Q9 FMEA失效模式效應分析

AnnexI.2FailureMode

EffectsAnalysis失效模式效應分析

(FMEA)I.2:FailureModeEffectsAnalysis失效模式效應分析(FMEA)(seeIEC60812

見IEC60812)EvaluationofpotentialfailuremodesforprocessesThelikelyeffectonoutcomesand/orproductperformanceOncefailuremodesareestablished,

riskreductioncanbeusedto

eliminate,reduceorcontrolthepotentialfailuresFMEAreliesonprocessunderstandingSummarizetheimportantmodesoffailure,factorscausingthesefailuresandthelikelyeffectsofthesefailures

Howtoperform?

BreakdownlargecomplexprocessesintomanageablestepsICHQ9I.2:FailureModeEffectsAnalysis失效模式效應分析(FMEA)(seeIEC60812

見IEC60812)工藝的潛在失效模式的評估

對結果和產品性能的可能的影響一旦失效模式建立，風險降低行動用于來消除、降低或控制潛在的失效依賴于對工藝的理解概述重要的失效模式，引起失效的因數(shù)和失效的可能的影響

如何實施?

將大的復雜的工藝分解成易處理的步驟ICHQ9I.2:FailureModeEffectsAnalysis(FMEA)

PotentialAreasofUse(s)PrioritizerisksMonitortheeffectivenessofriskcontrolactivitiesEquipmentandfacilitiesAnalyzeamanufacturingprocess

toidentifyhigh-riskstepsorcriticalparametersRNP:RiskPriorityNumberC.Kingery,TheSixSigmaMemoryJoggerIIICHQ9I.2:失效模式效應分析(FMEA)

可使用的潛在領域：Prioritizerisks優(yōu)先考慮的風險Monitortheeffectivenessofriskcontrolactivities監(jiān)控風險控制活動的效力Equipmentandfacilities

設備和設施Analyzeamanufacturingprocesstoidentifyhigh-riskstepsorcriticalparameters為了識別高風險步驟和關鍵參數(shù)分析一個生產工藝RNP:RiskPriorityNumberC.Kingery,TheSixSigmaMemoryJoggerIIICHQ9I.2:FailureModeEffectsAnalysis(FMEA)Howtoperform?1.Establishateam2.Identifytheknownandpotentialfailuremodes:Developlistsofknownproblemsandbrainstormotherpotentials…

e.g.ProductnotmeetingspecificationProcessnotmeetingyieldrequirementsMalfunctioningequipmentSoftwareproblemsNewlyidentifiedfailuremodesshouldbeaddedatanytimeEXAMPLEI.2:失效模式效應分析(FMEA)如何實施?1.成立一個小組2.識別已知和潛在的失效模式生成已知問題和集體討論的其他潛在問題的列表例如.產品不符合標準工藝不滿足收率需要設備故障軟件問題新發(fā)現(xiàn)的失效問題應該隨時加進來。EXAMPLEI.2:FailureModeEffectsAnalysis(FMEA)Howtoperform?3.Characterisetheseverity,probabilityanddetectability

AnequalnumberoflevelsissometimeshelpfulSomepreferenceto3,4,5,6or10levelsBut:anevennumberoflevelsavoidsthemidpointUsedifferentscalesLinear: 1,2,3,4Exponential: 1,2,4,8Logarithmic: 1,10,100,1000Selfmade: 1,3,7,10MultiplyingdifferentscaleswilldifferentiatetheoutcomeTheaimistocomeupwithamethodofprioritisingEXAMPLEI.2:失效模式效應分析(FMEA)如何實施?3.識別嚴重性、可能性和可檢測性一個相當?shù)臄?shù)字等級常常是很有用的一般優(yōu)先選擇等級3，4，5，6或10但是:一個偶數(shù)等級會避免中位數(shù)用不同的等級線性的: 1,2,3,4直數(shù)的: 1,2,4,8對數(shù): 1,10,100,1000自定義: 1,3,7,10不同的等級的乘積將區(qū)分結果目標是提出一個定義優(yōu)先順序的方法EXAMPLEI.2:FailureModeEffectsAnalysis(FMEA)Howtoperform?4.Defineactions5.Revisittheranking6.Defineresidualrisk7.PerformashortsummaryScopeDatafromtheassessment&control

(e.g.No.ofidentifiedfailuremodes)Levelofacceptedriskwithoutactionsi.e.residualrisk

(e.g.RiskpriorityNumber<50)Recommendedactions,responsibilitiesandduedates

(includingapproval,ifappropriate)Personinchargeforfollow-upofFMEAEXAMPLEI.2:失效模式效應分析(FMEA)如何實施?4.詳細說明行為5.重新評級6.詳細說明剩余的風險7.完成一個簡短的摘要范圍從評估和控制中得到的數(shù)據(jù)

(例如已識別失效模式的編號)不需要采取措施的可接受的風險的等級

即

剩余風險

(比如風險優(yōu)先號

<50)建議采取的措施,相關職責

和完成日期

(如果需要也包括批準)負責下一步FMEA的責任人EXAMPLESeverity(Consequencesoffailure)10ExtremePredictedtocausesevereimpacttoquality(Productoutofspecifications,noExpertStatementpossible)

7HighPredictedtocausesignificantimpactonquality(Failuretomeetspecifications,noStabilitydata,ExpertStatementpossible)

3ModeratePredictedtocauseminorimpactonquality(Failuretomeetspecifications,Stabilitydataavailable)

1LowPredictedtohaveno/minorimpactonqualityoftheproduct(Qualitywithinspecifications)EXAMPLE嚴重性

(失效的結果)10極高可能會對產品產品產生嚴重的影響

(產品OOS,可能無專家聲明)

7高可能對產品質量產生重大的影響

(不能滿足指標,沒有穩(wěn)定性數(shù)據(jù),可能需要專家聲明)

3中可能對產品質量產生小的影響(不能滿足指標要求,可能沒有穩(wěn)定性數(shù)據(jù))

1低可能對產品質量無影響或很微小的影響

(質量在指標之內)EXAMPLEProbability(Likelihoodfailurewillhappen)8RegularfailuresExpectedtohappenregularly

4RepeatedfailuresExpectedtohappeninalowfrequency

2OccasionalfailuresExpectedtohappeninfrequently

1UnlikelyfailuresUnlikelytohappenEXAMPLE可能性

(失效發(fā)生的概率)8經(jīng)常失效期望有規(guī)律的發(fā)生

4重復的失效期望以較低頻率發(fā)生

2偶爾失效

期望很少發(fā)生

1幾乎不會失效不太可能發(fā)生EXAMPLEDetectability(Abilitytofindthefailure)4NormallynotdetectedFailureverylikelytobeoverlooked,hencenotdetected

(notechnicalsolution,nomanualcontrol)3LikelynotdetectedFailuremaybeoverseen

(manualcontrol,spotchecks)2RegularlydetectedFailurewillnormallybedetected

(manualcontrol,routineworkwithstatisticalcontrol)1AlwaysdetectedFailurecanandwillbedetectedinallcases

(monitoring,technicalsolutionavailable)EXAMPLE可檢測性

(發(fā)現(xiàn)失效的能力)4通常不能被發(fā)現(xiàn)失效非常容易被忽視,因此不能發(fā)現(xiàn)

(沒有技術解決方法,沒有手動控制)3可能發(fā)現(xiàn)不了失效可能被檢查到

(手動控制,現(xiàn)場檢查)2定期檢查可以發(fā)現(xiàn)失效通常都能發(fā)現(xiàn)

(手動控制,

統(tǒng)計控制的例行工作)1隨時可以發(fā)現(xiàn)失效隨時會被發(fā)現(xiàn)

(檢測器,技術措施有效)EXAMPLEFMEA:QuantitationofRisk:Severity10DangerouslyHighFailurecouldleadtodeathorpermanentinjurytothecustomer.Financial:>$1,000,0009ExtremelyhighFailurecouldleadtoinjurytothecustomer.Failurewouldcreatenon-compliancewithregisteredspecifications.Failurelikelytoleadtorecall.Financial:$1,000,0008VeryHighFailurecouldleadtoadversereactionforcustomer.FailurewouldcreatenoncompliancewithGMPregulationsorproductregistrations.Failurepossibletoleadtorecall.Financial:$500,0007HighFailureleadstocustomerperceptionofsafetyissue.Failurerendersindividualunit(s)unusable.Failurecausesahighdegreeofcustomerdissatisfaction.RecallforbusinessreasonspossiblebutAuthorityrequiredrecallunlikely.Financial:$100,0006ModerateFailurecausesahighdegreeofcustomerdissatisfactionandnumerouscomplaints.Failureunlikelytoleadtorecall.Financial:$50,0005LowFailurelikelytocauseisolatedcustomercomplaints.Financial:$10,0004VeryLowFailurerelatestonon-dosageformissues(likeminorpackagingproblems)andcanbeeasilyovercomebythecustomer.Financial:$5,0003MinorFailurecouldbenoticedbythecustomerbutisunlikelytobeperceivedassignificantenoughtowarrantacomplaint.2VeryMinorFailurenotreadilyapparenttothecustomer.Financial:<$1,0001NoneFailurewouldnotbenoticeabletothecustomer.Financial:noneDr.GaryHarbour,PfizerEXAMPLEFMEA:風險的數(shù)值:嚴重性10高危險失效可能導致消費者死亡或永久的傷害，財產損失：>$1,000,0009極端高失效可能導致消費者的傷害。失效將產生與已注冊的標準不符合，失效會導致產品召回財產損失：$1,000,0008很高失效會導致消費者不良反應?？赡墚a生不符合GMP法規(guī)或產品注冊?？赡軙е抡倩?。財產損失：$500,0007高失效會引起客戶對安全問題的擔心，失效必須給單個單位給與補償，失效會導致客戶高度的不滿意，產品召回只是因為商業(yè)原因而不會引起強制召回，財產損失:$100,0006中失效會引起客戶高度的不滿意和大量的投訴。失效未必會引起產品召回，財產損失:$50,0005低失效會引起單個客戶投訴，財產損失:$10,0004非常低失效不涉及到劑型等問題（象包裝問題），可以很容易被客戶接受，財產損失:$5,0003較小失效會被客戶注意但是未必會引起客戶投訴2非常小失效不容易被客戶接受.財產損失:<$1,0001無失效不會引起客戶注意。財產損失：無Dr.GaryHarbour,PfizerEXAMPLEFMEA:QuantitationofRisk:Probability10VeryHigh:FailureisalmostinevitableMorethanoneoccurrenceperdayoraprobabilityofmorethanthreeoccurrencesin10units(Cpk<0.33or<1σ).9

Oneoccurrenceeverythreetofourdaysoraprobabilityofthreeoccurrencesin10units(Cpk~0.33or~1σ).8High:RepeatedfailuresOneoccurrenceperweekoraprobabilityof5occurrencesin100units(Cpk~0.67or~2σ).7

Oneoccurrenceeverymonthoroneoccurrencein100units(Cpk~0.83~2.5σ).6Moderate:OccasionalFailuresOneoccurrenceeverythreemonthsorthreeoccurrencesin1,000units(Cpk~1.00or~3σ).5

Oneoccurrenceeverysixmonthstooneyearoroneoccurrencein10,000units(Cpk~1.17or~3.5σ).4

Oneoccurrenceperyearorsixoccurrencesin100,000units(Cpk~1.33or~4σ).3Low:RelativelyfewFailuresOneoccurrenceeveryonetothreeyearsorsixoccurrencesin10,000,000units(Cpk~1.67or~5σ).2

Oneoccurrenceeverythreetofiveyearsor2occurrencesin1,000,000,000units(Cpk~2.00OR~6σ).1Remote:FailureisunlikelyOneoccurrenceingreaterthanfiveyearsorlessthantwooccurrencesin1,000,000,000units(Cpk>2.00OR>6σ).Forbatchfailuresusethetimescaleforunitfailuresusetheunitscale.Dr.GaryHarbour,PfizerEXAMPLEFMEA:風險數(shù)值:可能性10非常高:失效幾乎不可避免每天發(fā)生超過一次或可能性大于3/10(Cpk<0.33or<1σ).9

每三天或四天發(fā)生一次或可能性是3/10(Cpk~0.33or~1σ).8高:重復失效每周一次或可能性為5/100(Cpk~0.67or~2σ).7

每月發(fā)生一次或可能性為1/100(Cpk~0.83~2.5σ).6中:偶爾失效每三個月發(fā)生一次或可能性為3/1000(Cpk~1.00or~3σ).5

每六個月到一年發(fā)生一次或可能性為1/10，000(Cpk~1.17or~3.5σ).4

一年發(fā)生一次或可能性為6/100，000(Cpk~1.33or~4σ).3低:相對很少失效每一年至三年發(fā)生一次或可能性為6/10，000，000(Cpk~1.67or~5σ).2

每三至五年發(fā)生一次或可能性為1/1，000，000，000(Cpk~2.00OR~6σ).1微笑:失效幾乎不太可能超過五年發(fā)生一次或小于2/1，000，000，000(Cpk>2.00OR>6σ).Forbatchfailuresusethetimescaleforunitfailuresusetheunitscale.對于批失效用時間尺度，對于單元失效使用單位尺度Dr.GaryHarbour,PfizerEXAMPLEFMEA:QuantitationofRisk:Detection10AbsoluteUncertaintyTheproductisnotinspectedorthedefectcausedbythefailureisnotdetectable.9VeryRemoteProductissampled,inspected,andreleasedbasedonAcceptableQualityLevel(AQL)samplingplans.8RemoteProductisacceptedbasedonnodefectsinasample.7VeryLowProductis100%manuallyinspectedintheprocess.6LowProductis100%manuallyinspectedusinggo/no-goorothermistake-proofinggauges.5ModerateSomeStatisticalProcessControl(SPC)isusedintheprocessandproductisfinalinspectedoff-line.4ModeratelyHighSPCisusedandthereisimmediatereactiontoout-of-controlconditions.3HighAneffectiveSPCprogramisinplacewithprocesscapabilities(Cpk)greaterthan1.33.2VeryHighAllproductis100%automaticallyinspected.1AlmostCertainThedefectisobviousandthereis100%automaticinspectionwithregularcalibrationandpreventivemaintenanceoftheinspectionequipment.Dr.GaryHarbour,PfizerEXAMPLEFMEA:風險數(shù)值:可檢測性10絕對不確定產品不檢查或失效引起的缺陷檢測不到9非常微弱.產品基于可接受的質量平行取樣計劃進行取樣，檢查和放行8微弱樣品沒有缺陷產品就可以被接受。7很低在工藝中產品被100%的人為檢查。6低產品使用行/不行或其他防錯測量來進行100%的人為檢查5中一些統(tǒng)計過程控制（SPC）被用于工藝，產品生產完后做最終檢測。4中高使用SPC，對不受控制的條件有中間反應3高用工藝能力大于1.33的一個有效的SPC程序2很高所有產品100%自動檢查。1幾乎確定缺陷很明顯，定期校驗的100%的自動檢查和檢查設備的預防性維護。Dr.GaryHarbour,PfizerEXAMPLESeverity/Probability/Detection(SPD)PhDR.C.Mendson,Menson&Associations,Inc

ICHEWGLondon,March2004EXAMPLEI.2:FailureModeEffectsAnalysis(FMEA)Severity(S)LinktoendproductfunctionalfailureMedicalDepartmentinvolvementProbability(P)UsehistoricaldataSimilarprocessesproductsDetectionMethodvalidationstudiesHistoricaldataEXAMPLETakayoshiMatsumura,EisaiCo.DryingProcessI.2:失效模式效應分析

(FMEA)嚴重性

(S)聯(lián)系最終產品功能性失效引入醫(yī)學部門可能性

(P)使用歷史數(shù)據(jù)類似工藝產品可檢測性

方法驗證研究歷史數(shù)據(jù)EXAMPLETakayoshiMatsumura,EisaiCo.干燥過程/工藝RankingSeverity(S)Probability(P)Detection(D)10DeathMorethanonceadayImpossibletodetect9↓3–4timesadayRemote8PermanentinjuryOnceaweekVeryslight7↓OnceamonthSlight6TemporaryinjuryOnceinthreemonthLow5↓Onceinhalf–oneyearMedium4Reported/dissatisfiedOnceayearModeratelyhigh3↓Oncein1–3yearsHigh2Notice/noreportOncein3–5yearsVeryHigh1↓Lessthanoncein5yearsVirtuallycertainI.2:FailureModeEffectsAnalysis(FMEA)TakayoshiMatsumura,EsaiCoEXAMPLEDryingProcess級別嚴重性

(S)可能性

(P)可檢測性

(D)10死亡超過一天一次不可能9↓3–4次/每天微弱的8永久傷害1次/周非常微小7↓1次/月微小6暫時傷害1次/3月低5↓1次/6月中4報告的/不高興1次/年適度高3↓1次/1~3年高2通知/無報告1次/3~5年很高1↓<1次/5年近乎必然I.2:失效模式效應分析

(FMEA)TakayoshiMatsumura,EsaiCoEXAMPLE干燥過程/工藝ProcessPotentialFailureModePotentialCauseSPDRPN1.Setupcontaminationdisheveledgownofoperatorinsufficientcleaningofequipment2.Startdryingcontaminationdamageofinlet-airfilterdegradationofproductdamageofthermometer3.Maintaintemperaturelongdryingtimeunstablesupply-airvolumehighLossOnDrying(LOD)damageoftimerlowLODhighdew-pointnon-uniformityofLODuneventemperaturedistributionDryingProcessI.2:FailureModeEffectsAnalysis(FMEA)TakayoshiMatsumura,EsaiCoEXAMPLERPN:RiskPriorityNumber=S*P*D工藝潛在失效模式潛在原因SPDRPN1.進料污染操作者不潔凈的服裝設備清洗不充分2.開始干燥污染進口過濾器損壞產品降解溫度計損壞3.保持溫度長的烘干時間不穩(wěn)定的供應空氣體積高的干燥失重計時器損壞低的干燥失重高露點不均勻的干燥失重不均勻的溫度分布干燥過程/工藝I.2:失效模式效應分析

(FMEA)TakayoshiMatsumura,EsaiCoEXAMPLERPN:風險優(yōu)先因子

=S*P*DExistingcontrols:IPCofLODanddegradationproductafterdryingprocessDryingProcessProcessPotentialFailureModePotentialCauseSPDRPN1.Setupcontaminationdisheveledgownofoperator358120insufficientcleaningofequipment7281122.Startdryingcontaminationdamageofinlet-airfilter736126degradationofproductdamageofthermometer733633.Maintaintemperaturelongdryingtimeunstablesupply-airvolume24540highLODmalfunctionoftimer2228lowLODhighdue-point33327non-uniformityofLODuneventemperaturedistribution35345I.2:FailureModeEffectsAnalysis(FMEA)TakayoshiMatsumura,EisaiCoEXAMPLERPN:RiskPriorityNumber=S*P*D現(xiàn)有的控制:LOD的IPC和

烘干過程后的降解產品干燥過程/工藝工藝潛在失效模式潛在原因SPDRPN1.進料污染操作者不潔凈的服裝358120設備清洗不充分7281122.開始干燥污染進口過濾器損壞736126產品降解溫度計損壞733633.保持溫度長的烘干時間不穩(wěn)定的供應空氣體積24540高的干燥失重計時器損壞2228低的干燥失重高露點33327不均勻的干燥失重不均勻的溫度分布35345I.2:失效模式效應分析

(FMEA)TakayoshiMatsumura,EisaiCoEXAMPLERPN:風險優(yōu)先因子

=S*P*DTakeactionwhenRPNisover100Takeactionwhenseverityisover5Remainingcriticalparametersaftertakingaction;furthercontrolsrequiredDryingProcessProcessPotentialCauseRPNRecommendedActionSPDRPN1.Setupdisheveledgownofoperator120uselongglovesandgoggles32848insufficientcleaningofequipment112changecleaningprocedure724562.Startdryingdamageof