FMEA+4th+手冊介紹.ppt

FMEA4th手冊介紹 WhatisanFMEA Asystematicgroupofactivitiesintendedto 團隊活動 recognizeandevaluatethepotentialfailureofaproductorprocessandtheeffectsofthatfailure識別潛在失效模式和后果recognizeandprioritizeALLpotentialcausesofeachfailure Notelinktofishbone 所有潛在失效原因assessriskthroughouttheentireprocess notjustmanufacturing 評估風(fēng)險identifyactionsthatcouldeliminateorreducethechanceofthepotentialfailureoccurring采取行動消除潛在失效模式bea living documentthatshouldalwaysbeupdatedtoreflectcurrentconditions includingchanges動態(tài)文件 FMEAProcessobjectives目標(biāo) TheFMEAdrivesproductandprocessimprovements推動改進(jìn)Addressesallhighriskfailuremodes識別高風(fēng)險失效模式Usedtodevelopcontrolplans用于形成控制計劃Integratedwithprocessflowdiagramandtheprocesscontrolplan結(jié)合流程圖和控制計劃Considersallmajor lessonslearned i e nonconformingproduct warrantydata customercomplaints correctiveactions etc 獲取經(jīng)驗教訓(xùn) Improvementsinthe4theditionFMEAManual第4版手冊的改進(jìn) Changesinformatwithindexfornavigation索引目錄的改變Newformexamplesforguidance用于解釋的新例子Focusonmanagementinvolvementandsupport管理層支持MorefocusonthelinkageofDFMEAandPFMEA強調(diào)了DFMEA和PFMEA的聯(lián)系Improvedexamplesofrankingtables改進(jìn)了等級打分表Significantlyenhancedguidanceandexamples增加了例子和解釋ReducedemphasisonRPN不再強調(diào)RPN值A(chǔ)lternativeapproachesandmethods suchasFaultTreeanalysis引入了其它對失效原因和后果供選擇的分析方法 如故障樹 Chapter1 Introduction FMEAPROCESS Itsmostvisibleresultisthedocumentationofthecollectiveknowledgeofcross functionalteams 跨職能小組的集體知識文件化Timeliness Meanttobea beforetheevent action notan afterthefact exercise 是 事發(fā)前 行為 而不是 后見之明 Canbeappliedtonon manufacturingareas也可以運用于非制造區(qū)域Thereare3basiccasestoapplytheFMEAProcess三種基本情況 Newdesign technology orprocess新設(shè)計 新技術(shù)獲新過程Modificationstoexistingdesignorprocess修改現(xiàn)有的設(shè)計或過程Useofanexistingdesignorprocessinanewenvironment location application etc 在新的環(huán)境 地點 應(yīng)用等中使用現(xiàn)存的設(shè)計或過程 ImpactonOrganizationandManagement對組織和管理的影響 Musthaveprocessownerandseniormanagementcommitment 過程所有人和最高管理部門的承諾是很重要的 Acomprehensivetrainingprogramshouldbeimplementedincluding綜合培訓(xùn)項目的執(zhí)行包括 ManagementOverview管理的縱覽Trainingforusers對使用者培訓(xùn)Suppliertraining供應(yīng)商培訓(xùn)Facilitatortraining 建導(dǎo)者培訓(xùn) Ultimately managementhastheresponsibilityandownershipfordevelopmentandmaintenanceofFMEAs 最終 管理者對FMEA的開發(fā)和維護(hù)有責(zé)任和所有權(quán) FMEAExplained解釋 LinkagetoALL5phasesofAPQP同APQP5個階段緊密聯(lián)系 TheFMEAanalysisshouldnotbeconsideredasingleevent butalongtermcommitment toensurethatpotentialfailuremodesareevaluatedandactionsaretakentoreducetheirrisk 不是一個單獨事件 而是完成產(chǎn)品過程和開發(fā)的長期任務(wù) 以確保對潛在失效進(jìn)行了評估 并采取了措施減少風(fēng)險 ThelanguageusedinFMEAsshouldbeasspecificaspossible e g failuremodesandcauses FMEA語言應(yīng)明確的陳述 簡明扼要的術(shù)語 Follow upandContinuousImprovement持續(xù)改進(jìn) Theneedfortakingeffectivecorrective preventiveactions withappropriatefollo upcannotbeoveremphasized 采取有效的預(yù)防和糾正措施 以及后續(xù)行動跟蹤是需要的 Teamleadershipisinchargeofensuringthatallrecommendedactionshavebeenimplemented 管理層負(fù)責(zé)所有建議措施得以實施 TheFMEAisalivingdocumentandshouldalwaysreflectthelatestlevel aswellasthelatestrelevantactions FMEA是動態(tài)文件 反饋最新狀態(tài) 包括開始生產(chǎn)之后發(fā)生的措施 Chapter2 ManagementResponsibility管理職責(zé) ManagementownstheFMEAprocess Managementhastheultimateresponsibilityofselectingandapplyingresourcesandensuringaneffectiveriskmanagementprocessincludingtiming 管理者擁有FMEA過程 管理者對選擇和應(yīng)用資源 并保證一個包括時間安排得有效的風(fēng)險管理過程的最大責(zé)任 Managementresponsibilityalsoincludesprovidingdirectsupporttotheteamthroughongoingreviews eliminatingroadblocks andincorporatinglessonslearned 管理責(zé)任也包括通過持續(xù)評審為小組提供直接支持 消除障礙和吸取所學(xué)經(jīng)驗 ManagementSupport管理層支持 Mustbelieveintheprocessanditsvalue相信過程和其會產(chǎn)生價值Commitmenttotrainingandcompetenceneeds承諾提供培訓(xùn)Commitmenttoresources承諾提供資源Regularreviewofprocessandresults managementreview 5 6 2 1 定期回顧過程和結(jié)果EnsurethattheFMEAprocessisusedtodriveimprovementsversusjustrecordthem確保FMEA用于過程改進(jìn)而不只是記錄 LinkageofDFMEAandPFMEA DFMEA和PFMEA聯(lián)系Page69 DuringthedevelopmentofthePFMEA theteammayidentifydesignopportunitieswhich ifimplemented wouldeithereliminateorreducetheoccurrenceofaprocessfailuremode Suchinformationmustbeprovidedtotheresponsibledesignengineer 在PFMEA開發(fā)過程中 小組可能識別出設(shè)計機會 這種設(shè)計機會被實施的話 它會消除或降低失效模式發(fā)生的頻度 這樣的信息必須提供給負(fù)責(zé)的設(shè)計工程師 FMEAsareLIVINGdocuments 請記住FMEA是動態(tài)文件 Pages64and110 TheDFMEA PFMEAisalivingdocumentandshouldbereviewedandupdatedwheneverthereisaproductorprocessdesignchange FMEA是動態(tài)文件 只要有產(chǎn)品設(shè)計和過程變更 就應(yīng)該評審和更新Anotherelementofongoingmaintenanceshouldincludeaperiodicreviewoftherankings withspecificfocusontheOandDrankings withparticlularattentiontowherefieldissuesorproductionissueshaveoccurred 對FMEA中等級進(jìn)行評審 應(yīng)放在頻度和探測度的等級上 特別是出現(xiàn)售后市場出現(xiàn)問題或生產(chǎn)出現(xiàn)問題Canwefindevidenceofthishappening withalinkagetowarranty fieldandproductionfailuredata 結(jié)合已發(fā)生的證據(jù) 包括三包數(shù)據(jù) 售后 生產(chǎn)失效件 SignificantlyEnhancedGuidanceandExamples 增加的典型例子和解釋 GuidanceandExpectationofimprovedLinkagetoProcessFlowaskeyinput EnhancedGuidanceonRequirementsandPotentialFailureModes EnhancedGuidanceonEffectsofFailureModes ImprovedRankingCriteria ProvidedasexamplesRecommendedtonotmodifycriteriaforseverity9and10Occurrencescalenowprovidesforlessthan1in100 000 was 1 now 3 SPCremovedfromdetectioncriteria Nowconsideredasapreventioncontrol page95Doestheorganizationuserankingcriteriathatbestreflectstheirproductsandprocessesandusestheentireriskscaleof1000 NewPFMEASeverityCriteria NewPFMEAOccurrenceCriteria EnhancedGuidanceforPreventionvs DetectionControls OperatorerrorisNEVERanacceptablerootcause Theprocessallowedtheoperatortomaketheerror Humanbeingsareonlycapableof3errorsperthousandonarepetitivetask NewPFMEADetectionCriteria Enhancedguidanceonrecommendedactions 建議措施的解釋Seepages59 63forexamplesofrecommendedimprovementactionstoreduceoccurrenceanddetectionrankingfor59 63頁中描述DFMEA減少頻度和探測度的建議改進(jìn)措施 Seepages105 107forexamplesofrecommendedimprovementactionstoreduceoccurrenceanddetectionrankingforPFMEAs 105 107頁對PFMEA中減少頻度和探測度的建議改進(jìn)措施Morefocusonusingstudiesandstatisticalmethodstounderstandthesourcesofvariation 關(guān)注統(tǒng)計方法理解過程變差的來源Morefocusonmistakeproofinganderrorproofing 推薦采用防錯措施Isthecoreteamcompetentontheseconceptsandisthereevidenceoftheireffectiveuse 核心團隊能力能夠且有效執(zhí)行改進(jìn)措施 RecommendedActions建議措施Shouldfocusonreductionof O valuefirst then D 應(yīng)先降低頻度等級然后降低探測度等級Shouldcorrelatewithanycorrectiveorpreventiveactions 采用糾正和預(yù)防措施Thereshouldbea loop fromtheseprocessesthroughtheFMEAstoensureaccurateRPNsatalltimes 整個FMEA過程不斷循環(huán) 保證正確的RPN High SeverityitemsrequirespecialattentionregardlessoftheRPN 對嚴(yán)重度高的要特別關(guān)注 不管其RPN值大小 AlternativeForms AppendixB選擇的表格 The3rdeditionplacedtoomuchemphasisonthestandardform The4theditionprovidesforalternativeexamples多種選擇 Minimumrequirementsaredefined最起碼的要求的定義 pages24 74 3rdeditionformisstillacceptable第三版的表格也可接收Hastheorganizationidentifiedthebestapproachfortheirbusiness組織是否識別對口業(yè)務(wù)中最有效的方法 DoestheFMEAprocessandformsuseddriveimprovementsversusrecordthemFMEA是否有效推動改進(jìn) 而不只是記錄 ExampleofPFMEAFormrecommended SampleReference StopusinganRPNthresholdfordeterminingactions 不要強調(diào)RPN值來決定是否采取改進(jìn)措施Pages57and103 TheuseofanRPNthresholdisNOTarecommendedpracticefordeterminingtheneedforactions AlternativeRiskAssessments供選擇的風(fēng)險評估 SeeAppendixCforafewexamplesthatmighthelptheteambetterprioritizerecommendedactions附錄較多例子解釋排列優(yōu)先等級 SO SeverityxOccurrence focusesonpreventiveactions關(guān)注SxO 強調(diào)預(yù)防措施SOD S 7 O 3 D 5 RPN 105 SOD 735 focusesonseverity thenoccurrence thendete