风险管理计划

RiskManagementPlanLLLTPortableBC-0012011/5/136pages(includecover)RMP01LLLTPortableBC-0012011/5/136pages(includecover)RMP01A/0EngineeringdepartmentTYPE:Effectivedate:Page:DocumentNo.:Version:Department:MadeCheckApprovalPage1of6CONTENTSTOC\o"1-5"\h\zPurpose3\o"CurrentDocument"scope3\o"CurrentDocument"Assignmentofresponsibilitiesandauthorities3\o"CurrentDocument"requirementsforreviewofriskmanagementactivities3criteriaforriskacceptability.4Probabilityofhazards4Severityofhazards4Riskevaluation4\o"CurrentDocument"VERIFICATION5\o"CurrentDocument"METHOD（S）OFOBTAININGRELEVANTPOST-PRODUCTIONINFORMATION5\o"CurrentDocument"riskMANAGEMENTPROCEDURE5RiskManagementPlanPurposeTheriskmanagementplanwhichiswrittenaccordingtoISO14971:2007,IEC60601-1:2005andothercorrespondinginternationalstandardsfortheproducts,providesguidancefortheriskmanagementactivitiesthroughouttheentirelifecycleofLLLPortableBC-001.ScopeTherequirementsofthisplanisapplicabletoallstagesoftheentirelifecycleriskmanagementandcontrolofLLLTPortable.RiskmanagementteamshallidentifythehazardsofLLLTPortableanditsaccessories,estimateandevaluatetherisks,controltheserisksandsupervisetheeffectivenessofcontrolmeasures.AssignmentofresponsibilitiesandauthoritiesRiskmanagementactivitiesPersonnel/TeammemberDepartment/TitleRemarkRiskanalysisRiskevalutionteamQC&ENGRiskevaluationRiskevalutionteamQC&ENGRiskcontrolRiskevalutionteamQC&ENG&PIEOverallresidualriskevaluationRiskevalutionteamQC&ENG&PIERiskmanagementreportpreparationRiskevalutionteamQC&ENG&PIEProductionreviewRiskevalutionteamQC&ENG&PIEPost-productioninformationreviewRiskevalutionteamQC&ENG&PIERequirementsforreviewofriskmanagementactivitiesRiskmanagementreviewteam:RiskmanagementactivitiesPersonnel/TeammemberDepartment/TitleRemarkR&DengineerManufacturingengineerClinicalengineerRegulationengineerMarket/customerserviceengineerReviewtherisksaccordingtothefollowingsafetyrelatedinformationthroughoutthelifecycleofproducts:Ifunrecognizedrisksarepresent;Iftheoriginalrisksarisingfromsomehazardsarenolongeracceptable;Ifotheraspectsofinitialevaluationinvalidated;Iftheoverallresidualrisksarereducedtoacceptableregion,orestimatedtobeacceptableafterrisk/benefitanalysis.Reviewtheobtainingmethodsofproductionandpost-productioninformation,andmaintainthereviewrecord

toinsureallrequirementsofthisplanisproperlyimplementedinthelifecycleofthisproduct.5CriteriaforriskacceptabilityRiskmanagementteamshallestimatetherisksbytheirprobabilityandseverity,thenevaluatetheacceptanceofthoserisksaccordingtothecriteriaestablishedinthisplan.ProbabilityofhazardsCategoryProbabilitylevelFrequent:cannotavoidTherateismorethan1/35Probable:re-happeningTherateismorethan1/84Occasional:HappeningatlowrateTherateismorethan1/2003Remote:happeningrateisverylow.Therateismorethan1/20002Improbable:impossibletohappenTherateismorethan1/150001SeverityofhazardsCategoryDescriptionlevelCatastrophicUn-predictable,harmtheequipmentandoperator,Itbelongstoveryseriouslevel.6CriticalPredictableandmaybeeffectthesafetyofoperator,itbelongstothedangerouslevel.5SeriousCannotoperateandmissthefunction.4MiddleSeriousCanoperate,buttheeffectisnotdesirable3MinorCanoperate,buttheeffectisnotverywell2NegligibleCanoperate,butsomeotherfunctionisnotverywell1RiskevaluationRisklevelofahazardisexpressedastheseverityandlikelihoodofthehazard,(Risklevel=severity(S)xprobability(P))，SeverityProbability^^Negligibel1Moderate2Significant3Verysignificant4riskwithsign5Riskwithoutsign6Frequent551015202530Probable44812162024Occasional3369121518Remote224681012Improbable1123456Supplementaryinformation:Unacceptablerisk:12〜30ALARP4~11Acceptablerisk:1~3TheEstimatedriskRx(R1,R2,R3…)shallbefilledonabovesimilartable.VerificationThefirstverificationisthatmakesurethattheriskcontrolmeasurehasbeenimplementedinthefinaldesign.Thesecondverificationisthatensurethatthemeasureasimplementedactuallyreducestherisk.Method(s)ofobtainingrelevantpost-productioninformationManufacturersshouldestablishgenericprocedurestocollectinformationfromvarioussourcessuchasusers,servicepersonnel,trainingpersonnel,incidentreportsandcustomerfeedback.Thisinformationshallbeevaluatedforpossiblerelevancetosafety,especiallythefollowing:IfpreviouslyunrecognisedhazardsorhazardoussituationsarepresentorIftheestimatedrisk(s)arisingfromahazardoussituationis/arenolongeracceptable.Ifanyoftheaboveconditionsoccur:theimpactonpreviouslyimplementedriskmanagementactivitiesshallbeevaluatedandshallbefeedbackasaninputtotheriskmanagementprocessandareviewoftheriskmanagementfileforthemedicaldeviceshallbeconducted;ifthereisapotentialthattheresidualrisk(s)oritsacceptabilityhaschanged,theimpactonpreviouslyimplementedriskcontrolmeasuresshallbeevaluated.Theresultsofthisevaluationshallberecordedintheriskmanagementfile.RiskmanagementprocedureTheriskmanagementprocedurecontainsthefollowingprocess:riskanalysis,riskevaluation,riskcontrol,overallresidualriskevaluation,riskmanagementreport,productionandpost-productionandetc.TheriskmanagementprocedureisinaccordancewithasannexBofISO14971:IntendeduseIdenHWcharacteflMcs")Estimaterisk(a)forhazardoussrtualion(s)(4.4)upre旦mnOJIdentify*appropriateriskcontrolmeasureis).recardrl&kcontrolrequlrsments(6.2)Nd«—e-Eou

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PCEUDtISnpQudIrrplernEnt,nsGonjandverifyappropriatemeasures(6,3)&ihsr&sduariskancentahle?idemiftedhazandgcon