FMEAtraining(中英文对照)

FMEATraining目錄(Contents)一、何謂FMEA(WhatisanFMEA)二、FMEA的種類(TheTypeofFMEA)三、FMEA的實施(FMEAImplementation)四、FMEA的持續追蹤(Follow-Up)五、DFMEA填表說明(DesignFMEA)六、PFMEA填表說明(ProcessFMEA)何謂FMEA(WhatisanFMEA)FMEA:失效模式與效應分析(FailureModeandEffectsAnalysis)FMEA係藉由系統性的小組活動來進行下列工作:AnFMEAcanbedescribedasasystematicgroupofactivitiesintendedto:a.確認及評估產品/製程潛在的失效模式及其影響Recognizeandevaluatethepotentialfailureofaproduct/processandeffectsofthatfailureb.採取消除或降低潛在的失效發生機率Identifyactionsthatcouldeliminateorreducethechanceofthepotentialfailureoccurringc.記載全部的過程DocumenttheentireprocessFMEA的種類(TheTypeofFMEA)1.DFMEA:D→Design設計2.PFMEA:P→Process製程3.SFMEA:S→System系統4.MFMEA:M→Machinery機械設備1.將FMEA當作一專門的技術應用，以消除潛在失效為目的。UsingtheFMEAasadisciplinedtechniquetoidentifyandhelpminimizepotentialconcern2.全面實施FMEA確實能避免許多宣传活动的發生。StudiesofvehiclecampaignshaveshownthatfullyimplementedFMEAprogramscouldhavepreventedmanyofthecampaigns.3.要完成FMEA得依靠小組共同努力。FMEAinputshouldbeateameffort.4.小組成員應由知識或技術豐富人員共同組成而非應付式的派遣單位助理來權充人數。Teammembershouldbeknowledgeableandtechnicalexpert,andnottheassistantscombinedfromeachdepartments.FMEA的實施(FMEAImplementation)5.適時性是成功實施FMEA的重要因素之一，強調「事前的防範」，而非事後「事故的補救」。OneofthemostimportantfactorsforthesuccessfulimplementationofanFMEAprogramistimeliness.Itismeanttobea“before-the-event”action,notan“after-the-fact”exercise.6.FMEA不僅是簡單的填表工作，而是藉由對FMEA的瞭解，以消除風險，使計劃獲得適當的管制，藉以達到客戶的滿意。ItisnotsimplyacaseoffillingouttheformbutratherofunderstandingtheFMEAprocessinordertoeliminateriskandplantheappropriatecontrolstoensurecustomersatisfaction.FMEA的實施(FMEAImplementation)7.潛在FMEA實施步驟:行動結果現行的設計管制項目/失效潛在失效模式失效潛在效應嚴重度等級潛在原因/失效機制發生度預防偵測探測度RPN建議措施責任與目標完成日期採行措施嚴重度發生率探測度R.P.N功能，特微或要求為何？什麼會錯誤？－無功能－部分／過多　／降低功能－間歇功能－不預期功能效應為何？有多不好？原因為何？其發生頻率為何？如何能預防及發現這種原因及錯誤？這種方法發現這種問題有多好？能夠做什麼？－設計變更－製程變更－特別管制－標準，程序書或指引更FMEA的實施(FMEAImplementation)7.FMEAProcessSequence:FMEA的實施(FMEAImplementation)SubsystemFunctionReqt’sPotentialFailureModePotentialEffect(s)ofFailureSEVCLASSPotentialCause(s)/Mechanism(s)ofFailureOCCURCurrentControlsDETECR.P.N.RecommendedAction(s)Responsibility&TargetCompletionDateActionResultsActionsTakenSEVOCCDETR.P.N.PreventionDetectionWhataretheFunctions,FeaturesorRequirements?Whatcangowrong?-NoFunction-Partial/Over/DegradedFunction-IntermittentFunction-UnintendedFunctionWhataretheEffect(s)?Howbadisit?WhataretheCause(s)?Howoftendoesithappen?Howcanthisbepreventedanddetected?Howgoodisthismethodatdetectingit?Whatcanbedone?-DesignChanges-ProcessChanges-SpecialControls-ChangestoStandards,Procedures,orGuides8.實施FMEA的三種時機TherearethreebasiccasesforwhichFMEA’saregenerated,eachwithadifferentscopeorfocus.1.新設計、新技術或新製程Newdesign,newtechnology,ornewprocess2.當現有設計或製造將要變更時Modificationstoexistingdesignorprocess3.當現有設計或製程使用新的環境、位置或應用時Useofanexistingdesignorprocessinanewenvironment,location,orapplicationFMEA的實施(FMEAImplementation)9.FMEA的推動雖由指定專人負責,但其作業展開，應由FMEA小組來完成(一般跨功能小組=FMEA小組)AlthoughresponsibilityforthepreparationoftheFMEAisusuallyassignedtoanindividual,FMEAinputshouldbeateameffort.10.即使產品/製程是一致的，不同小組的比較及評價是不適宜的。Itisnotappropriatetocomparetheratingsofoneteam’sFMEAwiththeratingsofanotherteam’sFMEA,eveniftheproduct/processappearstobeidentical,sinceeachteam’senvironmentisuniqueandthustherespectiveindividualratingswillbeunique.11.FMEA文件的審查建議應對應於公司品質目標，且包含予公司管理審查會議中。AreviewoftheFMEAdocumentagainstFMEAqualityobjectivesisrecommended,includingamanagementreview.FMEA的實施(FMEAImplementation)1.FMEA的持續追蹤是非常重要的Theneedfortakingeffectivepreventive/correctiveactions,withappropriatefollow-uponthoseactions,cannotbeoveremphasized.2.負責工程師應確保所有的建議措施均已有效執行Theresponsibleengineerisinchargeofensuringthatallrecommendedactionshavebeenimplementationoradequatelyaddressed.3.FMEA是個隨時需要更新的文件,縱使該產品已經量產,如有設計或工程變更時亦需更新FMEA內容TheFMEAisalivingdocumentandshouldalwaysreflectthelatestlevel,aswellasthelatestrelevantactions,includingthoseoccurringafterthestartofproduction.FMEA的持續追蹤(Follow-Up)DesignFailureModeandEffectsAnalysis設計失效模式與效應分析DFMEA簡介(Introduction)設計FMEA主要是由負責設計的工程師/小組採用的一種分析技術，用來佐證在可能的範圍內已充分地考慮到，並指明各種潛在的失效模式及其相關的起因/機制。ADesignPotentialFMEAisananalyticaltechniqueusedprimarilybyaDesign-ResponsibleEngineer/Teamasameanstoensurethat,totheextentpossible,potentialfailuremodesandtheirassociatedcauses/mechanismshavebeenconsideredandaddressed.最終成品及所有相關的系統，子系統及零組件都應納入評估。Enditems,alongwitheveryrelatedsystem,subsystem,andcomponent,shouldbeevaluated.FMEA是設計小組想法的摘錄(包括依據經驗有可能失效事項之分析)。Initsmostrigorousform,anFMEAisasummaryoftheteam’sthoughts(includingananalysisofitemsthatcouldgowrongbasedonexperience)asacomponent,subsystem,orsystemisdesigned.根據潛在失效模式對顧客的影響程度，列出優先順序來，並據以建立設計、改善、開發及驗收測試或分析之優先順序系統。Developingarankedlistofpotentialfailuremodesaccordingtotheireffectonthe“customer”,thusestablishingaprioritysystemfordesignimprovements,development,andvalidationtesting/analysis.DFMEA簡介(Introduction)顧客的定義(CustomerDefined)設計FMEA中“顧客”的定義，不僅僅是指“最終使用者”，還包括負責車型設計或更高一級裝配過程設計的工程師/小組，以及在生產過程中負責製造、裝配和售後服務的工程師。Thedefinitionof“Customer”foraDesignFMEAisnotonlythe“EndUser”butalsothedesign-responsibleengineers/teamsofthevehicleorhigher-levelassemblies,and/orthem