【持续性肾脏替代治疗crrt英文精品课件】failure modes and effects analysis (fmea)

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1、FailureModesandEffectsAnalysis(FMEA)IE789ProductManufacturingEngineeringforMedicalSpring2010AgendaWhatisFMEA?TypesofFMEAStepsforFMEAAmedicalexampleWhatisFMEA?Failuremodesandeffectsanalysis(FMEA)isastep-by-stepapproachforidentifyingallpossiblefailuresinadesign,amanufacturingorassem

2、blyprocess,oraproductorservice.TypesofFMEASystem-focusesonglobalsystemfunctionsDesign-focusesoncomponentsandsubsystemsProcess-focusesonmanufacturingandassemblyprocessesService-focusesonservicefunctionsSoftware-focusesonsoftwarefunctionsFMEAUsageOftentheengineer(andnowthehealthcare

3、provider)usessafetyfactorsasawayofmakingsurethatthedesignortreatmentwillworkandprotecttheuseragainstproductorprocessfailure.Asdescribedinarecentarticle:"Alargesafetyfactordoesnotnecessarilytranslateintoareliableproduct.Instead,itoftenleadstoanover-designedproductwithreliabilitypr

4、oblems."FailureAnalysisBeatsMurphy'sLawMechanicalEngineering,September1993FMEAProcedureDescribetheproduct/processanditsfunction.Anunderstandingoftheproductorprocessunderconsiderationisimportanttohaveclearlyarticulated.Thisunderstandingsimplifiestheprocessofanalysisbyhelpingtheeng

5、ineeridentifythoseproduct/processusesthatfallwithintheintendedfunctionandwhichonesfalloutside.Itisimportanttoconsiderbothintentionalandunintentionalusessinceproductfailureoftenendsinlitigation,whichcanbecostlyandtimeconsuming.FMEAProcedure(continued)2.CreateaBlockDiagramoftheprod

6、uctorprocess.Ablockdiagramoftheproduct/processshouldbedeveloped.Thisdiagramshowsmajorcomponentsorprocessstepsasblocksconnectedtogetherbylinesthatindicatehowthecomponentsorstepsarerelated.ThediagramshowsthelogicalrelationshipsofcomponentsandestablishesastructurearoundwhichtheFMEAca

7、nbedeveloped.EstablishaCodingSystemtoidentifysystemelements.TheblockdiagramshouldalwaysbeincludedwiththeFMEAform.FMEAProcedure:CompletetheheaderontheFMEAFormworksheetFMEAProcedure(continued)4.Usethediagramtobeginlistingitemsorfunctions.Ifitemsarecomponents,listtheminalogicalmanne

8、rundertheirsubsystem/assemblybase