过程失效模式及后果分析(PFMEA)中英文

2024/9/9ProcessFailureModeand

EffectsAnalysis

过程失效模式及后果分析(PFMEA)

PFMEA

PFMEA陶国2024/9/9ProprietaryInformation

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。2024/9/9FormsandFormats

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。2024/9/9ProcessFMEA

过程FMEA何谓PFMEA何时作PFMEA何人作PFMEA如何作PFMEA16步工作步骤2024/9/9ProcessFMEA

过程FMEA何谓PFMEA何时作PFMEA何人作PFMEA如何作PFMEA16步工作步骤2024/9/9ProcessFMEA

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。2024/9/9formalprocess

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FMEA2024/9/9PFMEAisfocussedontheProductPFMEA关注对产品的影响ProcessFMEA

过程FMEA2024/9/9ProcessFMEA

过程FMEA何谓PFMEA何时作PFMEA何人作PFMEA如何作PFMEA16步工作步骤2024/9/9WhendowedoaPFMEA?

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2024/9/9PFMEAisanoutputofthe"ProcessDesignandDevelopment"phaseofAPQP

PFMEA是APQP中“过程设计和开发”阶段的产物WhendowedoaPFMEA?

何时进行PFMEA？2024/9/9ItisderivedfromaDFMEA

在DFMEA之后进行AnyDFMEAformsandsupportingdocumentsshoudbebroughttothePFMEAmeetings DFMEA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？2024/9/9DoaPFMEA(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？2024/9/9DoaPFMEA(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？2024/9/9ProcessFMEA

过程FMEA何谓PFMEA何时作PFMEA何人作PFMEA如何作PFMEA16步工作步骤2024/9/9WhoperformsaPFMEA?

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2024/9/9Cross-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2024/9/9ProcessFMEA

过程FMEA何谓PFMEA何时作PFMEA何人作PFMEA如何作PFMEA16步工作步骤2024/9/9HowdowedoaPFMEA?

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2024/9/9Assess， 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2024/9/9Calculatetheriskprioritynumber(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RPNHowdowedoaPFMEA?

ASummary

怎样进行PFMEA？提要2024/9/9HowdowedoaPFMEA?

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2024/9/9ProcessFMEA

过程FMEA何谓PFMEA何时作PFMEA何人作PFMEA如何作PFMEA16步工作步骤2024/9/91.Assembleateamand

planyouractivities

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2024/9/9Oneperson(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.Assembleateamand

planyouractivities

成立小组并制订计划2024/9/92.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2024/9/9

Supplier________________ Date_______________PartNumber_____________ RevisionLevel______PartDescription__________ Preparedby_________pressuremoldpartfabmovestoreinspstepoper.descr.item#KPCitem#KCCinspectpartforflashstorepartincontainercarrypartstoassyarea1noflash112342.Developaprocessflowdiagram

绘制过程流程图2024/9/9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112342024/9/92024/9/93.Listthefunction(s)of

eachoperation

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2024/9/9Don'tforgetauxiliaryfunctionsaswellaprimaryfunctions

基本功能和辅助功能都要考虑3.Listthefunction(s)of

eachoperation

列出每个操作的功能2024/9/94.Listthequality

requirements

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2024/9/95.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2024/9/9TypicalFailureModes，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2024/9/9Note，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2024/9/96.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2024/9/9Customercomplaintsareausefulsourceofinformation

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2024/9/9Aneffectcanbe，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2024/9/9Effectsoffailureoftenshowupasachainofevents,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2024/9/9Effectsontheprocess，对过程的影响:9-10 mayendangermachineoroperator， 可能导致设备或人员受损6-8 scrap，报废4-5 sortandrework，检验、返工2-3 reworkon-line，线上返工1 noeffect，无影响consideralsotheeffectsonthecustomer还要考虑对顾客的影响7.Assesstheseverity

ofeacheffect

评估每种后果的严重度2024/9/9Criteria: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.2024/9/98.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2024/9/9Causesoffailureoftenshowupasachainofevents,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2024/9/99.Assessthelikelihoodof

occurrenceofeachcause

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2024/9/99-10 Failurealmostinevitable，失效几乎不可避免7-8 Similarprocessesthathaveoftenfailedin thepast，以前类似过程常常失效4-6 Similarprocessesthathaveoccasional failures，类似过程偶尔失效1-3 Similarprocessesthathaveexperienced isolatedfailures，类似过程仅有过个别失效9.Assessthelikelihoodof

occurrenceofeachcause

评估每种失效原因产生的可能性2024/9/9Occurence(O)ProbabilityLikelyFailureRates*

VeryHigh:

PersistentFailures>=100per

thousandpiecesVeryHigh:

PersistentFailures50perthousandpiecesHigh:

FrequentFailures20perthousandpieces

High:

FrequentFailures10perthousandpieces

Moderate:

OccasionalFailures5perthousandpiecesModerate:

OccasionalFailures2perthousandpieces

Moderate:

OccasionalFailures1perthousandpieces

Low:Relatively

FewFailures0.5perthousandpieces

Low:Relatively

FewFailures0.1perthousandpieces

Remote:Failure

isUnlikely<=0.010perthousandpieces109876543212024/9/9CausesandEffects

HarnessClampCause-and-effectchainradiusoutofspectoolisworntoolnotreplacedlackofmaintenanceprocedureclampcracksatbendbundlefallsoutrattlingnoiseCAUSEchainEFFECTchain2024/9/9CausesandEffects

WiringAssemblyEffectsTreeCrossedWireNofunctionFireinPlantOperatorInjuryDamagedEquip.Mustrepairvehicle2024/9/9CausesandEffects

WiringAssemblyCausesTreeCrossedWireBoardErrorOperatorErrorPoorInstruct.NottrainedOperistired2024/9/910.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2024/9/9Assigncurrentlyusedprocesscontrolstofailuremodesandcauses，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2024/9/9Detectionisanassessmentoftheprobabilitythat，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2024/9/911.Detectingfailure

探测度DetectionRating(D)，探测度评分(D) 9-10 veryremotechancethiscontrol willdetectthecauseorfailure

查明失效或其原因的可能性极小

7-8 remotechance

，可能性很小

5-6 moderatetolowchance

，可能性不大

2-4 moderatelytoveryhighchance

，可能 性较大

1 almostcertainly(ifthepartpasses thistest,it'sOKtoship)

几乎都可以查到(如能通过这项检测，则可放 心发货)2024/9/9Detection(D)CriteriaInspection

TypesSuggestedRangeofDetectionMethods

ABC

AlmostImpossibleAbsolutecertaintyofnon-detection.

XCannotdetectorisnotchecked.VeryRemoteControlswillprobablynotdetect.

X

Controlisachievedwithindirectorrandomchecksonly.RemoteControlshavepoorchanceofdetection.

XControlisachievedwithvisualchecksonly.VeryLowControlshavepoorchanceofdetection.

XControlisachievedwithdoublevisualinspectiononly.LowControlsmaydetect.

X

X

Controlisachievedwithchartingmethods,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,