過程失效模式及后果中英文

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(guān)信息。FormsandFormats

形式和格式Y(jié)ourcustomermighthaveaspecificformatorformthattheyrequire.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(shè)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(dǎo)致的潛在產(chǎn)品失效模式，并確定所應(yīng)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(guān)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(jìn)行PFMEA？Whilethereisstilltimetobringaboutchangesintheprocessandintheproduct! 當(dāng)還有時間修改產(chǎn)品及工藝設(shè)計時！APFMEAdonesolelytofilloutaformandmeet“requirements”isjustanexercise 為了滿足QS9000要求而填寫PFMEA表格，僅是練習(xí)而已PFMEAisanoutputofthe"ProcessDesignandDevelopment"phaseofAPQPPFMEA是是APQP中中“過程設(shè)計計和開發(fā)”階階段的產(chǎn)物WhendowedoaPFMEA?

何時進(jìn)進(jìn)行PFMEA？ItisderivedfromaDFMEA在DFMEA之后進(jìn)行AnyDFMEAformsandsupportingdocumentsshoudbebroughttothePFMEAmeetingsDFMEA表表單和所有相相關(guān)文件都應(yīng)應(yīng)帶入PFMEAItshouldbeanaturalpartofconceptdevelopment應(yīng)成為過程設(shè)設(shè)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(jìn)進(jìn)行PFMEA？DoaPFMEA(oratleastreviewtheoldone)if:以下情況需進(jìn)進(jìn)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(jìn)進(jìn)行PFMEA？DoaPFMEA(oratleastreviewtheoldone)if:以下情況需進(jìn)進(jìn)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(wù)環(huán)境或法法律環(huán)境發(fā)生生變化PPAPconditionsapply需提交PPAPactualfailuresoccur發(fā)生實實際失失效WhendowedoaPFMEA?何何時時進(jìn)行行PFMFA？？ProcessFMEA過過程FMEA何謂PFMEA何時作PFMEA何人作PFMEA如何作PFMEA16步工工作步驟驟WhoperformsaPFMEA?由由誰進(jìn)進(jìn)行PFMEA？Across-functionalteamshouldbeused由跨部門門小組進(jìn)進(jìn)行Theleadershouldbetheprocess-responsibleengineer小組組長長應(yīng)是過過程設(shè)計計責(zé)任工工程師Cross-FunctionalTeam跨跨部門門小組5-9peoplefrom，，5-9人，由由從事如如下工作作的人員員組成Design，，設(shè)計Assembly，裝裝配manufacturing(operators,supervisors)，制制造(操作工工，班組組長)Industrial,mfg.Andtoolengineering，工業(yè)業(yè)工程，，工藝及及工裝設(shè)設(shè)計quality，質(zhì)量量管理materialsengineering，，材料工工程Servicepersonnel，機(jī)機(jī)修Supplierofproductandmachinery，，零件和和設(shè)備供供應(yīng)商Representativesfromthenextprocess,后后續(xù)工工序代表表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(jìn)進(jìn)行PFMEA？提提要Assemblethecross-functionalPFMEAteam組建跨部門門PFMEA小組Listthefailuremodes,theireffects,andtheircauses列出失效模模式，后果果以及原因因Assess，評評估theseverityoftheeffect(S)后果的嚴(yán)重重程度thelikelihoodofthecauses(O)原因出現(xiàn)的的可能性andtheabilityofprocesscontrolstodetectfailuremodesand/ortheircauses(D)過程控制探探測失效模模式和/或或原因的能能力HowdowedoaPFMEA?ASummary

怎樣進(jìn)進(jìn)行PFMEA？提提要Calculatetheriskprioritynumber(RPN)toprioritizecorrectiveactions計算風(fēng)險順順序數(shù)(RPN)以以確定應(yīng)優(yōu)優(yōu)先采取的的糾正措施施Plancorrectiveactionsandassignowner制訂糾正措措施并落實實責(zé)任人Performcorrectiveactionstoimprovetheproductorprocess,采取取糾正措施施以提高產(chǎn)產(chǎn)品和過程程質(zhì)量RecalculateRPN重新估算RPNHowdowedoaPFMEA?ASummary

怎樣進(jìn)進(jìn)行PFMEA？提提要HowdowedoaPFMEA?

ASuggestion

怎樣樣進(jìn)行PFMEA？？建議Doyourworkonscratchpaperfirst;astheteamreachesconsensus,recordtheinformationontheFMEAform先在一張草稿稿紙上進(jìn)行分分析；當(dāng)小組組達(dá)成一致意意見后，再將將有關(guān)信息填填在FMEA表上usefishboneandtreediagramsliberally充分利用魚刺刺圖和樹形圖圖tryingtousetheFMEAformasaworksheetleadstoconfusionandmessed-upFMEAs若將FMEA表當(dāng)做工作作單使用，就就會造成混亂亂，使FMEA一塌糊涂涂ProcessFMEA

過程FMEA何謂PFMEA何時作PFMEA何人作PFMEA如何作PFMEA16步工作步步驟1.Assembleateamandplanyouractivities成成立小組并并制訂計劃PFMEAmustneverbedonebyanindividual,because絕不不能能由由個個人人單單獨(dú)獨(dú)進(jìn)進(jìn)行行PFMEA，，因因為為：：individualeffortsproducebiasedresults,由個人進(jìn)行會會使結(jié)果出現(xiàn)現(xiàn)偏差anyactionswillrequirebuy-infromvariousgroups進(jìn)行任何活動動，都需要從從不同的組織織取得信息Oneperson(e.g.theleader)shouldbeassignedtomaintainingtheFMEAform應(yīng)指定一個人人(如組長)保管FMEA表格BesuretowritethenamesandfunctionsoftheteammembersontheFMEAform應(yīng)將小組成員員的姓名和職職責(zé)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(yùn)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(guān)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(yùn)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(zhuǎn)箱內(nèi)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基本功能和輔輔助功能都要要考慮3.Listthefunction(s)of

eachoperation

列出出每個操作的的功能4.Listthequalityrequirements列列出質(zhì)量要求求acustomerwantordesire顧客的希望或或要求couldseriouslyaffectcustomerperception有可能嚴(yán)重影影響顧客的看看法couldleadtoacustomercomplaint有可能導(dǎo)致顧顧客投訴5.Listthepotentialprocessfailuremodes列列出可能的過過程失效模式式adefect,flaw,orotherunsatisfactoryconditionintheproductthatoccurswhentheprocessfailstomeettheprocessrequirements由于過程未達(dá)達(dá)到要求而導(dǎo)導(dǎo)致的產(chǎn)品缺缺陷、瑕疵等等不良狀態(tài)failuremodesshouldbewrittenintermsoftheconditionoftheproduct失效模式體現(xiàn)現(xiàn)在產(chǎn)品上TypicalFailureModes，幾種典型型失效模式diameteroutofspec.，，直直徑徑超超差差missingseal，，漏漏裝裝密密封封墊墊cutstrands，，切切破破線線皮皮misorientedpart，，部部件件方方向向錯錯insufficientsolder，，焊焊劑劑不不足足toomuchsolder，，焊焊劑劑過過量量NFO，，未未充充滿滿Flash，，飛飛邊邊5.Listthepotentialprocessfailuremodes列列出出可可能能的的過過程程失失效效模模式式Note，，注注Assumethatincomingproductandmaterialsarecorrect假設(shè)設(shè)來來料料沒沒問問題題Assumethattheproductasdesignedwillmeetrequirements假設(shè)設(shè)產(chǎn)產(chǎn)品品設(shè)設(shè)計計能能夠夠滿滿足足客客戶戶需需求求5.Listthepotentialprocessfailuremodes列列出出可可能能的的過過程程失失效效模模式式6.Derivethepotentialeffectsofeachfailure列列出出每每一一失失效效模模式式的的所所有有可可能能后后果果Theramificationsoffailure后果果是是失失效效模模式式的的衍衍生生事事件件Theeffectcanbeon，，可可能能影影響響theultimatecustomer，，最最終終用用戶戶orintermediatecustomer(OEM,etc.)，，中中間間用用戶戶agovernmentregulation，，法法規(guī)規(guī)thenextprocessstep，，下下序序Customercomplaintsareausefulsourceofinformation顧客客抱抱怨怨是是非非常常有有用用的的信信息息來來源源6.Derivethepotentialeffectsofeachfailure列列出出每每一一失失效效模模式式的的所所有有可可能能后后果果Aneffectcanbe，，后后果果可可能能為為completelossoffunction，，功功能能完完全全喪喪失失degradationofperformanceorquality，，質(zhì)質(zhì)量量或或性性能能降降低低damageofprocessequipment，，設(shè)設(shè)備備受受損損injurytoanoperator，，員員工工受受傷傷shut-downofanassemblyline，，停停線線6.Derivethepotentialeffectsofeachfailure列列出出每每一一失失效效模模式式的的所所有有可可能能后后果果Effectsoffailureoftenshowupasachainofevents,fromimmediateeffecttotheultimateeffectonthecustomer，，失失效效的的后后果果通通常常表表現(xiàn)現(xiàn)為為從從對對顧顧客客的的直直接接影影響響到到最最終終影影響響等等一一系系列列連連鎖鎖反反應(yīng)應(yīng)ItisrecommendedthatthesechainsbedevelopedforeachfailuremodeandrecordedontheFMEAform建議議針針對對每每一一種種失失效效模模式式找找出出這這些些連連鎖鎖反反應(yīng)應(yīng)，，并并記記錄錄在在FMEA表表上上useatreediagram運(yùn)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(dǎo)致設(shè)設(shè)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(yán)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(yīng)表表述為為可糾正正或可可控制制的因素素Considerhumanerror,wear-outoftools,ambientconditions,andinteractionsoffactors，，如人人的過過失，，工裝裝磨損損、環(huán)環(huán)境條條件以以及因因素間間的相相互作作用Causesoffailureoftenshowupasachainofevents,fromimmediatecausetorootcause失效通常常是由一一連串的的原因造造成的，，從直接接原因到到根本原原因ItisrecommendedthatthesechainsbedevelopedforeachfailuremodeandrecordedontheFMEAform建議針對對每一種種失效模模式，找找出原因因鏈，記記入FMEA表表useatreeorfishbonediagramtodevelop可利利用用樹樹形形圖圖或或魚魚刺刺圖圖8.Cause(s)ofFailure失失效效原原因因9.Assessthelikelihoodofoccurrenceofeachcause評評估估每每種種失失效效原原因因產(chǎn)產(chǎn)生生的的可可能能性性Usehistoricaldata(asabaseline)，，利利用用歷歷史史資資料料Takeimprovementsintoaccount，，并并考考慮慮所所作作的的改改進(jìn)進(jìn)Usestatisticalmodelsandcomparisonwithsimilarprocesses利利用用可可靠靠性性模模型型，，與與類類似似的的過過程程進(jìn)進(jìn)行行比比較較9-10Failurealmostinevitable，，失失效效幾幾乎乎不不可可避避免免7-8Similarprocessesthathaveoftenfailedinthepast，，以以前前類類似似過過程程常常常常失失效效4-6Similarprocessesthathaveoccasionalfailures，，類類似似過過程程偶偶爾爾失失效效1-3Similarprocessesthathaveexperiencedisolatedfailures，，類類似似過過程程僅僅有有過過個個別別失失效效9.Assessthelikelihoodofoccurrenceofeachcause評評估估每每種種失失效效原原因因產(chǎn)產(chǎn)生生的的可可能能性性O(shè)ccurence(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列列出現(xiàn)現(xiàn)有過過程控控制Processcontrolscatchthedefectbeforetheproductreachesthecustomer，過過程控控制當(dāng)當(dāng)在產(chǎn)產(chǎn)品到到達(dá)顧顧客前前發(fā)現(xiàn)現(xiàn)缺陷陷!TherearethreeTypesofprocesscontrols,過過程控制制有三種類類型:(1)preventthecauseoffailure,orreducetherateofoccurrence，防防止原因出出現(xiàn)或降低低其出現(xiàn)的的可能性(2)detectthecause(s)offailureandleadtocorrectiveactions，查明明失效的原原因并找出出糾正措施施(3)detectthefailuremode(s)，檢檢測失效模模式Assigncurrentlyusedprocesscontrolstofailuremodesandcauses，，針對失效效模式或原原因列出現(xiàn)現(xiàn)行的過程程控制手段段Usedonsimilarprocessesinthepast，以前類類似過程如如何控制CanbeofanyType:1,2,or3,oranycombination，可可以是1、、2、3類類或其組合合Type1controlsaffectthelikelihoodofoccurrence,ifalreadypartofthedesign，若設(shè)設(shè)計中已有有體現(xiàn)，則則第1類方方法可降低低原因出現(xiàn)現(xiàn)的頻度Ifnone,write“None””，若沒沒有，則填填“無”。。10.ListtheCurrentProcessControls

列出現(xiàn)現(xiàn)有過程控控制Detectionisanassessmentoftheprobabilitythat，探測測度為下列列事件發(fā)生生的概率atype2controlcandetectthecauseandleadtocorrectiveaction,第第2類控控制能夠發(fā)發(fā)現(xiàn)原因并并找到糾正正措施atype3controlcandetectafailure，第3類類控制能夠夠在不良品品到達(dá)顧客客前發(fā)現(xiàn)缺缺陷...beforetheproductreachesthecustomer!detectioncanalsoassesshoweffectivelyatype1controlcanpreventfailure，第1類控制能能夠預(yù)防失失效的有效效程度11.Detectingfailure

探測度度11.Detectingfailure

探測度度DetectionRating(D)，，探測度評評分(D)9-10veryremotechancethiscontrolwilldetectthecauseorfailure查明失效或或其原因的的可能性極極小7-8remotechance，可能性很很小5-6moderatetolowchance，可能性不不大2-4moderatelytoveryhighchance，可能性性較大1almostcertainly(ifthepartpassesthistest,it'sOKtoship)幾乎都可以以查到(如如能通過這這項檢測，，則可放心心發(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.ManualInspe