SAE J 1739-2009 Potential Failure Mode and Effects Analysis in Design (Design FMEA) Potential Failure Mode and Effects Analysis in Manufacturing and Assembly Processes (Process FME.pdf

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4、Fax: 724-776-0790 Email: CustomerServicesae.org SAE WEB ADDRESS: http:/www.sae.orgSURFACEVEHICLESTANDARDJ1739 JAN2009 Issued 1994-07Revised 2009-01 Superseding J1739 AUG2002 (R) Potential Failure Mode and Effects Analysis in Design (Design FMEA), Potential Failure Mode and Effects Analysis in Manufa

5、cturing andAssembly Processes (Process FMEA) RATIONALEWidespread use of design and process FMEA is a benefit to consumers and manufacturers. The application of FMEA has been in place in the automotive industry since the late 1960s with emphasis on standard ranking criteria and forms since the early

6、1990s. The FMEA methodology has proven itself useful in the prevention and mitigation of potential failure modes. However, a growing need developed for improved failure mode ranking criteria and a change in thinking about the use of the Risk Priority Number (RPN). This standard includes updated rank

7、ing charts and de-emphasizes the use of an RPN threshold as the primary factor in determining preventive or corrective action efforts. It also includes a Boundary Diagram and Process Flow Diagram example as use of these tools has increased. The section for Potential Failure Mode and Effects Analysis

8、 for Machinery (Machinery FMEA) is a form of Design FMEA and has been removed. Machinery FMEA is a type of Design FMEA for equipment. There are numerous books, reference manuals and training references on the subject of FMEA. This standard serves as a common starting point for the development of an

9、effective DFMEA and PFMEA. FOREWORDThe former Recommended Practice for Potential Failure Mode and Effects Analysis in Design (DFMEA) and Potential Failure Mode and Effects Analysis in Manufacturing and Assembly Processes (PFMEA) has been revised and approved as a Standard. As such, it contains requi

10、rements and recommendations for effective use of DFMEA and PFMEA as a potential failure analysis tool. This document was revised by a balanced committee and represents current thoughts and practices on the subject from the viewpoint of OEM (Original Equipment Manufacturers) and their suppliers. 1. S

11、COPE This FMEA Standard describes Potential Failure Mode and Effects Analysis in Design (DFMEA) and Potential Failure Mode and Effects Analysis in Manufacturing and Assembly Processes (PFMEA). It assists users in the identification and mitigation of risk by providing appropriate terms, requirements,

12、 ranking charts, and worksheets. As a Standard, this document contains requirements “must” and recommendations “should” to guide the user through the FMEA process. The FMEA process and documentation must comply with this Standard as well as any corporate policy concerning this Standard. Documented r

13、ationale and agreement with the customer is necessary for deviations in order to justify new work or changed methods during customer or third-party audit reviews. Copyright SAE International Provided by IHS under license with SAENot for ResaleNo reproduction or networking permitted without license f

14、rom IHS-,-,-SAE J1739 Revised JAN2009 Page 2 of 322. REFERENCES 2.1 Related Information The following referenced documents may be useful in connection with the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the refere

15、nced document (including any amendments) applies. 2.1.1 SAE Publication Available from SAE International, 400 Commonwealth Drive, Warrendale, PA 15096-0001, Tel: 877-606-7323 (inside USA and Canada) or 724-776-4970 (outside USA), www.sae.org.ARP5880 Recommended Failure Modes and Effects Analysis (FM

16、EA) Practices for Non-Automobile Applications, Issued July 2001, (Replaces MIL-STD-1629a) 2.1.2 IEC Publication Available from International Electrotechnical Commission, 3, rue de Verambe, P.O. Box 131, 1211 Geneva 20, Switzerland, Tel: +41-22-919-02-11, www.iec.ch.IEC 60812 Analysis Techniques for

17、System Reliability Procedure for Failure Mode and Effects Analysis (FMEA), January 2006 2.1.3 AIAG Publication Available from Automotive Industry Action Group, 26200 Lahser Road, Suite 200, Southfield, MI 48034-7100, Tel: 248-358-3570, www.aiag.org.Potential Failure Mode and Effects Analysis (FMEA)

18、Reference Manual, Chrysler LLC, Ford Motor Company, General Motors Corporation, Fourth Edition, June 2008 3. TERMS AND DEFINITIONSFor the purposes of this document, the following terms and definitions apply. 3.1 Baseline FMEA A baseline FMEA document contains enough similarities when compared to the

19、 new FMEA project, to promote its usefulness as a starting point for that new FMEA project. The baseline FMEA is not program specific and its use is optional. Common names for a baseline FMEA also include Generic, Best Practice, and Gold Standard. 3.2 Block Diagram The Block or Boundary Diagram is a

20、 pictorial tool to facilitate analysis of system interfaces usually used in Design FMEAs. It defines the analysis scope and responsibility and it provides guidelines for structured brainstorming. The scope of analysis is defined by the boundaries of the system; however interfaces with external facto

21、rs/systems are to be addressed. An example of a block diagram can be found in Appendix D. An example of a boundary diagram can be found in Appendix E. Copyright SAE International Provided by IHS under license with SAENot for ResaleNo reproduction or networking permitted without license from IHS-,-,-

22、SAE J1739 Revised JAN2009 Page 3 of 323.3 Control Plan Written descriptions of the system used for controlling parts and processes. It can be component or process specific, or family where multiple parts are produced using the same processing line. The control plan describes the actions that are req

23、uired at each phase of the process including receiving, processing, material handling, and periodic requirements to assure that all process outputs will be in control. The control plan provides the process monitoring and control methods that will be used to control product or process characteristics

24、. Typical types include Prototype, Pre-Launch and Production.3.4 Customer The customer includes all users of the product. Customers are end users (external), manufacturing and assembly operations (internal) and service operations (external). Internal customers can be interim users of the product suc

25、h as the next higher-level assembly or users of the process such as subsequent manufacturing operations.3.5 FMEA Team A team consists of knowledgeable individuals who perform the FMEA analysis. This may include but is not limited to representatives from: Design, Manufacturing, Validation, Suppliers,

26、 Materials, Service, Quality, Reliability and Technical Experts. 3.6 FMEA Worksheet The content of the FMEA worksheet is the output of a Design or Process FMEA. The worksheet provides a structure for conducting risk analysis. An example of a DFMEA worksheet can be found in Appendix F. An example of

27、a PFMEA worksheet can be found in Appendix I. These worksheets can be modified to meet company requirements (e.g. add or move columns, but column headings are standardized and should not change so the logic of the analysis is not lost). 3.7 Hidden Factory A hidden factory is a deviation from the pla

28、nned process flow. A hidden factory occurs when the product is handled other than in accordance with the planned process flow (all operations included in a process flow such as rework/repair, scrap, material movement, etc. are planned). Examples such as ad hoc repairs in a storage facility, hand tor

29、que due to equipment being down for repair, handling of parts that have failed in-process tests, and extra parts at a station may be considered part of a hidden factory. Hidden factory processes may contribute to the realization of failure modes or defects in a manufacturing or assembly process beca

30、use a hidden factory doesnt prevent reject parts from re-entering the line or parts being mixed.3.8 Product Family DFMEA A product family FMEA is a specialized baseline design FMEA that generally contains consistent product boundaries and related functions. These would not typically change from one

31、application to another. Added to this product family FMEA would be the new project specific components and related functions to complete the new product FMEA. 3.9 Process Family PFMEA A process family FMEA is a PFMEA covering a series of operations that produce multiple products or part numbers. Pro

32、cesses producing many similar products do not need unique FMEAs for each product. The family PFMEA is dictated by the manufacturing process that is used to make the product, not by the products functional requirements or application. When the manufacturing process is the same as other parts in the f

33、amily then a family PFMEA is appropriate.Copyright SAE International Provided by IHS under license with SAENot for ResaleNo reproduction or networking permitted without license from IHS-,-,-SAE J1739 Revised JAN2009 Page 4 of 323.10 Process Flow Diagram A process flow diagram is a graphical represen

34、tation of the movement of product or a service as they travel through the processing cycle. A process flow includes the primary process flow as well as secondary operations such as off-line inspection or off-line repair and material movement. It can be macro level listing all operation steps or micr

35、o level detailing each incremental step of work or processing being performed within an operation. A process flow diagram may also include potential sources of variation (some of which may be process characteristics) and necessary product or process requirements. An example of a process flow diagram

36、 can be found in Appendix H. 3.11 Risk Mitigation The primary objective of the FMEA process is to identify potential high risks and try to keep those high risks from occurring in the end product or if that cannot be accomplished, then to minimize the risk effect(s) to the end product user. There are

37、 only three ways (factors) one can mitigate risk: change the design, prevent the risk from occurring or detect it so that a follow up action can take place to eliminate or reduce the risk effect(s).4. OVERVIEW 4.1 Introduction An FMEA can be described as a systematic group of activities intended to:

38、 (a) recognize and evaluate the potential failure of a product/process and the effects and causes of that failure, (b) identify actions that could eliminate or reduce the chance of the potential failure occurring, and (c) document the process. It is complementary to the process of defining what a de

39、sign or process must do to satisfy the customer.The earlier the FMEAs are started during the development phase, the better the chances of optimizing the various activities/designs/processes in a cost and time effective manner. One of the most important factors for the successful implementation of an

40、 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 should be done before a product or process failure mode has been incorporated into a product or process. Up front time spent properly completing an FM

41、EA, 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. There are three basic cases for which FMEAs are gen

42、erated, each with a different scope or focus: Case 1: New designs, new technology, or new process. The scope of the FMEA is the complete design, technology, or process.Case 2: Modifications to existing design or process (assumes there is an FMEA for the existing design or process). The scope of the

43、revision efforts should focus on the modification to design or process, possible interactions due to the modification, and field performance. Modifications include removal or addition of new parts or processing operations. Modifications also include changes to existing product or process functionsCa

44、se 3: Use of 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 revision is the impact of the new environment or location on the existing design or process.Although responsibility for the preparati

45、on of the FMEA is usually assigned to an individual, FMEA input should be a team effort. A team of knowledgeable individuals should be consulted (e.g., engineers with expertise in design, analysis/testing, manufacturing, assembly, service, recycling, quality, and reliability). The FMEA should be a c

46、atalyst to stimulate the interchange of ideas between the functions affected and thus promote a team approach. It is not appropriate to compare the ratings of one teams FMEA with the ratings of another teams FMEA, even if the product/process appear to be identical, since each teams environment is un

47、ique and thus their respective individual ratings will be unique (i.e., the ratings are subjective).Copyright SAE International Provided by IHS under license with SAENot for ResaleNo reproduction or networking permitted without license from IHS-,-,-SAE J1739 Revised JAN2009 Page 5 of 324.2 Purpose a

48、nd Objectives The intended purpose of the Design and Process FMEA is to support the processes used to design, manufacture, or assemble a product. The objectives can best be met by considering the following: a. Risk identification b. Risk prioritization c. Risk mitigation The fundamental value of the

49、 FMEA process is to identify potential risks, rank those risks, and then mitigate as many of those risks over time as possible. There are at least three key categories of risks discussed during the FMEA process including design risks (i.e., requirements and specification errors, engineering calculation error or material