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風險降低程序TSIS:RPNRiskReductionProcessVersion1.02011-10-123RPN4TSIS:RPNRiskReductionProcessWhatisRPN 什么是RPN SeverityRankSheet

嚴重度分級OccurrenceRankSheet

頻度數分級DetectionRankSheet

探測度分級HowtogetRPN 怎樣計算RPNRPNReduction RPN降低Proactive

主動式降低RPNtrackingchart RPN降低追蹤表Reactive 被動式降低TopFailuresList 最大失效清單LearningOutcome

學習內容4TSIS:RPNRiskReductionPro5海恩法則/Herren’sPrinciple:

每一起嚴重事故的背后，必然有29次輕微事故和300起未遂

先兆以及1000起事故隱患。 Everyseriousaccidentfollowsby29minoraccident, 300 signedfailuresand1000potentialdefects.

法則強調兩點:

2stressesofthePrinciple：事故的發生是量的積累的結果； Aquantitativechangecausesaqualitativechange.再好的技術，再完美的規章，在實際操作層面，也無法取代人自身的素質和責任心。 Atoperationallevel,people’scapabilityandresponsibilityaremuchmoreimportantthananyhigh-techorperfectprocedure.任何不安全事故都是可以預防的。AnyaccidentispreventableTSIS:RPNRiskReductionProcess5海恩法則/Herren’sPrinciple:TSIS6風險優先數(RPN-RiskPriorityNumber)：指嚴重度數（S）和頻度數（O）及不易探測度數（D）三項數字之乘積RPN=Severity(S)xOccurrence(O)xDetection(D)嚴重度Severity(S)：指一給定失效模式最嚴重的影響后果的級別，是單一的FMEA范圍內的相對定級結果。嚴重度數值的降低只有通過設計更改或重新設計才能夠實現。Severityisthevalueassociatedwiththemostseriouseffectforagivenfailuremode.SeverityisarelativerankingwithinthescopeoftheindividualFMEA.

Onlyadesignrevisioncanbringaboutareductionintheseverityranking.

頻度數Occurrence(O)：指某一特定的起因/機理發生的可能性，描述出現的可能性的級別數具有相對意義，但不是絕對的。

Occurrenceisthelikelihoodthataspecificcause/mechanismwilloccurresultinginthefailuremodewithinthedesignlife.Thelikelihoodofoccurrencerankingnumberhasarelativemeaningratherthananabsolutevalue探測度Detection(D)：指對在現有設計控制探測欄中列出的最好的探測控制的對應等級。DetectionistherankassociatedwiththebestdetectioncontrollistedintheDetectionControlscolumn.

TSIS:RPNRiskReductionProcess6風險優先數(RPN-RiskPriorityNum7過程失效模式及后果分析

PROCESSFAILUREMODE&EFFECTSANALYSIS

(PFMEA)

定義DEFINITION是對每一個過程步驟進行分析的技術，以識別：Ananalyticaltechniqueforeachprocessstepthatidentifies:過程可能達不到要求的情形waysaprocessmayfailtomeetrequirements.對內部/外部顧客的影響(嚴重度)consequencestotheinternal/externalcustomer(severity).失效可能發生的頻率(發生頻度)frequencythefailurewill/couldhappen(occurrence).當前控制的效果(預防和可探測度)effectivenessofcurrentcontrols(prevention&detection).原因和結果的等級(風險順序數)rankingofcausesandeffects(riskprioritynumber).是一個格式化程序，用以識別和消除潛在的過程失效模式Astructuredprocedureforidentifyingandeliminatingprocessrelatedfailuremodes.TSIS:RPNRiskReductionProcess7過8根據AIAG/PPAP手冊第4版嚴重度分級TSIS:RPNRiskReductionProcess8根據AIAG/PPAP手冊第4版嚴重度分級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根據AIAG/PPAP手冊第4版頻度數分級TSIS:RPNRiskReductionProcess10根據AIAG/PPAP手冊第4版頻度數分級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根據AIAG/PPAP手冊第4版探測度分級TSIS:RPNRiskReductionProcess12根據AIAG/PPAP手冊第4版探測度分級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過程潛在失效模式及后果影響(例)失效原因的頻率有多高？失效模式的風險有多高？會出現什么問題?它是怎樣影響客戶的

?如果問題發生，有多大可能我們會注意到它？TSIS:RPNRiskReductionProcess14過程潛在失效模式及后果影響(例)失效原因的頻率有多高Whatcangowrong?Howdoesitaffectcustomer?Howoftendoesthiscausehappen?Howlikelyarewetonoticeifthishappens?Howhighistherisk?

PROCESSFAILUREMODE&EFFECTS

ANALYSIS(Example)TSIS:RPNRiskReductionProcess15Whatcangowrong?Howdoesit16降低風險程序主動式PROACTIVE

RPN降低流程:RPNREDUCTIONPROCESS:降低潛在質量失效的風險ReducingtheriskofaPOTENTIALQUALITYFAILURE

被動式REACTIVE

對已發生的質量失效建立防錯裝置ERRORPROOFINGPASTQUALITYFAILURESTSIS:RPNRiskReductionProcess16降低風險程序主動式RPN降低流程:被17主動式降低風險的要求根據質量體系要求，PFMEA必須包括所有制造過程及與相關的支持職能。PFMEA’sshallbecompletedforallmanufacturingprocessesandsupportfunctionsasrequiredbytheQualityManagementSystem.支持職能包括如下方面：進料檢驗，廠內物料運輸，標識和發運，修理，返工等。Supportfunctionsinclude:(receivinginspection,materialhandling,labeling,shipping,repair,rework,etc…).PFMEA必須:

PFMEA’sshall:符合當前的AIAG要求和顧客的要求。conformtocurrentAIAGguidelinesandcustomerrequirements.定期更新（動態文件）。beupdatedonaregularbasis(livingdocuments).包括所有的生產線/零件號existforallproductlines/partnumbers.包括所有的過程和過程步驟。includeallprocessesandprocesssteps.用于持續改進。beutilizedforContinualImprovement.正確的嚴重度/發生頻度/可探測度打分。haveaccurateSeverity/Occurrence/Detectionratings.TSIS:RPNRiskReductionProcess17主動式降低風險的要求根據質量體系要求，PFMEA必須包括18PFMEA評審

必須建立多功能小組進行定期的PFMEA評審

Multi-disciplinaryteamsshallperformperiodicPFMEAReviews.

PFMEA審核的頻率或次數必須由供應商的領導層依據如下決定：客戶的期望(PPS,SafeLaunchAudit,等）customerexpectations(PPS，SLA,etc…)過程能力(一次下線合格率,SPC,等）processcapability(FTQ,SPC,etc…)過程更改（采用防錯方法，更換二級供應商，等）changestotheprocess(Errorproofing,Tier2changes,etc…)

PFMEA審核優先級次序的標準應包括：CriteriatoprioritizewhichPFMEAtoreviewinclude:外購的產品，工裝移動或分供方變更。productfromanacquisition,toolmoveorchangeinsupplier.PFMEA制定時沒有多功能小組參與。PFMEAdevelopedwithoutadequatecross-functionalinvolvement.過去發生PPS，顧客報怨，售后問題和一次下線合格率問題的零件。PFMEAforpart(s)withhistoryofPR/R,Customercomplaints，WarrantyorFTQissues.發生頻度(一次下線合格率,報廢率等)有顯著變化.Occurrenceratings(FTQ,scrap,etc…)havechangedsignificantly.舊版本的PFMEA。PFMEAatolderrevisionTSIS:RPNRiskReductionProcess18PFMEA評審必須建立多功能小組進行定期的PF19

PFMEA審核必須至少包含如下方面：PFMEAReviewshall

includethefollowingataminimum:確認包含所有的操作/過程并準備無誤(電鍍，熱處理，標識，等)。Verificationthatalloperations/processesareincludedandaccurate(paint,heattreat,materialhandling,labeling,etc…).包含所有的過程控制。Allprocesscontrolsareincluded.探測度打分選定準確。Detectionratingsareaccurate.發生率確定應依據數據分析(SPC，一次下線合格率FTQ，驗證崗位*，報廢率，過程分層審核*結果，等)。Occurrenceratingsareanalyzedusingdata(SPC,FTQ,VerificationStation*Scrap,LayeredProcessAudits*

results,etc…).

確認PFMEA滿足客戶要求及期望(AIAG,PPAP,SafeLaunch,等)verificationthatthePFMEAmeetscustomerrequirementsandexpectations(AIAG,PPAP,Launch,DDW,etc…).完成審核后,必須建立一個高(RPN)風險降低機會清單，或按新數據對高風險進行修改。Uponcompletionofthereview,alistofthehighest(RPN)RiskReductionopportunitiesisestablishedorrevisedbasedonthenewdata.多功能小組必須依據行動計劃跟蹤降低RPN風險值的進展情況。Anactionplanorequivalentshallbeutilizedbythemulti-disciplinaryteamtotrackprogressinreducingtheRPNratings.

TSIS:RPNRiskReductionProcess19PFMEA審核必須至少包含如下方面：完成審20

RPN降低跟蹤表(主動式)(例)跟蹤表上RPN降低的項目數取決于該產品和生產過程的復雜程度，工廠的規模大小，客戶質量反饋，等等…TSIS:RPNRiskReductionProcess20RPN降低跟蹤表(主動式)(例)跟蹤表上RP

RPNTRACKINGCHART(Proactive)(Example)ThenumberofRPNreductionopportunitiesonthelistisdependentoncomplexityofpartsandprocess,sizeofplant,customerfeedback,etc…TSIS:RPNRiskReductionProcess21RPNTRACKINGCHART(Proactive)22被動式風險降低：REACTIVERISKREDUCTION:對過去的質量失效采取防錯ERRORPROOFINGPASTQUALITYFAILURES

必須通過多功能組建立一個過去內部/外部質量失效的清單。Multi-disciplinaryteam(s)shallbeutilizedtodevelopalistofthepastinternalandexternalqualityfailures.小組共同識別PFMEA中每一個RPN真實的嚴重度，頻度和可探測度Team(s)identifytruePFMEASeverity,OccurrenceandDetectionratingforeachRPNusingAIAGguidelines.小組必須制定行動計劃對失效進行防錯。Team(s)shalldevelopanactionplantoErrorProofthefailures.建議采取防止或減少失效模式發生的改進行動。RecommendedActionsareimprovementsthatwillpreventorreducetheFailureMode.如防錯不可行，應制定計劃改善探測方式。WhenErrorProofingisnotfeasible,aplantoimprovedetectionshallbeestablished.

必須分派小組成員負責實施建議的行動。Ateammembershallbeassignedresponsibilityforimplementingtherecommendedaction.

必須制定合理的目標完成日期。Reasonabletargetcompletiondatesshallbeestablished.TSIS:RPNRiskReductionProcess22被動式風險降低：REACTIVERISKREDUCT23被動式風險降低：REACTIVERISKREDUCTION:對過去的質量失效采取防錯ERRORPROOFINGPASTQUALITYFAILURES防錯必須通過“防錯驗證*”程序得到驗證。ErrorproofingshallbeverifiedpertheErrorProofingVerification*

process.整改行動實施后，小組必須重新驗證新的發生頻度，可探測度和RPN結果。Whencorrectiveactionshavebeenimplemented,teamsshallvalidatethenewOccurrenceandDetectionrankingsandresultantRPN.小組必須將所有的整改行動措施更新到PFMEA中。TeamsshallupdatePFMEA’swithallcorrectiveactionmeasures.TSIS:RPNRiskReductionProcess23被動式風險降低：防錯必須通過“防錯驗證*”程序得到驗證。24被動式風險降低:最大失效清單(例)TSIS:RPNRiskReductionProcess24被動式風險降低:(例)TSIS:RPNRiskRREACTIVERISKREDUCTION:TOPFAILURESLIST(Example)TSIS:RPNRiskReductionProcess25REACTIVERISKREDUCTION:(Examp26TSIS:RPNRiskReductionProcess26TSIS:RPNRiskReductionPr27風險降低RISKREDUCTION工廠領導層必須：SITELEADERSHIP:至少每年對PFMEA培訓需求進行一次評估shouldreviewtheneedforPFMEAtrainingatleastonceperyear.

必須支持RPN降低活動并提供必需的資源

shallsupportRPNreductionactivitiesandprovidenecessaryresources.必須評估RPN降低跟蹤表shallreviewtheRPNreductiontrackingcharts.必須確保正式的多功能小組參與對PFMEA的準備與評估

shallensurethatformalmulti-disciplinaryteamsareutilizedinthepreparationandongoingreviewofPFMEA’sTSIS:RPNRiskReductionProcess27風險降低工廠領導層必須：TSIS:RPNRi28風險降低RiskReduction益處:BENEFITS:支持TS16949質量體系所期望的持續改進行動。SupportscontinualimprovementasexpectedbyTS16949.

使管理層集中有限的資源解決重大的質量風險。Allowsleadershiptoallocatelimitedresourcestocriticalareas.

提供一個有效防錯和問題解決的基礎。Providesabasisforeffectiveerror-proofingandproblemsolving.

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

提供經驗教訓文件。ProvidesaLessonsLearned*archive.

可以推動多功能小組的團隊協作.Promotescross-functionalteamwork.

滿足顧客“動態文件”的期望。Meetscustomerexpectationsfor“livingdocuments”.TSIS:RPNRiskReductionProcess28風險降低益處:支持TS16949質量體系所29風險降低總結RISKREDUCTIONSUMMARY主動式PROACTIVE工廠領導層必須支持RPN風險降低活動并提供必要的資源。LeadershipshallsupportRPNreductionactivitiesandprovidenecessaryresources.PFMEA必須進行全面的評審。PFMEA’sshallundergoacompletereview.必須建立高（RPN）風險降低項目的跟蹤列表。Alistofthehighest(RPN)RiskReductionopportunitiesshallbeestablished.多功能小組必須利用行動計劃或類似文件來跟蹤RPN降低活動的狀態。Anactionplanorequivalentshallbeutilizedbythemulti-disciplinaryteamtotrackprogressinreducingtheRPNratings.被動式REACTIVE多功能小組必須建立過去發生的內部/外部質量問題的清單。Alistofthepastinternalandexternalqualityfailuresshallbeestablished.多功能小組必須建立行動計劃以對失效進行防錯。Team(s)shalldevelopanactionplantoErrorProofthefailures.TSIS:RPNRiskReductionProcess29風險降低總結主動式TSIS:RPNR30TSIS:RPNRiskReductionProcessRPNclassroomexercise–tofillthecorrectnumberincellswhicharehighlightedinyellowRPN課堂練習–在黃色單元格內填寫正確的數字30TSIS:RPNRiskReductionPr31TSIS:RPNRiskReductionProcessRPNclassroomexerciseAnswerRPN課堂練習參考答案31TSIS:RPNRiskReductionPr32End

結束TSIS:RPNRiskReductionProcess32End

結束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風險降低程序TSIS:RPNRiskReductionProcessVersion1.02011-10-123RPN36TSIS:RPNRiskReductionProcessWhatisRPN 什么是RPN SeverityRankSheet

嚴重度分級OccurrenceRankSheet

頻度數分級DetectionRankSheet

探測度分級HowtogetRPN 怎樣計算RPNRPNReduction RPN降低Proactive

主動式降低RPNtrackingchart RPN降低追蹤表Reactive 被動式降低TopFailuresList 最大失效清單LearningOutcome

學習內容4TSIS:RPNRiskReductionPro37海恩法則/Herren’sPrinciple:

每一起嚴重事故的背后，必然有29次輕微事故和300起未遂

先兆以及1000起事故隱患。 Everyseriousaccidentfollowsby29minoraccident, 300 signedfailuresand1000potentialdefects.

法則強調兩點:

2stressesofthePrinciple：事故的發生是量的積累的結果； Aquantitativechangecausesaqualitativechange.再好的技術，再完美的規章，在實際操作層面，也無法取代人自身的素質和責任心。 Atoperationallevel,people’scapabilityandresponsibilityaremuchmoreimportantthananyhigh-techorperfectprocedure.任何不安全事故都是可以預防的。AnyaccidentispreventableTSIS:RPNRiskReductionProcess5海恩法則/Herren’sPrinciple:TSIS38風險優先數(RPN-RiskPriorityNumber)：指嚴重度數（S）和頻度數（O）及不易探測度數（D）三項數字之乘積RPN=Severity(S)xOccurrence(O)xDetection(D)嚴重度Severity(S)：指一給定失效模式最嚴重的影響后果的級別，是單一的FMEA范圍內的相對定級結果。嚴重度數值的降低只有通過設計更改或重新設計才能夠實現。Severityisthevalueassociatedwiththemostseriouseffectforagivenfailuremode.SeverityisarelativerankingwithinthescopeoftheindividualFMEA.

Onlyadesignrevisioncanbringaboutareductionintheseverityranking.

頻度數Occurrence(O)：指某一特定的起因/機理發生的可能性，描述出現的可能性的級別數具有相對意義，但不是絕對的。

Occurrenceisthelikelihoodthataspecificcause/mechanismwilloccurresultinginthefailuremodewithinthedesignlife.Thelikelihoodofoccurrencerankingnumberhasarelativemeaningratherthananabsolutevalue探測度Detection(D)：指對在現有設計控制探測欄中列出的最好的探測控制的對應等級。DetectionistherankassociatedwiththebestdetectioncontrollistedintheDetectionControlscolumn.

TSIS:RPNRiskReductionProcess6風險優先數(RPN-RiskPriorityNum39過程失效模式及后果分析

PROCESSFAILUREMODE&EFFECTSANALYSIS

(PFMEA)

定義DEFINITION是對每一個過程步驟進行分析的技術，以識別：Ananalyticaltechniqueforeachprocessstepthatidentifies:過程可能達不到要求的情形waysaprocessmayfailtomeetrequirements.對內部/外部顧客的影響(嚴重度)consequencestotheinternal/externalcustomer(severity).失效可能發生的頻率(發生頻度)frequencythefailurewill/couldhappen(occurrence).當前控制的效果(預防和可探測度)effectivenessofcurrentcontrols(prevention&detection).原因和結果的等級(風險順序數)rankingofcausesandeffects(riskprioritynumber).是一個格式化程序，用以識別和消除潛在的過程失效模式Astructuredprocedureforidentifyingandeliminatingprocessrelatedfailuremodes.TSIS:RPNRiskReductionProcess7過40根據AIAG/PPAP手冊第4版嚴重度分級TSIS:RPNRiskReductionProcess8根據AIAG/PPAP手冊第4版嚴重度分級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根據AIAG/PPAP手冊第4版頻度數分級TSIS:RPNRiskReductionProcess10根據AIAG/PPAP手冊第4版頻度數分級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根據AIAG/PPAP手冊第4版探測度分級TSIS:RPNRiskReductionProcess12根據AIAG/PPAP手冊第4版探測度分級TSIS:45DetectionRankBasedonthePotentialFailureModeandEffectAnalysisManualfromtheAIAG4t