Potential Failure Mode and Effects Analysis (FMEA) : 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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The content of this document is the technical equivalent of SAE J-1739. Potential Failure Mode and Effects Analysis (FMEA) should be used by suppliers to companies subscribing to QS-9000 or equivalent document.
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REFERENCE MANUAL
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POTENTIAL FAILURE MODE AND EFFECTS ANALYSIS (FMEA)
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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 and technical nomenclature used by Chrysler, Ford, and General Motors in their respective supplier quality systems. Accordingly, this manual and format, which is approved and endorsed by Chrysler, Ford and General Motors, should be used by suppliers implementing FMEA techniques into their design/ manufacturing processes. In the past, Chrysler, Ford and General Motors each had their own guidelines and formats for insuring supplier FMEA compliance. Differences between these guidelines and formats resulted in additional demands on supplier resources. To improve upon this situation, Chrysler, Ford and General Motors agreed to develop, and, through AIAG, distribute this Manual. The work group responsible for the Manual was led be George Baumgartner of Ford Motor Company. This Manual provides general guidelines for preparing an FMEA. It does not give specific instructions on how to arrive at each FMEA entry, a task best left to each FMEA team. This Manual also is not intended to be a comprehensive FMEA reference source or training document. While these guidelines are intended to cover all situation normally occurring either in the design phase or process analysis, there will be questions that arise. These questions should be directed to your customer's Supplier Quality Assurance (SQA) activity. If you are uncertain as to how to contact the appropriate SQA activity, the buyer in your customer's Purchasing office can help. The Task Force gratefully acknowledges: the leadership and commitment of Vice Presidents Thomas T. Stallkamp at Chrysler, Norman F. Ehlers at Ford, and J. Ignasio Lopez de Arriortua of General Motors; the assistance of the AIAG in the development, production, and distribution of the Procedure; the guidance of Task Force principals Russ Jacobs (Chrysler), Steve Walsh (Ford), Dan Reid (General Motors), and Rad Smith; and the assistance of the ASQC Automotive Division Reading Team. This team, led by Tripp Martin (Peterson Spring), reviewed the Manual for technical content and accuracy and made valuable contributions to form and content. Since the Manual was developed to meet specific needs of the automotive industry, the ASQC voluntary standards process defined by ASQC policies and procedures was not used in its development.
Additional copies can be ordered from AIAG and/or permission to copy portions of this Procedure for use within supplier organizations should be obtained from AIAG at 248-358-3003.
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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 technical development of FMEAs. This reference manual is consistent with the Supplier Quality Requirements Task Force charter to standardize the reference manuals, procedures, reporting formats and technical nomenclature used by suppliers to DaimlerChrysler, Ford Motor Company, and General Motors Corporation. Accordingly the FMEA, 3rd Edition Manual is written to provide guidance for the supplier. The manual does not define requirements, it does provide general guidelines intended to cover situations normally occurring when preparing FMEAs during the design phase or process analysis phase. This manual is the technical equivalent of SAE J1739, for Design and Process FMEAs. However, it does not include an application for Machinery FMEA. Interested parties in Machinery FMEA may refer to SAE J1739 for a related example. The Supplier Quality Requirements Task Force would like to thank the following individuals, and their companies, who have contributed their time and efforts to the development of either this edition of the FMEA manual or earlier editions. 3rd Edition Kevin A. Lange - DaimlerChrysler Steven C. Leggett - General Motors Corporation Beth Baker - AIAG Earlier Editions Howard Riley - DaimlerChrysler George R. Baumgartner - Ford Motor Company Lawrence R. McCullen - General Motors Robert A. May - Goodyear Tripp Martin - Peterson Spring
This manual is a copyright of DaimlerChrysler, Ford Motor Company and General Motors Corporation, with all rights reserved. Additional copies may be obtained from AIAG, Southfield, Michigan, by calling 248-3583003. 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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William D. Carlson - DaimlerChrysler Glen R. Vallance - Ford Motor Company Carl S. Carlson - General Motors Corporation
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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 edition.
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Mark T. Wrobbel - DaimlerChrysler Rebecca French - General Motors Mary Ann Raymond - Bosch William Ireland - Kelsey-Hayes
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TABLE OF CONTENTS
Page Number General Information ................................................................................................................................... 1 Overview ......................................................................................................................................... What Is an FMEA ............................................................................................................................ Manual Format ................................................................................................................................ FMEA Implementation .................................................................................................................... Follow Up .........................................................................................................................................
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18) 19) 20) 21) 22)
Follow-Up Actions ...................................................................................................................................... 31 Process FMEA .......................................................................................................................................... 33 Introduction ................................................................................................................................................ 35 Customer Defined ......................................................................................................................... 35 Team Effort ................................................................................................................................... 35 I
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1) 2) 3) 4) 5) 6) 7) 8) 9) 10) 11) 12)
FMEA Number ........................................................................................................................ System, Subsystem, or Component Name and Number ....................................................... Design Responsibility ............................................................................................................. Prepared By ............................................................................................................................ Model Year(s)/Program(s) ...................................................................................................... Key Date ................................................................................................................................. FMEA Date ............................................................................................................................. Core Team .............................................................................................................................. Item/Function .......................................................................................................................... Potential Failure Mode ........................................................................................................... Potential Effect(s) of Failure ................................................................................................... Severity (S) ............................................................................................................................. Suggested DFMEA Severity Evaluation Criteria .................................................................... Classification .......................................................................................................................... Potential Cause(s)/Mechanism(s) of Failure .......................................................................... Occurrence (O) ....................................................................................................................... Suggested DFMEA Occurrence Evaluation Criteria .............................................................. Current Design Controls ......................................................................................................... Detection (D) .......................................................................................................................... Suggested DFMEA Detection Evaluation Criteria ................................................................. Risk Priority Number (RPN) ................................................................................................... Recommended Action(s) ........................................................................................................ Responsibility for the Recommended Action(s) ..................................................................... Action(s) Taken ...................................................................................................................... Action Results .........................................................................................................................
Development of a Design FMEA ............................................................................................................... 10 13 13 13 13 13 13 13 15 15 15 17 17 19 19 19 21 23 23 25 27 27 29 29 31 31
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Customer Defined ........................................................................................................................... 9 Team Effort ..................................................................................................................................... 9
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Introduction ................................................................................................................................................... 9
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Design FMEA .............................................................................................................................................. 7
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TABLE OF CONTENTS - continued

Page Number
Development of a Process FMEA ............................................................................................................. 37 1) 2) 3) 4) 5) 6) 7) 8) 9) 10) 11) 12) 13) 14) 15) 16) 17) 18) 19) 20) 21) 22) FMEA Number ......................................................................................................................... Item ......................................................................................................................................... Process Responsibility ............................................................................................................ Prepared By ............................................................................................................................ Model Year(s)/Program(s) ...................................................................................................... Key Date .................................................................................................................................. FMEA Date .............................................................................................................................. Core Team .............................................................................................................................. Process Function/Requirements ............................................................................................. Potential Failure Mode ............................................................................................................ Potential Effect(s) of Failure .................................................................................................... Severity (S) .............................................................................................................................. Suggested PFMEA Severity Evaluation Criteria ..................................................................... Classification ........................................................................................................................... Potential Cause(s)/Mechanism(s) of Failure ........................................................................... Occurrence (O) ....................................................................................................................... Suggested PFMEA Occurrence Evaluation Criteria ............................................................... Current Process Controls ........................................................................................................ Detection (D) ........................................................................................................................... Suggested PFMEA Detection Evaluation Criteria .................................................................. Risk Priority Number (RPN) .................................................................................................... Recommended Action(s) ......................................................................................................... Responsibility for the Recommended Action(s) ...................................................................... Action(s) Taken ....................................................................................................................... Action Results ..........................................................................................................................
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Follow-Up Actions ...................................................................................................................................... 57
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37 39 39 39 39 39 39 39 39 39 41 41 43 45 45 47 49 49 51 53 53 55 57 57 57
A Design FMEA Quality Objectives ............................................................................................ B Process FMEA Quality Objectives ........................................................................................... C Design FMEA Block Diagram Example ................................................................................... D Standard Forms for Design FMEA (1 and 2 column for controls) ........................................... E Design FMEA Example ............................................................................................................ F System FMEA .......................................................................................................................... G Standard Forms for Process FMEA (1 and 2 column for controls) .......................................... H Process FMEA Example .......................................................................................................... I Suggested PFMEA Occurrence Evaluation Criteria With Ppk Values .................................... Glossary ........................................................................................................................................
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APPENDICES 59 60 61 62 64 65 68 70 71 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. An FMEA can be described as a systematic group of activities intended to: (a) recognize and evaluate the potential failure of a product/process and the effects of that failure, (b) identify actions that could eliminate or reduce the chance of the potential failure occurring, and (c) document the entire process. It is complementary to the process of defining what a design or process must do to satisfy the customer. All FMEAs focus on the design, whether it be of the product, or process.
What Is an FMEA
Manual Format
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This manual should be used by suppliers that subscribe to QS9000 or its equivalent. FMEA teams are allowed to use the guidelines listed herein in the manner that will be most effective for a given situation.
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This reference document presents two types of FMEA: Design FMEA, and Process FMEA.
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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. One of the most important factors for the successful implementation of an FMEA program is timeliness. It is meant to be a before-the-event action, not an after-the-fact exercise. To achieve the greatest value, the FMEA must be done before a product or process failure mode has been incorporated into a product or process. Up-front time spent properly completing an FMEA, when product/process changes can be most easily and inexpensively implemented, will minimize late change crises. An FMEA can reduce or eliminate the chance of implementing a preventive/corrective change that would create an even larger concern. Communication and coordination should occur among all FMEA teams. Figure 1 depicts the sequence in which an FMEA should be performed. It is not simply a case of filling out the form but rather of understanding the FMEA process in order to eliminate risk and plan the appropriate controls to ensure customer satisfaction. There are three basic cases for which FMEA's are generated, each with a different scope or focus:
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Case 2:
Case 1:
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Case 3:
Although responsibility for the preparation of the FMEA is usually assigned to an individual, FMEA input should be a team effort. A team of knowledgeable individuals should be assembled (e.g., engineers with expertise in design, analysis/ testing, manufacturing, assembly, service, recycling, quality, and reliability). The FMEA is initiated by the engineer from the responsible activity, which can be the Original Equipment Manufacturer (i.e., produces the final product), a supplier, or a subcontractor.
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New designs, new technology, or new process. The scope of the FMEA is the complete design, technology, or process. Modifications to existing design or process (assumes there is an FMEA for the existing design or process). The scope of the FMEA should focus on the modification to design or process, possible interactions due to the modification, and field history. Use of an existing design or process in a new environment, location, or application (assumes there is an FMEA for the existing design or process). The scope of the FMEA is the impact of the new environment or location on the existing design or process.
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P
POTENTIAL FAILURE MODE AND EFFECTS ANALYSIS SEQUENCE
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C S l e a v s s Action Results R. P. N. Recommended Action(s) Responsibility & Target Completion Date Actions Taken S O D e c e v c t R. P. N. Current Controls
Subsystem Potential Effect(s) of Failure
Function Reqt's
Potential Failure Mode
F o rd
Prevention Detection
Potential Cause(s)/ Mechanism(s) of Failure O c c u r D e t e c
M o to r C o m p a n y
How often does it happen? - Special Controls - Changes to Standards, Procedures, or Guides - Process Changes - Design Changes
What can be done?
What are the Effect(s)? How bad is it?
Figure 1. FMEA Process Sequence
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What are the Cause(s)?
What are the Functions, Features or Requirements?
What can go wrong?
- No Function
- Partial/Over/ Degraded Function
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- Intermittent Function
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How can this be prevented and detected? How good is this method at detecting it?
- Unintended Function
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It is not appropriate to compare the ratings of one teams FMEA with the ratings of another teams FMEA, even if the product/ process appears to be identical, since each team's environment is unique and thus the respective individual ratings will be unique (i.e., the ratings are subjective). A review of the FMEA document against FMEA quality objectives (see Appendix A and Appendix B) is recommended, including a management review.
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c. Reviewing Design/Process FMEAs, applications, and Control Plans.
b. Confirming the incorporation of changes to design/assembly/ manufacturing documentation, and,
a. Reviewing designs, processes, and, drawings, to ensure that recommended actions have been implemented,
The responsible engineer has several means of assuring that recommended actions are implemented. They include, but are not limited to the following:
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The responsible engineer is in charge of ensuring that all recommended actions have been implemented or adequately addressed. The FMEA is a living document and should always reflect the latest level, as well as the latest relevant actions, including those occurring after the start of production.
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Follow-Up
The need for taking effective preventive/corrective actions, with appropriate follow-up on those actions, cannot be overemphasized. Actions should be communicated to all affected activities. A thoroughly thought-out and well-developed FMEA will be of limited value without positive and effective preventive/corrective actions.
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FMEA
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DESIGN FMEA
POTENTIAL
(DESIGN FMEA)
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DESIGN
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FAILURE MODE AND EFFECTS ANALYSIS
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DESIGN FMEA INTRODUCTION

A Design Potential FMEA is an analytical technique used primarily by a Design-Responsible Engineer/Team as a means to ensure that, to the extent possible, potential failure modes and their associated causes/mechanisms have been considered and addressed. End items, along with every related system, subsystem, and component, should be evaluated. In its most rigorous form, an FMEA is a summary of the teams thoughts (including an analysis of items that could go wrong based on experience) as a component, subsystem, or system is designed. This systematic approach parallels, formalizes, and documents the mental disciplines that an engineer normally goes through in any design process.
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Team Effort
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Customer Defined
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Aiding in the objective evaluation of the design, including functional requirements and design alternatives, Evaluating the initial design for manufacturing, assembly, service, and recycling requirements, Increasing the probability that potential failure modes and their effects on system and vehicle operation have been considered in the design/development process, Providing additional information to aid in the planning of thorough and efficient design, development, and validation programs, Developing a ranked list of potential failure modes according to their effect on the customer, thus establishing a priority system for design improvements, development, and validation testing/analysis, Providing an open issue format for recommending and tracking risk-reducing actions, and, Providing future reference, (e.g. lessons learned), to aid in analyzing field concerns, evaluating design changes, and developing advanced designs.
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The definition of Customer for a Design FMEA is not only the End User but also the design-responsible engineers/teams of the vehicle or higher-level assemblies, and/or the manufacturing/process-responsible engineers in activities such as manufacturing, assembly, and service. During the initial Design FMEA process, the responsible engineer is expected to directly and actively involve representatives from all affected areas. These areas of expertise and responsibility should include but are not limited to assembly, manufacturing, design, analysis/test, reliability, materials, quality, service, and suppliers, as well as the design area responsible for the next higher or lower assembly or system, subsystem, or component. The FMEA should be a catalyst to stimulate the interchange of ideas between the functions affected and thus promote a team approach. 9
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The Design Potential FMEA supports the design process in reducing the risk of failures (including unintended outcomes) by:
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DESIGN FMEA
Unless the responsible engineer is experienced with FMEA and team facilitation, it is helpful to have an experienced FMEA facilitator assist the team in its activities. The Design FMEA is a living document and should: Be initiated before or at design concept finalization, Be continually updated as changes occur or additional information is obtained throughout the phases of product development, and Be fundamentally completed before the production drawings are released for tooling. Considering that manufacturing/assembly needs have been incorporated, the Design FMEA addresses the design intent and assumes the design will be manufactured/assembled to this intent. Potential failure modes and/or causes/mechanisms that can occur during the manufacturing or assembly process need not but may be included in a Design FMEA. When not included, their identification, effect, and control are covered by the Process FMEA. The Design FMEA does not rely on process controls to overcome potential design weaknesses, but it does take the technical/physical limits of a manufacturing/assembly process into consideration, for example: Necessary mold drafts Limited surface finish Assembling space/access for tooling Limited hardenability of steels Tolerances/process capability/performance
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The Design FMEA can also take into consideration the technical/physical limits of product maintenance (service) and recycling, for example: Tool access Diagnostic capability Material classification symbols (for recycling)
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DEVELOPMENT OF A DESIGN FMEA

The design-responsible engineer has at his or her disposal a number of documents that will be useful in preparing the Design FMEA. The process begins by developing a listing of what the design is expected to do and what it is expected not to do, i.e., the design intent. Customer wants and needs as may be determined from sources such as Quality Function Deployment (QFD), Vehicle Requirements Documents, known product requirements, and/or manufacturing/assembly/service/recycling requirements should be incorporated. The better the definition of the desired characteristics, the easier it is to identify potential failure modes for preventive/corrective action. A Design FMEA should begin with a block diagram for the system, subsystem, and/or component being analyzed. 10
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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. The diagram illustrates the primary relationship among the items covered in the analysis and establishes a logical order to the analysis. Copies of the diagrams used in FMEA preparation should accompany the FMEA. In order to facilitate documentation of the analysis of potential failures and their consequences, a blank Design FMEA form is available in Appendix D.
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FMEA Number 1234 of 1 Page 1
System
P p
Design Responsibility Body Engineering Prepared By A. Tate - X6412- Body Engr FMEA Date (Orig.) 8X 03 22 (Rev.) 8X 07 14 Key Date 9X 03 01 ER (Dalton, Fraser, Henley Assembly Plants)
Subsystem
POTENTIAL FAILURE MODE AND EFFECTS ANALYSIS (DESIGN FMEA)
Component 01.03/Body Closures
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MODEL YEARS(S)/Vehicle(s) 199X/Lion 4dr/Wagon
Core Team T. Fender-Car Product Dev., Childers-Manufacturing, J. Ford-Assy Ops
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Item Potential Cause(s)/ Mechanism(s) of Failure
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13
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Current Design Controls Prevention R. P. N. Recommended Action(s) Responsibility & Target Completion Date Actions Taken Current Design Controls Detection D e t e c
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16 19
Add laboratory A Tate-Body accelerated Engrg corrosion testing 8X 09 30 O c c u r
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Action Results
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S O D e c e v c t R. P. N.
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14 16 20
Vehicle general durability test veh. T-118 T-109 T-301 7 294 6 Upper edge of protective wax application specified for inner door panels is too low
Potential Effect(s) of Failure
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Based on test results (Test No. 1481) upper edge spec raised 125mm
Function
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C S l e a v s s
Front Door L.H. H8HX-0000-A
Corroded interior lower door panels
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2 28 Conduct Design of Experiments (DOE) on wax thickness Physical and Chem Lab test- Report No.1265 Vehicle general durability testing- as above 7 196 A Tate Body Engrg 9X 01 15 Add laboratory Combine w/test accelerated for wax upper corrosion testing edge verification
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Ingress to and egress from vehicle Occupant protection from weather, noise, and side impact 4 Insufficient wax thickness specified
Deteriorated life of 7 door leading to: Unsatisfactory appearance due to rust througH paint over time Impaired function 7 of interior door hardware
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TABLE 1. DESIGN FMEA
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7 Inappropriate wax formulation specified 2
7 Test results (Test No. 1481) show specified thickness is adequate. DOE shows 25% variation in specified thickness is acceptable.
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None
Entrapped air prevents 5 wax from entering corner/edge access
Design aid investigation with non-functioning spray head
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Add team Body Engrg & evaluation using Assy Ops production spray 8X 11 15 equipment and specified wax
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Drawing evaluation of spray head access
Based on test, 3 additional vent holes provided in affected areas
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Support anchorage for door hardware including mirror, hinges, latch and window regulator Provide proper surface for appearance items - Paint and soft trim 7 Insufficient room between panels for spray head access\ 4
Add team evaluation using design aid buck and spray head
Body Engrg & Assy Ops 8X 09 15
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Evaluation showed adequate access
SAMPLE
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DESIGN FMEA
1) FMEA Number
Enter the FMEA document number, which may be used for tracking. Note: For an example of items 1-22 see Table 1.
Subsystem FMEA Scope A Subsystem FMEA is generally a sub-set of a larger system. For example, the front suspension subsystem is a sub-set of the chassis system. Thus, the focus of the Subsystem FMEA is to ensure that all interfaces and interactions are covered among the various components that make up the subsystem. Component FMEA Scope A Component FMEA is a generally an FMEA focused on the sub-set of a subsystem. For example, a strut is a component of the front suspension (which is a subsystem of the chassis system.) Enter the OEM, department, and group. Also include the supplier name, if applicable. Enter the name, telephone number, and company of the engineer responsible for preparing the FMEA. Enter the intended model year(s)/program(s) that will use and/or be affected by the design being analyzed (if known). Enter the initial FMEA due date, which should not exceed the scheduled production design release date. Enter the date the original FMEA was compiled and the latest revision date.
3)
Design Responsibility
4) 5) 6) 7)
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Prepared By Model Year(s)/Program(s) Key Date FMEA Date
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System FMEA Scope A system can be considered to be made up of various subsystems. These subsystems often have been designed by different teams. Some typical System FMEAs might cover the following systems: Chassis System, or Powertrain System, or Interior System, etc. Thus, the focus of the System FMEA is to ensure that all interfaces and interactions are covered among the various subsystems that make up the system as well as interfaces to other vehicle systems and the customer.
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2)
System, Subsystem, or Component Name and Number
Indicate the appropriate level of analysis and enter the name and number of the system, subsystem, or component being analyzed. The FMEA team members must decide on what constitutes a system, subsystem, or component for their specific activities. The actual boundaries that divide a system, subsystem, and component are arbitrary and must be set by the FMEA team. Some descriptions are provided below and some examples are provided in Appendix F.
System
P p
Subsystem
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16 19
17
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Action Results
22
9
14 16 20
F
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Function
10
11
C S l e a v s s
rd M o to r C o m p
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14
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None
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8) Core Team
List the names of the responsible individuals and departments that have the authority to identify and/or perform tasks. (It is recommended that each team member's name, department, telephone number, address, etc., be included on a distribution list.) Enter the name and other pertinent information (e.g., the number, the part class, etc.) of the item being analyzed. Use the nomenclature and show the design level as indicated on the engineering drawing. Prior to initial release (e.g., in the conceptual phases), experimental numbers should be used. Enter, as concisely as possible, the function of the item being analyzed to meet the design intent. Include information (metrics/ measurables) regarding the environment in which this system operates (e.g., define temperature, pressure, humidity ranges, design life). If the item has more than one function with different potential modes of failure, list all the functions separately.
10) Potential Failure Mode
List each potential failure mode associated with the particular item and item function. The assumption is made that the failure could occur but may not necessarily occur. A recommended starting point is a review of past things-gone-wrong, concerns, reports, and group brainstorming. Potential failure modes that could occur only under certain operating conditions (i.e., hot, cold, dry, dusty, etc.) and under certain usage conditions (i.e., above-average mileage, rough terrain, city driving only, etc.) should be considered. Typical failure modes could be but are not limited to: Cracked Loosened Sticking Fractured Slips (does not hold full torque) Inadequate support (structural) Disengages too fast Intermittent signal EMC/RFI NOTE: Deformed Leaking Oxidized Does not transmit torque No support (structural) Harsh engagement Inadequate signal No signal Drift
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Potential failure mode is defined as the manner in which a component, subsystem, or system could potentially fail to meet or deliver the intended function described in the item/function column (i.e., intended function fails). The potential failure mode may also be the cause of a potential failure mode in a higherlevel subsystem or system, or be the effect of one in a lowerlevel component.
Potential failure modes should be described in physical or technical terms, not as a symptom necessarily noticeable by the customer.
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9)
Item/Function
System
P p
Subsystem
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2 4 7 6 8
5 e rt y
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13
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15
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16 19
17
18
Action Results
22
9
14 16 20
F
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Function
10
11
C S l e a v s s
rd M o to r C o m p
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16
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8 280
None
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DESIGN FMEA
11) Potential Effect(s) of Failure Potential effects of failure are defined as the effects of the failure
mode on the function, as perceived by the customer. Describe the effects of the failure in terms of what the customer might notice or experience, remembering that the customer may be an internal customer as well as the ultimate end user. State clearly if the failure mode could impact safety or noncompliance to regulations. The effects should always be stated in terms of the specific system, subsystem, or component being analyzed. Remember that a hierarchical relationship exists between the component, subsystem, and system levels. For example, a part could fracture, which may cause the assembly to vibrate, resulting in an intermittent system operation. The intermittent system operation could cause performance to degrade and ultimately lead to customer dissatisfaction. The intent is to forecast the failure effects, to the teams level of knowledge. Typical failure effects could be but are not limited to: Noise Erratic Operation Poor Appearance Unstable Intermittent Operation Leaks
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Suggested Evaluation Criteria The team should agree on an evaluation criteria and ranking system that is consistent, even if modified for individual product analysis. (See Table 2.) NOTE: It is not recommended to modify criteria ranking values of 9 and 10. Failure modes with a rank of severity 1 should not be analyzed further. High severity rankings can sometimes be reduced by making design revisions that compensate or mitigate the resultant severity of failure. For example, run flat tires can mitigate the severity of a sudden tire blowout and seat belts can mitigate the severity of a vehicle crash.
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NOTE:
12) Severity (S)
Severity is the rank associated with the most serious effect for a given failure mode. Severity is a relative ranking within the scope of the individual FMEA. A reduction in the severity ranking index can be effected only through a design change. Severity should be estimated using Table 2 as a guideline:
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Rough Inoperative Unpleasant Odor Operation Impaired Thermal Event Regulatory Non-Compliance
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System
P p
Subsystem
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2 4 7 6 8
5 e rt y
12
13
o
15
f o
16 19
17
18
Action Results
22
9
14 16 20
F
21
Function
10
11
C S l e a v s s
rd M o to r C o m p
28
28
Table 1. DESIGN FMEA
18
a y
8 280
None
In
4 112
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21
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SAMPLE
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DESIGN FMEA
12) Severity (S) (continued)
Table 2. Suggested DFMEA Severity Evaluation Criteria
Hazardous without warning
Very high severity ranking when a potential failure mode affects safe vehicle operation and/or involves noncompliance with government regulation without warning.
Hazardous Very high severity ranking when a potential failure mode affects safe vehicle with warning operation and/or involves noncompliance with government regulation with warning.
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O
9 8 7 6 5 4 3 2 1
13)
Classification
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14) Potential Cause(s)/ Mechanism(s) of Failure
None
No discernible effect.
This column may be used to classify any special product characteristics (e.g., critical, key, major, significant) for components, subsystems, or systems that may require additional design or process controls. This column may also be used to highlight high-priority failure modes for engineering assessment if the team finds this helpful or if local management requires it. Special product or process characteristic symbols and their usage is directed by specific company policy and is not standardized in this document. Potential cause of failure is defined as an indication of a design weakness, the consequence of which is the failure mode. List, to the extent possible, every potential cause and/or failure mechanism for each failure mode. The cause/mechanism should be listed as concisely and completely as possible so that remedial efforts can be aimed at pertinent causes.
to
Very Minor
Fit & Finish/Squeak & Rattle item does not conform. Defect noticed by discriminating customers (less than 25%).
19
Minor
Fit & Finish/Squeak & Rattle item does not conform. Defect noticed by 50% of customers.
Very Low
Fit & Finish/Squeak & Rattle item does not conform. Defect noticed by most customers (greater than 75%).
Low
Vehicle/item operable, but Comfort/Convenience item(s) operable at a reduced level of performance. Customer somewhat dissatisfied.
In
Moderate
Vehicle/item operable, but Comfort/Convenience item(s) inoperable. Customer dissatisfied.
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High
Vehicle/item operable but at reduced level of performance. Customer very dissatisfied.
Very High
Vehicle/item inoperable (loss of primary function).
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10
Effect
Criteria: Severity of Effect
Ranking
System
P p
Subsystem
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2 4 7 6 8
5 e rt y
12
13
o
15
f o
16 19
17
18
Action Results
22
9
14 16 20
F
21
Function
10
11
C S l e a v s s
rd M o to r C o m p
28
28
20
a y
8 280
None
In
4 112
te
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21
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SAMPLE
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DESIGN FMEA
14) Potential Cause(s)/ Mechanism(s) of Failure (continued)
Typical failure causes may include, but are not limited to: Incorrect Material Specified Inadequate Design Life Assumption Over-stressing Insufficient Lubrication Capability Inadequate Maintenance Instructions Incorrect Algorithm Improper Maintenance Instructions Improper Software Specification Improper Surface Finish Specification Inadequate Travel Specification Improper Friction Material Specified Excessive Heat Improper Tolerance Specified
rd
to
Estimate the likelihood of occurrence of potential failure cause/ mechanism on a 1 to 10 scale. In determining this estimate, questions such as the following should be considered: What is the service history/field experience with similar components, subsystems, or systems? Is the component a carryover or similar to a previous level component, subsystem or system? How significant are changes from a previous level component, subsystem, or system? Is the component radically different from a previous level component? Is the component completely new? Has the component application changed? What are the environmental changes? Has an engineering analysis (e.g., reliability) been used to estimate the expected comparable occurrence rate for the application? Have preventive controls been put in place?
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21
15) Occurrence (O)
Occurrence is the likelihood that a specific cause/mechanism will occur during the design life. The likelihood of occurrence ranking number has a relative meaning rather than an absolute value. Preventing or controlling the causes/mechanisms of the failure mode through a design change or design process change (e.g., design checklist, design review, design guide) is the only way a reduction in the occurrence ranking can be effected. (See Table 3.)
Typical failure mechanisms may include but are not limited to: Yield Chemical Oxidation Fatigue Electromigration Material Instability Creep Wear Corrosion
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System
P p
Subsystem
ro
2 4 7 6 8
5 e rt y
12
13
o
15
f o
16 19
17
18
Action Results
22
9
14 16 20
F
21
Function
10
11
C S l e a v s s
rd M o to r C o m p
28
28
22
a y
8 280
None
In
4 112
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21
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SAMPLE
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DESIGN FMEA
15) Occurrence (O) (continued)
A consistent occurrence ranking system should be used to ensure continuity. The occurrence ranking number is a relative rating within the scope of the FMEA and may not reflect the actual likelihood of occurrence. Suggested Evaluation Criteria The team should agree on an evaluation criteria and ranking system, that is consistent, even if modified for individual product analysis. (See Table 3.) Occurrence should be estimated using Table 3 as a guideline: NOTE: The ranking value of 1 is reserved for Remote: Failure Is unlikely.
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TABLE 3. Suggested DFMEA Occurrence Evaluation Criteria

Probability of Failure Very High: Persistent failures Possible Failure Rates > 100 per thousand vehicles/items Ranking 10 9 8 7 6 5 4 3 2 1
10 per thousand vehicles/items
Moderate: Occasional failures
to
Low: Relatively few failures
rd
Remote: Failure is unlikely
< 0.010 per thousand vehicles/items
16) Current Design Controls
List the prevention, design validation/verification (DV), or other activities that have been completed or committed to and that will assure the design adequacy for the failure mode and/or cause/mechanism under consideration. Current controls (e.g., design reviews, fail/safe designs such as a pressure relief valve, mathematical studies, rig/lab testing, feasibility review, prototype tests, road testing, fleet testing) are those that have been or are being used with the same or similar designs. The team should always be focused on improving design controls; for example, creating new system tests in the lab, or creating new system modeling algorithms, etc. There are two types of design controls to consider: Prevention: Prevent the cause/mechanism of failure or the failure mode from occurring, or reduce their rate of occurrence, Detection: Detect the cause/mechanism of failure or the failure mode, either by analytical or physical methods, before the item is released to production. 23
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5 per thousand vehicles/items 2 per thousand vehicles/items 1 per thousand vehicles/items
0.5 per thousand vehicles/items 0.1 per thousand vehicles/items
High: Frequent failures
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System
P p
Subsystem
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2 4 7 6 8
5 e rt y
12
13
o
15
f o
16 19
17
18
Action Results
22
9
14 16 20
F
21
Function
10
11
C S l e a v s s
rd M o to r C o m p
28
28
24
a y
8 280
None
In
4 112
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21
U s e
SAMPLE
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DESIGN FMEA
16) Current Design Controls (continued)
The preferred approach is to first use prevention controls, if possible. The initial occurrence rankings will be affected by the prevention controls provided they are integrated as part of the design intent. The initial rankings for detection will be based on design controls that either detect the cause/mechanism of failure, or detect the failure mode. The Design FMEA form in this manual has two columns for the design controls (i.e., separate columns for Prevention Controls and Detection Controls) to assist the team in clearly distinguishing between these two types of design controls. This allows for a quick visual determination that both types of design controls have been considered. Use of this two-column form is the preferred approach. Note: In the example included here, it is clear that the team has not identified any prevention controls. This could be due to prevention controls not having been used on the same or similar designs.
Once the design controls have been identified, review all prevention controls to determine if any occurrence rankings need to be revised.
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17) Detection (D)
to
Detection is the rank associated with the best detection control listed in the design control. Detection is a relative ranking, within the scope of the individual FMEA. In order to achieve a lower ranking, generally the planned design control (e.g., validation, and/or verification activities) has to be improved.
25
If a one-column (for design controls) form is used, then the following prefixes should be used. For prevention controls, place a 'P' before each prevention control listed. For detection controls, place a 'D' before each detection control listed.
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System
P p
Subsystem
ro
2 4 7 6 8
5 e rt y
12
13
o
15
f o
16 19
17
18
Action Results
22
9
14 16 20
F
21
Function
10
11
C S l e a v s s
rd M o to r C o m p
28
28
26
a y
8 280
None
In
4 112
te
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21
U s e
SAMPLE
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DESIGN FMEA
Suggested Evaluation Criteria The team should agree on an evaluation criteria and ranking system that is consistent, even if modified for individual product analysis. It is best to have detection controls in place as early as possible in the design development process.
Detection should be estimated using Table 4 as a guideline. NOTE:
Detection Absolute Uncertainty
to
Very Low Low Moderate Moderately High High Very High
Very low chance the Design Control will detect a potential cause/mechanism and subsequent failure mode.
Remote
Remote chance the Design Control will detect a potential cause/mechanism and subsequent failure mode.
Very Remote Very remote chance the Design Control will detect a potential cause/mechanism and subsequent failure mode.
Design Control will not and/or can not detect a potential cause/mechanism and subsequent failure mode; or there is no Design Control.
Criteria: Likelihood of Detection by Design Control
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TABLE 4. Suggested DFMEA Detection Evaluation Criteria

Ranking 10 9 8 7 6 5 4 3 2 1
18) Risk Priority Number (RPN) The risk priority number is the product of the severity (S),
occurrence (O), and detection (D) rankings. (S) x (O) x (D) = RPN Within the scope of the individual FMEA, this value (between 1 and 1000) can be used to rank order the concerns in the design.
ro
Almost Certain
rt y
High chance the Design Control will detect a potential cause/mechanism and subsequent failure mode. Very high chance the Design Control will detect a potential cause/mechanism and subsequent failure mode. Design Control will almost certainly detect a potential cause/mechanism and subsequent failure mode.
Moderately high chance the Design Control will detect a potential cause/ mechanism and subsequent failure mode.
Moderate chance the Design Control will detect a potential cause/mechanism and subsequent failure mode.
rd
Low chance the Design Control will detect a potential cause/mechanism and subsequent failure mode.
27
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The ranking value of 1 is reserved for almost certain.
U s e
NOTE:
After making the detection ranking, the team should review the occurrence ranking and ensure that the occurrence ranking is still appropriate.
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System
P p
Subsystem
ro
2 4 7 6 8
5 e rt y
12
13
o
15
f o
16 19
17
18
Action Results
22
9
14 16 20
F
21
Function
10
11
C S l e a v s s
rd M o to r C o m p
28
28
28
a y
8 280
None
In
4 112
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21
U s e
SAMPLE
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DESIGN FMEA
19) Recommended Action(s)
Engineering assessment for preventive/corrective action should be first directed at high severity, high RPN, and other items designated by the team. The intent of any recommended action is to reduce rankings in the following order: severity, occurrence, and detection. In general practice when the severity is a 9 or 10, special attention must be given to ensure that the risk is addressed through existing design controls or preventive/corrective action(s), regardless of the RPN. In all cases where the effect of an identified potential failure mode could be a hazard to the end user, preventive/corrective actions should be considered to avoid the failure mode by eliminating, mitigating, or controlling the cause(s). After special attention has been given to severity rankings of 9 or 10, the team then addresses other failure modes, with the intent of reducing severity, then occurrence, and then detection. Actions such as, but not limited to, the following should be considered: Revised Design Geometry and/or Tolerances, Revised Material Specification, Design of Experiments (particularly when multiple or interactive causes are present) or other problem-solving techniques, and, Revised Test Plan.
rt y
rd
20) Responsibility for the Recommended Action(s)
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to
The primary objective of recommended actions is to reduce risks and increase customer satisfaction by improving the design. Only a design revision can bring about a reduction in the severity ranking. A reduction in the occurrence ranking can be effected only by removing or controlling one or more of the causes/mechanisms of the failure mode through a design revision. An increase in design validation/verification actions will result in a reduction in the detection ranking only. Increasing the design validation/verification actions is a less desirable engineering action since it does not address the severity or occurrence of the failure mode. If engineering assessment leads to no recommended actions for a specific failure mode/cause/control combination, indicate this by entering None in this column. Enter the name of the organization and individual responsible for each recommended action and the target completion date.
29
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System
P p
Subsystem
ro
2 4 7 6 8
5 e rt y
12
13
o
15
f o
16 19
17
18
Action Results
22
9
14 16 20
F
21
Function
10
11
C S l e a v s s
rd M o to r C o m p
28
28
DESIGN FMEA
30
a y
8 280
None
In
4 112
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21
U s e
SAMPLE
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DESIGN FMEA
21) Action(s) Taken 22) Action Results
After the action has been implemented, enter a brief description of the actual action and effective date. After the preventive/corrective action has been identified, estimate and record the resulting severity, occurrence, and detection rankings. Calculate and record the resulting RPN. If no actions are taken, leave the related ranking columns blank. All revised ratings should be reviewed. If further action is considered necessary, repeat the analysis. The focus should always be on continuous improvement.
Follow-Up Actions
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Ensuring design requirements are achieved, Reviewing engineering drawings and specifications, Confirming incorporation in assembly/manufacturing documentation, and, Reviewing Process FMEAs and Control Plans.
31
The design-responsible engineer has several means of ensuring that concerns are identified and that recommended actions are implemented. They include, but are not limited to the following:
In
The design-responsible engineer is responsible for ensuring that all actions recommended have been implemented or adequately addressed. The FMEA is a living document and should always reflect the latest design level as well as the latest relevant actions, including those occurring after start of production.
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32
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PROCESS FMEA
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(PROCESS FMEA)
33
MANUFACTURING AND ASSEMBLY PROCESSES
IN
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FAILURE MODE AND EFFECTS ANALYSIS
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POTENTIAL
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34
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PROCESS FMEA INTRODUCTION

A Process Potential FMEA is an analytical technique used by a Manufacturing/Assembly-Responsible Engineer/Team as a means to ensure that, to the extent possible, potential failure modes and their associated causes/mechanisms have been considered and addressed. In its most rigorous form, an FMEA is a summary of the teams thoughts (including an analysis of items that could go wrong based on experience) as a process is developed. This systematic approach parallels and formalizes the mental discipline that an engineer normally goes through in any manufacturing planning process.
to
Team Effort
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rd
Customer Defined
The definition of Customer for a Process FMEA should normally be the End User. However, the customer can also be a subsequent or downstream manufacturing or assembly operation, a service operation, or government regulations.
During the initial development of the Process FMEA, the responsible engineer is expected to directly and actively involve representatives from all affected areas. These areas should include but are not limited to design, assembly, manufacturing, materials, quality, service, and suppliers, as well as the area responsible for the next assembly. The Process FMEA should be a catalyst to stimulate the interchange of ideas between the areas affected and thus promote a team approach. Unless the responsible engineer is experienced with FMEA and team facilitation, it is helpful to have an experienced FMEA facilitator assist the team in its activities.
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35
In
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Identifies the process functions and requirements, Identifies potential product and process-related failure modes, Assesses the effects of the potential failures on the customer, Identifies the potential manufacturing or assembly process causes and identifies process variables on which to focus controls for occurrence reduction or detection of the failure conditions, Identifies process variables on which to focus process controls, Develops a ranked list of potential failure modes, thus establishing a priority system for preventive/corrective action considerations, and, Documents the results of the manufacturing or assembly process.
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The Process Potential FMEA:
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P
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2
Process Responsibility Body Engrg. Prepared By J. Ford - X6521 - Assy Ops FMEA Date (Orig.) 9X 05 17 (Rev.) 9X 11 06 Key Date 9X 03 01 ER 9X 08 26 Job #1
POTENTIAL FAILURE MODE AND EFFECTS ANALYSIS (PROCESS FMEA)
Item
Front Door L.H./H8HX-000-A
3 4 7 6 8
Model Years(S)/Vehicle(s) 199X/Lion 4dr/Wagon
Core Team A. Tate Body Engrg., J. Smith-OC, R. James-Production, J. Jones-Maintenance

e5 rt y
17
D e t e c R. P. N. Recommended Action(s) Actions Taken Responsibility & Target Completion Date
Process Function C S l e a v s s Potential Cause(s)/ Mechanism(s) of Failure
12
13
o
15
Current Process Controls Prevention Current Process Controls Detection
f
O c c u r
18
Action Results
22
9
14 16 19
MFG Engrg 9X 10 15
F o
20 21 16 rd
8
Requirements
10
7 Manually inserted spray head not inserted far enough
11
M o to r
Visual check each hour1/shift for film thickness (depth meter) and coverage Automate spraying Mfg Engrg 9X 12 15
Visual check each hour1/shift for film thickness (depth meter) and coverage
Add positive 5 280 depth stop to sprayer
Stop added, sprayer checked on line Rejected due to complexity of different doors on same line
70
Insufficient Deteriorated life of Manual wax coverage door leading to: application of wax inside door over specified Unsatisfactory surface appearance due to rust through paint over time Impaired function of interior doo hardware 7 5 Test spray pattern at start-up and after idle periods, and preventive maintenance program to clean heads
Mfg Engrg 9X 10 01
35
TABLE 5. PROCESS FMEA
36
To cover inner door, lower surfaces at minimum wax thickness to retard corrosion
Spray heads clogged - Viscosity too high - Temperature too low - Pressure too low
o y
5 70 None
m p a n In
5 175 Use Design of Experiments (DOE) on viscosity vs. temperature vs. pressure
Temp and press limits were determined and limit controls have been installed control charts show process is in control Cpk=1.85
7 Spray head deformed due to impact 2 Preventive maintenance programs to maintain heads Visual check each hour1/shift for film thickness (depth meter) and coverage Operator instructions and lot sampling (10 doors / shift) to check for coverage of critical areas
7 Spray time insufficient 8
7 392 Install spray timer
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Maintenance 9X 09 15
49
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Automatic spray timer installed operator starts spray, timer controls shut-off control charts show process is in control Cpk=2.05
SAMPLE
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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. Early review and analysis of new or revised processes is promoted to anticipate, resolve, or monitor potential process concerns during the manufacturing planning stages of a new model or component program. The Process FMEA assumes the product as designed will meet the design intent. Potential failure modes that can occur because of a design weakness may be included in a Process FMEA. Their effect and avoidance is covered by the Design FMEA. The Process FMEA does not rely on product design changes to overcome weaknesses in the process. However, it does take into consideration a products design characteristics relative to the planned manufacturing or assembly process to assure that, to the extent possible, the resultant product meets customer needs and expectations.
rd
rt y
1)
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FMEA Number
to
The process-responsible engineer has at his or her disposal a number of documents that will be useful in preparing the Process FMEA. The FMEA begins by developing a list of what the process is expected to do and what it is expected not to do, i.e., the process intent. The Process FMEA should begin with a flow chart of the general process. This flow chart should identify the product/process characteristics associated with each operation. Identification of some product effects from the corresponding Design FMEA, should be included, if available. Copies of the flow chart used in FMEA preparation should accompany the FMEA. In order to facilitate documentation of the analysis of potential failures and their consequences, a Process FMEA form has been developed and is in Appendix G. Enter the FMEA document number, which may be used for tracking. Note: For an example of items 1-22 see Table 5.
DEVELOPMENT OF A PROCESS FMEA
37
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2
Item
3 4 7 6 8

e5 rt y
17
12
13
o
15
f
O c c u r
18
Action Results
22
9
14 16 19
MFG Engrg 9X 10 15
F o
20 21 16 rd
8
Requirements
10
11
M o to r
70
Mfg Engrg 9X 10 01
35
38
o y
5 70 None
m p a n In
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49
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PROCESS FMEA
2) 3) 4) 5) 6) Item Process Responsibility Prepared By Model Year(s)/Program(s) Key Date
Enter the name and number of the system, subsystem, or component for which the process is being analyzed. Enter the OEM, department, and group. Also include the supplier name if known. Enter the name, telephone number, and company of the engineer responsible for preparing the FMEA.
Note:
7) 8)
FMEA Date Core Team
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10) Potential Failure Mode
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to
9)
Process Function/ Requirements
Enter a simple description of the process or operation being analyzed (e.g., turning, drilling, tapping, welding, assembling). In addition, it is recommended to record the associated process/operation number for the step being analyzed. The team should review applicable performance, material, process, environmental, and safety standards. Indicate as concisely as possible the purpose of the process or operation being analyzed, including information about the design (metrics/ measurables) of the system, subsystem, or component. Where the process involves numerous operations (e.g., assembling) with different potential modes of failure, it may be desirable to list the operations as separate elements. Potential failure mode is defined as the manner in which the process could potentially fail to meet the process requirements and/or design intent as described in the process function/ requirements column. It is a description of the nonconformance at that specific operation. It can be a cause associated with a potential failure mode in a subsequent (downstream) operation or an effect associated with a potential failure in a previous (upstream) operation. However, in preparing the FMEA, assume that the incoming part(s)/material(s) are correct. Exceptions can be made by the FMEA team where historical data indicate deficiencies in incoming part quality. List each potential failure mode for the particular operation in terms of a component, subsystem, system, or process characteristic. Assume that the failure could occur but may not necessarily occur. The process engineer/team should be able to 39
List the names of the responsible individuals and departments that have the authority to identify and/or perform tasks. (It is recommended that each team member's name, department, telephone number, address, etc., be included on a distribution list.)
Enter the date the original FMEA was compiled and the latest revision date.
In
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In the case of a supplier, the initial FMEA due date should not exceed the customer required Production Part Approval Process (PPAP) submission date.
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Enter the initial FMEA due date, which should not exceed the scheduled start of production date.
U s e
Enter the intended model year(s)/program(s) that will use and/or be affected by the design/process being analyzed (if known).
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P
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2
Item
3 4 7 6 8

e5 rt y
17
12
13
o
15
f
O c c u r
18
Action Results
22
9
14 16 19
MFG Engrg 9X 10 15
F o
20 21 16 rd
8
Requirements
10
11
M o to r
70
Mfg Engrg 9X 10 01
35
40
o y
5 70 None
m p a n In
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PROCESS FMEA
10) Potential Failure Mode (continued)
pose and answer the following questions: How can the process/part fail to meet requirements? Regardless of engineering specifications, what would a customer (end user, subsequent operations, or service) consider objectionable? Start by comparing similar processes and reviewing customer (end user and subsequent operation) claims relating to similar components. In addition, a knowledge of the design intent is necessary. Typical failure modes could be but are not limited to: Bent Burred Hole off-location Cracked Hole too shallow Hole missing Handling damage Dirty Hole too deep Surface too rough Deformed Surface too smooth Open circuited Short circuited Mis-labeled
Describe the effects of the failure in terms of what the customer might notice or experience, remembering that the customer may be an internal customer as well as the ultimate end user. State clearly if the failure mode could impact safety or cause noncompliance to regulations. The customer(s) in this context could be the next operation, subsequent operations or locations, the dealer, and/or the vehicle owner. Each must be considered when assessing the potential effect of a failure. For the end user, the effects should always be stated in terms of product or system performance, such as: Noise Erratic operation Effort Unpleasant odor Operation impaired Intermittent operation Leaks Rework/Repairs Scrap Rough Excessive Inoperative Unstable Draft Poor appearance Vehicle control impaired Customer dissatisfaction
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If the customer is the next operation or subsequent operation(s)/ location(s), the effects should be stated in terms of process/ operation performance, such as: Cannot fasten Cannot bore/tap Cannot mount Cannot face Damages equipment Does not fit Does not connect Does not match Causes excessive tool wear Endangers operator
12) Severity (S)
Severity is the rank associated with the most serious effect for a given failure mode. Severity is a relative ranking within the 41
11) Potential Effect(s) of Failure
Potential effects of failure are defined as the effects of the failure mode on the customer(s).
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NOTE:
Potential failure modes should be described in "physical" or technical terms, not as a symptom noticeable by the customer.
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U s e
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P
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2
Item
3 4 7 6 8

e5 rt y
17
12
13
o
15
f
O c c u r
18
Action Results
22
9
14 16 19
MFG Engrg 9X 10 15
F o
20 21 16 rd
8
Requirements
10
11
M o to r
70
Mfg Engrg 9X 10 01
35
42
o y
5 70 None
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PROCESS FMEA
Table 6. Suggested PFMEA Severity Evaluation Criteria
Criteria: Severity of Effect This ranking results when a potential failure mode results in a final customer and/or a manufacturing/assembly plant defect. The final customer should always be considered first. If both occur, use the higher of the two severities. (Customer Effect) Very high severity ranking when a potential failure mode affects safe vehicle operation and/or involves noncompliance with government regulation without warning. Criteria: Severity of Effect This ranking results when a potential failure mode results in a final customer and/or a manufacturing/assembly plant defect. The final customer should always be considered first. If both occur, use the higher of the two severities. (Manufacturing/ Assembly Effect) Ranking Or may endanger operator (machine or assembly) without warning.
Effect Hazardous without warning
U s e
Very High
Moderate
Minor
ro
Very Low
rt y
Low
Vehicle/Item operable but Comfort/ Convenience item(s) operable at a reduced level of performance. Fit and Finish/Squeak and Rattle item does not conform. Defect noticed by most customers (greater than 75%). Fit and Finish/Squeak and Rattle item does not conform. Defect noticed by 50% of customers. Fit and Finish/Squeak and Rattle item does not conform. Defect noticed by discriminating customers (less than 25%). No discernible effect.
Vehicle/Item operable but Comfort/ Convenience item(s) inoperable. Customer dissatisfied.
rd
to
High
Vehicle/Item operable but at a reduced level of performance. Customer very dissatisfied.
Vehicle/item inoperable (loss of primary function).
Very high severity ranking when a Hazardous with warning potential failure mode affects safe vehicle operation and/or involves noncompliance with government regulation with warning.
Or 100% of product may have to be scrapped, or vehicle/item repaired in repair department with a repair time greater than one hour. Or product may have to be sorted and a portion (less than 100%) scrapped, or vehicle/item repaired in repair department with a repair time between a half-hour and an hour. Or a portion (less than 100%) of the product may have to scrapped with no sorting, or vehicle/item repaired in repair department with a repair time less than a half-hour. Or 100% of product may have to be reworked, or vehicle/item repaired offline but does not go to repair department. Or the product may have to be sorted, with no scrap, and a portion (less than 100%) reworked. Or a portion (less than 100%) of the product may have to be reworked, with no scrap, on-line but out-of-station. Or a portion (less than 100%) of the product may have to be reworked, with no scrap, on-line but in-station. Or slight inconvenience to operation or operator, or no effect.
Or may endanger operator (machine or assembly) with warning.
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Very Minor
None
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10
P
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Item
3 4 7 6 8

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12
13
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15
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O c c u r
18
Action Results
22
9
14 16 19
MFG Engrg 9X 10 15
F o
20 21 16 rd
8
Requirements
10
11
M o to r
70
Mfg Engrg 9X 10 01
35
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5 70 None
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12) Severity (S) (continued)
scope of the individual FMEA. A reduction in severity ranking index can be effected through a design change to system, subsystem or component, or a redesign of the process. If the customer affected by a failure mode is the manufacturing or assembly plant or the product user, assessing the severity may lie outside the immediate process engineers/teams field of experience or knowledge. In these cases, the Design FMEA, design engineer, and/or subsequent manufacturing or assembly plant process engineer, should be consulted. Suggested Evaluation Criteria The team should agree on an evaluation criteria and ranking system, that is consistent, even if modified for individual process analysis. (See Table 6)
13) Classification
14) Potential Cause(s)/ Mechanism(s) of Failure
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Special product or process characteristic symbols and their usage is directed by specific company policy and is not standardized in this document. Potential cause of failure is defined as how the failure could occur, described in terms of something that can be corrected or can be controlled. List, to the extent possible, every failure cause assignable to each potential failure mode. If a cause is exclusive to the failure mode, i.e., if correcting the cause has a direct impact on the failure mode, then this portion of the FMEA thought process is completed. Many causes, however, are not mutually exclusive, and to correct or control the cause, a design of experiments, for example, may be considered to determine which root causes are the major contributors and which can be most easily controlled. The causes should be described so that remedial efforts can be aimed at those causes which are pertinent. Typical failure causes may include, but are not limited to: Improper torque - over, under Improper weld - current, time, pressure Inaccurate gauging Improper heat treat - time, temperature
to
If a classification is identified in the Process FMEA, notify the design responsible engineer since this may affect the engineering documents concerning control item identification.
45
This column may also be used to highlight high priority failure modes for engineering assessment.
This column may be used to classify any special product or process characteristics (e.g., critical, key, major, significant) for components, subsystems, or systems that may require additional process controls.
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NOTE:
It is not recommended to modify criteria for ranking values of 9 and 10. Failure modes with a rank of severity 1 should not be analyzed further.
Severity should be estimated using Table 6 as a guideline:
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Item
3 4 7 6 8

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17
12
13
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15
f
O c c u r
18
Action Results
22
9
14 16 19
MFG Engrg 9X 10 15
F o
20 21 16 rd
8
Requirements
10
11
M o to r
70
Mfg Engrg 9X 10 01
35
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5 70 None
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PROCESS FMEA
14) Potential Cause(s)/ Mechanism(s) of Failure (continued)
Inadequate gating/venting Inadequate or no lubrication Part missing or mislocated Worn locator Worn tool Chip on locator Broken tool Improper machine setup Improper programming
Occurrence is the likelihood that a specific cause/mechanism of failure will occur. The likelihood of occurrence ranking number has a relative meaning rather than an absolute value. Preventing or controlling the causes/mechanisms of failure through a design or process change is the only way a reduction in the occurrence ranking can be effected.
A consistent occurrence ranking system should be used to ensure continuity. The occurrence ranking number is a relative rating within the scope of the FMEA and may not reflect the actual likelihood of occurrence.
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The Possible Failure Rates are based on the number of failures that are anticipated during the process execution. If statistical data are available from a similar process, the data should be used to determine the occurrence ranking. In all other cases, a subjective assessment can be made by using the word descriptions in the left column of the table, along with any historical data available for similar processes. Suggested Evaluation Criteria The team should agree on an evaluation criteria and ranking system that is consistent, even if modified for individual process analysis. (See Table 7) Occurrence should be estimated using Table 7 as a guideline: NOTE: The ranking value of 1 is reserved for failure is Unlikely. Remote:
47
Estimate the likelihood of occurrence of potential failure cause/ mechanism on a 1 to 10 scale.
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15) Occurrence (O)
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Only specific errors or malfunctions (e.g., operator fails to install seal) should be listed; ambiguous phrases (e.g., operator error, machine malfunction) should not be used.
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3 4 7 6 8

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12
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O c c u r
18
Action Results
22
9
14 16 19
MFG Engrg 9X 10 15
F o
20 21 16 rd
8
Requirements
10
11
M o to r
70
Mfg Engrg 9X 10 01
35
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PROCESS FMEA
Table 7. Suggested PFMEA Occurrence Evaluation Criteria
Probability Very High: Persistent Failures Likely Failure Rates* > 100 per thousand pieces 50 per thousand pieces High: Frequent Failures 20 per thousand pieces 10 per thousand pieces Moderate: Occasional Failures 5 per thousand pieces Ranking
O U s e l
1 per thousand pieces Low: Relatively Few Failures
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2 per thousand pieces
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Prevention:
16) Current Process Controls
Current Process Controls are descriptions of the controls that either prevent to the extent possible the failure mode or cause/ mechanism of failure from occurring, or detect the failure mode or cause/mechanism of failure should it occur. These controls can be process controls such as error/mistake proofing, statistical process control (SPC), or can be post-process evaluation. The evaluation may occur at the subject operation or at subsequent operations. There are two types of Process Controls to consider:
Detection:
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The preferred approach is to first use prevention controls, if possible. The initial occurrence rankings will be affected by the prevention controls provided they are integrated as part of the process intent. The initial rankings for detection will be based on process controls that either detect the cause/mechanism of failure, or detect the failure mode. The Process FMEA form in this manual has two columns for the process controls (i.e., separate columns for Prevention Controls and Detection Controls) to 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 twocolumn form is the preferred approach. 49
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*For associated Ppk calculations and values, see Appendix I.
Prevent the cause/mechanism of failure or the failure mode from occurring, or reduce their rate of occurrence, Detect the cause/mechanism of failure or the failure mode, and lead to corrective action(s).
Remote: Failure is Unlikely
< 0.01 per thousand pieces
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Item
3 4 7 6 8

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17
12
13
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15
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O c c u r
18
Action Results
22
9
14 16 19
MFG Engrg 9X 10 15
F o
20 21 16 rd
8
Requirements
10
11
M o to r
70
Mfg Engrg 9X 10 01
35
50
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5 70 None
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PROCESS FMEA
16) Current Process Controls (continued)
If a one-column (for process controls) form is used, then the following prefixes should be used. For prevention controls, place a 'P' before each prevention control listed. For detection controls, place a 'D' before each detection control listed. Once the process controls have been identified, review all prevention controls to determine if any occurrence rankings need to be revised.
Random quality checks are unlikely to detect the existence of an isolated defect and should not influence the detection ranking. Sampling done on a statistical basis is a valid detection control.
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Assume the failure has occurred and then assess the capabilities of all "Current Process Controls" to prevent shipment of the part having this failure mode or defect. Do not automatically presume that the detection ranking is low because the occurrence is low (e.g., when control charts are used), but do assess the ability of the process controls to detect low frequency failure modes or prevent them from going further in the process.
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17) Detection (D)
Detection is the rank associated with the best detection control listed in the process control column. Detection is a relative ranking, within the scope of the individual FMEA. In order to achieve a lower ranking, generally the planned process control has to be improved.
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12
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O c c u r
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Action Results
22
9
14 16 19
MFG Engrg 9X 10 15
F o
20 21 16 rd
8
Requirements
10
11
M o to r
70
Mfg Engrg 9X 10 01
35
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5 70 None
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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.) Detection should be estimated using Table 8 as a guideline.
Detection
Criteria
Almost Impossible Very Remote Remote Very Low Low Moderate
X X
Absolute certainty of nondetection. Controls will probably not detect. Controls have poor chance of detection. Controls have poor chance of detection. Controls may detect. Controls may detect.
X X X X
Cannot detect or is not checked.
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Inspection Types A B C
Suggested Range of Detection Methods
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TABLE 8. Suggested PFMEA Detection Evaluation Criteria
NOTE:
The ranking value of 1 is reserved for Certain to Detect.
Ranking
Control is achieved with indirect or random checks only. Control is achieved with visual inspection only.
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High
Controls have a good chance to detect.
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Moderately Controls have a good High chance to detect.
Very High
Very High
Controls certain to detect.
Controls almost certain to detect.
18) Risk Priority Number (RPN) The risk priority number is the product of the severity (S), occurrence (O), and detection (D) rankings. (S) x (O) x (D) = RPN Within the scope of the individual FMEA, this value (between 1 and 1000) can be used to rank order the concerns in the process.
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Inspection Types: A. Error-proofed B. Gauging C. Manual Inspection
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Control is achieved with double visual inspection only. Control is achieved with charting methods, such as SPC {Statistical Process Control}. Control is based on variable gauging after parts have left the station, or Go/No Go gauging performed on 100% of the parts after parts have left the station. Error detection in subsequent operations, OR gauging performed on setup and first-piece check (for set-up causes only). Error detection in-station, or error detection in subsequent operations by multiple layers of acceptance: supply, select, install, verify. Cannot accept discrepant part. Error detection in-station (automatic gauging with automatic stop feature). Cannot pass discrepant part. Discrepant parts cannot be made because item has been error-proofed by process/product design.
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12
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O c c u r
18
Action Results
22
9
14 16 19
MFG Engrg 9X 10 15
F o
20 21 16 rd
8
Requirements
10
11
M o to r
70
Mfg Engrg 9X 10 01
35
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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, occurrence, and detection. In general practice, when the severity is 9 or 10, special attention must be given to ensure that the risk is addressed through existing design actions/controls or process preventive/corrective action(s), regardless of the RPN. In all cases where the effect of an identified potential failure mode could be a hazard to manufacturing/assembly personnel, preventive/corrective actions should be taken to avoid the failure mode by eliminating or controlling the cause(s), or appropriate operator protection should be specified. After special attention has been given to severity rankings of 9 or 10, the team then addresses other failure modes, with the intent of reducing severity, then occurrence, and then detection.
to
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If engineering assessment leads to no recommended actions for a specific failure mode/cause/control combination, indicate this by entering None in this column.
Only a design and/or process revision can bring about a reduction in the severity ranking. The preferred method to accomplish a reduction in the detection ranking is the use of error/mistake proofing methods. Generally, improving detection controls is costly and ineffective for quality improvements. Increasing the frequency of quality controls inspection is not an effective preventive/corrective action and should only be used as a temporary measure since permanent preventive/corrective action is required. In some cases, a design change to a specific part may be required to assist in the detection. Changes to the current control system may be implemented to increase this probability. Emphasis must, however, be placed on preventing defects (i.e., reducing the occurrence) rather than detecting them. An example would be the use of statistical process control and process improvement rather than random quality checks or associated inspection.
55
To reduce the probability of occurrence, process and/or design revisions are required. An action-oriented study of the process using statistical methods could be implemented with an ongoing feedback of information to the appropriate operations for continuous improvement and defect prevention.
Actions such as, but not limited to, the following should be considered:
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12
13
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O c c u r
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Action Results
22
9
14 16 19
MFG Engrg 9X 10 15
F o
20 21 16 rd
8
Requirements
10
11
M o to r
70
Mfg Engrg 9X 10 01
35
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PROCESS FMEA
20) Responsibility for the Recommended Action(s) 21) Action(s) Taken 22) Action Results
Enter the individual responsible for the recommended action, and the target completion date. After the action has been implemented, enter a brief description of the actual action and effective date. After the preventive/corrective action has been identified, estimate and record the resulting severity, occurrence, and detection rankings. Calculate and record the resulting RPN. If no actions are taken, leave the related ranking columns blank. All revised ratings should be reviewed and if further action is considered necessary, repeat the analysis. The focus should always be on continuous improvement.
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The process-responsible engineer has several means of ensuring that concerns are identified and that recommended actions are implemented. They include, but are not limited to the following:
Ensuring that process/product requirements are achieved, Reviewing engineering drawings, process/product specifications, and process flow, Confirming the incorporation of changes in assembly/ manufacturing documentation and, Reviewing Control Plans and operation instructions.
57
The process-responsible engineer is responsible for ensuring that all actions recommended have been implemented or adequately addressed. The FMEA is a living document and should always reflect the latest design level as well as the latest relevant actions, including those occurring after the start of production.
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APPENDIX A
DESIGN FMEA QUALITY OBJECTIVES
Note: Specific Program Requirements take precedence
1. DESIGN IMPROVEMENTS
The FMEA drives Design Improvements as the primary objective. the FMEA team, with executable Action Plans. All other failure modes are considered.
3. A/D/V OR DVP & R PLANS
4. INTERFACES 5. LESSONS LEARNED
8. TEAM
10. TIME USAGE
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9. DOCUMENTATION
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The right people participate as part of the FMEA team throughout the analysis, and are adequately trained in FMEA methods. As appropriate, a facilitator should be used. The FMEA document is completely filled out "by the book", including "Action Taken" and new RPN values. Time spent by the FMEA team as early as possible is an effective and efficient use of time, with a value-added result. This assumes Recommended Actions are identified as required and the actions are implemented.
7. TIMING
The FMEA is completed during the Window of Opportunity where it could most efficiently impact the product design.
59
6. SPECIAL OR KEY CHARACTERISTICS
The FMEA identifies appropriate Key Characteristics candidates as input to the Key Characteristics selection process, if applicable due to company policy.
The FMEA considers all major lessons learned (such as high warranty, campaigns, etc.) as input to failure mode identification.
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The FMEA scope includes integration and interface failure modes in both block diagram and analysis.
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The Analysis/Development/Validation (A/D/V), and/or Design Verification Plan and Report (DVP&R) considers the failure modes from the FMEA.
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2. HIGH RISK FAILURE MODES The FMEA addresses all high risk Failure Modes, as identified by
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APPENDIX B
PROCESS FMEA QUALITY OBJECTIVES
Note: Specific Program Requirements take precedence.
1. PROCESS IMPROVEMENTS The FMEA drives Process Improvements as the primary

objective, with an emphasis on Error/Mistake Proofing solutions. the FMEA team, with executable Action Plans. All other failure modes are considered.
3. CONTROL PLANS 4. INTEGRATION
The Pre-launch and Production Control Plans consider the failure modes from the Process FMEA. The FMEA is integrated and consistent with the Process Flow Diagram and the Process Control Plan. The Process FMEA considers the Design FMEA, if available as part of its analysis. The FMEA considers all major lessons learned (such as high warranty, campaigns, non-conforming product, customer complaints, etc.) as input to failure mode identification. The FMEA identifies appropriate Key Characteristics candidates as input to the Key Characteristics selection process, if applicable due to company policy. The FMEA is completed during the Window of Opportunity where it could most efficiently impact the design of product or process. The right people participate as part of the FMEA team throughout the analysis, and are adequately trained in FMEA methods. As appropriate, a facilitator should be used. The FMEA document is completely filled out "by the book", including "Action Taken" and new RPN values. Time spent by the FMEA team as early as possible is an effective and efficient use of time, with a value-added result. This assumes Recommended Actions are identified as required and the actions are implemented.
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10. TIME USAGE
9. DOCUMENTATION
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8. TEAM
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7. TIMING
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6. SPECIAL OR KEY CHARACTERISTICS
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5. LESSONS LEARNED
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2. HIGH RISK FAILURE MODES The FMEA addresses all high risk Failure Modes, as identified by
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APPENDIX C
DESIGN FMEA BLOCK DIAGRAM EXAMPLE
FAILURE MODE AND EFFECTS ANALYSIS (FMEA)

BLOCK DIAGRAM/ENVIRONMENTAL EXTREMES
SYSTEM NAME: YEAR VEHICLE PLATFORM: FMEA I.D. NUMBER
OPERATIONAL ENVIRONMENTAL EXTREMES
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SWITCH ON/OFF C
BULB ASSEMBLY D
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HOUSING A
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4 1
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
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PLATE E +
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LETTERS = COMPONENTS NUMBERS = ATTACHING METHODS
= ATTACHED/JOINED
------- = INTERFACING, NOT JOINED
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TEMPERATURE: -20 TO 160 F CORROSIVE: TEST SCHEDULE B SHOCK: 6 FOOT DROP FOREIGN MATERIAL: DUST FLAMMABILITY: (WHAT COMPONENT(S) ARE NEAR HEAT SOURCE(S)? OTHER:
VIBRATION: NOT APPLICABLE HUMIDITY: 0 - 100 % RH
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BATTERIES B
SPRING F -
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COMPONENTS A. HOUSING B. BATTERIES (2 D CELL) C. ON/OFF SWITCH D. BULB ASSEMBLY E. PLATE F. SPRING
ATTACHING METHOD 1. SLIP FIT 2. RIVETS 3. THREAD 4. SNAP FIT 5. COMPRESSIVE FIT
61
O
= NOT INCLUDED IN THIS FMEA
FLASHLIGHT 1994 NEW PRODUCT XXXI10D001
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FMEA Number Page of Prepared By FMEA Date (Orig.) _________ (Rev.)
____ System
P
____ Subsystem
____ Component ___ Design Responsibility _________
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Key Date _________
Model Year(S)/Vehicle(s) _____________________
Core Team ___________________________________________________________________________________________
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Action Results R. P. N. Recommended Action(s) Responsibility & Target Completion Date Actions Taken Current Design Controls - Prevention - Detection D e t e c S O D e c e v c t R. P. N.
Item Potential Effect(s) of Failure
o f F o rd M o to r C o m p a n y In
C S l e a v s s Potential Cause(s)/ Mechanism(s) of Failure O c c u r
Function
APPENDIX D
STANDARD FORM FOR DESIGN FMEA
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FMEA Number Page of Prepared By FMEA Date (Orig.) (Rev.)
System
P p
Design Responsibility
Subsystem
Component
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Key Date
MODEL YEARS(S)/Vehicle(s)
Core Team
rt y o
Action Results R. P. N. Recommended Action(s) Responsibility & Target Completion Date Actions Taken Potential Cause(s)/ Mechanism(s) of Failure
Item
f F o rd M o to r C o m p a n y
Current Design Controls Prevention Current Design Controls Detection O c c u r D e t e c
Function
C S l e a v s s
S O D e c e v c t
R. P. N.
APPENDIX D
STANDARD FORM FOR DESIGN FMEA
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System
P p
Subsystem
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2 4 7 6 8
5 e rt y
12
13
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15
f o
16 19
17
18
Action Results
22
9
14 16 20
F
21
Function
10
11
C S l e a v s s
rd M o to r C o m p
28
28
APPENDIX E
DESIGN FMEA EXAMPLE
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None
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Appendix F System FMEA

To help illustrate the meaning of System, Subsystem, and Component FMEAs, two examples have been constructed below in Figure F1 (for Interfaces and Interactions) and in Figure F2 (for Item, Function, and Failure Modes). EXAMPLE 1: Interfaces and Interactions
Subsystem A
Subsystem B
Subsystem C
Subsystem D
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INTERACTIONS:
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NOTE: Each Subsystem FMEA should have its Interfaces included in its respective Subsystem FMEA. A CHANGE IN ONE SUBSYSTEM MIGHT CAUSE A CHANGE IN ANOTHER SUBSYSTEM. In Figure F1, interactions between subsystems can occur among any of the interfacing systems (e.g., Subsystem A heats up, resulting in Subsystem D and Subsystem B also gaining heat through the respective interfaces, as well as Subsystem A giving off heat to the environment). Interactions might also occur among non-contacting systems via transfer through the environment (e.g., if the environment is composed of high humidity and Subsystems A and C are dissimilar metals separated by a non-metal composing Subsystem B, Subsystems A and C can still have an electrolytic reaction due to the moisture from the environment). Thus, interactions among non-contacting subsystems can be relatively difficult to predict but are important and should be considered.
In Figure F1, interfaces between subsystems are shown where Subsystem A touches (connects with) Subsystem B, B touches C, C touches D, A touches D, and B touches D. The Environment also touches each of the subsystems listed in Figure F1, which requires that the Environmental Interfaces be considered when completing the FMEA.
rd
INTERFACES:
SUBSYSTEMS ARE DIRECTLY CONNECTED VIA INTERFACES.
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The FMEA team is responsible for specifying the scope of its respective FMEAs. The example in Figure F1 shows that the team has specified Subsystems A, B, C, and D along with the surrounding environment as comprising the System that must be considered while completing the System FMEA.
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Figure F1. Interfaces and Interactions
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Environment
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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:
Design Objectives (a statement of design objectives is often helpful)
- etc.....
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- FUNCTION 2 POTENTIAL FAILURE MODE A POTENTIAL FAILURE MODE B etc.....
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- FUNCTION 1 POTENTIAL FAILURE MODE A POTENTIAL FAILURE MODE B etc.....
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SystemP Level Subsystem Level Component Level

Upper Frame
Function: provides structural support Potential Failure Mode(s): structural failure excessive deflection
ro e rt y o f F o rd M
Function: provides pleasing appearance Potential Failure Mode(s): structural failure of seat support excessive deflection of seat support Function: provides stable attachment for seat support
Bicycle
p
Frame
Design Objectives: 1) minimum 3000 hours of riding without need for maintenance and 10,000 hours of riding for design life. 2) accommodates male adults comfortably to the 99.5th percentile 3) ... etc. ...
Function: ease of use Potential Failure Mode(s): finish (shine) deteriorates paint chips
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Function: provides dimensional control for correct finished frame geometry
Potential Failure Mode(s): difficult to steer difficult to pedal
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p a n
Potential Failure Mode(s): length of frame mounting points too long length of frame mounting points too short Function: support frame assembly production methods (welding)
Function: provide reliable transportation
Handle Bar Assembly Front Wheel Assembly Rear Wheel Assembly Sprocket Assembly Seat Assembly Chain Assembly
Potential Failure Mode(s): chain breaks frequently Tires require frequent maintenance
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Potential Failure Mode(s):
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Function: provide comfortable transportation
Lower Front Tube
Potential Failure Mode(s): seating position is not comfortable
Figure F2. Items, Functions, and Failures
ULower Rear Tube s e O Sprocket Tube n ly
P
FMEA Number Page of Prepared By FMEA Date (Orig.) _________ (Rev.)
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Process Responsibility __________ Key Date _________
Item
Model Year(S)/Vehicle(s) ____________________________
Core Team _____________________________________________________________________________________________________________________________________________________________________________
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R. P. N.
Process Function Potential Effect(s) of Failure
o f F
Actions Taken Potential Cause(s)/ Mechanism(s) of Failure Action Results R. P. N. Recommended Action(s) Responsibility & Target Completion Date C S l e a v s s
Requirements
o rd M o to r C o m p a n y In
O c c u r Current Process Controls - Prevention - Detection D e t e c
S O D e c e v c t
APPENDIX G
STANDARD FORM FOR PROCESS FMEA
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P
FMEA Number Page of Prepared By FMEA Date (Orig.) (Rev.)
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Process Responsibility Key Date
Item
Model Years(S)/Vehicle(s)
Core Team
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Action Results R. P. N. Recommended Action(s) Actions Taken Responsibility & Target Completion Date S O D e c e v c t R. P. N. Potential Cause(s)/ Mechanism(s) of Failure
Process Function C S l e a v s s
f F o rd M o to r C o m p a n y
O c c u r Current Process Controls Prevention Current Process Controls Detection D e t e c
Requirements
APPENDIX G
STANDARD FORM FOR PROCESS FMEA
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ro p
2
Item
3 4 7 6 8

e5 rt y
17
12
13
o
15
f
O c c u r
18
Action Results
22
9
14 16 19
MFG Engrg 9X 10 15
F o
20 21 16 rd
8
Requirements
10
11
M o to r
70
Mfg Engrg 9X 10 01
35
APPENDIX H
PROCESS FMEA EXAMPLE
70
o y
5 70 None
m p a n In
te
rn
49
U s e
SAMPLE
ly
APPENDIX I
SUGGESTED PFMEA OCCURRENCE EVALUATION CRITERIA WITH Ppk VALUES
Probability Very High: Persistent Failures Likely Failure Rates* > 100 per thousand pieces 50 per thousand pieces High: Frequent Failures 20 per thousand pieces 10 per thousand pieces Moderate: Occasional Failures 5 per thousand pieces 2 per thousand pieces 1 per thousand pieces Low: Relatively Few Failures 0.5 per thousand pieces Ppk < 0.55 0.55 0.78 0.86 0.94 Ranking
U s e
rn
1.00
1.10 1.20 1.30 1.67
te
In
Sample Calculation to determine Ppk value from a likely failure rate of 5 per thousand pieces. 5 = 1000
Using a "Z" table the associated "Z" value is 2.81 for a tail value of 0.0025.
where: x = Average SL = Specifications 2. Ppk =
ro
3. Replace using Z
Note:
4. Ppk =
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.
min (SL upper - x, x - SL lower) 3s Z 2.81 ~ = = 0.9367 = 0.94 3 3
rt y
1. Z =
SL - x s
rd
0.05 2
= 0.0025 divided by 2 for out-of-specifications high or low.
to
Defect rate =
0.005
71
Sample Calculation
Remote: Failure is Unlikely
< 0.01 per thousand pieces
n
8 7 6 5 4 3 2 1
ly
10
Glossary
Control Plans Design Intent Design Life Design Validation/Verification (DV) Design of Experiments (DOE) Error/Mistake Proofing Feature The control plan provides the process monitoring and control methods that will be used to control characteristics. List of what a given component/subsystem/system is expected to do or not do. The time period (e.g., cycles, time, mileage) for which the design is intended to perform its requirements. A program intended to ensure that the design meets its requirements. Methods that identify factors that affect the mean and variation with minimum testing/experimentation. Each OEM may have its own unique definition for Error/Mistake Proofing. Confer with the OEM for the appropriate definition. A measurable product characteristic (e.g., radius, hardness) or a measurable process characteristic (e.g., insertion force, temperature). A simple tool that can assist problem solving that involves ranking all potential problem areas. The combination of people, machines and equipment, raw materials, methods, and environment that produces a given product or service. A change in processing concept that could alter the capability of the process to meet the design requirements or the durability of the product. A structured method in which customer requirements are translated into appropriate technical requirements for each stage of product development and production. The root cause is the reason for the primary non-conformance and is the item that requires change to achieve permanent preventive/corrective action. A special process characteristic (e.g., critical, key, major, significant) is a process characteristic for which variation must be controlled to some target value to ensure that variation in a process or a special product characteristic is maintained to its target value during manufacturing and assembly. 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. Recall of vehicles for rework or safety inspection.
Quality Function Deployment (QFD)
Special Process Characteristic
Special Product Characteristic
Vehicle Campaign
ro
rt y
Root Cause
rd
to
Process Change
72
Process
Pareto
In
te
rn
U s e
ly
ro
73
In
te
rn
U s e
ly
ro
74
te
rn
U s e
ly
ro
75
In
te
rn
U s e
ly
ro
76
te
rn
U s e
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77
In
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U s e
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U s e
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Potential Failure Mode and Effects Analysis (FMEA) : Reference Manual

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POTENTIAL FAILURE MODE AND EFFECTS ANALYSIS (FMEA)

FOREWORD 1st and 2nd Edition

FOREWORD 3rd Edition

18) 19) 20) 21) 22)

13) 14) 15)

1) 2) 3) 4) 5) 6) 7) 8) 9) 10) 11) 12)

Development of a Design FMEA ............................................................................................................... 10 13 13 13 13 13 13 13 15 15 15 17 17 19 19 19 21 23 23 25 27 27 29 29 31 31

Customer Defined ........................................................................................................................... 9 Team Effort ..................................................................................................................................... 9

Design FMEA .............................................................................................................................................. 7

TABLE OF CONTENTS - continued

Subsystem Potential Effect(s) of Failure

Potential Failure Mode

Potential Cause(s)/ Mechanism(s) of Failure O c c u r D e t e c

What can be done?

What are the Effect(s)? How bad is it?

Figure 1. FMEA Process Sequence

What are the Functions, Features or Requirements?

What can go wrong?

- Partial/Over/ Degraded Function

c. Reviewing Design/Process FMEAs, applications, and Control Plans.

b. Confirming the incorporation of changes to design/assembly/ manufacturing documentation, and,

FAILURE MODE AND EFFECTS ANALYSIS

DESIGN FMEA INTRODUCTION

DEVELOPMENT OF A DESIGN FMEA

FMEA Number 1234 of 1 Page 1

POTENTIAL FAILURE MODE AND EFFECTS ANALYSIS (DESIGN FMEA)

Component 01.03/Body Closures

MODEL YEARS(S)/Vehicle(s) 199X/Lion 4dr/Wagon

Core Team T. Fender-Car Product Dev., Childers-Manufacturing, J. Ford-Assy Ops

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

Potential Failure Mode

Potential Effect(s) of Failure

Front Door L.H. H8HX-0000-A

Corroded interior lower door panels

TABLE 1. DESIGN FMEA

Entrapped air prevents 5 wax from entering corner/edge access

Design aid investigation with non-functioning spray head

Based on test, 3 additional vent holes provided in affected areas

Body Engrg & Assy Ops 8X 09 15

Evaluation showed adequate access

Prepared By Model Year(s)/Program(s) Key Date FMEA Date

System, Subsystem, or Component Name and Number

FMEA Number 1234 of 1 Page 1

POTENTIAL FAILURE MODE AND EFFECTS ANALYSIS (DESIGN FMEA)

Component 01.03/Body Closures

MODEL YEARS(S)/Vehicle(s) 199X/Lion 4dr/Wagon

Core Team T. Fender-Car Product Dev., Childers-Manufacturing, J. Ford-Assy Ops

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

Potential Failure Mode

Potential Effect(s) of Failure

Front Door L.H. H8HX-0000-A

Corroded interior lower door panels

TABLE 1. DESIGN FMEA

Entrapped air prevents 5 wax from entering corner/edge access

Design aid investigation with non-functioning spray head

Based on test, 3 additional vent holes provided in affected areas

Body Engrg & Assy Ops 8X 09 15

Evaluation showed adequate access

10) Potential Failure Mode

FMEA Number 1234 of 1 Page 1

POTENTIAL FAILURE MODE AND EFFECTS ANALYSIS (DESIGN FMEA)

Component 01.03/Body Closures