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

RiskManagementforMedicalDevicesSafeandEffectiveProductsPaulMcDanielASQCQM/OEExecutiveVPOperationsandQASicelTechnologiesOverviewProductLifeCycleModelRoleProcessHintsIn-depthdiscussionofaRiskManagementAnalyticalTool:FMEARiskManagementDefined

(apractitioner'sdefinition)Risk:probabilityofharmoccurringANDtheseverityofharmRiskManagement:Useofrelevantinformationtoidentifypossibleharmfulevents,toassesstheevent’sacceptabilityintheeye’softheatriskpopulation(probability*severity),andexerteffectivecontrolsoftheriskRiskAnalysis-IntendeduseandIdofCharrelatedtosafetyofthedevice-Idhazards-EstriskforeachhazardoussituationRiskevaluationRiskControl-Optionanalysis-Implementcontrols-Residualriskevaluation-Risk/benefitanalysis-Risksarisingfromcontrolmeasures-CompletenessofriskcontrolRiskAssessmentEvaluationofoverallresidualriskacceptabilityRiskManagementReportProductionandpost-productioninformationRiskManagementAdaptedfromISO14971:2007Figure1ProductLifeCycleModelRoleUnderstandtheRegulatoryModelAproductlifecyclehasmanyphasesInformation/Products/Designatthestartofaphaseisinput;possiblyinputrequirementsInformation/Products/DesignattheendofeachphaseisoutputOutputsmustbeverifiedagainstinputsThemodelassumesverificationateachphaseendProductLifeCycleModelRoleTheCurrentStateoftheRiskManagementStandardAssumestheRegulatorymodelYoumayfollowthedescribedprocessandbeconfusedunlessyourecognizethephaseboundariesHowcanIdeterminetheanswerto“isriskacceptable”ifI’mjustdefiningdesigninputsTheplannedmitigationisacceptable,detaildesignmayintroducenewinformation,stayalertinthenextphase!RiskManagementbyPhaseDesignInput(HazardAnalysis/FaultTree)Focusongeneratingproduct“shallnotdo”or“shallcomplywithstandard...”typeofspecificationrequirementsDetailedDesign(FaultTree/FMEA)LooktoyourproductarchitectureandaddarchitectureinterfaceriskstoyouranalysesFurtheron,examinehigherriskareasandproductfailurerisksindetailRiskManagementbyPhaseDesignVerification/ValidationWatchforoccurrenceofanticipatedbut“intendedtobe”mitigatedrisksRiskControlfailureAssessimpactofV&VfindingsfornewrisksneedinganalysesWedidn’timaginethatwouldhappen:Risk?Listentoanycustomerfeedbackforriskacceptability“Thosesafetylockoutsaretooconfusingtoworkwith,canwedisablethem?”RiskManagementbyPhaseCommercialDistribution/DisposalVigilanceReportingisaRiskAnalysisUpdateOpportunityNEWfor2007!ProductionfeedbackintotheRiskAnalysisAmIseeinghigherratesofoccurrence?Arenewfailuremodespresentingthemselvesthatwehaven’tanalyzed?ArewehavingcontrolfailuresorexcessivecausefailuresRiskAnalysisinProductionNon-conformingmaterialandMaterialReviewBoardProcesses?Cantheyeffectivelyconsiderrisksoneachoccurrence?Controlcharts,acceptancedataAreriskcontrolspartofacceptancetesting?Frequencyofoccurrencesuggestinganything“Riskoffailurewasrankedasremoteyetwe’vehadthreecatastrophichot-pottestfailuresthismonth!”RiskAnalysisinProductionCommentperiod…………ProcessConsiderationsDefinethescopeofyouranalysisWhatsystems,whatinterfaces,whoasuser...Therecordsproducedwillbesubjecttosecondguessingifharmoccurs:don’tallowhindsighttochangetherulesDocumentyourinformationsources!!!!!!!Whenyoumadeyourriskacceptabilitydecision,whatinformationwasavailableandused?Wecanonlybediligent,notpsychicAnalysisScopeIntendedUse:Useforwhichtheproduct,processorserviceisintendedaccordingtothespecifications,instructions,andinformationsuppliedbythemanufacturerEssentialPerformance:PerformancenecessarytoachievefreedomfromunacceptableriskNote:ismosteasilyunderstoodbyconsideringwhetheritsabsenceordegradationwouldresultinanunacceptableriskYoumusthavethesetwoclearlyinfrontoftheanalysisteam.ProcessConsiderationsUseaRiskSourceListasaReminderISO14971hassuchlistsAddyourIndustry’sExperienceIfaharmfuleventhasbeenreported,ithashighermitigationprioritythanhypotheticalrisksflagrealoccurrencesinyouranalysesRelyonacceptedstandardsIfthereisa“test”standard,understandtheunderlyingreasonforthetestsProcessConsiderationsSourcesofharmshouldsuggestactionelectricityisnotharmful,electrocutionisAhazardexistsAsequenceofeventsleadstoahazardoussituation(normalorfaultconditions)Thehazardoussituationhasaprobability(P1)HarmoccursfromthesituationAprobabilityofharmexists(P2)Aseverityofoutcomecanbeassigned(S)Risk=S,P1xP2ProcessConsiderationsWhiledefiningthesysteminputs,whatharmfulthingscanoccur:Veryearlyon,a“PreliminaryHazardAnalysis”canscreenouthigherriskapproachesWhataretheharmfulthingsthatthesystemcandoconsidering:user,patient,environmentorproperty(asubject)ProcessConsiderationsTypically,theDeviceDesignRequirementsAreBrokenDownIntoSmallerPiecesDuringDetailedDesignfocusoninterfaces,signalanddatapathintegritytracesystemrequirementstosub-systemUseFaultTreeAnalysis(topdown)ConsiderUsingFailureModesandEffectsAnalysis(bottomsup)ProcessConsiderationsObserveVerification/ValidationfindingsforunanticipateddevicebehaviorthebestdesignanalystsmissthingsInitiateaprocessforV&Vfindingsclassificationdidharmoccur?,orifthebehaviorre-occurs,couldharmoccur?ifIcan’trecreatethebehavior,IstillmayhavetomitigateitRiskManagementProcessToolsSystemHazardAnalysis

(designinput)DrawboundariesbetweenthesystemandtheatrisksubjectanddefineharmfuleventsEnergysentacrossaboundaryLookforpotentialtokineticenergytransitiondidyoucontrolthetransitionChangesinstatemaybepotentiallyharmfulYourseedlistmayleaveyouwithmany“deferredanswers”ProbabilityandSeverityEstimatesRiskmanagementreliesonexpertjudgmentsodon’tletnovicesworkalone!Focusononedevice,onedevicelifetimeSetQuantitativeorQualitativecriteriahighprobabilityis...severaltimesinadevicelifetime???,1<permillionusesmoderateinjuryis....medicalattentiontoreturntopre-riskexposurestateProbabilityandSeverity

(usegraphicaltechniques)IncreasingSeverityIncreasingprobabilityunacceptableokayIncreasingSeverityIncreasingprobabilitynoriskortoogreatariskiseasy,whataboutmoderaterisks?SplitupthequadrantstorefinetheestimatesinstagesofanalysisDetailedRiskAnalysesOneofthemorepopulardesignevaluationtoolsistheFailureModesandEffectsAnalysis(FMEA)IEC60812,Analysistechniquesforsystemreliability-ProcedureforfailuremodesandeffectsanalysisFMEAisusedmorefordesignevaluationthanfordesigndevelopmentWorksformanufacturingprocessestoo!DetailedRiskAnalysesDefinitions:FMEA:astructuredanalyticaltechniquewhichdeterminesrelationshipsbetweenbasicelementfailurecharacteristicsandthesystemfailuresFailuremodeishowafailuremanifestsitself(systemshutsdown)Failuremechanismiswhyafailureoccurs(defectinthetransistorsilicon)ProcessNeedsforaFMEAPriorriskanalysisworktobuildonifavailableSystemlevelharmfuleventswillbeanalyzedtoseehowcomponent/assembliesmaycontributetotheharmcauseSystemfailureanddegradedmodesdefinitionsfunctionalblockdiagramsmaybeneededforeachoperating/failuremodeFMEAProcessNeedsadesignsolution,downtothecomponent