1、FMEA 4th 手册介绍,What is an FMEA? A systematic group of activities intended to（团队活动）: recognize and evaluate the potential failure of a product or process and the effects of that failure识别潜在失效模式和后果 recognize and prioritize ALL potential causes of each failure. Note link to fishbone所有潜在失效原因 assess risk
2、throughout the entire process (not just manufacturing)评估风险 identify actions that could eliminate or reduce the chance of the potential failure occurring采取行动消除潜在失效模式 be a “living” document that should always be updated to reflect current conditions, including changes动态文件,FMEA Process objectives目标: Th
3、e FMEA drives product and process improvements 推动改进 Addresses all high risk failure modes识别高风险失效模式 Used to develop control plans用于形成控制计划 Integrated with process flow diagram and the process control plan结合流程图和控制计划 Considers all major “lessons learned” (i.e., nonconforming product, warranty data, cust
4、omer complaints, corrective actions, etc.)获取经验教训,Improvements in the 4th edition FMEA Manual第4版手册的改进: Changes in format with index for navigation索引目录的改变 New form examples for guidance用于解释的新例子 Focus on management involvement and support 管理层支持 More focus on the linkage of DFMEA and PFMEA强调了DFMEA和PFMEA
5、的联系 Improved examples of ranking tables 改进了等级打分表 Significantly enhanced guidance and examples增加了例子和解释 Reduced emphasis on RPN 不再强调RPN值 Alternative approaches and methods，such as Fault Tree analysis引入了其它对失效原因和后果供选择的分析方法，如故障树,Chapter 1 - Introduction FMEA PROCESS: “Its most visible result is the docum
6、entation of the collective knowledge of cross-functional teams”跨职能小组的集体知识文件化 Timeliness - Meant to be a “before the event” action, not an “after the fact” exercise是“事发前”行为，而不是“后见之明” Can be applied to non-manufacturing areas也可以运用于非制造区域 There are 3 basic cases to apply the FMEA Process三种基本情况: New desi
7、gn, technology, or process新设计，新技术获新过程 Modifications to existing design or process修改现有的设计或过程 Use of an existing design or process in a new environment, location, application, etc.在新的环境、地点、应用等中使用现存的设计或过程,Impact on Organization and Management对组织和管理的影响: “Must have process owner and senior management com
8、mitment”过程所有人和最高管理部门的承诺是很重要的 “A comprehensive training program should be implemented including综合培训项目的执行包括: Management Overview管理的纵览 Training for users对使用者培训 Supplier training供应商培训 Facilitator training”建导者培训 “Ultimately, management has the responsibility and ownership for development and maintenance
9、of FMEAs”最终，管理者对FMEA的开发和维护有责任和所有权,FMEA Explained解释: Linkage to ALL 5 phases of APQP 同APQP 5个阶段紧密联系 “The FMEA analysis should not be considered a single event, but a long term commitment to ensure that potential failure modes are evaluated and actions are taken to reduce their risk”不是一个单独事件，而是完成产品过程和
10、开发的长期任务，以确保对潜在失效进行了评估，并采取了措施减少风险 “The language used in FMEAs should be as specific as possible (e.g. failure modes and causes)”FMEA语言应明确的陈述，简明扼要的术语,Follow-up and Continuous Improvement持续改进: “The need for taking effective corrective / preventive actions, with appropriate follo-up cannot be overemphas
11、ized”采取有效的预防和纠正措施，以及后续行动跟踪是需要的 “Team leadership is in charge of ensuring that all recommended actions have been implemented”管理层负责所有建议措施得以实施 “The FMEA is a living document and should always reflect the latest level, as well as the latest relevant actions” FMEA是动态文件，反馈最新状态，包括开始生产之后发生的措施,Chapter 2 Mana
12、gement Responsibility管理职责 “Management owns the FMEA process. Management has the ultimate responsibility of selecting and applying resources and ensuring an effective risk management process including timing.”管理者拥有FMEA过程，管理者对选择和应用资源，并保证一个包括时间安排得有效的风险管理过程的最大责任 “Management responsibility also includes
13、providing direct support to the team through ongoing reviews, eliminating roadblocks, and incorporating lessons learned.”管理责任也包括通过持续评审为小组提供直接支持，消除障碍和吸取所学经验,Management Support管理层支持: Must believe in the process and its value相信过程和其会产生价值 Commitment to training and competence needs承诺提供培训 Commitment to re
14、sources承诺提供资源 Regular review of process and results (management review / 5.6.2.1)定期回顾过程和结果 Ensure that the FMEA process is used to drive improvements versus just record them确保FMEA用于过程改进而不只是记录,Linkage of DFMEA and PFMEA:DFMEA和PFMEA联系 Page 69 “During the development of the PFMEA, the team may identify
15、 design opportunities which, if implemented, would either eliminate or reduce the occurrence of a process failure mode Such information must be provided to the responsible design engineer.”在PFMEA 开发过程中，小组可能识别出设计机会，这种设计机会被实施的话，它会消除或降低失效模式发生的频度，这样的信息必须提供给负责的设计工程师,FMEAs are LIVING documents!请记住FMEA 是动态
16、文件！ Pages 64 and 110 “The DFMEA / PFMEA is a living document and should be reviewed and updated whenever there is a product or process design change FMEA是动态文件，只要有产品设计和过程变更，就应该评审和更新 Another element of ongoing maintenance should include a periodic review of the rankings with specific focus on the O an
17、d D rankings with particlular attention to where field issues or production issues have occurred”对FMEA中等级进行评审，应放在频度和探测度的等级上，特别是出现售后市场出现问题或生产出现问题 Can we find evidence of this happening， with a linkage to warranty, field and production failure data?结合已发生的证据，包括三包数据，售后，生产失效件,Significantly Enhanced Guida
18、nce and Examples! 增加的典型例子和解释,Guidance and Expectation of improved Linkage to Process Flow as key input,Enhanced Guidance on Requirements and Potential Failure Modes,Enhanced Guidance on Effects of Failure Modes,Improved Ranking Criteria: Provided as examples Recommended to not modify criteria for se
19、verity 9 and 10 Occurrence scale now provides for less than 1 in 100,000 (was =1, now = 3) SPC removed from detection criteria. Now considered as a prevention control page 95 Does the organization use ranking criteria that best reflects their products and processes and uses the entire risk scale of
20、1000?,New PFMEA Severity Criteria,New PFMEA Occurrence Criteria,Enhanced Guidance for Prevention vs. Detection Controls,Operator error is NEVER an acceptable root cause! The process allowed the operator to make the error! Human beings are only capable of 3 errors per thousand on a repetitive task.,N
21、ew PFMEA Detection Criteria,Enhanced guidance on recommended actions!建议措施的解释 See pages 59-63 for examples of recommended improvement actions to reduce occurrence and detection ranking for 59-63页中描述DFMEA减少频度和探测度的建议改进措施. See pages 105-107 for examples of recommended improvement actions to reduce occur
22、rence and detection ranking for PFMEAs.105-107页对PFMEA中减少频度和探测度的建议改进措施 More focus on using studies and statistical methods to understand the sources of variation.关注统计方法理解过程变差的来源 More focus on mistake proofing and error proofing.推荐采用防错措施 Is the core team competent on these concepts and is there eviden
23、ce of their effective use?核心团队能力能够且有效执行改进措施,Recommended Actions 建议措施 Should focus on reduction of “O” value first, then “D”.应先降低频度等级然后降低探测度等级 Should correlate with any corrective or preventive actions. 采用纠正和预防措施 There should be a “loop” from these processes through the FMEAs to ensure accurate RPNs
24、at all times.”整个FMEA过程不断循环，保证正确的RPN“ “High” Severity items require special attention regardless of the RPN.对严重度高的要特别关注，不管其RPN值大小,Alternative Forms Appendix B选择的表格: The 3rd edition placed too much emphasis on the standard form. The 4th edition provides for alternative examples 多种选择. Minimum requireme
25、nts are defined 最起码的要求的定义(pages 24, 74) 3rd edition form is still acceptable第三版的表格也可接收 Has the organization identified the best approach for their business组织是否识别对口业务中最有效的方法? Does the FMEA process and forms used drive improvements versus record themFMEA是否有效推动改进，而不只是记录?,Example of PFMEA Form recommend
26、ed,Sample Reference,Stop using an RPN threshold for determining actions!不要强调RPN值来决定是否采取改进措施 Pages 57 and 103 “The use of an RPN threshold is NOT a recommended practice for determining the need for actions.”,Alternative Risk Assessments供选择的风险评估: See Appendix C for a few examples that might help the t
27、eam better prioritize recommended actions附录较多例子解释排列优先等级. SO Severity x Occurrence focuses on preventive actions 关注 S x O，强调预防措施 SOD S=7, O=3, D=5, RPN=105, SOD = 735 focuses on severity, then occurrence, then detection instead of only the total RPN严重度第一，频度第二，最后探测度来排列优先措施，而不是RPN值 No calculation metho
28、d is recommended over another and all have their limitations and risks. The team should consider many methods to best prioritize their efforts.没有唯一的方法，每一种方法都有它的局限性，由团队讨论和取舍,See how each risk calculation provides different insights that might help the team better prioritize recommended actions?每一种方法提
29、供不同的角度，有助于团队列出应优先采取的措施,Summary 总结 Are efforts made to regularly validate SO&D values and identify improvements? Who is involved?有无定期验证SO&D值并采取措施，哪些人参与了？ Are FMEAs primarily used to drive improvements or record them? FMEA是否首要用来推动改进还是充当记录？ Is FMEA data used to analyze risk and measure improvement?FMEA数据用于分析风险和衡量改进吗？ Does Top Management review and act upon data derived from FMEAs? 管理层定期回顾和基于数据之上采取行动吗？ Does all of the time and effort spent on FMEAs provide a return on investment?为FMEA付出的精力和努力带来了回报吗？,
