过程失效模式及后果FMEA 中英文

ProcessFailureModeand

EffectsAnalysis

过程失效模式及后果分析(PFMEA)

PFMEA

PFMEA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FMEAananalyticaltoolusedbyaprocessdesignteamtoidentifypotentialproductfailurescausedbyfailureofthemanufacturingandassemblyprocesstomeetrequirements,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FMEAPFMEAisfocussedontheProductPFMEA关注对产品的影响ProcessFMEA

过程FMEAProcessFMEA

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PFMEAisanoutputofthe"ProcessDesignandDevelopment"phaseofAPQPPFMEA是是APQP中中“过程设计计和开发”阶阶段的产物WhendowedoaPFMEA?

何时进进行PFMEA？ItisderivedfromaDFMEA在DFMEA之后进行AnyDFMEAformsandsupportingdocumentsshoudbebroughttothePFMEAmeetingsDFMEA表表单和所有相相关文件都应应带入PFMEAItshouldbeanaturalpartofconceptdevelopment应成为过程设设计的一个必必要组成部分分PFMEAisnever““finished”.itisalivingdocument是动态文件WhendowedoaPFMEA?

何时进进行PFMEA？DoaPFMEA(oratleastreviewtheoldone)if:以下情况需进进行PFMEA(或至少少评审过去的的PFMEA)：theprocessisnew是新的过程theproductisnew,orhasneverbeenmadewiththisprocess新产品，或从从未用本过程程加工的产品品anexistingprocesschanges原有的过程发发生变化customerrequirementsordesireschange顾客要求或希希望发生变化化WhendowedoaPFMEA?

何时进进行PFMEA？DoaPFMEA(oratleastreviewtheoldone)if:以下情况需进进行PFMEA(或至少少评审过去的的PFMEA)：thecompetitive,business,orlegalenvironmentchanges竞争环境、业业务环境或法法律环境发生生变化PPAPconditionsapply需提交PPAPactualfailuresoccur发生实际失失效WhendowedoaPFMEA?

何时时进行PFMFA？？ProcessFMEA过过程FMEA何谓PFMEA何时作PFMEA何人作PFMEA如何作PFMEA16步工作作步骤WhoperformsaPFMEA?

由谁进进行PFMEA？Across-functionalteamshouldbeused由跨部门小小组进行Theleadershouldbetheprocess-responsibleengineer小组组长应应是过程设设计责任工工程师Cross-FunctionalTeam

跨部门门小组5-9peoplefrom，5-9人，，由从事如如下工作的的人员组成成Design，设计计Assembly，，装配manufacturing(operators,supervisors)，制造造(操作作工，班组组长)Industrial,mfg.Andtoolengineering，工业工工程，工艺艺及工装设设计quality，质质量管理materialsengineering，材料工工程Servicepersonnel，机修Supplierofproductandmachinery，零件和和设备供应应商Representativesfromthenextprocess,后后续工序代代表ProcessFMEA过过程FMEA何谓PFMEA何时作PFMEA何人作PFMEA如何作PFMEA16步工作作步骤HowdowedoaPFMEA?ASummary

怎样进进行PFMEA？提提要Assemblethecross-functionalPFMEAteam组建建跨跨部部门门PFMEA小小组组Listthefailuremodes,theireffects,andtheircauses列出出失失效效模模式式，，后后果果以以及及原原因因Assess，，评评估估theseverityoftheeffect(S)后果果的的严严重重程程度度thelikelihoodofthecauses(O)原因因出出现现的的可可能能性性andtheabilityofprocesscontrolstodetectfailuremodesand/ortheircauses(D)过程程控控制制探探测测失失效效模模式式和和/或或原原因因的的能能力力HowdowedoaPFMEA?ASummary怎怎样样进进行行PFMEA？？提提要要Calculatetheriskprioritynumber(RPN)toprioritizecorrectiveactions计算算风风险险顺顺序序数数(RPN)以以确确定定应应优优先先采采取取的的纠纠正正措措施施Plancorrectiveactionsandassignowner制订纠纠正措措施并并落实实责任任人Performcorrectiveactionstoimprovetheproductorprocess,采采取取纠正正措施施以提提高产产品和和过程程质量量RecalculateRPN重新估估算RPNHowdowedoaPFMEA?ASummary怎怎样进进行PFMEA？提提要HowdowedoaPFMEA?ASuggestion怎怎样样进行行PFMEA？？建议议Doyourworkonscratchpaperfirst;astheteamreachesconsensus,recordtheinformationontheFMEAform先在一一张草草稿纸纸上进进行分分析；；当小小组达达成一一致意意见后后，再再将有有关信信息填填在FMEA表表上usefishboneandtreediagramsliberally充分利利用鱼鱼刺图图和树树形图图tryingtousetheFMEAformasaworksheetleadstoconfusionandmessed-upFMEAs若将FMEA表表当做做工作作单使使用，，就会会造成成混乱乱，使使FMEA一塌塌糊涂涂ProcessFMEA过过程FMEA何谓PFMEA何时作PFMEA何人作PFMEA如何作PFMEA16步工作作步骤1.Assembleateamandplanyouractivities

成立小小组并制订订计划PFMEAmustneverbedonebyanindividual,because绝不能由个个人单独进进行PFMEA，因因为：individualeffortsproducebiasedresults,由个人进行行会使结果果出现偏差差anyactionswillrequirebuy-infromvariousgroups进行任何活活动，都需需要从不同同的组织取取得信息Oneperson(e.g.theleader)shouldbeassignedtomaintainingtheFMEAform应指定一个人人(如组长)保管FMEA表格BesuretowritethenamesandfunctionsoftheteammembersontheFMEAform应将小组成员员的姓名和职职责填入FMEA表格1.Assembleateamandplanyouractivities成成立小组并并制订计划2.Developaprocessflowdiagram绘绘制过程流流程图UsetheProcessFlowDiagramformat运用正规的过过程流程图identifiesfabricate,move,storeandinspectoperations辨别四种作业业类型identifiesKeyCharacteristics辨别关键特性性Supplier________________Date_______________PartNumber_____________RevisionLevel______PartDescription__________ Preparedby_________pressuremoldpartfabmovestoreinspstepoper.descr.item#KPCitem#KCCinspectpartforflashstorepartincontainercarrypartstoassyarea1noflash112342.Developaprocessflowdiagram绘绘制过程流流程图过程流程图moldpart注塑零部件fab加工move搬运store存放insp检验step步骤oper.descr.作业说明item#编号KPCitem#编号KCCinspectpartforflash检验零件有无飞边storepartincontainer将零部件放入周转箱内carrypartstoassyarea将零部件送往装配区1noflash无飞边pressure压力112343.Listthefunction(s)of

eachoperation

列出出每个操作的的功能Afunctioniswhattheoperationdoes功能系指该操操作所起的作作用Statethefunctionas，说明功功能为：Verb+Object+Qualifier动词+宾语+修饰词moldpart，零零件成型crimpterminalontocable在线端压接端端子formbendinpart,零件件弯曲成型examples例如Don'tforgetauxiliaryfunctionsaswellaprimaryfunctions基本本功功能能和和辅辅助助功功能能都都要要考考虑虑3.Listthefunction(s)ofeachoperation列列出出每每个个操操作作的的功功能能4.Listthequalityrequirements列列出出质质量量要要求求acustomerwantordesire顾客客的的希希望望或或要要求求couldseriouslyaffectcustomerperception有可可能能严严重重影影响响顾顾客客的的看看法法couldleadtoacustomercomplaint有可可能能导导致致顾顾客客投投诉诉5.Listthepotentialprocessfailuremodes列列出出可可能能的的过过程程失失效效模模式式adefect,flaw,orotherunsatisfactoryconditionintheproductthatoccurswhentheprocessfailstomeettheprocessrequirements由于过过程未未达到到要求求而导导致的的产品品缺陷陷、瑕瑕疵等等不良良状态态failuremodesshouldbewrittenintermsoftheconditionoftheproduct失效模模式体体现在在产品品上TypicalFailureModes，几几种典典型失失效模模式diameteroutofspec.，，直径径超差差missingseal，，漏装装密封封垫cutstrands，切切破线线皮misorientedpart，，部件件方向向错insufficientsolder，焊焊剂不不足toomuchsolder，焊焊剂过过量NFO，未未充满Flash，飞边5.Listthepotentialprocessfailuremodes列列出可能能的过程失失效模式Note，，注Assumethatincomingproductandmaterialsarecorrect假设来料没没问题Assumethattheproductasdesignedwillmeetrequirements假设产品设设计能够满满足客户需需求5.Listthepotentialprocessfailuremodes列列出可能能的过程失失效模式6.Derivethepotentialeffectsofeachfailure列列出出每一失效效模式的所所有可能后后果Theramificationsoffailure后果是失失效模式式的衍生生事件Theeffectcanbeon，，可能影影响theultimatecustomer，，最终用用户orintermediatecustomer(OEM,etc.)，，中间用用户agovernmentregulation，，法规thenextprocessstep，，下序Customercomplaintsareausefulsourceofinformation顾客抱怨怨是非常常有用的的信息来来源6.Derivethepotentialeffectsofeachfailure列列出每一一失效模模式的所所有可能能后果Aneffectcanbe，后果果可能为为completelossoffunction，功能能完全丧丧失degradationofperformanceorquality，质量量或性能能降低damageofprocessequipment，，设备受受损injurytoanoperator，，员工受受伤shut-downofanassemblyline，停停线6.Derivethepotentialeffectsofeachfailure列列出每一一失效模模式的所所有可能能后果Effectsoffailureoftenshowupasachainofevents,fromimmediateeffecttotheultimateeffectonthecustomer，失效效的后果果通常表表现为从从对顾客客的直接接影响到到最终影影响等一一系列连连锁反应应ItisrecommendedthatthesechainsbedevelopedforeachfailuremodeandrecordedontheFMEAform建议针对对每一种种失效模模式找出出这些连连锁反应应，并记记录在FMEA表上useatreediagram运用树形形图6.Derivethepotentialeffectsofeachfailure列列出每一一失效模模式的所所有可能能后果Effectsontheprocess，对过过程的影影响:9-10 mayendangermachineoroperator，可可能能导致设设备或人人员受损损6-8scrap，报废废4-5sortandrework，检检验、返返工2-3reworkon-line，线上上返工1noeffect，，无影响响consideralsotheeffectsonthecustomer还要考虑虑对顾客客的影响响7.Assesstheseverityofeacheffect评评估每每种后果果的严重重度Criteria:SeverityofEffect

Thisrankingresultswhenapotentialfailuremoderesultsinafinalcustomerand/oramanufacturing/assemblyplantdefect.Thefinalcustomershouldalwaysbeconsideredfirst.Ifbothoccur,usethehigherofthetwosev

Hazardous-withoutwarning10Veryhighseverityrankingwhenapotentialfailuremodeaffectssafevehicleoperationand/orinvolvesnoncompliancewithgovernmentregulationwithoutwarning.Ormayendangeroperator(machineorassembly)withoutwarning.

Hazardous-withwarning9Veryhighseverityrankingwhenapotentialfailuremodeaffectssafevehicleoperationand/orinvolvesnoncompliancewithgovernmentregulationwithwarning.Ormayendangeroperator(machineorassembly)withwarning.

VeryHigh8Vehicle/iteminoperable(lossofprimaryfunction).Or100%ofproductmayhavetobescrapped,orvehicle/itemrepairedinrepairdepartmentwitharepairtimegreaterthanonehour.

High7Vehicle/itemoperablebutatareducedlevelofperformance.Customerverydissatisfied.Orproductmayhavetobesortedandaportion(lessthan100%)scrapped,orvehicle/itemrepairedinrepairdepartmentwitharepairtimebetweenahalf-hourandanonehour.

Moderate6Vehicle/itemoperablebutComfort/Convenienceitem(s)inoperable.Customerdissatisfied.Oraportion(lessthan100%)oftheproductmayhavetobescrappedwithnosorting,orvehicle/itemrepairedinrepairdepartmentwitharepairtimelessthanahalf-hour.

Low5Vehicle/itemoperablebutComfort/Convenienceitem(s)operableatreducedlevelofperformance.Or100%ofproductmayhavetobereworked,orvehicle/itemrepairedoff-linebutdoesnotgotorepairdepartment.

VeryLow4Fit&Finish/Squeak&Rattleitemdoesnotconform.Defectnoticedbymostcustomers(greaterthan75%).Ortheproductmayhavetobesorted,withnoscrap,andaportion(lessthan100%)reworked.

Minor3Fit&Finish/Squeak&Rattleitemdoesnotconform.Defectnoticedby50%ofcustomers.Oraportion(lessthan100%)oftheproductmayhavetobereworked,withnoscrap,on-linebutout-of-station.

VeryMinor2Fit&Finish/Squeak&Rattleitemdoesnotconform.Defectnoticedbydiscriminatingcustomers(lessthan25%).Oraportion(lessthan100%)oftheproductmayhavetobereworked,withnoscrap,on-linebutin-station.

None1Nodiscernibleeffect.Orslightincoveniencetooperationoroperator,ornoeffect.8.Determinepotentialcause(s)ofeachfailuremode确确定每每一失效效模式的的可能原原因Acauseoffailureishowthefailurecanoccurintheprocess，失失效原因因：过程程为何会会失效Shouldbewrittenintermsofsomethingintheprocessthatcanbecorrectedandcontrolled，应表述述为可纠正或或可控制制的因素Considerhumanerror,wear-outoftools,ambientconditions,andinteractionsoffactors，如人人的过失，工工装磨损、环环境条件以及及因素间的相相互作用Causesoffailureoftenshowupasachainofevents,fromimmediatecausetorootcause失效通常是由由一连串的原原因造成的，，从直接原因因到根本原因因ItisrecommendedthatthesechainsbedevelopedforeachfailuremodeandrecordedontheFMEAform建议针对每一一种失效模式式，找出原因因链，记入FMEA表useatreeorfishbonediagramtodevelop可利用树形图图或鱼刺图8.Cause(s)ofFailure

失效原原因9.Assessthelikelihoodofoccurrenceofeachcause评评估每种失效效原因产生的的可能性Usehistoricaldata(asabaseline)，，利用历史史资料Takeimprovementsintoaccount，，并考虑所作作的改进Usestatisticalmodelsandcomparisonwithsimilarprocesses利利用可靠性模模型，与类似似的过程进行行比较9-10Failurealmostinevitable，，失效几乎不不可避免7-8 Similarprocessesthathaveoftenfailedin thepast，以前类类似过程常常常失效4-6 Similarprocessesthathaveoccasional failures，类似过过程偶尔失效效1-3 Similarprocessesthathaveexperiencedisolatedfailures，类似过过程仅有过个个别失效9.Assessthelikelihoodofoccurrenceofeachcause评评估每种失效效原因产生的的可能性Occurence(O)ProbabilityLikelyFailureRates*VeryHigh:

PersistentFailures>=100per

thousandpiecesVeryHigh:

PersistentFailures50perthousandpiecesHigh:

FrequentFailures20perthousandpiecesHigh:

FrequentFailures10perthousandpiecesModerate:

OccasionalFailures5perthousandpiecesModerate:

OccasionalFailures2perthousandpiecesModerate:

OccasionalFailures1perthousandpiecesLow:Relatively

FewFailures0.5perthousandpiecesLow:Relatively

FewFailures0.1perthousandpiecesRemote:Failure

isUnlikely<=0.010perthousandpieces10987654321CausesandEffects

HarnessClampCause-and-effectchainradiusoutofspectoolisworntoolnotreplacedlackofmaintenanceprocedureclampcracksatbendbundlefallsoutrattlingnoiseCAUSEchainEFFECTchainCausesandEffects

WiringAssemblyEffectsTreeCrossedWireNofunctionFireinPlantOperatorInjuryDamagedEquip.MustrepairvehicleCausesandEffects

WiringAssemblyCausesTreeCrossedWireBoardErrorOperatorErrorPoorInstruct.NottrainedOperistired10.ListtheCurrentProcessControls

列出现现有过程控制制Processcontrolscatchthedefectbeforetheproductreachesthecustomer，过程程控制当在产产品到达顾客客前发现缺陷陷!TherearethreeTypesofprocesscontrols,过过程控制有有三种类型:(1)preventthecauseoffailure,orreducetherateofoccurrence，防止原原因出现或降降低其出现的的可能性(2)detectthecause(s)offailureandleadtocorrectiveactions，查明失效效的原因并找找出纠正措施施(3)detectthefailuremode(s)，检测失效效模式Assigncurrentlyusedprocesscontrolstofailuremodesandcauses，针针对失效模式式或原因列出出现行的过程程控制手段Usedonsimilarprocessesinthepast，以前类类似过程如何何控制CanbeofanyType:1,2,or3,oranycombination，可以是1、2、3类类或其组合Type1controlsaffectthelikelihoodofoccurrence,ifalreadypartofthedesign，若设计计中已有体现现，则第1类类方法可降低低原因出现的的频度Ifnone,write““None””，若没有有，则填“无无”。10.ListtheCurrentProcessControls

列出现现有过程控制制Detectionisanassessmentoftheprobabilitythat，，探测度为下下列事件发生生的概率atype2controlcandetectthecauseandleadtocorrectiveaction,第2类控制能够够发现原因并并找到纠正措措施atype3controlcandetectafailure，第3类类控制能够在在不良品到达达顾客前发现现缺陷...beforetheproductreachesthecustomer!detectioncanalsoassesshoweffectivelyatype1controlcanpreventfailure，第1类控制能够够预防失效的的有效程度11.Detectingfailure

探测度度11.Detectingfailure

探测度度DetectionRating(D)，，探测度评分分(D)9-10veryremotechancethiscontrolwilldetectthecauseorfailure查明失效或其其原因的可能能性极小7-8remotechance，可能性很小小5-6moderatetolowchance，可能性不大大2-4moderatelytoveryhighchance，可能能性性较较大1almostcertainly(ifthepartpassesthistest,it'sOKtoship)几乎都都可以以查到到(如如能通通过这这项检检测，，则可可放心心发货货)Detection(D)CriteriaInspection

TypesSuggestedRangeofDetectionMethods

ABC

AlmostImpossibleAbsolutecertaintyofnon-detection.

XCannotdetectorisnotchecked.VeryRemoteControlswillprobablynotdetect.

XControlisachievedwithindirectorrandomchecksonly.RemoteControlshavepoorchanceofdetection.

XControlisachievedwithvisualchecksonly.VeryLowControlshavepoorchanceofdetection.

XControlisachievedwithdoublevisualinspectiononly.LowControlsmaydetect.

X

XControlisachievedwithchartingmethods,suchasSPC{StatisticalProcessControl}.ModerateControlsmaydetect.

X

Controlisbasedonvariablegaugingafterpartshaveleftthestation,orGo/NoGogaugingperformedon100%ofthepartsafterpartshaveleftthestation.ModeratelyHigh

Errordetectionisinsubsequentoperations,ORgaugingperformedonsetupandfirst-piececheck(forset-upcausesonly).Controlshaveagoodchancetodetect.XX

High

Errordetectionin-station,orerrordetectioninsubsequentoperationsbymultiplelayersofacceptance:supply,select,install,verify.Cannotacceptdescrepantpart.Controlshaveagoodchancetodetect.XX

VeryHighControlsalmostcertaintodetect.

X

X

Errordetectionin-station(automaticgaugingwithautomaticstopfeature).Cannotpassdiscrepantpart.VeryHighControlscertaintodetect.

X

Discrepantpartscannotbemadebecauseitemhasbeenerror-proofedbyprocess/productdesign.InspectionTypes:A.Error-proofed,B.Gauging,C.ManualInspection12.CalculatetheRiskPriorityNumber(RPN)计算风风险顺顺序数数(RPN)RPN=SxOxD=SeverityofEffectxOccurrenceRatingxDetectionRating