过程失效模式及后果分析中英文2

ProcessFailureModeand

EffectsAnalysis

过程失效模式及后果分析(PFMEA)

PFMEA

PFMEA陶国ProprietaryInformation专专有信息息YourFMEA((ControlPlan,ProcessCapability,etc..)maybeconsideredproprietaryandshouldnotbesharedwithanyoneoutsidethedivisionwithoutfirstconsultingyourmanagement.FMEA(控控制计划划、过程程能力等等)可可视为专专有信息息，在未未事先征征得管管理部门门同意之之前，不不得向部部门以外外的任何何人透露露。thisincludesthesharingofinformationwithyourcustomer也不得向向顾客透透露有关关信息。。FormsandFormats形形式和格格式Yourcustomermighthaveaspecificformatorformthattheyrequire.Ifso,youwillneedtogettheirwrittenapprovaltouseanalternateformat.顾客可能能要求特特定的格格式或表表单。如如果是这这样，你你只有征征得他们们的书面面同意，，才能采采用其它它格式。。ProcessFMEA过过程FMEA何谓PFMEA何时作PFMEA何人作PFMEA如何作PFMEA16步工工作步骤骤ProcessFMEA过过程FMEA何谓PFMEA何时作PFMEA何人作PFMEA如何作PFMEA16步工工作步骤骤ProcessFMEA过过程FMEAananalyticaltoolusedbyaprocessdesignteamtoidentifypotentialproductfailurescausedbyfailureofthemanufacturingandassemblyprocesstomeetrequirements,,andidentifycorrectiveactionstobetaken是过程设设计小组组采用的的一种分分析方法法，用于于识别由由于制造造或装配配过程的的失效而而导致的的潜在产产品失效效模式，，并确定定所应采采取的纠纠正措施施。formalprocess正式程序序customerfocused着眼于顾顾客usesengineeringjudgment,andharddatawhereitisavailable利用工程程经验判判断和可可靠的数数据ProcessFMEA过过程FMEAPFMEAisfocussedontheProductPFMEA关关注对产品的影响ProcessFMEA过过程FMEAProcessFMEA过过程FMEA何谓PFMEA何时作PFMEA何人作PFMEA如何作PFMEA16步工工作步骤骤WhendowedoaPFMEA??

何时时进行PFMEA？Whilethereisstilltimetobringaboutchangesintheprocessandintheproduct!当还有时时间修改改产品及及工艺设设计时！！APFMEAdonesolelytofilloutaformandmeet““requirements”isjustanexercise为了满足足QS9000要求而而填写PFMEA表格格，仅是是练习而而已PFMEAisanoutputofthe"ProcessDesignandDevelopment""phaseofAPQP

PFMEA是APQP中“过过程设计计和开发发”阶段段的产物物WhendowedoaPFMEA??

何时时进行PFMEA？ItisderivedfromaDFMEA在DFMEA之之后进行行AnyDFMEAformsandsupportingdocumentsshoudbebroughttothePFMEAmeetingsDFMEA表单单和所有有相关文文件都应应带入PFMEAItshouldbeanaturalpartofconceptdevelopment应成为过过程设计计的一个个必要组组成部分分PFMEAisnever““finished””.itisalivingdocument是动态文文件WhendowedoaPFMEA??

何时时进行PFMEA？DoaPFMEA(oratleastreviewtheoldone))if:以下情况况需进行行PFMEA(或至少评评审过去去的PFMEA)：：theprocessisnew是新的过过程theproductisnew,,orhasneverbeenmadewiththisprocess新产品，，或从未未用本过过程加工工的产品品anexistingprocesschanges原有的过过程发生生变化customerrequirementsordesireschange顾客要求求或希望望发生变变化WhendowedoaPFMEA??

何时时进行PFMEA？DoaPFMEA(oratleastreviewtheoldone))if:以下情况况需进行行PFMEA((或至少少评审过过去的PFMEA)：：thecompetitive,,business,orlegalenvironmentchanges竞争环境境、业务务环境或或法律环环境发生生变化PPAPconditionsapply需提交PPAPactualfailuresoccur发生实际际失效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步工工作步骤骤WhoperformsaPFMEA?由由谁进进行PFMEA？Across-functionalteamshouldbeused由跨部门门小组进进行Theleadershouldbetheprocess-responsibleengineer小组组长长应是过过程设计计责任工工程师Cross-FunctionalTeam跨跨部门门小组5-9peoplefrom，，5-9人，由由从事如如下工作作的人员员组成Design，，设计Assembly，装装配manufacturing(operators,,supervisors)，制制造((操作工工，班组组长)Industrial,mfg..Andtoolengineering，工业业工程，，工艺及及工装设设计quality，质量量管理materialsengineering，，材料工工程Servicepersonnel，机机修Supplierofproductandmachinery，，零件和和设备供供应商Representativesfromthenextprocess,后后续工工序代表表ProcessFMEA过过程FMEA何谓PFMEA何时作PFMEA何人作PFMEA如何作PFMEA16步工工作步骤骤HowdowedoaPFMEA?ASummary怎怎样进进行PFMEA？提要要Assemblethecross--functionalPFMEAteam组建跨部部门PFMEA小组Listthefailuremodes,theireffects,andtheircauses列出失效效模式，，后果以以及原因因Assess，， 评估估theseverityoftheeffect((S)后果的严严重程度度thelikelihoodofthecauses(O)原因出现现的可能能性andtheabilityofprocesscontrolstodetectfailuremodesand//ortheircauses(D)过程控制制探测失失效模式式和/或或原因的的能力HowdowedoaPFMEA?ASummary怎怎样进进行PFMEA？提要要Calculatetheriskprioritynumber(RPN))toprioritizecorrectiveactions计算风险险顺序数数(RPN)以以确定应应优先采采取的纠纠正措施施Plancorrectiveactionsandassignowner制订纠正正措施并并落实责责任人Performcorrectiveactionstoimprovetheproductorprocess,,采采取纠正正措施以以提高产产品和过过程质量量RecalculateRPN重新估算算RPNHowdowedoaPFMEA?ASummary怎怎样进进行PFMEA？提要要HowdowedoaPFMEA?ASuggestion

怎样样进行PFMEA？建建议Doyourworkonscratchpaperfirst;astheteamreachesconsensus,recordtheinformationontheFMEAform先在一张张草稿纸纸上进行行分析；；当小组组达成一一致意见见后，再再将有关关信息填填在FMEA表表上usefishboneandtreediagramsliberally充分利用用鱼刺图图和树形形图tryingtousetheFMEAformasaworksheetleadstoconfusionandmessed--upFMEAs若将FMEA表表当做工工作单使使用，就就会造成成混乱，，使FMEA一一塌糊涂涂ProcessFMEA过过程FMEA何谓PFMEA何时作PFMEA何人作PFMEA如何作PFMEA16步工作步步骤1.Assembleateamandplanyouractivities成成立小小组并制制订计划划PFMEAmustneverbedonebyanindividual,because绝不能由由个人单单独进行行PFMEA，，因为：：individualeffortsproducebiasedresults,由个人进进行会使使结果出出现偏差差anyactionswillrequirebuy-infromvariousgroups进行任何何活动，，都需要要从不同同的组织织取得信信息Oneperson(e.g..theleader))shouldbeassignedtomaintainingtheFMEAform应指定一一个人((如组长长)保管管FMEA表格格BesuretowritethenamesandfunctionsoftheteammembersontheFMEAform应将小组组成员的的姓名和和职责填填入FMEA表表格1.Assembleateamandplanyouractivities成成立小小组并制制订计划划2.Developaprocessflowdiagram绘绘制过程程流程图图UsetheProcessFlowDiagramformat运用正规规的过程程流程图图identifiesfabricate,move,storeandinspectoperations辨别四种种作业类类型identifiesKeyCharacteristics辨别关键键特性

Supplier_____________________Date____________________PartNumber_________________RevisionLevel________PartDescription_____________Preparedby____________pressuremoldpartfabmovestoreinspstepoper.descr.item#KPCitem#KCCinspectpartforflashstorepartincontainercarrypartstoassyarea1noflash112342.Developaprocessflowdiagram绘绘制过程程流程图图过程流程程图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)ofeachoperation

列出出每个操操作的功功能Afunctioniswhattheoperationdoes功能系指指该操作作所起的的作用Statethefunctionas，，说明明功能为为：Verb+Object+Qualifier动词+宾宾语+修修饰词moldpart，，零件成成型crimpterminalontocable在线端压压接端子子formbendinpart,零零件弯弯曲成型型examples例如如Don''tforgetauxiliaryfunctionsaswellaprimaryfunctions基本功能能和辅助助功能都都要考虑虑3.Listthefunction((s)ofeachoperation

列出出每个操操作的功功能4.Listthequalityrequirements

列出出质量要要求acustomerwantordesire顾客的希希望或要要求couldseriouslyaffectcustomerperception有可能严严重影响响顾客的的看法couldleadtoacustomercomplaint有可能导导致顾客客投诉5.Listthepotentialprocessfailuremodes列列出可能能的过程程失效模模式adefect,flaw,orotherunsatisfactoryconditionintheproductthatoccurswhentheprocessfailstomeettheprocessrequirements由于过程程未达到到要求而而导致的的产品缺缺陷、瑕瑕疵等不不良状态态failuremodesshouldbewrittenintermsoftheconditionoftheproduct失效模式式体现在在产品上上TypicalFailureModes，，几种典典型失效效模式diameteroutofspec..，直径径超差missingseal，，漏装密密封垫cutstrands，切切破线皮皮misorientedpart，部件件方向错错insufficientsolder，焊剂剂不足toomuchsolder，，焊剂过过量NFO，，未充满满Flash，飞飞边5.Listthepotentialprocessfailuremodes列列出可能能的过程程失效模模式Note，注Assumethatincomingproductandmaterialsarecorrect假设来料料没问题题Assumethattheproductasdesignedwillmeetrequirements假设产品品设计能能够满足足客户需需求5.Listthepotentialprocessfailuremodes列列出可能能的过程程失效模模式6.Derivethepotentialeffectsofeachfailure列列出每一一失效模模式的所所有可能能后果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，如人人的过失失，工装装磨损、、环境条条件以及及因素间间的相互互作用Causesoffailureoftenshowupasachainofevents,fromimmediatecausetorootcause失效通常常是由一一连串的的原因造造成的，，从直接接原因到到根本原原因ItisrecommendedthatthesechainsbedevelopedforeachfailuremodeandrecordedontheFMEAform建议针对对每一种种失效模模式，找找出原因因链，记记入FMEA表表useatreeorfishbonediagramtodevelop可利用树树形图或或鱼刺图图8.Cause(s)ofFailure

失效效原因9.Assessthelikelihoodofoccurrenceofeachcause评评估每每种失效效原因产产生的可可能性Usehistoricaldata(asabaseline)，，利用历历史资料料Takeimprovementsintoaccount，，并考虑虑所作的的改进

Usestatisticalmodelsandcomparisonwithsimilarprocesses利利用可靠靠性模型型，与类类似的过过程进行行比较9-10 Failurealmostinevitable，，失效几几乎不可可避免7-8Similarprocessesthathaveoftenfailedinthepast，，以前类类似过程程常常失失效4-6Similarprocessesthathaveoccasionalfailures，类似似过程偶偶尔失效效1-3Similarprocessesthathaveexperiencedisolatedfailures，类类似过程程仅有过过个别失失效9.Assessthelikelihoodofoccurrenceofeachcause评评估每每种失效效原因产产生的可可能性Occurence(O)ProbabilityLikelyFailureRates*VeryHigh:

PersistentFailures>=100per

thousandpiecesVeryHigh:

PersistentFailures50perthousandpiecesHigh:

FrequentFailures20perthousandpiecesHigh:

FrequentFailures10perthousandpiecesModerate:

OccasionalFailures5perthousandpiecesModerate:

OccasionalFailures2perthousandpiecesModerate:

OccasionalFailures1perthousandpiecesLow:Relatively

FewFailures0.5perthousandpiecesLow:Relatively

FewFailures0.1perthousandpiecesRemote:Failure

isUnlikely<=0.010perthousandpieces10987654321CausesandEffectsHarnessClampCause-and--effectchainradiusoutofspectoolisworntoolnotreplacedlackofmaintenanceprocedureclampcracksatbendbundlefallsoutrattlingnoiseCAUSEchainEFFECTchainCausesandEffectsWiringAssemblyEffectsTreeCrossedWireNofunctionFireinPlantOperatorInjuryDamagedEquip.MustrepairvehicleCausesandEffectsWiringAssemblyCausesTreeCrossedWireBoardErrorOperatorErrorPoorInstruct.NottrainedOperistired10.ListtheCurrentProcessControls

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

列出出现有过过程控制制Detectionisanassessmentoftheprobabilitythat，探探测度为为下列事事件发生生的概率率atype2controlcandetectthecauseandleadtocorrectiveaction,第第2类控控制能够够发现原原因并找找到纠正正措施atype3controlcandetectafailure，第3类控制制能够在在不良品品到达顾顾客前发发现缺陷陷...beforetheproductreachesthecustomer!!detectioncanalsoassesshoweffectivelyatype1controlcanpreventfailure，，第1类类控制能能够预防防失效的的有效程程度11.Detectingfailure探测度11.Detectingfailure探测度DetectionRating(D)，探探测度评评分(D)9-10veryremotechancethiscontrolwilldetectthecauseorfailure查明失效效或其原原因的可可能性极极小7-8remotechance，可能性性很小5-6moderatetolowchance，可能性性不大2-4moderatelytoveryhighchance，可能性性较较大1almostcertainly(ifthepartpassesthistest,,it'sOKtoship)几乎都可可以查到到(如能能通过这这项检测测，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.ManualInspe