Front Cover

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.
POTENTIAL
FAILURE MODE AND
EFFECTS ANALYSIS
(FMEA)
REFERENCE MANUAL
First Edition Issued February, 1993 Second Edition, February, 1995 Third Edition, April, 2001
Copyright 1993, 1995, 2001
DaimlerChrysler Corporation, Ford Motor Company, General Motors Corporation
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).
The ASQC/AIAG Task Force charter is to standardize the reference manuals, procedures, reporting formats
and technical nomenclature used by Chrysler, Ford, and General Motors in their respective supplier quality
systems. Accordingly, this manual and format, which is approved and endorsed by Chrysler, Ford and
General Motors, should be used by suppliers implementing FMEA techniques into their design/
manufacturing processes.
In the past, Chrysler, Ford and General Motors each had their own guidelines and formats for insuring
supplier FMEA compliance. Differences between these guidelines and formats resulted in additional
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
be George Baumgartner of Ford Motor Company.
This Manual provides general guidelines for preparing an FMEA. It does not give specific instructions on
how to arrive at each FMEA entry, a task best left to each FMEA team. This Manual also is not intended to
be a comprehensive FMEA reference source or training document.
While these guidelines are intended to cover all situation normally occurring either in the design phase or
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
activity, the buyer in your customer's Purchasing office can help.
The Task Force gratefully acknowledges: the leadership and commitment of Vice Presidents Thomas T.
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
Task Force principals Russ Jacobs (Chrysler), Steve Walsh (Ford), Dan Reid (General Motors), and Rad
Smith; and the assistance of the ASQC Automotive Division Reading Team. This team, led by Tripp Martin
(Peterson Spring), reviewed the Manual for technical content and accuracy and made valuable
contributions to form and content. Since the Manual was developed to meet specific needs of the
automotive industry, the ASQC voluntary standards process defined by ASQC policies and procedures was
not used in its development.
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.
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-
ize the reference manuals, procedures, reporting formats and technical nomenclature used by suppliers to
DaimlerChrysler, Ford Motor Company, and General Motors Corporation. Accordingly the FMEA, 3rd
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
during the design phase or process analysis phase.
This manual is the technical equivalent of SAE J1739, for Design and Process FMEAs. However, it does
not include an application for Machinery FMEA. Interested parties in Machinery FMEA may refer to SAE
J1739 for a related example.
The Supplier Quality Requirements Task Force would like to thank the following individuals, and their
companies, who have contributed their time and efforts to the development of either this edition of the
FMEA manual or earlier editions.
3rd Edition
Kevin A. Lange - DaimlerChrysler
Steven C. Leggett - General Motors Corporation
Beth Baker - AIAG
Earlier Editions
Howard Riley - DaimlerChrysler Mark T. Wrobbel - DaimlerChrysler
George R. Baumgartner - Ford Motor Company Rebecca French - General Motors
Lawrence R. McCullen - General Motors Mary Ann Raymond - Bosch
Robert A. May - Goodyear William Ireland - Kelsey-Hayes
Tripp Martin - Peterson Spring
In addition, the Supplier Quality Requirements Task Force would like to thank the following individuals from
the SAE J1739 work group who contributed significantly to the technical changes and improvements in this
edition.
William D. Carlson - DaimlerChrysler
Glen R. Vallance - Ford Motor Company
Carl S. Carlson - General Motors Corporation
This manual is a copyright of DaimlerChrysler, Ford Motor Company and General Motors Corporation, with
all rights reserved. Additional copies may be obtained from AIAG, Southfield, Michigan, by calling 248-358-
3003. Supply chain organizations of DaimlerChrysler, Ford Motor Company or General Motors Corporation
have permission to copy forms used in this manual.
TABLE OF CONTENTS
Page
Number
General Information ................................................................................................................................... 1
Overview ......................................................................................................................................... 1
What Is an FMEA ............................................................................................................................ 1
Manual Format ................................................................................................................................ 1
FMEA Implementation .................................................................................................................... 2
Design FMEA .............................................................................................................................................. 7
Introduction ................................................................................................................................................... 9
Customer Defined ........................................................................................................................... 9
Team Effort ..................................................................................................................................... 9
Development of a Design FMEA ............................................................................................................... 10
1) FMEA Number ........................................................................................................................ 13
2) System, Subsystem, or Component Name and Number ....................................................... 13
3) Design Responsibility ............................................................................................................. 13
4) Prepared By ............................................................................................................................ 13
5) Model Year(s)/Program(s) ...................................................................................................... 13
6) Key Date ................................................................................................................................. 13
7) FMEA Date ............................................................................................................................. 13
8) Core Team .............................................................................................................................. 15
9) Item/Function .......................................................................................................................... 15
10) Potential Failure Mode ........................................................................................................... 15
11) Potential Effect(s) of Failure ................................................................................................... 17
12) Severity (S) ............................................................................................................................. 17
Suggested Evaluation Criteria ................................................................................................ 19
13) Classification .......................................................................................................................... 19
14) Potential Cause(s)/Mechanism(s) of Failure .......................................................................... 19
15) Occurrence (O) ....................................................................................................................... 21
Suggested Evaluation Criteria ................................................................................................ 23
16) Current Design Controls ......................................................................................................... 25
17) Detection (D) .......................................................................................................................... 25
Suggested Evaluation Criteria ................................................................................................ 27
18) Risk Priority Number (RPN) ................................................................................................... 27
19) Recommended Action(s) ........................................................................................................ 29
20) Responsibility for the Recommended Action(s) ..................................................................... 29
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
Page
Number
Development of a Process FMEA ............................................................................................................. 37
1) FMEA Number ......................................................................................................................... 37
2) Item ......................................................................................................................................... 39
3) Process Responsibility ............................................................................................................ 39
4) Prepared By ............................................................................................................................ 39
5) Model Year(s)/Program(s) ...................................................................................................... 39
6) Key Date .................................................................................................................................. 39
7) FMEA Date .............................................................................................................................. 39
8) Core Team .............................................................................................................................. 39
9) Process Function/Requirements ............................................................................................. 39
10) Potential Failure Mode ............................................................................................................ 39
11) Potential Effect(s) of Failure .................................................................................................... 41
12) Severity (S) .............................................................................................................................. 41
Suggested Evaluation Criteria ................................................................................................ 43
13) Classification ........................................................................................................................... 45
14) Potential Cause(s)/Mechanism(s) of Failure ........................................................................... 45
15) Occurrence (O) ....................................................................................................................... 47
Suggested Evaluation Criteria ................................................................................................ 47
16) Current Process Controls ........................................................................................................ 49
17) Detection (D) ........................................................................................................................... 51
Suggested Evaluation Criteria ................................................................................................ 53
18) Risk Priority Number (RPN) .................................................................................................... 53
19) Recommended Action(s) ......................................................................................................... 55
20) Responsibility for the Recommended Action(s) ...................................................................... 57
21) Action(s) Taken ....................................................................................................................... 57
22) Action Results .......................................................................................................................... 57
Follow-Up Actions ...................................................................................................................................... 57
APPENDICES
A Design FMEA Quality Objectives ............................................................................................ 59
B Process FMEA Quality Objectives ........................................................................................... 60
C Design FMEA Block Diagram Example ................................................................................... 61
D Standard Forms for Design FMEA (1 and 2 column for controls) ........................................... 62
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 Occurrence Evaluation Criteria With Cpk Values .................................................................... 71
Il
Ill
1
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
product/process and the effects of that failure, (b) identify
actions that could eliminate or reduce the chance of the
potential failure occurring, and (c) document the entire process.
It is complementary to the process of defining what a design or
process must do to satisfy the customer.
All FMEAs focus on the design, whether it be of the product, or
process.
Manual Format This reference document presents two types of FMEA: Design
FMEA, and Process FMEA.
This manual should be used by suppliers that subscribe to QS-
9000 or its equivalent. FMEA teams are allowed to use the
guidelines listed herein in the manner that will be most effective
for a given situation.
GENERAL INFORMATION
2
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 mos t important factors for the s ucces s ful
implementation of an FMEA program is timeliness. It is meant to
be a before-the-event action, not an after-the-fact exercise.
To achieve the greatest value, the FMEA must be done before a
product or process failure mode has been incorporated into a
product or process. Up-front time spent properly completing an
FMEA, when product/process changes can be most easily and
inexpensively implemented, will minimize late change crises. An
FMEA can reduce or eliminate the chance of implementing a
preventive/corrective change that would create an even larger
concern. Communication and coordination s hould occur
among all FMEA teams.
Figure 1 depicts the sequence in which an FMEA should be
performed. It is not simply a case of filling out the form but
rather of understanding the FMEA process in order to eliminate
risk and plan the appropriate controls to ensure customer
satisfaction.
There are three basic cases for which FMEA's are generated,
each with a different scope or focus:
Case 1: New designs, new technology, or new process. The
s cope of the FMEA is the complete des ign,
technology, or process.
Case 2: Modifications to existing design or process (assumes
there is a FMEA for the existing design or process).
The s cope of the FMEA s hould focus on the
modification to design process, possible interactions
due to the modification, and field history.
Case 3: Us e of exis ting des ign or proces s in a new
environment, location, or application (assumes there
is an FMEA for the existing design or process). The
s cope of the FMEA is the impact of the new
environment or location on the existing design or
process.
Although responsibility for the preparation of the FMEA is
usually assigned to an individual, FMEA input should be a team
effort. A team of knowledgeable individuals s hould be
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
res pons ible activity, which can be the Original Equipment
Manufacturer (i.e., produces the final product), a supplier, or a
subcontractor.
3
Figure 1. FMEA Process Sequence
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It is not appropriate to compare the ratings of one teams FMEA
with the ratings of another teams 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 agains t FMEA quality
objectives (see Appendix A and Appendix B) is recommended,
including a management review.
Follow-Up The need for taking effective preventive/corrective actions, with
appropriate follow- up on thos e actions , cannot be
overemphas ized. Actions s hould be communicated to all
affected activities. A thoroughly thought-out and well-developed
FMEA will be of limited value without positive and effective
preventive/corrective actions.
The responsible engineer is in charge of ensuring that all
recommended actions have been implemented or adequately
addressed. The FMEA is a living document and should always
reflect the latest level, as well as the latest relevant actions,
including those occurring after the start of production.
The responsible engineer has several means of assuring that
recommended actions are implemented. They include, but are
not limited to the following:
a. Reviewing designs, processes, and, drawings, to ensure that
recommended actions have been implemented.
b. Confirming the incorporation of changes to design/assembly/
manufacturing documentation.
c. Reviewing Des ign/Proces s FMEAs , s pecial FMEA
applications, and Control Plans.
5
6
POTENTIAL
FAILURE MODE AND EFFECTS ANALYSIS
IN
DESIGN
(DESIGN FMEA)
DESIGN FMEA
7
8
9
A Des ign Potential FMEA is an analytical technique us ed
primarily by a Design-Responsible Engineer/Team as a means
to ensure that, to the extent possible, potential failure modes
and their associated causes/mechanisms have been considered
and addressed. End items, along with every related system,
subassembly, and component, should be evaluated. In its most
rigorous form, an FMEA is a summary of the teams thoughts
(including an analysis of items that could go wrong based on
experience) as a component, subsystem, or system is designed.
This systematic approach parallels, formalizes, and documents
the mental disciplines that an engineer normally goes through in
any design process.
The Design Potential FMEA supports the design process in
reducing the risk of failures (including unintended outcomes) by:
Aiding in the objective evaluation of design, including
functional requirements and design alternatives,
Evaluating the initial des ign for manufacturing,
assembly, service, and recycling requirements,
Increasing the probability that potential failure modes
and their effects on system and vehicle operation have
been considered in the design/development process,
Providing additional information to aid in the planning of
thorough and efficient des ign, development, and
validation programs,
Developing a ranked list of potential failure modes
according to their effect on the cus tomer, thus
establishing a priority system for design improvements,
development, and validation testing/analysis,
Providing an open issue format for recommending and
tracking risk-reducing actions, and,
Providing future reference, e.g., lessons learned, to aid
in analyzing field concerns, evaluating design changes,
and developing advanced designs.
Customer Defined The definition of Customer for a Design FMEA is not only the
End User but also the design-responsible engineers/teams of
the vehicle or higher- level as s emblies , and/or the
manufacturing/process-responsible engineers in activities such
as manufacturing, assembly, and service.
Team Effort During the initial Des ign FMEA proces s , the res pons ible
engineer is expected to directly and actively involve
representatives from all affected areas. These areas of expertise
and res pons ibility s hould include but are not limited to
as s embly, manufacturing, des ign, analys is /tes t, reliability,
materials, quality, service, and suppliers, as well as the design
area responsible for the next higher or lower assembly or
system, sub-assembly, or component. The FMEA should be a
catalyst to stimulate the interchange of ideas between the
functions affected and thus promote a team approach.
INTRODUCTION
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
information is obtained throughout the phas es of
product development, and
Be fundamentally completed before the production
drawings are released for tooling.
Considering that manufacturing/assembly needs have been
incorporated, the Design FMEA addresses the design intent and
assumes the design will be manufactured/assembled to this
intent. Potential failure modes and/or causes/mechanisms that
can occur during the manufacturing or assembly process need
not but may be included in a Design FMEA. When not included,
their identification, effect, and control are covered by the
Process FMEA.
The Des ign FMEA does not rely on proces s controls to
overcome potential design weaknesses, but it does take the
technical/physical limits of a manufacturing/assembly process
into consideration, for example:
Necessary mold drafts
Limited surface finish
Assembling space/access for tooling
Limited hardenability of steels
Tolerances/process capability/performance
The Des ign FMEA can als o take into cons ideration the
technical/physical limits of product maintenance (service) and
recycling, for example:
Tool access
Diagnostic capability
Material classification symbols (for recycling)
DEVELOPMENT OF A DESIGN FMEA
The design-responsible engineer has at his or her disposal a
number of documents that will be useful in preparing the Design
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.,
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 s hould 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
11
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
covered in the analysis and establishes a logical order to the
analysis. Copies of the diagrams used in FMEA preparation
should accompany the FMEA.
In order to facilitate documentation of the analysis of potential
failures and their consequences, a blank Design FMEA form is
available in Appendix D.
DESIGN FMEA
12
TABLE 1. DESIGN FMEA
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6
S
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13
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.
Indicate the appropriate level of analysis and enter the name
and number of the system, subsystem, or component being
analyzed. The FMEA team members must decide on what
cons titutes a s ys tem, s ubs ys tem, or component for their
specific activities. The actual boundaries that divide a system,
subsystem, and component are arbitrary and must be set by the
FMEA team. Some descriptions are provided below and some
examples are provided in Appendix F.
System FMEA Scope
A s ys tem can be cons idered to be made up of various
subsystems. These subsystems often have been designed by
different teams. Some typical System FMEAs might cover the
following systems: Chassis System, or Powertrain System, or
Interior System, etc. Thus, the focus of the System FMEA is to
ensure that all interfaces and interactions are covered among
the various subsystems that make up the system as well as
interfaces to other vehicle systems and the customer.
Subsystem FMEA Scope
A Subsystem FMEA is generally a sub-set of a larger system.
For example, the front suspension subsystem is a sub-set of the
chassis system. Thus, the focus of the Subsystem FMEA is to
ensure that all interfaces and interactions are covered among
the various components that make up the subsystem.
Component FMEA Scope
A Component FMEA is a generally an FMEA focused on the
sub-set of a subsystem. For example, a strut is a component of
the front suspension (which is a subsystem of the chassis
system.)
3) Design Responsibility Enter the OEM, department, and group. Als o include the
supplier name, if applicable.
4) Prepared By Enter the name, telephone number, and company of the
engineer responsible for preparing the FMEA.
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.
DESIGN FMEA
2) System,
Subsystem, or
Component Name
and Number
14
TABLE 1. DESIGN FMEA
I
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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, addresse, etc., be included on a distribution
list.)
9) Item/Function Enter the name and other pertinent information (e.g., the
number, the part class, etc.) of the item being analyzed. Use the
nomenclature and show the design level as indicated on the
engineering drawing. Prior to initial releas e (e.g., in the
conceptual phases), experimental numbers should be used.
Enter, as concisely as possible, the function of the item being
analyzed to meet the design intent. Include information (metrics/
measurables) regarding the environment in which this system
operates (e.g., define temperature, pressure, humidity ranges,
design life). If the item has more than one function with different
potential modes of failure, list all the functions separately.
10) Potential Failure Mode Potential failure mode is defined as the manner in which a
component, subsystem, or system could potentially fail to meet
or deliver the intended function described in the item/function
column (i.e., intended function fails). The potential failure mode
may also be the cause of a potential failure mode in a higher-
level subsystem or system, or be the effect of one in a lower-
level component.
List each potential failure mode associated with the particular
item and item function. The assumption is made that the failure
could occur but may not necessarily occur. A recommended
starting point is a review of past things-gone-wrong, concerns,
reports, and group brainstorming.
Potential failure modes that could occur only under certain
operating conditions (i.e., hot, cold, dry, dusty, etc.) and under
certain usage conditions (i.e., above-average mileage, rough
terrain, city driving only, etc.) should be considered.
Typical failure modes could be but are not limited to:
Cracked Deformed
Loosened Leaking
Sticking Oxidized
Fractured Does not transmit torque
Slips (does not hold full torque) No support (structural)
Inadequate support (structural) Harsh engagement
Disengages too fast Inadequate signal
Intermittent signal No signal
EMC/RFI Drift
NOTE: Potential failure modes s hould be des cribed in
physical or technical terms, not as a symptom
necessarily noticeable by the customer.
15
DESIGN FMEA
16
TABLE 1. DESIGN FMEA
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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
clearly if the failure mode could impact s afety or non-
compliance to regulations. The effects should always be stated
in terms of the specific system, subsystem, or component being
analyzed. Remember that a hierarchical relationship exists
between the component, subsystem, and system levels. For
example, a part could fracture, which may cause the assembly
to vibrate, resulting in an intermittent system operation. The
intermittent system operation could cause performance to
degrade and ultimately lead to customer dissatisfaction. The
intent is to forecast the failure effects, to the teams level of
knowledge.
Typical failure effects could be but are not limited to:
Noise Rough
Erratic Operation Inoperative
Poor Appearance Unpleasant Odor
Unstable Operation Impaired
Intermittent Operation Thermal Event
Leaks Regulatory Non-Compliance
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
scope of the individual FMEA. A reduction in the severity
ranking index can be effected only through a design change.
Severity should be estimated using Table 2 as a guideline:
Suggested Evaluation Criteria
The team should agree on an evaluation criteria and ranking
system that is consistent, even if modified for individual product
analysis. (See Table 2.)
NOTE: It is not recommended to modify criteria ranking
values of 9 and 10. Failure modes with a rank of
severity 1 should not be analyzed further.
NOTE: High severity rankings can sometimes be reduced by
making design revisions that compensate or mitigate
the resultant severity of failure. For example, run
flat tires can mitigate the severity of a sudden tire
blowout and seat belts can mitigate the severity of
a vehicle crash.
DESIGN FMEA
18
Table 1. DESIGN FMEA
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19
13) Classification This column may be used to classify any special product
characteris tics (e.g., critical, key, major, s ignificant) for
components , s ubs ys tems , or s ys tems that may require
additional design or process controls.
This column may also be used to highlight high-priority failure
modes for engineering assessment if the team finds this helpful
or if local management requires it.
Special product or process characteristic symbols and their
us age is directed by s pecific company policy and is not
standardized in this document.
Potential cause of failure is defined as an indication of a design
weakness, the consequence of which is the failure mode.
List, to the extent possible, every potential cause and/or failure
mechanis m for each failure mode. The caus e/mechanis m
should be listed as concisely and completely as possible so that
remedial efforts can be aimed at pertinent causes.
Effect
Hazardous
without
warning
Hazardous
with warning
Very High
High
Moderate
Low
Very Low
Minor
Very Minor
None
Very high severity ranking when a potential failure mode affects safe vehicle
operation and/or involves noncompliance with government regulation without
warning.
Very high severity ranking when a potential failure mode affects safe vehicle
operation and/or involves noncompliance with government regulation with warning.
Vehicle/item inoperable (loss of primary function).
Vehicle/item operable but at reduced level of performance. Customer very
dissatisfied.
Vehicle/item operable, but Comfort/Convenience item(s) inoperable. Customer
dissatisfied.
Vehicle/item operable, but Comfort/Convenience item(s) operable at a reduced
level of performance. Customer somewhat dissatisfied.
Fit & Finish/Squeak & Rattle item does not conform. Defect noticed by most
customers (greater than 75%).
Fit & Finish/Squeak & Rattle item does not conform. Defect noticed by 50% of
customers.
Fit & Finish/Squeak & Rattle item does not conform. Defect noticed by discriminat-
ing customers (less than 25%).
No discernible effect.
Criteria: Severity of Effect Ranking
10
9
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7
6
5
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3
2
1
Table 2. Suggested DFMEA Severity Evaluation Criteria
DESIGN FMEA
14) Potential Cause(s)/
Mechanism(s) of Failure
12) Severity (S) (continued)
20
TABLE 1. DESIGN FMEA
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Typical failure causes may include, but are not limited to:
Incorrect Material Specified
Inadequate Design Life Assumption
Over-stressing
Insufficient Lubrication Capability
Inadequate Maintenance Instructions
Incorrect Algorithm
Improper Maintenance Instructions
Improper Software Specification
Improper Surface Finish Specification
Inadequate Travel Specification
Improper Friction Material Specified
Excessive Heat
Improper Tolerance Specified
Typical failure mechanisms may include but are not limited to:
Yield Chemical Oxidation
Fatigue Electromigration
Material Instability
Creep
Wear
Corrosion
15) Occurrence (O) Occurrence is the likelihood that a specific cause/mechanism
will occur during the design life. The likelihood of occurrence
ranking number has a relative meaning rather than an absolute
value. Preventing or controlling the causes/mechanisms of the
failure mode through a design change or design process
change (e.g., design checklist, design review, design guide) is
the only way a reduction in the occurrence ranking can be
effected. (See Table 3.)
Estimate the likelihood of occurrence of potential failure cause/
mechanism on a 1 to 10 scale. In determining this estimate,
questions such as the following should be considered:
What is the service history/field experience with similar
components, subsystems, or systems?
Is the component a carryover or similar to a previous
level component, subsystem or system?
How significant are changes from a previous level
component, subsystem, or system?
Is the component radically different from a previous
level component?
Is the component completely new?
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?
DESIGN FMEA
14) Potential Cause(s)/
Mechanism(s) of Failure
(continued)
22
TABLE 1. DESIGN FMEA
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A consistent occurrence ranking system should be used to
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.
Suggested Evaluation Criteria
The team should agree on an evaluation criteria and ranking
system, that is consistent, even if modified for individual product
analysis. (See Table 3.) Occurrence should be estimated using
Table 3 as a guideline:
NOTE: The ranking value of 1 is reserved for Remote: Failure
Is unlikely.
Ranking
Possible Failure Rates
10
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1
> 100 per thousand vehicles/items
50 per thousand vehicles/items
20 per thousand vehicles/items
10 per thousand vehicles/items
5 per thousand vehicles/items
2 per thousand vehicles/items
1 per thousand vehicles/items
0.5 per thousand vehicles/items
0.1 per thousand vehicles/items
< 0.010 per thousand vehicles/items
Very High: Persistent failures
High: Frequent failures
Moderate: Occasional failures
Low: Relatively few failures
Remote: Failure is unlikely
Probability of Failure
TABLE 3. Suggested DFMEA Occurrence Evaluation Criteria
16) Current Design Controls List the prevention, design validation/verification (DV), or other
activities that have been completed or committed to and that
will assure the design adequacy for the failure mode and/or
cause/mechanism under consideration. Current controls (e.g.,
design reviews, fail/safe designs such as a pressure relief valve,
mathematical s tudies , rig/lab tes ting, feas ibility review,
prototype tests, road testing, fleet testing) are those that have
been or are being used with the same or similar designs. The
team should always be focused on improving design controls;
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 releas ed to
production.
DESIGN FMEA
15) Occurrence (O)
(continued)
24
TABLE 1. DESIGN FMEA
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25
DESIGN FMEA
16) Current Design Controls
(continued)
The preferred approach is to first use prevention controls, if
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.
The Design FMEA form in this manual has two columns for the
design controls (i.e., separate columns for Prevention Controls
and Detection Controls ) to as s is t the team in clearly
distinguishing between these two types of design controls. This
allows for a quick visual determination that both types of design
controls have been considered. Use of this two-column form is
the preferred approach.
Note: In the example included here, it is clear that the team
has not identified any prevention controls. This could
be due to prevention controls not having been used
on the same or similar designs.
If a one-column (for design controls) form is used, then the
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 des ign controls have been identified, review all
prevention controls to determine if any occurrence rankings
need to be revised.
17) Detection (D) Detection is the rank associated with the best detection control
listed in the design control. Detection is a relative ranking,
within the scope of the individual FMEA. In order to achieve a
lower ranking, generally the planned des ign control (e.g.,
validation, and/or verification activities) has to be improved.
26
TABLE 1. DESIGN FMEA
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27
DESIGN FMEA
Suggested Evaluation Criteria
The team should agree on an evaluation criteria and ranking
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.
NOTE: After making the detection ranking, the team should
review the occurrence ranking and ensure that the
occurrence ranking is still appropriate.
Detection should be estimated using Table 4 as a guideline.
NOTE: The ranking value of 1 is res erved for almos t
certain.
Detection
Absolute
Uncertainty
Very Remote
Remote
Very Low
Low
Moderate
Moderately
High
High
Very High
Almost
Certain
Design Control will not and/or can not detect a potential cause/mechanism and
subsequent failure mode; or there is no Design Control.
Very remote chance the Design Control will detect a potential cause/mechanism
and subsequent failure mode.
Remote chance the Design Control will detect a potential cause/mechanism and
subsequent failure mode.
Very low chance the Design Control will detect a potential cause/mechanism and
subsequent failure mode.
Low chance the Design Control will detect a potential cause/mechanism
and subsequent failure mode.
Moderate chance the Design Control will detect a potential cause/mechanism and
subsequent failure mode.
Moderately high chance the Design Control will detect a potential cause/ mecha-
nism and subsequent failure mode.
High chance the Design Control will detect a potential cause/mechanism and
subsequent failure mode.
Very high chance the Design Control will detect a potential cause/mechanism
and subsequent failure mode.
Design Control will almost certainly detect a potential cause/mechanism and
subsequent failure mode.
10
9
8
7
6
5
4
3
2
1
Criteria: Likelihood of Detection by Design Control Ranking
TABLE 4. Suggested Detection Evaluation Criteria
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.
28
TABLE 1. DESIGN FMEA
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29
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: s everity,
occurrence, and detection.
In general practice when the severity is a 9 or 10, special
attention must be given to ensure that the risk is addressed
through exis ting des ign controls or preventive/corrective
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
user, preventive/corrective actions should be considered to
avoid the failure mode by eliminating, mitigating, or controlling
the cause(s).
After special attention has been given to severity rankings of 9
or 10, the team then addresses other failure modes, with the
intent of reducing severity, then occurrence, and then detection.
Actions such as, but not limited to, the following should be
considered:
Revised Design Geometry and/or Tolerances,
Revised Material Specification,
Design of Experiments (particularly when multiple or
interactive causes are present) or other problem-solving
techniques, and,
Revised Test Plan.
The primary objective of recommended actions is to reduce
risks and increase customer satisfaction by improving the
design.
Only a design revision can bring about a reduction in the
severity ranking. A reduction in the occurrence ranking can be
effected only by removing or controlling one or more of the
caus es /mechanis ms of the failure mode through a des ign
revision. An increase in design validation/verification actions will
result in a reduction in the detection ranking only. Increasing
the design validation/verification actions is a less desirable
engineering action since it does not address the severity or
occurrence of the failure mode.
If engineering assessment leads to no recommended actions for
a specific failure mode/cause/control combination, indicate this
by entering None in this column.
Enter the name of organization and individual responsible for
each recommended action and the target completion date.
20) Responsibility for the
Recommended Action(s)
30
DESIGN FMEA
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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.
All revised ratings should be reviewed. If further action is
considered necessary, repeat the analysis. The focus should
always be on continuous improvement.
Follow-Up Actions
The design-responsible engineer is responsible for ensuring that
all actions recommended have been implemented or adequately
addressed. The FMEA is a living document and should always
reflect the latest design level as well as the latest relevant
actions, including those occurring after start of production.
The design-responsible engineer has several means of ensuring
that concerns are identified and that recommended actions are
implemented. They include, but are not limited to the following:
Ensuring design requirements are achieved,
Reviewing engineering drawings and specifications,
Confirming incorporation in assembly/manufacturing
documentation, and,
Reviewing Process FMEAs and Control Plans.
DESIGN FMEA
32
POTENTIAL
FAILURE MODE AND EFFECTS ANALYSIS
IN
MANUFACTURING AND ASSEMBLY PROCESSES
(PROCESS FMEA)
PROCESS FMEA
33
34
35
A Process Potential FMEA is an analytical technique used by a
Manufacturing/As s embly-Res pons ible Engineer/Team as a
means to ensure that, to the extent possible, potential failure
modes and their associated causes/mechanisms have been
considered and addressed. In its most rigorous form, an FMEA
is a summary of the teams thoughts (including an analysis of
items that could go wrong based on experience) as a process is
developed. This systematic approach parallels and formalizes
the mental discipline that an engineer normally goes through in
any manufacturing planning process.
The Process Potential FMEA:
Identifies the process functions and requirements
Identifies potential product and process-related failure
modes,
Assesses the effects of the potential failures on the
customer,
Identifies the potential manufacturing or as s embly
process causes and identifies process variables on
which to focus controls for occurrence reduction or
detection of the failure conditions,
Identifies process variables on which to focus process
controls,
Develops a ranked list of potential failure modes, thus
establishing a priority system for preventive/corrective
action considerations, and,
Documents the res ults of the manufacturing or
assembly process.
Customer Defined The definition of Cus tomer for a Proces s FMEA s hould
normally be the End User. However, the customer can also be
a s ubs equent or downs tream manufacturing or as s embly
operation, a service operation, or government regulations.
.
Team Effort During the initial development of the Proces s FMEA, the
responsible engineer is expected to directly and actively involve
representatives from all affected areas. These areas should
include but are not limited to design, assembly, manufacturing,
materials, quality, service, and suppliers, as well as the area
responsible for the next assembly. The Process FMEA should
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.
PROCESS FMEA
INTRODUCTION
36
TABLE 5. PROCESS FMEA

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The Process FMEA is a living document and should be initiated:
Before or at the feasibility stage,
Prior to tooling for production, and
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individual components to assemblies.
Early review and analys is of new or revis ed proces s es is
promoted to anticipate, resolve, or monitor potential process
concerns during the manufacturing planning stages of a new
model or component program.
The Process FMEA assumes the product as designed will meet
the des ign intent. Potential failure modes that can occur
because of a design weakness may be included in a Process
FMEA. Their effect and avoidance is covered by the Design
FMEA.
The Process FMEA does not rely on product design changes to
overcome weaknesses in the process. However, it does take
into consideration a products design characteristics relative to
the planned manufacturing or assembly process to assure that,
to the extent possible, the resultant product meets customer
needs and expectations.
DEVELOPMENT OF A PROCESS FMEA
The process-responsible engineer has at his or her disposal a
number of documents that will be useful in preparing the
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,
i.e., the process intent.
The Process FMEA should begin with a flow chart of the general
process. This flow chart should identify the product/process
characteristics associated with each operation. Identification of
some product effects from the corresponding Design FMEA,
should be included, if available. Copies of the flow chart used in
FMEA preparation should accompany the FMEA.
In order to facilitate documentation of the analysis of potential
failures and their consequences, a Process FMEA form has
been developed and is in Appendix G.
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.
PROCESS FMEA
INTRODUCTION (Continued)
38
TABLE 5. PROCESS FMEA

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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. Als o include the
supplier name if known.
4) Prepared By Enter the name, telephone number, and company of the
engineer responsible for preparing the FMEA.
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).
6) Key Date Enter the initial FMEA due date, which should not exceed the
scheduled start of production date.
Note: In the case of a supplier, the initial FMEA due date
should not exceed the customer required Production
Part Approval Process (PPAP) submission date.
7) FMEA Date Enter the date the original FMEA was compiled and the latest
revision date.
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, addresse, etc., be included on a distribution
list.)
Enter a simple description of the process or operation being
analyzed (e.g., turning, drilling, tapping, welding, assembling).
In addition, it is recommended to record the as s ociated
process/operation number for the step being analyzed. The
team should review applicable performance, material, process,
environmental, and safety standards. Indicate as concisely as
pos s ible the purpos e of the proces s or operation being
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measurables) of the system, subsystem, or component. Where
the process involves numerous operations (e.g., assembling)
with different potential modes of failure, it may be desirable to
list the operations as separate elements.
10) Potential Failure Mode Potential failure mode is defined as the manner in which the
process could potentially fail to meet the process requirements
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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
potential failure mode in a subsequent (downstream) operation
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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, s ubs ys tem, s ys tem, or proces s
characteristic. Assume that the failure could occur but may not
necessarily occur. The process engineer/team should be able to
9) Process Function/
Requirements
PROCESS FMEA
40
TABLE 5. PROCESS FMEA

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41
pose and answer the following questions:
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?
Start by comparing similar processes and reviewing customer
(end user and subsequent operation) claims relating to similar
components. In addition, a knowledge of the design intent is
necessary. Typical failure modes could be but are not limited to:
Bent Burred Hole off-location
Cracked Hole too shallow Hole missing
Handling damage Dirty Hole too deep
Surface too rough Deformed Surface too smooth
Open circuited Short circuited Mis-labeled
NOTE: Potential failure modes s hould be des cribed in
"physical" or technical terms, not as a symptom
noticeable by the customer.
Potential effects of failure are defined as the effects of the failure
mode on the customer(s).
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
clearly if the failure mode could impact s afety or caus e
noncompliance to regulations. The customer(s) in this context
could be the next operation, s ubs equent operations or
locations, the dealer, and/or the vehicle owner. Each must be
considered when assessing the potential effect of a failure.
For the end user, the effects should always be stated in terms of
product or system performance, such as:
Noise Rough
Erratic operation Excessive
Effort Inoperative
Unpleasant odor Unstable
Operation impaired Draft
Intermittent operation Poor appearance
Leaks Vehicle control impaired
Rework/Repairs Customer dissatisfaction
Scrap
If the customer is the next operation or subsequent operation(s)/
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
PROCESS FMEA
10) Potential Failure Mode
(continued)
11) Potential Effect(s) of
Failure
42
TABLE 5. PROCESS FMEA

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43
Effect Ranking
Table 6. Suggested PFMEA Severity Evaluation Criteria
Criteria: Severity of Effect
This ranking results when a
potential failure mode results in a
final customer and/or a
manufacturing/assembly plant
defect. The final customer should
always be considered first. If both
occur, use the higher of the two
severities.
(Customer Effect) (Manufacturing/ Assembly Effect)
Hazardous
without
warning
Very high s everity ranking when a
potential failure mode affects s afe
vehicle operation and/or involves
noncompliance with government
regulation without warning.
Or may endanger operator (machine
or assembly) without warning.
10
Hazardous
with warning
9
Very high s everity ranking when a
potential failure mode affects s afe
vehicle operation and/or involves
noncompliance with government
regulation with warning.
Or may endanger operator (machine
or assembly) with warning.
Very High
8
Vehicle/item inoperable (los s of
primary function).
Or 100% of product may have to be
scrapped, or vehicle/item repaired in
repair department with a repair time
greater than one hour.
High
7
Vehicle/Item operable but at a
reduced level of performance.
Customer very dissatisfied.
Or product may have to be sorted
and a portion (les s than 100%)
scrapped, or vehicle/item repaired in
repair department with a repair time
between a half-hour and an hour.
Moderate
6
Vehicle/Item operable but Comfort/
Convenience item(s ) inoperable.
Customer dissatisfied.
Or a portion (less than 100%) of the
product may have to scrapped with
no sorting, or vehicle/item repaired in
repair department with a repair time
less than a half-hour.
Low
5
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Convenience item(s ) operable at a
reduced level of performance.
Or 100% of product may have to be
reworked, or vehicle/item repaired off-
line but does not go to repair
department.
Very Low
4
Fit and Finish/Squeak and Rattle item
does not conform. Defect noticed by
most customers (greater than 75%).
Or the product may have to be
sorted, with no scrap, and a portion
(less than 100%) reworked.
Minor
3
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does not conform. Defect noticed by
50% of customers.
Or a portion (less than 100%) of the
product may have to be reworked,
with no scrap, on-line but out-of-sta-
tion.
Very Minor
2
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does not conform. Defect noticed by
discriminating customers (less than
25%).
Or a portion (less than 100%) of the
product may have to be reworked,
with no scrap, on-line but in-station.
None
1
No discernible effect. Or slight inconvenience to operation
or operator, or no effect.
Criteria: Severity of Effect
This ranking results when a
potential failure mode results in a
final customer and/or a
manufacturing/assembly plant
defect. The final customer should
always be considered first. If both
occur, use the higher of the two
severities.
PROCESS FMEA
44
TABLE 5. PROCESS FMEA

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45
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 engineers/teams 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.
Suggested Evaluation Criteria
The team should agree on an evaluation criteria and ranking
s ys tem, that is cons is tent, even if modified for individual
process analysis. (See Table 6)
Severity should be estimated using Table 6 as a guideline:
NOTE: It is not recommended to modify criteria for ranking
values of 9 and 10. Failure modes with a rank of
severity 1 should not be analyzed further.
13) Classification This column may be used to classify any special product or
process characteristics (e.g., critical, key, major, significant) for
components , s ubs ys tems , or s ys tems that may require
additional process controls.
This column may also be used to highlight high priority failure
modes for engineering assessment.
If a classification is identified in the Process FMEA, notify the
des ign res pons ible engineer s ince this may affect the
engineering documents concerning control item identification.
Special product or process characteristic symbols and their
us age is directed by s pecific company policy and is not
standardized in this document.
Potential cause of failure is defined as how the failure could
occur, described in terms of something that can be corrected or
can be controlled.
List, to the extent possible, every failure cause assignable to
each potential failure mode. If a cause is exclusive to the failure
mode, i.e., if correcting the cause has a direct impact on the
failure mode, then this portion of the FMEA thought process is
completed. Many causes, however, are not mutually exclusive,
and to correct or control the cause, a design of experiments, for
example, may be considered to determine which root causes
are the major contributors and which can be mos t eas ily
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
14) Potential Cause(s)/
Mechanism(s) of Failure
12) Severity (S) (continued)
46
TABLE 5. PROCESS FMEA

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Only specific errors or malfunctions (e.g., operator fails to install
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15) Occurrence (O) Occurrence is the likelihood that a specific cause/mechanism of
failure will occur. The likelihood of occurrence ranking number
has a relative meaning rather than an absolute value. Preventing
or controlling the causes/mechanisms of failure through a
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occurrence ranking can be effected.
Estimate the likelihood of occurrence of potential failure cause/
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A consistent occurrence ranking system should be used to
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The Possible Failure Rates are based on the number of
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Suggested Evaluation Criteria
The team should agree on an evaluation criteria and ranking
system that is consistent, even if modified for individual process
analysis. (See Table 7)
Occurrence should be estimated using Table 7 as a guideline:
NOTE: The ranking value of 1 is reserved for Remote:
failure is Unlikely .
PROCESS FMEA
14) Potential Cause(s)/
Mechanism(s) of Failure
(continued)
TABLE 5. PROCESS FMEA
48

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49
*For associated Ppk calculations and values, see Appendix I.
Current Process Controls are descriptions of the controls that
either prevent to the extent possible the failure mode or cause/
mechanism of failure from occurring, or detect the failure mode
or cause/mechanism of failure should it occur. These controls
can be proces s controls s uch as error/mis take proofing,
s tatis tical proces s control (SPC), or can be pos t-proces s
evaluation. The evaluation may occur at the subject operation
or at subsequent operations.
There are two types of Process Controls to consider:
Prevention: Prevent the cause/mechanism of failure or
the failure mode from occurring, or reduce
their rate or occurrence,
Detection: Detect the cause/mechanism of failure or the
failure mode, and lead to corrective
action(s).
The preferred approach is to first use prevention controls, if
possible. The initial occurrence rankings will be affected by the
prevention controls provided they are integrated as part of the
process intent. The initial rankings for detection will be based
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 as s is t 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.
PROCESS FMEA
Ranking
Likely Failure Rates*
10
9
8
7
6
5
4
3
2
1
> 100 per thousand pieces
50 per thousand pieces
20 per thousand pieces
10 per thousand pieces
5 per thousand pieces
2 per thousand pieces
1 per thousand pieces
0.5 per thousand pieces
0.1 per thousand pieces
< 0.01 per thousand pieces
Very High: Persistent Failures
High: Frequent Failures
Moderate: Occasional Failures
Low: Relatively Few Failures
Remote: Failure is Unlikely
Probability
Table 7. Suggested PFMEA Occurrence Evaluation Criteria
16) Current Process
Controls
TABLE 5. PROCESS FMEA
50

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51
If a one-column (for process controls) form is used, then the
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
need to be revised.
17) Detection (D) Detection is the rank associated with the best detection control
listed in the process control column. Detection is a relative
ranking, within the scope of the individual FMEA. In order to
achieve a lower ranking, generally the planned process control
has to be improved.
As s ume the failure has occurred and then as s es s the
capabilities of all "Current Proces s Controls " to prevent
shipment of the part having this failure mode or defect. Do not
automatically presume that the detection ranking is low because
the occurrence is low (e.g., when control charts are used), but
do assess the ability of the process controls to detect low
frequency failure modes or prevent them from going further in
the process.
Random quality checks are unlikely to detect the existence of an
isolated defect and should not influence the detection ranking.
Sampling done on a statistical basis is a valid detection control.
PROCESS FMEA
16) Current Process
Controls (continued)
TABLE 5. PROCESS FMEA
52

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S
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53
Suggested Evaluation Criteria
The team should agree on an evaluation criteria and ranking
system that is consistent, even if modified for individual
product analysis. (See Table 8.)
Detection should be estimated using Table 8 as a guideline.
NOTE: The ranking value of 1 is reserved for Certain to
Detect.
PROCESS FMEA
17) Detection (D) (continued)
TABLE 8. Suggested PFMEA Detection Evaluation Criteria
Detection Criteria Ranking
A B C
Inspection
Types
Suggested Range of Detection Methods
Almost
Impossible
Absolute certainty of non-
detection.
Cannot detect or is not checked. 10
Very
Remote
Controls will probably not
detect.
X Control is achieved with indirect or random
checks only.
9
Remote Controls have poor chance
of detection.
X Control is achieved with visual inspection only. 8
Very Low Controls have poor chance
of detection.
X Control is achieved with double visual inspection
only.
7
Low Controls may detect. X Control is achieved with charting methods, such
as SPC {Statistical Process Control}.
6 X
Moderate Controls may detect. Control is based on variable gauging after parts
have left the s tation, or Go/No Go gauging
performed on 100% of the parts after parts have
left the station.
5 X
Moderately
High
Controls have a good
chance to detect.
Error detection in subsequent operations, OR
gauging performed on s etup and firs t-piece
check (for set-up causes only).
4 X X
High Controls have a good
chance to detect.
Error detection in-station, or error detection in
s ubs equent operations by multiple layers of
acceptance: supply, select, install, verify. Cannot
accept discrepant part.
3 X X
Very High Controls almost certain to
detect.
Error detection in-station (automatic gauging with
automatic stop feature). Cannot pass discrepant
part.
2 X X
Very High Controls certain to detect. Discrepant parts cannot be made because item
has been error-proofed by proces s /product
design.
1 X
Inspection Types:
A. Error-proofed
B. Gauging
C. Manual Inspection
X
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.
TABLE 5. PROCESS FMEA
54

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h
a
r
d
w
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C
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Sev7777
Occur8528
Detec5557
R
.
P
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N
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2
8
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1
7
5
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9
2
Sev777
R
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7
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5
4
9
Occ211
Det557
L
L
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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-
tion must be given to ensure that the risk is addressed through
existing design actions/controls or process preventive/correc-
tive action(s), regardless of the RPN. In all cases where the
effect of an identified potential failure mode could be a hazard
to manufacturing/assembly personnel, preventive/corrective ac-
tions should be taken to avoid the failure mode by eliminating or
controlling the cause(s), or appropriate operator protection
should be specified.
After special attention has been given to severity rankings of 9
or 10, the team then addresses other failure modes, with the
intent of reducing severity, then occurrence, and then detection.
Actions such as, but not limited to, the following should be
considered:
To reduce the probability of occurrence, process and/or
design revisions are required. An action-oriented study
of the process using statistical methods could be imple-
mented with an ongoing feedback of information to the
appropriate operations for continuous improvement and
defect prevention.
Only a design and/or process revision can bring about a
reduction in the severity ranking.
The preferred method to accomplish a reduction in the
detection ranking is the use of error/mistake proofing
methods. Generally, improving detection controls is
costly and ineffective for quality improvements. Increas-
ing the frequency of quality controls inspection is not an
effective preventive/corrective action and should only
be used as a temporary measure since permanent pre-
ventive/corrective action is required. In some cases, a
design change to a specific part may be required to
assist in the detection. Changes to the current control
system may be implemented to increase this probabil-
ity.
Emphasis must, however, be placed on preventing
defects (i.e., reducing the occurrence) rather than
detecting them. An example would be the us e of
statistical process control and process improvement
rather than random quality checks or as s ociated
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
PROCESS FMEA
TABLE 5. PROCESS FMEA
56

1
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h
a
r
d
w
a
r
e
C
lass
Sev7777
Occur8528
Detec5557
R
.
P
.
N
.
2
8
0
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7
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2
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R
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7
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57
PROCESS FMEA
20) Responsibility for the
Recommended Action(s)
Enter the individual responsible for the recommended action,
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,
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.
All revised ratings should be reviewed and if further action is
considered necessary, repeat the analysis. The focus should
always be on continuous improvement.
Follow-Up Actions
The process-responsible engineer is responsible for ensuring
that all actions recommended have been implemented or
adequately addressed. The FMEA is a living document and
should always reflect the latest design level as well as the latest
relevant actions, including those occurring after the start of
production.
The proces s -res pons ible engineer has s everal means of
ensuring that concerns are identified and that recommended
actions are implemented. They include, but are not limited to
the following:
Ensuring that process/product requirements are achieved,
Reviewing engineering drawings , proces s /product
specifications, and process flow,
Confirming the incorporation of changes in assembly/
manufacturing documentation and,
Reviewing Control Plans and operation instructions.
PROCESS FMEA
58
59
APPENDIX A
DESIGN FMEA QUALITY OBJ ECTIVES
Note: Specific Program Requirements take precedence
1. DESIGN IMPROVEMENTS The FMEA drives Des ign Improvements as the primary
objective.
2. HIGH RISK FAILURE MODES The FMEA addresses all high risk Failure Modes, as identified by
the FMEA team, with executable Action Plans. All other failure
modes are considered.
3. A/D/V OR DVP & R PLANS The Analysis/Development/Validation (A/D/V), and/or Design
Verification Plan and Report (DVP&R) considers the failure
modes from the FMEA.
4. INTERFACES The FMEA scope includes integration and interface failure
modes in both block diagram and analysis.
5. LESSONS LEARNED The FMEA considers all major lessons learned (such as high
warranty, campaigns , etc.) as input to failure mode
identification.
The FMEA identifies appropriate Key Characteristics candidates
as input to the Key Characteris tics s election proces s , if
applicable due to company policy.
7. TIMING The FMEA is completed during the Window of Opportunity
where it could most efficiently impact the product design.
8. TEAM The right people participate as part of the FMEA team through-
out the analysis, and are adequately trained in FMEA methods.
As appropriate, a facilitator should be used.
9. DOCUMENTATION The FMEA document is completely filled out "by the book",
including "Action Taken" and new RPN values.
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
assumes Recommended Actions are identified as required and
the actions are implemented.
6. SPECIAL OR KEY
CHARACTERISTICS
60
APPENDIX B
PROCESS FMEA QUALITY OBJ ECTIVES
Note: Specific Program Requirements take precedence.
1. PROCESS IMPROVEMENTS The FMEA drives Proces s Improvements as the primary
objective, with an emphasis on Error/Mistake Proofing solutions.
2. HIGH RISK FAILURE MODES The FMEA addresses all high risk Failure Modes, as identified by
the FMEA team, with executable Action Plans. All other failure
modes are considered.
3. CONTROL PLANS The Pre-launch and Production Control Plans consider the
failure modes from the Process FMEA.
4. INTEGRATION The FMEA is integrated and consistent with the Process Flow
Diagram and the Process Control Plan. The Process FMEA
considers the Design FMEA, if available as part of its analysis.
5. LESSONS LEARNED The FMEA considers all major lessons learned (such as high
warranty, campaigns , non-conforming product, cus tomer
complaints, etc.) as input to failure mode identification.
The FMEA identifies appropriate Key Characteristics candidates
as input to the Key Characteris tics s election proces s , if
applicable due to company policy.
7. TIMING The FMEA is completed during the Window of Opportunity
where it could most efficiently impact the design of product or
process.
8. TEAM The right people participate as part of the FMEA team
throughout the analysis, and are adequately trained in FMEA
methods. As appropriate, a facilitator should be used.
9. DOCUMENTATION The FMEA document is completely filled out "by the book",
including "Action Taken" and new RPN values.
10.TIME USAGE Time spent by the FMEA team as early as possible is an
effective and efficient use of time, with a value-added result.
This assumes Recommended Actions are identified as required
and the actions are implemented.
6. SPECIAL OR KEY
CHARACTERISTICS
61
APPENDIX C
DESIGN FMEA BLOCK DIAGRAM EXAMPLE
FAILURE MODE AND EFFECTS ANALYSIS (FMEA)
BLOCK DIAGRAM/ENVIRONMENTAL EXTREMES
SYSTEM NAME: FLASHLIGHT
YEAR VEHICLE PLATFORM: 1994 NEW PRODUCT
FMEA I.D. NUMBER XXXI10D001
OPERATIONAL ENVIRONMENTAL EXTREMES
TEMPERATURE: CORROSIVE: VIBRATION:
SHOCK: FOREIGN MATERIAL: HUMIDITY:
FLAMMABILITY: (WHAT COMPONENT(S) ARE NEAR HEAT SOURCE(S)?
OTHER:
LETTERS = COMPONENTS = ATTACHED/JOINED ------- = INTERFACING, NOT JOINED = NOT INCLUDED IN
NUMBERS = ATTACHING METHODS
-20 TO 160 F TEST SCHEDULE B NOT APPLICABLE
6 FOOT DROP DUST 0 - 100 % RH
THIS FMEA
The example below is a relational block diagram. Other types of block diagrams may be used by the FMEA
Team to clarify the item(s) being considered in their analysis
SWITCH
ON/OFF
C
BULB
ASSEMBLY
D
HOUSING
A
PLATE
E
+
BATTERIES
B
SPRING
F
-
5
5
4 4
1
2
3
ATTACHING METHOD
1. SKIP FIT
2. RIVETS
3. THREAD
4. SNAP FIT
5. COMPRESSIVE FIT
COMPONENTS
A. HOUSING
B. BATTERIES (2 D CELL)
C. ON/OFF SWITCH
D. BULB ASSEMBLY
E. PLATE
F. SPRING
APPENDIX D
STANDARD FORM FOR DESIGN FMEA
62
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63
APPENDIX D
STANDARD FORM FOR DESIGN FMEA
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APPENDIX E
DESIGN FMEA EXAMPLE
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Appendix F System FMEA
To help illustrate the meaning of System, Subsystem, and Component FMEAs, 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
Figure F1. Interfaces and Interactions
The FMEA team is responsible for specifying the scope of its respective FMEAs. The example in Figure
F1 shows that the team has specified Subsystems A, B, C, and D along with the surrounding environment
as comprising the System that must be considered while completing the System FMEA.
INTERFACES: SUBSYSTEMS ARE DIRECTLY CONNECTED VIA INTERFACES.
In Figure F1, interfaces between subsystems are shown where Subsystem A touches
(connects with) Subsystem B, B touches C, C touches D, A touches D, and B touches
D. The Environment also touches each of the subsystems listed in Figure F1, which
requires that the Environmental Interfaces be considered when completing the
FMEA.
NOTE: Each Subsystem FMEA should have its Interfaces included in its respective
Subsystem FMEA.
INTERACTIONS: A CHANGE IN ONE SUBSYSTEM MIGHT CAUSE A CHANGE IN ANOTHER
SUBSYSTEM.
In Figure F1, interactions between subsystems can occur among any of the interfacing
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.
System
Subsystem D
Subsystem A Subsystem C
Subsystem B
Environment
65
66
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:
ITEM
Design Objectives (a statement of design objectives is often helpful)
- FUNCTION 1
POTENTIAL FAILURE MODE A
POTENTIAL FAILURE MODE B
etc.....
- FUNCTION 2
POTENTIAL FAILURE MODE A
POTENTIAL FAILURE MODE B
etc.....
- etc.....
67
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F
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M
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F
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M
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B
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B
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F
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M
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F
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a
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F
a
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l
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s
68
APPENDIX G
STANDARD FORM FOR PROCESS FMEA
C
o
r
e

T
e
a
m



_
_
_
_
_
_
_
_
_
_
_
_
_
_
_
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_
_
_
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_
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_
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_
_
_
_
_
_
_
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_
_
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_
_
_
_
_
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_
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_
_
_
_
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_
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_
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_
_
_
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_
_
_
_
_
_
_
_
_
_
_
_
_
_
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_
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_
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_
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-

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F
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R
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q
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_
_
_
_
_
_
_
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D
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_
_
_
_
_
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_
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R
e
c
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m
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d
A
c
t
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(
s
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APPENDIX G
STANDARD FORM FOR PROCESS FMEA
69
C
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r
e

T
e
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m
P
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s
s

R
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P
r
e
v
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n
t
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n
70
APPENDIX H
PROCESS FMEA EXAMPLE

1
0
C
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T
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m



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Ranking
Likely Failure Rates*
10
9
8
7
6
5
4
3
2
1
> 100 per thousand pieces
50 per thousand pieces
20 per thousand pieces
10 per thousand pieces
5 per thousand pieces
2 per thousand pieces
1 per thousand pieces
0.5 per thousand pieces
0.1 per thousand pieces
< 0.01 per thousand pieces
Very High: Persistent Failures
High: Frequent Failures
Moderate: Occasional Failures
Low: Relatively Few Failures
Remote: Failure is Unlikely
Probability
Ppk
< 0.55
0.55
0.78
0.86
0.94
1.00
1.10
1.20
1.30
1.67
71
APPENDIX I
SUGGESTED PFMEA OCCURRENCE EVALUATION
CRITERIA WITH Ppk VALUES
Sample Calculation
Sample Calculation to determine Ppk value from a likely failure rate of 5 per thousand pieces.
Defect rate = = .
= 0.0025 divided by 2 for out-of-specifications high or low.
Using a "Z" table the associated "Z" value is 2.81 for a tail value of 0.0025.
1. Z =
where:
x = Average
SL = Specifications
2. Ppk =
3. Replace using Z
4. Ppk = = = 0.9367 =
~
0.94
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.
5
1000
0.05
SL - x

s
min (SL upper - x, x - SL lower)
3
s
Z
3
2.81
3
0.05
2

72
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.
Design Validation/Verification (DV) A program intended to ens ure that the des ign meets its
requirements.
Design of Experiments (DOE) Methods that identify factors that affect the mean and variation
with minimum testing/experimentation.
Error/Mistake Proofing Each OEM may have its own unique definition for Error/Mistake
Proofing. Confer with the OEM for the appropriate definition.
Feature A measurable product characteristic (e.g., radius, hardness) or a
meas urable proces s characteris tic (e.g., ins ertion force,
temperature).
Pareto A simple tool that can assist problem solving that involves
ranking all potential problem areas.
Process The combination of people, machines and equipment, raw
materials, methods, and environment that produces a given
product or service.
Process Change A change in processing concept that could alter the capability of
the process to meet the design requirements or the durability of
the product.
Quality Function Deployment (QFD) A s tructured method in which cus tomer requirements are
translated into appropriate technical requirements for each
stage of product development and production.
Root Cause The root cause is the reason for the primary non-conformance
and is the item that requires change to achieve permanent
preventive/corrective action.
Special Process Characteristic A s pecial proces s characteris tic (e.g., critical, key, major,
significant) is a process characteristic for which variation must
be controlled to some target value to ensure that variation in a
process or a special product characteristic is maintained to its
target value during manufacturing and assembly.
Special Product Characteristic A s pecial product characteris tic (e.g., critical, key, major,
significant) is a product characteristic for which reasonably
anticipated variation could significantly affect a products 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.
73
74
Inside Back Cover
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