FailureModeandEffectAnalysis

失效模式及其影響分析1FailureModeandEffectAnalysModuleObjectives課程目的DescribeFMEAprinciplesandtechniques.描述FMEA的法則及技巧。Summarizetheconcepts,definitions,applicationoptionsandrelationshipswithothertools.摘要概念、定義、應(yīng)用的選擇和其他工具的關(guān)聯(lián)。PerformaFMEA執(zhí)行一個(gè)FMEA。2ModuleObjectives課程目的DescribeFMEA:FailureModesandEffectsAnalysisFMEAisasystematicapproachusedtoexaminepotentialfailuresandpreventtheiroccurrence.Itenhancesourabilitytopredictproblemsandprovidesasystemofranking,orprioritization,sothemostlikelyfailuremodescanbeaddressed. FMEA是用來檢查潛在失效和預(yù)防它再次發(fā)生的系統(tǒng)性方法.它增強(qiáng)了我們預(yù)測(cè)問題的能力,并提供了一個(gè)排序或區(qū)分優(yōu)先次序的系統(tǒng),因而使得最可能的失效模式得以確定.FMEAisgenerallyappliedduringtheinitialstagesofaprocessorproductdesign.Brainstormingisusedtodeterminepotentialfailuremodes,theircauses,theirseverity,andtheirlikelihoodofoccurring.InSixSigma,weapplyFMEAtoknowfailuremodes.Ourmaininterestsarethecauseandlikelihoodofoccurrence,forwhichwehaveactualdataanddonotneedtorelyonbrainstorming.FMEA通常應(yīng)用在工藝及產(chǎn)品設(shè)計(jì)的初期，自由討論決定潛在失效的模式、原因、嚴(yán)重度及發(fā)生的可能性。在6S中，我們應(yīng)用FMEA去了解失效的模式。我們主要感興趣的是原因及發(fā)生的可能性。FMEAisalsoavaluabletoolformanagingtasksduringdefect/failurereductionprojects.FMEA也是一個(gè)在失效縮小的管理任務(wù)的有價(jià)值的工具。FMEA3FMEA:FailureModesandEffectDefinitionofFMEA定義recognizeandevaluate

thepotentialfailuremodesandcausesassociatedwiththedesigningandmanufacturingofanewproductorachangetoanexistingproduct.

認(rèn)識(shí)和評(píng)估新產(chǎn)品的設(shè)計(jì)和制造時(shí)或?qū)ΜF(xiàn)有產(chǎn)品做出改變時(shí)相關(guān)的潛在失效模式和原因identify

actionswhichcouldeliminateorreducethechanceofthepotentialfailureoccurring,

確定消除或減少潛在失效發(fā)生機(jī)會(huì)的行動(dòng)document

theprocess.

使過程形成文件FMEAisa

systematic

designevaluationprocedurewhosepurposeisto:是系統(tǒng)的設(shè)計(jì)評(píng)估程序4DefinitionofFMEA定義recognizeFailuretoperformadefinedfunction 執(zhí)行既定功能的失效Somethingoccurringthatyoudon‘texpect,orwant 發(fā)生了你不希望或不想要的事情Wrongapplication

應(yīng)用錯(cuò)誤AFailureModeis...失效模式是……5FailuretoperformadefinedfFMEAUsebyBlack/Brown/GreenBeltsToidentifypotentialfailuremodesandratetheseverityoftheireffectsToidentifycriticalcharacteristicsandsignificantcharacteristicsTorankpotentialdesignandprocessdeficienciesTohelpallofusfocusoneliminatingproductandprocessconcernsandpreventproblemsfromrecurringReducetheproductdevelopmenttimingandcost6FMEAUsebyBlack/Brown/GrBackgroundDevelopedinearly60’sbyNASAto“fail-proof”Apollomissions.Adoptedinearly70’sbyUSNavy.Bylate80’s,automotiveindustryhadimplementedFMEAandbeganrequiringsuppliersdothesame.Liabilitycostswerethemaindrivingforce.Usedsporadicallythroughoutindustryduring1980’s.AdoptedbyMSIin?

SixSigmaisthecatalyst.7BackgroundDevelopedinearly6NASAusedFMEAtoidentifySinglePointFailuresonApolloproject(SPF=noredundancy&lossofmission).Howmanydidtheyfind?420andwethoughtwehadproblems!8NASAusedFMEAtoidentifySinTypesofFMEA’sSYSTEMDESIGNPROCESSSystemFMEAisusedtoanalyzesystemsandsubsystemsintheearlyconceptanddesignstages.DesignFMEAisusedtoanalyzeproductsbeforetheyarereleasedtoproductionProcessFMEAisusedtoanalyzemanufacturing,assemblyandadministrativeprocesses9TypesofFMEA’sSYSTEMDESIGNPRWhenistheFMEAStarted?“Dothebestyoucanwithwhatyouhave”ASEARLYASPOSSIBLE!Guideline:10WhenistheFMEAStarted?“DotWhentoStart???Whennewsystems,productsandprocessesarebeingdesignedWhenexistingdesignsandprocessesarebeingchangedWhencarry-overdesignsorprocesseswillbeusedinnewapplicationsorenvironmentsAftercompletingaProblemSolvingStudy,topreventrecurrenceofaproblem11WhentoStart???WhennewsystBeginningandEnd12BeginningandEnd12EffectofFMEAonProcessandDesignchangesDesignStartDevelopmentProductionReleaseProductionTimeNoofEngineeringChangesTraditionalapproachFMEAapproach13EffectofFMEAonProcessandProcessFMEAForm14ProcessFMEAForm14JLExample15JLExample15ElementsofFMEAFailureMode Anywayinwhichaprocesscouldfailtomeetsomemeasurableexpectation.Effect

Assumingafailuredoesoccur,describetheeffects.Listseparatelyeachmaineffectonbothadownstreamoperationandtheenduser.Severity

Usingascaleprovided,ratetheseriousnessoftheeffect.10representsworstcase,1representsleastsevere.Causes

Thisisthelistofcausesand/orpotentialcausesofthefailuremode.Occurrence

Thisisaranking,onascaleprovided,ofthelikelihoodofthefailureoccurring.10representsnearcertainty;1represents6sigma.InthecaseofaSixSigmaproject,occurrenceisgenerallyderivedfromdefectdata.CurrentControls

Allmeansofdetectingthefailurebeforeproductreachestheend user,arelistedundercurrentcontrols.Detection Theeffectivenessofeachcurrentcontrolmethodisratedonaprovidedscalefrom1to10.A10impliesthecontrolwillnotdetectthepresenceofafailure;a1suggestsdetectionisnearlycertain.16ElementsofFMEAFailureModeProcessFailureModeThepotentialfailuremodeisthemannerinwhichtheprocesscouldfailtoperformitsintendedfunction.Thefailuremodeforaparticularoperationcouldbeacauseinasubsequent(downstream)operationoraneffectassociatedwithapotentialfailureinaprevious(upstream)operation.FAILUREMODEEFFECTPREVIOUSOPERATIONCAUSENEXTOPERATION17ProcessFailureModeThepotentProcessCauses

ProcessFMEAconsidersprocessvariabilitydueto:OPERATORSET-UPMACHINEMETHODENVIRONMENTMEASUREMENT18ProcessCausesProcessFMEACurrentControlsAssessmentoftheabilityofthecontroltodetectthefailurebeforetheitemleavesthemanufacturingareaandshipstothecustomer.CapabilityofallcontrolsintheprocesstopreventescapesSPCProcessCapabilityGageR&RSamplingTestingDOE19CurrentControlsAssessmentofTypesofMeasuresSEVERITYAsitappliestotheeffectsonthelocalsystem,nextlevel,andenduserOCCURRENCELikelihoodthataspecificcausewilloccurandresultinaspecificfailuremodeDETECTIONAbilityofthecurrent/proposedcontrolmechanismtodetectandidentifythefailuremodeTypically,threeitemsarescored:20TypesofMeasuresSEVERITYTypicRiskPriorityNumberRPN=OxSxD

Occurrencex Severityx DetectionOSD

xx=RPN21RiskPriorityNumberOSDxx=RPShortcomingsofRPN

A 8

4 3 96 B 4

8 3 96SAMERESULTFailureModeSeverityOccurrenceEffectivenessRPN22ShortcomingsofRPNSAMERESULTSeverity23Severity23Occurance24Occurance24Detection25Detection25Itisconductedonatimely

basisand

Itisappliedbyaproduct

teamandItsresultsaredocumentedFMEAisMostEffectiveWhen26ItisconductedonatimelybaWhatIsAGoodApplication?InvolvenewtechnologyHavechangedfrompreviousArechronicallyintroubleHaveahighdegreeofoperatorcontrolHaveahighdegreeofvariationChoosedesignsorprocesseswhich...InvolvenewtechnologyHavechangedfrompreviousArechronicallyintroubleHaveahighdegreeofoperatorcontrolHaveahighdegreeofvariationChoosedesignsorprocesseswhich...27WhatIsAGoodApplication?InvFMEAProcessManufacturingEngineerBuyerProcessOperatorProcessKnowledgePreviousExperiencePastProblemsChronicProblemsReliabilityEngineerProcessFunctions,PotentialFailureModesEffects,Causes,CurrentControlsActionPriorityActionstoEliminateorReduceFailureModeWarrantyClaims28FMEAProcessManufacturingBuyeBasicSteps1.DevelopaStrategy29BasicSteps1.DevelopaStrate1.DevelopaStrategy2.Reviewthedesign/process

EFFECTCAUSESBasicSteps301.DevelopaStrategyEFFBasicSteps1.DevelopaStrategy2.Reviewthedesign/process3.ListfunctionsDevelopaStrategyReviewthedesign/processListfunctions31BasicSteps1.DevelopaStrate1.DevelopaStrategy2.Reviewthedesign/process3.Listfunctions4.BrainstormpotentialfailuremodesBasicStepsBasicSteps:1.Developastrategy2.Reviewthedesign/process3.Listfunctions4.Brainstormpotentialfailuremodes321.DevelopaStrategyBasicSte1.DevelopaStrategy2.Reviewthedesign/process3.Listfunctions4.Brainstormpotentialfailuremodes5.OrganizepotentialfailuremodesBasicStepstopictopicAffinityDiagram331.DevelopaStrategyBasicSte1.DevelopaStrategy2.Reviewthedesign/process3.Listfunctions4.Brainstormpotentialfailuremodes5.Organizepotentialfailuremodes6.AnalyzepotentialfailuremodesBasicSteps341.DevelopaStrategyBasicSte1.DevelopaStrategy2.Reviewthedesign/process3.Listfunctions4.Brainstormpotentialfailuremodes5.Organizepotentialfailuremodes6.Analyzepotentialfailuremodes7.EstablishriskpriorityVITALFEWTRIVIALMANYBasicSteps351.DevelopaStrategyVITALTRIV1.DevelopaStrategy2.Reviewthedesign/process3.Listfunctions4.Brainstormpotentialfailuremodes5.Organizepotentialfailuremodes6.Analyzepotentialfailuremodes7.Establishriskpriority8.TakeactiontoreduceriskBasicSteps361.DevelopaStrategyBasicSte1.DevelopaStrategy2.Reviewthedesign/process3.Listfunctions4.Brainstormpotentialfailuremodes5.Organizepotentialfailuremodes6.Analyzepotentialfailuremodes7.Establishriskpriority8.Takeactiontoreducerisk9.CalculateresultingRPN’sBasicStepsO*S*D=RPN371.DevelopaStrategyBasicSte1.DevelopaStrategy2.Reviewthedesign/process3.Listfunctions4.Brainstormpotentialfailuremodes5.Organizepotentialfailuremodes6.Analyzepotentialfailuremodes7.Establishriskpriority8.Takeactiontoreducerisk9.CalculateresultingRPN’s10.FollowupBasicSteps381.DevelopaStrategyBasicSteTestingtheRelationshipsIFTHENHOWDOIKNOW?CAUSEFAILUREMODEEFFECT39TestingtheRelationshipsIFTHEActionsThedesignorprocessmustbeimprovedbasedontheresultsoftheFMEAstudy.Awell-developedFMEAwillbeoflimitedvaluewithoutpositiveandeffectivecorrectiveactions.40ActionsThedesignorprocessmModuleObjectivesDescribeFMEAprinciplesandtechniques.Summarizetheconcepts,definitions,applicationoptionsandrelationshipswithothertools.PerformaFMEA41ModuleObjectivesDescribeFMEADescribeFMEAprinciplesandtechniques.Summarizetheconcepts,definitions,applicationoptionsandrelationshipswithothertools.PerformaFMEAModuleObjectives…...42DescribeFMEAprinciplesandtOrganizationalLearningandSystemsThinking組織學(xué)習(xí)和系統(tǒng)思維AManagementSystem43OrganizationalLearningandSyBuildingOrganizationalMemoryEyelashLearningCurveABILITYTODOJOBTIMEOLDEMPLOYEELEAVESWITHKNOWLEDGENEWEMPLOYEEBEGINSThereisnoorganizationalmemorytoallowpeopletostartwheretheirpredecessorsleftoffNothinginplacetocapturetheneworimprovedmethodsthatproduceresults*44BuildingOrganizationalMemoryRapidLearningCurveABILITYTODOJOBTIMENEWEMPLOYEECOMESONANDPICKSUPALMOSTWHEREPREVIOUSEMPLOYEELEFTOFFOrganizationcontinuestoadvanceitsknowledgebypreservingthelessonseachlearnsRapidlearning=lesswaste,lesscomplexity,highercustomervalue,lowercosts*45RapidLearningCurveABILITYTOHowDoWeCreateRapidLearning?Twokeyingredients:1.Havingbestknownmethodsdocumented2.TrainingpeopleonwhatthosemethodsareWhototrain?

NewemployeesManagersExperiencedemployees*SixSigma46HowDoWeCreateRapidLearninProsandConsofStandardMethodsAdvantages:優(yōu)點(diǎn)Customerprogressismorevisibleandcanbetrackedovertime 顧客進(jìn)步更可見而且可以隨時(shí)間跟蹤C(jī)aptureandsharelessonslearned

吸取和分享教訓(xùn)Systemitselfdoesnotbecomeasourceofvariation

系統(tǒng)自身不會(huì)成為變異的來源Leadstoefficientpractices導(dǎo)致有效率的實(shí)踐

*47ProsandConsofStandardMethProsandConsofStandardMethodsDisadvantages:缺點(diǎn)Stiflecreativityandleadtostagnation 抑制創(chuàng)造力導(dǎo)致停滯不前Interferewithcustomerfocus干涉客戶的焦點(diǎn)Addbureaucracyandredtape助長官僚作風(fēng)Makeworkinflexibleandboring 使工作欠缺靈活性，使人容易感到厭煩Onlydescribetheminimalacceptableoutput

只描述最小的可接受輸出48ProsandConsofStandardMethFindingaBalance尋找平衡Thedifficultywefaceis....theargumentsforandagainststandardizationarebothtrue公說公有理，婆說婆有理Toachieveabalance,developstandardsjudiciously-whereitmattersthemostWheneffectivelymanaged,standardsprovidethefoundationforimprovement

49FindingaBalance尋找平衡ThediffEffectiveStandardization有效的標(biāo)準(zhǔn)Companiesthatusestandardizationeffectivelyoperateverydifferently:ThecompanyknowswhyitisdevelopingstandardsandhowtheycontributetoitsoverallpurposeManagementusesbest-knownmethodsthemselvesandstronglysupportsandchecksusageEmployeesunderstandhowdifferentfacetsoftheirworkaffecttheproductsandservices

Employeesknowwhichelements/functionsarecriticaltoproducinghigh-qualityoutput50EffectiveStandardization有效的標(biāo)CreateStandardsJudiciously明智地創(chuàng)造標(biāo)準(zhǔn)LeveragePoint:Aplacewherealittlechangehasagreatimpact支點(diǎn)：小小的變化就能有巨大的影響的地方。三兩撥千斤？“....everyjob,everyprocess,haswithinithigh-leveragepointsthatwemuststandardizeifwewanttoachieveconsistentlyhighperformance,andlow-leveragepointswherestandardizationissuperfluous,servingonlytorestrictflexibility.”51CreateStandardsJudiciously明KnowWhatIsandWhatIsNotImportant“Knowledgeaboutwhatisnotimportantisalmostasvaluableasknowledgeaboutwhatisimportant.Itfreesourattentiontobetterfocusonthefewthingsthatmakeadifference.”

“Thiskindofflexibilityshowsupinalljobs.”

“Asaruleofthumb,keepthedegreeofstandardizationaslowaspossiblebutdo

notneglectanyleveragepoints.”52KnowWhatIsandWhatIsNotILeveragePointThinking-HowDoYouTurntheShip?

KnowingtheleveragepointsiscriticalfordeterminingprioritiesandstrategiesforimprovementVitalFewTrivialManyParetoPrinciple80%oftheproblemsarecausedbyonlyabout20%ofthecontributingfactors*53LeveragePointThinking-How5454What’stheConnection?聯(lián)系Companiesrunintotroublebecausetheychangetheirmethodsbeforetheyunderstandwhythemethodsarethereinthefirstplace.陷入麻煩的公司是因?yàn)樗麄冊(cè)诓涣私猬F(xiàn)有方法存在的原因之前就盲目改變它。Theyeliminatesafetynetsintheirprocesseswithoutcontrollingthefactorsthatmadethemessential.55What’stheConnection?聯(lián)系CompaResistthetemptationtochangeuntilwedetermine:

?Arethedocumentedstandardsthebest?

?Whatistheimpactontherestofthesystem?

?Arethemethodsactuallybeingfollowed?

What’stheConnection?56ResistthetemptationtochangEmployeeResponsibility員工的責(zé)任Beforeanyonecanbeheldresponsibleforthequalityoftheirownwork,theymust:1.Knowthejob

了解工作Isthejobclearlydocumented?Aregoalsandtargetsvisible?Hasadequatetrainingbeendone?Doworkersknowhowproductisused?2.Knowthestandard

了解標(biāo)準(zhǔn)Outputmustbemeasurablewithimmediatefeedbackonperformance.Don’tbevagueorrequireinterpretation(i.e.wordslikeflat,smooth,etc.)57EmployeeResponsibility員工的責(zé)任BEmployeeResponsibility(cont)3.Havetheabilitytoregulate

擁有調(diào)節(jié)的能力Whenthejobdoesnotmeetthestandard,aretherereactionprocedures?Arebestpracticesleveraged?Musthaveall3-inorder!(SeeAppendixAforChecklist)58EmployeeResponsibility(cont)CAP-Do-DeterminetheNeedforStandardization1.CheckMakesureweknowwhytheworkisbeingdone

SeeifthepurposeisclearlydocumentedCompareactualpracticewithdocumentedmethodsIfnodocumentedmethodsexist,comparedifferentpracticesamongpeopledoingtheworkComparehowtheeffectivenessoftheworkissupposedtobecheckedandhowitisactuallycheckedPLANDOACTCHECKToanswerthesequestions,usetheCAP-Do(variationofDeming’sPDCA-Plan-Do-Check-Act)59CAP-Do-DeterminetheNeedfoCAP-Do-DeterminetheNeedforStandardization

2.ActReconcileactualpracticesanddocumentationChangeonetomatchtheotherasappropriateIfnostandardmethodsareinplaceandnoonecandemonstrate(withdata)thatconsistencyamongoperatorsexists,simplyagreeonamethodthatallwilluse.Thiswillestablishaconsistentbaselineuponwhichimprovementscanbebuilt.PLANDOACTCHECK60CAP-Do-DeterminetheNeedfo3.PlanDeterminehowtodetectflawsandpotentialimprovementsinthestandardConductaPotentialProblemAnalysis(Kepner-Tregoe)todeterminecontingenciesandtriggersforcontingenciesDevelopaplanforupgradingthedocumentation,orformakingitmoreusefulDevelopaplanforencouragingtheuseofthedocumentedstandardCAP-Do-DeterminetheNeedforStandardization

PLANDOACTCHECK613.PlanCAP-Do-Determinethe4.DoTraintothenewdocumentedstandardUsethenewstandard5.CheckOnceagaincompareactualpracticestodocumentedstandardsInvestigateinconsistencies6.ActReconciletheactualpracticewiththedocumentationMakechangesbasedonthedata!!PLANDOACTCHECKCAP-Do-DeterminetheNeedforStandardization

624.DoPLANDOACTCHECKCAP-Do-De“TheIlliterateoftheYear2000...

2000年的文盲...willnotbetheindividualwhocannotreadandwrite,buttheonewhocannotlearn,unlearnandrelearn”不是不會(huì)讀和寫的人，而是不能學(xué)習(xí)、再學(xué)習(xí)和重新學(xué)習(xí)的人AlvinToffler*63“TheIlliterateoftheYear20FailureModeandEffectAnalysis

失效模式及其影響分析64FailureModeandEffectAnalysModuleObjectives課程目的DescribeFMEAprinciplesandtechniques.描述FMEA的法則及技巧。Summarizetheconcepts,definitions,applicationoptionsandrelationshipswithothertools.摘要概念、定義、應(yīng)用的選擇和其他工具的關(guān)聯(lián)。PerformaFMEA執(zhí)行一個(gè)FMEA。65ModuleObjectives課程目的DescribeFMEA:FailureModesandEffectsAnalysisFMEAisasystematicapproachusedtoexaminepotentialfailuresandpreventtheiroccurrence.Itenhancesourabilitytopredictproblemsandprovidesasystemofranking,orprioritization,sothemostlikelyfailuremodescanbeaddressed. FMEA是用來檢查潛在失效和預(yù)防它再次發(fā)生的系統(tǒng)性方法.它增強(qiáng)了我們預(yù)測(cè)問題的能力,并提供了一個(gè)排序或區(qū)分優(yōu)先次序的系統(tǒng),因而使得最可能的失效模式得以確定.FMEAisgenerallyappliedduringtheinitialstagesofaprocessorproductdesign.Brainstormingisusedtodeterminepotentialfailuremodes,theircauses,theirseverity,andtheirlikelihoodofoccurring.InSixSigma,weapplyFMEAtoknowfailuremodes.Ourmaininterestsarethecauseandlikelihoodofoccurrence,forwhichwehaveactualdataanddonotneedtorelyonbrainstorming.FMEA通常應(yīng)用在工藝及產(chǎn)品設(shè)計(jì)的初期，自由討論決定潛在失效的模式、原因、嚴(yán)重度及發(fā)生的可能性。在6S中，我們應(yīng)用FMEA去了解失效的模式。我們主要感興趣的是原因及發(fā)生的可能性。FMEAisalsoavaluabletoolformanagingtasksduringdefect/failurereductionprojects.FMEA也是一個(gè)在失效縮小的管理任務(wù)的有價(jià)值的工具。FMEA66FMEA:FailureModesandEffectDefinitionofFMEA定義recognizeandevaluate

thepotentialfailuremodesandcausesassociatedwiththedesigningandmanufacturingofanewproductorachangetoanexistingproduct.

認(rèn)識(shí)和評(píng)估新產(chǎn)品的設(shè)計(jì)和制造時(shí)或?qū)ΜF(xiàn)有產(chǎn)品做出改變時(shí)相關(guān)的潛在失效模式和原因identify

actionswhichcouldeliminateorreducethechanceofthepotentialfailureoccurring,

確定消除或減少潛在失效發(fā)生機(jī)會(huì)的行動(dòng)document

theprocess.

使過程形成文件FMEAisa

systematic

designevaluationprocedurewhosepurposeisto:是系統(tǒng)的設(shè)計(jì)評(píng)估程序67DefinitionofFMEA定義recognizeFailuretoperformadefinedfunction 執(zhí)行既定功能的失效Somethingoccurringthatyoudon‘texpect,orwant 發(fā)生了你不希望或不想要的事情Wrongapplication

應(yīng)用錯(cuò)誤AFailureModeis...失效模式是……68FailuretoperformadefinedfFMEAUsebyBlack/Brown/GreenBeltsToidentifypotentialfailuremodesandratetheseverityoftheireffectsToidentifycriticalcharacteristicsandsignificantcharacteristicsTorankpotentialdesignandprocessdeficienciesTohelpallofusfocusoneliminatingproductandprocessconcernsandpreventproblemsfromrecurringReducetheproductdevelopmenttimingandcost69FMEAUsebyBlack/Brown/GrBackgroundDevelopedinearly60’sbyNASAto“fail-proof”Apollomissions.Adoptedinearly70’sbyUSNavy.Bylate80’s,automotiveindustryhadimplementedFMEAandbeganrequiringsuppliersdothesame.Liabilitycostswerethemaindrivingforce.Usedsporadicallythroughoutindustryduring1980’s.AdoptedbyMSIin?

SixSigmaisthecatalyst.70BackgroundDevelopedinearly6NASAusedFMEAtoidentifySinglePointFailuresonApolloproject(SPF=noredundancy&lossofmission).Howmanydidtheyfind?420andwethoughtwehadproblems!71NASAusedFMEAtoidentifySinTypesofFMEA’sSYSTEMDESIGNPROCESSSystemFMEAisusedtoanalyzesystemsandsubsystemsintheearlyconceptanddesignstages.DesignFMEAisusedtoanalyzeproductsbeforetheyarereleasedtoproductionProcessFMEAisusedtoanalyzemanufacturing,assemblyandadministrativeprocesses72TypesofFMEA’sSYSTEMDESIGNPRWhenistheFMEAStarted?“Dothebestyoucanwithwhatyouhave”ASEARLYASPOSSIBLE!Guideline:73WhenistheFMEAStarted?“DotWhentoStart???Whennewsystems,productsandprocessesarebeingdesignedWhenexistingdesignsandprocessesarebeingchangedWhencarry-overdesignsorprocesseswillbeusedinnewapplicationsorenvironmentsAftercompletingaProblemSolvingStudy,topreventrecurrenceofaproblem74WhentoStart???WhennewsystBeginningandEnd75BeginningandEnd12EffectofFMEAonProcessandDesignchangesDesignStartDevelopmentProductionReleaseProductionTimeNoofEngineeringChangesTraditionalapproachFMEAapproach76EffectofFMEAonProcessandProcessFMEAForm77ProcessFMEAForm14JLExample78JLExample15ElementsofFMEAFailureMode Anywayinwhichaprocesscouldfailtomeetsomemeasurableexpectation.Effect

Assumingafailuredoesoccur,describetheeffects.Listseparatelyeachmaineffectonbothadownstreamoperationandtheenduser.Severity

Usingascaleprovided,ratetheseriousnessoftheeffect.10representsworstcase,1representsleastsevere.Causes

Thisisthelistofcausesand/orpotentialcausesofthefailuremode.Occurrence

Thisisaranking,onascaleprovided,ofthelikelihoodofthefailureoccurring.10representsnearcertainty;1represents6sigma.InthecaseofaSixSigmaproject,occurrenceisgenerallyderivedfromdefectdata.CurrentControls

Allmeansofdetectingthefailurebeforeproductreachestheend user,arelistedundercurrentcontrols.Detection Theeffectivenessofeachcurrentcontrolmethodisratedonaprovidedscalefrom1to10.A10impliesthecontrolwillnotdetectthepresenceofafailure;a1suggestsdetectionisnearlycertain.79ElementsofFMEAFailureModeProcessFailureModeThepotentialfailuremodeisthemannerinwhichtheprocesscouldfailtoperformitsintendedfunction.Thefailuremodeforaparticularoperationcouldbeacauseinasubsequent(downstream)operationoraneffectassociatedwithapotentialfailureinaprevious(upstream)operation.FAILUREMODEEFFECTPREVIOUSOPERATIONCAUSENEXTOPERATION80ProcessFailureModeThepotentProcessCauses

ProcessFMEAconsidersprocessvariabilitydueto:OPERATORSET-UPMACHINEMETHODENVIRONMENTMEASUREMENT81ProcessCausesProcessFMEACurrentControlsAssessmentoftheabilityofthecontroltodetectthefailurebeforetheitemleavesthemanufacturingareaandshipstothecustomer.CapabilityofallcontrolsintheprocesstopreventescapesSPCProcessCapabilityGageR&RSamplingTestingDOE82CurrentControlsAssessmentofTypesofMeasuresSEVERITYAsitappliestotheeffectsonthelocalsystem,nextlevel,andenduserOCCURRENCELikelihoodthataspecificcausewilloccurandresultinaspecificfailuremodeDETECTIONAbilityofthecurrent/proposedcontrolmechanismtodetectandidentifythefailuremodeTypically,threeitemsarescored:83TypesofMeasuresSEVERITYTypicRiskPriorityNumberRPN=OxSxD

Occurrencex Severityx DetectionOSD

xx=RPN84RiskPriorityNumberOSDxx=RPShortcomingsofRPN

A 8

4 3 96 B 4

8 3 96SAMERESULTFailureModeSeverityOccurrenceEffectivenessRPN85ShortcomingsofRPNSAMERESULTSeverity86Severity23Occurance87Occurance24Detection88Detection25Itisconductedonatimely

basisand

Itisappliedbyaproduct

teamandItsresultsaredocumentedFMEAisMostEffectiveWhen89ItisconductedonatimelybaWhatIsAGoodApplication?InvolvenewtechnologyHavechangedfrompreviousArechronicallyintroubleHaveahighdegreeofoperatorcontrolHaveahighdegreeofvariationChoosedesignsorprocesseswhich...InvolvenewtechnologyHavechangedfrompreviousArechronicallyintroubleHaveahighdegreeofoperatorcontrolHaveahighdegreeofvariationChoosedesignsorprocesseswhich...90WhatIsAGoodApplication?InvFMEAProcessManufacturingEngineerBuyerProcessOperatorProcessKnowledgePreviousExperiencePastProblemsChronicProblemsReliabilityEngineerProcessFunctions,PotentialFailureModesEffects,Causes,CurrentControlsActionPriorityActionstoEliminateorReduceFailureModeWarrantyClaims91FMEAProcessManufacturingBuyeBasicSteps1.DevelopaStrategy92BasicSteps1.DevelopaStrate1.DevelopaStrategy2.Reviewthedesign/process

EFFECTCAUSESBasicSteps931.DevelopaStrategyEFFBasicSteps1.DevelopaStrategy2.Reviewthedesign/process3.ListfunctionsDevelopaStrategyReviewthedesign/processListfunctions94BasicSteps1.DevelopaStrate1.DevelopaStrategy2.Reviewthedesign/process3.Listfunctions4.BrainstormpotentialfailuremodesBasicStepsBasicSteps:1.Developastrategy2.Reviewthedesign/process3.Listfunctions4.Brainstormpotentialfailuremodes951.DevelopaStrategyBasicSte1.DevelopaStrategy2.Reviewthedesign/process3.Listfunctions4.Brainstormpotentialfailuremodes5.Organizepotentialfailure