fmea_training_guide.pdf

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1、ManufacturingTechnologyCommittee–RiskManagementWorkingGroupRiskManagementTrainingGuidesFailureModesandEffectsAnalysisGuide1OverviewFailureModesandEffectsAnalysis(FMEA)iscommonlyusedinavarietyofindustriesforRiskManagement,wheresimplequantificationofriskisinsufficient,andwhereidentificat

2、ionofrootcausesofrisksandmeansofmitigationareparamount.FMEAisoneofthemostusefulandeffectivetoolsfordevelopingdesigns,processesandservices.ThegoalofFMEAistoaligntherisksascloselyaspossiblewithitssource.Thisenablesthedeterminationoftherootcauseoftherisk,andallowstheselectionofwaystodetec

3、ttheoccurrenceofaparticularfailureand/ortofindoptionstopreventormitigatetheeffectsofaparticularfailure.GoodFMEAmethodologyallowsfortheidentificationanddocumentationofpotentialfailuresofasystemandtheirresultingeffects.Italsoallowsfortheassessmentofthepotentialfailuretodetermineactionsth

4、atwouldreduceseverity,reduceoccurrence,andincreasedetection.DuringFMEA,allstepsareanalyzedforpotentialfailureopportunities;theultimateeffecttoproductqualityorpatientsafetyand/orefficacyasaresultofeachpotentialfailureopportunityisthenquantified;andthenadjustedbasedoncapabilitiestodetect

5、ormitigate,toreachafinalassignedscoreofrisk..Theriskforeachfailureisoftentimesenteredintoariskscorematrixwhichenableseasydeterminationofthepriorityand/orlevelofattentionrequiredtobeappliedtoeachstepbasedonitstotalriskprioritynumber(RPN).TheoutcomeoftheFMEAisalistofrecommendationstoredu

6、ceoverallrisktoanacceptablelevel,andcanbeusedasasourcefordesigningacontrolstrategy.ThisdocumentpresentsguidingprinciplesfortheexecutionofFailureModesandEffectsAnalysis(FMEA).Successfulapplicationofanyriskmanagementmodelrequiresthatthetoolsareusedinconcertwithanoverallqualityriskmanagem

7、entprocess,similartothatdescribedbyICHQ9.1.1UseFailureModesandEffectsAnalysiscanbeausefultoolin:selectionandoptimizationofdrugproductformulationdefiningthedesignspaceformanufacturingprocessesfordrugsubstancesanddrugproductsdesignandmanufactureofdevicesTrainingGuide:FailureModesandEff