过程失效模式及后果分析(PFMEA)(ppt61)中英文(2).ppt

,ProcessFailureModeandEffectsAnalysis过程失效模式及后果分析(PFMEA)PFMEAPFMEA,陶国,ProprietaryInformation专有信息,YourFMEA(ControlPlan,ProcessCapability,etc.)maybeconsideredproprietaryandshouldnotbesharedwithanyoneoutsidethedivisionwithoutfirstconsultingyourmanagement.FMEA(控制计划、过程能力等)可视为专有信息，在未事先征得管理部门同意之前，不得向部门以外的任何人透露。thisincludesthesharingofinformationwithyourcustomer也不得向顾客透露有关信息。,FormsandFormats形式和格式,Yourcustomermighthaveaspecificformatorformthattheyrequire.Ifso,youwillneedtogettheirwrittenapprovaltouseanalternateformat.顾客可能要求特定的格式或表单。如果是这样，你只有征得他们的书面同意，才能采用其它格式。,ProcessFMEA过程FMEA,何谓PFMEA何时作PFMEA何人作PFMEA如何作PFMEA16步工作步骤,ProcessFMEA过程FMEA,何谓PFMEA何时作PFMEA何人作PFMEA如何作PFMEA16步工作步骤,ProcessFMEA过程FMEA,ananalyticaltoolusedbyaprocessdesignteamtoidentifypotentialproductfailurescausedbyfailureofthemanufacturingandassemblyprocesstomeetrequirements,andidentifycorrectiveactionstobetaken是过程设计小组采用的一种分析方法，用于识别由于制造或装配过程的失效而导致的潜在产品失效模式，并确定所应采取的纠正措施。,formalprocess正式程序customerfocused着眼于顾客usesengineeringjudgment,andharddatawhereitisavailable利用工程经验判断和可靠的数据,ProcessFMEA过程FMEA,PFMEAisfocussedontheProductPFMEA关注对产品的影响,ProcessFMEA过程FMEA,ProcessFMEA过程FMEA,何谓PFMEA何时作PFMEA何人作PFMEA如何作PFMEA16步工作步骤,WhendowedoaPFMEA?何时进行PFMEA？,Whilethereisstilltimetobringaboutchangesintheprocessandintheproduct!当还有时间修改产品及工艺设计时！APFMEAdonesolelytofilloutaformandmeet“requirements”isjustanexercise为了满足QS9000要求而填写PFMEA表格，仅是练习而已,PFMEAisanoutputoftheProcessDesignandDevelopmentphaseofAPQPPFMEA是APQP中“过程设计和开发”阶段的产物,WhendowedoaPFMEA?何时进行PFMEA？,ItisderivedfromaDFMEA在DFMEA之后进行AnyDFMEAformsandsupportingdocumentsshoudbebroughttothePFMEAmeetingsDFMEA表单和所有相关文件都应带入PFMEAItshouldbeanaturalpartofconceptdevelopment应成为过程设计的一个必要组成部分PFMEAisnever“finished”.itisalivingdocument是动态文件,WhendowedoaPFMEA?何时进行PFMEA？,DoaPFMEA(oratleastreviewtheoldone)if:以下情况需进行PFMEA(或至少评审过去的PFMEA)：theprocessisnew是新的过程theproductisnew,orhasneverbeenmadewiththisprocess新产品，或从未用本过程加工的产品anexistingprocesschanges原有的过程发生变化customerrequirementsordesireschange顾客要求或希望发生变化,WhendowedoaPFMEA?何时进行PFMEA？,DoaPFMEA(oratleastreviewtheoldone)if:以下情况需进行PFMEA(或至少评审过去的PFMEA)：thecompetitive,business,orlegalenvironmentchanges竞争环境、业务环境或法律环境发生变化PPAPconditionsapply需提交PPAPactualfailuresoccur发生实际失效,WhendowedoaPFMEA?何时进行PFMFA？,ProcessFMEA过程FMEA,何谓PFMEA何时作PFMEA何人作PFMEA如何作PFMEA16步工作步骤,WhoperformsaPFMEA?由谁进行PFMEA？,Across-functionalteamshouldbeused由跨部门小组进行Theleadershouldbetheprocess-responsibleengineer小组组长应是过程设计责任工程师,Cross-FunctionalTeam跨部门小组,5-9peoplefrom，5-9人，由从事如下工作的人员组成Design，设计Assembly，装配manufacturing(operators,supervisors)，制造(操作工，班组长)Industrial,mfg.Andtoolengineering，工业工程，工艺及工装设计quality，质量管理materialsengineering，材料工程Servicepersonnel，机修Supplierofproductandmachinery，零件和设备供应商Representativesfromthenextprocess,后续工序代表,ProcessFMEA过程FMEA,何谓PFMEA何时作PFMEA何人作PFMEA如何作PFMEA16步工作步骤,HowdowedoaPFMEA?ASummary怎样进行PFMEA？提要,Assemblethecross-functionalPFMEAteam组建跨部门PFMEA小组Listthefailuremodes,theireffects,andtheircauses列出失效模式，后果以及原因,Assess，评估theseverityoftheeffect(S)后果的严重程度thelikelihoodofthecauses(O)原因出现的可能性andtheabilityofprocesscontrolstodetectfailuremodesand/ortheircauses(D)过程控制探测失效模式和/或原因的能力,HowdowedoaPFMEA?ASummary怎样进行PFMEA？提要,Calculatetheriskprioritynumber(RPN)toprioritizecorrectiveactions计算风险顺序数(RPN)以确定应优先采取的纠正措施Plancorrectiveactionsandassignowner制订纠正措施并落实责任人Performcorrectiveactionstoimprovetheproductorprocess,采取纠正措施以提高产品和过程质量RecalculateRPN重新估算RPN,HowdowedoaPFMEA?ASummary怎样进行PFMEA？提要,HowdowedoaPFMEA?ASuggestion怎样进行PFMEA？建议,Doyourworkonscratchpaperfirst;astheteamreachesconsensus,recordtheinformationontheFMEAform先在一张草稿纸上进行分析；当小组达成一致意见后，再将有关信息填在FMEA表上usefishboneandtreediagramsliberally充分利用鱼刺图和树形图tryingtousetheFMEAformasaworksheetleadstoconfusionandmessed-upFMEAs若将FMEA表当做工作单使用，就会造成混乱，使FMEA一塌糊涂,ProcessFMEA过程FMEA,何谓PFMEA何时作PFMEA何人作PFMEA如何作PFMEA16步工作步骤,1.Assembleateamandplanyouractivities成立小组并制订计划,PFMEAmustneverbedonebyanindividual,because绝不能由个人单独进行PFMEA，因为：individualeffortsproducebiasedresults,由个人进行会使结果出现偏差anyactionswillrequirebuy-infromvariousgroups进行任何活动，都需要从不同的组织取得信息,Oneperson(e.g.theleader)shouldbeassignedtomaintainingtheFMEAform应指定一个人(如组长)保管FMEA表格BesuretowritethenamesandfunctionsoftheteammembersontheFMEAform应将小组成员的姓名和职责填入FMEA表格,1.Assembleateamandplanyouractivities成立小组并制订计划,2.Developaprocessflowdiagram绘制过程流程图,UsetheProcessFlowDiagramformat运用正规的过程流程图identifiesfabricate,move,storeandinspectoperations辨别四种作业类型identifiesKeyCharacteristics辨别关键特性,Supplier_Date_PartNumber_RevisionLevel_PartDescription_Preparedby_,pressure,2.Developaprocessflowdiagram绘制过程流程图,过程流程图,3.Listthefunction(s)ofeachoperation列出每个操作的功能,Afunctioniswhattheoperationdoes功能系指该操作所起的作用Statethefunctionas，说明功能为：Verb+Object+Qualifier动词+宾语+修饰词moldpart，零件成型crimpterminalontocable在线端压接端子formbendinpart,零件弯曲成型,examples例如,Dontforgetauxiliaryfunctionsaswellaprimaryfunctions基本功能和辅助功能都要考虑,3.Listthefunction(s)ofeachoperation列出每个操作的功能,4.Listthequalityrequirements列出质量要求,acustomerwantordesire顾客的希望或要求couldseriouslyaffectcustomerperception有可能严重影响顾客的看法couldleadtoacustomercomplaint有可能导致顾客投诉,5.Listthepotentialprocessfailuremodes列出可能的过程失效模式,adefect,flaw,orotherunsatisfactoryconditionintheproductthatoccurswhentheprocessfailstomeettheprocessrequirements由于过程未达到要求而导致的产品缺陷、瑕疵等不良状态failuremodesshouldbewrittenintermsoftheconditionoftheproduct失效模式体现在产品上,TypicalFailureModes，几种典型失效模式diameteroutofspec.，直径超差missingseal，漏装密封垫cutstrands，切破线皮misorientedpart，部件方向错insufficientsolder，焊剂不足toomuchsolder，焊剂过量NFO，未充满Flash，飞边,5.Listthepotentialprocessfailuremodes列出可能的过程失效模式,Note，注Assumethatincomingproductandmaterialsarecorrect假设来料没问题Assumethattheproductasdesignedwillmeetrequirements假设产品设计能够满足客户需求,5.Listthepotentialprocessfailuremodes列出可能的过程失效模式,6.Derivethepotentialeffectsofeachfailure列出每一失效模式的所有可能后果,Theramificationsoffailure后果是失效模式的衍生事件Theeffectcanbeon，可能影响theultimatecustomer，最终用户orintermediatecustomer(OEM,etc.)，中间用户agovernmentregulation，法规thenextprocessstep，下序,Customercomplaintsareausefulsourceofinformation顾客抱怨是非常有用的信息来源,6.Derivethepotentialeffectsofeachfailure列出每一失效模式的所有可能后果,Aneffectcanbe，后果可能为completelossoffunction，功能完全丧失degradationofperformanceorquality，质量或性能降低damageofprocessequipment，设备受损injurytoanoperator，员工受伤shut-downofanassemblyline，停线,6.Derivethepotentialeffectsofeachfailure列出每一失效模式的所有可能后果,Effectsoffailureoftenshowupasachainofevents,fromimmediateeffecttotheultimateeffectonthecustomer，失效的后果通常表现为从对顾客的直接影响到最终影响等一系列连锁反应ItisrecommendedthatthesechainsbedevelopedforeachfailuremodeandrecordedontheFMEAform建议针对每一种失效模式找出这些连锁反应，并记录在FMEA表上useatreediagram运用树形图,6.Derivethepotentialeffectsofeachfailure列出每一失效模式的所有可能后果,Effectsontheprocess，对过程的影响:9-10mayendangermachineoroperator，可能导致设备或人员受损6-8scrap，报废4-5sortandrework，检验、返工2-3reworkon-line，线上返工1noeffect，无影响consideralsotheeffectsonthecustomer还要考虑对顾客的影响,7.Assesstheseverityofeacheffect评估每种后果的严重度,8.Determinepotentialcause(s)ofeachfailuremode确定每一失效模式的可能原因,Acauseoffailureishowthefailurecanoccurintheprocess，失效原因：过程为何会失效Shouldbewrittenintermsofsomethingintheprocessthatcanbecorrectedandcontrolled，应表述为可纠正或可控制的因素Considerhumanerror,wear-outoftools,ambientconditions,andinteractionsoffactors，如人的过失，工装磨损、环境条件以及因素间的相互作用,Causesoffailureoftenshowupasachainofevents,fromimmediatecausetorootcause失效通常是由一连串的原因造成的，从直接原因到根本原因ItisrecommendedthatthesechainsbedevelopedforeachfailuremodeandrecordedontheFMEAform建议针对每一种失效模式，找出原因链，记入FMEA表useatreeorfishbonediagramtodevelop可利用树形图或鱼刺图,8.Cause(s)ofFailure失效原因,9.Assessthelikelihoodofoccurrenceofeachcause评估每种失效原因产生的可能性,Usehistoricaldata(asabaseline)，利用历史资料Takeimprovementsintoaccount，并考虑所作的改进Usestatisticalmodelsandcomparisonwithsimilarprocesses利用可靠性模型，与类似的过程进行比较,9-10Failurealmostinevitable，失效几乎不可避免7-8Similarprocessesthathaveoftenfailedinthepast，以前类似过程常常失效4-6Similarprocessesthathaveoccasionalfailures，类似过程偶尔失效1-3Similarprocessesthathaveexperiencedisolatedfailures，类似过程仅有过个别失效,9.Assessthelikelihoodofoccurrenceofeachcause评估每种失效原因产生的可能性,CausesandEffectsHarnessClamp,Cause-and-effectchain,toolisworn,toolnotreplaced,lackofmaintenanceprocedure,clampcracksatbend,bundlefallsout,rattlingnoise,CAUSEchain,EFFECTchain,CausesandEffectsWiringAssembly,EffectsTree,CrossedWire,Nofunction,FireinPlant,OperatorInjury,DamagedEquip.,Mustrepairvehicle,CausesandEffectsWiringAssembly,CausesTree,CrossedWire,BoardError,OperatorError,PoorInstruct.,Nottrained,Operistired,10.ListtheCurrentProcessControls列出现有过程控制,Processcontrolscatchthedefectbeforetheproductreachesthecustomer，过程控制当在产品到达顾客前发现缺陷!TherearethreeTypesofprocesscontrols,过程控制有三种类型:(1)preventthecauseoffailure,orreducetherateofoccurrence，防止原因出现或降低其出现的可能性(2)detectthecause(s)offailureandleadtocorrectiveactions，查明失效的原因并找出纠正措施(3)detectthefailuremode(s)，检测失效模式,Assigncurrentlyusedprocesscontrolstofailuremodesandcauses，针对失效模式或原因列出现行的过程控制手段Usedonsimilarprocessesinthepast，以前类似过程如何控制CanbeofanyType:1,2,or3,oranycombination，可以是1、2、3类或其组合Type1controlsaffectthelikelihoodofoccurrence,ifalreadypartofthedesign，若设计中已有体现，则第1类方法可降低原因出现的频度Ifnone,write“None”，若没有，则填“无”。,10.ListtheCurrentProcessControls列出现有过程控制,Detectionisanassessmentoftheprobabilitythat，探测度为下列事件发生的概率atype2controlcandetectthecauseandleadtocorrectiveaction,第2类控制能够发现原因并找到纠正措施atype3controlcandetectafailure，第3类控制能够在不良品到达顾客前发现缺陷.beforetheproductreachesthecustomer!detectioncanalsoassesshoweffectivelyatype1controlcanpreventfailure，第1类控制能够预防失效的有效程度,11.Detectingfailure探测度,11.Detectingfailure探测度,DetectionRating(D)，探测度评分(D)9-10veryremotechancethiscontrolwilldetectthecauseorfailure查明失效或其原因的可能性极小7-8remotechance，可能性很小5-6moderatetolowchance，可能性不大2-4moderatelytoveryhighchance，可能性较大1almostcertainly(ifthepartpassesthistest,itsOKtoship)几乎都可以查到(如能通过这项检测，则可放心发货),12.CalculatetheRiskPriorityNumber(RPN)计算风险顺序数(RPN),RPN=SxOxD=SeverityofEffectxOccurrenceRatingxDetectionRating=后果的严重度x原因可能出现的频度x探测度FocusonhighRPNs关注RPN较高的项目,RecommendedCorrectiveAction推荐的纠正措施,AimforPREVENTIONratherthandetection以预防而非探测为目的BeginwiththehighestRPNitems,从RPN高的项目开始dontsetanapriori“cut-off”value(i.e.priortobeginningtheFMEA)，勿预先设定“分数线”Giveseriousattentiontoite