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1VisionTechnologyInternationalLimitedJan1,2003Rev11過程失效模式及效應分析ProcessFailureModeEffectAnalysis(PFMEA)VisionTechnologyInternationalLimitedJan1,2003Rev12什么是FMEA!asystematicgroupofactivitiesintendedto:!FMEA可以描述为一组系统化的活动，其目的是：!recognizeandevaluatethepotentialfailureofaproduct/processandtheeffectsofthatfailure,!认可并评价产品/过程中的潜在失效以及该失效的后果；!identifyactionsthatcouldeliminateorreducethechangeofthepotentialfailureoccurring,and!确定能够消除或减少潜在失效发生机会的措施；!documenttheentireprocess!将全部过程形成文件2VisionTechnologyInternationalLimitedJan1,2003Rev13什么是FMEA!acomplementarytotheprocessofdefiningwhatadesignorprocessmustdotosatisfythecustomer,!FMEA是对确定设计或过程必须做哪些事情才能使顾客满意这一过程的补充；!focusonthedesign,whetheritbeofproductorprocess.!所有FMEA都关注设计，无论是产品设计或者是过程设计。VisionTechnologyInternationalLimitedJan1,2003Rev14FMEA的益处Benefit!Improveproductquality,reliabilityandsafety!改进企业产品质量、可靠性与安全性!Improvecorporationcompetence!改进企业公司的形象与竞争力!Helptoenhancecustomersatisfaction!帮助增加客户的满意程度!Reduceproductdevelopmenttimeandcost!降低产品开发时间与成本!documentactionstominimizeriskandpotentialfailure!书面规定所采取的措施以减少风险与潜在失效3VisionTechnologyInternationalLimitedJan1,2003Rev15FMEA的时间性Timing!Before-the-eventactionnotanafter-the-factexercise!“事件发生前”的措施，而非“事实发生后”的演练!mustbedonebeforeaproductorprocessfailuremodehasbeenincorporatedintoaproductorprocess!FMEA必须在产品或过程失效模式被纳入到产品或过程之前进行；!Up-fronttimespentproperlycompletinganFMEA,whenproduct/processchangescanbemosteasilyandinexpensivelyimplemented,willminimizelatechangecrises!事前的分析能最容易、低成本地对产品或过程进行更改，从而最低程度地降低后期更改的危机VisionTechnologyInternationalLimitedJan1,2003Rev16时间Customercomplaint客户投诉Manufacturing&Assembly制造及装配DesignApproval设计核准FMEAProductplanning产品策划Design设计Manufacturing制造Application应用预防寻找方法及解决问题成本1000100101各阶段纠正问题的成本COPQatdifferentstages4VisionTechnologyInternationalLimitedJan1,2003Rev17FMEA的逻辑顺序ProcessSequenceRPN難檢度D發生度O嚴重度S執行措施負責人及日期建議措施難撿度現行過程控制失效原因等級潛在失效效應潛在失效模式執行結果風險優先數RPN發生度嚴重度過程功能／要求910111213141516171819202122功能、特性或要求是什么？会有什么问题？无功能；部分功能/功能过强/功能降级；功能间歇；非预期功能后果是什么？有多糟糕？起因是什么？发生的频度如何？怎样能得到预防与探测？该方法在探测时有多好？能做些什么？设计更改；过程变更；特殊控制；标准、程序或指南的变更VisionTechnologyInternationalLimitedJan1,2003Rev18FMEA的逻辑顺序ProcessSequenceRPNDetOccSevActiontakenResponsibilityandtargetcompletiondateRecommendedactionsDetectCurrentcontrolsPotentialcauses/MechanismoffailureClassPotentialeffectsoffailurePotentialfailuremodeActionresultsRPNOccurSevProcessfunction/Requirement910111213141516171819202122Whatarethefunctions,featuresorrequirements?Whatcangowrong?nofunction;partial/over/degradedfunction;intermittentfunction;unintendedfunctionWhataretheeffects?Howbadisit?Whatarethecauses?Howoftendoesithappen?Howcanthisbepreventedanddetected?Howgoodisthismethodatdetectingit?Whatcanbedone?Design/Processchanges;Specialcontrols;Changestostandards/procedures/guides5VisionTechnologyInternationalLimitedJan1,2003Rev193basiccases实施FMEA的三种情形!Case1:newdesigns,newtechnology,ornewprocess!情形1：新设计、新技术或新过程。FMEA的范围是全部设计、技术或过程；!Case2:modificationstoexistingdesignorprocess!情形2：对现有设计或过程的修改。FMEA的范围应集中于对设计或过程的修改、由于修改可能产生的相互影响以及现场的历史情况；!Case3:Useofanexistingdesignorprocessinanewenvironment,location,orapplication!情形3：将现有的设计或过程用于新的环境、场所或应用。FMEA的范围是新环境或场所对现有设计或过程的影响。VisionTechnologyInternationalLimitedJan1,2003Rev110誰編制FMEA？!FMEAinputshouldbeateameffort!FMEA的编制责任通常都指派到某个人，但是FMEA的输入应是工作小組的努力!Ateamofknowledgeableindividualsshouldbeassembled,e.g.,engineerswithexpertiseindesign,analysis/testing,manufacturing,assembly,service,recycling,qualityandreliability!小组应由知识丰富的人员组成，例如设计、分析/试验、制造、装配、装配、服务、回收、质量及可靠性!initiatedbytheengineerfromtheresponsibleactivity,whichcanbetheoriginalequipmentmanufacturer,asupplier,orasubcontractor!由责任单位工程师启动，负责单位可能是原设备制造厂、供方或分包方6VisionTechnologyInternationalLimitedJan1,2003Rev111FMEA的跟踪!Theresponsibleengineerisinchargeofensuringthatallrecommendedactionshavebeenimplementedoradequatelyaddressed!责任工程师负责确保所有的建议措施都得到实施或充分的强调；!actionsshouldbecommunicatedtoallaffectedactivities!措施应传递到所有受影响的部门；VisionTechnologyInternationalLimitedJan1,2003Rev112FMEA的跟踪!Athoroughlythought-outandwell-developedFMEAwillbeoflimitedvaluewithoutpositiveandeffectivepreventive/correctiveactions!一个经过彻底思考、周密开发的FMEA，如果没有积极有效的预防/纠正措施，其价值将是非常有限的；!Reviewingdesigns,processes,anddrawings,toensurethatrecommendedactionshavebeenimplemented!对设计、过程及图样进行评审，以确保建议的措施得到实施；!Confirmingtheincorporationofchangestodesign/assembly/manufacturingdocumentation,and,!确认更改已纳入到设计/装配/制造文件中；!Reviewingdesign/processFMEAs,specialFMEAapplications,andControlPlans!对设计/过程FMEA、FMEA的特殊应用以及控制计划进行评审7VisionTechnologyInternationalLimitedJan1,2003Rev113!FMEAisalivingdocumentandshouldalwaysreflectthelatestlevel,aswellasthelatestrelevantactions,includingthoseoccurringafterthestartofproduction!FMEA是一份动态文件,始终反映最新水平以及最近的相关措施，包括生产以后发生的。!Updateconditions更新条件!Wheneverproductdesign,application,environment,materialormanufacturing/assemblychange!凡产品设计、应用、环境、材料或产品的制造/装配过程有更改时何時更新FMEA？VisionTechnologyInternationalLimitedJan1,2003Rev114PFMEA制造及装配过程潜在失效模式及后果分析8VisionTechnologyInternationalLimitedJan1,2003Rev115!AprocesspotentialFMEAisananalyticaltechniqueusedbyamanufacturing/assembly-