Risk Management for Medical Devices - ASQ Raleigh：医疗器械的风险管理-ASQ罗利

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1、RiskManagementforMedicalDevicesSafeandEffectiveProductsPaulMcDanielASQCQM/OEExecutiveVPOperationsandQASicelTechnologiesOverviewProductLifeCycleModelRoleProcessHintsIn-depthdiscussionofaRiskManagementAnalyticalTool:FMEARiskManagementDefined(apractitioner'sdefinition)Risk:probabilityofharmoccurringA

2、NDtheseverityofharmRiskManagement:Useofrelevantinformationtoidentifypossibleharmfulevents,toassesstheevent’sacceptabilityintheeye’softheatriskpopulation(probability*severity),andexerteffectivecontrolsoftheriskRiskAnalysis-IntendeduseandIdofCharrelatedtosafetyofthedevice-Idhazards-Estriskforeachhaz

3、ardoussituationRiskevaluationRiskControl-Optionanalysis-Implementcontrols-Residualriskevaluation-Risk/benefitanalysis-Risksarisingfromcontrolmeasures-CompletenessofriskcontrolRiskAssessmentEvaluationofoverallresidualriskacceptabilityRiskManagementReportProductionandpost-productioninformationRiskMa

4、nagementAdaptedfromISO14971:2007Figure1ProductLifeCycleModelRoleUnderstandtheRegulatoryModelAproductlifecyclehasmanyphasesInformation/Products/Designatthestartofaphaseisinput;possiblyinputrequirementsInformation/Products/DesignattheendofeachphaseisoutputOutputsmustbeverifiedagainstinputsThemodelas

5、sumesverificationateachphaseendProductLifeCycleModelRoleTheCurrentStateoftheRiskManagementStandardAssumestheRegulatorymodelYoumayfollowthedescribedprocessandbeconfusedunlessyourecognizethephaseboundariesHowcanIdeterminetheanswerto“isriskacceptable”ifI’mjustdefiningdesigninputsTheplannedmitigationi

6、sacceptable,detaildesignmayintroducenewinformation,stayalertinthenextphase!RiskManagementbyPhaseDesignInput(HazardAnalysis/FaultTree)Focusongeneratingproduct“shallnotdo”or“shallcomplywithstandard...”typeofspecificationrequirementsDetailedDesign(FaultTree/FMEA)Looktoyourproductarchitectureandaddarc

7、hitectureinterfaceriskstoyouranalysesFurtheron,examinehigherriskareasandproductfailurerisksindetailRiskManagementbyPhaseDesignVerification/ValidationWatchforoccurrenceofanticipatedbut“intendedtobe”mitigatedrisksR