection is the rank associated with the best detection control
listed in the Detection Controls column. Detection is a relative
ranking within the scope of the individual FMEA. In order to

y
achieve a lower ranking, generally the planned detection control

an
has to be improved.
When more than one control is identified, it is recommended that
the detection ranking of each control be included as part of the

p
description of the control. Record the lowest ranking value in the

nl om
Detection column.
Assume the failure has occurred and then assess the capabilities
of all "Current Process Controls" to prevent shipment of the part

O C
having this failure mode. Do not automatically presume that the
detection ranking is low because the occurrence is low, but do
assess the ability of the process controls to detect low frequency

r
y
failure modes or prevent them from going further in the process.

se o
U ot
Random quality checks are unlikely to detect the existence of an
isolated problem and should not influence the detection ranking.
al M

Suggested Evaluation Criteria

rn rd

The team should agree on evaluation criteria and a ranking

te o

system and apply them consistently, even if modified for

individual product analysis. Detection should be estimated using
In f F

Table Cr3 as a guideline.

The ranking value of one (1) is reserved for failure prevention

through proven process design solutions.
ty
er
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99
Chapter IV Process Failure Mode and Effects Analysis

Opportunity for Criteria: Likelihood

Rank
Detection Likelihood of Detection by Process Control of Detection

y
No detection No current process control; Cannot detect or is not Almost

an
opportunity analyzed.
10
Impossible
Not likely to detect Failure Mode and/or Error (Cause) is not easily detected

p
at any stage (e.g., random audits).
9 Very Remote

nl om
Problem Detection Failure Mode detection post-processing by
Post Processing operator through visual/tactile/audible means.
8 Remote

O C
Failure Mode detection in-station by operator through
Problem Detection visual/tactile/audible means or post-processing through
7 Very Low

r
at Source use of attribute gauging (go/no-go, manual torque

y
se o
check/clicker wrench, etc.).
U ot Failure Mode detection post-processing by operator
al M
Problem Detection through use of variable gauging or in-station by operator
Post Processing through use of attribute gauging (go/no-go, manual
6 Low
torque check/clicker wrench, etc).
rn rd

Failure Mode or Error (Cause) detection in-station by

operator through use of variable gauging or by
te o

Problem Detection automated controls in-station that will detect discrepant

5 Moderate
In f F

at Source part and notify operator (light, buzzer, etc.). Gauging

performed on setup and first-piece check (for set-up
causes only).
o

Failure Mode detection post-processing by automated

Problem Detection Moderately
ty

Post Processing
controls that will detect discrepant part and lock part to 4
prevent further processing. High
er

Failure Mode detection in-station by automated controls

Problem Detection
at Source
that will detect discrepant part and automatically lock 3 High
op

part in station to prevent further processing.

Error Detection Error (Cause) detection in-station by automated controls
and/or Problem that will detect error and prevent discrepant part from 2 Very High
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Prevention being made.

Error (Cause) prevention as a result of fixture design,
Detection not
machine design or part design. Discrepant parts cannot be Almost
applicable; Error
made because item has been error-proofed by
1
Prevention Certain
process/product design.

Table Cr3 Suggested Process FMEA Detection Evaluation Criteria

100
Chapter IV Process Failure Mode and Effects Analysis

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101
Pr
POTENTIAL
FAILURE MODE AND EFFECTS ANALYSIS FMEA Number A
(PROCESS FMEA) Page of
op
Item: _________________________________________________
B Process Responsibility ______________________________________
C Prepared By: H
Chapter IV

Severity
Mode Failure Failure Prevention Detection Completion Date Completion Date
Severity

Function
Detection

Detection

Classification
Occurrence
Occurrence

102
• Impaired function - Viscosity too high after idle periods (DOE) on 0X 10 01 determined and
of interior door - Temperature too viscosity vs. limit controls have
al M
and preventative Visual check
hardware low maintenance for coverage. temperature vs. been installed-
- Pressure too low program to pressure Control charts
clean heads show process is in
control Cpk=1.85
U ot
Spray head Preventative 2 Variables check 5 70 None
deformed due to maintenance for film thickness
impact programs to
maintain heads
se o
Visual check
for coverage.
r
Spray time None 5 Operator 7 245 Install Spray Maintenance Automatic spray 7 1 7 49
O C sufficient instructions timer. XX/XX/XX timer installed-
operator starts
Lot sampling spray, timer
(visual) check controls shut-off
coverage of control charts
critical areas show process is in
control – Cpk=2.05
SAMPLE
nl om
y
Excessive wax
pcoverage over
specified surface an
a1 a2 b c de f h g h i j k l m ----n----

Table IV.1 Sample PFMEA Form with Minimal Information Elements & Example Entries
Process Failure Mode and Effects Analysis

y
Chapter IV Process Failure Mode and Effects Analysis

Determining Action Priorities

Once the team has completed the initial identification of failure
modes and effects, causes and controls, including rankings for
severity, occurrence and detection, they must decide if further
efforts are needed to reduce the risk. Due to the inherent

y
limitations on resources, time, technology, and other factors,
they must choose how to best prioritize these efforts.

an
The initial focus of the team should be oriented towards failure
modes with the highest severity rankings. When the severity is 9

p
or 10, it is imperative that the team ensure that the risk is
addressed through existing design controls or recommended

nl om
actions (as documented in the FMEA).
For failure modes with severities of 8 or below the team should
consider causes having the highest occurrence or detection

O C
rankings. It is the team’s responsibility to look at the
information, decide upon an approach, and determine how to

r
best prioritize their risk reduction efforts which best serve their

y
se o
organization and customers.
U ot
Risk Evaluation;
al M
Risk Priority Number (RPN) (j)
One approach to assist in action prioritization has been to use the
rn rd

Risk Priority Number:

RPN = Severity (S) x Occurrence (O) x Detection (D)
te o

Within the scope of the individual FMEA, this value can range
In f F

between 1 and 1000.

The use of an RPN threshold is NOT a recommended practice
for determining the need for actions.
o

Applying thresholds assumes that RPNs are a measure of relative

risk (which they often are not) and that continuous improvement
is not required (which it is).
er

For example, if the customer applied an arbitrary threshold of

100 to the following, the supplier would be required to take
op

action on the characteristic B with the RPN of 112.

Item Severity Occurrence Detection RPN

A 9 2 5 90
B 7 4 4 112

In this example, the RPN is higher for characteristic B than

characteristic A. However, the priority should be to work on A
with the higher severity of 9, although its RPN is 90 which is
lower and below the threshold.

103
Pr
POTENTIAL
FAILURE MODE AND EFFECTS ANALYSIS FMEA Number A
(PROCESS FMEA) Page of
op
Item: _________________________________________________
B Process Responsibility ______________________________________
C Prepared By: H
Chapter IV

Severity
Mode Failure Failure Prevention Detection Completion Date Completion Date
Severity

Function
Detection

Detection

Classification
Occurrence
Occurrence

104
• Impaired function - Viscosity too high after idle periods (DOE) on 0X 10 01 determined and
of interior door - Temperature too viscosity vs. limit controls have
al M
and preventative Visual check
hardware low maintenance for coverage. temperature vs. been installed-
- Pressure too low program to pressure Control charts
clean heads show process is in
control Cpk=1.85
U ot
Spray head Preventative 2 Variables check 5 70 None
deformed due to maintenance for film thickness
impact programs to
maintain heads
se o
Visual check
for coverage.
r
Spray time None 5 Operator 7 245 Install Spray Maintenance Automatic spray 7 1 7 49
O C sufficient instructions timer. XX/XX/XX timer installed-
operator starts
Lot sampling spray, timer
(visual) check controls shut-off
coverage of control charts
critical areas show process is in
control – Cpk=2.05
SAMPLE
nl om
y
Excessive wax
pcoverage over
specified surface an
a1 a2 b c de f h g h i j k l m ----n----

Table IV.1 Sample PFMEA Form with Minimal Information Elements & Example Entries
Process Failure Mode and Effects Analysis

y
Chapter IV Process Failure Mode and Effects Analysis

Another concern with using the threshold approach is that there

is no specific RPN value that requires mandatory action.
Unfortunately, establishing such thresholds may promote the
wrong behavior causing team members to spend time trying to
justify a lower occurrence or detection ranking value to reduce
the RPN. This type of behavior avoids addressing the real

y
problem that underlies the cause of the failure mode and merely

an
keeps the RPN below the threshold. It is important to recognize
that while determining “acceptable” risk at a particular program
milestone (e.g., vehicle launch) is desirable, it should be based

p
on an analysis of severity, occurrence and detection and not

nl om
through the application of RPN thresholds.

Use of the RPN index in the discussions of the team can be a

useful tool. The limitations of the use of RPN need to be

O C
understood. However, the use of RPN thresholds to determine
action priority is not recommended.

r
y
se o
Recommended Action(s) (k)
U ot
In general, prevention actions (i.e., reducing the occurrence) are
preferable to detection actions. An example of this is the use of
al M
process design error proofing rather than random quality checks
or associated inspection.
rn rd

The intent of any recommended action is to reduce rankings in

the following order: severity, occurrence, and detection.
te o

Example approaches to reduce these are explained below:

•
In f F

To Reduce Severity (S) Ranking: Only a design or process

revision can bring about a reduction in the severity ranking.
o

A product/process design change, in and of itself, does not imply

that the severity will be reduced. Any product/process design
ty

change should be reviewed by the team to determine the effect

on the product functionality and process.
er

For maximum effectiveness and efficiency of this approach,

changes to the product and process design should be
implemented early in the development process. For example,
op

process technology needs to be considered very early in the

process development if severity is to be reduced.
Pr

• To Reduce Occurrence (O) Ranking: To reduce occurrence,

process and design revisions may be required. A reduction in
the occurrence ranking can be effected by removing or
controlling one or more of the causes of the failure mode
through a product or process design revision.
Studies to understand the sources of variation of the process
using statistical methods may be implemented. These studies

105
Pr
POTENTIAL
FAILURE MODE AND EFFECTS ANALYSIS FMEA Number A
(PROCESS FMEA) Page of
op
Item: _________________________________________________
B Process Responsibility ______________________________________
C Prepared By: H
Chapter IV

Severity
Mode Failure Failure Prevention Detection Completion Date Completion Date
Severity

Function
Detection

Detection

Classification
Occurrence
Occurrence

106
• Impaired function - Viscosity too high after idle periods (DOE) on 0X 10 01 determined and
of interior door - Temperature too viscosity vs. limit controls have
al M
and preventative Visual check
hardware low maintenance for coverage. temperature vs. been installed-
- Pressure too low program to pressure Control charts
clean heads show process is in
control Cpk=1.85
U ot
Spray head Preventative 2 Variables check 5 70 None
deformed due to maintenance for film thickness
impact programs to
maintain heads
se o
Visual check
for coverage.
r
Spray time None 5 Operator 7 245 Install Spray Maintenance Automatic spray 7 1 7 49
O C sufficient instructions timer. XX/XX/XX timer installed-
operator starts
Lot sampling spray, timer
(visual) check controls shut-off
coverage of control charts
critical areas show process is in
control – Cpk=2.05
SAMPLE
nl om
y
Excessive wax
pcoverage over
specified surface an
a1 a2 b c de f h g h i j k l m ----n----

Table IV.1 Sample PFMEA Form with Minimal Information Elements & Example Entries
Process Failure Mode and Effects Analysis

y
Chapter IV Process Failure Mode and Effects Analysis

may result in actions that reduce occurrence. Further, the

knowledge gained may assist in the identification of suitable
controls including ongoing feedback of information to the
appropriate operations for continuous improvement and problem
prevention.
• To Reduce Detection (D) Ranking: The preferred method is

y
the use of error/mistake proofing. A redesign of the

an
detection methodology may result in a reduction of the
detection ranking. In some cases, a design change to a
process step may be required to increase the likelihood of

p
detection (i.e., reduce the detection ranking.) Generally,

nl om
improving detection controls requires the knowledge and
understanding of the dominant causes of process variation
and any special causes. Increasing the frequency of
inspection is usually not an effective action and should only

O C
be used as a temporary measure to collect additional
information on the process so that permanent
preventive/corrective action can be implemented 12 .

r
y
se o
U ot If the assessment leads to no recommended actions for a specific
failure mode/cause/control combination, indicate this by entering
“None” in this column. It may be useful to also include a
al M
rationale if “None” is entered, especially in case of high severity.
For process actions, the evaluation may include but is not limited
to a review of:
rn rd

• Results of process DOE or other testing when applicable

te o

• Modified process flow diagram, floor plan, work instructions

In f F

or preventive maintenance plan

• Review of equipment, fixtures or machinery specifications
•
o

New or modified sensing/detection device

Table IV.5 below provides an example of the application of

causes (Column f), controls (Column h) and recommended
er

actions (Column k).

Responsibility & Target Completion Date (l)

Enter the name of the individual and organization responsible for
Pr

completing each recommended action including the target

completion date. The process-responsible engineer/team leader is
responsible for ensuring that all actions recommended have been
implemented or adequately addressed.

12
See Chrysler, Ford, GM; SPC Manual, AIAG.

107
Pr
POTENTIAL
FAILURE MODE AND EFFECTS ANALYSIS FMEA Number A
(PROCESS FMEA) Page of
op
Item: _________________________________________________
B Process Responsibility ______________________________________
C Prepared By: H
Chapter IV

Severity
Mode Failure Failure Prevention Detection Completion Date Completion Date
Severity

Function
Detection

Detection

Classification
Occurrence
Occurrence

108
• Impaired function - Viscosity too high after idle periods (DOE) on 0X 10 01 determined and
of interior door - Temperature too viscosity vs. limit controls have
al M
and preventative Visual check
hardware low maintenance for coverage. temperature vs. been installed-
- Pressure too low program to pressure Control charts
clean heads show process is in
control Cpk=1.85
U ot
Spray head Preventative 2 Variables check 5 70 None
deformed due to maintenance for film thickness
impact programs to
maintain heads
se o
Visual check
for coverage.
r
Spray time None 5 Operator 7 245 Install Spray Maintenance Automatic spray 7 1 7 49
O C sufficient instructions timer. XX/XX/XX timer installed-
operator starts
Lot sampling spray, timer
(visual) check controls shut-off
coverage of control charts
critical areas show process is in
control – Cpk=2.05
SAMPLE
nl om
y
Excessive wax
pcoverage over
specified surface an
a1 a2 b c de f h g h i j k l m ----n----

Table IV.1 Sample PFMEA Form with Minimal Information Elements & Example Entries
Process Failure Mode and Effects Analysis

y
Chapter IV Process Failure Mode and Effects Analysis

Action Results (m-n)

This section identifies the results of any completed actions and
their effect on S, O, D rankings and RPN.

Action(s) Taken and Completion Date (m)

y
After the action has been implemented, enter a brief description

an
of the action taken and actual completion date.

p
Severity, Occurrence, Detection and RPN (n)

nl om
After the preventive/corrective action has been completed,
determine and record the resulting severity, occurrence, and
detection rankings.

O C
Calculate and record the resulting action (risk) priority indicator
(e.g., RPN).

r
y
All revised rankings should be reviewed. Actions alone do not

se o
guarantee that the problem was solved (i.e., cause addressed),
U ot
thus an appropriate analysis or test should be completed as
verification. If further action is considered necessary, repeat the
al M
analysis. The focus should always be on continuous
improvement.
rn rd
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In f F
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109
Chapter IV Process Failure Mode and Effects Analysis

Process Failure Prevention Detection Recommended

Step/Function Requirement Cause
Mode Controls Controls Actions
Op. 20 (attach Four screws Fewer than Too few Visual aids Visual In-station torque
seat cushion to four screws screws illustrating Inspection monitoring;
track using a inadvertently correct in station Line lockout if
torque gun) installed quantity fewer than four
Select four

y
Operator
screws
training

an
Specified Wrong Similar Visual aids Visual In-station torque
screws screw used screws illustrating inspection angle monitoring;

p
(larger dia.) available at correct in station Line lockout if
station screw angle not met

nl om
Operator
training Error proof by
design: use one
type screw for

O C
station/product
Op. 20 (attach Assembly Screw More than Visual aids Visual Add position
seat cushion to sequence: placed in one hole identifying inspection sensor to nut

r
y
track using a First screw any other available to location of in station runner not

se o
torque gun) in right front hole operator first screw allowing tool to
Beginning withU ot hole operate unless
right front hole, Operator runner is aligned
torque each screw training with correct hole
to the required
al M
torque
rn rd

Table IV.5 Examples of Causes, Controls and Actions

te o
In f F

Maintaining PFMEAs
o

The PFMEA is a living document and should be reviewed

whenever there is a product or process design change and
ty

updated, as required.
Another element of on-going maintenance of PFMEAs should
er

include a periodic review. Specific focus should be given to

Occurrence and Detection rankings. This is particularly
op

important where there have been product or process changes or

improvements in process controls. Additionally, in cases where
either field issues or production issues, such as disruptions, have
Pr

occurred, the rankings should be revised accordingly.

Leveraging PFMEAs
The use of a fundamentally sound PFMEA is the starting point
that provides the greatest opportunity to leverage the use of past
experience and knowledge.

110
Chapter IV Process Failure Mode and Effects Analysis

If a new project or application is functionally similar to the

existing product and the process to be used is similar, a single
PFMEA may be used with customer concurrence. If there are
differences, the team should identify and focus on the effects of
these differences.

y
Linkages

an
The PFMEA is not a “stand-alone” document. Figure IV.5 shows
some common linkages.

p
nl om
DFMEA, Process Flow
Diagram, etc.

O C r
PFMEA

y
se o
U ot
al M
Process Control Plans
rn rd

Figure IV.5 PFMEA Information Interrelationship Flow

te o
In f F

To DFMEA
o

In the development of a PFMEA it is important to utilize the

information and knowledge gained in the creation of the
DFMEA. However, the link between the two documents is not
ty

always obvious. The difficulty occurs because the focus of each

FMEA is different. The DFMEA focuses on part function
er

whereas the PFMEA focuses on the manufacturing steps or

process. Information in the columns of each form is not directly
op

aligned. For example, Item/Function-Design does not equal

Process Functions/Requirements; potential design failure mode
does not equal potential process failure mode; potential design
Pr

cause of failure does not equal potential process cause of failure.

However, by comparing the overall analysis of design and
process, a connection can be made. One such connection is
between the characteristics identified during the DFMEA and
PFMEA analysis.
Another connection is the relationship between potential design
cause of failure (DFMEA) and potential process failure mode
(PFMEA). For example, the design of a feature such as a hole
can cause a particular failure mode. The corresponding process

111
Chapter IV Process Failure Mode and Effects Analysis

failure mode is the inability of the process to manufacture the

same feature as designed. In this example, the potential design
cause of failure (hole diameter designed too large) would appear
to be similar to the potential process failure mode (hole drilled
too large). The potential effect of the failure mode for both
design and process may be identical if there were no additional

y
process related effects. In other words, the end result (effect) of

an
the failure mode is the same, but there are two distinct causes.
While developing the PFMEA, it is the team’s responsibility to
ensure that all process related potential failure modes which lead

p
to product related effects are consistent between the DFMEA

nl om
and the PFMEA.
To Control Plan
In addition to the list of Recommended Actions and their

O C
subsequent follow-up as a result of the PFMEA activity, a
Control Plan should be developed 13 . Some organizations may

r
elect not to specifically identify the related product and process

y
se o
characteristics” in the PFMEA. In this situation, the “Product
U ot Characteristics” portion of the Control Plan may be derived from
the “Requirements” portion of the “Process
Function/Requirements” column and the “Process
al M
Characteristics” portion may be derived from the “Potential
Cause(s) of Failure Mode” column.
rn rd

When the team develops the Control Plan, they need to assure
that the PFMEA current controls are consistent with the control
te o

methods specified in the Control Plan.

In f F
o
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er
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13
Guidelines for Control Plan development are included in Chrysler, Ford, GM; Advanced Product Quality
Planning and Control Plan (APQP), AIAG.

112
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113
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U ot
APPENDICES
se o
O C r
nl om
y p an
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Appendix A Sample Forms

Appendix A: Sample Forms

DFMEA Forms
• Form A: Basic form (with minimal information) 14

y
o With Prevention and Detection Controls as separate

an
columns 15
• Form B: Form with Item/Function and Requirements in

p
separate columns

nl om
o To assist in the determination of failure modes
• Form C: Form A with Prevention Controls column to the left
of the Occurrence column

O C
o To better show the relationship between prevention
controls and occurrence ranking

r
y
•

se o
Form D: Form B and C combined
•
U ot Form E: Form D with separate columns for Current
Detection Design Controls (Cause and Failure Mode)
al M
o To highlight the need to consider cause-related
controls
•
rn rd

Form F: Form B with separate columns for Responsibility

and Target Completion Date and Actions Taken and
Completion Date
te o

o To allow sorting by dates

In f F
o
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er
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14
This form was provided in the Chrysler, Ford, and GM; FMEA Manual 3rd Edition, AIAG.
15
Preventive and Detective Controls may be in the same column if each control is identified with a “P”
or “D” respectively.

114
POTENTIAL
______ System FAILURE MODE AND EFFECTS ANALYSIS FMEA Number
Pr
(DESIGN FMEA) Page of
______ Subsystem

Component; _ Design Responsibility ________ Prepared By:

op
Appendix A

Model Year(s)/Program(s)_ Key Date ________________ FMEA Date (Orig.)

Core Team
er
Item / Action Results
Current Current
Function Responsibility
ty
Potential Potential Potential Design Design
Failure Effect(s) of Cause(s) Controls Recommended & Target Actions Taken
Controls Action

RPN
Completion Date
RPN

Mode Failure

Severity
& Effective Date
Severity

of Failure Prevention Detection

Detection

Occurrence
o
Occurance

Requirements

Classification
In f F
te o
rn rd

115
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DFMEA Form A
U ot
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O C r
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Sample Forms

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Pr
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Appendix A

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In f F
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116
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DFMEA Form B
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O C r
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Sample Forms

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Pr
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Appendix A

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In f F
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117
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DFMEA Form C
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Sample Forms

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Pr
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Appendix A

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In f F
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118
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DFMEA Form D
U ot
se o
O C r
nl om
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Sample Forms

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Pr
op
Appendix A

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o
In f F
te o
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119
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DFMEA Form E
U ot
se o
O C r
nl om
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Sample Forms

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Pr
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Appendix A

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In f F
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120
al M

DFMEA Form F
U ot
se o
O C r
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Sample Forms

an
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Appendix A Sample Forms

PFMEA Forms
• Form A: Basic form (with minimal information) 16
o With Prevention and Detection Controls as separate
columns 17

y
• Form B: Form A with Process Step/Function and

an
Requirements as separate columns
o To assist in the determination of failure modes

p
• Form C: Form A with Prevention Controls Column to the
left of the Occurrence column

nl om
o To better show the relationship between prevention
controls to occurrence ranking

O C
• Form D: Form B and C combined
• Form E: Form D with separate columns for Current

r
y
Detection Process Controls (Cause and Failure Mode)

se o
U ot o To highlight the need to consider cause related
controls
• Form F: Form B with separate columns for Responsibility
al M
and Target Completion Date and Actions Taken and
Completion Date
rn rd

o To allow sorting by dates

• Form G: Form B with ID, Product and Process within a
te o

bridged Requirements column

In f F

o To provide consistency among the Process Flow,

PFMEA and Control Plan
•
o

Form H: Form D and G combined

ty
er
op
Pr

16
This form was adapted from that provided in the Chrysler, Ford, and GM; FMEA Manual 3rd Edition, AIAG.
17
Preventive and Detective Controls may be in the same column if each control is identified with a “P” or “D”
respectively.

121
POTENTIAL
FAILURE MODE AND EFFECTS ANALYSIS FMEA Number
Pr
(PROCESS FMEA) Page of

Item: ___________ Process Responsibility Prepared By:

op
Appendix A

Model Year(s)/Program(s)_ Key Date __________________ FMEA Date (Orig.)

Core Team
er
Action Results
Process Step Current Current
/ Function Potential Potential Responsibility
Potential
ty
Failure Effect(s) of Process Process Recommended
Cause(s) Controls & Target Actions Taken
Controls Action

RPN
Completion Date
RPN

Mode Failure

Severity
of Failure & Effective Date
Severity
Detection

Detection

Occurrence
Occurance

Classification
Requirements
In f F
te o
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122
al M

PFMEA Form A
U ot
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O C r
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Sample Forms

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Pr
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Appendix A

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In f F
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123
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PFMEA Form B
U ot
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O C r
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Sample Forms

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Pr
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Appendix A

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In f F
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124
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PFMEA Form C
U ot
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O C r
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Sample Forms

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Pr
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Appendix A

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In f F
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125
al M

PFMEA Form D
U ot
se o
O C r
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Sample Forms

an
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POTENTIAL
FAILURE MODE AND EFFECTS ANALYSIS FMEA Number
Pr
(PROCESS FMEA) Page of

Item: ___________ Process Responsibility Prepared By:

op
Appendix A

Model Year(s)/Vehicle(s ) Key Date ________________ FMEA Date (Orig.)

Core Team
er
Action Results
Process Current Current Detection Responsibility
ty
Step Potential Potential Potential Process
Failure Effect(s) of Cause(s) Process Controls Recommended
Requirements Controls & Target Actions Taken
Action

RPN
Completion Date
RPN

Mode Failure Prevention

Severity
of Failure & Effective Date
Severity

Cause Failure Mode

Detection

o
Detection

Occurrence
Occurance

Classification
Function In f F
te o
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126
al M

PFMEA Form E
U ot
se o
O C r
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Sample Forms

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Pr
op
Appendix A

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In f F
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127
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PFMEA Form F
U ot
se o
O C r
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Sample Forms

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Pr
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Appendix A

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In f F
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128
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PFMEA Form G
U ot
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O C r
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Sample Forms

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Appendix A

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In f F
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129
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PFMEA Form H
U ot
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O C r
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Sample Forms

an
y
Appendix B System Level FMEA

Appendix B: System Level FMEA

The process for a System FMEA is generally the same as the
development of other FMEAs. The major differences between
System level FMEAs and other types of FMEAs is the focus on

y
functions and relationships that are unique to the system as a

an
whole (i.e., do not exist at lower levels). The System level
FMEA includes failure modes associated with interfaces and
interactions in addition to considering single point failures which

p
is the primary focus of product level FMEAs.

nl om
To help illustrate the meaning of System, Subsystem, and
Component FMEAs, two examples have been constructed below

O C
in Figure B.1 (for Interfaces and Interactions) and in Figure B.2
(for Item, Function, and Failure Modes.).

r
y
se o
U ot
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te o
In f F
o
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Figure B.1 Interfaces and Interactions

The FMEA team is responsible for specifying the scope of its

respective FMEAs. The example in Figure B.1 shows that the
team has specified Subsystems A, B, C, and D along with the
surrounding environment as comprising the System that must be
considered while completing the System FMEA.

130
Appendix B System Level FMEA

Interfaces
In Figure B.1, interfaces between subsystems are shown where
Subsystem A touches and (connects with) Subsystem B, B
touches or connects with C, and a clearance between D and B,

y
signified by the dashed line. The Environment also touches each

an
of the subsystems listed in Figure B.1, which requires the
“Environmental Interfaces” be considered when completing the
FMEA. Also, the interfaces to major and minor subsystems,

p
whether direct or indirect, should be included.

nl om
The interfaces which are identified in the System FMEA should
be included in the respective Subsystem FMEA.

O C
Figure B.2 shows a system and its interrelationships in a

r
y
“hardware” oriented approach.

se o
Interactions
U ot
al M
A change in one subsystem or component may cause a change in
another subsystem or component.
rn rd

In Figure B.1, interactions between subsystems and components

can occur among any of the interfacing systems. For example,
te o

Subsystem A heats up, resulting in Subsystem B and D gaining

heat through their respective interfaces, as well as Subsystem A
In f F

giving off heat to the environment. Interactions might also occur

among ‘non-contacting’ systems via transfer through the
‘environment’. For example, if the environment is composed of
o

high humidity and Subsystems A and C are dissimilar metals

separated by a non-metal composing Subsystem B, Subsystem A
ty

and C can still have an electrolytic reaction due to the moisture

from the environment. Thus, interactions among non-contacting
er

subsystems can be relatively difficult to predict but are important

and should be considered.
op
Pr

131
Appendix B System Level FMEA

y
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Figure B.2 Item, Functions, and Failure

132
Appendix B System Level FMEA

Relationships
Multiple Levels of Design FMEAs
More likely than not, the focus of a DFMEA is an item which is
a subset of a larger system. The FMEAs at the different levels of

y
the design hierarchy (i.e., system, subsystem and component) are
linked through the cause Æ failure mode Æ effect of failure

an
relationships. This is a two way linkage (see Figure B.3):
From Lower to Higher Level: The effect of a failure mode at a

p
given level is a failure mode at the next higher level.

nl om
For example, the effect of a part 2 failure mode would be a
failure mode of module 3 either directly or indirectly by causing
another part to fail. The effect of a module 4 failure mode is a
failure mode of subsystem 4. Consequently, the effect of a

O C
failure mode at any sublevel may ultimately become a system
failure mode with its customer / user related effects.

r
y
From Higher to Lower level: The linkage from a higher level to

se o
U ot the next lower level is related to the physics of failure rather than
a pure cause and effect relationship since in the development of a
DFMEA, the causes identified at any level deal with the design
al M
process and only indirectly with the failure mechanisms.
Understanding these relationships will provide a consistency of
analysis and an economy of effort in the development of
rn rd

DFMEAs.
te o
In f F
o
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Pr

133
Appendix B System Level FMEA

y
p an
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In f F
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Figure B.3 DFMEA Effects Linkages

134
Appendix C: Alternative Risk Assessment

Appendix C: Alternative Risk Assessments

Alternatives to RPN
The risk priority number is the product of the severity (S),
occurrence (O), and detection (D) rankings.

y
an
(S) x (O) x (D) = RPN
Within the scope of the individual FMEA, this value (between 1

p
and 1000) can be used to assist the team in ranking the concerns
in the design of the product and process.

nl om
The table below, however, illustrates how different Severity (S),
Occurrence (O) & Detection (D) scenarios result in equal RPN
values. 18

O C
Upon review of each scenario, priorities would not be
established by the team based on the RPN alone.

r
y
se o Fifteen Different Situations with an RPN=360
U ot Severity of Likelihood of Likelihood of
al M
Problem Occurrence Detection
1 Hazardous 10 High 9 Moderate 4
2 Hazardous 10 Moderate 6 Low 6
rn rd

3 Hazardous 10 Moderate 4 Very Remote 9

4 Hazardous 9 Very High 10 Mod High 4
te o

5 Hazardous 9 High 8 Moderate 5

In f F

6 Hazardous 9 Moderate 5 Remote 8

7 Hazardous 9 Moderate 4 Impossible 10
8 High 8 High 9 Moderate 5
o

9 High 8 Moderate 5 Very Remote 9

10 Moderate 6 Very High 10 Low 6
ty

11 Moderate 6 Moderate 6 Impossible 10

12 Moderate 5 High 9 Remote 8

13 Moderate 5 High 8 Very Remote 9
op

14 Moderate 4 Very High 10 Very Remote 9

15 Moderate 4 High 9 Impossible 10
Pr

The ease of calculation and sorting of this index has led many to
use it exclusively and without consideration to what may be a
more appropriate means of prioritizing. Examples of some such
alternatives follow.

135
Appendix C: Alternative Risk Assessment

Alternative: SO (S x O)
Some organizations may choose to primarily focus on Severity
and Occurrence. The SO index is the product of the Severity, and
Occurrence rankings. In using this index, the organization may
focus on how to reduce SO by reducing the value of “O” through

y
preventive actions. Furthermore this may lead to subsequent
detection improvements for those with the highest SO value.

an
Alternative: SOD, SD

p
Some organizations have chosen to use SOD or SD as a
prioritization tool. SOD is the non-arithmetic combination of the

nl om
Severity, Occurrence and Detection rankings. SD is the non-
arithmetic combination of the Severity and Detection rankings.
Example (SOD):

O C
Severity, S=7
Occurrence, O=3

r
y
se o
Detection, D=5
U ot The resulting SOD is 735
Example (SD):
al M
Severity, S=7
Detection, D=5
rn rd

The resulting SD is 75
te o
In f F

The SOD, when sorted in numerical, descending order, will

prioritize the scenarios first by severity, second by occurrence
and lastly by detection.
o
ty

S O D RPN SOD SD
7 7 3 147 773 73
er

Very
7 3 7 147 737 77 Different
op

3 7 7 147 377 37 Scenarios

Equal RPN Values
Pr

Table C.1 Contrast among RPN, SOD and SD

Just as with RPN, use of the SOD/SD index should be used in

context of team discussion. Defining priorities simply based on
the SOD has limitations just as with the RPN. For example, a
failure mode with a SOD of 711 would be ranked higher (i.e.,
have to be considered before) a failure mode with 599.

136
Appendix D Alternative Analysis Techniques

Appendix D: Alternative Analyses Techniques

Failure Mode and Effects Analysis is one of many techniques
used to evaluate and analyze design risk. Other methods have
been developed for specific areas and can be used to complement

y
the analysis in the FMEA process. They may be used as a

an
replacement for an FMEA with authorization by the customer.
These are only a few of the examples.
Failure Mode, Effect

p
and Criticality

nl om
Analysis (FMECA)
FMECA is similar to FMEA. The C in FMECA indicates that the

O C
criticality (or severity) of the various failure effects are
considered and ranked. Today, FMEA is often used as a

r
synonym for FMECA.

y
se o
Design Review Based
U ot
on Failure Modes
(DRBFM)
al M
Design Review Based on Failure Modes is a cause and effect
analysis of concerns related to a design change. It is a tool used
rn rd

to guide and manage good discussion in relation to the change.

DRBFM focuses on the impact of the change on design,
te o

evaluation procedures, and manufacturing systems with the

In f F

intent of anticipating and preventing problems. A design review

by subject matter experts to evaluate the change(s) and related
improvements is an integral part of DRBFM. (Reference Figure
o

D.1).
Fault Tree Analysis
ty

(FTA)
er

FTA is a technique for system analysis where system faults are

analyzed from a single potential failure to identify all possible
op

causes. FTA considers combinations of interdependent as well as

independent causes. In addition to the structure of the fault tree
and all of the logic interdependencies, the FTA normally
Pr

includes the failure probabilities identification. This allows the

calculation of system reliability given the component
reliabilities. 19 (Reference Figure D.2).

19
References: IEC 61025; QICID (ASQ-20352).

137
Appendix D Alternative Analysis Techniques

y
p an
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O C r
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se o
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In f F
o
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Figure D.1 Example of DRBFM Elements

138
Appendix D Alternative Analysis Techniques

y
p an
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O C r
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In f F
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Figure D.2 FTA Tree Structure

139
References and Suggested Readings

References and Suggested Readings

IEC 60300-3-1, Dependability management – Part 3-1: Application guide – Analysis techniques for
dependability – Guide on methodology.
IEC 60812, Edition 2; Failure modes and effects analysis, January 2006.

y
IEC 61025, Edition 2; Fault tree analysis, January 2007.

an
QICID (ASQ-20352) “System Reliability Through Fault Tree Analysis”.
SAE ARP 5580, Recommended Failure Modes and Effects Analysis (FMEA). Practices for Non-

p
Automotive Applications. (Replacement for MIL-STD-1629A, 1998 (withdrawn)).

nl om
SAE J1739:2002, Potential Failure Mode and Effects Analysis in Design (Design FMEA) and Potential
Failure Mode and Effects Analysis in Manufacturing and Assembly Processes (Process FMEA).
Alfredo, H.S. Ang and Wilson, H. Tang (1990). “Probability Concepts in Engineering Planning and

O C
Design, Volume II -- Decision Risk and Reliability”, Wiley Publications.
Bowles, J. (2003). “An Assessment of RPN Prioritization in a Failure Modes Effects and Criticality
Analysis”, Proceedings Annual Reliability and Maintainability Symposium, pp 380-386; also in Journal of

r
y
the IEST, Institute of Environmental Sciences and Technology, Vol 47, 2004, pp. 51-56.

se o
Krasich, M. (2007). “Physics of Failure Approach to FMEA”, Tutorial Proceedings Reliability and
U ot
Maintainability Symposium.
al M
Krasich, M. (2005). “Fault Tree Analysis in Product Reliability Improvement”, Tutorial Proceedings
Reliability and Maintainability Symposium.
O’Conner, P.D.T., (2002). Practical Reliability Engineering. 4th edition, (Wiley).
rn rd

Shu-Ho Dai and Ming-O Wang (1992), Reliability Analysis in Engineering Applications, Van Nostrand
Reinhold.
te o

Wheeler, D. J. (2005). The Six Sigma Practitioner's Guide to Data Analysis, SPC Press, Knoxville, pp.311-
In f F

315.
Rausand, M. (2004). System Reliability Theory (2nd ed), Wiley, 2004.
o
ty
er
op
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140
Index

Index
APQP (Advanced Product Quality Planning), 2, occurrence, 3, 13, 45, 46, 49, 53, 57, 59, 61, 63,
5 64, 68, 69, 92, 93, 95, 99, 103, 105, 107, 109,
block diagram, 18, 19, 29 110, 135, 136
classification, 39, 91 OEM (GM, Ford, Chrysler), 11, 17, 27, 75

y
continuous improvement, 6, 57, 63, 103, 107, PFMEA (Process Failure Mode and Effects
109 Analysis), 5, 17, 66, 68-71, 75, 77, 83, 91, 95,

an
control plans, 6, 13, 111 110, 111
cross-functional, 2, 9, 17, 69, 71 potential cause, 12, 39, 41, 91, 92
current design controls, 49, 53 potential failure mode, 11, 16-18, 31, 61, 70-71,

p
design improvements, 16 81, 112
design intent, 11, 12, 22, 29, 41, 49, 68, 79 preventive controls, 45

nl om
design life, 45 process step, 77, 79, 107
detection, 13, 18, 49, 51, 57-64, 68, 73, 95, 99- recommended actions, 6, 13, 18, 57, 59, 61, 103,
110, 135, 136 107
detection controls, 49, 66, 99, 107 responsible engineer, 17, 63, 69, 70, 91, 107

O C
DFMEA (Design Failure Mode and Effects RPN (Risk Priority Number), 57, 59, 63, 103,
Analysis), 5, 16-19, 22, 25, 29, 39, 41, 64-66, 105, 109, 135, 136

r
70, 73, 83, 84, 111, 133 scope, 3, 4, 8, 10, 11, 18, 25, 68, 70, 71, 73, 75,

y
se o
DOE (Design of Experiments), 61, 107 130
DRBFM (Design Review by Failure Mode), 137,
U ot SD (Ranking by Severity and Detection), 136
error proofing, 73, 105 Severity, 13, 37, 57, 59, 63, 84, 87, 103, 109,
evaluation criteria, 37, 45, 53, 87, 92, 99 135, 136
al M
flow diagram, 70, 71, 81, 107 SO (Ranking by Severity and Occurrence), 136
FMECA (Failure Mode, Effect and Critical SOD (Ranking based on Severity, Occurrence
Analysis), 3, 137 and Detection), 136
Follow-up, 6
rn rd

SPC (Statistical Process Control), 95, 107

FTA (Fault Tree Analysis), 137, 139 special characteristic, 39, 91
function, 16, 18, 19 ,21 , 29 , 31, 35, 71, 79, 111 specification, 11, 13, 61, 107
te o

functional requirements, 8,16,18, 25 team, 2, 4, 5, 8, 9, 10, 14, 17, 18, 21, 22, 27, 29,
interactions, 3,10, 130, 131 35, 37, 41, 45, 49, 53, 57, 59, 69, 71, 73, 81,
In f F

interfaces, 10, 11, 29, 130,131 87, 91, 95, 99, 103, 105, 111
item, 73, 75, 111, 133 team leader, 6, 9, 69, 70, 107
linkages, 65, 111, 134 thresholds, 57, 59, 103, 105
o

mistake proofing, 61, 107 validation, 16, 31, 49, 59, 61

ty
er
op
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141
Pr
op
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o
In f F
te o
rn rd

142
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U ot
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