過程失效模式及后果FMEA 中英文

ProcessFailureModeand

EffectsAnalysis

過程失效模式及后果分析(PFMEA)

PFMEA

PFMEA陶國ProprietaryInformation

專有信息YourFMEA(ControlPlan,ProcessCapability,etc.)maybeconsideredproprietaryandshouldnotbesharedwithanyoneoutsidethedivisionwithoutfirstconsultingyourmanagement.FMEA(控制計劃、過程能力等)可視為專有信息，在未事先征得管理部門同意之前，不得向部門以外的任何人透露。thisincludesthesharingofinformationwithyourcustomer 也不得向顧客透露有關信息。FormsandFormats

形式和格式Yourcustomermighthaveaspecificformatorformthattheyrequire.Ifso,youwillneedtogettheirwrittenapprovaltouseanalternateformat.顧客可能要求特定的格式或表單。如果是這樣，你只有征得他們的書面同意，才能采用其它格式。ProcessFMEA

過程FMEA何謂PFMEA何時作PFMEA何人作PFMEA如何作PFMEA16步工作步驟ProcessFMEA

過程FMEA何謂PFMEA何時作PFMEA何人作PFMEA如何作PFMEA16步工作步驟ProcessFMEA

過程FMEAananalyticaltoolusedbyaprocessdesignteamtoidentifypotentialproductfailurescausedbyfailureofthemanufacturingandassemblyprocesstomeetrequirements,andidentifycorrectiveactionstobetaken是過程設計小組采用的一種分析方法，用于識別由于制造或裝配過程的失效而導致的潛在產(chǎn)品失效模式，并確定所應采取的糾正措施。formalprocess 正式程序customerfocused 著眼于顧客usesengineeringjudgment,andharddatawhereitisavailable 利用工程經(jīng)驗判斷和可靠的數(shù)據(jù)ProcessFMEA

過程FMEAPFMEAisfocussedontheProductPFMEA關注對產(chǎn)品的影響ProcessFMEA

過程FMEAProcessFMEA

過程FMEA何謂PFMEA何時作PFMEA何人作PFMEA如何作PFMEA16步工作步驟WhendowedoaPFMEA?

何時進行PFMEA？Whilethereisstilltimetobringaboutchangesintheprocessandintheproduct! 當還有時間修改產(chǎn)品及工藝設計時！APFMEAdonesolelytofilloutaformandmeet“requirements”isjustanexercise 為了滿足QS9000要求而填寫PFMEA表格，僅是練習而已PFMEAisanoutputofthe"ProcessDesignandDevelopment"phaseofAPQPPFMEA是是APQP中中“過程設計計和開發(fā)”階階段的產(chǎn)物WhendowedoaPFMEA?

何時進進行PFMEA？ItisderivedfromaDFMEA在DFMEA之后進行AnyDFMEAformsandsupportingdocumentsshoudbebroughttothePFMEAmeetingsDFMEA表表單和所有相相關文件都應應帶入PFMEAItshouldbeanaturalpartofconceptdevelopment應成為過程設設計的一個必必要組成部分分PFMEAisnever““finished”.itisalivingdocument是動態(tài)文件WhendowedoaPFMEA?

何時進進行PFMEA？DoaPFMEA(oratleastreviewtheoldone)if:以下情況需進進行PFMEA(或至少少評審過去的的PFMEA)：theprocessisnew是新的過程theproductisnew,orhasneverbeenmadewiththisprocess新產(chǎn)品，或從從未用本過程程加工的產(chǎn)品品anexistingprocesschanges原有的過程發(fā)發(fā)生變化customerrequirementsordesireschange顧客要求或希希望發(fā)生變化化WhendowedoaPFMEA?

何時進進行PFMEA？DoaPFMEA(oratleastreviewtheoldone)if:以下情況需進進行PFMEA(或至少少評審過去的的PFMEA)：thecompetitive,business,orlegalenvironmentchanges競爭環(huán)境、業(yè)業(yè)務環(huán)境或法法律環(huán)境發(fā)生生變化PPAPconditionsapply需提交PPAPactualfailuresoccur發(fā)生實際失失效WhendowedoaPFMEA?

何時時進行PFMFA？？ProcessFMEA過過程FMEA何謂PFMEA何時作PFMEA何人作PFMEA如何作PFMEA16步工作作步驟WhoperformsaPFMEA?

由誰進進行PFMEA？Across-functionalteamshouldbeused由跨部門小小組進行Theleadershouldbetheprocess-responsibleengineer小組組長應應是過程設設計責任工工程師Cross-FunctionalTeam

跨部門門小組5-9peoplefrom，5-9人，，由從事如如下工作的的人員組成成Design，設計計Assembly，，裝配manufacturing(operators,supervisors)，制造造(操作作工，班組組長)Industrial,mfg.Andtoolengineering，工業(yè)工工程，工藝藝及工裝設設計quality，質質量管理materialsengineering，材料工工程Servicepersonnel，機修Supplierofproductandmachinery，零件和和設備供應應商Representativesfromthenextprocess,后后續(xù)工序代代表ProcessFMEA過過程FMEA何謂PFMEA何時作PFMEA何人作PFMEA如何作PFMEA16步工作作步驟HowdowedoaPFMEA?ASummary

怎樣進進行PFMEA？提提要Assemblethecross-functionalPFMEAteam組建建跨跨部部門門PFMEA小小組組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，，評評估估theseverityoftheeffect(S)后果果的的嚴嚴重重程程度度thelikelihoodofthecauses(O)原因因出出現(xiàn)現(xiàn)的的可可能能性性andtheabilityofprocesscontrolstodetectfailuremodesand/ortheircauses(D)過程程控控制制探探測測失失效效模模式式和和/或或原原因因的的能能力力HowdowedoaPFMEA?ASummary怎怎樣樣進進行行PFMEA？？提提要要Calculatetheriskprioritynumber(RPN)toprioritizecorrectiveactions計算算風風險險順順序序數(shù)數(shù)(RPN)以以確確定定應應優(yōu)優(yōu)先先采采取取的的糾糾正正措措施施Plancorrectiveactionsandassignowner制訂糾糾正措措施并并落實實責任任人Performcorrectiveactionstoimprovetheproductorprocess,采采取取糾正正措施施以提提高產(chǎn)產(chǎn)品和和過程程質量量RecalculateRPN重新估估算RPNHowdowedoaPFMEA?ASummary怎怎樣進進行PFMEA？提提要HowdowedoaPFMEA?ASuggestion怎怎樣樣進行行PFMEA？？建議議Doyourworkonscratchpaperfirst;astheteamreachesconsensus,recordtheinformationontheFMEAform先在一一張草草稿紙紙上進進行分分析；；當小小組達達成一一致意意見后后，再再將有有關信信息填填在FMEA表表上usefishboneandtreediagramsliberally充分利利用魚魚刺圖圖和樹樹形圖圖tryingtousetheFMEAformasaworksheetleadstoconfusionandmessed-upFMEAs若將FMEA表表當做做工作作單使使用，，就會會造成成混亂亂，使使FMEA一塌塌糊涂涂ProcessFMEA過過程FMEA何謂PFMEA何時作PFMEA何人作PFMEA如何作PFMEA16步工作作步驟1.Assembleateamandplanyouractivities

成立小小組并制訂訂計劃PFMEAmustneverbedonebyanindividual,because絕不能由個個人單獨進進行PFMEA，因因為：individualeffortsproducebiasedresults,由個人進行行會使結果果出現(xiàn)偏差差anyactionswillrequirebuy-infromvariousgroups進行任何活活動，都需需要從不同同的組織取取得信息Oneperson(e.g.theleader)shouldbeassignedtomaintainingtheFMEAform應指定一個人人(如組長)保管FMEA表格BesuretowritethenamesandfunctionsoftheteammembersontheFMEAform應將小組成員員的姓名和職職責填入FMEA表格1.Assembleateamandplanyouractivities成成立小組并并制訂計劃2.Developaprocessflowdiagram繪繪制過程流流程圖UsetheProcessFlowDiagramformat運用正規(guī)的過過程流程圖identifiesfabricate,move,storeandinspectoperations辨別四種作業(yè)業(yè)類型identifiesKeyCharacteristics辨別關鍵特性性Supplier________________Date_______________PartNumber_____________RevisionLevel______PartDescription__________ Preparedby_________pressuremoldpartfabmovestoreinspstepoper.descr.item#KPCitem#KCCinspectpartforflashstorepartincontainercarrypartstoassyarea1noflash112342.Developaprocessflowdiagram繪繪制過程流流程圖過程流程圖moldpart注塑零部件fab加工move搬運store存放insp檢驗step步驟oper.descr.作業(yè)說明item#編號KPCitem#編號KCCinspectpartforflash檢驗零件有無飛邊storepartincontainer將零部件放入周轉箱內carrypartstoassyarea將零部件送往裝配區(qū)1noflash無飛邊pressure壓力112343.Listthefunction(s)of

eachoperation

列出出每個操作的的功能Afunctioniswhattheoperationdoes功能系指該操操作所起的作作用Statethefunctionas，說明功功能為：Verb+Object+Qualifier動詞+賓語+修飾詞moldpart，零零件成型crimpterminalontocable在線端壓接端端子formbendinpart,零件件彎曲成型examples例如Don'tforgetauxiliaryfunctionsaswellaprimaryfunctions基本本功功能能和和輔輔助助功功能能都都要要考考慮慮3.Listthefunction(s)ofeachoperation列列出出每每個個操操作作的的功功能能4.Listthequalityrequirements列列出出質質量量要要求求acustomerwantordesire顧客客的的希希望望或或要要求求couldseriouslyaffectcustomerperception有可可能能嚴嚴重重影影響響顧顧客客的的看看法法couldleadtoacustomercomplaint有可可能能導導致致顧顧客客投投訴訴5.Listthepotentialprocessfailuremodes列列出出可可能能的的過過程程失失效效模模式式adefect,flaw,orotherunsatisfactoryconditionintheproductthatoccurswhentheprocessfailstomeettheprocessrequirements由于過過程未未達到到要求求而導導致的的產(chǎn)品品缺陷陷、瑕瑕疵等等不良良狀態(tài)態(tài)failuremodesshouldbewrittenintermsoftheconditionoftheproduct失效模模式體體現(xiàn)在在產(chǎn)品品上TypicalFailureModes，幾幾種典典型失失效模模式diameteroutofspec.，，直徑徑超差差missingseal，，漏裝裝密封封墊cutstrands，切切破線線皮misorientedpart，，部件件方向向錯insufficientsolder，焊焊劑不不足toomuchsolder，焊焊劑過過量NFO，未未充滿Flash，飛邊5.Listthepotentialprocessfailuremodes列列出可能能的過程失失效模式Note，，注Assumethatincomingproductandmaterialsarecorrect假設來料沒沒問題Assumethattheproductasdesignedwillmeetrequirements假設產(chǎn)品設設計能夠滿滿足客戶需需求5.Listthepotentialprocessfailuremodes列列出可能能的過程失失效模式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，，可能影影響theultimatecustomer，，最終用用戶orintermediatecustomer(OEM,etc.)，，中間用用戶agovernmentregulation，，法規(guī)thenextprocessstep，，下序Customercomplaintsareausefulsourceofinformation顧客抱怨怨是非常常有用的的信息來來源6.Derivethepotentialeffectsofeachfailure列列出每一一失效模模式的所所有可能能后果Aneffectcanbe，后果果可能為為completelossoffunction，功能能完全喪喪失degradationofperformanceorquality，質量量或性能能降低damageofprocessequipment，，設備受受損injurytoanoperator，，員工受受傷shut-downofanassemblyline，停停線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現(xiàn)為從從對顧客客的直接接影響到到最終影影響等一一系列連連鎖反應應ItisrecommendedthatthesechainsbedevelopedforeachfailuremodeandrecordedontheFMEAform建議針對對每一種種失效模模式找出出這些連連鎖反應應，并記記錄在FMEA表上useatreediagram運用樹形形圖6.Derivethepotentialeffectsofeachfailure列列出每一一失效模模式的所所有可能能后果Effectsontheprocess，對過過程的影影響:9-10 mayendangermachineoroperator，可可能能導致設設備或人人員受損損6-8scrap，報廢廢4-5sortandrework，檢檢驗、返返工2-3reworkon-line，線上上返工1noeffect，，無影響響consideralsotheeffectsonthecustomer還要考慮慮對顧客客的影響響7.Assesstheseverityofeacheffect評評估每每種后果果的嚴重重度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確確定每每一失效效模式的的可能原原因Acauseoffailureishowthefailurecanoccurintheprocess，失失效原因因：過程程為何會會失效Shouldbewrittenintermsofsomethingintheprocessthatcanbecorrectedandcontrolled，應表述述為可糾正或或可控制制的因素Considerhumanerror,wear-outoftools,ambientconditions,andinteractionsoffactors，如人人的過失，工工裝磨損、環(huán)環(huán)境條件以及及因素間的相相互作用Causesoffailureoftenshowupasachainofevents,fromimmediatecausetorootcause失效通常是由由一連串的原原因造成的，，從直接原因因到根本原因因ItisrecommendedthatthesechainsbedevelopedforeachfailuremodeandrecordedontheFMEAform建議針對每一一種失效模式式，找出原因因鏈，記入FMEA表useatreeorfishbonediagramtodevelop可利用樹形圖圖或魚刺圖8.Cause(s)ofFailure

失效原原因9.Assessthelikelihoodofoccurrenceofeachcause評評估每種失效效原因產(chǎn)生的的可能性Usehistoricaldata(asabaseline)，，利用歷史史資料Takeimprovementsintoaccount，，并考慮所作作的改進Usestatisticalmodelsandcomparisonwithsimilarprocesses利利用可靠性模模型，與類似似的過程進行行比較9-10Failurealmostinevitable，，失效幾乎不不可避免7-8 Similarprocessesthathaveoftenfailedin thepast，以前類類似過程常常常失效4-6 Similarprocessesthathaveoccasional failures，類似過過程偶爾失效效1-3 Similarprocessesthathaveexperiencedisolatedfailures，類似過過程僅有過個個別失效9.Assessthelikelihoodofoccurrenceofeachcause評評估每種失效效原因產(chǎn)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

列出現(xiàn)現(xiàn)有過程控制制Processcontrolscatchthedefectbeforetheproductreachesthecustomer，過程程控制當在產(chǎn)產(chǎn)品到達顧客客前發(fā)現(xiàn)缺陷陷!TherearethreeTypesofprocesscontrols,過過程控制有有三種類型:(1)preventthecauseoffailure,orreducetherateofoccurrence，防止原原因出現(xiàn)或降降低其出現(xiàn)的的可能性(2)detectthecause(s)offailureandleadtocorrectiveactions，查明失效效的原因并找找出糾正措施施(3)detectthefailuremode(s)，檢測失效效模式Assigncurrentlyusedprocesscontrolstofailuremodesandcauses，針針對失效模式式或原因列出出現(xiàn)行的過程程控制手段Usedonsimilarprocessesinthepast，以前類類似過程如何何控制CanbeofanyType:1,2,or3,oranycombination，可以是1、2、3類類或其組合Type1controlsaffectthelikelihoodofoccurrence,ifalreadypartofthedesign，若設計計中已有體現(xiàn)現(xiàn)，則第1類類方法可降低低原因出現(xiàn)的的頻度Ifnone,write““None””，若沒有有，則填“無無”。10.ListtheCurrentProcessControls

列出現(xiàn)現(xiàn)有過程控制制Detectionisanassessmentoftheprobabilitythat，，探測度為下下列事件發(fā)生生的概率atype2controlcandetectthecauseandleadtocorrectiveaction,第2類控制能夠夠發(fā)現(xiàn)原因并并找到糾正措措施atype3controlcandetectafailure，第3類類控制能夠在在不良品到達達顧客前發(fā)現(xiàn)現(xiàn)缺陷...beforetheproductreachesthecustomer!detectioncanalsoassesshoweffectivelyatype1controlcanpreventfailure，第1類控制能夠夠預防失效的的有效程度11.Detectingfailure

探測度度11.Detectingfailure

探測度度DetectionRating(D)，，探測度評分分(D)9-10veryremotechancethiscontrolwilldetectthecauseorfailure查明失效或其其原因的可能能性極小7-8remotechance，可能性很小小5-6moderatetolowchance，可能性不大大2-4moderatelytoveryhighchance，可能能性性較較大1almostcertainly(ifthepartpassesthistest,it'sOKtoship)幾乎都都可以以查到到(如如能通通過這這項檢檢測，，則可可放心心發(fā)貨貨)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)計算風風險順順序數(shù)數(shù)(RPN)RPN=SxOxD=SeverityofEffectxOccurrenceRatingxDetectionRating