质量体系的分析研究.ppt

ImplementingaHolisticApproachtoyourQualityManagementSystem,StevenR.CagleV.P.ofMarketingandSubmittingrelevantinformationonidentifiedqualityproblems,aswellascorrectiveandpreventiveactions,formanagementreview,QualityRegulation21CFR211.22,VerysimilaristheU.S.FDAsregulationforpharmaceuticalmanufacturers21CFRPart211.22(QualityControlUnit)responsibilitiesofaqualitycontrolunit.toassurethatnoerrorshaveoccurredor,iferrorshaveoccurred,thattheyhavebeenfullyinvestigated.Thequalitycontrolunitshallhavetheresponsibilityforapprovingorrejectingallproceduresorspecificationsimpactingontheidentity,strength,quality,anpurityofthedrugproductandinPart211.92(ProductionRecordReview)AnyunexplaineddiscrepancyorthefailureofabatchoranyofitscomponentstomeetanyofitsspecificationsshallbethoroughlyinvestigatedTheinvestigationshallextendtootherbatchesofthesamedrugproductandotherdrugproductsthatmayhavebeenassociatedwiththespecificfailureordiscrepancy.Awrittenrecordoftheinvestigationshallbemadeandshallincludetheconclusionsandfollow-up.,QuotesfromCurrentFDAWarningLetters,Eachmanufacturershallestablishproceduresforqualityauditsandconductsuchauditstoassurethatthequalitysystemisincompliancewiththeestablishedqualitysystemrequirementsandtodeterminetheeffectivenessofthequalitysystem.Qualityauditsshallbeconductedbyindividualswhodonothavedirectresponsibilityforthemattersandshallbetakenwhennecessary.Areportoftheresultsofeachqualityaudit,andreaudit(s)wheretaken,shallbemadeandsuchreportsshallbereviewedbymanagementhavingresponsibilityforthemattersaudited.Thedatesandresultsofqualityauditsandreauditsshallbedocumentedasrequiredby21CFR820.22.internalqualityauditsconductedbyyourfirmfailedtoverifythatthequalitysystemwaseffectiveinfulfillingqualitysystemobjectives(FDA483,Item#2).,QuotesfromCurrentFDAWarningLetters,Yourfirmfailstoimplementandmaintaincorrectiveandpreventiveaction(CAPA)proceduresthatincluderequirementsforanalyzingprocesses,workoperations,concessions,qualityauditreports,qualityrecords,servicerecords,complaints,returnedproduct,andothersourcesofqualitydatatoidentifyexistingandpotentialcausesofnonconformingproduct,orotherqualityproblemsasrequiredby21CFR820.100(a)(1).Yourfirmfailstoestablishandimplementcorrectiveandpreventiveaction(CAPA)proceduresthatincluderequirementsforidentifyingtheaction(s)neededtocorrectandpreventrecurrenceofnon-conformingproductandotherqualityproblemsasrequiredby21CFR820.100(a)(3)Allactivitiesrequiredby21CFR820.100mustbeverifiedorvalidatedtoensurethatsuchactioniseffectiveanddoesnotadverselyaffectfinisheddevices,andtheresultsoftheseactivitiesshallbedocumentedasrequiredby21CFR820.100(a)(4)and(b).YourfirmsCAPAproceduresfailtodocumenthowanalysisisdoneandfailstorequireverification/validationthatCAPAdoesnotadverselyaffectfinisheddevices(FDA483,Item#8).,CommissionDirective2003/94/EC,PreambleHavingregardtotheTreatyestablishingtheEuropeanCommunity,Allmanufacturersshouldoperateaneffectivequalitymanagementsystemoftheirmanufacturingoperations,whichrequirestheimplementationofapharmaceuticalqualityassurancesystem.Article13-ComplaintsAnycomplaintconcerningadefectshallberecordedandinvestigatedbythemanufacturerArticle14-InspectionsThemanufacturershallconductrepeatedself-inspectionsinordertomonitortheimplementationandrespectofgoodmanufacturingpracticeandtoproposeanynecessarycorrectivemeasures.Recordsshallbemaintainedofsuchself-inspectionsandanycorrectiveactionsubsequentlytaken.,Morethanjustcorrectiveactions,CAPAismuchmorethanjust“correctiveactions”and“preventiveactions”.AnyopportunitytoimprovequalityinyourorganizationisaCAPA!,HolisticQMSDefinesCAPASources,Complaints,InternalInspections,SupplierAudits,RegulatoryAudits,Non-conformance,Deviations,OutofSpecification,OutofSpecification,AdverseTrends,AdverseEvents,IncomingInspections,Andmore,NumeroussourceareasforCAPAScopeof“problems”thatdriveCAPAsgobeyondnonconformingproductAnyprocessthataffectsproductqualityisincluded,CAPAProcessbestpractices,VerifyEffectiveness,ImplementActions,Review&ApprovePlan,Investigate,RootCause,ActionPlan,Identify&Triage,Regardlessofwheretheproblemoriginates,orwhattypeitis,itmustfollowaprocess,IdentifyproblemAssessimpactQuality/Regulatory/ManagementNotificationInvestigationProcess?,CompleteInvestigationDetermineRootCauseProposedCorrective/PreventiveActionsPlaneffectiveness,AssesschangesEnsurenoimpacttoproductqualityConsensusfromSMEsApproval,ImplementActionsVerifycompletedInformstakeholders,MeasuretoensureproblemhasbeenresolvedMonitortoensureitisnotre-occurring,ChangeControl,MetricsandReporting,AddressingQMSChallenges,TypicalQMSChallenges,ChallengesinProblemIdentificationMissingviewofthebigpictureLackofownershipandaccountabilityInabilitytolinkrelatedproblemsInsufficienttoolsfortrendingandanalysis,ChallengesinInvestigationQualityofinvestigationsispoorMissing&incompleteinformationInabilitytoeasilyreviewsimilarpastinvestigationsInconsistentinvestigationprocess&RootCauseNotdeterminingrootcausePastdueinvestigations,notbeingclosed,getlost,ProblemIdentification,Identify&InvestigateRootCause,CreateActionPlan,ChallengesinPlanningVaguerootcauseanalysisConfusionoverwhatis“corrective”andwhatis“preventive”actionInabilitytorelatecorrectiveactionstosourceproblemsLackofintegrationtoChangeControlSystem,TypicalQMSChallenges(cont.),VerifyEffectiveness,ImplementActions,ChallengesinImplementationNowaytotrackissuesthroughworkflowLackofvisibilitytoopenitemsLackofvisibilitytorelateditemsChangestoplanmid-streamCompliancerisk,ChallengesinEffectivenessEasyto“forget”tomeasureeffectivenessDifficulttogathernecessarymetricsNomeanstogeneratemetricsInabilitytomeasureeffectivenessdoesnotgiveusanyassuranceifweareaddressingtherootcauseoftheproblems,Review&ApprovePlan,ChallengesinReview&ApprovalNotsurewhoneedstoapproveApprovalsinserial,notparallelApprovalprocesstakeslongtimeLackofkeystakeholderinput,Solution,HolisticApproachtoQualityManagementGlobalize(harmonize)aroundacommonphilosophyandapproachtoCAPAandsourceEventsObtainfullcompliancewithcGxPs,aswellasregulatory&customerexpectationsUsequalitymetricsasabasisforcontinuousimprovementsTrendingProblemAnalysisThoroughInvestigationsandRootCauseAnalysisEnsuringCAPAeffectivenessBringattentiontoriskareastopreventproblemsImplementacentralizedQualityManagementSystem:ManagesallinputsandoutputsaswellastheactualactionsScalabletobedeployedonaglobalbasisFunctionality/Flexibilitytomeetbusinessrequirements,Re-definingCAPA,Re-definingCAPA,DefinitionsStandardizedefinitionsacrosstheorganizationTermslike“deviation”,“event”,“nonconformance”,correction”,“correctiveaction”,“preventiveaction”,“discrepancy”mustbeconsistentforeachoperatingunitThesametermshouldhavethesamemeaningeverywhere,anddrivethesameprocessCAPAsourcesinclude:Complaints,AuditsObservations,TrendscanfeedCAPADetermine,scopeidentification&impactofnewsystemWheredoestheprocessneedtochange?Whowillthesystemaffect?Whatexistingpoliciesmaychange?Understandthedifferencebetweenthe“what”andthe“who”,DefinetheInputs&Process,RecordtheEvent,CaptureallrelateddataofanyeventregardlessofthetypeSourceDate&TimeofEventTypeDescriptionDepartmentForissuessurroundingEvents,utilizeaqualityevaluation:QualityEventonlyQualityEvent+CAPAQualityEvent+Investigation+CAPA+ChangeControlLogobservations/trendstoimplementpro-activechanges,PerformAssessment&Investigation,AssignInvestigatorUse“Push”or“Pull”conceptAssessimpact,considerdecisiontreeapproachCreateInvestigationPlanUseParent-Childconceptstrackeachinvestigation“task”UseInvestigationTemplatesTrack&CompleteInvestigationsUseworkflow,duedatesandremindersEscalationofpastdueinvestigationsSearch&ReportingUserDashboardsAnalyzeRootCauseStructureRootcauseAnalysisTreeUseRootCausetoDriveCAPAprocess,CAPAPlan&Approval,ReviewcurrentlyinprogressCAPAsCreateCAPAsandlinktorootcauseIfmultipleCAPAsidentifywhichonesresolvewhichrootcause?Whichactionsmustbeclosedtoclosethedeviation?CreateanEffectivenessPlanatthistimeDetermineApproversUsepre-setapproverfunctionsifpossibleRouteInvestigation&CAPAplanforapprovalEmailalerts,remindersDashboardsObtainApprovalAbilitytorejecttovariouspreviousworkflowstates,ImplementingCAPA&Effectiveness,EachCAPArecordshouldhaveitsownrecordandworkflowUseParent-childrelationshipstobreakuptheprocessinto“smallerbites”ActionItemTrackingTrackcompletionandverificationofeachCAPAUseworkflow,duedatesandremindersEscalationofpastdueinvestigationsSearch&ReportingUserDashboardsMeasureeffectivenessaccordingtotheplan-evidencethatrootcausehasbeeneliminated,ImportantQMSRequirements,HighLevelRequirements,Centralizeddatabase,Handlesallprocessareas-modular,Workflowdriven,Proactiveusernotificationandescalation,Actionitemsmanagement,Querying&Reporting,Elaboratesecuritybyuser-group,DefiningtheRequirements,Managementreports,PerformanceMetrics&Trending,Part11Compliance,ManagementofallData,ModularapproachtohandlingallsourceareasbutmaintainsindividualrequirementMultiple“RecordTypes”tohandleallprocessareasAbilitytocreateuserdefinedfieldsConfigurabledataentryformsValidationandbusinessrulesIntegrationtoexternalsystemsE.g.,CreatedeviationsautomaticallyfromERPE.g.,CreateOOSInvestigationfromLIMSMasterdata(customer,product/item,etc.),WorkflowManagement,ConfigurableworkflowAutomatereviewandapprovalprocessbasedonmetadataBusiness-rulebasedworkflowsParallelApprovalsProcesschangingactivityE-mailnotificationsIntegratedsourceareasprocesstoCorrectiveActionprocessParentchildrelationshipsCrossreferencing,Workflow,EscalationsandBusinessRules,BusinessrulesenforcementDateDue,MilestoneDatesAutomaticallyassigninginvestigators,reviewers,approversAutomaticallyschedulingtasksbasedontypeofRecordEscalation“Reminders”oftasksreachingexpectedcompletiondateEscalationofCAPApastdue,Workflow,BusinessRules&Escalation,Query,Reporting,Trending,Workflow,BusinessRules&Escalation,Search,Report,Trend,QueryingAbilitytoqueryonallfieldsFulltext/searchenginefunctionalityAbilitytosavesearchesReportingCustomizablereportformatOnscreenview,print,email,saveStatusreportingTrendingAcrossallsitesAcrossallsourceareasRootcauseanalysisIdentifyoccurrenceratedecrease/increaseAbilitytodetecttrendsautomatically,CompliancewithPart11,DoesthesystemconformwithyourfirmsPart11requirements?Hasthesoftware“passed”thetest,I.e.,hasitgonethroughFDAauditsatanotherfirm?Canitbevalidated?Howconfidentareyouintheaboveassessment?,FullaudittrailReportingfeaturesConfigurablesecuritygroupsCompleterecordofcreatedandmodifieddataEnforcedworkflowsequencingPasswordcompositionrulesElectronicSignaturesmadeupoftwouniquecomponents,Passwordaging/expirationCannotre-usepreviouspasswordAccountLockingandAdminNotificationafterfailedlog-inAttemptsSessiontime-outRequirementof“reason”fordatamodificationAdministrator/ConfigurationAuditTrail,ImplementSolution,Quality,Operations,IT,StructuredProjectOrganization,CustomerSystemAdministratorImplementationConsultant,ProjectManagement,CustomerExecutiveSponsor,Sr.Mgmt.Support,Business&ITProjectMgr.VendorProjectManager,ProjectTeam,ChangeManagementValidationPartnersOperationsmanagement,VendorSMEs,QA&CustomerSatisfaction,TechnicalSupport,LAN/WANDBAServers,CustomerITSponsor,MedtronicLeads:,MedtronicLeads:,Customer.OwnerTeamCAPAComplaintsAuditsRMAsOthers,SteeringCommittee,InternalComputerSystemsValidationVendor3rdParty(recommended),ValidationTeam,VendorAdministrativeResources,RapidROI-PhasedApproach,CriticalSystemsPrioritization,Phase-1:FIRSTQMSConfigure,Prototype,Train,Validation,Phase-2:AdditionalQSImplementation,Configure,Prototype,Train,DATAMigration&SystemsIntegration,ReducedValidationviaMigrationtool,FullyintegratedCAPA,InitialROI/BusinessandcomplianceBenefits,RolloutProduction,AdditionalQS,Yes,No,PrioritizedQMSListandimplementationProjectPlan,GoLive!,ProjectTeamWorkshop-2FinalizeConfigurationDesignReportsCustomizationTrainonValidationTemplatesDevelopValidationProtocolsCompletesetupofintegrationtoolsDevelopUserRequirementDefinitionFunctionalspecif