潛在的失效模式及其效應(yīng)分析FMEA培訓(xùn)教材課件

潛在的失效模式及其效應(yīng)分析

（FMEA）培訓(xùn)員:王運(yùn)良潛在的失效模式及其效應(yīng)分析

（FMEA）培訓(xùn)員:王運(yùn)良1內(nèi)容課程目的什么是FMEAFMEA的起源為什么要用FMEAFMEA的分類(lèi)什么時(shí)候用FMEA特殊特性在FMEA怎樣做FMEA怎樣降低過(guò)程的風(fēng)險(xiǎn)（RPN）FMEA中常見(jiàn)的問(wèn)題缺陷樹(shù)分析和FMEA內(nèi)容課程目的2課程目的明白FMEA的角色和作用明白過(guò)程FMEA（DFMEA）的概念和技術(shù)以及怎樣應(yīng)用明白設(shè)計(jì)FMEA（DFMEA）的概念了解缺陷樹(shù)分析（FTA）了解零缺陷質(zhì)量控制和防錯(cuò)法的概念以及他們對(duì)FMEA的含意課程目的明白FMEA的角色和作用3什么是FMEA?潛在的失效模式及其效應(yīng)分析潛在的而不只是現(xiàn)有的失效模式研究的對(duì)象效應(yīng)（后果）失效模式的影響什么是FMEA?潛在的失效模式及其效應(yīng)分析4是一個(gè)前期質(zhì)量策劃的工具用來(lái)評(píng)估潛在的失效模式和失效模式產(chǎn)生的原因區(qū)分失效的優(yōu)先次序。根據(jù)失效模式的風(fēng)險(xiǎn)和所采取的行動(dòng)來(lái)消滅和減少發(fā)生的幾率。提供一個(gè)方法用來(lái)分析制程并持續(xù)改進(jìn)。FMEA必須與別的質(zhì)量工具結(jié)合才能更好的解決問(wèn)題，如DOE，SPC，因果分析圖等FMEA的焦點(diǎn)是通過(guò)問(wèn)題的前攝來(lái)達(dá)到預(yù)防的目的而不是解決現(xiàn)有的問(wèn)題。什么是FMEA?是一個(gè)前期質(zhì)量策劃的工具用來(lái)評(píng)估潛在的失效模式和失效模式產(chǎn)生5FMEA的分類(lèi)三種類(lèi)型的FMEA系統(tǒng)FMEA(SFMEA)設(shè)計(jì)FMEA(DFMEA)過(guò)程FMEA(PFMEA)FMEA的分類(lèi)三種類(lèi)型的FMEA6FMEA的起源FMECA（FailureModeEffectsandCriticalityAnalysis）失效模式的后果及其危險(xiǎn)程度分析起源于20世紀(jì)50年代－航空航天業(yè)以及美國(guó)軍工業(yè)分類(lèi)和等級(jí)目標(biāo)是預(yù)防致命的問(wèn)題的發(fā)生特別強(qiáng)調(diào)安全問(wèn)題FMEA失效模式及其效應(yīng)分析-1960’s和70’s首先使用FMEA的是可靠性工程師FMEA的起源FMECA（FailureModeEff7為什么要用FMEA?歐美發(fā)達(dá)國(guó)家制定的質(zhì)量責(zé)任的有關(guān)法律法規(guī)的條款FMEA的“嚴(yán)重度”第10等級(jí)體現(xiàn)了這一點(diǎn)違反法律法規(guī)人身安全案例：針對(duì)Ford汽車(chē)的索賠案三菱帕杰羅剎車(chē)故障案Ford和凡士通的官司事關(guān)企業(yè)的存亡！為什么要用FMEA?歐美發(fā)達(dá)國(guó)家制定的質(zhì)量責(zé)任的有關(guān)法律法規(guī)8汽車(chē)行業(yè)QS9000和TS16949APQP手冊(cè)過(guò)程安全管理行動(dòng)(PSM)（美國(guó)職業(yè)安全健康局）CFR1910.119999999列出PFMEA是六種方法中的一種用來(lái)評(píng)估危險(xiǎn)性FDA（美國(guó)藥品管理局）-GMPs設(shè)計(jì)FMEA是其中一個(gè)工具用來(lái)評(píng)估一個(gè)新的設(shè)計(jì)。ISO9001預(yù)防行動(dòng)的要求.FMEA是一個(gè)很好的持續(xù)改進(jìn)的工具來(lái)符合這個(gè)條款的要求。ISO14000可以用來(lái)評(píng)估有害物質(zhì)的風(fēng)險(xiǎn)。

為什么用FMEA？汽車(chē)行業(yè)為什么用FMEA？9一個(gè)早期的FMEA一個(gè)早期的FMEA10SFMEA從概念開(kāi)發(fā)的開(kāi)始階段到正式的設(shè)計(jì)方案開(kāi)始前。用于評(píng)估系統(tǒng)的失效風(fēng)險(xiǎn)DFMEA從概念開(kāi)發(fā)的后期階段開(kāi)始到設(shè)計(jì)方案完成。用于評(píng)估設(shè)計(jì)的失效風(fēng)險(xiǎn)PFMEA從設(shè)計(jì)開(kāi)發(fā)完成開(kāi)始到產(chǎn)品的試產(chǎn)前。用于評(píng)估制造過(guò)程的失效風(fēng)險(xiǎn)。什么時(shí)候做FMEA？SFMEA什么時(shí)候做FMEA？11FMEA的時(shí)間表DFMEA:從過(guò)程的早期開(kāi)始.設(shè)計(jì)的草圖完成后，在任何的工具設(shè)計(jì)開(kāi)始前。PFMEA:從過(guò)程開(kāi)發(fā)的早期階段開(kāi)始，已經(jīng)大致確定了過(guò)程的初步方案。應(yīng)在量產(chǎn)的方案確定之前或量產(chǎn)批準(zhǔn)前。概念設(shè)計(jì)設(shè)計(jì)設(shè)計(jì)完成試生產(chǎn)產(chǎn)品和過(guò)程批準(zhǔn)量產(chǎn)開(kāi)始PFMEADFMEASFMEAFMEA的時(shí)間表DFMEA:概念設(shè)計(jì)設(shè)計(jì)設(shè)計(jì)完12三種FMEA之間的關(guān)系SFMEAPFMEADFMEA失效模式后果原因來(lái)自SFMEA中的問(wèn)題的原因來(lái)自SFMEA有著更好定義的中的后果對(duì)設(shè)計(jì)失效的新的根本原因來(lái)自DFMEA中的問(wèn)題的原因與DFMEA相同的后果對(duì)過(guò)程失效模式的特定的根本原因問(wèn)題的分支問(wèn)題問(wèn)題的原因三種FMEA之間的關(guān)系SFMEAPFMEADFMEA失效模13系統(tǒng)設(shè)計(jì)制程零件子系統(tǒng)主系統(tǒng)人員機(jī)器方法物料測(cè)量環(huán)境零件子系統(tǒng)主系統(tǒng)把系統(tǒng)失效模式的后果最小化焦點(diǎn)把設(shè)計(jì)的失效模式的后果最小化焦點(diǎn)最大化系統(tǒng)的質(zhì)量，可靠性，成本和可維護(hù)性目標(biāo)最大化設(shè)計(jì)的質(zhì)量，可靠性，成本和可維護(hù)性目標(biāo)機(jī)器工具，工作崗位，生產(chǎn)線，員工培訓(xùn)，制程，量具把整個(gè)制程的失效模式的后果最小化焦點(diǎn)最大化整個(gè)制程的質(zhì)量，可靠性，成本和可維護(hù)性目標(biāo)三種FMEA之間的關(guān)系系統(tǒng)設(shè)計(jì)制程零件子系統(tǒng)14潛在的失效模式及其效應(yīng)分析FMEA培訓(xùn)教材課件15典型的汽車(chē)產(chǎn)品發(fā)展的三步曲產(chǎn)品流程圖和產(chǎn)品的工程規(guī)格PFMEA控制計(jì)劃輸入輸出過(guò)程客戶(hù)的要求是什么？？典型的汽車(chē)產(chǎn)品發(fā)展的三步曲產(chǎn)品流程圖和產(chǎn)品的工程規(guī)格PFME16典型的汽車(chē)產(chǎn)品發(fā)展的三步曲PFMEA（包括所有的過(guò)程）關(guān)鍵特性和失效的后果DFMEA過(guò)程的控制計(jì)劃（來(lái)自PFMEA的關(guān)鍵過(guò)程）關(guān)鍵特性和特性的控制可能被包括的一些元素流程圖（包括所有的過(guò)程）APQP時(shí)間表典型的汽車(chē)產(chǎn)品發(fā)展的三步曲PFMEA關(guān)鍵特性和失效的后果DF17典型的汽車(chē)產(chǎn)品發(fā)展的三步曲過(guò)程的流向及清單檢查客戶(hù)的要求選擇每一個(gè)“關(guān)鍵”的過(guò)程到FMEA表中評(píng)估每一個(gè)過(guò)程的FMEA項(xiàng)目發(fā)展包含了特殊特性的控制計(jì)劃仔細(xì)考慮所選的“關(guān)鍵”過(guò)程用適當(dāng)?shù)腞PN數(shù)值和一些別的意見(jiàn)來(lái)決定關(guān)鍵的特性（過(guò)程）發(fā)展針對(duì)特殊特性的控制機(jī)制仔細(xì)考慮控制計(jì)劃的各個(gè)階段：－樣板－試產(chǎn)－量產(chǎn)注意：FMEA＝還應(yīng)當(dāng)包含對(duì)產(chǎn)品特殊特性的評(píng)估。典型的汽車(chē)產(chǎn)品發(fā)展的三步曲過(guò)程的流向及清單檢查客戶(hù)的要求選擇18SomeKeyFMEATermsCustomerInputTeam-TeamSelection(Cross-Functional)Ranking-RankingofDecisionsRiskPriorityAssessment?DesignProcess?ProductionProcessSomeKeyFMEATermsCustomerIn19AutomotiveAcronyms:AIAG:AutomotiveIndustryActionGroupAPQP:AdvancedProductQualityPlanningDFMEA:DesignFailureModeandEffectsAnalysisDOE:DesignofExperimentsFMA:FailureModesAnalysisFMEA:FailureModeandEffectsAnalysisKCC:KeyControlCharacteristicKPC:KeyProductCharacteristicPFMEA:ProcessFailureModeandEffectsAnalysisPPAP:ProductionPartApprovalProcessPSW:ProductSubmissionWarrantQFD:QualityFunctionDeploymentAutomotiveAcronyms:AIAG:Auto20AutomotiveMadnessAutomotiveMadness21特殊特性產(chǎn)品的特殊特性尺寸，性能參數(shù)。。。影響產(chǎn)品的功能，可靠性，壽命，耐用性，安全性可能影響法律法規(guī)的符合性一般由客戶(hù)指定，圖紙上用特殊的符號(hào)標(biāo)出。如“à”，“?”等。特殊特性產(chǎn)品的特殊特性22特殊特性過(guò)程的特殊特性可能產(chǎn)品的影響產(chǎn)品的功能，可靠性，壽命，耐用性，安全性，或可能影響法律法規(guī)的符合性或產(chǎn)品后續(xù)生產(chǎn)過(guò)程的制造過(guò)程參數(shù)。一般通過(guò)FMEA評(píng)估產(chǎn)生，由制造商自己指定。產(chǎn)品和過(guò)程的特殊特性都應(yīng)當(dāng)包含在控制計(jì)劃中。特殊特性過(guò)程的特殊特性23CharacteristicsICharacteristicsI24CharacteristicsIICharacteristicsII25CharacteristicsIIICharacteristicsIII26CharacteristicsIVCharacteristicsIV27CharacteristicsVCharacteristicsV28怎樣用FMEA評(píng)估過(guò)程的風(fēng)險(xiǎn)？什么是失效模式一般指的產(chǎn)品的失效（缺陷）。這些缺陷可能是功能，裝配，外形方面的問(wèn)題，對(duì)客戶(hù)滿(mǎn)意度有不同程度的影響。注意：不一定是外部客戶(hù)，有可能指的是內(nèi)部客戶(hù)。怎樣用FMEA評(píng)估過(guò)程的風(fēng)險(xiǎn)？什么是失效模式29潛在的失效模式及其效應(yīng)分析FMEA培訓(xùn)教材課件30潛在的失效模式及其效應(yīng)分析FMEA培訓(xùn)教材課件31怎樣用FMEA評(píng)估過(guò)程的風(fēng)險(xiǎn)？失效模式的風(fēng)險(xiǎn)度一般用RPN（風(fēng)險(xiǎn)度序數(shù)）來(lái)表示過(guò)程的風(fēng)險(xiǎn)度，RPN最小為1，最大是1000。RPN越大，被評(píng)估過(guò)程的風(fēng)險(xiǎn)越大。

怎樣用FMEA評(píng)估過(guò)程的風(fēng)險(xiǎn)？失效模式的風(fēng)險(xiǎn)度32潛在的失效模式及其效應(yīng)分析FMEA培訓(xùn)教材課件33怎樣用FMEA評(píng)估過(guò)程的風(fēng)險(xiǎn)？失效模式的嚴(yán)重度（S）一般用S（嚴(yán)重度）來(lái)表示產(chǎn)品的缺陷對(duì)最終使用，或下道工序，以及客戶(hù)滿(mǎn)意度的影響程度。D最小為1，最大是10。D越大，產(chǎn)品的缺陷越嚴(yán)重，缺陷造成的后果

越嚴(yán)重。怎樣用FMEA評(píng)估過(guò)程的風(fēng)險(xiǎn)？失效模式的嚴(yán)重度（S）34怎樣用FMEA評(píng)估過(guò)程的風(fēng)險(xiǎn)？失效模式的發(fā)生頻率（O）用O（發(fā)生頻率）來(lái)表示產(chǎn)品的缺陷的可能性。O最小為1，最大是10。O越大，產(chǎn)品的缺陷發(fā)生的可能性越大。怎樣用FMEA評(píng)估過(guò)程的風(fēng)險(xiǎn)？失效模式的發(fā)生頻率（O）35怎樣用FMEA評(píng)估過(guò)程的風(fēng)險(xiǎn)？失效模式的不可探測(cè)度（D）用D（不可探測(cè)度）來(lái)表示產(chǎn)品的缺陷的被發(fā)現(xiàn)的可能性。D最小為1，最大是10。D越大，產(chǎn)品的缺陷越難以被探測(cè)到的可能性越小。怎樣用FMEA評(píng)估過(guò)程的風(fēng)險(xiǎn)？失效模式的不可探測(cè)度（D）36潛在的失效模式及其效應(yīng)分析FMEA培訓(xùn)教材課件37潛在的失效模式及其效應(yīng)分析FMEA培訓(xùn)教材課件38潛在的失效模式及其效應(yīng)分析FMEA培訓(xùn)教材課件39怎樣做PFMEA？成立一個(gè)跨部門(mén)的小組制造（工藝）工程師設(shè)備工程師設(shè)計(jì)工程師品質(zhì)工程師生產(chǎn)工程師/主管可靠性工程師工業(yè)工程師等。。。在開(kāi)始FMEA前，把小組的人員先寫(xiě)在FMEA表格的上邊。一般是組長(zhǎng)怎樣做PFMEA？成立一個(gè)跨部門(mén)的小組一般是組長(zhǎng)40潛在的失效模式及其效應(yīng)分析FMEA培訓(xùn)教材課件41潛在的失效模式及其效應(yīng)分析FMEA培訓(xùn)教材課件42潛在的失效模式及其效應(yīng)分析FMEA培訓(xùn)教材課件43潛在的失效模式及其效應(yīng)分析FMEA培訓(xùn)教材課件44潛在的失效模式及其效應(yīng)分析FMEA培訓(xùn)教材課件45潛在的失效模式及其效應(yīng)分析FMEA培訓(xùn)教材課件46潛在的失效模式及其效應(yīng)分析FMEA培訓(xùn)教材課件47潛在的失效模式及其效應(yīng)分析FMEA培訓(xùn)教材課件48潛在的失效模式及其效應(yīng)分析FMEA培訓(xùn)教材課件49怎樣做PFMEA？2.定義所涉及的產(chǎn)品的特殊特性：客戶(hù)圖紙規(guī)格書(shū)等。。必要時(shí)應(yīng)與客戶(hù)溝通，以確保領(lǐng)會(huì)客戶(hù)的要求。怎樣做PFMEA？2.定義所涉及的產(chǎn)品的特殊特性：50潛在的失效模式及其效應(yīng)分析FMEA培訓(xùn)教材課件51練習(xí)1指定一個(gè)產(chǎn)品，并定義產(chǎn)品的特殊特性。練習(xí)1指定一個(gè)產(chǎn)品，并定義產(chǎn)品的特殊特性。52怎樣做PFMEA？3.畫(huà)出產(chǎn)品的生產(chǎn)流程圖.怎樣做PFMEA？3.畫(huà)出產(chǎn)品的生產(chǎn)流程圖.53PROCESSFLOWDOCUMENT?FlowCHART,PreliminaryProcessDescriptionofanticipatedmanufacturingprocessdevelopedfrompreliminarybillofmaterialandproduct/processassumptions.(P10#1.10APQP)&(P104APQP)?FlowDIAGRAM,ProcessDepictstheflowofmaterialsthroughtheprocess,includinganyreworkorrepairoperations.(P50PPAP)PROCESSFLOWDOCUMENT?FlowCH54潛在的失效模式及其效應(yīng)分析FMEA培訓(xùn)教材課件55潛在的失效模式及其效應(yīng)分析FMEA培訓(xùn)教材課件56潛在的失效模式及其效應(yīng)分析FMEA培訓(xùn)教材課件57潛在的失效模式及其效應(yīng)分析FMEA培訓(xùn)教材課件58潛在的失效模式及其效應(yīng)分析FMEA培訓(xùn)教材課件59潛在的失效模式及其效應(yīng)分析FMEA培訓(xùn)教材課件60潛在的失效模式及其效應(yīng)分析FMEA培訓(xùn)教材課件61HowToUseTheFlowChart?Usetohelpdeterminewhoshouldbeinvolvedbyidentifyingalltheworkareasinaprocess?Useasajobaidtoremindpeopleaboutprocessstandards?Useasachecklisttocollectdataonwhereproblemsoccur?Usetoinvestigatewhyreworkisoccurringatacertainplaceintheprocess?Usethe‘idealprocess’flowchartdatatocommunicateyourproposedsolutionHowToUseTheFlowChart62FlowChartTips?Ifaprocesssteporboxhastwooutputarrows,considerwhetheradecisionboxisneeded?Rememberthatthepeopleclosesttotheworkknowitbest.Makesurepeopleareinvolvedindevelopingtheflowchart?Softwarepackagesmakeflowchartproductioneasy.FlowChartTips63怎樣做PFMEA？4.把出對(duì)產(chǎn)品的特殊特性有影響的過(guò)程先標(biāo)出來(lái)，這些過(guò)程應(yīng)當(dāng)優(yōu)先評(píng)估。5。把對(duì)下道工序有影響的工序標(biāo)出來(lái)，這些過(guò)程也應(yīng)當(dāng)優(yōu)先評(píng)估。6。把每道工序的功能寫(xiě)下來(lái)。

思考：想一下，為什么？？怎樣做PFMEA？4.把出對(duì)產(chǎn)品的特殊特性有影響的過(guò)程先標(biāo)64練習(xí)2畫(huà)出產(chǎn)品的生產(chǎn)流程圖.把出對(duì)產(chǎn)品的特殊特性有影響的過(guò)程先標(biāo)出來(lái)，這些過(guò)程應(yīng)當(dāng)優(yōu)先評(píng)估。把對(duì)下道工序有影響的工序標(biāo)出來(lái)，這些過(guò)程也應(yīng)當(dāng)優(yōu)先評(píng)估。把每道工序的功能寫(xiě)下來(lái)。練習(xí)2畫(huà)出產(chǎn)品的生產(chǎn)流程圖.65怎樣做PFMEA？7.列出每一個(gè)過(guò)程的失效模式，即每一個(gè)過(guò)程可能產(chǎn)生的缺陷。注意：是可能發(fā)生的缺陷，是潛在的，不一定是已有發(fā)生的。8.評(píng)估每一個(gè)缺陷可能造成的后果，根據(jù)FMEA的規(guī)則對(duì)后果進(jìn)行評(píng)分。即S的分?jǐn)?shù)。怎樣做PFMEA？7.列出每一個(gè)過(guò)程的失效模式，即每一個(gè)66潛在的失效模式及其效應(yīng)分析FMEA培訓(xùn)教材課件67潛在的失效模式及其效應(yīng)分析FMEA培訓(xùn)教材課件68潛在的失效模式及其效應(yīng)分析FMEA培訓(xùn)教材課件69潛在的失效模式及其效應(yīng)分析FMEA培訓(xùn)教材課件70潛在的失效模式及其效應(yīng)分析FMEA培訓(xùn)教材課件71潛在的失效模式及其效應(yīng)分析FMEA培訓(xùn)教材課件72潛在的失效模式及其效應(yīng)分析FMEA培訓(xùn)教材課件73潛在的失效模式及其效應(yīng)分析FMEA培訓(xùn)教材課件74潛在的失效模式及其效應(yīng)分析FMEA培訓(xùn)教材課件75潛在的失效模式及其效應(yīng)分析FMEA培訓(xùn)教材課件76潛在的失效模式及其效應(yīng)分析FMEA培訓(xùn)教材課件77潛在的失效模式及其效應(yīng)分析FMEA培訓(xùn)教材課件78潛在的失效模式及其效應(yīng)分析FMEA培訓(xùn)教材課件79FMEA–RatingofS,O,DFMEA–RatingofS,O,D80潛在的失效模式及其效應(yīng)分析FMEA培訓(xùn)教材課件81潛在的失效模式及其效應(yīng)分析FMEA培訓(xùn)教材課件82RecommendedActions?WhenthefailuremodeshavebeenrankedbytheirRPN,correctiveactionsshouldbefirstdirectedatthehighestrankedconcernsandcriticalitemsidentified.?Theintentofanyrecommendedactionistoreduceoneormore(orall)oftheoccurrence,severityand/ordetectionrankings.?Onlyadesignrevisioncanbringaboutareductionintheseverityranking.Ifnoactionsarerecommendedforaspecificcause,thisshouldbeindicated.?Areductionintheoccurrencerankingcanonlybeeffectedbyremovingorcontrollingoneormoreofthecausesofthefailuremodethroughadesignrevision.?AnincreaseindesignverificationactionswillresultinareductioninthedetectionrankingONLY.?DesignFMEAdoesn’trelyonprocesscontrolstoovercomepotentialweaknessesinthedesign;however,itdoestaketechnicalandphysicallimitationsofaprocessintoconsideration(DesignRules)RecommendedActions83潛在的失效模式及其效應(yīng)分析FMEA培訓(xùn)教材課件84TheProcessPotentialFMEA?Identifiespotentialproduct-relatedfailuremodes?Assessesthepotentialcustomereffectsofthefailures?Identifiesthepotentialinternalandexternalmanufacturingorassemblyprocesscausesandidentifiesprocessvariablesonwhichtofocuscontrolsforoccurrencereductionand/ordetectionofthefailurecondition(s)?Developsrankedlistofpotentialfailuremodes,thusestablishingaprioritysystemforcorrectiveactionconsiderations?DocumentstheresultsofthemanufacturingorassemblyprocessTheProcessPotentialFMEA85ProcessPotentialFMEA?AProcessPotentialFMEAisananalyticaltoolutilizedbyaProcessFMEAteamasameanstoensurepotentialfailuremodesandtheirassociatedcausesareidentified,consideredandaddressed.?Teamsshouldberunbytheowneroftheprocessorsomeonewhounderstandstheprocesswell.?Definesreasonsforrejectionatspecificoperations.?InpreparationfortheFMEA,theassumptionshouldbemadethattheincomingpartsandmaterialsarecorrect.?Acomparisonofsimilarprocessesandareviewofcustomerclaimsrelatingtosimilarcomponentsisarecommendedstartingpoint.Aknowledgeofthepurposeofthedesignisnecessary.?Itcanbecause-associatedwithapotentialfailuremodeinasubsequentoperationoraneffectassociatedwithapotentialfailureinapreviousoperation.?Eachpotentialfailuremodefortheparticularoperationshouldbelistedintermsofapartorprocesscharacteristic.ProcessPotentialFMEA86潛在的失效模式及其效應(yīng)分析FMEA培訓(xùn)教材課件87ProcessFMEAFociCustomersinclude:?EndUser?NextManufacturingorProcessStep?ProcessEngineers?AssemblyEngineers?RepairFunctions?TestEngineers?ProductAnalysis?DealershiporotherSalesOutletProcessFMEAFoci88ProcessFMEABenefits?Asasystematicapproach,theProcessPotentialFMEAparallelsandformalizesthementaldisciplinethatanengineergoesthroughinanymanufacturingplanningprocess.?TheProcessPotentialFMEAidentifiespotentialproductrelatedprocessfailuremodes.?TheProcessPotentialFMEAassessesthepotentialcustomereffectsofthefailures.?TheProcessPotentialFMEAidentifiespotentialmanufacturingand/orassemblyprocesscauses.?TheProcessPotentialFMEAidentifiessignificantprocessvariablestofocuscontrolsforoccurrencereductionanddetectionoffailureconditions.?TheProcessPotentialFMEAdevelopsalistofpotentialfailuremodesrankedaccordingtotheiraffectonthecustomer,thusestablishingaprioritysystemforcorrectiveandpreventiveactionconsiderations.ProcessFMEABenefits89MoreProcessFMEAConsiderations?TheProcessFMEAisalivingdocument.?TheProcessFMEAshouldbecontinuallyupdatedaschangesoccurthroughoutallphasesofproductdevelopmentandonintoandthroughtotheendofproduction.?TheProcessFMEAshouldbeginwithaflowchartoftheprocesses-fromreceivingthroughshippingandwarehousing.?ThePotentialFailureModes/CauseswhichcanoccurduringmanufacturingorassemblyprocessarecoveredbytheProcessFMEAbutsomeinformation(severityrankings,identificationofsomeeffects)maycomefromtheDesignFMEA.Areductioninoccurrencerankingcanonlybeachievedbyimplementingaprocesschangethatcontrolsoreliminatesoneormorecausesofthefailuremode.MoreProcessFMEAConsideratio90潛在的失效模式及其效應(yīng)分析FMEA培訓(xùn)教材課件91GeneralRatingofS,O,DGeneralRatingofS,O,D921.Omittedprocessing2.Processingerrors3.Errorssettingupworkpieces4.Missingparts5.Wrongparts6.Processingwrongworkpiece7.Mis-operation8.Adjustmenterror9.Equipmentnotsetupproperly10.Toolsand/orfixturesimproperlyprepared11.Poorcontrolprocedures12.Improperequipmentmaintenance13.Badrecipe14.Fatigue15.LackofSafety16.Hardwarefailure17.Failuretoenforcecontrols18.Environment19.Stressconnections20.PoorFMEA(s).ProcessFailureCauses11.PoorcontrolproceduresPro931.Standardizedworkinstructions/procedures2.Fixturesandjigs3.Mechanicalinterferenceinterfaces4.Mechanicalcounters5.Mechanicalsensors6.Electrical/Electronicsensors7.JobsheetsorProcesspackages8.Barcodingwithsoftwareintegrationandcontrol9.Marking10.Trainingandrelatededucationalsafeguards11.VisualChecks12.Gagestudies13.Preventivemaintenance14.Automation(RealTimeControl)ControlscanbeprocesscontrolssuchasfixturefoolproofingorSPC,orcanbepost-processinspection/testing.Inspection/testingmayoccuratthesubjectoperationoratsubsequentoperation(s)thatcandetectthesubjectfailuremode.ProcessControlExamples1.Standardizedworkinstructi94TypicalProcessDocuments?SPCrecords?Visualaides?Workinstructions?Inspectioninstructions/records?Equipmentoperatinginstructions?Trainingrecords?TraceabilityrecordsTypicalProcessDocuments95RecommendedActions?CorrectiveActionshouldbefirstdirectedatthehighestconcernsasrankorderedbyRPN.?Theintentofanyrecommendedactionistoreducetheoccurrence,severityand/ordetectionrankings.?Ifnoactionsarerecommendedforaspecificcause,thenthisshouldbeindicated.?Onlyadesignrevisioncanbringaboutareductionintheseverityranking.?Toreducetheprobabilityofoccurrence,processand/orspecificationrevisionsarerequired.?Toincreasetheprobabilityofdetection,processcontroland/orinspectionchangesarerequired.Improvingdetectioncontrolsistypicallycostly.Theemphasisshouldbeplacedonpreventing,ratherthandetecting,defects.RecommendedActions96?Fault-treeanalysisisadeductiveprocessEspeciallyusefulforAnalyzingfailures,whenthecausesoffailureshavenotbeenidentified?ReliabilityengineeringToolMotorFailureTheRoleandFunctionofFTAMotorFailure?Fault-treeanalysisisaded97潛在的失效模式及其效應(yīng)分析FMEA培訓(xùn)教材課件98FaultTreeSymbols?TheEllipseThetopevent,theellipse,containsthedescriptionofthesystem-levelfaultorundesiredevent.Thissymbolappearsattheheadortopofthetreeandisincludedonlyonceinanytree.Theinputtotheellipseisfromalogicgate.?TheRectangleThefaultevent,therectangle,containsabriefdescriptionofalower-levelfault.Thisdescriptionshouldbeshortwithoutbeingvague.Faulteventsappearthroughoutthetreeandhaveboththeirinputandoutputfromalogicgate.?LogicGatesLogicGateinputsandoutputs,exceptfortheInhibitGate,whichisaddressedbelow,havesimilarconnections.TheoutputfromalogicgateistoanyfaulteventblockortoaTransferOutfunction.TheinputisfromanyfaulteventblockorfromaTransferInfunction.TheANDGateisthelogicgateinwhichtheoutputoccursonlyifallinputsexist.TheORGateisthelogicgateinwhichtheoutputoccursonlyifoneormoreoftheinputeventsoccur.FaultTreeSymbols99FaultTreeFundamentals1.DefiningtheUndesiredEvent(s)(MajorFault(s))a.Theundesiredeventismostoftenthefaultwhich,uponoccurrence,resultsincompletefailureofthesystem,thefailureofaback-upsystem,degradation,oranundetectedfailure.Thisisconsideredcatastrophicfailure.Themajorfaultisafailurewhichcauseslossofavailabilitythroughthedegradationorsystemshut-downand/orposesasafetyhazardtooperatorsand/ormaintenancepersonnel.Theundesiredevent,however,maybeanunusualfailureatasubsystemlevel,therootcauseofwhichisunknown.Anyobservableeventmaybechosenasthe“undesiredevent”.TheanalystmustrecognizethattheFTAwillnotidentifyfailuresunrelatedtothechosenevent.b.Todefinetheundesiredevent,thenormalsystemoperationandenvironmentmustbeknowninordertoallowtheanalysistoshowtheundesiredeventasafailure.Whendefiningtheundesiredevent,caremustbetakentopreventtherangeofthefaultsfrombecomingtoobroad.Forexample,“Failuretocompletetrip”,foranautomobile,isnotspecificenoughtoallowforeaseofanalysis.Thisisbecausefailurecouldvaryfromanairconditioningfault,whichcauseddiscomfort,tolossofenginepower,whichcausedlossofmobility.Bothfaultscouldbeconsideredfailure;however,lossofmobilityisobviouslyamuchmoreseverefaultthanlosingairconditioning.FaultTreeFundamentals100FaultTreeFundamentals(Continued1)2.DefiningTypesofFaultsFaultsfallintotwobasiccategories:operationalandcomponent.OperationFaultTheoperationalfaultisonewhichoccurswhenacomponentisoperatingasitwasdesignedto,butataninappropriatetimeorplace.Anexampleisafailureofacontrolvalvetocloseortointerrupttheintroductionofareactantintoachemicalprocessduetoaninappropriatesignalfromanotherdevice.ComponentFaultThecomponentfaultcanbefurtherdividedintotwosub-categories:primaryandsecondary.APrimarycomponentfaultoccurswhenacomponentfailstofunctioninitsintendedenvironment.Example:Aradarunitdesignedforuseinaircraftwhichfailsduetovibration.ASecondarycomponentfailureoccurswhenacomponentfailstofunctioninanenvironmentotherthantheenvironmentforwhichitisintended.Example:Aradarunitdesignedforacargoaircraftfailsinafighteraircraftduetovibration.FaultTreeFundamentals101FaultTreeFundamentals(Continued2)3.ComparisonofFaultOccurrenceandFaultExistenceThetermFaultOccurrencereferstothefactthatanundesiredeventhastakenplaceandmayormaynotstillexist.FaultExistence,however,impliesthatthefaulthasoccurredandcontinuestoexist.Therefore,thefaultcanbedescribedasbeingeithertransientorpermanent.Duringtheconstructionofthefaulttree,allsystemsanalystsshoulduseFaultOccurrence,ratherthanFaultExistence,asthefocusofinterest.4.ComparisonofFailureCausesandFaultEffectsAfailureisconsideredtobeaninabilitytoperformanormalfunction.Example:Valvedoesnotopen.AfaultisahigherlevelOccurrencewhichisusuallyprecededbyalower-levelfailure,suchasacasingcrackingduetooverheatingbecauseofalackofcoolantinductionduetoaninoperablevalve(lowerleveloffailure).However,afaultmayalsooccurwhennofailureispresent.Example:Coolantvalveoperatesproperly,butthesignaltooperateitencountersadelay.Afaulthasoccurred,butthereisnovalvefailure.Becauseofthis,itcanbestatedthatanyfailurecausesafault,butnoteveryfaultiscausedbyafailure.FailureCategories:a.Component,b.Environment,c.Human,d.Software.FaultTreeFundamentals102FaultTreeConstructionStepsSummary?Determinetheleveltowhichtheexaminationshouldbeconstructed?Beginwiththesystem-levelfault?Fullydescribealleventswhichimmediatelycausethisevent?Witheachlower-levelfault,continuedescribingitsimmediatecausesuntilacomponentlevelfailureorhumanerrorcanbeattributedtothefaultFaultTreeConstructionSteps103FaultTreeConstructionStepsSummary(continued)?Fullydefineeachbranchofthetreebeforebeginninganotherbranch?Duringtheconstructionofthetree,itisadvisabletouseablockdiagramofthesystemtosimplifydeterminingthemainbranches?IftheresultsoftheFMECAonthesystemareavailableatthetimeoftheFTAitisadvisabletousetheresultsindefiningthetopevent(s)FaultTreeConstructionSteps104AnalyzingtheFaultTree1.Determinetheminimalcut-setstosimplifythetree(qualitativeanalysis).2.Determinetheprobabilityofeachinputevent3.Combinetheprobabilityinputstologicgatesasfollows:a.ANDGate-Theprobabilityofoutputistheproductoftheprobabilitiesoftheinputs(P0=Pi1?Pi2...?Pin)b.ORGate-Theprobabilityofoutputisthesumoftheprobabilitiesoftheinputs(P0=Pi1+Pi2...?Pin)4.Combinethegateinputprobabilitiesuntiltheprobabilityofthetopeventisdetermined.AnalyzingtheFaultTree105?Identifythesystemorequipmentlevelfaultstate(s)[undesiredevent(s)]?Constructthefaulttree?PerformtheanalysistothecomponentlevelFault-TreeAnalysisProcedures?Identifythesystemorequip106CriteriaforIdentifyingtheUndesiredEvent?Thetopeventmustbemeasurableanddefinable?Thetopeventmustbeinclusiveofthelowerevents?ThetopeventistheresultofthelowereventsCriteriaforIdentifyingtheU107CluesaboutCauses?Cananyequipmentfailurescontributetothiseffect??Materialfaults??Humanerrors??MethodsandProcedures??Softwareperformance??Maintenanceerrorsortheabsenceofmaintenance??Inaccuraciesormalfunctionofmeasurementdevice(s)??Environmentssuchaschemicals,dust,vibration,shockand/ortemperature?CluesaboutCauses108Errors1Almostallerrorsarecausedbyhumanerror.?Forgetfulness-Sometimesweforgetthingswhenwearenotconcentrating.Example:Apersonforgetstosethis/heralarmclockatnight.Safeguard:Establisharoutinewhichincludescheckingbeforegoingtobed.?Errorsduetomisunderstanding-Sometimeswemakemistakeswhenwejumptothewrongconclusionbeforewe’refamiliarwiththesituation.Example:Apersonusedtoastickshiftpushesthebrakepetalinanautomaticthinkingitistheclutch.Safeguards:Training,checkinginadvance,standardizingworkprocedures.?Errorsinidentification-Sometimeswemisjudgeasituationbecauseweviewittooquicklyoraretoofarawaytoseitclearly.Forexample,a$1billismistakenfora$10bill.Safeguards:Training,attentiveness,vigilance.Errors1109Errors2?Errorsmadebyamateurs-Sometimeswemakemistakesthroughlackofexperience.Example:Anewworkerdoesnotknowtheoperationorisjustbarelyfamiliarwithit.Safeguards:Training,skillbuilding,workstandardization.?Willfulerrors-Sometimeserrorsoccurwhenwedecidethatwecanignoretherulesundercertaincircumstances.Example:Crossingastreetagainstaredlightbecauseweseenocars.Safeguards:Basiceducation,experience.?Inadvertenterrors-Sometimesweare‘a(chǎn)bsentminded’andmakemistakeswithoutknowinghowtheyhappened.Example:Someonelostinthoughttriestocrossthestreetwithoutevennoticingwhetherthelightisredornot.Safeguards:Attentiveness,discipline,workstandardization.?Errorsduetoslowness-Sometimeswemakemistakeswhenouractionsaresloweddownbydelaysinjudgment.Example:Apersonlearningtodriveisslowtosteponthebrake.Safeguards:Skillbuilding,workstandardization.Errors2110Errors3?Errorsduetolackofstandards

-Someerrorsoccurwhentherearenotsuitableinstructionsorworkstandards.Example:Ameasurementmaybelefttoanindividual’sdiscretion.Safeguards:Workstandardization,workinstructions.?Surpriseerrors

-Errorssometimesoccurwhenequipmentrunsdifferentlythanexpected.Example:AMachinemalfunctionwithoutwarning.Safeguards:TotalProductiveMaintenance,workstandardization.?Intentionalerrors

-Somepeoplemakemistakesdeliberately.Crimesandsabotageareexamples.Safeguards:Fundamentaleducation,discipline.Mistakeshappenformanyreasons,butalmostallcanbepreventedifwetaketimetoidentifywhenandwhytheyhappenandthentakestepstopreventthembyusingPoka-Yokemethodswithconsiderationtootheravailablesafeguards.Errors3111MethodsofMistake-Proofing?Variationcontrolusingassemblyaids?Identificationbyvisualtechniques?Poka-YokeMethodsofMistake-Proofing112潛在的失效模式及其效應(yīng)分析FMEA培訓(xùn)教材課件113潛在的失效模式及其效應(yīng)分析FMEA培訓(xùn)教材課件114潛在的失效模式及其效應(yīng)分析FMEA培訓(xùn)教材課件115潛在的失效模式及其效應(yīng)分析FMEA培訓(xùn)教材課件116潛在的失效模式及其效應(yīng)分析

（FMEA）培訓(xùn)員:王運(yùn)良潛在的失效模式及其效應(yīng)分析

（FMEA）培訓(xùn)員:王運(yùn)良117內(nèi)容課程目的什么是FMEAFMEA的起源為什么要用FMEAFMEA的分類(lèi)什么時(shí)候用FMEA特殊特性在FMEA怎樣做FMEA怎樣降低過(guò)程的風(fēng)險(xiǎn)（RPN）FMEA中常見(jiàn)的問(wèn)題缺陷樹(shù)分析和FMEA內(nèi)容課程目的118課程目的明白FMEA的角色和作用明白過(guò)程FMEA（DFMEA）的概念和技術(shù)以及怎樣應(yīng)用明白設(shè)計(jì)FMEA（DFMEA）的概念了解缺陷樹(shù)分析（FTA）了解零缺陷質(zhì)量控制和防錯(cuò)法的概念以及他們對(duì)FMEA的含意課程目的明白FMEA的角色和作用119什么是FMEA?潛在的失效模式及其效應(yīng)分析潛在的而不只是現(xiàn)有的失效模式研究的對(duì)象效應(yīng)（后果）失效模式的影響什么是FMEA?潛在的失效模式及其效應(yīng)分析120是一個(gè)前期質(zhì)量策劃的工具用來(lái)評(píng)估潛在的失效模式和失效模式產(chǎn)生的原因區(qū)分失效的優(yōu)先次序。根據(jù)失效模式的風(fēng)險(xiǎn)和所采取的行動(dòng)來(lái)消滅和減少發(fā)生的幾率。提供一個(gè)方法用來(lái)分析制程并持續(xù)改進(jìn)。FMEA必須與別的質(zhì)量工具結(jié)合才能更好的解決問(wèn)題，如DOE，SPC，因果分析圖等FMEA的焦點(diǎn)是通過(guò)問(wèn)題的前攝來(lái)達(dá)到預(yù)防的目的而不是解決現(xiàn)有的問(wèn)題。什么是FMEA?是一個(gè)前期質(zhì)量策劃的工具用來(lái)評(píng)估潛在的失效模式和失效模式產(chǎn)生121FMEA的分類(lèi)三種類(lèi)型的FMEA系統(tǒng)FMEA(SFMEA)設(shè)計(jì)FMEA(DFMEA)過(guò)程FMEA(PFMEA)FMEA的分類(lèi)三種類(lèi)型的FMEA122FMEA的起源FMECA（FailureModeEffectsandCriticalityAnalysis）失效模式的后果及其危險(xiǎn)程度分析起源于20世紀(jì)50年代－航空航天業(yè)以及美國(guó)軍工業(yè)分類(lèi)和等級(jí)目標(biāo)是預(yù)防致命的問(wèn)題的發(fā)生特別強(qiáng)調(diào)安全問(wèn)題FMEA失效模式及其效應(yīng)分析-1960’s和70’s首先使用FMEA的是可靠性工程師FMEA的起源FMECA（FailureModeEff123為什么要用FMEA?歐美發(fā)達(dá)國(guó)家制定的質(zhì)量責(zé)任的有關(guān)法律法規(guī)的條款FMEA的“嚴(yán)重度”第10等級(jí)體現(xiàn)了這一點(diǎn)違反法律法規(guī)人身安全案例：針對(duì)Ford汽車(chē)的索賠案三菱帕杰羅剎車(chē)故障案Ford和凡士通的官司事關(guān)企業(yè)的存亡！為什么要用FMEA?歐美發(fā)達(dá)國(guó)家制定的質(zhì)量責(zé)任的有關(guān)法律法規(guī)124汽車(chē)行業(yè)QS9000和TS16949APQP手冊(cè)過(guò)程安全管理行動(dòng)(PSM)（美國(guó)職業(yè)安全健康局）CFR1910.119999999列出PFMEA是六種方法中的一種用來(lái)評(píng)估危險(xiǎn)性FDA（美國(guó)藥品管理局）-GMPs設(shè)計(jì)FMEA是其中一個(gè)工具用來(lái)評(píng)估一個(gè)新的設(shè)計(jì)。ISO9001預(yù)防行動(dòng)的要求.FMEA是一個(gè)很好的持續(xù)改進(jìn)的工具來(lái)符合這個(gè)條款的要求。ISO14000可以用來(lái)評(píng)估有害物質(zhì)的風(fēng)險(xiǎn)。

為什么用FMEA？汽車(chē)行業(yè)為什么用FMEA？125一個(gè)早期的FMEA一個(gè)早期的FMEA126SFMEA從概念開(kāi)發(fā)的開(kāi)始階段到正式的設(shè)計(jì)方案開(kāi)始前。用于評(píng)估系統(tǒng)的失效風(fēng)險(xiǎn)DFMEA從概念開(kāi)發(fā)的后期階段開(kāi)始到設(shè)計(jì)方案完成。用于評(píng)估設(shè)計(jì)的失效風(fēng)險(xiǎn)PFMEA從設(shè)計(jì)開(kāi)發(fā)完成開(kāi)始到產(chǎn)品的試產(chǎn)前。用于評(píng)估制造過(guò)程的失效風(fēng)險(xiǎn)。什么時(shí)候做FMEA？SFMEA什么時(shí)候做FMEA？127FMEA的時(shí)間表DFMEA:從過(guò)程的早期開(kāi)始.設(shè)計(jì)的草圖完成后，在任何的工具設(shè)計(jì)開(kāi)始前。PFMEA:從過(guò)程開(kāi)發(fā)的早期階段開(kāi)始，已經(jīng)大致確定了過(guò)程的初步方案。應(yīng)在量產(chǎn)的方案確定之前或量產(chǎn)批準(zhǔn)前。概念設(shè)計(jì)設(shè)計(jì)設(shè)計(jì)完成試生產(chǎn)產(chǎn)品和過(guò)程批準(zhǔn)量產(chǎn)開(kāi)始PFMEADFMEASFMEAFMEA的時(shí)間表DFMEA:概念設(shè)計(jì)設(shè)計(jì)設(shè)計(jì)完128三種FMEA之間的關(guān)系SFMEAPFMEADFMEA失效模式后果原因來(lái)自SFMEA中的問(wèn)題的原因來(lái)自SFMEA有著更好定義的中的后果對(duì)設(shè)計(jì)失效的新的根本原因來(lái)自DFMEA中的問(wèn)題的原因與DFMEA相同的后果對(duì)過(guò)程失效模式的特定的根本原因問(wèn)題的分支問(wèn)題問(wèn)題的原因三種FMEA之間的關(guān)系SFMEAPFMEADFMEA失效模129系統(tǒng)設(shè)計(jì)制程零件子系統(tǒng)主系統(tǒng)人員機(jī)器方法物料測(cè)量環(huán)境零件子系統(tǒng)主系統(tǒng)把系統(tǒng)失效模式的后果最小化焦點(diǎn)把設(shè)計(jì)的失效模式的后果最小化焦點(diǎn)最大化系統(tǒng)的質(zhì)量，可靠性，成本和可維護(hù)性目標(biāo)最大化設(shè)計(jì)的質(zhì)量，可靠性，成本和可維護(hù)性目標(biāo)機(jī)器工具，工作崗位，生產(chǎn)線，員工培訓(xùn)，制程，量具把整個(gè)制程的失效模式的后果最小化焦點(diǎn)最大化整個(gè)制程的質(zhì)量，可靠性，成本和可維護(hù)性目標(biāo)三種FMEA之間的關(guān)系系統(tǒng)設(shè)計(jì)制程零件子系統(tǒng)130潛在的失效模式及其效應(yīng)分析FMEA培訓(xùn)教材課件131典型的汽車(chē)產(chǎn)品發(fā)展的三步曲產(chǎn)品流程圖和產(chǎn)品的工程規(guī)格PFMEA控制計(jì)劃輸入輸出過(guò)程客戶(hù)的要求是什么？？典型的汽車(chē)產(chǎn)品發(fā)展的三步曲產(chǎn)品流程圖和產(chǎn)品的工程規(guī)格PFME