RiskManagementSystem风险管理系统PPT课件.ppt

Welcome Wewillbeginthewebconferenceshortly Whenyouarrive pleasetypethephonenumberfromwhichyouarecallingintothechatfield Tologintotheaudioportionofthewebconference dial1 866 740 1260 onyourphoneandusetheaccesscodeprovidedtoyouwhenprompted IfyouarecallingfromMexico dial001 800 514 8716 IfyouarecallingfromBrazil dial0800 891 8965 1 RiskManagementforMedicalDevices ISO14971 2007 byTomKahrmann Sr MedicalDeviceManager BSI DiscussionPoints BackgroundofRiskManagementRiskManagement2007 featuresandchanges7PitfallstoAvoidinImplementingRiskManagementRiskManagementCertification BackgroundofRiskManagement ApplicabilityofISO14971 2007 RegulatorsviewisthattheManufacturerisresponsibletoensureasafeMedicalDeviceAnincreasingnumberofTechnicalStandardsrequireRMItisacknowledgedthatthereissomeriskassociatedwithuseofmedicaldevices ManufacturersmustmanagetheriskRiskneedstobeconsideredwithrespecttothepatient thecare giverandtheenvironment 5 ApplicabilityofISO14971 2007 Thewayariskisperceivedalsotakesintoaccount Whetherexposuretothehazardseemstobeinvoluntary avoidable fromaman madesource duetonegligence arisingfromapoorlyunderstoodcause ordirectedatavulnerablegroupwithinsociety Residualrisksneedtobebalancedagainsttheanticipatedbenefitsofthemedicaldevice Suchjudgmentsshouldtakeintoaccounttheintendeduse performanceandrisksassociatedwiththemedicaldevice aswellastherisksandbenefitsassociatedwiththeclinicalprocedureorthecircumstancesofuse Thatsomejudgmentscanbemadeonlybyaqualifiedmedicalpractitionerwithknowledgeofthestateofhealthofanindividualpatientorthepatient sownopinion 6 ApplicabilityofISO14971 2007 BSENISO14971 2007isastate of the artriskmanagementstandardtakingintoaccountthefactorsjustmentioned 7 ApplicabilityofISO14971 2007 Canbeusedtodevelopasystematicprocess ToidentifythehazardsassociatedwithmedicaldevicesToEstimateandevaluatetherisksToControltheserisksToMonitortheeffectivenessofthecontrolAppliedtoallstagesofthelifecycleofamedicaldeviceWhichcanbeanintegralpartofaqualitysystem 8 ApplicabilityofISO14971 2007 ItisnotrequiredthatthemanufacturerhaveaQMSorcertificationinanyotherstandardGoodnews thenewstandardcanbeappliedtootherhealthcareindustriesasinformativeguidance Whilegearedtowardmanufacturers thiscouldinclude HumantissuemanufactureAnimalcarefeedandhealthcareproductsPharmaceuticalmanufacturersEtc 9 InternationalStandardsIncorporatingRiskManagement IEC60601 1 2005ISOTS20993ISO14155IECTS80002IEC62304TECTS80001IEC62366ISO13485 IEC60812ISO14969IEC61025ISO9000 3IEC60300 3 9IEC TR60513EN12442 1Andmoretocome In2003 therewere8technicalorQSstandardswhichhadincorporatedriskanalysisintotheprocess 10 RiskManagement2007 Featuresofnewversion LifeCycle frominitialconcepttofinaldecommissioninganddisposalRobustprocessdefinitionisneeded andnewstandardisbasedontheprocessmodelTopManagementInvolvementwithRiskManagementEffectiveplanningisrequired adistinctareaoffocus donoharm residualriskwillnotbezerobutbenefitsmustoutweighresidualrisksFinalreportBeforegoingtomarket 12 ProcessApproach 9001 13485 13 MedicalDeviceTechnologyLifeCycle ProductsforHealthCareSector TopManagementSetspolicyforAcceptableRisk RegulatorsandCustomers RegulatorsandCustomers Requirements Feedback Output NeedsAssessment DevelopmentCycle Manufacturing UtilizationCycle Product Input End of lifeCycle RiskManagement 14 throughout Productrealisation Organizationsareusuallyweakintheareaofconsideringthelife cycle RiskManagementismanytimesincorrectlylimitedtoDesignControlandComplaintsorCAPA 15 PlanningisessentialbeforeconductingRiskManagement DefineProcess 3 1 EvidenceofTopManagementCommitmentDemonstrated 3 2 Qualificationofpersonnel 3 3 ThePlan 3 4 TheFile 3 5 RiskManagementProcess RiskManagementRecords Processmustbeestablisheddocumented maintained considerlife cycle analysis evaluation control productionandpost production AssignmentofqualifiedpersonnelDefineacceptabilitypolicyPeriodicallyreviewtheprocessMeasureeffectiveness 16 RiskManagementProcess 2001 RiskAnalysis Intendeduse intendedpurposeidentificationHazardidentificationRiskestimation RiskEvaluation Riskacceptabilitydecision RiskControl OptionanalysisImplementationResidualriskevaluationOverallriskacceptance Post ProductionInformation Post productionexperienceReviewofriskmanagementexperience RiskAssessment RiskManagement 17 RiskManagementProcess 2007 RiskAnalysis Intendeduse purposeHazardidentificationRiskestimationforeachhazardoussituation RiskEvaluation RiskControl OptionanalysisImplementationResidualriskevaluationRisk benefitanalysisConsequentialRisksCompletenessofcontrol Evaluationofoverallriskacceptability RiskAssessment RiskManagement Riskmanagementreport Productionandpost production 18 Processescontrasted Highlighting hazardoussituations thatcanresultfromhazardidentification LeadstosystematicanalysistoidentifysituationsnotpreviouslyrecognizedBringsfocustopossiblesequencesofeventsaswellassingle faultthinkingAdecisionpointhasbeenaddedtodeterminedisclosureofresidualrisks atRREandatR BA Evaluationofoverallresidualriskacceptabilitynowidentifiedasspecificitem stepback considercombinedimpactofalldecisionsandconcludeonwisdomofproceeding 19 Processescontrasted RiskmanagementreportmustbeissuedbeforecommercialdistributionTraceabilitywasinfinalreport mustnowbeinfileReportishighlevel mustensurethatPlanhasbeenappropriatelyimplementedOverallresidualriskisacceptableMethodsinplaceforproductionandpost productioninformation 20 Morefeaturesofnewversion De emphasisonALARP sincethereareresidualrisksandbenefitmustoutweightherisk coupledwiththeconceptofdisclosureContinuedde emphasison detectability aspartofRPNcalculationRiskmanagementplanningmustincludeinformationonproductiondatagatheringaswellasPost productiondata 21 Morefeaturesofnewversion EmphasisonRMfile inparticulartoensurethatit CoverseachmedicaldeviceIsmaintainedProvidestraceabilityforeachidentifiedhazardtoaconclusionRecordrequirementsappear21timesPrimaryfocusisonMDmanufacturers butopensthedoorfor otherhealthcareindustries Specificallynotesconcernforcaregivers otheroperatorsandtheenvironment inadditiontothepatient 22 ISO14971 2007Requirements TopManagementSupport Demonstratecommitmentby DefiningpolicyfordeterminingacceptableriskProvidingadequateresourcesEnsuringtrained qualifiedpersonnel medicaldeviceandriskmanagementtechniques 23 2020 1 27 24 ISO14971 2007Requirements TopManagementSupport TopManagementMUSTbeinvolvedinreviewingeffectivenessoftheprocess andthatsafemedicaldevicesarebeingplacedonthemarketAdoptionofthisstandarddemonstratesconsiderationofuser caregiverandenvironment 25 ISO14971 2007Requirements RiskManagementPlanning Riskmanagementplanforeachmedicaldeviceoraccessory ThescopeoftheplanVerificationplanAllocationofresponsibilitiesRequirementsforthereviewofriskmanagementactivitiesCriteriaforriskacceptabilityPlanforproductionandpost productioninformationgathering 26 7PitfallstoAvoidinImplementingRiskManagement Pitfall 1 PROCESS LackofaclearlydefinedProcessforISO14971 2007OrganizationdoesnotaddresshowallrequirementsaremetOrganizationdoesnotmakeclearhowtomovefromstage to stageOrganizationdoesnotdefinelinkstolife cycleOrganizationdoesnotdescribehowvariousRMtoolsareusedatvariousstages 28 Pitfall 2 LIFECYCLE Incompleteconsiderationofthelife cycleofthedeviceandhowlife cyclepertainstoriskmanagementLife cyclestartsatinitialinceptionanddoesnotenduntildecommissioninganddisposalThePost productiondatamanytimesdoesnotfeed backintoboththeassumptionsmadefortheindividualproduct andtheprocessforconductingriskmanagement 29 Pitfall 2 LIFECYCLE Thisisaparticularconcern because13485 2003statedthatriskmanagementhastobeconsidered throughoutproductrealization OrganizationsareweakinthisconceptandmanytimesconsiderDesigncontrol complaints injuryButdonotconsiderplanning customer relatedprocesses impactofpurchasing manufacturingandmeasurementprocesses14971broadenstheconceptevenfurtherinthatlifecyclestartsbeforeproductdesign andgoesonwayafterproductisdiscontinuedfrommanufacture butmaystillbeonthemarket 30 Pitfall 3 TMSUPPORT MisunderstandingTopManagementsupportrequirementsAdequateresourcesQualifiedpersonnelSettingriskmanagementpolicySettingtherequirementsforriskacceptabilityReviewoftheprocessfromtime to time inparticularunderstandingrequirementsforeffectivenessreview 31 Pitfall 4 TOOLS NoclearlydefinedprocessforwhichRMtoolsareappropriateatwhichstagesofLife CycleHAZOP HACCP FMEA FMECA FTA PHAaretoolsidentifiedin14971 CertaintoolsaremoreappropriateatcertainLife CyclestagesProvisionofresourcesnotonlyindicatesaneedtohavequalitypersonnel experts engineers manufacturing etc asappropriate buttraininginthetoolsthecompanyutilizes 32 Pitfall 5 PLANNINGANDRECORDS NotenoughplanningandthePlannotincludingPMSandproductionPlannotinaccordancewithprocessPlannotmaintainedandnotadequatelyplacedinRMfilePlannotincludingallrequirementsoforganization sprocessANDthestandardRiskManagementFILErequirementsarementioned42timesinthestandard ThePlanandthefilehavetobemaintained 33 Pitfall 6 HAZARDANALYSIS IncompletedocumentationontheintendeduseandpossiblemisusesIncompletelistingofqualitativeandquantitativecharacteristicsNotincludingdefinedlimitswhereappropriateNotfullyaddressingboth normal and fault conditionsNotrecordingsequencesofeventsNotrecordingcombinationsofevents 34 Pitfall 6 HAZARDANALYSIS Hazardanalysisforaparticularmedicaldeviceorfamilyofmedicaldevicecannotbeover emphasized Itismuchbettertoidentify1 000potentialhazardsandmitigate100 thantoidentify100andmitigate50InadequatehazardanalysisindicatesLackofunderstandingofcommitmenttosafetyInadequateteamresourcesand ortrainingInsufficientreviewofPMSforownandotherproductsalreadyonthemarket 35 Pitfall 7 RESIDUALRISKS Risksareeither acceptable or unacceptable Residualriskshavetobejudged acceptable ortheprojectabandoned oradditionalactionstakenInadequateobjectiveevidenceofwhichresidualriskstodiscloseNotfullyusingtheinformativeannexes whichwhilstnotrequirements inparticulargiveguidanceonhowtothinkaboutdisclosureAfterrisk benefitanalysis inadequateevidenceofwhichinformationforsafetyisdisclosedNoreviewofoverallresidualriskbeforefinalreportbutaftercompletionofriskcontrol 36 WhatTrainingandresourcesareAvailable BSIProductsAvailableNow Training2hourwebinaroverview14971 20071daytraining publicoron site14971 2007Analysisof2001comparedwith2007versionUsefultooltohelpclientstransitionRiskManagementCertificationProgram 38 BSIMedicalDevicesRiskManagementCertificationProgram Certificateiscurrentlyunaccredited butaccreditationisexpectedBSENISO14971published4 18 07BSI strainingmaterialsandcertificationaretothenewversionofthestandard 14971BSIProduct RiskmanagementCertificateagainst2007versionofthestandardCertificationlinkedtoLife Cycleandrisklevelasdefinedbyclient scopeliststheprocess Nottheproduct UtilizeBSICoreprovenprocessesPreassessmentDocumentReviewInitialassessment CertificateofRegistration exampleRISKMANAGEMENTSYSTEM ISO14971 2007Thisisthecertifythat AdamsMedicalDeviceCompany12286DavisRoadNashville TN37912HoldsCertificateNo RM10992AndoperatesaRiskManagementSystemwhichcomplieswiththerequirementsofISO14971 2007forthefollowingscope 41 Riskmanagementthroughoutthemedicaldevicelife cyc