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1、LOGOManagementRegulation管理规范Number文件编号：WD-PE-OOIDepartment部门：PE工艺SUbjeCtPFMEARegulation过程潜在失效模式和后果分析实施规范Revision版本：EffectiveDate生效日期：Page1of91.02014.7.21批准：审核：作成：ChangeHistorv变更记录Revision版本EffectiveDate生效日期Originator编写人ReasonsforChange修改原因1.02020.7.21Jessica1 .根据第四版FME,重新界定建议措施的评定标准2 .根据最新组织架构，FMEA划
2、分给PE,表单编号更新为AA-PE-OOl1.0Purpose目的TheprocedureprovidesguidanceandregulationsfortheformulationandmaintenanceofPFMEA.本程序是为过程失效模式及后果分析的制定和维护提供指导和规定。2.0Scope范围TheprocedureappliestopotentialPFMEAofproductionprocessofsemi-finishedproductsandfinishedproducts.本程序适用于半成品及成品的生产以及装配过程的过程潜在的失效模式及后果分析。3.0DefinitiO
3、nS定义3.1 FMEA:istheabbreviationofFailureModeandEfectsAnalysis.ItcanbedividedintodesignFMEA(DFMEA)andprocessFMEA(PFMEA)andisamethodofanalysisandadvancedpreventioninordertoeliminateorreducepotentialfailureopportunityofproductandprocess.FMEA:是FailureModeandEfectsAnalysis的简称，即为失效模式及后果分析可分为设计FMEA(DFMEA)及过
4、程FMEA(PFMEA),是为了消除或减少产品或过程的潜在失效发生机会而进行分析及事前预防的方法3.2 RPN:RiskPriorityNumber风险顺序数3.2.1 Severityoffailure(三)1occurrenceoffailurecause/structure,detectionofpotentialcause/structureorfailuremode(D),theproductofseverity,occurrenceanddetection,thatis,RPN=(三)(O)(D).为失效效应的严重度(三),失效原因/结构的发生度(O),检测出潜在原因/结构或检测出
5、失效模式的检出度(D),这三者的乘积,即RPN=(三)*(O)*(D)3.2.2 Whentheseverityis9or10,itisimperativethattheteamensurethattheriskisaddressedthroughexistingdesigncontrolsorrecommendedactions(asdocumentedintheFMEA).当严重度达到9或10,小组必须确保该风险已经通过现有设计控制或者建议措施(在FMEA内有记录)得到处理。3.2.3 AccordingtofourtheditionFMEAManual,theuseofanRPNthre
6、sholdisNOTarecommendedpracticefordeterminingtheneedforactions.根据第四版FMEA手册，不推荐使用RPN阀值来决定是否需要采取措施。3.2.4 Firstforfailuremodeswithseverities*occurrenceof32ormore,theteamshouldconsidetakethereccomendedactions,Throughtoreducedetection,soastoreducetheRPNvalues.ThenconsiderifRPN100,correctiveactionsshallbet
7、akentoreduceRPNtobelow100.首先当严重度*发生度大于等于32的失效模式，小组应当考虑采取必要的建议措施，通过降低探测度或者发生度的评分，来降低RPN值;然后再考虑如果RPN100,则必须采取纠正措施，以便将RPN降到100以下。3.2.5 Ifcustomerhavespecialrequirements,performaccordingtocustomersrequest如果客户有特殊要求，按客户要求执行4.0ReSPOnSibiIity权责PE工艺工程师1.eadtomakeandmodifyPFMEAwithcoreteammember,主导并与核心小组成员一起进
8、行PFMEA的制定以及修改。4.1 QlJalitydePartment质量部协助进行PFMEA的制定与修改SupporttodefineandmodifythePFMEA4.2 Productiondepartment生产部协助进行PFMEA的制定与修改SupporttodefineandmodifythePFMEA5.0ProCedUre程序5.1 PFMEAteamisresponsibleforthepreparationofPFMEAandiscomposedofpersonnelofDevelopmentdepartment,Qualitydepartment,Marketing&
9、Salesdepartment,PurchasingDepartment,Productiondepartmentandsoon.PFMEA小组负责PFMEA的编制，小组主要由项目部、质量部、采购部、生产部等部门人员组成。5.2 DocumentsanddataneededforcompilingPFMEAareasfollows编制PFMEA时所需文件及资料如下。5.2.1 DFMEA5.2.2 Processflowchart过程流程图5.2.3 Customersdrawing/specification,etc.客户的图纸/规范等5.2.4 FMEAofsimilarproductso
10、fthecompany本公司以往类似产品的PFMEA或经验PFMEA5.2.5 Previousdataofcustomercomplaintsorcustomerreturns本公司以往客户抱怨或客户退货资料5.2.6 Statisticaldataofdefectiverateofsimilarproducts本公司类似产品的不良率统计资料5.2.7 Statisticaldataofdefectiveoperationofequipmentandtools设备及工装运行不良的统计资料.5.3 Changerequirements变更条件Accordingtothechangeofcust
11、omerrequirements,material,productionequipment,toolsorprocessChangeS.顾客的要求发生变更时，材料变更时，生产设备或工装变更时，工艺过程变更时。5.4 PFMEA编制方法PFMEAcompilationmethods5.4.1 FMEAnumber:fillinFMEAdocumentnumberforinquiry.、FMEA编号：填入FMEA文件编号，以便查询5.4.2 Applicablescope:recordapplicablenameorprocessofparts适用范围：记录适用的零部件名称或过程5.4.3 Res
12、ponsibilityofprocessdesign:thedepartmentorteamthatfillsinrelatedprocesses过程设计责任：填入相关过程的实行部门或小组5.4.4 Compiler:fillintheinformationsuchasnameandtelephoneofengineerwhoisresponsibleforcompilingFMEA编制者：填入负责编制FMEA的工程师的姓名、电话等信息5.4.5 Keydate:fillinfirstscheduletimeofthecompletionofFMEA关键Fl期：填入初次FMEA应完成的预定时间
13、5.4.6 FMEAdate:fillinthedateofcompilingoriginaltextandlatestrevisiondateofFMEA.FMEA日期：填入编制FMEA原始稿的日期及最新修订的日期5.4.7 Coreteam:listteammemberswhoareresponsibleforcompilingandimplementingFMEA核心小组：列出编制和执行FMEA的小组成员5.4.8 Processfunctionandrequirement:brieflydescribeanalyzedprocessorintentionandcorrespondwit
14、hoperationnumberonprocessflowchart过程功能、要求：简要描述被分析的工艺过程或工序目的，需与过程过程流程图上的作业编号对应5.4.9 Potentialfailuremode:processmaynotorisimpossibletorealizeexpectedspecialcharacteristics潜在失效模式：是指工艺过程有可能未达到或不能实现预期的特殊特性5.4.10 Potentialfailureeffects:theconditionoffailuremodeaffectsnextprocesswhichcausesthefailureofeq
15、uipmentanddeviceandaffectscustomer潜在失效后果：失效模式情况下对下个过程致使设备设施失效及顾客产生的影响5.4.11 Severity:thedegreeofseveritythatbringstonextprocessandcustomer,thegradeofthemostseriousresultasthestandardandevaluationstandardofseverity(Appendix2)严重度：指对下个过程及顾客的影响的严重程度，以最严重的影响后果的级别为准，严重度评价标准(附件1)Appendixl:SuggestedPFMEASev
16、erityOccurrenceEvaluationCriteriaEffectCriteria:SeverityofEffectonProduct(CustomerEffect)RankEffectCriteria:SeverityofEffectonProcess(ManufacturingZAssembIyEffect)FailuretoMeetSafetyand/orReguLitoryRequiremeDtiPotentudfhmQXXieafictssaftvehicleopeaticmand),orinvolvesncocomphancevithgovenmetregulatmwi
17、thoutWXnung.10FailuretoMetSafetyand.orRegulator%*ReqmremeotsNfayendngeoperator(nuchineorambly)WlthOutwaxnizg.PotentialuhuemodeaffectssaVdIiCIeoperationmd*,orinvolvesncncoQhancewithgv三mnentregxlatmWzthwarning.9Nfayendangeroperator(machineorassembly)WXthwammg.LossorDegndAtionofPrimaryFunctionLossofPll
18、malyfunction(VnCIexnoperabledoesnotafictufevehicleoperation).8MjorDhruprioD100ofproductmayhavetobescrapped.Lineshutdownorstopsh.DegradationofPnmalyfunction(vehicleoperable,butatreducedIeVelofPeIfonnlnCe).7SignificantDisruptionApotionofthea*oductionrunmayhavetobescrapped.De*iatxm6cxnpnmaxyprocessinch
19、dmgdecreasedlineSPMdoraddedxxunpwLossorDegradationofSecondaryFuncdonLossofSeCOndaryfimctum(VehICIeoperable,butComfoItCODVemeDCefuncommopenbh).6ModerateDiirnptioB1005ofpxhctcnranuyhavetobeIeWOdCed。任Imexxiaccepted.DegiadatiOQofsecondan*ftmctm(VehiCieoperable,butcomfot/emv*emencefunctionsatreducedIeVeI
20、ofpfbxunce)5ApotionofthePrOdUCtigranmayhavetobeewtconformAXMinoticedbymostcustomers(75%).4ModerateDiSruPtion1(XWofpxxhconnmmayhavetobexewkedinsutioWfbxitisproc*d.AppearanceorAxbleNoise,VriUCieoperable,itemdoesnotcofonandDOClCedbymanyCU与Omen(50%).3AportionoftheproductionrunmayhavetobexewokedHmtionbef
21、oreitMprocessed.AppeaxanceorAudxbltNoise,VthiCkoperable,itemdoe%notconformandDOdCedbydiscnminatingcustomer(on,ovoperator.NoeffectNodhctmbleeffect.1NoeffecfNoJhcemibleef&ct.附件h推荐的PFMEA严重度评估标准彩*对产品彩的产值度(对的影网)ICUfti对过影响的尸度(对制造/装配的影峋)不兽含安全看在关就楼人电了汽/制安全送行Iwg含不普念Rin注媒法震第失火发才打天M不算含或金伐或罐艘食使柞SiiHt怠It-MMAKtt)
22、.失依H2时无畏海在失或密7汽隼的安全Jt行I噬者包含不H含B席汰震港IeWIllL%xHnn*.9会慢作员H处京哈-VltfJte(K).M本访央失tXH.不总哨汽享安全户*率产aMIWNJi声.上产雄美Hlet/止M7中断-M分尸Ia必修宫.MaSu。做变产线速及成*人力.次动费失攻功U次0*央朱，汽车可”蜻疗.他叫&便6不W实中中IO(M产品仍75%)VSM.中等中,wo%的产品女今就前,Man*x.可胪峥鹿汽毒禽作项目上第河(50%)一分产金含量H晅.介Mt.Vita.汽作校8上筑僧fl只少IK谀M力匕IIX25%)竟1小”K3f.作应代员景Jftna的不便.授女却R发我可兴配的越物I
23、段5.4.12 Gradeclassificationsareasfollows:级别分类如下:Blank:Ordinarymanagement空格：一般管理C：Criticalcharacteristicsmeanseveritygradeis9and10,characteristicsrelatingtosafety.C：CAtiCal关键特性，指严重度等级为9和10,与安全相关的特性S：Significantcharacteristics,derivefromdefinitioninprocessflowchart,includingthecharacteristicsofcustome
24、rspecificrequirementsandtheattributeofspecialmanagementsystemS：Sig川ficant重要特性,来源于过程流程图中的定义,包括顾客特殊要求的特性,需要特殊管制的属性5.4.13 Potentialcause/mechanismoffailure:listeverypotentialcauseandmechanismofeachfailuremodeaspossible.Cause/mechanismshallbelistedasbrieflyasandascomprehensivelyaspossiblesothattargetedr
25、emedialactionscouldbetaken.失效的潜在起因/机理：尽可能的列出每一失效模式的每一个潜在起因和/或失效机理。起因/机理应尽可能简明而全面的列出，以便有针对性的采取补救的措施5.4.14 Occurrence:thepossibilityoftheoccurrenceofonespecialcause/mechanism,occurrenceevaluationstandardisasfollows.(Appendix：2)频度：指某一特定的起因/机理发生的可能性，频度评价标准如下(附件2)5.4.15 CurrentprocessControl现行过程控制Itmeans
26、adoptedcontrolmethodwhichcancontrol/preventtheoccurrenceofpotentialfailurecausesorpotentialfailuremode.指已经采用的控制方法，这种控制方法可以控制/防止潜在失效原因或潜在失效模式发生。Prevention:preventtheoccurrenceoffailurecause/mechanismorfailuremodeorreducetherateofoccurrence.预防：防止失效的起因/机理或失效模式出现，或者降低出现率。Detection:detectfailurecause/mec
27、hanismorfailuremodeandleadtopreventiveactions.探测：探测出失效的起因/机理或者失效模式，并引导出预防措施。5.4.16 Deteetion探测度Evaluatethepossibilityofdiscoveringfailuremodebyuseofcurrentprocesscontrolmethod.Detectionisthebestdetectioncontrolgradelistedinprocesscolumn.Detectionevaluationstandardisasfollows:(Appendix3)评估现行过程控制方法对失效
28、模式得到发现的可能性，探测度是与过程控制栏中所列的最佳的探测控制等级探测度评价标准如下：(附件3)5.4.17 RiskPriorityNumber(RPN):RiskPriorityNumber=SeverityxOccurrencexDetection风险顺序数(RPN)：风险顺序数=严重度X频度X探测度5.4.18 Suggestedaction:EngineeringevaluationofpreventiveactionsshallbeimplementedtoitemsofhighseverityandhighRPNandotheritemsappointedbyteam.Thei
29、ntentionofanysuggestedactionistoreduceriskgradeaccordingtothesequence:severity,occurrenceanddetection.NomatterhowlargeRPNvalueis,whenseverityis9or10,specialattentionshallbepaid.建议措施：对高严重度，高RPN值和小组指定的其它项目进行预防措施的工程评价,任何建议措施的意图都是要依以下顺序降低其风险级别：严重度，频度和探测度。不管RPN值是多大，当严重度是9或10时，必须予以特别注意5.4.19 Completiondat
30、eofresponsibilityandobjective:recordtheresponsiblepersonofeachsuggestedactionandscheduledtargetdateofcompletion.责任和目标完成日期：记录每一项建议措施的责任人以及预计完成的目标日期5.4.20 Actionstaken:aftertakingactions,fillinactuallyadoptedactions.采取的措施：实施措施之后，填入实际被采取的措施5.4.21 Resultofimplementation:afterdeterminingpreventiveaction,
31、estimateandrecordtheresultofseverity,occurrenceanddetection,calculateandrecordtheresultofRPN.Ifnoactionstaken,leaverelatedcolumnsblank.措施执行结果：在确定了预防措施以后，估计并记录严重度、频度和探测度的结果，计算并记录RPN的结果，如果没有采取任何措施，将相关栏空白即可。6.0ReferenceDocuments参考文件None无7.0ReferenceForms参考表单None无8.0FlowChart流程图None无Appendix2:SuggestedP
32、FMEAOccurrenceEvaluationCriteriaLikelihoodofFailureCriteria:OccurrenceofCause-PFMEARank(Incidentsperitems/vehicles)VeryHigh100perthousand1in1010High50pertlousand1in20920perthousand1in50810perthousand1in1007Moderate2perthousand1in5006.5perthousand1in2,0005.1perthousand1inIO5OOO4Low.01pertlousand1in10
33、0.0003.001perthousand1in1,000,0002VeryLowFailureiseliminatedthouglpreventiveconol.1失效可能性标准，原因的发生频度-PFMEAH（每个项目他辆车的事件）I等.很高11011O!0高-50/10001/20920/101/50810/1000117-中彝2/10001560.5/10001/200050.1/10001/10,0004低一0.01/100011,00030.00110001/1,000,0002很低通过预防控制消除了失效1Appendix3:SuggestedProcessFMEADetection
34、EvaluationCriteriaOpportunityforDetectionCriteria:1.ikelihoodofDetectionbyProcessControlRankLikelihoodofDetectionNodetectionopportunityNocuetprocesscontrol;Cannotdetectorisnotanalyzed.10AlmostImpossibleNotlikelytodetectatanystageFailureModeand/orError(Cause)isnoteasilydetected(eg.,randomaudits).9Ver
35、yRemoteProblemDetectionPostProcessingFailureModedetectionpost-processingbyoperatorthrouglvisual/tactile/audiblemeans.8RemoteProblemDetectionatSourceFaihireModedetectionm-statonbyoperatorthrouglViSUaI/tactile/audiblemeansorpost-processingthrougluseofattributegauging(gono-gomanualtorquecheck/clickerwr
36、ench,etc).7VeryLowProblemDetectionPostProcessingFailureModedetectionpost-processingbyoperatorthroughuseofvaiablegaugmgorin-stationbyoperatorthroughuseofattnbutegaugmg(go/no-go.manualtorquecheck/clickerwrench,etc).6LowProblemDetectionatSourceFailureModeorError(Cause)detectionin-stationbyoperatorthrou
37、gluseofvariablegaugingorbyautomatedcontrolsin-stationthatwilldetectdiscrepantpartandnotifyoperator(light,buzzer,etc).Gaugingperformedonsetupandfirst-piececheck(forSet-呼causesonly).5ModerateProblemDetectionPostPrOCeSSingFailureModedetectionpost-processingbyautomatedcontrolsthatwilldetectdiscrepantpar
38、tandlockparttopreventfurtherprocessing.4ModeratelyHighProblemDetectionatSourceFaIlUreModedetectionin-stationbyautomatedcontiolsthatwilldetectdiscrepantpartandautomaticallylockpartmstationtopreventftrtherprocessing.3HighErrorDetectionand/orProblemPreventionError(Cause)detectionin-stationbyautomatedco
39、ntrolsthatwilldetecterrorandpreventdiscrepantpartfrombeingmade.2VeryHighDetectionnotappcable;ErrorPreventionError(Cause)preventionasaresultoffixturedesign,machinedesignorpartdesign.Discrepantpartscannotbemadebecauseitemhasbeenerror-proofedbyprocess/productdesign.1AlmostCertain探测几率标准I通过过程控制来探测的可能性-S探
40、测可能性没高探海几率没有现行过程挖制：不能探温或并未分析.10几乎不可靛在任何给依都不容易探戈失效模式和/或储误谏因）不容，版探泅则（比如；机审核）.9很稽少在后工序搜黑问JK操作员通过税觉/触觉/听觉方式对失效模式在后工停探海.8少在来源处探渊闷敏程作员通过视党/触觉/听觉方式，在询位上实检失效模式的探满,或者通过计数22量具（酒/止我,手动扭矩检查/援手等）在后工序探测.7很低在后工序探嘉网KE播作员通过计量奥兵在后工惇探涌,或者遢过计数&H具（遢/止税.手动扭矩除壹Afi手等）在本*位上实毓探测6低在来骞处探测间Ifi拗作员通过计慑R具.在岗位上实*失效模式或UIiX，原因）第探澜,或者通E自动控N来保淘不规范由邨件,并通知播作员（灯光,警指籥等）IHt对安装设和菌件检查（只管对设康因）.5中等在后工序探涌间M通过在后工序的自动控制来实现失效粳式的报淘,撩测不规范的零件.封锁事件，防止零件进入下一个诜程.4中等偏高在未衰处睬X间通过自动控制投测不统范的零件，自动打福零件，防止年件遇入下一步流程,在本岗位上实施失效模式的双黑3XWiXKMM/或同箱及防通过自动控制防止不发范事件的生产,在词位上实Illl馔（事因）的撩澜.一-2很高撩泅不选ML幡谡及防防修谡MB）的夹具设计.机桃设计或学体设计由于过程/产品的防储设计,不现负事件无法生产.1几乎可以定
