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时间:2018-10-11
《【持续性肾脏替代治疗crrt英文精品课件】failure modes and effects analysis (fmea)》由会员上传分享,免费在线阅读,更多相关内容在教育资源-天天文库。
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
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