過程失效模式及后果分析中英文2

ProcessFailureModeand

EffectsAnalysis

過程失效模式及后果分析(PFMEA)

PFMEA

PFMEA陶國ProprietaryInformation專專有信息息YourFMEA((ControlPlan,ProcessCapability,etc..)maybeconsideredproprietaryandshouldnotbesharedwithanyoneoutsidethedivisionwithoutfirstconsultingyourmanagement.FMEA(控控制計劃劃、過程程能力等等)可可視為專專有信息息，在未未事先征征得管管理部門門同意之之前，不不得向部部門以外外的任何何人透露露。thisincludesthesharingofinformationwithyourcustomer也不得向向顧客透透露有關(guān)關(guān)信息。。FormsandFormats形形式和格格式Y(jié)ourcustomermighthaveaspecificformatorformthattheyrequire.Ifso,youwillneedtogettheirwrittenapprovaltouseanalternateformat.顧客可能能要求特特定的格格式或表表單。如如果是這這樣，你你只有征征得他們們的書面面同意，，才能采采用其它它格式。。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ProcessFMEA過過程FMEAananalyticaltoolusedbyaprocessdesignteamtoidentifypotentialproductfailurescausedbyfailureofthemanufacturingandassemblyprocesstomeetrequirements,,andidentifycorrectiveactionstobetaken是過程設(shè)設(shè)計小組組采用的的一種分分析方法法，用于于識別由由于制造造或裝配配過程的的失效而而導(dǎo)致的的潛在產(chǎn)產(chǎn)品失效效模式，，并確定定所應(yīng)采采取的糾糾正措施施。formalprocess正式程序序customerfocused著眼于顧顧客usesengineeringjudgment,andharddatawhereitisavailable利用工程程經(jīng)驗判判斷和可可靠的數(shù)數(shù)據(jù)ProcessFMEA過過程FMEAPFMEAisfocussedontheProductPFMEA關(guān)關(guān)注對產(chǎn)品的影響ProcessFMEA過過程FMEAProcessFMEA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WhendowedoaPFMEA??

何時時進行PFMEA？Whilethereisstilltimetobringaboutchangesintheprocessandintheproduct!當還有時時間修改改產(chǎn)品及及工藝設(shè)設(shè)計時??！APFMEAdonesolelytofilloutaformandmeet““requirements”isjustanexercise為了滿足足QS9000要求而而填寫PFMEA表格格，僅是是練習而而已PFMEAisanoutputofthe"ProcessDesignandDevelopment""phaseofAPQP

PFMEA是APQP中“過過程設(shè)計計和開發(fā)發(fā)”階段段的產(chǎn)物物WhendowedoaPFMEA??

何時時進行PFMEA？ItisderivedfromaDFMEA在DFMEA之之后進行行AnyDFMEAformsandsupportingdocumentsshoudbebroughttothePFMEAmeetingsDFMEA表單單和所有有相關(guān)文文件都應(yīng)應(yīng)帶入PFMEAItshouldbeanaturalpartofconceptdevelopment應(yīng)成為過過程設(shè)計計的一個個必要組組成部分分PFMEAisnever““finished””.itisalivingdocument是動態(tài)文文件WhendowedoaPFMEA??

何時時進行PFMEA？DoaPFMEA(oratleastreviewtheoldone))if:以下情況況需進行行PFMEA(或至少評評審過去去的PFMEA)：：theprocessisnew是新的過過程theproductisnew,,orhasneverbeenmadewiththisprocess新產(chǎn)品，，或從未未用本過過程加工工的產(chǎn)品品anexistingprocesschanges原有的過過程發(fā)生生變化customerrequirementsordesireschange顧客要求求或希望望發(fā)生變變化WhendowedoaPFMEA??

何時時進行PFMEA？DoaPFMEA(oratleastreviewtheoldone))if:以下情況況需進行行PFMEA((或至少少評審過過去的PFMEA)：：thecompetitive,,business,orlegalenvironmentchanges競爭環(huán)境境、業(yè)務(wù)務(wù)環(huán)境或或法律環(huán)環(huán)境發(fā)生生變化PPAPconditionsapply需提交PPAPactualfailuresoccur發(fā)生實際際失效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步工工作步驟驟WhoperformsaPFMEA?由由誰進進行PFMEA？Across-functionalteamshouldbeused由跨部門門小組進進行Theleadershouldbetheprocess-responsibleengineer小組組長長應(yīng)是過過程設(shè)計計責任工工程師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，機機修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步工工作步驟驟HowdowedoaPFMEA?ASummary怎怎樣進進行PFMEA？提要要Assemblethecross--functionalPFMEAteam組建跨部部門PFMEA小組Listthefailuremodes,theireffects,andtheircauses列出失效效模式，，后果以以及原因因Assess，， 評估估theseverityoftheeffect((S)后果的嚴嚴重程度度thelikelihoodofthecauses(O)原因出現(xiàn)現(xiàn)的可能能性andtheabilityofprocesscontrolstodetectfailuremodesand//ortheircauses(D)過程控制制探測失失效模式式和/或或原因的的能力HowdowedoaPFMEA?ASummary怎怎樣進進行PFMEA？提要要Calculatetheriskprioritynumber(RPN))toprioritizecorrectiveactions計算風險險順序數(shù)數(shù)(RPN)以以確定應(yīng)應(yīng)優(yōu)先采采取的糾糾正措施施Plancorrectiveactionsandassignowner制訂糾正正措施并并落實責責任人Performcorrectiveactionstoimprovetheproductorprocess,,采采取糾正正措施以以提高產(chǎn)產(chǎn)品和過過程質(zhì)量量RecalculateRPN重新估算算RPNHowdowedoaPFMEA?ASummary怎怎樣進進行PFMEA？提要要HowdowedoaPFMEA?ASuggestion

怎樣樣進行PFMEA？建建議Doyourworkonscratchpaperfirst;astheteamreachesconsensus,recordtheinformationontheFMEAform先在一張張草稿紙紙上進行行分析；；當小組組達成一一致意見見后，再再將有關(guān)關(guān)信息填填在FMEA表表上usefishboneandtreediagramsliberally充分利用用魚刺圖圖和樹形形圖tryingtousetheFMEAformasaworksheetleadstoconfusionandmessed--upFMEAs若將FMEA表表當做工工作單使使用，就就會造成成混亂，，使FMEA一一塌糊涂涂ProcessFMEA過過程FMEA何謂PFMEA何時作PFMEA何人作PFMEA如何作PFMEA16步工作步步驟1.Assembleateamandplanyouractivities成成立小小組并制制訂計劃劃PFMEAmustneverbedonebyanindividual,because絕不能由由個人單單獨進行行PFMEA，，因為：：individualeffortsproducebiasedresults,由個人進進行會使使結(jié)果出出現(xiàn)偏差差anyactionswillrequirebuy-infromvariousgroups進行任何何活動，，都需要要從不同同的組織織取得信信息Oneperson(e.g..theleader))shouldbeassignedtomaintainingtheFMEAform應(yīng)指定一一個人((如組長長)保管管FMEA表格格BesuretowritethenamesandfunctionsoftheteammembersontheFMEAform應(yīng)將小組組成員的的姓名和和職責填填入FMEA表表格1.Assembleateamandplanyouractivities成成立小小組并制制訂計劃劃2.Developaprocessflowdiagram繪繪制過程程流程圖圖UsetheProcessFlowDiagramformat運用正規(guī)規(guī)的過程程流程圖圖identifiesfabricate,move,storeandinspectoperations辨別四種種作業(yè)類類型identifiesKeyCharacteristics辨別關(guān)鍵鍵特性

Supplier_____________________Date____________________PartNumber_________________RevisionLevel________PartDescription_____________Preparedby____________pressuremoldpartfabmovestoreinspstepoper.descr.item#KPCitem#KCCinspectpartforflashstorepartincontainercarrypartstoassyarea1noflash112342.Developaprocessflowdiagram繪繪制過程程流程圖圖過程流程程圖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(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)ofeachoperation

列出出每個操操作的功功能Afunctioniswhattheoperationdoes功能系指指該操作作所起的的作用Statethefunctionas，，說明明功能為為：Verb+Object+Qualifier動詞+賓賓語+修修飾詞moldpart，，零件成成型crimpterminalontocable在線端壓壓接端子子formbendinpart,零零件彎彎曲成型型examples例如如Don''tforgetauxiliaryfunctionsaswellaprimaryfunctions基本功能能和輔助助功能都都要考慮慮3.Listthefunction((s)ofeachoperation

列出出每個操操作的功功能4.Listthequalityrequirements

列出出質(zhì)量要要求acustomerwantordesire顧客的希希望或要要求couldseriouslyaffectcustomerperception有可能嚴嚴重影響響顧客的的看法couldleadtoacustomercomplaint有可能導(dǎo)導(dǎo)致顧客客投訴5.Listthepotentialprocessfailuremodes列列出可能能的過程程失效模模式adefect,flaw,orotherunsatisfactoryconditionintheproductthatoccurswhentheprocessfailstomeettheprocessrequirements由于過程程未達到到要求而而導(dǎo)致的的產(chǎn)品缺缺陷、瑕瑕疵等不不良狀態(tài)態(tài)failuremodesshouldbewrittenintermsoftheconditionoftheproduct失效模式式體現(xiàn)在在產(chǎn)品上上TypicalFailureModes，，幾種典典型失效效模式diameteroutofspec..，直徑徑超差missingseal，，漏裝密密封墊cutstrands，切切破線皮皮misorientedpart，部件件方向錯錯insufficientsolder，焊劑劑不足toomuchsolder，，焊劑過過量NFO，，未充滿滿Flash，飛飛邊5.Listthepotentialprocessfailuremodes列列出可能能的過程程失效模模式Note，注Assumethatincomingproductandmaterialsarecorrect假設(shè)來料料沒問題題Assumethattheproductasdesignedwillmeetrequirements假設(shè)產(chǎn)品品設(shè)計能能夠滿足足客戶需需求5.Listthepotentialprocessfailuremodes列列出可能能的過程程失效模模式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(zhì)量量或性能能降低damageofprocessequipment，，設(shè)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(yīng)應(yīng)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(yīng)應(yīng)，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(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，如人人的過失失，工裝裝磨損、、環(huán)境條條件以及及因素間間的相互互作用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可利用樹樹形圖或或魚刺圖圖8.Cause(s)ofFailure

失效效原因9.Assessthelikelihoodofoccurrenceofeachcause評評估每每種失效效原因產(chǎn)產(chǎn)生的可可能性Usehistoricaldata(asabaseline)，，利用歷歷史資料料Takeimprovementsintoaccount，，并考慮慮所作的的改進

Usestatisticalmodelsandcomparisonwithsimilarprocesses利利用可靠靠性模型型，與類類似的過過程進行行比較9-10 Failurealmostinevitable，，失效幾幾乎不可可避免7-8Similarprocessesthathaveoftenfailedinthepast，，以前類類似過程程常常失失效4-6Similarprocessesthathaveoccasionalfailures，類似似過程偶偶爾失效效1-3Similarprocessesthathaveexperiencedisolatedfailures，類類似過程程僅有過過個別失失效9.Assessthelikelihoodofoccurrenceofeachcause評評估每每種失效效原因產(chǎn)產(chǎn)生的可可能性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

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

列出出現(xiàn)有過過程控制制Detectionisanassessmentoftheprobabilitythat，探探測度為為下列事事件發(fā)生生的概率率atype2controlcandetectthecauseandleadtocorrectiveaction,第第2類控控制能夠夠發(fā)現(xiàn)原原因并找找到糾正正措施atype3controlcandetectafailure，第3類控制制能夠在在不良品品到達顧顧客前發(fā)發(fā)現(xiàn)缺陷陷...beforetheproductreachesthecustomer!!detectioncanalsoassesshoweffectivelyatype1controlcanpreventfailure，，第1類類控制能能夠預(yù)防防失效的的有效程程度11.Detectingfailure探測度11.Detectingfailure探測度DetectionRating(D)，探探測度評評分(D)9-10veryremotechancethiscontrolwilldetectthecauseorfailure查明失效效或其原原因的可可能性極極小7-8remotechance，可能性性很小5-6moderatetolowchance，可能性性不大2-4moderatelytoveryhighchance，可能性性較較大1almostcertainly(ifthepartpassesthistest,,it'sOKtoship)幾乎都可可以查到到(如能能通過這這項檢測測，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.ManualInspe