资源描述：
《FMEA_Presentation_AR4.0》由会员上传分享，免费在线阅读，更多相关内容在学术论文-天天文库。
1、ApplicationofFailureModesandEffectsAnalysistoBiologicalManufacturingProcessesBobSeelyAmgen,Inc.,BoulderCOrseely@amgen.comOUTLINEIntroduceriskassessmentPresent“classical”FMEAAdjustmentstobiologicalprocessesEvaluationcriteriaSeverityratingscaleReviewReferencesPurpose“Riskassessmentisas
2、ystematicmethodofidentifyingandpreventingproductandprocessproblemsbeforetheyoccur.Itisfocusedonpreventingdefects,enhancingsafety,andincreasingcustomersatisfaction.Ideallyitisconductedintheproductdesignorprocessdevelopmentstages.”Ref.1,P.3Purpose,continued“Itisatoolthatprovidesastruct
3、uretothinkingthroughandevaluatingaproductionprocess,aswellasameansofquantifyinganddocumentingthatthoughtprocess.”Ref.2TWOPRIMARYTECHNIQUES1.HazardAnalysisandCriticalControlPoints(HACCP).Qualitative.Identifiescriticalcontrolpointsassociatedwith:Biological(non-sterility)Chemical(impuri
4、ties)Physical(deformities)CCPmonitoringrequirementsWidelyusedinthefoodindustryTWOPRIMARYTECHNIQUES2.FailureModeandEffectAnalysis(FMEA)Quantitative(albeitwithsomesubjectivity)AddressesawiderrangeoffailuremodesPrioritizespotentialfailurepointsWidelyusedinmanufacturingsettingsHISTORYHAC
5、CP:1960s,Pillsbury,Astronautfood1973,cannedfood1997,seafoodGuidelinebyFDADept.Agriculture21CFR820.301998,meat,medicaldevicesFMEA:Mid-1960s,chemicalprocessindustriesInitially,aimedatsafetyissues,thenfailurepreventionNow,usedinallareasofproductionCLASSICALFMEAVerydetailedI.D.allfailure
6、modesMultipleeffectsforeachfailuremodeMultiplecausesforeacheffectForcescorrectiveactionforeverycauseoffailureReiterativePost-controls,re-doFMEAforeverycausefornewRPNsAPPROACHforProcessTransfers1.Evaluateeveryparameterintheprocess:Whichwilldefinitelyremainthesameduringthetransfer,whic
7、hwillbechanged?TheonesthatarenotchangingwillnotbesubjectedtoFMEA.2.Theonesthatwillbechanged,hopefullyonlyafew,willbelistedinthematrixandFMEAwillbeapplied.APPROACHforProcessCharacterization1.Evaluateeveryparameterintheprocess:ThemoreclassicalFMEAwillbeperformed.2.Theonesthatarepoorlyu
8、nderstoodorc
