Professional Documents
Culture Documents
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(FMEA)
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REFERENCE MANUAL
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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).
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/
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
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to develop, and, through AIAG, distribute this Manual. The work group responsible for the Manual was led
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
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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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
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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.
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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
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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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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-
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
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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
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FMEA manual or earlier editions.
3rd Edition In
Kevin A. Lange - DaimlerChrysler
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Earlier Editions
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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
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edition.
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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-
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
Overview ......................................................................................................................................... 1
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
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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Introduction ................................................................................................................................................ 35
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TABLE OF CONTENTS - continued
Page
Number
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2) Item ......................................................................................................................................... 39
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3) Process Responsibility ............................................................................................................ 39
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4) Prepared By ............................................................................................................................ 39
5) Model Year(s)/Program(s) ...................................................................................................... 39
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6) Key Date .................................................................................................................................. 39
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7) FMEA Date .............................................................................................................................. 39
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8) Core Team .............................................................................................................................. 39
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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
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12) Severity (S) .............................................................................................................................. 41
Suggested PFMEA Severity Evaluation Criteria .....................................................................
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13) Classification ........................................................................................................................... 45
14) Potential Cause(s)/Mechanism(s) of Failure ........................................................................... 45
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APPENDICES
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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 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.
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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
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FMEA, and Process FMEA.
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This manual should be used by suppliers that subscribe to QS-
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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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.
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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
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performed. It is not simply a case of filling out the form but
rather of understanding the FMEA process in order to eliminate
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risk and plan the appropriate controls to ensure customer
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There are three basic cases for which FMEA's are generated,
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technology, or process.
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process.
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POTENTIAL
FAILURE MODE AND EFFECTS ANALYSIS SEQUENCE
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Subsystem
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C Potential O D Action Results
Potential Potential
y 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.
Mode Failure
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v s of Failure u e N. Completion Date Taken e c e P.
Function f
s r c v c t N.
Reqt's Prevention Detection
G
e What can be done?
What
n - Design
are the How bad e Changes
Effect(s)? is it?
- Process
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What are the o Controls
Functions, Features or
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Requirements? to - Changes to
Standards,
How often Procedures,
What
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does it or Guides
are the
What can go wrong? Cause(s)? happen? In
- No Function te
- Partial/Over/
Degraded
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Function a
Figure 1. FMEA Process Sequence
- Intermittent
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Function How can this be U
prevented and s
- Unintended detected? e
Function
How good is this
method at
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detecting it? n
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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).
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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
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,
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including those occurring after the start of production.
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The responsible engineer has several means of assuring that
recommended actions are implemented. They include, but are
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not limited to the following:
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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
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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 teams thoughts
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(including an analysis of items that could go wrong based on
experience) as a component, subsystem, or system is designed.
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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
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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
alternatives,
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validation programs,
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Customer Defined
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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.
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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.
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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
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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,
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their identification, effect, and control are covered by the
Process FMEA.
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The Design FMEA does not rely on process controls to
overcome potential design weaknesses, but it does take the
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Tolerances/process capability/performance
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Tool access
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Diagnostic capability
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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.
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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
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available in Appendix D.
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FMEA Number 1234
1
POTENTIAL
System
FAILURE MODE AND EFFECTS ANALYSIS
X Subsystem (DESIGN FMEA) Page 1 of 1
Item 12 C O 15 Current Current 17 D 18 Action Results 22
Potential
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Potential Potential S l 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
o u Prevention Detection e N. Completion Date Taken e c e P.
of Failure
Function s f r c v c t N.
10 11 14 16 16 19 20 21
Front Door L.H. Corroded Deteriorated life of
G 7 2 2 28
Upper edge of 6 Vehicle general durability 7 294 Add laboratory A Tate-Body Based on test
7 e
H8HX-0000-A interior door leading to: protective wax test veh. T-118 accelerated Engrg results (Test No.
lower door Unsatisfactory application specified for n 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
e 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
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vehicle of interior door Insufficient wax testing- as above accelerated for wax upper (Test No. 1481)
Occupant hardware thickness specified
l corrosion testing edge verification show specified
protection M thickness is
from weather, adequate. DOE
noise, and o Conduct Design A Tate shows 25%
side impact of Experiments Body Engrg variation in
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to (DOE) on wax 9X 01 15 specified thickness
thickness is acceptable.
2) System, Indicate the appropriate level of analysis and enter the name
Subsystem, or and number of the system, subsystem, or component being
analyzed. The FMEA team members must decide on what
Component Name
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constitutes a system, subsystem, or component for their
and Number specific activities. The actual boundaries that divide a system,
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subsystem, and component are arbitrary and must be set by the
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FMEA team. Some descriptions are provided below and some
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examples are provided in Appendix F.
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System FMEA Scope
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A system can be considered to be made up of various
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subsystems. These subsystems often have been designed by
different teams. Some typical System FMEAs might cover the
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following systems: Chassis System, or Powertrain System, or
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Interior System, etc. Thus, the focus of the System FMEA is to
ensure that all interfaces and interactions are covered among
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system.)
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3) Design Responsibility Enter the OEM, department, and group. Also include the
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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 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.
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FMEA Number 1234
1
POTENTIAL
System
FAILURE MODE AND EFFECTS ANALYSIS
X Subsystem (DESIGN FMEA) Page 1 of 1
Item 12 C O 15 Current Current 17 D 18 Action Results 22
Potential
13 ty
Potential Potential S l 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
o u Prevention Detection e N. Completion Date Taken e c e P.
of Failure
Function s f r c v c t N.
10 11 14 16 16 19 20 21
Front Door L.H. Corroded Deteriorated life of
G 7 2 2 28
Upper edge of 6 Vehicle general durability 7 294 Add laboratory A Tate-Body Based on test
7 e
H8HX-0000-A interior door leading to: protective wax test veh. T-118 accelerated Engrg results (Test No.
lower door Unsatisfactory application specified for n 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
e 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
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vehicle of interior door Insufficient wax testing- as above accelerated for wax upper (Test No. 1481)
Occupant hardware thickness specified
l corrosion testing edge verification show specified
protection M thickness is
from weather, adequate. DOE
noise, and o Conduct Design A Tate shows 25%
side impact of Experiments Body Engrg variation in
14
to (DOE) on wax 9X 01 15 specified thickness
thickness is acceptable.
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
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engineering drawing. Prior to initial release (e.g., in the
conceptual phases), experimental numbers should be used.
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Enter, as concisely as possible, the function of the item being
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analyzed to meet the design intent. Include information (metrics/
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measurables) regarding the environment in which this system
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operates (e.g., define temperature, pressure, humidity ranges,
design life). If the item has more than one function with different
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potential modes of failure, list all the functions separately.
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10) Potential Failure Mode Potential failure mode is defined as the manner in which a
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component, subsystem, or system could potentially fail to meet
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or deliver the intended function described in the item/function
column (i.e., intended function fails). The potential failure mode
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level component.
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item and item function. The assumption is made that the failure
could occur but may not necessarily occur. A recommended
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operating conditions (i.e., hot, cold, dry, dusty, etc.) and under
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Cracked Deformed
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Loosened Leaking
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Sticking Oxidized
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FMEA Number 1234
1
POTENTIAL
System
FAILURE MODE AND EFFECTS ANALYSIS
X Subsystem (DESIGN FMEA) Page 1 of 1
Item 12 C O 15 Current Current 17 D 18 Action Results 22
Potential
13 ty
Potential Potential S l 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
o u Prevention Detection e N. Completion Date Taken e c e P.
of Failure
Function s f r c v c t N.
10 11 14 16 16 19 20 21
Front Door L.H. Corroded Deteriorated life of
G 7 2 2 28
Upper edge of 6 Vehicle general durability 7 294 Add laboratory A Tate-Body Based on test
7 e
H8HX-0000-A interior door leading to: protective wax test veh. T-118 accelerated Engrg results (Test No.
lower door Unsatisfactory application specified for n 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
e 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
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vehicle of interior door Insufficient wax testing- as above accelerated for wax upper (Test No. 1481)
Occupant hardware thickness specified
l corrosion testing edge verification show specified
protection M thickness is
from weather, adequate. DOE
noise, and o Conduct Design A Tate shows 25%
side impact of Experiments Body Engrg variation in
16
to (DOE) on wax 9X 01 15 specified thickness
thickness is acceptable.
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.
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in terms of the specific system, subsystem, or component being
analyzed. Remember that a hierarchical relationship exists
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between the component, subsystem, and system levels. For
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example, a part could fracture, which may cause the assembly
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to vibrate, resulting in an intermittent system operation. The
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intermittent system operation could cause performance to
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degrade and ultimately lead to customer dissatisfaction. The
intent is to forecast the failure effects, to the teams level of
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knowledge.
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Typical failure effects could be but are not limited to:
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Noise In Rough
Erratic Operation Inoperative
Poor Appearance Unpleasant Odor
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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
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FMEA Number 1234
1
POTENTIAL
System
FAILURE MODE AND EFFECTS ANALYSIS
X Subsystem (DESIGN FMEA) Page 1 of 1
Item 12 C O 15 Current Current 17 D 18 Action Results 22
Potential
13 ty
Potential Potential S l 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
o u Prevention Detection e N. Completion Date Taken e c e P.
of Failure
Function s f r c v c t N.
10 11 14 16 16 19 20 21
Front Door L.H. Corroded Deteriorated life of
G 7 2 2 28
Upper edge of 6 Vehicle general durability 7 294 Add laboratory A Tate-Body Based on test
7 e
H8HX-0000-A interior door leading to: protective wax test veh. T-118 accelerated Engrg results (Test No.
lower door Unsatisfactory application specified for n 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
e 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
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vehicle of interior door Insufficient wax testing- as above accelerated for wax upper (Test No. 1481)
Occupant hardware thickness specified
l corrosion testing edge verification show specified
protection M thickness is
from weather, adequate. DOE
noise, and o Conduct Design A Tate shows 25%
side impact of Experiments Body Engrg variation in
18
to (DOE) on wax 9X 01 15 specified thickness
thickness is acceptable.
Hazardous Very high severity ranking when a potential failure mode affects safe vehicle 10
without operation and/or involves noncompliance with government regulation without
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warning warning.
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Hazardous Very high severity ranking when a potential failure mode affects safe vehicle 9
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with warning operation and/or involves noncompliance with government regulation with warning.
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Very High Vehicle/item inoperable (loss of primary function). 8
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High Vehicle/item operable but at reduced level of performance. Customer very 7
dissatisfied.
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Moderate Vehicle/item operable, but Comfort/Convenience item(s) inoperable. Customer 6
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dissatisfied.
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Low Vehicle/item operable, but Comfort/Convenience item(s) operable at a reduced 5
level of performance. Customer somewhat dissatisfied.
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Very Low Fit & Finish/Squeak & Rattle item does not conform. Defect noticed by most 4
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Minor Fit & Finish/Squeak & Rattle item does not conform. Defect noticed by 50% of 3
customers.
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Fit & Finish/Squeak & Rattle item does not conform. Defect noticed by discriminat-
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Very Minor 2
ing customers (less than 25%).
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13) Classification This column may be used to classify any special product
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FMEA Number 1234
1
POTENTIAL
System
FAILURE MODE AND EFFECTS ANALYSIS
X Subsystem (DESIGN FMEA) Page 1 of 1
Item 12 C O 15 Current Current 17 D 18 Action Results 22
Potential
13 ty
Potential Potential S l 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
o u Prevention Detection e N. Completion Date Taken e c e P.
of Failure
Function s f r c v c t N.
10 11 14 16 16 19 20 21
Front Door L.H. Corroded Deteriorated life of
G 7 2 2 28
Upper edge of 6 Vehicle general durability 7 294 Add laboratory A Tate-Body Based on test
7 e
H8HX-0000-A interior door leading to: protective wax test veh. T-118 accelerated Engrg results (Test No.
lower door Unsatisfactory application specified for n 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
e 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
ra
vehicle of interior door Insufficient wax testing- as above accelerated for wax upper (Test No. 1481)
Occupant hardware thickness specified
l corrosion testing edge verification show specified
protection M thickness is
from weather, adequate. DOE
noise, and o Conduct Design A Tate shows 25%
side impact of Experiments Body Engrg variation in
20
to (DOE) on wax 9X 01 15 specified thickness
thickness is acceptable.
ly
Improper Software Specification
Improper Surface Finish Specification
n
Inadequate Travel Specification
O
Improper Friction Material Specified
e
Excessive Heat
s
Improper Tolerance Specified
U
Typical failure mechanisms may include but are not limited to:
l
a
Yield Chemical Oxidation
rn
Fatigue Electromigration
Material Instability
te
Creep
Wear
Corrosion
In
rs
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?
21
FMEA Number 1234
1
POTENTIAL
System
FAILURE MODE AND EFFECTS ANALYSIS
X Subsystem (DESIGN FMEA) Page 1 of 1
Item 12 C O 15 Current Current 17 D 18 Action Results 22
Potential
13 ty
Potential Potential S l 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
o u Prevention Detection e N. Completion Date Taken e c e P.
of Failure
Function s f r c v c t N.
10 11 14 16 16 19 20 21
Front Door L.H. Corroded Deteriorated life of
G 7 2 2 28
Upper edge of 6 Vehicle general durability 7 294 Add laboratory A Tate-Body Based on test
7 e
H8HX-0000-A interior door leading to: protective wax test veh. T-118 accelerated Engrg results (Test No.
lower door Unsatisfactory application specified for n 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
e 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
ra
vehicle of interior door Insufficient wax testing- as above accelerated for wax upper (Test No. 1481)
Occupant hardware thickness specified
l corrosion testing edge verification show specified
protection M thickness is
from weather, adequate. DOE
noise, and o Conduct Design A Tate shows 25%
side impact of Experiments Body Engrg variation in
22
to (DOE) on wax 9X 01 15 specified thickness
thickness is acceptable.
ly
Table 3 as a guideline:
n
NOTE: The ranking value of 1 is reserved for Remote: Failure
O
Is unlikely.
e
s
TABLE 3. Suggested DFMEA Occurrence Evaluation Criteria
U
l
a
Probability of Failure Possible Failure Rates Ranking
rn
Very High: Persistent failures > 100 per thousand vehicles/items
te
10
50 per thousand vehicles/items
In 9
High: Frequent failures 20 per thousand vehicles/items 8
rs
16) Current Design Controls List the prevention, design validation/verification (DV), or other
o
will assure the design adequacy for the failure mode and/or
rt
prototype tests, road testing, fleet testing) are those that have
been or are being used with the same or similar designs. The
P
Item 12 C O 15 Current Current 17 D 18 Action Results 22
Potential
13 ty
Potential Potential S l 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
o u Prevention Detection e N. Completion Date Taken e c e P.
of Failure
Function s f r c v c t N.
10 11 14 16 16 19 20 21
Front Door L.H. Corroded Deteriorated life of
G 7 2 2 28
Upper edge of 6 Vehicle general durability 7 294 Add laboratory A Tate-Body Based on test
7 e
H8HX-0000-A interior door leading to: protective wax test veh. T-118 accelerated Engrg results (Test No.
lower door Unsatisfactory application specified for n 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
e 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
ra
vehicle of interior door Insufficient wax testing- as above accelerated for wax upper (Test No. 1481)
Occupant hardware thickness specified
l corrosion testing edge verification show specified
protection M thickness is
from weather, adequate. DOE
noise, and o Conduct Design A Tate shows 25%
side impact of Experiments Body Engrg variation in
24
to (DOE) on wax 9X 01 15 specified thickness
thickness is acceptable.
The Design FMEA form in this manual has two columns for the
design controls (i.e., separate columns for Prevention Controls
ly
and Detection Controls) to assist the team in clearly
distinguishing between these two types of design controls. This
n
allows for a quick visual determination that both types of design
O
controls have been considered. Use of this two-column form is
e
the preferred approach.
s
U
Note: In the example included here, it is clear that the team
has not identified any prevention controls. This could
l
a
be due to prevention controls not having been used
rn
on the same or similar designs.
te
If a one-column (for design controls) form is used, then the
In
following prefixes should be used. For prevention controls,
place a 'P' before each prevention control listed. For detection
rs
need to be revised.
M
l
ra
17) Detection (D) Detection is the rank associated with the best detection control
listed in the design control. Detection is a relative ranking,
e
25
FMEA Number 1234
1
POTENTIAL
System
FAILURE MODE AND EFFECTS ANALYSIS
X Subsystem (DESIGN FMEA) Page 1 of 1
Item 12 C O 15 Current Current 17 D 18 Action Results 22
Potential
13 ty
Potential Potential S l 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
o u Prevention Detection e N. Completion Date Taken e c e P.
of Failure
Function s f r c v c t N.
10 11 14 16 16 19 20 21
Front Door L.H. Corroded Deteriorated life of
G 7 2 2 28
Upper edge of 6 Vehicle general durability 7 294 Add laboratory A Tate-Body Based on test
7 e
H8HX-0000-A interior door leading to: protective wax test veh. T-118 accelerated Engrg results (Test No.
lower door Unsatisfactory application specified for n 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
e 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
ra
vehicle of interior door Insufficient wax testing- as above accelerated for wax upper (Test No. 1481)
Occupant hardware thickness specified
l corrosion testing edge verification show specified
protection M thickness is
from weather, adequate. DOE
noise, and o Conduct Design A Tate shows 25%
side impact of Experiments Body Engrg variation in
26
to (DOE) on wax 9X 01 15 specified thickness
thickness is acceptable.
ly
review the occurrence ranking and ensure that the
occurrence ranking is still appropriate.
n
O
Detection should be estimated using Table 4 as a guideline.
e
s
NOTE: The ranking value of 1 is reserved for almost
U
certain.
l
TABLE 4. Suggested DFMEA Detection Evaluation Criteria
a
rn
Detection
te
Criteria: Likelihood of Detection by Design Control Ranking
Absolute In
Design Control will not and/or can not detect a potential cause/mechanism and 10
Uncertainty subsequent failure mode; or there is no Design Control.
rs
Very Remote Very remote chance the Design Control will detect a potential cause/mechanism 9
and subsequent failure mode.
to
Remote Remote chance the Design Control will detect a potential cause/mechanism and
o
8
subsequent failure mode.
M
Very Low Very low chance the Design Control will detect a potential cause/mechanism and 7
l
Low Low chance the Design Control will detect a potential cause/mechanism
e
6
and subsequent failure mode.
n
e
Moderate Moderate chance the Design Control will detect a potential cause/mechanism and 5
G
Moderately Moderately high chance the Design Control will detect a potential cause/ mecha- 4
o
High High chance the Design Control will detect a potential cause/mechanism and 3
rt
Very High Very high chance the Design Control will detect a potential cause/mechanism 2
p
Almost Design Control will almost certainly detect a potential cause/mechanism and 1
P
18) Risk Priority Number (RPN) The risk priority number is the product of the severity (S),
occurrence (O), and detection (D) rankings.
27
FMEA Number 1234
1
POTENTIAL
System
FAILURE MODE AND EFFECTS ANALYSIS
X Subsystem (DESIGN FMEA) Page 1 of 1
Item 12 C O 15 Current Current 17 D 18 Action Results 22
Potential
13 ty
Potential Potential S l 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
o u Prevention Detection e N. Completion Date Taken e c e P.
of Failure
Function s f r c v c t N.
10 11 14 16 16 19 20 21
Front Door L.H. Corroded Deteriorated life of
G 7 2 2 28
Upper edge of 6 Vehicle general durability 7 294 Add laboratory A Tate-Body Based on test
7 e
H8HX-0000-A interior door leading to: protective wax test veh. T-118 accelerated Engrg results (Test No.
lower door Unsatisfactory application specified for n 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
e 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
ra
vehicle of interior door Insufficient wax testing- as above accelerated for wax upper (Test No. 1481)
Occupant hardware thickness specified
l corrosion testing edge verification show specified
protection M thickness is
from weather, adequate. DOE
noise, and o Conduct Design A Tate shows 25%
side impact of Experiments Body Engrg variation in
28
to (DOE) on wax 9X 01 15 specified thickness
thickness is acceptable.
ly
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
n
user, preventive/corrective actions should be considered to
O
avoid the failure mode by eliminating, mitigating, or controlling
e
the cause(s).
s
U
After special attention has been given to severity rankings of 9
or 10, the team then addresses other failure modes, with the
l
a
intent of reducing severity, then occurrence, and then detection.
rn
Actions such as, but not limited to, the following should be
te
considered:
In
Revised Design Geometry and/or Tolerances,
rs
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
FAILURE MODE AND EFFECTS ANALYSIS
X Subsystem (DESIGN FMEA) Page 1 of 1
Item 12 C O 15 Current Current 17 D 18 Action Results 22
Potential
13 ty
Potential Potential S l 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
o u Prevention Detection e N. Completion Date Taken e c e P.
of Failure
Function s f r c v c t N.
10 11 14 16 16 19 20 21
Front Door L.H. Corroded Deteriorated life of
G 7 2 2 28
Upper edge of 6 Vehicle general durability 7 294 Add laboratory A Tate-Body Based on test
7 e
H8HX-0000-A interior door leading to: protective wax test veh. T-118 accelerated Engrg results (Test No.
lower door Unsatisfactory application specified for n 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
e 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
ra
vehicle of interior door Insufficient wax testing- as above accelerated for wax upper (Test No. 1481)
Occupant hardware thickness specified
l corrosion testing edge verification show specified
protection M thickness is
from weather, adequate. DOE
noise, and o Conduct Design A Tate shows 25%
side impact of Experiments Body Engrg variation in
30
to (DOE) on wax 9X 01 15 specified thickness
thickness is acceptable.
door hardware
In
including
mirror,
hinges, latch
te
and window Design aid investigation 8 280 Add team Body Engrg & Based on test, 3 7 1 3 21
7 Entrapped air prevents 5
regulator with non-functioning evaluation using Assy Ops additional vent
wax from entering
rn
Provide proper spray head production spray 8X 11 15 holes provided in
corner/edge access
surface for equipment and
a affected areas
appearance specified wax
l
items
- Paint and 4 Drawing evaluation 4 112 Add team U Body Engrg & Evaluation 7 1 1 7
7 Insufficient room
soft trim of spray head access evaluation using Assy Ops showed
between panels for s
spray head access\ design aid buck 8X 09 15 adequate access
and spray head 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
considered necessary, repeat the analysis. The focus should
always be on continuous improvement.
n
O
Follow-Up Actions
e
s
U
The design-responsible engineer is responsible for ensuring that
all actions recommended have been implemented or adequately
l
a
addressed. The FMEA is a living document and should always
rn
reflect the latest design level as well as the latest relevant
actions, including those occurring after start of production.
te
The design-responsible engineer has several means of ensuring
In
that concerns are identified and that recommended actions are
implemented. They include, but are not limited to the following:
rs
to
documentation, and,
Reviewing Process FMEAs and Control Plans.
l
ra
e
n
e
G
f
o
y
rt
e
p
ro
P
31
P
ro
p
e
rt
y
o
f
G
e
n
e
ra
l
M
o
32
to
rs
In
te
rn
a
l
U
s
e
O
n
ly
PROCESS FMEA
ly
n
O
e
POTENTIAL
s
U
l
FAILURE MODE AND EFFECTS ANALYSIS
a
rn
te
IN
In
MANUFACTURING AND ASSEMBLY PROCESSES
rs
to
(PROCESS FMEA)
o
M
l
ra
e
n
e
G
f
o
y
rt
e
p
ro
P
33
P
ro
p
e
rt
y
o
f
G
e
n
e
ra
l
M
o
34
to
rs
In
te
rn
a
l
U
s
e
O
n
ly
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
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
ly
developed. This systematic approach parallels and formalizes
n
the mental discipline that an engineer normally goes through in
O
any manufacturing planning process.
e
The Process Potential FMEA:
s
U
Identifies the process functions and requirements,
Identifies potential product and process-related failure
l
a
modes,
rn
Assesses the effects of the potential failures on the
customer,
te
Identifies the potential manufacturing or assembly
In
process causes and identifies process variables on
which to focus controls for occurrence reduction or
rs
controls,
Develops a ranked list of potential failure modes, thus
o
assembly process.
e
n
Customer Defined
e
.
y
rt
Team Effort
e
35
FMEA Number 1450
1
POTENTIAL
FAILURE MODE AND EFFECTS ANALYSIS
P (PROCESS FMEA) Page 1 of 1
Process 12 C Potential
13 ty O 15 Current Current 17 D 18 Action Results 22
Function Potential Potential S l Cause(s)/ c Process Process 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
o
of Failure u Prevention Detection e N. Completion Date Taken e c e P.
s r
f c v c t N.
Requirements 10 11 14 16 16 19 20 21
G Add positive MFG Engrg Stop added,
Manual Insufficient Deteriorated life of Manually inserted 8 Visual check each hour- 5 280 depth stop to 9X 10 15 sprayer checked 7 2 5 70
7 e
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 n (depth meter) and
surface appearance due enough coverage Automate Mfg Engrg
e Rejected due to
to rust through spraying 9X 12 15 complexity of
paint over time
different doors
Impaired function
on same line
ra
of interior doo
hardware 7 Spray heads 5 Test spray pattern at l Visual check each hour- 5 175 Use Design of Mfg Engrg Temp and press 7 1 5 35
clogged start-up and after idle M 1/shift for film thickness Experiments 9X 10 01 limits were
- Viscosity too periods, and preventive (depth meter) and (DOE) on determined and
To cover inner high maintenance program to coverage
o viscosity vs. limit controls
door, lower - Temperature clean heads temperature vs. have been
36
surfaces at too low pressure installed -
- Pressure control charts
to
minimum wax
thickness to too low show process is
retard corrosion in control
rs
Cpk=1.85
7 Spray time 8 Operator instructions and 7 392 Install spray Maintenance Automatic spray 7 1 7 49
rn
insufficient lot sampling (10 doors / timer 9X 09 15 timer installed -
TABLE 5. PROCESS FMEA
O
n
ly
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
individual components to assemblies.
ly
promoted to anticipate, resolve, or monitor potential process
n
concerns during the manufacturing planning stages of a new
O
model or component program.
e
The Process FMEA assumes the product as designed will meet
s
the design intent. Potential failure modes that can occur
U
because of a design weakness may be included in a Process
l
FMEA. Their effect and avoidance is covered by the Design
a
FMEA.
rn
The Process FMEA does not rely on product design changes to
te
overcome weaknesses in the process. However, it does take
In
into consideration a products design characteristics relative to
the planned manufacturing or assembly process to assure that,
rs
The Process FMEA should begin with a flow chart of the general
o
1) FMEA Number Enter the FMEA document number, which may be used for
tracking.
37
FMEA Number 1450
1
POTENTIAL
FAILURE MODE AND EFFECTS ANALYSIS
P (PROCESS FMEA) Page 1 of 1
Process 12 C Potential
13 ty O 15 Current Current 17 D 18 Action Results 22
Function Potential Potential S l Cause(s)/ c Process Process 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
o
of Failure u Prevention Detection e N. Completion Date Taken e c e P.
s r
f c v c t N.
Requirements 10 11 14 16 16 19 20 21
G Add positive MFG Engrg Stop added,
Manual Insufficient Deteriorated life of Manually inserted 8 Visual check each hour- 5 280 depth stop to 9X 10 15 sprayer checked 7 2 5 70
7 e
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 n (depth meter) and
surface appearance due enough coverage Automate Mfg Engrg
e Rejected due to
to rust through spraying 9X 12 15 complexity of
paint over time
different doors
Impaired function
on same line
ra
of interior doo
hardware 7 Spray heads 5 Test spray pattern at l Visual check each hour- 5 175 Use Design of Mfg Engrg Temp and press 7 1 5 35
clogged start-up and after idle M 1/shift for film thickness Experiments 9X 10 01 limits were
- Viscosity too periods, and preventive (depth meter) and (DOE) on determined and
To cover inner high maintenance program to coverage
o viscosity vs. limit controls
door, lower - Temperature clean heads temperature vs. have been
38
surfaces at too low pressure installed -
- Pressure control charts
to
minimum wax
thickness to too low show process is
retard corrosion in control
rs
Cpk=1.85
7 Spray time 8 Operator instructions and 7 392 Install spray Maintenance Automatic spray 7 1 7 49
rn
insufficient lot sampling (10 doors / timer 9X 09 15 timer installed -
TABLE 5. PROCESS FMEA
O
n
ly
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.
ly
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).
n
O
6) Key Date Enter the initial FMEA due date, which should not exceed the
e
scheduled start of production date.
s
U
Note: In the case of a supplier, the initial FMEA due date
should not exceed the customer required Production
l
a
Part Approval Process (PPAP) submission date.
rn
7) FMEA Date Enter the date the original FMEA was compiled and the latest
te
revision date.
8) Core Team
In
List the names of the responsible individuals and departments
rs
10) Potential Failure Mode Potential failure mode is defined as the manner in which the
p
39
FMEA Number 1450
1
POTENTIAL
FAILURE MODE AND EFFECTS ANALYSIS
P (PROCESS FMEA) Page 1 of 1
Process 12 C Potential
13 ty O 15 Current Current 17 D 18 Action Results 22
Function Potential Potential S l Cause(s)/ c Process Process 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
o
of Failure u Prevention Detection e N. Completion Date Taken e c e P.
s r
f c v c t N.
Requirements 10 11 14 16 16 19 20 21
G Add positive MFG Engrg Stop added,
Manual Insufficient Deteriorated life of Manually inserted 8 Visual check each hour- 5 280 depth stop to 9X 10 15 sprayer checked 7 2 5 70
7 e
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 n (depth meter) and
surface appearance due enough coverage Automate Mfg Engrg
e Rejected due to
to rust through spraying 9X 12 15 complexity of
paint over time
different doors
Impaired function
on same line
ra
of interior doo
hardware 7 Spray heads 5 Test spray pattern at l Visual check each hour- 5 175 Use Design of Mfg Engrg Temp and press 7 1 5 35
clogged start-up and after idle M 1/shift for film thickness Experiments 9X 10 01 limits were
- Viscosity too periods, and preventive (depth meter) and (DOE) on determined and
To cover inner high maintenance program to coverage
o viscosity vs. limit controls
door, lower - Temperature clean heads temperature vs. have been
40
surfaces at too low pressure installed -
- Pressure control charts
to
minimum wax
thickness to too low show process is
retard corrosion in control
rs
Cpk=1.85
7 Spray time 8 Operator instructions and 7 392 Install spray Maintenance Automatic spray 7 1 7 49
rn
insufficient lot sampling (10 doors / timer 9X 09 15 timer installed -
operator starts
TABLE 5. PROCESS FMEA
O
n
ly
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?
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
ly
necessary. Typical failure modes could be but are not limited to:
n
Bent Burred Hole off-location
O
Cracked Hole too shallow Hole missing
Handling damage Dirty Hole too deep
e
Surface too rough Deformed Surface too smooth
s
U
Open circuited Short circuited Mis-labeled
l
NOTE: Potential failure modes should be described in
a
"physical" or technical terms, not as a symptom
rn
noticeable by the customer.
te
11) Potential Effect(s) of Potential effects of failure are defined as the effects of the failure
In
Failure mode on the customer(s).
rs
For the end user, the effects should always be stated in terms of
e
Noise Rough
f
Effort Inoperative
y
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
FMEA Number 1450
1
POTENTIAL
FAILURE MODE AND EFFECTS ANALYSIS
P (PROCESS FMEA) Page 1 of 1
Process 12 C Potential
13 ty O 15 Current Current 17 D 18 Action Results 22
Function Potential Potential S l Cause(s)/ c Process Process 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
o
of Failure u Prevention Detection e N. Completion Date Taken e c e P.
s r
f c v c t N.
Requirements 10 11 14 16 16 19 20 21
G Add positive MFG Engrg Stop added,
Manual Insufficient Deteriorated life of Manually inserted 8 Visual check each hour- 5 280 depth stop to 9X 10 15 sprayer checked 7 2 5 70
7 e
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 n (depth meter) and
surface appearance due enough coverage Automate Mfg Engrg
e Rejected due to
to rust through spraying 9X 12 15 complexity of
paint over time
different doors
Impaired function
on same line
ra
of interior doo
hardware 7 Spray heads 5 Test spray pattern at l Visual check each hour- 5 175 Use Design of Mfg Engrg Temp and press 7 1 5 35
clogged start-up and after idle M 1/shift for film thickness Experiments 9X 10 01 limits were
- Viscosity too periods, and preventive (depth meter) and (DOE) on determined and
To cover inner high maintenance program to coverage
o viscosity vs. limit controls
door, lower - Temperature clean heads temperature vs. have been
42
surfaces at too low pressure installed -
- Pressure control charts
to
minimum wax
thickness to too low show process is
retard corrosion in control
rs
Cpk=1.85
7 Spray time 8 Operator instructions and 7 392 Install spray Maintenance Automatic spray 7 1 7 49
rn
insufficient lot sampling (10 doors / timer 9X 09 15 timer installed -
operator starts
TABLE 5. PROCESS FMEA
O
n
ly
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
manufacturing/assembly plant manufacturing/assembly plant
defect. The final customer should defect. The final customer should
always be considered first. If both always be considered first. If both
ly
occur, use the higher of the two occur, use the higher of the two
n
severities. severities.
O
Effect (Customer Effect) (Manufacturing/ Assembly Effect) Ranking
e
Hazardous Very high severity ranking when a Or may endanger operator (machine 10
s
without potential failure mode affects safe or assembly) without warning.
U
warning vehicle operation and/or involves
noncompliance with government
l
a
regulation without warning.
rn
Hazardous Very high severity ranking when a Or may endanger operator (machine 9
te
with warning potential failure mode affects safe or assembly) with warning.
vehicle operation and/or involves
noncompliance with government In
regulation with warning.
rs
Moderate Vehicle/Item operable but Comfort/ Or a portion (less than 100%) of the 6
G
5
Convenience item(s) operable at a reworked, or vehicle/item repaired off-
e
department.
ro
Very Low Fit and Finish/Squeak and Rattle item Or the product may have to be 4
P
does not conform. Defect noticed by sorted, with no scrap, and a portion
most customers (greater than 75%). (less than 100%) reworked.
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
FMEA Number 1450
1
POTENTIAL
FAILURE MODE AND EFFECTS ANALYSIS
P (PROCESS FMEA) Page 1 of 1
Process 12 C Potential
13 ty O 15 Current Current 17 D 18 Action Results 22
Function Potential Potential S l Cause(s)/ c Process Process 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
o
of Failure u Prevention Detection e N. Completion Date Taken e c e P.
s r
f c v c t N.
Requirements 10 11 14 16 16 19 20 21
G Add positive MFG Engrg Stop added,
Manual Insufficient Deteriorated life of Manually inserted 8 Visual check each hour- 5 280 depth stop to 9X 10 15 sprayer checked 7 2 5 70
7 e
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 n (depth meter) and
surface appearance due enough coverage Automate Mfg Engrg
e Rejected due to
to rust through spraying 9X 12 15 complexity of
paint over time
different doors
Impaired function
on same line
ra
of interior doo
hardware 7 Spray heads 5 Test spray pattern at l Visual check each hour- 5 175 Use Design of Mfg Engrg Temp and press 7 1 5 35
clogged start-up and after idle M 1/shift for film thickness Experiments 9X 10 01 limits were
- Viscosity too periods, and preventive (depth meter) and (DOE) on determined and
To cover inner high maintenance program to coverage
o viscosity vs. limit controls
door, lower - Temperature clean heads temperature vs. have been
44
surfaces at too low pressure installed -
- Pressure control charts
to
minimum wax
thickness to too low show process is
retard corrosion in control
rs
Cpk=1.85
7 Spray time 8 Operator instructions and 7 392 Install spray Maintenance Automatic spray 7 1 7 49
rn
insufficient lot sampling (10 doors / timer 9X 09 15 timer installed -
operator starts
TABLE 5. PROCESS FMEA
O
n
ly
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.
ly
The team should agree on an evaluation criteria and ranking
system, that is consistent, even if modified for individual
n
process analysis. (See Table 6)
O
e
Severity should be estimated using Table 6 as a guideline:
s
U
NOTE: It is not recommended to modify criteria for ranking
values of 9 and 10. Failure modes with a rank of
l
a
severity 1 should not be analyzed further.
rn
13) Classification This column may be used to classify any special product or
te
process characteristics (e.g., critical, key, major, significant) for
components, subsystems, or systems that may require
In
additional process controls.
rs
14) Potential Cause(s)/ Potential cause of failure is defined as how the failure could
f
can be controlled.
y
rt
45
FMEA Number 1450
1
POTENTIAL
FAILURE MODE AND EFFECTS ANALYSIS
P (PROCESS FMEA) Page 1 of 1
Process 12 C Potential
13 ty O 15 Current Current 17 D 18 Action Results 22
Function Potential Potential S l Cause(s)/ c Process Process 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
o
of Failure u Prevention Detection e N. Completion Date Taken e c e P.
s r
f c v c t N.
Requirements 10 11 14 16 16 19 20 21
G Add positive MFG Engrg Stop added,
Manual Insufficient Deteriorated life of Manually inserted 8 Visual check each hour- 5 280 depth stop to 9X 10 15 sprayer checked 7 2 5 70
7 e
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 n (depth meter) and
surface appearance due enough coverage Automate Mfg Engrg
e Rejected due to
to rust through spraying 9X 12 15 complexity of
paint over time
different doors
Impaired function
on same line
ra
of interior doo
hardware 7 Spray heads 5 Test spray pattern at l Visual check each hour- 5 175 Use Design of Mfg Engrg Temp and press 7 1 5 35
clogged start-up and after idle M 1/shift for film thickness Experiments 9X 10 01 limits were
- Viscosity too periods, and preventive (depth meter) and (DOE) on determined and
To cover inner high maintenance program to coverage
o viscosity vs. limit controls
door, lower - Temperature clean heads temperature vs. have been
46
surfaces at too low pressure installed -
- Pressure control charts
to
minimum wax
thickness to too low show process is
retard corrosion in control
rs
Cpk=1.85
7 Spray time 8 Operator instructions and 7 392 Install spray Maintenance Automatic spray 7 1 7 49
rn
insufficient lot sampling (10 doors / timer 9X 09 15 timer installed -
operator starts
TABLE 5. PROCESS FMEA
O
n
ly
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
Improper machine setup
Improper programming
ly
Only specific errors or malfunctions (e.g., operator fails to install
n
seal) should be listed; ambiguous phrases (e.g., operator error,
O
machine malfunction) should not be used.
e
s
15) Occurrence (O) Occurrence is the likelihood that a specific cause/mechanism of
U
failure will occur. The likelihood of occurrence ranking number
has a relative meaning rather than an absolute value. Preventing
l
a
or controlling the causes/mechanisms of failure through a
rn
design or process change is the only way a reduction in the
occurrence ranking can be effected.
te
In
Estimate the likelihood of occurrence of potential failure cause/
mechanism on a 1 to 10 scale.
rs
47
FMEA Number 1450
1
POTENTIAL
FAILURE MODE AND EFFECTS ANALYSIS
P (PROCESS FMEA) Page 1 of 1
Process 12 C Potential
13 ty O 15 Current Current 17 D 18 Action Results 22
Function Potential Potential S l Cause(s)/ c Process Process 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
o
of Failure u Prevention Detection e N. Completion Date Taken e c e P.
s r
f c v c t N.
Requirements 10 11 14 16 16 19 20 21
G Add positive MFG Engrg Stop added,
Manual Insufficient Deteriorated life of Manually inserted 8 Visual check each hour- 5 280 depth stop to 9X 10 15 sprayer checked 7 2 5 70
7 e
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 n (depth meter) and
surface appearance due enough coverage Automate Mfg Engrg
e Rejected due to
to rust through spraying 9X 12 15 complexity of
paint over time
different doors
Impaired function
on same line
ra
of interior doo
hardware 7 Spray heads 5 Test spray pattern at l Visual check each hour- 5 175 Use Design of Mfg Engrg Temp and press 7 1 5 35
clogged start-up and after idle M 1/shift for film thickness Experiments 9X 10 01 limits were
- Viscosity too periods, and preventive (depth meter) and (DOE) on determined and
To cover inner high maintenance program to coverage
o viscosity vs. limit controls
door, lower - Temperature clean heads temperature vs. have been
48
surfaces at too low pressure installed -
- Pressure control charts
to
minimum wax
thickness to too low show process is
retard corrosion in control
rs
Cpk=1.85
7 Spray time 8 Operator instructions and 7 392 Install spray Maintenance Automatic spray 7 1 7 49
rn
insufficient lot sampling (10 doors / timer 9X 09 15 timer installed -
operator starts
TABLE 5. PROCESS FMEA
O
n
ly
SAMPLE
PROCESS FMEA
Table 7. Suggested PFMEA Occurrence Evaluation Criteria
ly
n
10 per thousand pieces 7
O
Moderate: Occasional Failures 5 per thousand pieces 6
e
2 per thousand pieces 5
s
U
1 per thousand pieces 4
l
0.5 per thousand pieces
a
Low: Relatively Few Failures 3
rn
0.1 per thousand pieces 2
te
Remote: Failure is Unlikely < 0.01 per thousand pieces 1
In
*For associated Ppk calculations and values, see Appendix I.
rs
to
16) Current Process Current Process Controls are descriptions of the controls that
Controls either prevent to the extent possible the failure mode or cause/
o
or at subsequent operations.
n
action(s).
p
ro
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
FMEA Number 1450
1
POTENTIAL
FAILURE MODE AND EFFECTS ANALYSIS
P (PROCESS FMEA) Page 1 of 1
Process 12 C Potential
13 ty O 15 Current Current 17 D 18 Action Results 22
Function Potential Potential S l Cause(s)/ c Process Process 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
o
of Failure u Prevention Detection e N. Completion Date Taken e c e P.
s r
f c v c t N.
Requirements 10 11 14 16 16 19 20 21
G Add positive MFG Engrg Stop added,
Manual Insufficient Deteriorated life of Manually inserted 8 Visual check each hour- 5 280 depth stop to 9X 10 15 sprayer checked 7 2 5 70
7 e
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 n (depth meter) and
surface appearance due enough coverage Automate Mfg Engrg
e Rejected due to
to rust through spraying 9X 12 15 complexity of
paint over time
different doors
Impaired function
on same line
ra
of interior doo
hardware 7 Spray heads 5 Test spray pattern at l Visual check each hour- 5 175 Use Design of Mfg Engrg Temp and press 7 1 5 35
clogged start-up and after idle M 1/shift for film thickness Experiments 9X 10 01 limits were
- Viscosity too periods, and preventive (depth meter) and (DOE) on determined and
To cover inner high maintenance program to coverage
o viscosity vs. limit controls
door, lower - Temperature clean heads temperature vs. have been
50
surfaces at too low pressure installed -
- Pressure control charts
to
minimum wax
thickness to too low show process is
retard corrosion in control
rs
Cpk=1.85
7 Spray time 8 Operator instructions and 7 392 Install spray Maintenance Automatic spray 7 1 7 49
rn
insufficient lot sampling (10 doors / timer 9X 09 15 timer installed -
operator starts
TABLE 5. PROCESS FMEA
O
n
ly
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.
ly
17) Detection (D) Detection is the rank associated with the best detection control
n
listed in the process control column. Detection is a relative
O
ranking, within the scope of the individual FMEA. In order to
e
achieve a lower ranking, generally the planned process control
s
has to be improved.
U
Assume the failure has occurred and then assess the
l
a
capabilities of all "Current Process Controls" to prevent
rn
shipment of the part having this failure mode or defect. Do not
automatically presume that the detection ranking is low because
te
the occurrence is low (e.g., when control charts are used), but
In
do assess the ability of the process controls to detect low
frequency failure modes or prevent them from going further in
rs
the process.
to
51
FMEA Number 1450
1
POTENTIAL
FAILURE MODE AND EFFECTS ANALYSIS
P (PROCESS FMEA) Page 1 of 1
Process 12 C Potential
13 ty O 15 Current Current 17 D 18 Action Results 22
Function Potential Potential S l Cause(s)/ c Process Process 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
o
of Failure u Prevention Detection e N. Completion Date Taken e c e P.
s r
f c v c t N.
Requirements 10 11 14 16 16 19 20 21
G Add positive MFG Engrg Stop added,
Manual Insufficient Deteriorated life of Manually inserted 8 Visual check each hour- 5 280 depth stop to 9X 10 15 sprayer checked 7 2 5 70
7 e
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 n (depth meter) and
surface appearance due enough coverage Automate Mfg Engrg
e Rejected due to
to rust through spraying 9X 12 15 complexity of
paint over time
different doors
Impaired function
on same line
ra
of interior doo
hardware 7 Spray heads 5 Test spray pattern at l Visual check each hour- 5 175 Use Design of Mfg Engrg Temp and press 7 1 5 35
clogged start-up and after idle M 1/shift for film thickness Experiments 9X 10 01 limits were
- Viscosity too periods, and preventive (depth meter) and (DOE) on determined and
To cover inner high maintenance program to coverage
o viscosity vs. limit controls
door, lower - Temperature clean heads temperature vs. have been
52
surfaces at too low pressure installed -
- Pressure control charts
to
minimum wax
thickness to too low show process is
retard corrosion in control
rs
Cpk=1.85
7 Spray time 8 Operator instructions and 7 392 Install spray Maintenance Automatic spray 7 1 7 49
rn
insufficient lot sampling (10 doors / timer 9X 09 15 timer installed -
operator starts
TABLE 5. PROCESS FMEA
O
n
ly
SAMPLE
PROCESS FMEA
17) Detection (D) (continued) 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.)
ly
TABLE 8. Suggested PFMEA Detection Evaluation Criteria
n
O
Detection Criteria Inspection Suggested Range of Detection Methods Ranking
e
Types
s
A B C
U
Almost Absolute certainty of non- X Cannot detect or is not checked. 10
Impossible detection.
l
a
Very Controls will probably not X Control is achieved with indirect or random 9
rn
Remote detect. checks only.
Remote Controls have poor chance X Control is achieved with visual inspection only. 8
te
of detection.
Very Low Controls have poor chance
of detection.
X In
Control is achieved with double visual inspection
only.
7
rs
Low Controls may detect. X X Control is achieved with charting methods, such 6
as SPC {Statistical Process Control}.
to
Moderate Controls may detect. X Control is based on variable gauging after parts 5
have left the station, or Go/No Go gauging
o
Very High Controls almost certain to X X Error detection in-station (automatic gauging with 2
f
part.
y
Very High Controls certain to detect. X Discrepant parts cannot be made because item 1
rt
Inspection Types:
p
A. Error-proofed
ro
B. Gauging
P
C. Manual Inspection
18) Risk Priority Number (RPN) The risk priority number is the product of the severity (S), occur-
rence (O), and detection (D) rankings.
53
FMEA Number 1450
1
POTENTIAL
FAILURE MODE AND EFFECTS ANALYSIS
P (PROCESS FMEA) Page 1 of 1
Process 12 C Potential
13 ty O 15 Current Current 17 D 18 Action Results 22
Function Potential Potential S l Cause(s)/ c Process Process 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
o
of Failure u Prevention Detection e N. Completion Date Taken e c e P.
s r
f c v c t N.
Requirements 10 11 14 16 16 19 20 21
G Add positive MFG Engrg Stop added,
Manual Insufficient Deteriorated life of Manually inserted 8 Visual check each hour- 5 280 depth stop to 9X 10 15 sprayer checked 7 2 5 70
7 e
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 n (depth meter) and
surface appearance due enough coverage Automate Mfg Engrg
e Rejected due to
to rust through spraying 9X 12 15 complexity of
paint over time
different doors
Impaired function
on same line
ra
of interior doo
hardware 7 Spray heads 5 Test spray pattern at l Visual check each hour- 5 175 Use Design of Mfg Engrg Temp and press 7 1 5 35
clogged start-up and after idle M 1/shift for film thickness Experiments 9X 10 01 limits were
- Viscosity too periods, and preventive (depth meter) and (DOE) on determined and
To cover inner high maintenance program to coverage
o viscosity vs. limit controls
door, lower - Temperature clean heads temperature vs. have been
54
surfaces at too low pressure installed -
- Pressure control charts
to
minimum wax
thickness to too low show process is
retard corrosion in control
rs
Cpk=1.85
7 Spray time 8 Operator instructions and 7 392 Install spray Maintenance Automatic spray 7 1 7 49
rn
insufficient lot sampling (10 doors / timer 9X 09 15 timer installed -
operator starts
TABLE 5. PROCESS FMEA
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.
ly
tive action(s), regardless of the RPN. In all cases where the
effect of an identified potential failure mode could be a hazard
n
to manufacturing/assembly personnel, preventive/corrective ac-
O
tions should be taken to avoid the failure mode by eliminating or
e
controlling the cause(s), or appropriate operator protection
s
should be specified.
U
After special attention has been given to severity rankings of 9
l
a
or 10, the team then addresses other failure modes, with the
rn
intent of reducing severity, then occurrence, and then detection.
te
Actions such as, but not limited to, the following should be
considered: In
rs
defect prevention.
l
ra
55
FMEA Number 1450
1
POTENTIAL
FAILURE MODE AND EFFECTS ANALYSIS
P (PROCESS FMEA) Page 1 of 1
Process 12 C Potential
13 ty O 15 Current Current 17 D 18 Action Results 22
Function Potential Potential S l Cause(s)/ c Process Process 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
o
of Failure u Prevention Detection e N. Completion Date Taken e c e P.
s r
f c v c t N.
Requirements 10 11 14 16 16 19 20 21
G Add positive MFG Engrg Stop added,
Manual Insufficient Deteriorated life of Manually inserted 8 Visual check each hour- 5 280 depth stop to 9X 10 15 sprayer checked 7 2 5 70
7 e
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 n (depth meter) and
surface appearance due enough coverage Automate Mfg Engrg
e Rejected due to
to rust through spraying 9X 12 15 complexity of
paint over time
different doors
Impaired function
on same line
ra
of interior doo
hardware 7 Spray heads 5 Test spray pattern at l Visual check each hour- 5 175 Use Design of Mfg Engrg Temp and press 7 1 5 35
clogged start-up and after idle M 1/shift for film thickness Experiments 9X 10 01 limits were
- Viscosity too periods, and preventive (depth meter) and (DOE) on determined and
To cover inner high maintenance program to coverage
o viscosity vs. limit controls
door, lower - Temperature clean heads temperature vs. have been
56
surfaces at too low pressure installed -
- Pressure control charts
to
minimum wax
thickness to too low show process is
retard corrosion in control
rs
Cpk=1.85
7 Spray time 8 Operator instructions and 7 392 Install spray Maintenance Automatic spray 7 1 7 49
rn
insufficient lot sampling (10 doors / timer 9X 09 15 timer installed -
operator starts
TABLE 5. PROCESS FMEA
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,
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 and if further action is
O
considered necessary, repeat the analysis. The focus should
e
always be on continuous improvement.
s
U
Follow-Up Actions
l
a
rn
The process-responsible engineer is responsible for ensuring
te
that all actions recommended have been implemented or
adequately addressed. The FMEA is a living document and
In
should always reflect the latest design level as well as the latest
relevant actions, including those occurring after the start of
rs
production.
to
57
P
ro
p
e
rt
y
o
f
G
e
n
e
ra
l
M
o
58
to
rs
In
PROCESS FMEA
te
rn
a
l
U
s
e
O
n
ly
APPENDIX A
DESIGN FMEA QUALITY OBJECTIVES
Note: Specific Program Requirements take precedence
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
ly
modes are considered.
n
3. A/D/V OR DVP & R PLANS
O
The Analysis/Development/Validation (A/D/V), and/or Design
Verification Plan and Report (DVP&R) considers the failure
e
modes from the FMEA.
s
U
4. INTERFACES The FMEA scope includes integration and interface failure
modes in both block diagram and analysis.
l
a
rn
5. LESSONS LEARNED The FMEA considers all major lessons learned (such as high
warranty, campaigns, etc.) as input to failure mode
te
identification.
In
6. SPECIAL OR KEY The FMEA identifies appropriate Key Characteristics candidates
rs
8. TEAM
l
9. DOCUMENTATION The FMEA document is completely filled out "by the book",
e
10. TIME USAGE Time spent by the FMEA team as early as possible is an effec-
o
59
APPENDIX B
PROCESS FMEA QUALITY OBJECTIVES
Note: Specific Program Requirements take precedence.
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
ly
modes are considered.
n
3. CONTROL PLANS
O
The Pre-launch and Production Control Plans consider the
failure modes from the Process FMEA.
e
s
4. INTEGRATION The FMEA is integrated and consistent with the Process Flow
U
Diagram and the Process Control Plan. The Process FMEA
considers the Design FMEA, if available as part of its analysis.
l
a
rn
5. LESSONS LEARNED The FMEA considers all major lessons learned (such as high
warranty, campaigns, non-conforming product, customer
te
complaints, etc.) as input to failure mode identification.
In
6. SPECIAL OR KEY The FMEA identifies appropriate Key Characteristics candidates
rs
process.
l
ra
9. DOCUMENTATION The FMEA document is completely filled out "by the book",
G
10. TIME USAGE Time spent by the FMEA team as early as possible is an
y
60
APPENDIX C
DESIGN FMEA BLOCK DIAGRAM EXAMPLE
ly
OPERATIONAL ENVIRONMENTAL EXTREMES
n
O
TEMPERATURE: -20 TO 160 F CORROSIVE: TEST SCHEDULE B VIBRATION: NOT APPLICABLE
SHOCK: 6 FOOT DROP FOREIGN MATERIAL: DUST HUMIDITY: 0 - 100 % RH
e
FLAMMABILITY: (WHAT COMPONENT(S) ARE NEAR HEAT SOURCE(S)?
s
OTHER:
U
l
LETTERS = COMPONENTS = ATTACHED/JOINED ------- = INTERFACING, NOT JOINED = NOT INCLUDED IN
a
NUMBERS = ATTACHING METHODS THIS FMEA
rn
te
In
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
rs
to
SWITCH
o
ON/OFF
M
C
l
ra
2
e
n
e
BULB 3 HOUSING
G
ASSEMBLY A
D
f
o
y
4 4
rt
1
e
p
ro
PLATE SPRING
E BATTERIES
P
F
+ 5 B 5 -
61
POTENTIAL FMEA Number
____ System
FAILURE MODE AND EFFECTS ANALYSIS
____ Subsystem (DESIGN FMEA) Page of
62
to
rs
APPENDIX D
In
te
rn
a
l
STANDARD FORM FOR DESIGN FMEA
U
s
e
O
n
ly
POTENTIAL FMEA Number
System
FAILURE MODE AND EFFECTS ANALYSIS
Subsystem (DESIGN FMEA) Page of
Component
P Design Responsibility Prepared By
ro
MODEL YEARS(S)/Vehicle(s) Key Date FMEA Date (Orig.) (Rev.)
Core Team
p
e
Action Results
rt
Item C Potential
y O Current Current D
Potential Potential S l Cause(s)/ c Design Design e R. Recommended Responsibility
Failure Effect(s) of e a Mechanism(s)o c Controls Controls t P. Action(s) & Target Actions S O D R.
Mode Failure v s of Failure u Prevention Detection e N. Completion Date Taken e c e P.
Function s f r c v c t N.
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APPENDIX D
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STANDARD FORM FOR DESIGN FMEA
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FMEA Number 1234
1
POTENTIAL
System
FAILURE MODE AND EFFECTS ANALYSIS
X Subsystem (DESIGN FMEA) Page 1 of 1
Item 12 C O 15 Current Current 17 D 18 Action Results 22
Potential
13 ty
Potential Potential S l 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
o u Prevention Detection e N. Completion Date Taken e c e P.
of Failure
Function s f r c v c t N.
10 11 14 16 16 19 20 21
Front Door L.H. Corroded Deteriorated life of
G 7 2 2 28
Upper edge of 6 Vehicle general durability 7 294 Add laboratory A Tate-Body Based on test
7 e
H8HX-0000-A interior door leading to: protective wax test veh. T-118 accelerated Engrg results (Test No.
lower door Unsatisfactory application specified for n 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
e 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
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vehicle of interior door Insufficient wax testing- as above accelerated for wax upper (Test No. 1481)
Occupant hardware thickness specified
l corrosion testing edge verification show specified
protection M thickness is
from weather, adequate. DOE
noise, and o Conduct Design A Tate shows 25%
side impact of Experiments Body Engrg variation in
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to (DOE) on wax 9X 01 15 specified thickness
thickness is acceptable.
and window Design aid investigation 8 280 Add team Body Engrg & Based on test, 3 7 1 3 21
7 Entrapped air prevents 5
regulator with non-functioning evaluation using Assy Ops additional vent
wax from entering
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Provide proper spray head production spray 8X 11 15 holes provided in
corner/edge access
surface for equipment and
a affected areas
appearance specified wax
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items
- Paint and 4 Drawing evaluation 4 112 Add team U Body Engrg & Evaluation 7 1 1 7
7 Insufficient room
soft trim of spray head access evaluation using Assy Ops showed
between panels for s
spray head access\ design aid buck 8X 09 15 adequate access
and spray head e
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SAMPLE
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).
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Subsystem B
Subsystem A Subsystem C
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Subsystem D
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Environment
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Figure F1. Interfaces and Interactions
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The FMEA team is responsible for specifying the scope of its respective FMEAs. The example in Figure
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F1 shows that the team has specified Subsystems A, B, C, and D along with the surrounding environment
M
as comprising the System that must be considered while completing the System FMEA.
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In Figure F1, interfaces between subsystems are shown where Subsystem A touches
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D. The Environment also touches each of the subsystems listed in Figure F1, which
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FMEA.
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NOTE: Each Subsystem FMEA should have its Interfaces included in its respective
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Subsystem FMEA.
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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.
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:
ITEM
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Design Objectives (a statement of design objectives is often helpful)
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- FUNCTION 1
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POTENTIAL FAILURE MODE A
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POTENTIAL FAILURE MODE B
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etc.....
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- FUNCTION 2
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POTENTIAL FAILURE MODE A
POTENTIAL FAILURE MODE B In
etc.....
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- etc.....
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System Level Subsystem Level Component Level
P
Bicycle Frame Upper Frame
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Design Objectives: e Function: Function:
1) minimum 3000 hours of riding rt provides stable attachment for provides structural support
without need for maintenance y seat support
and 10,000 hours of riding for o Potential Failure Mode(s):
design life. f Potential Failure Mode(s): structural failure
2) accommodates male adults structural failure of seat support excessive deflection
comfortably to the 99.5th
G excessive deflection of seat
percentile e support Function:
3) ... etc. ... n provides dimensional control
e
Function: for correct finished frame
Function: provides pleasing appearance
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ease of use l
Potential Failure Mode(s):
M Potential Failure Mode(s):
Potential Failure Mode(s): finish (shine) deteriorates length of frame mounting points
difficult to steer paint chips o too long
67
difficult to pedal
to length of frame mounting points
too short
Function:
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provide reliable transportation Handle Bar Assembly I Function:
n support frame assembly
Potential Failure Mode(s): te production methods (welding)
chain breaks frequently Front Wheel Assembly
Tires require frequent Potential Failure Mode(s):
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maintenance Rear Wheel Assembly a
l Lower Front Tube
Function: U
provide comfortable Sprocket Assembly s
transportation e
Lower Rear Tube
Potential Failure Mode(s): Seat Assembly O
seating position is not n
comfortable Chain Assembly Sprocket
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APPENDIX G
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STANDARD FORM FOR PROCESS FMEA
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POTENTIAL FMEA Number
FAILURE MODE AND EFFECTS ANALYSIS
P (PROCESS FMEA) Page of
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APPENDIX G
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STANDARD FORM FOR PROCESS FMEA
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FMEA Number 1450
1
POTENTIAL
FAILURE MODE AND EFFECTS ANALYSIS
P (PROCESS FMEA) Page 1 of 1
Process 12 C Potential
13 ty O 15 Current Current 17 D 18 Action Results 22
Function Potential Potential S l Cause(s)/ c Process Process 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
o
of Failure u Prevention Detection e N. Completion Date Taken e c e P.
s r
f c v c t N.
Requirements 10 11 14 16 16 19 20 21
G Add positive MFG Engrg Stop added,
Manual Insufficient Deteriorated life of Manually inserted 8 Visual check each hour- 5 280 depth stop to 9X 10 15 sprayer checked 7 2 5 70
7 e
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 n (depth meter) and
surface appearance due enough coverage Automate Mfg Engrg
e Rejected due to
to rust through spraying 9X 12 15 complexity of
paint over time
different doors
Impaired function
on same line
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of interior doo
hardware 7 Spray heads 5 Test spray pattern at l Visual check each hour- 5 175 Use Design of Mfg Engrg Temp and press 7 1 5 35
clogged start-up and after idle M 1/shift for film thickness Experiments 9X 10 01 limits were
- Viscosity too periods, and preventive (depth meter) and (DOE) on determined and
To cover inner high maintenance program to coverage
o viscosity vs. limit controls
door, lower - Temperature clean heads temperature vs. have been
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surfaces at too low pressure installed -
- Pressure control charts
to
minimum wax
thickness to too low show process is
retard corrosion in control
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Cpk=1.85
APPENDIX H
7 Spray time 8 Operator instructions and 7 392 Install spray Maintenance Automatic spray 7 1 7 49
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insufficient lot sampling (10 doors / timer 9X 09 15 timer installed -
shift) to check for a operator starts
coverage of critical areas spray, timer
l controls shut-off
U control charts
show process is
s in control
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APPENDIX I
SUGGESTED PFMEA OCCURRENCE EVALUATION
CRITERIA WITH Ppk VALUES
Very High: Persistent Failures > 100 per thousand pieces < 0.55 10
50 per thousand pieces 0.55 9
High: Frequent Failures 20 per thousand pieces 0.78 8
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10 per thousand pieces 0.86 7
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Moderate: Occasional Failures 5 per thousand pieces 0.94 6
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2 per thousand pieces 1.00 5
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1 per thousand pieces 1.10 4
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Low: Relatively Few Failures 0.5 per thousand pieces 1.20 3
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0.1 per thousand pieces 1.30 2
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Remote: Failure is Unlikely < 0.01 per thousand pieces 1.67 1
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Sample Calculation
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Sample Calculation to determine Ppk value from a likely failure rate of 5 per thousand pieces.
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0.05
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Using a "Z" table the associated "Z" value is 2.81 for a tail value of 0.0025.
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SL - x
1. Z =
G
s
f
where:
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x = Average
y
SL = Specifications
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3. Replace using Z
P
Z 2.81 ~ 0.94
4. Ppk = = = 0.9367 =
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 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 ensure that the design meets its
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requirements.
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Design of Experiments (DOE) Methods that identify factors that affect the mean and variation
O
with minimum testing/experimentation.
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Error/Mistake Proofing Each OEM may have its own unique definition for Error/Mistake
U
Proofing. Confer with the OEM for the appropriate definition.
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Feature A measurable product characteristic (e.g., radius, hardness) or a
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measurable process characteristic (e.g., insertion force,
temperature).
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Pareto A simple tool that can assist problem solving that involves
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ranking all potential problem areas.
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Process Change A change in processing concept that could alter the capability of
the process to meet the design requirements or the durability of
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the product.
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Quality Function Deployment (QFD) A structured method in which customer requirements are
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Root Cause The root cause is the reason for the primary non-conformance
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Special Process Characteristic A special process characteristic (e.g., critical, key, major,
e
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 products safety
or compliance with governmental standards or regulations, or is
likely to significantly affect customer satisfaction with a product.
72
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