QSB 2009_(Chinese Version) 风险降低

QualitySystemsBasicsrevMarch2009FRNCPWPOSWI(SOS)OI(JES)SOT(JIT)RiskEPVLPAVSContamSCMMCPSWSGlobalPurchasingandSupplyChain8.0–风险降低过程主动式降低潜在质量失效的风险逆向PFMEA过程被动式对已发生的质量失效进行防错1QualitySystemsBasicsrevMarch2009FRNCPWPOSWI(SOS)OI(JES)SOT(JIT)RiskEPVLPAVSContamSCMMCPSWSGlobalPurchasingandSupplyChain风险降低目录8.0)导言：目的、范围、职责8.1)益处8.2)PFMEA概述8.3)PFMEA评审过程8.4)RPN降低过程8.4.1)主动式RPN降低过程8.4.2)逆向PFMEA过程8.4.3)被动式RPN降低过程8.5)管理要求8.5.1)跟踪矩阵图8.6)总结，必须2QualitySystemsBasicsrevMarch2009FRNCPWPOSWI(SOS)OI(JES)SOT(JIT)RiskEPVLPAVSContamSCMMCPSWSGlobalPurchasingandSupplyChain3风险降低过程•目的：•降低潜在质量失效的风险•对已发生的质量失效进行防错•确保对失效模式具备采取正确（恰当）的控制方法（预防/探测）和正确地作业（并严格地执行）•范围：•装配区•制造工位•发货/进货•所有操作•其它辅助职能3职责：•负责人工程经理生产经理•针对各种异常状况的应急计划8.0–导言QualitySystemsBasicsrevMarch2009FRNCPWPOSWI(SOS)OI(JES)SOT(JIT)RiskEPVLPAVSContamSCMMCPSWSGlobalPurchasingandSupplyChain4•支持TS16949期望的持续改进。•能让领导将有限的资源分配到重大的问题。•提供一个有效防错和问题解决的基础。•是APQP的核心工具和PPAP的要求。•提供一个经验教训档案。•促进跨功能团队合作。•达到顾客对“动态文件”的期望。风险降低过程48.1–益处QualitySystemsBasicsrevMarch2009FRNCPWPOSWI(SOS)OI(JES)SOT(JIT)RiskEPVLPAVSContamSCMMCPSWSGlobalPurchasingandSupplyChain5PFMEA定义：•一种对每一个过程步骤的分析方法，可以识别：–过程可能达不到要求的情形。–对内/外部顾客造成的后果(严重度)。–将/可能发生失效的频率(频度)。–当前控制的有效性(预防&探测)。–原因和后果的等级(风险顺序数)。•一个格式化程序，用以识别和消除与过程有关的失效模式。风险降低过程8.2–PFMEA概述5QualitySystemsBasicsrevMarch2009FRNCPWPOSWI(SOS)OI(JES)SOT(JIT)RiskEPVLPAVSContamSCMMCPSWSGlobalPurchasingandSupplyChainPOTENTIALFAILUREMODEANDEFFECTSANALYSIS(PROCESSFMEA)REV'DDATE:15xxxxxMODELYEAR/CARLINE:FMEADATE:PRODUCTIONPLANT:FMEACONDUCTEDBY:10InstallpilotbearingIncorrectpartinstalledMisbuild:partdoesnotfunction.7Manual:incorrectpartselected7NopreventionNodetection1049020Correctsub-assyIncorrectorreversedsub-assemblyunabletoinstall7MachineVisionIDIncorrect3NopreventionIn-lineAudits6126DETRPNPREVENTIONDETECTIONCURRENTCONTROLSSEVCLASSPOTENTIALCAUSE(S)/MECHANISM(S)OFFAILUREOCCPROCESSNAME/NUMBERPROCESSFUNCTIONPOTENTIALFAILUREMODEPOTENTIALEFFECT(S)OFFAILUREPOTENTIALFAILUREMODEANDEFFECTSANALYSIS(PROCESSFMEA)B/PLevel:001,7-NOV-02SensortodetectbearingtypeShad,B.3/1/02774146NewLaserStation.NA73242RESPONSIBILITY&TARGETCOMPLETIONDATEACTIONRESULTSACTIONSTAKENSEVOCCDETRPNRECOMMENDEDACTION(S)会有什么错误？它怎样影响顾客？此原因发生的次数如何？发生时，我们能注意到的可能性？风险多大？(AIAGPFMEA手册)（例）风险降低过程8.2–PFMEA概述（续）6QualitySystemsBasicsrevMarch2009FRNCPWPOSWI(SOS)OI(JES)SOT(JIT)RiskEPVLPAVSContamSCMMCPSWSGlobalPurchasingandSupplyChain风险降低过程由跨功能小组按AIAGPFMEA手册来确定PFMEA的严重度、频度和探测度。PpKRanking0.55100.5590.7880.8670.9461.0051.1041.2031.3021.671ProbabilityLikelyFailureRates100perThousandPieces50perThousandPieces20perThousandPieces10perThousandPiecesVeryHigh:PersistentFailuresHigh:FrequentFailures5perThousandPieces2perThousandPieces1perThousandPiecesModerate:OccasionalFailures0.5perThousandPieces0.1perThousandPiecesRemote:FailureisUnlikely0.01perThousandPiecesLow:RelativelyFewFailuresRatingDetectionCriteriaErrorProofedGaugedManualInspectionSuggestedrangeofdetectionmethods10AlmostImpossibleAbsolutecertaintyofnon-detection.XCannotdetectorisnotchecked.9VeryRemoteControlswillprobablynotdetect.XControlachievedwithIndirectorrandomchecksonly.8RemoteControlshavepoorchanceofdetection.XControlisachievedwithvisualinspectiononly.7VeryLowControlshavepoorchanceofdetection.XControlisachievedwithdoublevisualinspectiononly.6LowControlsmaydetect.XXControlisachievedwithchartingmethods,suchasSPC.5ModerateControlsmaydetect.XControlisbasedonvariablegaugingafterpartshaveleftthestation,orgo/no-gogaugingperformedon100%ofthepartsafterpartshaveleftthestation.4ModeratelyHighControlshaveagoodchancetodetect.XXErrordetectioninsubsequentoperations,ORgaugingperformedonset-upandfirstpiececheck(forset-upcausesonly).3HighControlshaveagoodchancetodetect.XXErrordetectioninstation,ORerrordetectioninsubsequentoperationsbymultiplelayersofacceptance:Supply,select,install,verify.Cannotacceptdiscrepantpart.2VeryHighControlsalmostcertaintodetect.XErrordetectionin-station(automaticgaugingwithautomaticstopfeature).Cannotpassdiscrepantpart.1CertainControlscertaintodetect.XDiscrepantpartscannotbemadebecauseitemhasbeenerrorproofedbyprocess/productdesign.SEVERITYRANKINGSDETECTIONRANKINGSOCCURRENCERANKING8.2–PFMEA概述（续）7EffectCriteria:SeverityofEffectThisrankingresultswhenapotentialfailuremoderesultsinafinalcustomerand/oramanufacturing/assemblyplantdefect.Thefinalcustomershouldalwaysbeconsideredfirst.Ifbothoccur,usethehigherofthetwoseverities.(CustomerEffect)Criteria:SeverityofEffectThisrankingresultswhenapotentialfailuremoderesultsinafinalcustomerand/oramanufacturing/assemblyplantdefect.Thefinalcustomershouldalwaysbeconsideredfirst.Ifbothoccur,usethehigherofthetwoseverities.(Manufacturing/AssemblyEffect)RankingHazardouswithoutwarningVeryhighseverityrankingwhenapotentialfailuremodeaffectssafevehicleoperationand/orinvolvesnoncompliancewithgovernmentregulationwithoutwarning.Ormayendangeroperator(machineorassembly)withoutwarning.10HazardouswithwarningVeryhighseverityrankingwhenapotentialfailuremodeaffectssafevehicleoperationand/orinvolvesnoncompliancewithgovernmentregulationwithwarning.Ormayendangeroperator(