FME 4th 手册介绍.ppt

FMEA4th手册介绍,WhatisanFMEA?Asystematicgroupofactivitiesintendedto（团队活动）:recognizeandevaluatethepotentialfailureofaproductorprocessandtheeffectsofthatfailure识别潜在失效模式和后果recognizeandprioritizeALLpotentialcausesofeachfailure.Notelinktofishbone所有潜在失效原因assessriskthroughouttheentireprocess(notjustmanufacturing)评估风险identifyactionsthatcouldeliminateorreducethechanceofthepotentialfailureoccurring采取行动消除潜在失效模式bea“living”documentthatshouldalwaysbeupdatedtoreflectcurrentconditions,includingchanges动态文件,FMEAProcessobjectives目标:TheFMEAdrivesproductandprocessimprovements推动改进Addressesallhighriskfailuremodes识别高风险失效模式Usedtodevelopcontrolplans用于形成控制计划Integratedwithprocessflowdiagramandtheprocesscontrolplan结合流程图和控制计划Considersallmajor“lessonslearned”(i.e.,nonconformingproduct,warrantydata,customercomplaints,correctiveactions,etc.)获取经验教训,Improvementsinthe4theditionFMEAManual第4版手册的改进:Changesinformatwithindexfornavigation索引目录的改变Newformexamplesforguidance用于解释的新例子Focusonmanagementinvolvementandsupport管理层支持MorefocusonthelinkageofDFMEAandPFMEA强调了DFMEA和PFMEA的联系Improvedexamplesofrankingtables改进了等级打分表Significantlyenhancedguidanceandexamples增加了例子和解释ReducedemphasisonRPN不再强调RPN值Alternativeapproachesandmethods，suchasFaultTreeanalysis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,Chapter1-IntroductionFMEAPROCESS:“Itsmostvisibleresultisthedocumentationofthecollectiveknowledgeofcross-functionalteams”跨职能小组的集体知识文件化Timeliness-Meanttobea“beforetheevent”action,notan“afterthefact”exercise是“事发前”行为，而不是“后见之明”Canbeappliedtonon-manufacturingareas也可以运用于非制造区域Thereare3basiccasestoapplytheFMEAProcess三种基本情况:Newdesign,technology,orprocess新设计，新技术或新过程Modificationstoexistingdesignorprocess修改现有的设计或过程Useofanexistingdesignorprocessinanewenvironment,location,application,etc.在新的环境、地点、应用等中使用现存的设计或过程,ImpactonOrganizationandManagement对组织和管理的影响:“Musthaveprocessownerandseniormanagementcommitment”过程所有人和最高管理部门的承诺是很重要的“Acomprehensivetrainingprogramshouldbeimplementedincluding综合培训项目的执行包括:ManagementOverview管理的纵览Trainingforusers对使用者培训Suppliertraining供应商培训Facilitatortraining”建导者培训“Ultimately,managementhastheresponsibilityandownershipfordevelopmentandmaintenanceofFMEAs”最终，管理者对FMEA的开发和维护有责任和所有权,FMEAExplained解释:LinkagetoALL5phasesofAPQP同APQP5个阶段紧密联系“TheFMEAanalysisshouldnotbeconsideredasingleevent,butalongtermcommitmenttoensurethatpotentialfailuremodesareevaluatedandactionsaretakentoreducetheirrisk”不是一个单独事件，而是完成产品过程和开发的长期任务，以确保对潜在失效进行了评估，并采取了措施减少风险“ThelanguageusedinFMEAsshouldbeasspecificaspossible(e.g.failuremodesandcauses)”FMEA语言应明确的陈述，简明扼要的术语,Follow-upandContinuousImprovement持续改进:“Theneedfortakingeffectivecorrective/preventiveactions,withappropriatefollo-upcannotbeoveremphasized”采取有效的预防和纠正措施，以及后续行动跟踪是需要的“Teamleadershipisinchargeofensuringthatallrecommendedactionshavebeenimplemented”管理层负责所有建议措施得以实施“TheFMEAisalivingdocumentandshouldalwaysreflectthelatestlevel,aswellasthelatestrelevantactions”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,Chapter2ManagementResponsibility管理职责“ManagementownstheFMEAprocess.Managementhastheultimateresponsibilityofselectingandapplyingresourcesandensuringaneffectiveriskmanagementprocessincludingtiming.”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“Managementresponsibilityalsoincludesprovidingdirectsupporttotheteamthroughongoingreviews,eliminatingroadblocks,andincorporatinglessonslearned.”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,ManagementSupport管理层支持:Mustbelieveintheprocessanditsvalue相信过程和其会产生价值Commitmenttotrainingandcompetenceneeds承诺提供培训Commitmenttoresources承诺提供资源Regularreviewofprocessandresults(managementreview/5.6.2.1)定期回顾过程和结果EnsurethattheFMEAprocessisusedtodriveimprovementsversusjustrecordthem确保FMEA用于过程改进而不只是记录,LinkageofDFMEAandPFMEA:DFMEA和PFMEA联系Page69“DuringthedevelopmentofthePFMEA,theteammayidentifydesignopportunitieswhich,ifimplemented,wouldeithereliminateorreducetheoccurrenceofaprocessfailuremodeSuchinformationmustbeprovidedtotheresponsibledesignengineer.”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,FMEAsareLIVINGdocuments!请记住FMEA是动态文件！Pages64and110“TheDFMEA/PFMEAisalivingdocumentandshouldbereviewedandupdatedwheneverthereisaproductorprocessdesignchangeFMEA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AnotherelementofongoingmaintenanceshouldincludeaperiodicreviewoftherankingswithspecificfocusontheOandDrankingswithparticlularattentiontowherefieldissuesorproductionissueshaveoccurred”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Canwefindevidenceofthishappening，withalinkagetowarranty,fieldandproductionfailuredata?结合已发生的证据，包括三包数据，售后，生产失效件,SignificantlyEnhancedGuidanceandExamples!增加的典型例子和解释,GuidanceandExpectationofimprovedLinkagetoProcessFlowaskeyinput,EnhancedGuidanceonRequirementsandPotentialFailureModes,EnhancedGuidanceonEffectsofFailureModes,ImprovedRankingCriteria:ProvidedasexamplesRecommendedtonotmodifycriteriaforseverity9and10Occurrencescalenowprovidesforlessthan1in100,000(was=1,now=3)SPCremovedfromdetectioncriteria.Nowconsideredasapreventioncontrolpage95Doestheorganizationuserankingcriteriathatbestreflectstheirproductsandprocessesandusestheentireriskscaleof1000?,NewPFMEASeverityCriteria,NewPFMEAOccurrenceCriteria,EnhancedGuidanceforPreventionvs.DetectionControls,OperatorerrorisNEVERanacceptablerootcause!Theprocessallowedtheoperatortomaketheerror!Humanbeingsareonlycapableof3errorsperthousandonarepetitivetask.,NewPFMEADetectionCriteria,Enhancedguidanceonrecommendedactions!建议措施的解释Seepages59-63forexamplesofrecommendedimprovementactionstoreduceoccurrenceanddetectionrankingfor59-63页中描述DFMEA减少频度和探测度的建议改进措施.Seepages105-107forexamplesofrecommendedimprovementactionstoreduceoccurrenceanddetectionrankingforPFMEAs.105-107页对PFMEA中减少频度和探测度的建议改进措施Morefocusonusingstudiesandstatisticalmethodstounderstandthesourcesofvariation.关注统计方法理解过程变差的来源Morefocusonmistakeproofinganderrorproofing.推荐采用防错措施Isthecoreteamcompetentontheseconceptsandisthereevidenceoftheireffectiveuse?核心团队能力能够且有效执行改进措施,RecommendedActions建议措施Shouldfocusonreductionof“O”valuefirst,then“D”.应先降低频度等级然后降低探测度等级Shouldcorrelatewithanycorrectiveorpreventiveactions.采用纠正和预防措施Thereshouldbea“loop”fromtheseprocessesthroughtheFMEAstoensureaccurateRPNsatalltimes.”整个FMEA过程不断循环，保证正确的RPN“High”SeverityitemsrequirespecialattentionregardlessoftheRPN.对严重度高的要特别关注，不管其RPN值大小,AlternativeFormsAppendixB选择的表格:The3rdeditionplacedtoomuchemphasisonthestandardform.The4theditionprovidesforalternativeexamples多种选择.Minimumrequirementsaredefined最起码的要求的定义(pages24,74)3rdeditionformisstillacceptable第三版的表格也可接收Hastheorganizationidentifiedthebestapproachfortheirbusiness组织是否识别对口业务中最有效的方法?DoestheFMEAprocessandformsuseddriveimprovementsversusrecordthemFMEA是否有效推动改进，而不只是记录?,ExampleofPFMEAFormrecommended,SampleReference,StopusinganRPNthresholdfordeterminingactions!不要强调RPN值来决定是否采取改进措施Pages57and103“TheuseofanRPNthresholdisNOTarecommendedpracticefordeterminingtheneedforactions.”,AlternativeRiskAssessments供选择的风险评估:SeeAppendixCforafewexamplesthatmighthelptheteambetterprioritizerecommendedactions附录较多例子解释排列优先等级.SOSeverityxOccurrencefocusesonpreventiveactions关注SxO，强调预防措施SODS=7,O=3,D=5,RPN=105,SOD=735focusesonseverity,thenoccurrence,thendetect