FMEA

POTENTIAL
FAILURE MODE AND
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EFFECTS ANALYSIS
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(FMEA)
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REFERENCE MANUAL
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The content of this document is the technical equivalent of SAE J-1739.

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Potential Failure Mode and Effects Analysis (FMEA) should be used by

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suppliers to companies subscribing to QS-9000 or equivalent document.

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First Edition Issued February, 1993 • Second Edition, February, 1995 • Third Edition, July, 2001
Copyright © 1993, © 1995, © 2001
DaimlerChrysler Corporation, Ford Motor Company, General Motors Corporation
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FOREWORD
1st and 2nd Edition
This reference Manual and Reporting Format was developed by the Failure Mode and Effects Analysis
(FMEA) teams at Chrysler, Ford and General Motors, working under the auspices of the Automotive
Division of the American Society for Quality Control (ASQC) and the Automotive Industry Action Group
(AIAG).
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The ASQC/AIAG Task Force charter is to standardize the reference manuals, procedures, reporting formats
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and technical nomenclature used by Chrysler, Ford, and General Motors in their respective supplier quality
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systems. Accordingly, this manual and format, which is approved and endorsed by Chrysler, Ford and
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General Motors, should be used by suppliers implementing FMEA techniques into their design/
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manufacturing processes.
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In the past, Chrysler, Ford and General Motors each had their own guidelines and formats for insuring
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supplier FMEA compliance. Differences between these guidelines and formats resulted in additional
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demands on supplier resources. To improve upon this situation, Chrysler, Ford and General Motors agreed
to develop, and, through AIAG, distribute this Manual. The work group responsible for the Manual was led
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be George Baumgartner of Ford Motor Company.
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This Manual provides general guidelines for preparing an FMEA. It does not give specific instructions on
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how to arrive at each FMEA entry, a task best left to each FMEA team. This Manual also is not intended to
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be a comprehensive FMEA reference source or training document.

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While these guidelines are intended to cover all situation normally occurring either in the design phase or
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process analysis, there will be questions that arise. These questions should be directed to your customer's
Supplier Quality Assurance (SQA) activity. If you are uncertain as to how to contact the appropriate SQA
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activity, the buyer in your customer's Purchasing office can help.

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The Task Force gratefully acknowledges: the leadership and commitment of Vice Presidents Thomas T.
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Stallkamp at Chrysler, Norman F. Ehlers at Ford, and J. Ignasio Lopez de Arriortua of General Motors; the
assistance of the AIAG in the development, production, and distribution of the Procedure; the guidance of
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Task Force principals Russ Jacobs (Chrysler), Steve Walsh (Ford), Dan Reid (General Motors), and Rad
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Smith; and the assistance of the ASQC Automotive Division Reading Team. This team, led by Tripp Martin
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(Peterson Spring), reviewed the Manual for technical content and accuracy and made valuable
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contributions to form and content. Since the Manual was developed to meet specific needs of the
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automotive industry, the ASQC voluntary standards process defined by ASQC policies and procedures was
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not used in its development.

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Additional copies can be ordered from AIAG and/or permission to copy portions of this Procedure for use
within supplier organizations should be obtained from AIAG at 248-358-3003.
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FOREWORD
3rd Edition
The FMEA 3rd Edition (QS-9000) is a reference manual to be used by suppliers to DaimlerChrysler, Ford
Motor Company, and General Motors Corporation as a guide to assist them in the development of both
Design and Process FMEAs. This reference manual is intended to clarify questions concerning the techni-
cal development of FMEAs.
This reference manual is consistent with the Supplier Quality Requirements Task Force charter to standard-
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ize the reference manuals, procedures, reporting formats and technical nomenclature used by suppliers to
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DaimlerChrysler, Ford Motor Company, and General Motors Corporation. Accordingly the FMEA, 3rd
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Edition Manual is written to provide guidance for the supplier. The manual does not define requirements, it
does provide general guidelines intended to cover situations normally occurring when preparing FMEAs
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during the design phase or process analysis phase.
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This manual is the technical equivalent of SAE J1739, for Design and Process FMEAs. However, it does
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not include an application for Machinery FMEA. Interested parties in Machinery FMEA may refer to SAE
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J1739 for a related example.
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The Supplier Quality Requirements Task Force would like to thank the following individuals, and their
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companies, who have contributed their time and efforts to the development of either this edition of the
FMEA manual or earlier editions.
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3rd Edition
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Kevin A. Lange - DaimlerChrysler
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Steven C. Leggett - General Motors Corporation

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Beth Baker - AIAG

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Earlier Editions
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Howard Riley - DaimlerChrysler Mark T. Wrobbel - DaimlerChrysler

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George R. Baumgartner - Ford Motor Company Rebecca French - General Motors

Lawrence R. McCullen - General Motors Mary Ann Raymond - Bosch
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Robert A. May - Goodyear William Ireland - Kelsey-Hayes

Tripp Martin - Peterson Spring
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In addition, the Supplier Quality Requirements Task Force would like to thank the following individuals from
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the SAE J1739 work group who contributed significantly to the technical changes and improvements in this
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edition.
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William D. Carlson - DaimlerChrysler

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Glen R. Vallance - Ford Motor Company

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Carl S. Carlson - General Motors Corporation

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This manual is a copyright of DaimlerChrysler, Ford Motor Company and General Motors Corporation, with
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all rights reserved. Additional copies may be obtained from AIAG, Southfield, Michigan, by calling 248-358-
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3003. Supply chain organizations of DaimlerChrysler, Ford Motor Company or General Motors Corporation
have permission to copy forms used in this manual.
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TABLE OF CONTENTS
Page
Number
General Information ................................................................................................................................... 1
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Overview ......................................................................................................................................... 1
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What Is an FMEA ............................................................................................................................ 1
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Manual Format ................................................................................................................................ 1
FMEA Implementation .................................................................................................................... 2
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Follow Up ......................................................................................................................................... 4
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Design FMEA .............................................................................................................................................. 7
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Introduction ................................................................................................................................................... 9
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Customer Defined ........................................................................................................................... 9
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Team Effort ..................................................................................................................................... 9
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Development of a Design FMEA ............................................................................................................... 10
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1) FMEA Number ........................................................................................................................ 13
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2) System, Subsystem, or Component Name and Number ....................................................... 13

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3) Design Responsibility ............................................................................................................. 13

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4) Prepared By ............................................................................................................................ 13
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5) Model Year(s)/Program(s) ...................................................................................................... 13

6) Key Date ................................................................................................................................. 13
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7) FMEA Date ............................................................................................................................. 13

8) Core Team .............................................................................................................................. 15
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9) Item/Function .......................................................................................................................... 15
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10) Potential Failure Mode ........................................................................................................... 15

11) Potential Effect(s) of Failure ................................................................................................... 17
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12) Severity (S) ............................................................................................................................. 17

Suggested DFMEA Severity Evaluation Criteria .................................................................... 19
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13) Classification .......................................................................................................................... 19

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14) Potential Cause(s)/Mechanism(s) of Failure .......................................................................... 19

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15) Occurrence (O) ....................................................................................................................... 21

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Suggested DFMEA Occurrence Evaluation Criteria .............................................................. 23

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16) Current Design Controls ......................................................................................................... 23

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17) Detection (D) .......................................................................................................................... 25

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Suggested DFMEA Detection Evaluation Criteria ................................................................. 27

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18) Risk Priority Number (RPN) ................................................................................................... 27

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19) Recommended Action(s) ........................................................................................................ 29

20) Responsibility for the Recommended Action(s) ..................................................................... 29
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21) Action(s) Taken ...................................................................................................................... 31

22) Action Results ......................................................................................................................... 31
Follow-Up Actions ...................................................................................................................................... 31
Process FMEA .......................................................................................................................................... 33
Introduction ................................................................................................................................................ 35
Customer Defined ......................................................................................................................... 35

Team Effort ................................................................................................................................... 35
–I–
TABLE OF CONTENTS - continued
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Number
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Development of a Process FMEA ............................................................................................................. 37
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1) FMEA Number ......................................................................................................................... 37
2) Item ......................................................................................................................................... 39
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3) Process Responsibility ............................................................................................................ 39
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4) Prepared By ............................................................................................................................ 39
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5) Model Year(s)/Program(s) ...................................................................................................... 39
6) Key Date .................................................................................................................................. 39
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7) FMEA Date .............................................................................................................................. 39
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8) Core Team .............................................................................................................................. 39
9) Process Function/Requirements ............................................................................................. 39
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10) Potential Failure Mode ............................................................................................................ 39
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11) Potential Effect(s) of Failure .................................................................................................... 41
12) Severity (S) .............................................................................................................................. 41
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Suggested PFMEA Severity Evaluation Criteria .....................................................................
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13) Classification ........................................................................................................................... 45
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14) Potential Cause(s)/Mechanism(s) of Failure ........................................................................... 45
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15) Occurrence (O) ....................................................................................................................... 47

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Suggested PFMEA Occurrence Evaluation Criteria ............................................................... 49

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16) Current Process Controls ........................................................................................................ 49

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17) Detection (D) ........................................................................................................................... 51

Suggested PFMEA Detection Evaluation Criteria .................................................................. 53
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18) Risk Priority Number (RPN) .................................................................................................... 53

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19) Recommended Action(s) ......................................................................................................... 55

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20) Responsibility for the Recommended Action(s) ...................................................................... 57

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21) Action(s) Taken ....................................................................................................................... 57

22) Action Results .......................................................................................................................... 57
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Follow-Up Actions ...................................................................................................................................... 57

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APPENDICES
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A Design FMEA Quality Objectives ............................................................................................ 59

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B Process FMEA Quality Objectives ........................................................................................... 60

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C Design FMEA Block Diagram Example ................................................................................... 61

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D Standard Forms for Design FMEA (1 and 2 column for controls) ........................................... 62
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E Design FMEA Example ............................................................................................................ 64

F System FMEA .......................................................................................................................... 65
G Standard Forms for Process FMEA (1 and 2 column for controls) .......................................... 68
H Process FMEA Example .......................................................................................................... 70
I Suggested PFMEA Occurrence Evaluation Criteria With Ppk Values .................................... 71
Glossary ........................................................................................................................................ 72
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GENERAL INFORMATION
Overview This manual introduces the topic of Potential Failure Mode and
Effects Analysis (FMEA) and gives general guidance in the
application of the technique.
What Is an FMEA An FMEA can be described as a systematic group of activities

intended to: (a) recognize and evaluate the potential failure of a
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product/process and the effects of that failure, (b) identify
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actions that could eliminate or reduce the chance of the
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potential failure occurring, and (c) document the entire process.
It is complementary to the process of defining what a design or
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process must do to satisfy the customer.
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All FMEAs focus on the design, whether it be of the product, or
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process.
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Manual Format This reference document presents two types of FMEA: Design
FMEA, and Process FMEA.
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This manual should be used by suppliers that subscribe to QS-
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9000 or its equivalent. FMEA teams are allowed to use the
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guidelines listed herein in the manner that will be most effective
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for a given situation.
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–1–
FMEA Implementation Because of the general industry trend to continually improve
products and processes whenever possible, using the FMEA as
a disciplined technique to identify and help minimize potential
concern is as important as ever. Studies of vehicle campaigns
have shown that fully implemented FMEA programs could have
prevented many of the campaigns.
One of the most important factors for the successful

implementation of an FMEA program is timeliness. It is meant to
be a “before-the-event” action, not an “after-the-fact” exercise.
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To achieve the greatest value, the FMEA must be done before a
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product or process failure mode has been incorporated into a
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product or process. Up-front time spent properly completing an
FMEA, when product/process changes can be most easily and
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inexpensively implemented, will minimize late change crises. An
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FMEA can reduce or eliminate the chance of implementing a
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preventive/corrective change that would create an even larger
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concern. Communication and coordination should occur
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among all FMEA teams.
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Figure 1 depicts the sequence in which an FMEA should be
performed. It is not simply a case of filling out the form but
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rather of understanding the FMEA process in order to eliminate
risk and plan the appropriate controls to ensure customer
satisfaction.
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There are three basic cases for which FMEA's are generated,
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each with a different scope or focus:

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

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scope of the FMEA is the complete design,

technology, or process.
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Case 2: Modifications to existing design or process (assumes

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there is an FMEA for the existing design or process).

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The scope of the FMEA should focus on the

modification to design or process, possible
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interactions due to the modification, and field history.

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Case 3: Use of an existing design or process in a new

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environment, location, or application (assumes there

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is an FMEA for the existing design or process). The

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scope of the FMEA is the impact of the new

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environment or location on the existing design or

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process.
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Although responsibility for the preparation of the FMEA is

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usually assigned to an individual, FMEA input should be a team

effort. A team of knowledgeable individuals should be
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assembled (e.g., engineers with expertise in design, analysis/

testing, manufacturing, assembly, service, recycling, quality,
and reliability). The FMEA is initiated by the engineer from the
responsible activity, which can be the Original Equipment
Manufacturer (i.e., produces the final product), a supplier, or a
subcontractor.
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P POTENTIAL
ro FAILURE MODE AND EFFECTS ANALYSIS SEQUENCE
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Subsystem o C Potential O D Action Results
Potential Potential f S l Cause(s)/ c Current e R. Recommended Responsibility
Failure Effect(s) of e a Mechanism(s) c Controls t P. Action(s) & Target Actions S O D R.
Function
Mode Failure
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v s of Failure u e N. Completion Date Taken e c e P.
s o r c v c t N.
Reqt's Prevention Detection
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What can be done?
What
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are the How bad o Changes
Effect(s)? is it?
- Process
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Changes
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C - Special
What are the Controls
Functions, Features or o
–3–
Requirements? m - Changes to
Standards,
What How often
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does it a or Guides
are the
What can go wrong? Cause(s)? happen? n
- No Function
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- Partial/Over/
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Function
Figure 1. FMEA Process Sequence
- Intermittent
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Function How can this be a
prevented and l
- Unintended detected?
Function
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How good is this s
method at
detecting it?
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It is not appropriate to compare the ratings of one team’s FMEA
with the ratings of another team’s FMEA, even if the product/
process appears to be identical, since each team's environment
is unique and thus the respective individual ratings will be
unique (i.e., the ratings are subjective).
A review of the FMEA document against FMEA quality

objectives (see Appendix A and Appendix B) is recommended,
including a management review.
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Follow-Up The need for taking effective preventive/corrective actions, with
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appropriate follow-up on those actions, cannot be
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overemphasized. Actions should be communicated to all
affected activities. A thoroughly thought-out and well-developed
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FMEA will be of limited value without positive and effective
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preventive/corrective actions.
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The responsible engineer is in charge of ensuring that all
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recommended actions have been implemented or adequately
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addressed. The FMEA is a living document and should always
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reflect the latest level, as well as the latest relevant actions,
including those occurring after the start of production.
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The responsible 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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a. Reviewing designs, processes, and, drawings, to ensure that

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recommended actions have been implemented,

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b. Confirming the incorporation of changes to design/assembly/

manufacturing documentation, and,
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c. Reviewing Design/Process FMEAs, special FMEA

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applications, and Control Plans.

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DESIGN FMEA
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POTENTIAL
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FAILURE MODE AND EFFECTS ANALYSIS
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DESIGN
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(DESIGN FMEA)
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DESIGN FMEA
INTRODUCTION
A Design Potential FMEA is an analytical technique used

primarily by a Design-Responsible Engineer/Team as a means
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to ensure that, to the extent possible, potential failure modes
and their associated causes/mechanisms have been considered
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and addressed. End items, along with every related system,
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subsystem, and component, should be evaluated. In its most
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rigorous form, an FMEA is a summary of the team’s thoughts
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(including an analysis of items that could go wrong based on
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experience) as a component, subsystem, or system is designed.
This systematic approach parallels, formalizes, and documents
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the mental disciplines that an engineer normally goes through in
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any design process.
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The Design Potential FMEA supports the design process in
reducing the risk of failures (including unintended outcomes) by:
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• Aiding in the objective evaluation of the design,
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including functional requirements and design
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alternatives,
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• Evaluating the initial design for manufacturing,

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assembly, service, and recycling requirements,

• Increasing the probability that potential failure modes
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and their effects on system and vehicle operation have

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been considered in the design/development process,

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• Providing additional information to aid in the planning of

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thorough and efficient design, development, and

validation programs,
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• Developing a ranked list of potential failure modes

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according to their effect on the “customer,” thus

establishing a priority system for design improvements,
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development, and validation testing/analysis,

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• Providing an open issue format for recommending and

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tracking risk-reducing actions, and,

• Providing future reference, (e.g. lessons learned), to aid
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in analyzing field concerns, evaluating design changes,

and developing advanced designs.
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Customer Defined The definition of “Customer” for a Design FMEA is not only the
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“End User” but also the design-responsible engineers/teams of

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the vehicle or higher-level assemblies, and/or the

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manufacturing/process-responsible engineers in activities such

as manufacturing, assembly, and service.
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Team Effort During the initial Design FMEA process, the responsible
engineer is expected to directly and actively involve
representatives from all affected areas. These areas of expertise
and responsibility should include but are not limited to
assembly, manufacturing, design, analysis/test, reliability,
materials, quality, service, and suppliers, as well as the design
area responsible for the next higher or lower assembly or
system, subsystem, or component. The FMEA should be a
catalyst to stimulate the interchange of ideas between the
functions affected and thus promote a team approach.
–9–
DESIGN FMEA
Unless the responsible engineer is experienced with FMEA and
team facilitation, it is helpful to have an experienced FMEA
facilitator assist the team in its activities.
The Design FMEA is a living document and should:

• Be initiated before or at design concept finalization,
• Be continually updated as changes occur or additional
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information is obtained throughout the phases of
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product development, and
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• Be fundamentally completed before the production
drawings are released for tooling.
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Considering that manufacturing/assembly needs have been
incorporated, the Design FMEA addresses the design intent and
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assumes the design will be manufactured/assembled to this
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intent. Potential failure modes and/or causes/mechanisms that
can occur during the manufacturing or assembly process need
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not but may be included in a Design FMEA. When not included,
their identification, effect, and control are covered by the
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Process FMEA.
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The Design FMEA does not rely on process controls to
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overcome potential design weaknesses, but it does take the
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technical/physical limits of a manufacturing/assembly process

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into consideration, for example:

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• Necessary mold drafts

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• Limited surface finish

• Assembling space/access for tooling
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• Limited hardenability of steels

• Tolerances/process capability/performance
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The Design FMEA can also take into consideration the

technical/physical limits of product maintenance (service) and
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recycling, for example:

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• Tool access
• Diagnostic capability
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• Material classification symbols (for recycling)

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DEVELOPMENT OF A DESIGN FMEA

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The design-responsible engineer has at his or her disposal a

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number of documents that will be useful in preparing the Design

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FMEA. The process begins by developing a listing of what the

design is expected to do and what it is expected not to do, i.e.,
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the design intent. Customer wants and needs — as may be

determined from sources such as Quality Function Deployment
(QFD), Vehicle Requirements Documents, known product
requirements, and/or manufacturing/assembly/service/recycling
requirements — should be incorporated. The better the
definition of the desired characteristics, the easier it is to identify
potential failure modes for preventive/corrective action.
A Design FMEA should begin with a block diagram for the

system, subsystem, and/or component being analyzed.
– 10 –
DESIGN FMEA
An example block diagram is shown in Appendix C. The block
diagram can also indicate the flow of information, energy, force,
fluid, etc. The object is to understand the deliverables (input) to
the block, the process (function) performed in the block, and the
deliverables (output) from the block.
The diagram illustrates the primary relationship among the items
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covered in the analysis and establishes a logical order to the
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analysis. Copies of the diagrams used in FMEA preparation
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should accompany the FMEA.
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In order to facilitate documentation of the analysis of potential
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failures and their consequences, a blank Design FMEA form is
available in Appendix D.
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– 11 –
FMEA Number 1234
1
POTENTIAL
System
P FAILURE MODE AND EFFECTS ANALYSIS
X Subsystem (DESIGN FMEA) Page 1 of 1
2 3 4
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Component 01.03/Body Closures Design Responsibility Body Engineering Prepared By A. Tate - X6412- Body Engr
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MODEL YEARS(S)/Vehicle(s) 199X/Lion 4dr/Wagon e5 Key Date 9X 03 01 ER FMEA Date (Orig.) 8X 03 22 (Rev.) 8X 07 14
Core Team T. Fender-Car Product Dev., Childers-Manufacturing, J. Ford-Assy Ops (Dalton, Fraser, Henley Assembly Plants)
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▲
▲
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Item 12 C 13 o O 15 Current Current 17 D 18 Action Results 22
Potential
Potential Potential S l f
Cause(s)/ c Design Design e R. Recommended Responsibility
Failure Effect(s) of e a Mechanism(s) c Controls Controls t P. Action(s) & Target Actions S O D R.
9 Mode Failure v s F u Prevention Detection e N. Completion Date Taken e c e P.
of Failure
Function s or c v c t N.
10 11 14 16 16 19 20 21
Front Door L.H. Corroded Deteriorated life of 6 Vehicle general durability 7 294 Based on test 7 2 2 28
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7 Upper edge of Add laboratory A Tate-Body
H8HX-0000-A interior door leading to: protective wax test veh. T-118 accelerated Engrg results (Test No.
lower door • Unsatisfactory application specified for M T-109 corrosion testing 8X 09 30 1481) upper
panels appearance due inner door panels is T-301 edge spec raised
to rust througH too low o 125mm
• Ingress to and paint over time
egress from • Impaired function 4 Vehicle general durability 7 196 Add laboratory Combine w/test Test results 7 2 2 28
7
to
vehicle of interior door Insufficient wax testing- as above accelerated for wax upper (Test No. 1481)
• Occupant hardware thickness specified r corrosion testing edge verification show specified
protection thickness is
from weather, C adequate. DOE
noise, and Conduct Design A Tate shows 25%
side impact o of Experiments Body Engrg variation in
– 12 –
m (DOE) on wax 9X 01 15 specified thickness
thickness is acceptable.
7
2
p
Physical and Chem Lab 2 28 None
• Support Inappropriate wax test- Report No.1265
a
anchorage for formulation specified
door hardware
n
including y
mirror,
hinges, latch
Design aid investigation
and window
In
8 280 Add team Based on test, 3 7 1 3 21
7 Entrapped air prevents 5 Body Engrg &
regulator with non-functioning evaluation using Assy Ops additional vent
wax from entering
TABLE 1. DESIGN FMEA
• Provide proper spray head production spray 8X 11 15 holes provided in

te
corner/edge access
surface for equipment and affected areas
appearance specified wax
items
rn
- Paint and 4 Drawing evaluation 4 112 Add team Body Engrg & Evaluation 7 1 1 7
7 Insufficient room a
soft trim of spray head access evaluation using Assy Ops showed
between panels for l
spray head access\ design aid buck 8X 09 15 adequate access
and spray head U
s
e
O
n
ly
SAMPLE
DESIGN FMEA
1) FMEA Number Enter the FMEA document number, which may be used for
tracking.
Note: For an example of items 1-22 see Table 1.
2) System, Indicate the appropriate level of analysis and enter the name
ly
Subsystem, or and number of the system, subsystem, or component being
n
analyzed. The FMEA team members must decide on what
Component Name
O
constitutes a system, subsystem, or component for their
and Number specific activities. The actual boundaries that divide a system,
e
subsystem, and component are arbitrary and must be set by the
s
U
FMEA team. Some descriptions are provided below and some
examples are provided in Appendix F.
l
a
rn
System FMEA Scope
te
A system can be considered to be made up of various
subsystems. These subsystems often have been designed by
In
different teams. Some typical System FMEAs might cover the
following systems: Chassis System, or Powertrain System, or
y
Interior System, etc. Thus, the focus of the System FMEA is to
n
ensure that all interfaces and interactions are covered among
a
the various subsystems that make up the system as well as
p
interfaces to other vehicle systems and the customer.

m
o
Subsystem FMEA Scope

C
A Subsystem FMEA is generally a sub-set of a larger system.

For example, the front suspension subsystem is a sub-set of the
r
to
chassis system. Thus, the focus of the Subsystem FMEA is to

ensure that all interfaces and interactions are covered among
o
the various components that make up the subsystem.

M
Component FMEA Scope

rd
A Component FMEA is a generally an FMEA focused on the

o
sub-set of a subsystem. For example, a strut is a component of

F
the front suspension (which is a subsystem of the chassis

system.)
f
o
y
3) Design Responsibility Enter the OEM, department, and group. Also include the
rt
supplier name, if applicable.

e
p
ro
4) Prepared By Enter the name, telephone number, and company of the

engineer responsible for preparing the FMEA.
P
5) Model Year(s)/Program(s) Enter the intended model year(s)/program(s) that will use and/or
be affected by the design being analyzed (if known).
6) Key Date Enter the initial FMEA due date, which should not exceed the
scheduled production design release date.
7) FMEA Date Enter the date the original FMEA was compiled and the latest
revision date.
– 13 –
FMEA Number 1234
1
POTENTIAL
System
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ro
p 6 7
rt
y 8
▲
▲
▲
▲
Potential
of Failure
10 11 14 16 16 19 20 21
rd
7
to
– 14 –
7
2
p
a
door hardware
n
including y
mirror,
hinges, latch
and window
In
wax from entering

te
corner/edge access
items
rn
and spray head U
s
e
O
n
ly
SAMPLE
DESIGN FMEA
8) Core Team List the names of the responsible individuals and departments
that have the authority to identify and/or perform tasks. (It is
recommended that each team member's name, department,
telephone number, address, etc., be included on a distribution
list.)
9) Item/Function Enter the name and other pertinent information (e.g., the
ly
number, the part class, etc.) of the item being analyzed. Use the
n
nomenclature and show the design level as indicated on the
O
engineering drawing. Prior to initial release (e.g., in the
conceptual phases), experimental numbers should be used.
e
s
U
Enter, as concisely as possible, the function of the item being
analyzed to meet the design intent. Include information (metrics/
l
a
measurables) regarding the environment in which this system
rn
operates (e.g., define temperature, pressure, humidity ranges,
design life). If the item has more than one function with different
te
potential modes of failure, list all the functions separately.
In
10) Potential Failure Mode Potential failure mode is defined as the manner in which a
component, subsystem, or system could potentially fail to meet
y
or deliver the intended function described in the item/function
n
column (i.e., intended function fails). The potential failure mode
a
may also be the cause of a potential failure mode in a higher-
p
level subsystem or system, or be the effect of one in a lower-

m
level component.
o
C
List each potential failure mode associated with the particular

item and item function. The assumption is made that the failure
r
to
could occur but may not necessarily occur. A recommended

starting point is a review of past things-gone-wrong, concerns,
o
reports, and group brainstorming.

M
Potential failure modes that could occur only under certain

rd
operating conditions (i.e., hot, cold, dry, dusty, etc.) and under
o
certain usage conditions (i.e., above-average mileage, rough

F
terrain, city driving only, etc.) should be considered.

f
o
Typical failure modes could be but are not limited to:

y
Cracked Deformed
rt
Loosened Leaking
e
Sticking Oxidized
p
Fractured Does not transmit torque

ro
Slips (does not hold full torque) No support (structural)

Inadequate support (structural) Harsh engagement
P
Disengages too fast Inadequate signal

Intermittent signal No signal
EMC/RFI Drift
NOTE: Potential failure modes should be described in

“physical” or technical terms, not as a symptom
necessarily noticeable by the customer.
– 15 –
FMEA Number 1234
1
POTENTIAL
System
2 3 4
ro
p 6 7
rt
y 8
▲
▲
▲
▲
Potential
of Failure
10 11 14 16 16 19 20 21
rd
7
to
– 16 –
7
2
p
a
door hardware
n
including y
mirror,
hinges, latch
and window
In
wax from entering

te
corner/edge access
items
rn
and spray head U
s
e
O
n
ly
SAMPLE
DESIGN FMEA
11) Potential Effect(s) of Failure Potential effects of failure are defined as the effects of the failure
mode on the function, as perceived by the customer.
Describe the effects of the failure in terms of what the customer

might notice or experience, remembering that the customer may
be an internal customer as well as the ultimate end user. State
ly
clearly if the failure mode could impact safety or non-
n
compliance to regulations. The effects should always be stated
O
in terms of the specific system, subsystem, or component being
analyzed. Remember that a hierarchical relationship exists
e
between the component, subsystem, and system levels. For
s
example, a part could fracture, which may cause the assembly
U
to vibrate, resulting in an intermittent system operation. The
l
intermittent system operation could cause performance to
a
degrade and ultimately lead to customer dissatisfaction. The
rn
intent is to forecast the failure effects, to the team’s level of
te
knowledge.
In
Typical failure effects could be but are not limited to:
y
Noise n Rough
Erratic Operation Inoperative
a
Poor Appearance Unpleasant Odor
p
Unstable Operation Impaired

m
Intermittent Operation Thermal Event

o
Leaks Regulatory Non-Compliance

C
12) Severity (S) Severity is the rank associated with the most serious effect for a
r
to
given failure mode. Severity is a relative ranking within the

scope of the individual FMEA. A reduction in the severity
o
ranking index can be effected only through a design change.

M
Severity should be estimated using Table 2 as a guideline:

rd
Suggested Evaluation Criteria

The team should agree on an evaluation criteria and ranking
o
system that is consistent, even if modified for individual product

F
analysis. (See Table 2.)

f
o
NOTE: It is not recommended to modify criteria ranking

y
values of 9 and 10. Failure modes with a rank of

rt
severity 1 should not be analyzed further.

e
p
NOTE: High severity rankings can sometimes be reduced by

ro
making design revisions that compensate or mitigate

the resultant severity of failure. For example, “run
P
flat tires” can mitigate the severity of a sudden tire

blowout and “seat belts” can mitigate the severity of
a vehicle crash.
– 17 –
FMEA Number 1234
1
POTENTIAL
System
2 3 4
ro
p 6 7
rt
y 8
▲
▲
▲
▲
Potential
of Failure
10 11 14 16 16 19 20 21
rd
7
to
– 18 –
7
2
p
a
door hardware
n
including y
mirror,
hinges, latch
and window
In
regulator with non-functioning
Table 1. DESIGN FMEA
wax from entering evaluation using Assy Ops additional vent

te
corner/edge access
items
rn
and spray head U
s
e
O
n
ly
SAMPLE
DESIGN FMEA
12) Severity (S) (continued)
Table 2. Suggested DFMEA Severity Evaluation Criteria
Effect Criteria: Severity of Effect Ranking
ly
n
Hazardous Very high severity ranking when a potential failure mode affects safe vehicle 10
without operation and/or involves noncompliance with government regulation without
O
warning warning.
e
Hazardous Very high severity ranking when a potential failure mode affects safe vehicle 9
s
with warning operation and/or involves noncompliance with government regulation with warning.
U
Very High Vehicle/item inoperable (loss of primary function). 8
l
a
High Vehicle/item operable but at reduced level of performance. Customer very 7
rn
dissatisfied.
te
Moderate Vehicle/item operable, but Comfort/Convenience item(s) inoperable. Customer 6
dissatisfied.
In
Low Vehicle/item operable, but Comfort/Convenience item(s) operable at a reduced 5
y
level of performance. Customer somewhat dissatisfied.
n
a
Very Low Fit & Finish/Squeak & Rattle item does not conform. Defect noticed by most 4
customers (greater than 75%).
p
m
Minor Fit & Finish/Squeak & Rattle item does not conform. Defect noticed by 50% of 3
o
customers.
C
Very Minor Fit & Finish/Squeak & Rattle item does not conform. Defect noticed by discriminat- 2
ing customers (less than 25%).
r
to
None No discernible effect. 1

o
M
13) Classification This column may be used to classify any special product
characteristics (e.g., critical, key, major, significant) for
rd
components, subsystems, or systems that may require

o
additional design or process controls.

F
This column may also be used to highlight high-priority failure

f
o
modes for engineering assessment if the team finds this helpful

or if local management requires it.
y
rt
Special product or process characteristic symbols and their

e
usage is directed by specific company policy and is not

p
standardized in this document.

ro
P
14) Potential Cause(s)/ Potential cause of failure is defined as an indication of a design

Mechanism(s) of Failure weakness, the consequence of which is the failure mode.
List, to the extent possible, every potential cause and/or failure

mechanism for each failure mode. The cause/mechanism
should be listed as concisely and completely as possible so that
remedial efforts can be aimed at pertinent causes.
– 19 –
FMEA Number 1234
1
POTENTIAL
System
2 3 4
ro
p 6 7
rt
y 8
▲
▲
▲
▲
Potential
of Failure
10 11 14 16 16 19 20 21
rd
7
to
– 20 –
7
2
p
a
door hardware
n
including y
mirror,
hinges, latch
and window
In
wax from entering

te
corner/edge access
items
rn
and spray head U
s
e
O
n
ly
SAMPLE
DESIGN FMEA
14) Potential Cause(s)/ Typical failure causes may include, but are not limited to:
Mechanism(s) of Failure
(continued) Incorrect Material Specified
Inadequate Design Life Assumption
Over-stressing
Insufficient Lubrication Capability
Inadequate Maintenance Instructions
ly
Incorrect Algorithm
n
Improper Maintenance Instructions
O
Improper Software Specification
Improper Surface Finish Specification
e
Inadequate Travel Specification
s
U
Improper Friction Material Specified
Excessive Heat
l
a
Improper Tolerance Specified
rn
Typical failure mechanisms may include but are not limited to:
te
Yield Chemical Oxidation
Fatigue Electromigration
In
Material Instability
Creep
y
Wear n
Corrosion
a
p
15) Occurrence (O) Occurrence is the likelihood that a specific cause/mechanism

m
will occur during the design life. The likelihood of occurrence

o
ranking number has a relative meaning rather than an absolute

C
value. Preventing or controlling the causes/mechanisms of the

failure mode through a design change or design process
r
to
change (e.g., design checklist, design review, design guide) is

the only way a reduction in the occurrence ranking can be
o
effected. (See Table 3.)

M
Estimate the likelihood of occurrence of potential failure cause/

rd
mechanism on a 1 to 10 scale. In determining this estimate,

o
questions such as the following should be considered:

F
• What is the service history/field experience with similar

f
o
components, subsystems, or systems?

• Is the component a carryover or similar to a previous
y
level component, subsystem or system?

rt
• How significant are changes from a previous level

e
component, subsystem, or system?

p
• Is the component radically different from a previous

ro
level component?
• Is the component completely new?
P
• Has the component application changed?

• What are the environmental changes?
• Has an engineering analysis (e.g., reliability) been used
to estimate the expected comparable occurrence rate
for the application?
• Have preventive controls been put in place?
– 21 –
FMEA Number 1234
1
POTENTIAL
System
2 3 4
ro
p 6 7
rt
y 8
▲
▲
▲
▲
Potential
of Failure
10 11 14 16 16 19 20 21
rd
7
to
– 22 –
7
2
p
a
door hardware
n
including y
mirror,
hinges, latch
and window
In
wax from entering

te
corner/edge access
items
rn
and spray head U
s
e
O
n
ly
SAMPLE
DESIGN FMEA
15) Occurrence (O) A consistent occurrence ranking system should be used to
(continued) ensure continuity. The occurrence ranking number is a relative
rating within the scope of the FMEA and may not reflect the
actual likelihood of occurrence.

ly
system, that is consistent, even if modified for individual product
n
analysis. (See Table 3.) Occurrence should be estimated using
O
Table 3 as a guideline:
e
NOTE: The ranking value of 1 is reserved for “Remote: Failure
s
U
Is unlikely.”
l
a
TABLE 3. Suggested DFMEA Occurrence Evaluation Criteria
rn
te
Probability of Failure Possible Failure Rates Ranking
In
Very High: Persistent failures > 100 per thousand vehicles/items 10
y
50 per thousand vehicles/items
n 9
a
High: Frequent failures 20 per thousand vehicles/items 8
p
m
10 per thousand vehicles/items 7

o
Moderate: Occasional failures 5 per thousand vehicles/items 6

C

r
to

o
Low: Relatively few failures 0.5 per thousand vehicles/items 3

M
0.1 per thousand vehicles/items 2

rd
Remote: Failure is unlikely < 0.010 per thousand vehicles/items 1

o
F
16) Current Design Controls List the prevention, design validation/verification (DV), or other
f
activities that have been completed or committed to and that

o
will assure the design adequacy for the failure mode and/or
cause/mechanism under consideration. Current controls (e.g.,
y
rt
design reviews, fail/safe designs such as a pressure relief valve,

mathematical studies, rig/lab testing, feasibility review,
e
prototype tests, road testing, fleet testing) are those that have
p
been or are being used with the same or similar designs. The
ro
team should always be focused on improving design controls;

P
for example, creating new system tests in the lab, or creating

new system modeling algorithms, etc.
There are two types of design controls to consider:
Prevention: Prevent the cause/mechanism of failure or the

failure mode from occurring, or reduce their
rate of occurrence,
Detection: Detect the cause/mechanism of failure or the
failure mode, either by analytical or physical
methods, before the item is released to
production.
– 23 –
FMEA Number 1234
1
POTENTIAL
System
2 3 4
ro
p 6 7
rt
y 8
▲
▲
▲
▲
Potential
of Failure
10 11 14 16 16 19 20 21
rd
7
to
– 24 –
7
2
p
a
door hardware
n
including y
mirror,
hinges, latch
and window
In
wax from entering

te
corner/edge access
items
rn
and spray head U
s
e
O
n
ly
SAMPLE
DESIGN FMEA
16) Current Design Controls The preferred approach is to first use prevention controls, if
(continued) possible. The initial occurrence rankings will be affected by the
prevention controls provided they are integrated as part of the
design intent. The initial rankings for detection will be based on
design controls that either detect the cause/mechanism of
failure, or detect the failure mode.
ly
The Design FMEA form in this manual has two columns for the
n
design controls (i.e., separate columns for Prevention Controls
O
and Detection Controls) to assist the team in clearly
distinguishing between these two types of design controls. This
e
allows for a quick visual determination that both types of design
s
U
controls have been considered. Use of this two-column form is
the preferred approach.
l
a
rn
Note: In the example included here, it is clear that the team
has not identified any prevention controls. This could
te
be due to prevention controls not having been used
on the same or similar designs.
In
If a one-column (for design controls) form is used, then the
y
following prefixes should be used. For prevention controls,
n
place a 'P' before each prevention control listed. For detection
a
controls, place a 'D' before each detection control listed.
p
m
Once the design controls have been identified, review all

o
prevention controls to determine if any occurrence rankings

C
need to be revised.
r
to
17) Detection (D) Detection is the rank associated with the best detection control
o
listed in the design control. Detection is a relative ranking,

M
within the scope of the individual FMEA. In order to achieve a

lower ranking, generally the planned design control (e.g.,
rd
validation, and/or verification activities) has to be improved.

o
F
f
o
y
rt
e
p
ro
P
– 25 –
FMEA Number 1234
1
POTENTIAL
System
2 3 4
ro
p 6 7
rt
y 8
▲
▲
▲
▲
Potential
of Failure
10 11 14 16 16 19 20 21
rd
7
to
– 26 –
7
2
p
a
door hardware
n
including y
mirror,
hinges, latch
and window
In
wax from entering

te
corner/edge access
items
rn
and spray head U
s
e
O
n
ly
SAMPLE
DESIGN FMEA
system that is consistent, even if modified for individual product
analysis.
It is best to have detection controls in place as early as possible

in the design development process.
ly
n
NOTE: After making the detection ranking, the team should
O
review the occurrence ranking and ensure that the
occurrence ranking is still appropriate.
e
s
U
Detection should be estimated using Table 4 as a guideline.
l
a
NOTE: The ranking value of 1 is reserved for “almost
rn
certain.”
TABLE 4. Suggested DFMEA Detection Evaluation Criteria
te
In
Detection Criteria: Likelihood of Detection by Design Control Ranking
y
Absolute n
Design Control will not and/or can not detect a potential cause/mechanism and 10
a
Uncertainty subsequent failure mode; or there is no Design Control.
p
Very Remote Very remote chance the Design Control will detect a potential cause/mechanism 9
m
and subsequent failure mode.

o
Remote Remote chance the Design Control will detect a potential cause/mechanism and 8
C
subsequent failure mode.

r
Very Low Very low chance the Design Control will detect a potential cause/mechanism and
to
7
o
Low Low chance the Design Control will detect a potential cause/mechanism 6
M

rd
Moderate Moderate chance the Design Control will detect a potential cause/mechanism and 5
o
Moderately
F
Moderately high chance the Design Control will detect a potential cause/ mecha- 4
High nism and subsequent failure mode.
f
o
High High chance the Design Control will detect a potential cause/mechanism and 3
y
rt
Very High Very high chance the Design Control will detect a potential cause/mechanism 2
e

p
Almost Design Control will almost certainly detect a potential cause/mechanism and 1
ro
Certain subsequent failure mode.

P
18) Risk Priority Number (RPN) The risk priority number is the product of the severity (S),
occurrence (O), and detection (D) rankings.
(S) x (O) x (D) = RPN
Within the scope of the individual FMEA, this value (between 1

and 1000) can be used to rank order the concerns in the design.
– 27 –
FMEA Number 1234
1
POTENTIAL
System
2 3 4
ro
p 6 7
rt
y 8
▲
▲
▲
▲
Potential
of Failure
10 11 14 16 16 19 20 21
rd
7
to
– 28 –
7
2
p
a
door hardware
n
including y
mirror,
hinges, latch
and window
In
wax from entering

te
corner/edge access
items
rn
and spray head U
s
e
O
n
ly
SAMPLE
DESIGN FMEA
19) Recommended Action(s) Engineering assessment for preventive/corrective action should
be first directed at high severity, high RPN, and other items
designated by the team. The intent of any recommended action
is to reduce rankings in the following order: severity,
occurrence, and detection.
In general practice when the severity is a 9 or 10, special
ly
attention must be given to ensure that the risk is addressed
n
through existing design controls or preventive/corrective
O
action(s), regardless of the RPN. In all cases where the effect of
an identified potential failure mode could be a hazard to the end
e
user, preventive/corrective actions should be considered to
s
U
avoid the failure mode by eliminating, mitigating, or controlling
the cause(s).
l
a
rn
After special attention has been given to severity rankings of 9
or 10, the team then addresses other failure modes, with the
te
intent of reducing severity, then occurrence, and then detection.
In
Actions such as, but not limited to, the following should be
considered:
y
n
• Revised Design Geometry and/or Tolerances,
a
• Revised Material Specification,
p
• Design of Experiments (particularly when multiple or

m
interactive causes are present) or other problem-solving

o
techniques, and,
C
• Revised Test Plan.

r
to
The primary objective of recommended actions is to reduce

risks and increase customer satisfaction by improving the
o
design.
M
Only a design revision can bring about a reduction in the

rd
severity ranking. A reduction in the occurrence ranking can be

o
effected only by removing or controlling one or more of the

F
causes/mechanisms of the failure mode through a design

revision. An increase in design validation/verification actions will
f
o
result in a reduction in the detection ranking only. Increasing

the design validation/verification actions is a less desirable
y
engineering action since it does not address the severity or

rt
occurrence of the failure mode.

e
p
If engineering assessment leads to no recommended actions for

ro
a specific failure mode/cause/control combination, indicate this

by entering “None” in this column.
P
20) Responsibility for the Enter the name of the organization and individual responsible for
Recommended Action(s) each recommended action and the target completion date.
– 29 –
FMEA Number 1234
1
POTENTIAL
System
2 3 4
ro
p 6 7
rt
y 8
▲
▲
▲
▲
Potential
of Failure
10 11 14 16 16 19 20 21
rd
7
to
– 30 –
7
2
p
a
anchorage for formulation specified n
DESIGN FMEA
door hardware
including y
mirror,
hinges, latch
and window
In
wax from entering
te
corner/edge access
items
rn
and spray head U
s
e
O
n
ly
SAMPLE
DESIGN FMEA
21) Action(s) Taken After the action has been implemented, enter a brief description
of the actual action and effective date.
22) Action Results After the preventive/corrective action has been identified,
estimate and record the resulting severity, occurrence, and
detection rankings. Calculate and record the resulting RPN. If
no actions are taken, leave the related ranking columns blank.
ly
n
All revised ratings should be reviewed. If further action is
O
considered necessary, repeat the analysis. The focus should
always be on continuous improvement.
e
s
U
Follow-Up Actions
l
a
The design-responsible engineer is responsible for ensuring that
rn
all actions recommended have been implemented or adequately
te
addressed. The FMEA is a living document and should always
reflect the latest design level as well as the latest relevant
In
actions, including those occurring after start of production.
y
The design-responsible engineer has several means of ensuring
n
that concerns are identified and that recommended actions are
a
implemented. They include, but are not limited to the following:
p
m
• Ensuring design requirements are achieved,

o
• Reviewing engineering drawings and specifications,

C
• Confirming incorporation in assembly/manufacturing

documentation, and,
r
• Reviewing Process FMEAs and Control Plans.

to
o
M
rd
o
F
f
o
y
rt
e
p
ro
P
– 31 –
P
ro
p
e
rt
y
o
f
F
o
rd
M
o
to
r
C
o
– 32 –
m
p
a
n
y
In
te
rn
a
l
U
s
e
O
n
ly
PROCESS FMEA
ly
n
O
e
s
U
l
POTENTIAL
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MANUFACTURING AND ASSEMBLY PROCESSES
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(PROCESS FMEA)
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PROCESS FMEA
INTRODUCTION
A Process Potential FMEA is an analytical technique used by a
Manufacturing/Assembly-Responsible Engineer/Team as a
means to ensure that, to the extent possible, potential failure
modes and their associated causes/mechanisms have been
ly
considered and addressed. In its most rigorous form, an FMEA
is a summary of the team’s thoughts (including an analysis of
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items that could go wrong based on experience) as a process is
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developed. This systematic approach parallels and formalizes
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the mental discipline that an engineer normally goes through in
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any manufacturing planning process.
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The Process Potential FMEA:
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• Identifies the process functions and requirements,
• Identifies potential product and process-related failure
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modes,
• Assesses the effects of the potential failures on the
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customer,
• Identifies the potential manufacturing or assembly
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process causes and identifies process variables on
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which to focus controls for occurrence reduction or
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detection of the failure conditions,

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• Identifies process variables on which to focus process

controls,
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• Develops a ranked list of potential failure modes, thus

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establishing a priority system for preventive/corrective

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action considerations, and,

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• Documents the results of the manufacturing or

assembly process.
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Customer Defined The definition of “Customer” for a Process FMEA should

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normally be the “End User.” However, the customer can also be

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a subsequent or downstream manufacturing or assembly

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operation, a service operation, or government regulations.

.
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Team Effort During the initial development of the Process FMEA, the
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responsible engineer is expected to directly and actively involve

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representatives from all affected areas. These areas should

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include but are not limited to design, assembly, manufacturing,

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materials, quality, service, and suppliers, as well as the area

responsible for the next assembly. The Process FMEA should
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be a catalyst to stimulate the interchange of ideas between the

areas affected and thus promote a team approach.
Unless the responsible engineer is experienced with FMEA and

team facilitation, it is helpful to have an experienced FMEA
facilitator assist the team in its activities.
– 35 –
P FMEA Number 1450
1
POTENTIAL
(PROCESS FMEA) Page 1 of 1
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Item Front Door L.H./H8HX-000-A
p 2 3 4
Process Responsibility Body Engrg. Prepared By J. Ford - X6521 - Assy Ops
e5 6 7
Model Years(S)/Vehicle(s) 199X/Lion 4dr/Wagon rt Key Date 9X 03 01 ER 9X 08 26 Job #1 FMEA Date (Orig.) 9X 05 17 (Rev.) 9X 11 06
Core Team A. Tate Body Engrg., J. Smith-OC, R. James-Production, J. Jones-Maintenance
y 8
▲
▲
▲
▲
Process 12 C 13 o
Potential O 15 Current Current 17 D 18 Action Results 22
Function Potential Potential S l Cause(s)/f c Process Process e R. Recommended Responsibility
9 Mode Failure v s of Failure Fu Prevention Detection e N. Completion Date Taken e c e P.
s r
o c v c t N.
Requirements 10 11 14 16 19 20 21
Add positive MFG Engrg Stop added,
Manual Insufficient Deteriorated life of Manually inserted 8 Visual check each hour- sprayer checked 7 2 5 70
rd16
7
5 280 depth stop to 9X 10 15
application of wax coverage door leading to: spray head not 1/shift for film thickness sprayer on line
wax inside door over specified • Unsatisfactory inserted far M (depth meter) and
surface appearance due enough coverage Automate Mfg Engrg Rejected due to
to rust through o spraying 9X 12 15 complexity of
paint over time
different doors
• Impaired function
on same line
to
of interior doo
hardware 7 Spray heads 5 Test spray pattern at r Visual check each hour- 5 175 Use Design of Mfg Engrg Temp and press 7 1 5 35
clogged start-up and after idle 1/shift for film thickness Experiments 9X 10 01 limits were
- Viscosity too periods, and preventive (depth meter) and
C (DOE) on determined and
To cover inner high maintenance program to coverage viscosity vs. limit controls
door, lower - Temperature clean heads o temperature vs. have been
– 36 –
surfaces at too low m pressure installed -
minimum wax - Pressure control charts
thickness to too low p show process is
retard corrosion in control
a Cpk=1.85
7 Spray head 2 Preventive maintenance Visual check each hour-

n 5 70 None
deformed due programs to maintain heads 1/shift for film thickness y
to impact (depth meter) and
coverage In
7 Spray time 8 Operator instructions and 7 392 Install spray Maintenance Automatic spray 7 1 7 49
insufficient lot sampling (10 doors / timer 9X 09 15 timer installed -
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TABLE 5. PROCESS FMEA
shift) to check for operator starts

coverage of critical areas spray, timer
controls shut-off
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a control charts
show process is
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U Cpk=2.05
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SAMPLE
PROCESS FMEA
INTRODUCTION (Continued)
The Process FMEA is a living document and should be initiated:
• Before or at the feasibility stage,
• Prior to tooling for production, and
• Take into account all manufacturing operations, from
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individual components to assemblies.
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Early review and analysis of new or revised processes is
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promoted to anticipate, resolve, or monitor potential process
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concerns during the manufacturing planning stages of a new
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model or component program.
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The Process FMEA assumes the product as designed will meet
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the design intent. Potential failure modes that can occur
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because of a design weakness may be included in a Process
FMEA. Their effect and avoidance is covered by the Design
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FMEA.
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The Process FMEA does not rely on product design changes to
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overcome weaknesses in the process. However, it does take
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into consideration a product’s design characteristics relative to
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the planned manufacturing or assembly process to assure that,
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to the extent possible, the resultant product meets customer

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needs and expectations.

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DEVELOPMENT OF A PROCESS FMEA

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The process-responsible engineer has at his or her disposal a

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number of documents that will be useful in preparing the

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Process FMEA. The FMEA begins by developing a list of what

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

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The Process FMEA should begin with a flow chart of the general
process. This flow chart should identify the product/process
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characteristics associated with each operation. Identification of

some product effects from the corresponding Design FMEA,
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should be included, if available. Copies of the flow chart used in

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FMEA preparation should accompany the FMEA.

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In order to facilitate documentation of the analysis of potential

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failures and their consequences, a Process FMEA form has

been developed and is in Appendix G.
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1) FMEA Number Enter the FMEA document number, which may be used for
tracking.
Note: For an example of items 1-22 see Table 5.
– 37 –
P FMEA Number 1450
1
POTENTIAL
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Process 12 C 13 o
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Requirements 10 11 14 16 19 20 21
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paint over time
different doors
on same line
to
of interior doo
– 38 –
a Cpk=1.85

n 5 70 None
coverage In
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controls shut-off
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show process is
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U Cpk=2.05
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SAMPLE
PROCESS FMEA
2) Item Enter the name and number of the system, subsystem, or
component for which the process is being analyzed.
3) Process Responsibility Enter the OEM, department, and group. Also include the
supplier name if known.
4) Prepared By Enter the name, telephone number, and company of the
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engineer responsible for preparing the FMEA.
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5) Model Year(s)/Program(s) Enter the intended model year(s)/program(s) that will use and/or
be affected by the design/process being analyzed (if known).
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6) Key Date
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Enter the initial FMEA due date, which should not exceed the
scheduled start of production date.
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Note: In the case of a supplier, the initial FMEA due date
should not exceed the customer required Production
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Part Approval Process (PPAP) submission date.
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7) FMEA Date Enter the date the original FMEA was compiled and the latest
revision date.
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8) Core Team List the names of the responsible individuals and departments
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that have the authority to identify and/or perform tasks. (It is
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recommended that each team member's name, department,

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telephone number, address, etc., be included on a distribution

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list.)
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9) Process Function/ Enter a simple description of the process or operation being

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Requirements analyzed (e.g., turning, drilling, tapping, welding, assembling).

In addition, it is recommended to record the associated
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process/operation number for the step being analyzed. The

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team should review applicable performance, material, process,

environmental, and safety standards. Indicate as concisely as
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possible the purpose of the process or operation being

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analyzed, including information about the design (metrics/

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measurables) of the system, subsystem, or component. Where

the process involves numerous operations (e.g., assembling)
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with different potential modes of failure, it may be desirable to

list the operations as separate elements.
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10) Potential Failure Mode Potential failure mode is defined as the manner in which the
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process could potentially fail to meet the process requirements

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and/or design intent as described in the process function/

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requirements column. It is a description of the nonconformance

at that specific operation. It can be a cause associated with a
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potential failure mode in a subsequent (downstream) operation

or an effect associated with a potential failure in a previous
(upstream) operation. However, in preparing the FMEA, assume
that the incoming part(s)/material(s) are correct. Exceptions can
be made by the FMEA team where historical data indicate
deficiencies in incoming part quality.
List each potential failure mode for the particular operation in

terms of a component, subsystem, system, or process
characteristic. Assume that the failure could occur but may not
necessarily occur. The process engineer/team should be able to
– 39 –
P FMEA Number 1450
1
POTENTIAL
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Process 12 C 13 o
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Requirements 10 11 14 16 19 20 21
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7
paint over time
different doors
on same line
to
of interior doo
– 40 –
a Cpk=1.85

n 5 70 None
coverage In
te
operator starts
shift) to check for

controls shut-off
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a control charts
show process is
l in control
U Cpk=2.05
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SAMPLE
PROCESS FMEA
10) Potential Failure Mode pose and answer the following questions:
(continued)
• How can the process/part fail to meet requirements?
• Regardless of engineering specifications, what would a
customer (end user, subsequent operations, or service)
consider objectionable?
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Start by comparing similar processes and reviewing customer
(end user and subsequent operation) claims relating to similar
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components. In addition, a knowledge of the design intent is
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necessary. Typical failure modes could be but are not limited to:
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Bent Burred Hole off-location
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Cracked Hole too shallow Hole missing
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Handling damage Dirty Hole too deep
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Surface too rough Deformed Surface too smooth
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Open circuited Short circuited Mis-labeled
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NOTE: Potential failure modes should be described in
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"physical" or technical terms, not as a symptom
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noticeable by the customer.
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11) Potential Effect(s) of Potential effects of failure are defined as the effects of the failure
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Failure mode on the customer(s).
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Describe the effects of the failure in terms of what the customer

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might notice or experience, remembering that the customer may

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be an internal customer as well as the ultimate end user. State

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clearly if the failure mode could impact safety or cause

noncompliance to regulations. The customer(s) in this context
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could be the next operation, subsequent operations or

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locations, the dealer, and/or the vehicle owner. Each must be

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considered when assessing the potential effect of a failure.

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For the end user, the effects should always be stated in terms of
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product or system performance, such as:

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Noise Rough
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Erratic operation Excessive

Effort Inoperative
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Unpleasant odor Unstable

Operation impaired Draft
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Intermittent operation Poor appearance

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Leaks Vehicle control impaired

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Rework/Repairs Customer dissatisfaction

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Scrap
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If the customer is the next operation or subsequent operation(s)/

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location(s), the effects should be stated in terms of process/

operation performance, such as:
Cannot fasten Does not fit
Cannot bore/tap Does not connect
Cannot mount Does not match
Cannot face Causes excessive tool wear
Damages equipment Endangers operator
12) Severity (S) Severity is the rank associated with the most serious effect for a
given failure mode. Severity is a relative ranking within the
– 41 –
P FMEA Number 1450
1
POTENTIAL
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p 2 3 4
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Process 12 C 13 o
s r
o c v c t N.
Requirements 10 11 14 16 19 20 21
rd16
7
paint over time
different doors
on same line
to
of interior doo
– 42 –
a Cpk=1.85

n 5 70 None
coverage In
te
operator starts
shift) to check for

controls shut-off
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a control charts
show process is
l in control
U Cpk=2.05
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SAMPLE
PROCESS FMEA
Table 6. Suggested PFMEA Severity Evaluation Criteria
Criteria: Severity of Effect Criteria: Severity of Effect
This ranking results when a This ranking results when a
potential failure mode results in a potential failure mode results in a
final customer and/or a final customer and/or a
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manufacturing/assembly plant manufacturing/assembly plant
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defect. The final customer should defect. The final customer should
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always be considered first. If both always be considered first. If both
occur, use the higher of the two occur, use the higher of the two
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severities. severities.
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Effect (Customer Effect) (Manufacturing/ Assembly Effect) Ranking
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Hazardous Very high severity ranking when a Or may endanger operator (machine 10
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without potential failure mode affects safe or assembly) without warning.
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warning vehicle operation and/or involves
noncompliance with government
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regulation without warning.
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Hazardous Very high severity ranking when a Or may endanger operator (machine 9
with warning potential failure mode affects safe or assembly) with warning.
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vehicle operation and/or involves
noncompliance with government n
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regulation with warning.
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Very High Vehicle/item inoperable (loss of Or 100% of product may have to be

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primary function). scrapped, or vehicle/item repaired in
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repair department with a repair time

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greater than one hour.

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High Vehicle/Item operable but at a Or product may have to be sorted 7

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reduced level of performance. and a portion (less than 100%)

Customer very dissatisfied. scrapped, or vehicle/item repaired in
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between a half-hour and an hour.

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Moderate Vehicle/Item operable but Comfort/ Or a portion (less than 100%) of the 6
Convenience item(s) inoperable. product may have to scrapped with
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Customer dissatisfied. no sorting, or vehicle/item repaired in

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less than a half-hour.
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Low Vehicle/Item operable but Comfort/ Or 100% of product may have to be 5

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Convenience item(s) operable at a reworked, or vehicle/item repaired off-

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reduced level of performance. line but does not go to repair

department.
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Very Low Fit and Finish/Squeak and Rattle item Or the product may have to be 4
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does not conform. Defect noticed by sorted, with no scrap, and a portion
most customers (greater than 75%). (less than 100%) reworked.
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Minor Fit and Finish/Squeak and Rattle item Or a portion (less than 100%) of the 3
does not conform. Defect noticed by product may have to be reworked,
50% of customers. with no scrap, on-line but out-of-sta-
tion.
Very Minor Fit and Finish/Squeak and Rattle item Or a portion (less than 100%) of the 2
does not conform. Defect noticed by product may have to be reworked,
discriminating customers (less than with no scrap, on-line but in-station.
25%).
None No discernible effect. Or slight inconvenience to operation
or operator, or no effect. 1
– 43 –
P FMEA Number 1450
1
POTENTIAL
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Process 12 C 13 o
s r
o c v c t N.
Requirements 10 11 14 16 19 20 21
rd16
7
paint over time
different doors
on same line
to
of interior doo
– 44 –
a Cpk=1.85

n 5 70 None
coverage In
te
operator starts
shift) to check for

controls shut-off
rn
a control charts
show process is
l in control
U Cpk=2.05
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SAMPLE
12) Severity (S) (continued) scope of the individual FMEA. A reduction in severity ranking
index can be effected through a design change to system,
subsystem or component, or a redesign of the process.
If the customer affected by a failure mode is the manufacturing

or assembly plant or the product user, assessing the severity
may lie outside the immediate process engineer’s/team’s field of
experience or knowledge. In these cases, the Design FMEA,
design engineer, and/or subsequent manufacturing or assembly
plant process engineer, should be consulted.
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system, that is consistent, even if modified for individual
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process analysis. (See Table 6)
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Severity should be estimated using Table 6 as a guideline:
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NOTE: It is not recommended to modify criteria for ranking
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values of 9 and 10. Failure modes with a rank of
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severity 1 should not be analyzed further.
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13) Classification This column may be used to classify any special product or
process characteristics (e.g., critical, key, major, significant) for
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components, subsystems, or systems that may require
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additional process controls.
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This column may also be used to highlight high priority failure

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modes for engineering assessment.

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If a classification is identified in the Process FMEA, notify the

design responsible engineer since this may affect the
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engineering documents concerning control item identification.

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Special product or process characteristic symbols and their

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usage is directed by specific company policy and is not

standardized in this document.
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14) Potential Cause(s)/ Potential cause of failure is defined as how the failure could
F
Mechanism(s) of Failure occur, described in terms of something that can be corrected or

can be controlled.
f
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List, to the extent possible, every failure cause assignable to

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each potential failure mode. If a cause is exclusive to the failure

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mode, i.e., if correcting the cause has a direct impact on the

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failure mode, then this portion of the FMEA thought process is

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completed. Many causes, however, are not mutually exclusive,

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and to correct or control the cause, a design of experiments, for

example, may be considered to determine which root causes
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are the major contributors and which can be most easily

controlled. The causes should be described so that remedial
efforts can be aimed at those causes which are pertinent.
Typical failure causes may include, but are not limited to:
Improper torque - over, under

Improper weld - current, time, pressure
Inaccurate gauging
Improper heat treat - time, temperature
– 45 –
P FMEA Number 1450
1
POTENTIAL
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p 2 3 4
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▲
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▲
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Process 12 C 13 o
s r
o c v c t N.
Requirements 10 11 14 16 19 20 21
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7
paint over time
different doors
on same line
to
of interior doo
– 46 –
a Cpk=1.85

n 5 70 None
coverage In
te
operator starts
shift) to check for

controls shut-off
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a control charts
show process is
l in control
U Cpk=2.05
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SAMPLE
PROCESS FMEA
14) Potential Cause(s)/ Inadequate gating/venting
Mechanism(s) of Failure Inadequate or no lubrication
(continued) Part missing or mislocated
Worn locator
Worn tool
Chip on locator
Broken tool
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Improper machine setup
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Improper programming
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Only specific errors or malfunctions (e.g., operator fails to install
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seal) should be listed; ambiguous phrases (e.g., operator error,
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machine malfunction) should not be used.
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15) Occurrence (O)
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Occurrence is the likelihood that a specific cause/mechanism of
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failure will occur. The likelihood of occurrence ranking number
has a relative meaning rather than an absolute value. Preventing
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or controlling the causes/mechanisms of failure through a
design or process change is the only way a reduction in the
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occurrence ranking can be effected.
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Estimate the likelihood of occurrence of potential failure cause/
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mechanism on a 1 to 10 scale.
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A consistent occurrence ranking system should be used to

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ensure continuity. The occurrence ranking number is a relative

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rating within the scope of the FMEA and may not reflect the
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actual likelihood of occurrence.

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The “Possible Failure Rates” are based on the number of

failures that are anticipated during the process execution. If
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statistical data are available from a similar process, the data

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should be used to determine the occurrence ranking. In all other

cases, a subjective assessment can be made by using the word
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descriptions in the left column of the table, along with any

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historical data available for similar processes.

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system that is consistent, even if modified for individual process
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analysis. (See Table 7)

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Occurrence should be estimated using Table 7 as a guideline:

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NOTE: The ranking value of 1 is reserved for “Remote:

failure is Unlikely”.
P
– 47 –
P FMEA Number 1450
1
POTENTIAL
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p 2 3 4
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Process 12 C 13 o
s r
o c v c t N.
Requirements 10 11 14 16 19 20 21
rd16
7
paint over time
different doors
on same line
to
of interior doo
– 48 –
a Cpk=1.85

n 5 70 None
coverage In
te
operator starts
shift) to check for

controls shut-off
rn
a control charts
show process is
l in control
U Cpk=2.05
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SAMPLE
PROCESS FMEA
Table 7. Suggested PFMEA Occurrence Evaluation Criteria
Probability Likely Failure Rates* Ranking
Very High: Persistent Failures > 100 per thousand pieces 10
ly
50 per thousand pieces 9
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High: Frequent Failures 20 per thousand pieces 8
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Moderate: Occasional Failures 5 per thousand pieces 6
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0.5 per thousand pieces
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Low: Relatively Few Failures 3
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2
Remote: Failure is Unlikely < 0.01 per thousand pieces 1
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*For associated Ppk calculations and values, see Appendix I.
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p
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16) Current Process Current Process Controls are descriptions of the controls that
o
Controls either prevent to the extent possible the failure mode or cause/
C
mechanism of failure from occurring, or detect the failure mode

or cause/mechanism of failure should it occur. These controls
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can be process controls such as error/mistake proofing,

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statistical process control (SPC), or can be post-process

o
evaluation. The evaluation may occur at the subject operation

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or at subsequent operations.
There are two types of Process Controls to consider:
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Prevention: Prevent the cause/mechanism of failure or

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the failure mode from occurring, or reduce

their rate of occurrence,
f
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Detection: Detect the cause/mechanism of failure or the

failure mode, and lead to corrective
y
action(s).
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e
The preferred approach is to first use prevention controls, if

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

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prevention controls provided they are integrated as part of the

process intent. The initial rankings for detection will be based
P
on process controls that either detect the cause/mechanism of

failure, or detect the failure mode.
The Process FMEA form in this manual has two columns for the
process controls (i.e., separate columns for Prevention Controls
and Detection Controls) to assist the team in clearly
distinguishing between these two types of process controls.
This allows for a quick visual determination that both types of
process controls have been considered. Use of this two-
column form is the preferred approach.
– 49 –
P FMEA Number 1450
1
POTENTIAL
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Process 12 C 13 o
s r
o c v c t N.
Requirements 10 11 14 16 19 20 21
rd16
7
paint over time
different doors
on same line
to
of interior doo
– 50 –
a Cpk=1.85

n 5 70 None
coverage In
te
operator starts
shift) to check for

controls shut-off
rn
a control charts
show process is
l in control
U Cpk=2.05
s
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SAMPLE
PROCESS FMEA
16) Current Process If a one-column (for process controls) form is used, then the
Controls (continued) following prefixes should be used. For prevention controls,
place a 'P' before each prevention control listed. For detection
controls, place a 'D' before each detection control listed.
Once the process controls have been identified, review all

prevention controls to determine if any occurrence rankings
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need to be revised.
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17) Detection (D) Detection is the rank associated with the best detection control
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listed in the process control column. Detection is a relative
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ranking, within the scope of the individual FMEA. In order to
achieve a lower ranking, generally the planned process control
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has to be improved.
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Assume the failure has occurred and then assess the
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capabilities of all "Current Process Controls" to prevent
shipment of the part having this failure mode or defect. Do not
In
automatically presume that the detection ranking is low because
the occurrence is low (e.g., when control charts are used), but
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do assess the ability of the process controls to detect low
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frequency failure modes or prevent them from going further in
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the process.
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Random quality checks are unlikely to detect the existence of an

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isolated defect and should not influence the detection ranking.

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Sampling done on a statistical basis is a valid detection control.

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ro
P
– 51 –
P FMEA Number 1450
1
POTENTIAL
ro
p 2 3 4
e5 6 7
y 8
▲
▲
▲
▲
Process 12 C 13 o
s r
o c v c t N.
Requirements 10 11 14 16 19 20 21
rd16
7
paint over time
different doors
on same line
to
of interior doo
– 52 –
a Cpk=1.85

n 5 70 None
coverage In
te
operator starts
shift) to check for

controls shut-off
rn
a control charts
show process is
l in control
U Cpk=2.05
s
e
O
n
ly
SAMPLE
PROCESS FMEA
17) Detection (D) (continued) Suggested Evaluation Criteria
system that is consistent, even if modified for individual
product analysis. (See Table 8.)
Detection should be estimated using Table 8 as a guideline.
ly
NOTE: The ranking value of 1 is reserved for “Certain to
n
Detect.
O
TABLE 8. Suggested PFMEA Detection Evaluation Criteria
e
s
Detection Criteria Inspection Suggested Range of Detection Methods Ranking
U
Types
l
a
A B C
rn
Almost Absolute certainty of non- X Cannot detect or is not checked. 10
Impossible detection.
te
Very Controls will probably not X Control is achieved with indirect or random 9
Remote detect. checks only.
In
Remote Controls have poor chance X Control is achieved with visual inspection only. 8
of detection.
y
Very Low Controls have poor chance
of detection.
X n
Control is achieved with double visual inspection
only.
7
a
p
Low Controls may detect. X X Control is achieved with charting methods, such 6
as SPC {Statistical Process Control}.
m
Moderate Controls may detect. X Control is based on variable gauging after parts 5
o
have left the station, or Go/No Go gauging

C
performed on 100% of the parts after parts have

left the station.
r
Moderately Controls have a good X X Error detection in subsequent operations, OR 4

to
High chance to detect. gauging performed on setup and first-piece

check (for set-up causes only).
o
M
High Controls have a good X X Error detection in-station, or error detection in 3

chance to detect. subsequent operations by multiple layers of
acceptance: supply, select, install, verify. Cannot
rd
accept discrepant part.

o
Very High Controls almost certain to X X Error detection in-station (automatic gauging with 2
F
detect. automatic stop feature). Cannot pass discrepant

part.
f
o
Very High Controls certain to detect. X Discrepant parts cannot be made because item 1
has been error-proofed by process/product
y
design.
rt
Inspection Types:
e
A. Error-proofed
p
B. Gauging
ro
C. Manual Inspection
P
18) Risk Priority Number (RPN) The risk priority number is the product of the severity (S), occur-
rence (O), and detection (D) rankings.
(S) x (O) x (D) = RPN
Within the scope of the individual FMEA, this value (between 1

and 1000) can be used to rank order the concerns in the pro-
cess.
– 53 –
P FMEA Number 1450
1
POTENTIAL
ro
p 2 3 4
e5 6 7
y 8
▲
▲
▲
▲
Process 12 C 13 o
s r
o c v c t N.
Requirements 10 11 14 16 19 20 21
rd16
7
paint over time
different doors
on same line
to
of interior doo
– 54 –
a Cpk=1.85

n 5 70 None
coverage In
te
operator starts
shift) to check for

controls shut-off
rn
a control charts
show process is
l in control
U Cpk=2.05
s
e
O
n
ly
SAMPLE
PROCESS FMEA
19) Recommended Action(s) Engineering assessment for preventive/corrective action should
be first directed at high severity, high RPN, and other items
designated by the team. The intent of any recommended action
is to reduce rankings in the following order: severity, occur-
rence, and detection.
In general practice, when the severity is 9 or 10, special atten-
ly
tion must be given to ensure that the risk is addressed through
n
existing design actions/controls or process preventive/correc-
O
tive action(s), regardless of the RPN. In all cases where the
effect of an identified potential failure mode could be a hazard
e
to manufacturing/assembly personnel, preventive/corrective ac-
s
U
tions should be taken to avoid the failure mode by eliminating or
controlling the cause(s), or appropriate operator protection
l
a
should be specified.
rn
After special attention has been given to severity rankings of 9
te
or 10, the team then addresses other failure modes, with the
intent of reducing severity, then occurrence, and then detection.
In
Actions such as, but not limited to, the following should be
y
considered: n
a
• To reduce the probability of occurrence, process and/or
p
design revisions are required. An action-oriented study

m
of the process using statistical methods could be imple-

o
mented with an ongoing feedback of information to the

C
appropriate operations for continuous improvement and

defect prevention.
r
to
• Only a design and/or process revision can bring about a

o
reduction in the severity ranking.

M
• The preferred method to accomplish a reduction in the

rd
detection ranking is the use of error/mistake proofing

o
methods. Generally, improving detection controls is

F
costly and ineffective for quality improvements. Increas-

ing the frequency of quality controls inspection is not an
f
o
effective preventive/corrective action and should only

be used as a temporary measure since permanent pre-
y
ventive/corrective action is required. In some cases, a

rt
design change to a specific part may be required to

e
assist in the detection. Changes to the current control

p
system may be implemented to increase this probabil-

ro
ity. Emphasis must, however, be placed on preventing

defects (i.e., reducing the occurrence) rather than de-
P
tecting them. An example would be the use of statistical

process control and process improvement rather than
random quality checks or associated inspection.
If engineering assessment leads to no recommended actions for

a specific failure mode/cause/control combination, indicate this
by entering “None” in this column.
– 55 –
P FMEA Number 1450
1
POTENTIAL
ro
p 2 3 4
e5 6 7
y 8
▲
▲
▲
▲
Process 12 C 13 o
s r
o c v c t N.
Requirements 10 11 14 16 19 20 21
rd16
7
paint over time
different doors
on same line
to
of interior doo
– 56 –
a Cpk=1.85

n 5 70 None
coverage In
te
operator starts
shift) to check for

controls shut-off
rn
a control charts
show process is
l in control
U Cpk=2.05
s
e
O
n
ly
SAMPLE
PROCESS FMEA
20) Responsibility for the Enter the individual responsible for the recommended action,
Recommended Action(s) and the target completion date.
21) Action(s) Taken After the action has been implemented, enter a brief description
of the actual action and effective date.
22) Action Results After the preventive/corrective action has been identified,
ly
estimate and record the resulting severity, occurrence, and
n
detection rankings. Calculate and record the resulting RPN. If
O
no actions are taken, leave the related ranking columns blank.
e
All revised ratings should be reviewed and if further action is
s
considered necessary, repeat the analysis. The focus should
U
always be on continuous improvement.
l
a
rn
Follow-Up Actions
te
In
The process-responsible engineer is responsible for ensuring
that all actions recommended have been implemented or
y
adequately addressed. The FMEA is a living document and
n
should always reflect the latest design level as well as the latest
a
relevant actions, including those occurring after the start of
p
production.
m
o
The process-responsible engineer has several means of

C
ensuring that concerns are identified and that recommended

actions are implemented. They include, but are not limited to
r
the following:
to
o
• Ensuring that process/product requirements are achieved,

M
• Reviewing engineering drawings, process/product

specifications, and process flow,
rd
• Confirming the incorporation of changes in assembly/

manufacturing documentation and,
o
• Reviewing Control Plans and operation instructions.

F
f
o
y
rt
e
p
ro
P
– 57 –
P
ro
p
e
rt
y
o
f
F
o
rd
M
o
to
r
C
o
– 58 –
m
p
a
n
PROCESS FMEA
y
In
te
rn
a
l
U
s
e
O
n
ly
APPENDIX A
DESIGN FMEA QUALITY OBJECTIVES
Note: Specific Program Requirements take precedence
1. DESIGN IMPROVEMENTS The FMEA drives Design Improvements as the primary

objective.
ly
2. HIGH RISK FAILURE MODES The FMEA addresses all high risk Failure Modes, as identified by
n
the FMEA team, with executable Action Plans. All other failure
O
modes are considered.
e
3. A/D/V OR DVP & R PLANS
s
The Analysis/Development/Validation (A/D/V), and/or Design
U
Verification Plan and Report (DVP&R) considers the failure
modes from the FMEA.
l
a
rn
4. INTERFACES The FMEA scope includes integration and interface failure
modes in both block diagram and analysis.
te
5. LESSONS LEARNED The FMEA considers all major “lessons learned” (such as high
In
warranty, campaigns, etc.) as input to failure mode
identification.
y
n
a
6. SPECIAL OR KEY The FMEA identifies appropriate Key Characteristics candidates
p
CHARACTERISTICS as input to the Key Characteristics selection process, if

m
applicable due to company policy.

o
7. TIMING The FMEA is completed during the “Window of Opportunity”

C
where it could most efficiently impact the product design.

r
to
8. TEAM The right people participate as part of the FMEA team through-
out the analysis, and are adequately trained in FMEA methods.
o
As appropriate, a facilitator should be used.

M
9. DOCUMENTATION The FMEA document is completely filled out "by the book",
rd
including "Action Taken" and new RPN values.

o
F
10. TIME USAGE Time spent by the FMEA team as early as possible is an effec-
tive and efficient use of time, with a value-added result. This
f
o
assumes Recommended Actions are identified as required and

the actions are implemented.
y
rt
e
p
ro
P
– 59 –
APPENDIX B
PROCESS FMEA QUALITY OBJECTIVES
Note: Specific Program Requirements take precedence.
1. PROCESS IMPROVEMENTS The FMEA drives Process Improvements as the primary

objective, with an emphasis on Error/Mistake Proofing solutions.
ly
2. HIGH RISK FAILURE MODES The FMEA addresses all high risk Failure Modes, as identified by
n
the FMEA team, with executable Action Plans. All other failure
O
modes are considered.
e
3. CONTROL PLANS
s
The Pre-launch and Production Control Plans consider the
U
failure modes from the Process FMEA.
l
a
4. INTEGRATION The FMEA is integrated and consistent with the Process Flow
rn
Diagram and the Process Control Plan. The Process FMEA
considers the Design FMEA, if available as part of its analysis.
te
5. LESSONS LEARNED The FMEA considers all major “lessons learned” (such as high
In
warranty, campaigns, non-conforming product, customer
complaints, etc.) as input to failure mode identification.
y
n
a
6. SPECIAL OR KEY The FMEA identifies appropriate Key Characteristics candidates
p
CHARACTERISTICS as input to the Key Characteristics selection process, if

m
applicable due to company policy.

o
7. TIMING The FMEA is completed during the “Window of Opportunity”

C
where it could most efficiently impact the design of product or

r
process.
to
8. TEAM The right people participate as part of the FMEA team

o
throughout the analysis, and are adequately trained in FMEA

M
methods. As appropriate, a facilitator should be used.

rd
9. DOCUMENTATION The FMEA document is completely filled out "by the book",
o
including "Action Taken" and new RPN values.

F
10. TIME USAGE Time spent by the FMEA team as early as possible is an
f
o
effective and efficient use of time, with a value-added result.

This assumes Recommended Actions are identified as required
y
and the actions are implemented.

rt
e
p
ro
P
– 60 –
APPENDIX C
DESIGN FMEA BLOCK DIAGRAM EXAMPLE
FAILURE MODE AND EFFECTS ANALYSIS (FMEA)

BLOCK DIAGRAM/ENVIRONMENTAL EXTREMES
SYSTEM NAME: FLASHLIGHT
ly
YEAR VEHICLE PLATFORM: 1994 NEW PRODUCT
n
FMEA I.D. NUMBER XXXI10D001
O
OPERATIONAL ENVIRONMENTAL EXTREMES
e
s
TEMPERATURE: -20 TO 160 F CORROSIVE: TEST SCHEDULE B VIBRATION: NOT APPLICABLE
U
SHOCK: 6 FOOT DROP FOREIGN MATERIAL: DUST HUMIDITY: 0 - 100 % RH
FLAMMABILITY: (WHAT COMPONENT(S) ARE NEAR HEAT SOURCE(S)?
l
OTHER:
a
rn
LETTERS = COMPONENTS = ATTACHED/JOINED ------- = INTERFACING, NOT JOINED = NOT INCLUDED IN
te
NUMBERS = ATTACHING METHODS THIS FMEA
In
y
The example below is a relational block diagram. Other types of block diagrams may be used by the FMEA
n
a
Team to clarify the item(s) being considered in their analysis
p
m
SWITCH
o
C
ON/OFF
C
r
to
2
o
M
rd
BULB 3 HOUSING
ASSEMBLY
o
A
D
F
f
o
4 4
y
1
rt
e
p
PLATE SPRING
BATTERIES
ro
E F
+ 5 B 5 -
P
COMPONENTS ATTACHING METHOD

A. HOUSING 1. SLIP FIT
B. BATTERIES (2 D CELL) 2. RIVETS
C. ON/OFF SWITCH 3. THREAD
D. BULB ASSEMBLY 4. SNAP FIT
E. PLATE 5. COMPRESSIVE FIT
F. SPRING
– 61 –
POTENTIAL FMEA Number
____ System P FAILURE MODE AND EFFECTS ANALYSIS
____ Subsystem ro (DESIGN FMEA) Page of
____ Component ___ Design Responsibility _________ Prepared By

p
Model Year(S)/Vehicle(s) _____________________ e Key Date _________ FMEA Date (Orig.) _________ (Rev.)
Core Team ___________________________________________________________________________________________

rt
y
Item
o C Potential O Current D Action Results
Potential Potential fS l Cause(s)/ c Design e R. Recommended Responsibility
Mode Failure v s
F of Failure u - Prevention e N. Completion Date Taken e c e P.
Function s o r - Detection c v c t N.
rd
M
o
to
r
C
o
– 62 –
m
p
a
APPENDIX D
n
y
In
te
rn
STANDARD FORM FOR DESIGN FMEA
a
l
U
s
e
O
n
ly
POTENTIAL FMEA Number
System P FAILURE MODE AND EFFECTS ANALYSIS
Subsystem ro (DESIGN FMEA) Page of
Component Design Responsibility Prepared By

p
MODEL YEARS(S)/Vehicle(s) e Key Date FMEA Date (Orig.) (Rev.)
Core Team
rt
y
Item C
o
Potential O Current Current D Action Results
Potential Potential S l Cause(s)/
f c Design Design e R. Recommended Responsibility
Mode Failure v s of Failure
F u Prevention Detection e N. Completion Date Taken e c e P.
Function s o r c v c t N.
rd
M
o
to
r
C
o
– 63 –
m
p
a
APPENDIX D
n
y
In
te
rn
STANDARD FORM FOR DESIGN FMEA
a
l
U
s
e
O
n
ly
FMEA Number 1234
1
POTENTIAL
System
2 3 4
ro
p 6 7
rt
y 8
▲
▲
▲
▲
Potential
of Failure
10 11 14 16 16 19 20 21
rd
7
to
– 64 –
7
2
p
a
APPENDIX E

door hardware
n
including y
mirror,
hinges, latch
DESIGN FMEA EXAMPLE

and window
In
wax from entering
te
corner/edge access
items
rn
and spray head U
s
e
O
n
ly
SAMPLE
Appendix F System FMEA
To help illustrate the meaning of System, Subsystem, and Component FMEA’s, two
examples have been constructed below in Figure F1 (for Interfaces and Interactions)
and in Figure F2 (for Item, Function, and Failure Modes).
EXAMPLE 1: Interfaces and Interactions
ly
n
O
e
Subsystem B
Subsystem A Subsystem C
s
U
System
l
a
rn
Subsystem D
te
Environment
In
y
n
a
Figure F1. Interfaces and Interactions
p
m
o
The FMEA team is responsible for specifying the scope of its respective FMEA’s. The example in Figure
C
F1 shows that the team has specified Subsystems A, B, C, and D along with the surrounding environment
r
as comprising the System that must be considered while completing the System FMEA.
to
o
INTERFACES: SUBSYSTEMS ARE DIRECTLY CONNECTED VIA INTERFACES.

M
In Figure F1, interfaces between subsystems are shown where Subsystem A touches
rd
(connects with) Subsystem B, B touches C, C touches D, A touches D, and B touches

o
D. The Environment also touches each of the subsystems listed in Figure F1, which
F
requires that the ‘Environmental Interfaces’ be considered when completing the

FMEA.
f
o
NOTE: Each Subsystem FMEA should have its Interfaces included in its respective
y
Subsystem FMEA.
rt
e
INTERACTIONS: A CHANGE IN ONE SUBSYSTEM MIGHT CAUSE A CHANGE IN ANOTHER

p
SUBSYSTEM.
ro
In Figure F1, interactions between subsystems can occur among any of the interfacing
P
systems (e.g., Subsystem A heats up, resulting in Subsystem D and Subsystem B also
gaining heat through the respective interfaces, as well as Subsystem A giving off heat
to the environment). Interactions might also occur among ‘non-contacting’ systems via
transfer through the ‘environment’ (e.g., if the environment is composed of high
humidity and Subsystems A and C are dissimilar metals separated by a non-metal
composing Subsystem B, Subsystems A and C can still have an electrolytic reaction
due to the moisture from the environment). Thus, interactions among non-contacting
subsystems can be relatively difficult to predict but are important and should be
considered.
– 65 –
EXAMPLE 2: Items, Functions, and Failure Modes
Figure F2 (see next page) describes a method of showing the Items, Functions, and Failure Modes in a
‘tree arrangement’ that can assist the team in visualizing the System, Subsystems, and Components.
At the System Level, the descriptions will tend to be much more general than for the Subsystems and
Components (Components will usually have the most specific descriptions).
The ‘tree arrangement’ is arranged as follows for the System, Subsystem, and Components:
ly
ITEM
n
O
Design Objectives (a statement of design objectives is often helpful)
e
s
U
- FUNCTION 1
POTENTIAL FAILURE MODE A
l
a
POTENTIAL FAILURE MODE B
rn
etc.....
te
In
- FUNCTION 2
POTENTIAL FAILURE MODE A
POTENTIAL FAILURE MODE B
y
n
etc.....
a
p
m
- etc.....
o
C
r
to
o
M
rd
o
F
f
o
y
rt
e
p
ro
P
– 66 –
SystemPLevel Subsystem Level Component Level
ro
p
Bicycle e Frame Upper Frame
rt
Design Objectives: y Function: Function:
1) minimum 3000 hours of riding o – provides stable attachment for – provides structural support
without need for maintenance f seat support
and 10,000 hours of riding for Potential Failure Mode(s):
design life.
F Potential Failure Mode(s): • structural failure
2) accommodates male adults
o • structural failure of seat support • excessive deflection
comfortably to the 99.5th • excessive deflection of seat
rd
percentile support Function:
3) ... etc. ...
M – provides dimensional control
Function:
o for correct finished frame
Function: – provides pleasing appearance
to geometry
– ease of use
r
Potential Failure Mode(s): Potential Failure Mode(s):
Potential Failure Mode(s): C
• finish (shine) deteriorates • length of frame mounting points
• difficult to steer • paint chips o too long
– 67 –
• difficult to pedal m • length of frame mounting points
p too short
Function: a
– provide reliable transportation Handle Bar Assembly n Function:
y – support frame assembly
Potential Failure Mode(s): production methods (welding)
• chain breaks frequently Front Wheel Assembly In
• Tires require frequent te Potential Failure Mode(s):
maintenance Rear Wheel Assembly rn
Function: a Lower Front Tube
– provide comfortable Sprocket Assembly l
transportation ULower Rear Tube
Potential Failure Mode(s): Seat Assembly s
• seating position is not
e
comfortable Chain Assembly Sprocket
O Tube
n
ly
Figure F2. Items, Functions, and Failures
P POTENTIAL FMEA Number
(PROCESS FMEA) Page of
ro
Item p Process Responsibility __________ Prepared By
e
Model Year(S)/Vehicle(s) ____________________________
rt Key Date _________ FMEA Date (Orig.) _________ (Rev.)
Core Team _____________________________________________________________________________________________________________________________________________________________________________
y
Process o C Potential O Current D Action Results
Function Potential Potential S l
f Cause(s)/ c Process e R. Recommended Responsibility
Mode Failure v s F of Failure u - Prevention e N. Completion Date Taken e c e P.
Requirements s o r - Detection c v c t N.
rd
M
o
to
r
C
o
– 68 –
m
p
a
APPENDIX G
n
y
In
te
rn
a
STANDARD FORM FOR PROCESS FMEA
l
U
s
e
O
n
ly
P POTENTIAL FMEA Number
Page of
ro
(PROCESS FMEA)
Item
p Process Responsibility Prepared By
e
Model Years(S)/Vehicle(s) rt Key Date FMEA Date (Orig.) (Rev.)
Core Team y
Process C
o
Potential O Current Current D Action Results
Function Potential Potential S l Cause(s)/ f c Process Process e R. Recommended Responsibility
Mode Failure v s of Failure
F
u Prevention Detection e N. Completion Date Taken e c e P.
s r o c v c t N.
Requirements
rd
M
o
to
r
C
o
– 69 –
m
p
a
APPENDIX G
n
y
In
te
rn
a
STANDARD FORM FOR PROCESS FMEA
l
U
s
e
O
n
ly
P FMEA Number 1450
1
POTENTIAL
ro
p 2 3 4
e5 6 7
y 8
▲
▲
▲
▲
Process 12 C 13 o
s r
o c v c t N.
Requirements 10 11 14 16 19 20 21
rd16
7
paint over time
different doors
on same line
to
of interior doo
– 70 –
a Cpk=1.85
APPENDIX H

n 5 70 None
coverage In
PROCESS FMEA EXAMPLE
te
controls shut-off
rn
a control charts
show process is
l in control
U Cpk=2.05
s
e
O
n
ly
SAMPLE
APPENDIX I
SUGGESTED PFMEA OCCURRENCE EVALUATION
CRITERIA WITH Ppk VALUES
Probability Likely Failure Rates* Ppk Ranking
Very High: Persistent Failures > 100 per thousand pieces < 0.55 10
ly
50 per thousand pieces ≥ 0.55 9
n
O
High: Frequent Failures 20 per thousand pieces ≥ 0.78 8
e
s
Moderate: Occasional Failures 5 per thousand pieces ≥ 0.94 6
U
2 per thousand pieces ≥ 1.00
l
5
a
rn
te
Low: Relatively Few Failures ≥ 1.20 3
In
≥ 1.30 2
Remote: Failure is Unlikely < 0.01 per thousand pieces ≥ 1.67 1
y
n
a
Sample Calculation
p
m
Sample Calculation to determine Ppk value from a likely failure rate of 5 per thousand pieces.
o
C
5
Defect rate = = 0.005
r
1000
to
0.05
= 0.0025 divided by 2 for out-of-specifications high or low.
o
2
M
Using a "Z" table the associated "Z" value is 2.81 for a tail value of 0.0025.
rd
SL - x
1. Z =
σˆ s
o
F
where:
f
x = Average
o
SL = Specifications
y
min (SL upper - x, x - SL lower)

rt
2. Ppk =
3σˆ s
e
p
3. Replace using Z
ro
Z 2.81 ~ 0.94
4. Ppk = = = 0.9367 =
P
3 3
Note: The above Ppk values are to be used by the FMEA team as guidance to assist in determining an
occurrence ranking when valid statistical data is available. No other use of the above Ppk values
is intended.
– 71 –
Glossary
Control Plans The control plan provides the process monitoring and control
methods that will be used to control characteristics.
Design Intent List of what a given component/subsystem/system is expected

to do or not do.
Design Life The time period (e.g., cycles, time, mileage) for which the design
is intended to perform its requirements.
ly
n
Design Validation/Verification (DV) A program intended to ensure that the design meets its
O
requirements.
e
Design of Experiments (DOE) Methods that identify factors that affect the mean and variation
s
with minimum testing/experimentation.
U
l
Error/Mistake Proofing Each OEM may have its own unique definition for Error/Mistake
a
Proofing. Confer with the OEM for the appropriate definition.
rn
te
Feature A measurable product characteristic (e.g., radius, hardness) or a
measurable process characteristic (e.g., insertion force,
In
temperature).
Pareto
y
A simple tool that can assist problem solving that involves
n
ranking all potential problem areas.
a
p
Process The combination of people, machines and equipment, raw

m
materials, methods, and environment that produces a given

o
product or service.
C
Process Change A change in processing concept that could alter the capability of
r
to
the process to meet the design requirements or the durability of

the product.
o
M
Quality Function Deployment (QFD) A structured method in which customer requirements are
translated into appropriate technical requirements for each
rd
stage of product development and production.

o
Root Cause The root cause is the reason for the primary non-conformance
F
and is the item that requires change to achieve permanent

f
preventive/corrective action.
o
y
Special Process Characteristic A special process characteristic (e.g., critical, key, major,
rt
significant) is a process characteristic for which variation must

e
be controlled to some target value to ensure that variation in a

p
process or a special product characteristic is maintained to its

ro
target value during manufacturing and assembly.

P
Special Product Characteristic A special product characteristic (e.g., critical, key, major,
significant) is a product characteristic for which reasonably
anticipated variation could significantly affect a product’s safety
or compliance with governmental standards or regulations, or is
likely to significantly affect customer satisfaction with a product.
Vehicle Campaign Recall of vehicles for rework or safety inspection.
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FMEA

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FMEA

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POTENTIAL

FAILURE MODE AND

The content of this document is the technical equivalent of SAE J-1739.

Potential Failure Mode and Effects Analysis (FMEA) should be used by

suppliers to companies subscribing to QS-9000 or equivalent document.

be a comprehensive FMEA reference source or training document.

activity, the buyer in your customer's Purchasing office can help.

not used in its development.

Steven C. Leggett - General Motors Corporation

Beth Baker - AIAG

Howard Riley - DaimlerChrysler Mark T. Wrobbel - DaimlerChrysler

George R. Baumgartner - Ford Motor Company Rebecca French - General Motors

Robert A. May - Goodyear William Ireland - Kelsey-Hayes

William D. Carlson - DaimlerChrysler

Glen R. Vallance - Ford Motor Company

Carl S. Carlson - General Motors Corporation

General Information ................................................................................................................................... 1

2) System, Subsystem, or Component Name and Number ....................................................... 13

3) Design Responsibility ............................................................................................................. 13

5) Model Year(s)/Program(s) ...................................................................................................... 13

7) FMEA Date ............................................................................................................................. 13

10) Potential Failure Mode ........................................................................................................... 15

12) Severity (S) ............................................................................................................................. 17

13) Classification .......................................................................................................................... 19

14) Potential Cause(s)/Mechanism(s) of Failure .......................................................................... 19

15) Occurrence (O) ....................................................................................................................... 21

Suggested DFMEA Occurrence Evaluation Criteria .............................................................. 23

16) Current Design Controls ......................................................................................................... 23

17) Detection (D) .......................................................................................................................... 25

Suggested DFMEA Detection Evaluation Criteria ................................................................. 27

18) Risk Priority Number (RPN) ................................................................................................... 27

19) Recommended Action(s) ........................................................................................................ 29

21) Action(s) Taken ...................................................................................................................... 31

Follow-Up Actions ...................................................................................................................................... 31

Process FMEA .......................................................................................................................................... 33

Customer Defined ......................................................................................................................... 35

15) Occurrence (O) ....................................................................................................................... 47

Suggested PFMEA Occurrence Evaluation Criteria ............................................................... 49

16) Current Process Controls ........................................................................................................ 49

17) Detection (D) ........................................................................................................................... 51

18) Risk Priority Number (RPN) .................................................................................................... 53

19) Recommended Action(s) ......................................................................................................... 55

20) Responsibility for the Recommended Action(s) ...................................................................... 57

21) Action(s) Taken ....................................................................................................................... 57

Follow-Up Actions ...................................................................................................................................... 57

A Design FMEA Quality Objectives ............................................................................................ 59

B Process FMEA Quality Objectives ........................................................................................... 60

C Design FMEA Block Diagram Example ................................................................................... 61

E Design FMEA Example ............................................................................................................ 64

What Is an FMEA An FMEA can be described as a systematic group of activities

One of the most important factors for the successful

each with a different scope or focus:

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

scope of the FMEA is the complete design,

Case 2: Modifications to existing design or process (assumes

there is an FMEA for the existing design or process).

The scope of the FMEA should focus on the

interactions due to the modification, and field history.

Case 3: Use of an existing design or process in a new

environment, location, or application (assumes there

is an FMEA for the existing design or process). The

scope of the FMEA is the impact of the new

environment or location on the existing design or