RPN风险评估及降低课件

1TRWSupplierImprovementStrategies

QualityBasics1)QuickResponseProcess2)LayeredProcessAudits3)ControlofNon-ConformingProduct4)ProblemSolvingProcess/Tools

5)RPNRiskReduction(P-FMEA)6)Error-ProofingDevicesandVerification7)WorkplaceOrganization/VisualManagement8)VerificationStations/StationAlarmEscalation

ProcessControls1)BasicStatistics2)CapabilityStudies3)ControlCharting(X-bar&R,Pre-Control...)4)MeasurementSystemAnalysis5)Set-UpApproval/DailyFirstPiece6)SpecialProcessAssessments7)PracticalProblemSolvingfortheShopfloor8)StandardOperationandJobElements

ProgramManagement1)ProgramManagementOffice2)ProgramManagerRoles&Responsibilities3)Cross-FunctionalTeams4)ProjectMilestoneReviews5)Phase-GatedProcessLinkedtoAPQPPhases6)ExecutiveGateReviews7)TripleConstraintManagement8)Escalation/ChangeManagementProcess

ContinuousImprovement1)ValueStreamMapping2)StandardizedWork3)ContinuousOne-PieceFlow4)AndonandJidoka5)BasicTotalProductiveMaintenance6)LessonsLearned/Read-AcrossProcess7)Bottleneck/ConstraintManagement8)Sub-SupplierManagementTRWSupplierImprovementStrategies1TRWSupplierImprovementStraQUALITYBASICSError-ProofingDevices/VerificationRPNRiskReduction(P-FMEA)VerificationStations/StationAlarmEscalationControlofNon-ConformingProductQuickResponseProcessLayeredProcessAuditsProblemSolvingProcess/ToolsWorkplaceOrganization/VisualManagementTRWSupplierImprovementStrategies2QUALITYError-ProofingDevices3RPNRISKREDUCTIONPROCESS风险降低程序TSIS:RPNRiskReductionProcessVersion1.02011-10-123RPN4TSIS:RPNRiskReductionProcessWhatisRPN 什么是RPN SeverityRankSheet

严重度分级OccurrenceRankSheet

频度数分级DetectionRankSheet

探测度分级HowtogetRPN 怎样计算RPNRPNReduction RPN降低Proactive

主动式降低RPNtrackingchart RPN降低追踪表Reactive 被动式降低TopFailuresList 最大失效清单LearningOutcome

学习内容4TSIS:RPNRiskReductionPro5海恩法则/Herren’sPrinciple:

每一起严重事故的背后，必然有29次轻微事故和300起未遂

先兆以及1000起事故隐患。 Everyseriousaccidentfollowsby29minoraccident, 300 signedfailuresand1000potentialdefects.

法则强调两点:

2stressesofthePrinciple：事故的发生是量的积累的结果； Aquantitativechangecausesaqualitativechange.再好的技术，再完美的规章，在实际操作层面，也无法取代人自身的素质和责任心。 Atoperationallevel,people’scapabilityandresponsibilityaremuchmoreimportantthananyhigh-techorperfectprocedure.任何不安全事故都是可以预防的。AnyaccidentispreventableTSIS:RPNRiskReductionProcess5海恩法则/Herren’sPrinciple:TSIS6风险优先数(RPN-RiskPriorityNumber)：指严重度数（S）和频度数（O）及不易探测度数（D）三项数字之乘积RPN=Severity(S)xOccurrence(O)xDetection(D)严重度Severity(S)：指一给定失效模式最严重的影响后果的级别，是单一的FMEA范围内的相对定级结果。严重度数值的降低只有通过设计更改或重新设计才能够实现。Severityisthevalueassociatedwiththemostseriouseffectforagivenfailuremode.SeverityisarelativerankingwithinthescopeoftheindividualFMEA.

Onlyadesignrevisioncanbringaboutareductionintheseverityranking.

频度数Occurrence(O)：指某一特定的起因/机理发生的可能性，描述出现的可能性的级别数具有相对意义，但不是绝对的。

Occurrenceisthelikelihoodthataspecificcause/mechanismwilloccurresultinginthefailuremodewithinthedesignlife.Thelikelihoodofoccurrencerankingnumberhasarelativemeaningratherthananabsolutevalue探测度Detection(D)：指对在现有设计控制探测栏中列出的最好的探测控制的对应等级。DetectionistherankassociatedwiththebestdetectioncontrollistedintheDetectionControlscolumn.

TSIS:RPNRiskReductionProcess6风险优先数(RPN-RiskPriorityNum7过程失效模式及后果分析

PROCESSFAILUREMODE&EFFECTSANALYSIS

(PFMEA)

定义DEFINITION是对每一个过程步骤进行分析的技术，以识别：Ananalyticaltechniqueforeachprocessstepthatidentifies:过程可能达不到要求的情形waysaprocessmayfailtomeetrequirements.对内部/外部顾客的影响(严重度)consequencestotheinternal/externalcustomer(severity).失效可能发生的频率(发生频度)frequencythefailurewill/couldhappen(occurrence).当前控制的效果(预防和可探测度)effectivenessofcurrentcontrols(prevention&detection).原因和结果的等级(风险顺序数)rankingofcausesandeffects(riskprioritynumber).是一个格式化程序，用以识别和消除潜在的过程失效模式Astructuredprocedureforidentifyingandeliminatingprocessrelatedfailuremodes.TSIS:RPNRiskReductionProcess7过8根据AIAG/PPAP手册第4版严重度分级TSIS:RPNRiskReductionProcess8根据AIAG/PPAP手册第4版严重度分级TSIS9SeverityRankEffectCriteria:

SeverityofEffectonProduct

(Customereffect)

Rank

EffectCriteria:

SeverityofEffectonProcess

(Manufacturing/AssemblyEffect)

FailuretoMeetSafetyand/orregulatoryRequirementsPotentialfailuremodeaffectssafevehicleand/orinvolvesnoncompliancewithgovernmentregulationwithoutwarning

10

FailuretoMeetSafetyand/orregulatoryRequirementsMayendangeroperator(machineorassembly)withoutwarningPotentialfailuremodeaffectssafevehicleand/orinvolvesnoncompliancewithgovernmentregulationwithwarning

9

Mayendangeroperator(machineorassembly)withwarningLossorDegradationofprimaryfunctionLossofprimaryfunction(vehicleinoperable,doesnotaffectsafevehicleoperation)

8

Majordisruptions100%ofproductmayhavetobescrapped.LineshutdownorstopshipDegradationofprimaryfunction(vehicleoperablebutatareducedlevelofperformance)

7

SignificantdisruptionsAportionoftheproductionmayhavetobescrapped.DeviationfromprimaryprocessincludingdecreasedlinespeedoraddedmanpowerLossorDegradationofsecondaryfunctionLossofsecondaryfunction(vehicleoperable,butcomfort/conveniencefunctionsinoperable)

6

Moderatedisruption100%ofproductionrunmayhavetobereworkedofflineandacceptedDegradationofsecondaryfunction(vehicleoperablebutatareducedlevelofperformance)

5

AportionoftheproductionrunmayhavetobereworkedofflineandacceptedAnnoyanceAppearanceoraudibleNoise,vehicleoperable,itemdoesnotconformandnoticedbymostcustomers(>75%)

4

Moderatedisruption100%ofproductionrunmayhavetobereworkedinstationbeforeitisprocessedAppearanceoraudibleNoise,vehicleoperable,itemdoesnotconformandnoticedbymanycustomers(>50%)

3

AportionoftheproductionrunmayhavetobereworkedinstationbeforeitisprocessedAppearanceoraudibleNoise,vehicleoperable,itemdoesnotconformandnoticedbydiscriminatingcustomers(>25%)

2

MinordisruptionSlightinconveniencetoprocess,operation,oroperator.NoeffectNodiscernibleeffect

1

NoeffectNodiscernibleeffectBasedonthePotentialFailureModeandEffectAnalysisManualfromtheAIAG4thEditionTSIS:RPNRiskReductionProcess9SeverityRankEffectCriteria:

10根据AIAG/PPAP手册第4版频度数分级TSIS:RPNRiskReductionProcess10根据AIAG/PPAP手册第4版频度数分级TSIS:11OccurrenceRankBasedonthePotentialFailureModeandEffectAnalysisManualfromtheAIAG4thEditionLikelihoodoffailureCriteria:Occurrenceofcause-PFMEA(incidentsperitems/vehicles)

Rank

VeryHigh>=100perThousand

>=1in10

10High50perThousand

1in20

920perThousand

1in50

810perThousand

1in100

7Moderate2perThousand

1in500

60.5perThousand

1in2,000

50.1perThousand

1in10,000

4Low0.01perThousand

1in100,000

3<=0.001perThousand

1in1,000,000

2VerylowFailureiseliminatedthroughpreventivecontrol

1TSIS:RPNRiskReductionProcess11OccurrenceRankBasedonthe12根据AIAG/PPAP手册第4版探测度分级TSIS:RPNRiskReductionProcess12根据AIAG/PPAP手册第4版探测度分级TSIS:13DetectionRankBasedonthePotentialFailureModeandEffectAnalysisManualfromtheAIAG4thEditionOpportunityforDetectionCriteria:

LikelihoodofdetectionbyProcessControl

RankLikelihoodofDetection

NodetectionOpportunityNocurrentprocesscontrol;Cannotdetectorisnotanalyzed

10AlmostImpossibleNotlikelytodetectatanystageFailureModeand/orerror(Cause)isnoteasilydetected(e.g.,randomaudits)

9VeryRemoteProblemdetectionpostprocessingFailureModedetectionpost-processingbyoperatorthroughvisual/tactile/audiblemeans

8RemoteProblemdetectionatsourceFailureModedetectionin-stationbyoperatorthroughvisual/tactile/audiblemeansorpost-processingthroughuseofattributegauging(go/no-go),manualtorquecheck/clickerwrench,etc.)

7VerylowProblemdetectionpostprocessingFailureModedetectionpost-processingbyoperatorthroughuseofvariablegaugingorin-stationbyoperatorthroughuseofattributegauging(go/no-go),manualtorquecheck/clickerwrench,etc.)

6LowProblemdetectionatsourceFailureModeorerror(Cause)detectioninstationbyoperatorthroughuseofvariablegaugingorbyautomatedcontrolsin-stationthatwilldetectdiscrepantpartandnotifyoperatorlight,buzzer,etc.).Gaugingperformedonset-upandfirstpiececheck(forset-upcausesonly)

5ModerateProblemdetectionpostprocessingFailureModedetectionpost-processingbyautomatedcontrolsthatwilldetectdiscrepantpartandlockparttopreventfurtherprocessing

4ModeratelyHighProblemdetectionatsourceFailureModedetectionin-stationbyautomatedcontrolsthatwilldetectdiscrepantpartandlockparttopreventfurtherprocessing

3HighErrorDetectionand/orproblemPreventionError(Cause)detectionin-stationbyautomatedcontrolsthatwilldetecterrorandpreventdiscrepantpartfrombeingmade.

2VeryhighDetectionnotapplicable;ErrorPreventionError(Cause)preventionasaresultoffixturedesign,machinedesignorpartdesign.Discrepantpartscannotbemadebecauseitemhasbeenerrorproofedbyprocess/productdesign.

1AlmostCertainTSIS:RPNRiskReductionProcess13DetectionRankBasedontheP14过程潜在失效模式及后果影响(例)失效原因的频率有多高？失效模式的风险有多高？会出现什么问题?它是怎样影响客户的

?如果问题发生，有多大可能我们会注意到它？TSIS:RPNRiskReductionProcess14过程潜在失效模式及后果影响(例)失效原因的频率有多高Whatcangowrong?Howdoesitaffectcustomer?Howoftendoesthiscausehappen?Howlikelyarewetonoticeifthishappens?Howhighistherisk?

PROCESSFAILUREMODE&EFFECTS

ANALYSIS(Example)TSIS:RPNRiskReductionProcess15Whatcangowrong?Howdoesit16降低风险程序主动式PROACTIVE

RPN降低流程:RPNREDUCTIONPROCESS:降低潜在质量失效的风险ReducingtheriskofaPOTENTIALQUALITYFAILURE

被动式REACTIVE

对已发生的质量失效建立防错装置ERRORPROOFINGPASTQUALITYFAILURESTSIS:RPNRiskReductionProcess16降低风险程序主动式RPN降低流程:被17主动式降低风险的要求根据质量体系要求，PFMEA必须包括所有制造过程及与相关的支持职能。PFMEA’sshallbecompletedforallmanufacturingprocessesandsupportfunctionsasrequiredbytheQualityManagementSystem.支持职能包括如下方面：进料检验，厂内物料运输，标识和发运，修理，返工等。Supportfunctionsinclude:(receivinginspection,materialhandling,labeling,shipping,repair,rework,etc…).PFMEA必须:

PFMEA’sshall:符合当前的AIAG要求和顾客的要求。conformtocurrentAIAGguidelinesandcustomerrequirements.定期更新（动态文件）。beupdatedonaregularbasis(livingdocuments).包括所有的生产线/零件号existforallproductlines/partnumbers.包括所有的过程和过程步骤。includeallprocessesandprocesssteps.用于持续改进。beutilizedforContinualImprovement.正确的严重度/发生频度/可探测度打分。haveaccurateSeverity/Occurrence/Detectionratings.TSIS:RPNRiskReductionProcess17主动式降低风险的要求根据质量体系要求，PFMEA必须包括18PFMEA评审

必须建立多功能小组进行定期的PFMEA评审

Multi-disciplinaryteamsshallperformperiodicPFMEAReviews.

PFMEA审核的频率或次数必须由供应商的领导层依据如下决定：客户的期望(PPS,SafeLaunchAudit,等）customerexpectations(PPS，SLA,etc…)过程能力(一次下线合格率,SPC,等）processcapability(FTQ,SPC,etc…)过程更改（采用防错方法，更换二级供应商，等）changestotheprocess(Errorproofing,Tier2changes,etc…)

PFMEA审核优先级次序的标准应包括：CriteriatoprioritizewhichPFMEAtoreviewinclude:外购的产品，工装移动或分供方变更。productfromanacquisition,toolmoveorchangeinsupplier.PFMEA制定时没有多功能小组参与。PFMEAdevelopedwithoutadequatecross-functionalinvolvement.过去发生PPS，顾客报怨，售后问题和一次下线合格率问题的零件。PFMEAforpart(s)withhistoryofPR/R,Customercomplaints，WarrantyorFTQissues.发生频度(一次下线合格率,报废率等)有显著变化.Occurrenceratings(FTQ,scrap,etc…)havechangedsignificantly.旧版本的PFMEA。PFMEAatolderrevisionTSIS:RPNRiskReductionProcess18PFMEA评审必须建立多功能小组进行定期的PF19

PFMEA审核必须至少包含如下方面：PFMEAReviewshall

includethefollowingataminimum:确认包含所有的操作/过程并准备无误(电镀，热处理，标识，等)。Verificationthatalloperations/processesareincludedandaccurate(paint,heattreat,materialhandling,labeling,etc…).包含所有的过程控制。Allprocesscontrolsareincluded.探测度打分选定准确。Detectionratingsareaccurate.发生率确定应依据数据分析(SPC，一次下线合格率FTQ，验证岗位*，报废率，过程分层审核*结果，等)。Occurrenceratingsareanalyzedusingdata(SPC,FTQ,VerificationStation*Scrap,LayeredProcessAudits*

results,etc…).

确认PFMEA满足客户要求及期望(AIAG,PPAP,SafeLaunch,等)verificationthatthePFMEAmeetscustomerrequirementsandexpectations(AIAG,PPAP,Launch,DDW,etc…).完成审核后,必须建立一个高(RPN)风险降低机会清单，或按新数据对高风险进行修改。Uponcompletionofthereview,alistofthehighest(RPN)RiskReductionopportunitiesisestablishedorrevisedbasedonthenewdata.多功能小组必须依据行动计划跟踪降低RPN风险值的进展情况。Anactionplanorequivalentshallbeutilizedbythemulti-disciplinaryteamtotrackprogressinreducingtheRPNratings.

TSIS:RPNRiskReductionProcess19PFMEA审核必须至少包含如下方面：完成审20

RPN降低跟踪表(主动式)(例)跟踪表上RPN降低的项目数取决于该产品和生产过程的复杂程度，工厂的规模大小，客户质量反馈，等等…TSIS:RPNRiskReductionProcess20RPN降低跟踪表(主动式)(例)跟踪表上RP

RPNTRACKINGCHART(Proactive)(Example)ThenumberofRPNreductionopportunitiesonthelistisdependentoncomplexityofpartsandprocess,sizeofplant,customerfeedback,etc…TSIS:RPNRiskReductionProcess21RPNTRACKINGCHART(Proactive)22被动式风险降低：REACTIVERISKREDUCTION:对过去的质量失效采取防错ERRORPROOFINGPASTQUALITYFAILURES

必须通过多功能组建立一个过去内部/外部质量失效的清单。Multi-disciplinaryteam(s)shallbeutilizedtodevelopalistofthepastinternalandexternalqualityfailures.小组共同识别PFMEA中每一个RPN真实的严重度，频度和可探测度Team(s)identifytruePFMEASeverity,OccurrenceandDetectionratingforeachRPNusingAIAGguidelines.小组必须制定行动计划对失效进行防错。Team(s)shalldevelopanactionplantoErrorProofthefailures.建议采取防止或减少失效模式发生的改进行动。RecommendedActionsareimprovementsthatwillpreventorreducetheFailureMode.如防错不可行，应制定计划改善探测方式。WhenErrorProofingisnotfeasible,aplantoimprovedetectionshallbeestablished.

必须分派小组成员负责实施建议的行动。Ateammembershallbeassignedresponsibilityforimplementingtherecommendedaction.

必须制定合理的目标完成日期。Reasonabletargetcompletiondatesshallbeestablished.TSIS:RPNRiskReductionProcess22被动式风险降低：REACTIVERISKREDUCT23被动式风险降低：REACTIVERISKREDUCTION:对过去的质量失效采取防错ERRORPROOFINGPASTQUALITYFAILURES防错必须通过“防错验证*”程序得到验证。ErrorproofingshallbeverifiedpertheErrorProofingVerification*

process.整改行动实施后，小组必须重新验证新的发生频度，可探测度和RPN结果。Whencorrectiveactionshavebeenimplemented,teamsshallvalidatethenewOccurrenceandDetectionrankingsandresultantRPN.小组必须将所有的整改行动措施更新到PFMEA中。TeamsshallupdatePFMEA’swithallcorrectiveactionmeasures.TSIS:RPNRiskReductionProcess23被动式风险降低：防错必须通过“防错验证*”程序得到验证。24被动式风险降低:最大失效清单(例)TSIS:RPNRiskReductionProcess24被动式风险降低:(例)TSIS:RPNRiskRREACTIVERISKREDUCTION:TOPFAILURESLIST(Example)TSIS:RPNRiskReductionProcess25REACTIVERISKREDUCTION:(Examp26TSIS:RPNRiskReductionProcess26TSIS:RPNRiskReductionPr27风险降低RISKREDUCTION工厂领导层必须：SITELEADERSHIP:至少每年对PFMEA培训需求进行一次评估shouldreviewtheneedforPFMEAtrainingatleastonceperyear.

必须支持RPN降低活动并提供必需的资源

shallsupportRPNreductionactivitiesandprovidenecessaryresources.必须评估RPN降低跟踪表shallreviewtheRPNreductiontrackingcharts.必须确保正式的多功能小组参与对PFMEA的准备与评估

shallensurethatformalmulti-disciplinaryteamsareutilizedinthepreparationandongoingreviewofPFMEA’sTSIS:RPNRiskReductionProcess27风险降低工厂领导层必须：TSIS:RPNRi28风险降低RiskReduction益处:BENEFITS:支持TS16949质量体系所期望的持续改进行动。SupportscontinualimprovementasexpectedbyTS16949.

使管理层集中有限的资源解决重大的质量风险。Allowsleadershiptoallocatelimitedresourcestocriticalareas.

提供一个有效防错和问题解决的基础。Providesabasisforeffectiveerror-proofingandproblemsolving.

是APQP和PPAP要求的核心工具。CoretoolforAPQPandPPAPrequirements.

提供经验教训文件。ProvidesaLessonsLearned*archive.

可以推动多功能小组的团队协作.Promotescross-functionalteamwork.

满足顾客“动态文件”的期望。Meetscustomerexpectationsfor“livingdocuments”.TSIS:RPNRiskReductionProcess28风险降低益处:支持TS16949质量体系所29风险降低总结RISKREDUCTIONSUMMARY主动式PROACTIVE工厂领导层必须支持RPN风险降低活动并提供必要的资源。LeadershipshallsupportRPNreductionactivitiesandprovidenecessaryresources.PFMEA必须进行全面的评审。PFMEA’sshallundergoacompletereview.必须建立高（RPN）风险降低项目的跟踪列表。Alistofthehighest(RPN)RiskReductionopportunitiesshallbeestablished.多功能小组必须利用行动计划或类似文件来跟踪RPN降低活动的状态。Anactionplanorequivalentshallbeutilizedbythemulti-disciplinaryteamtotrackprogressinreducingtheRPNratings.被动式REACTIVE多功能小组必须建立过去发生的内部/外部质量问题的清单。Alistofthepastinternalandexternalqualityfailuresshallbeestablished.多功能小组必须建立行动计划以对失效进行防错。Team(s)shalldevelopanactionplantoErrorProofthefailures.TSIS:RPNRiskReductionProcess29风险降低总结主动式TSIS:RPNR30TSIS:RPNRiskReductionProcessRPNclassroomexercise–tofillthecorrectnumberincellswhicharehighlightedinyellowRPN课堂练习–在黄色单元格内填写正确的数字30TSIS:RPNRiskReductionPr31TSIS:RPNRiskReductionProcessRPNclassroomexerciseAnswerRPN课堂练习参考答案31TSIS:RPNRiskReductionPr32End

结束TSIS:RPNRiskReductionProcess32End

结束TSIS:RPNRiskReduct33TRWSupplierImprovementStrategies

QualityBasics1)QuickResponseProcess2)LayeredProcessAudits3)ControlofNon-ConformingProduct4)ProblemSolvingProcess/Tools

5)RPNRiskReduction(P-FMEA)6)Error-ProofingDevicesandVerification7)WorkplaceOrganization/VisualManagement8)VerificationStations/StationAlarmEscalation

ProcessControls1)BasicStatistics2)CapabilityStudies3)ControlCharting(X-bar&R,Pre-Control...)4)MeasurementSystemAnalysis5)Set-UpApproval/DailyFirstPiece6)SpecialProcessAssessments7)PracticalProblemSolvingfortheShopfloor8)StandardOperationandJobElements

ProgramManagement1)ProgramManagementOffice2)ProgramManagerRoles&Responsibilities3)Cross-FunctionalTeams4)ProjectMilestoneReviews5)Phase-GatedProcessLinkedtoAPQPPhases6)ExecutiveGateReviews7)TripleConstraintManagement8)Escalation/ChangeManagementProcess

ContinuousImprovement1)ValueStreamMapping2)StandardizedWork3)ContinuousOne-PieceFlow4)AndonandJidoka5)BasicTotalProductiveMaintenance6)LessonsLearned/Read-AcrossProcess7)Bottleneck/ConstraintManagement8)Sub-SupplierManagementTRWSupplierImprovementStrategies1TRWSupplierImprovementStraQUALITYBASICSError-ProofingDevices/VerificationRPNRiskReduction(P-FMEA)VerificationStations/StationAlarmEscalationControlofNon-ConformingProductQuickResponseProcessLayeredProcessAuditsProblemSolvingProcess/ToolsWorkplaceOrganization/VisualManagementTRWSupplierImprovementStrategies34QUALITYError-ProofingDevices35RPNRISKREDUCTIONPROCESS风险降低程序TSIS:RPNRiskReductionProcessVersion1.02011-10-123RPN36TSIS:RPNRiskReductionProcessWhatisRPN 什么是RPN SeverityRankSheet

严重度分级OccurrenceRankSheet

频度数分级DetectionRankSheet

探测度分级HowtogetRPN 怎样计算RPNRPNReduction RPN降低Proactive

主动式降低RPNtrackingchart RPN降低追踪表Reactive 被动式降低TopFailuresList 最大失效清单LearningOutcome

学习内容4TSIS:RPNRiskReductionPro37海恩法则/Herren’sPrinciple:

每一起严重事故的背后，必然有29次轻微事故和300起未遂

先兆以及1000起事故隐患。 Everyseriousaccidentfollowsby29minoraccident, 300 signedfailuresand1000potentialdefects.

法则强调两点:

2stressesofthePrinciple：事故的发生是量的积累的结果； Aquantitativechangecausesaqualitativechange.再好的技术，再完美的规章，在实际操作层面，也无法取代人自身的素质和责任心。 Atoperationallevel,people’scapabilityandresponsibilityaremuchmoreimportantthananyhigh-techorperfectprocedure.任何不安全事故都是可以预防的。AnyaccidentispreventableTSIS:RPNRiskReductionProcess5海恩法则/Herren’sPrinciple:TSIS38风险优先数(RPN-RiskPriorityNumber)：指严重度数（S）和频度数（O）及不易探测度数（D）三项数字之乘积RPN=Severity(S)xOccurrence(O)xDetection(D)严重度Severity(S)：指一给定失效模式最严重的影响后果的级别，是单一的FMEA范围内的相对定级结果。严重度数值的降低只有通过设计更改或重新设计才能够实现。Severityisthevalueassociatedwiththemostseriouseffectforagivenfailuremode.SeverityisarelativerankingwithinthescopeoftheindividualFMEA.

Onlyadesignrevisioncanbringaboutareductionintheseverityranking.

频度数Occurrence(O)：指某一特定的起因/机理发生的可能性，描述出现的可能性的级别数具有相对意义，但不是绝对的。

Occurrenceisthelikelihoodthataspecificcause/mechanismwilloccurresultinginthefailuremodewithinthedesignlife.Thelikelihoodofoccurrencerankingnumberhasarelativemeaningratherthananabsolutevalue探测度Detection(D)：指对在现有设计控制探测栏中列出的最好的探测控制的对应等级。DetectionistherankassociatedwiththebestdetectioncontrollistedintheDetectionControlscolumn.

TSIS:RPNRiskReductionProcess6风险优先数(RPN-RiskPriorityNum39过程失效模式及后果分析

PROCESSFAILUREMODE&EFFECTSANALYSIS

(PFMEA)

定义DEFINITION是对每一个过程步骤进行分析的技术，以识别：Ananalyticaltechniqueforeachprocessstepthatidentifies:过程可能达不到要求的情形waysaprocessmayfailtomeetrequirements.对内部/外部顾客的影响(严重度)consequencestotheinternal/externalcustomer(severity).失效可能发生的频率(发生频度)frequencythefailurewill/couldhappen(occurrence).当前控制的效果(预防和可探测度)effectivenessofcurrentcontrols(prevention&detection).原因和结果的等级(风险顺序数)rankingofcausesandeffects(riskprioritynumber).是一个格式化程序，用以识别和消除潜在的过程失效模式Astructuredprocedureforidentifyingandeliminatingprocessrelatedfailuremodes.TSIS:RPNRiskReductionProcess7过40根据AIAG/PPAP手册第4版严重度分级TSIS:RPNRiskReductionProcess8根据AIAG/PPAP手册第4版严重度分级TSIS41SeverityRankEffectCriteria:

SeverityofEffectonProduct

(Customereffect)

Rank

EffectCriteria:

SeverityofEffectonProcess

(Manufacturing/AssemblyEffect)

FailuretoMeetSafetyand/orregulatoryRequirementsPotentialfailuremodeaffectssafevehicleand/orinvolvesnoncompliancewithgovernmentregulationwithoutwarning

10

FailuretoMeetSafetyand/orregulatoryRequirementsMayendangeroperator(machineorassembly)withoutwarningPotentialfailuremodeaffectssafevehicleand/orinvolvesnoncompliancewithgovernmentregulationwithwarning

9

Mayendangeroperator(machineorassembly)withwarningLossorDegradationofprimaryfunctionLossofprimaryfunction(vehicleinoperable,doesnotaffectsafevehicleoperation)

8

Majordisruptions100%ofproductmayhavetobescrapped.LineshutdownorstopshipDegradationofprimaryfunction(vehicleoperablebutatareducedlevelofperformance)

7

SignificantdisruptionsAportionoftheproductionmayhavetobescrapped.DeviationfromprimaryprocessincludingdecreasedlinespeedoraddedmanpowerLossorDegradationofsecondaryfunctionLossofsecondaryfunction(vehicleoperable,butcomfort/conveniencefunctionsinoperable)

6

Moderatedisruption100%ofproductionrunmayhavetobereworkedofflineandacceptedDegradationofsecondaryfunction(vehicleoperablebutatareducedlevelofperformance)

5

AportionoftheproductionrunmayhavetobereworkedofflineandacceptedAnnoyanceAppearanceoraudibleNoise,vehicleoperable,itemdoesnotconformandnoticedbymostcustomers(>75%)

4

Moderatedisruption100%ofproductionrunmayhavetobereworkedinstationbeforeitisprocessedAppearanceoraudibleNoise,vehicleoperable,itemdoesnotconformandnoticedbymanycustomers(>50%)

3

AportionoftheproductionrunmayhavetobereworkedinstationbeforeitisprocessedAppearanceoraudibleNoise,vehicleoperable,itemdoesnotconformandnoticedbydiscriminatingcustomers(>25%)

2

MinordisruptionSlightinconveniencetoprocess,operation,oroperator.NoeffectNodiscernibleeffect

1

NoeffectNodiscernibleeffectBasedonthePotentialFailureModeandEffectAnalysisManualfromtheAIAG4thEditionTSIS:RPNRiskReductionProcess9SeverityRankEffectCriteria:

42根据AIAG/PPAP手册第4版频度数分级TSIS:RPNRiskReductionProcess10根据AIAG/PPAP手册第4版频度数分级TSIS:43OccurrenceRankBasedonthePotentialFailureModeandEffectAnalysisManualfromtheAIAG4thEditionLikelihoodoffailureCriteria:Occurrenceofcause-PFMEA(incidentsperitems/vehicles)

Rank

VeryHigh>=100perThousand

>=1in10

10High50perThousand

1in20

920perThousand

1in50

810perThousand

1in100

7Moderate2perThousand

1in500

60.5perThousand

1in2,000

50.1perThousand

1in10,000

4Low0.01perThousand

1in100,000

3<=0.001perThousand

1in1,000,000

2VerylowFailureiseliminatedthroughpreventivecontrol

1TSIS:RPNRiskReductionProcess11OccurrenceRankBasedonthe44根据AIAG/PPAP手册第4版探测度分级TSIS:RPNRiskReductionProcess12根据AIAG/PPAP手册第4版探测度分级TSIS:45DetectionRankBasedonthePotentialFailureModeandEffectAnalysisManualfromtheAIAG4t