质量体系的分析研究.pptx

质量体系的分析研究.pptx

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ImplementingaHolisticApproachtoyourQualityManagementSystem,StevenR.CagleV.P.ofMarketing&ProductDevelopmentSpartaSystems,Inc.,Agenda,SessionObjectivesQualityManagementSystemOverviewTraditionalChallengesRe-definingCAPAImplementingaQualityManagementSoftwareSolutionConclusionQ&A,2,SessionObjective,DiscusscriticalcomponentsofaneffectiveQualityManagementSystem（QMS）,challengeswithcurrentsystems,andsolutionstoovercomethesechallengesbyimplementingaholisticQualityManagementSoftwaresolution.,3,GeneralIntroduction,DefiningCAPAISO13485:

2003,8.5.2CorrectiveActionCorrectiveactionsshallbeappropriatetotheeffectsofthenonconformitiesencountered.Adocumentedprocedureshallbeestablishedtodefinerequirementsforreviewingnonconformities（includingcustomercomplaints）determiningthecauseofnonconformitiesevaluatingtheneedforactiontoensurethatnonconformitiestonotrecurdeterminingandimplementingactionneeded,including,ifappropriate,updatingdocumentationrecordingoftheresultsofanyinvestigationandofactiontaken,andreviewingthecorrectiveactiontakenanditseffectiveness,5,DefiningCAPAISO13485:

2003,8.5.3PreventiveactionTheorganizationshalldetermineactiontoeliminatethecausesofpotentialnonconformitiesinordertopreventtheiroccurrence.Preventiveactionsshallbeappropriatetotheeffectsofthepotentialproblems.Itisalsodeterminepotentialnonconformitiesandtheircausesevaluatingtheneedforactiontopreventoccurrenceofnonconformitiesdeterminingandimplementingactionneededrecordingoftheresultsofanyinvestigationsandofactiontaken,andreviewingpreventiveactiontakenanditseffectiveness,6,QualityRegulation21CFR820.100,U.S.FoodandDrugAdministrationsregulationgoverningmedicaldevicemanufacturersqualitysystems:

（a）Eachmanufacturershallestablishandmaintainproceduresforimplementingcorrectiveandpreventiveaction:

analyzingprocesses,workoperations,concessions,qualityauditreports,qualityrecords,servicerecords,complaints,returnedproducts,andothersourcesofqualitydatatoidentifyexistingandpotentialcausesofnonconformingproduct,orotherqualityproblemsinvestigatingthecauseofnonconformitiesrelatingtoproduct,processes,andthequalitysystemidentifyingtheactionsneededtocorrectandpreventrecurrenceofnonconformingproductandotherqualityproblemsverifyingorvalidatingthecorrectiveandpreventiveactionImplementingandrecordingchangesinmethodsandproceduresneededtocorrectandpreventidentifiedqualityproblemsEnsuringthatinformationrelatedtoqualityproblemsornonconformingproductisdisseminatedtothosedirectlyresponsibleforassuringthequalityofsuchproductorthepreventionofsuchproblems;andSubmittingrelevantinformationonidentifiedqualityproblems,aswellascorrectiveandpreventiveactions,formanagementreview,7,QualityRegulation21CFR211.22,VerysimilaristheU.S.FDAsregulationforpharmaceuticalmanufacturers21CFRPart211.22（QualityControlUnit）responsibilitiesofaqualitycontrolunit.toassurethatnoerrorshaveoccurredor,iferrorshaveoccurred,thattheyhavebeenfullyinvestigated.Thequalitycontrolunitshallhavetheresponsibilityforapprovingorrejectingallproceduresorspecificationsimpactingontheidentity,strength,quality,anpurityofthedrugproductandinPart211.92（ProductionRecordReview）AnyunexplaineddiscrepancyorthefailureofabatchoranyofitscomponentstomeetanyofitsspecificationsshallbethoroughlyinvestigatedTheinvestigationshallextendtootherbatchesofthesamedrugproductandotherdrugproductsthatmayhavebeenassociatedwiththespecificfailureordiscrepancy.Awrittenrecordoftheinvestigationshallbemadeandshallincludetheconclusionsandfollow-up.,8,QuotesfromCurrentFDAWarningLetters,Eachmanufacturershallestablishproceduresforqualityauditsandconductsuchauditstoassurethatthequalitysystemisincompliancewiththeestablishedqualitysystemrequirementsandtodeterminetheeffectivenessofthequalitysystem.Qualityauditsshallbeconductedbyindividualswhodonothavedirectresponsibilityforthemattersandshallbetakenwhennecessary.Areportoftheresultsofeachqualityaudit,andreaudit（s）wheretaken,shallbemadeandsuchreportsshallbereviewedbymanagementhavingresponsibilityforthemattersaudited.Thedatesandresultsofqualityauditsandreauditsshallbedocumentedasrequiredby21CFR820.22.internalqualityauditsconductedbyyourfirmfailedtoverifythatthequalitysystemwaseffectiveinfulfillingqualitysystemobjectives（FDA483,Item#2）.,9,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）.,10,CommissionDirective2003/94/EC,PreambleHavingregardtotheTreatyestablishingtheEuropeanCommunity,Allmanufacturersshouldoperateaneffectivequalitymanagementsystemoftheirmanufacturingoperations,whichrequirestheimplementationofapharmaceuticalqualityassurancesystem.Article13-ComplaintsAnycomplaintconcerningadefectshallberecordedandinvestigatedbythemanufacturerArticle14-InspectionsThemanufacturershallconductrepeatedself-inspectionsinordertomonitortheimplementationandrespectofgoodmanufacturingpracticeandtoproposeanynecessarycorrectivemeasures.Recordsshallbemaintainedofsuchself-inspectionsandanycorrectiveactionsubsequentlytaken.,11,Morethanjustcorrectiveactions,CAPAismuchmorethanjust“correctiveactions”and“preventiveactions”.AnyopportunitytoimprovequalityinyourorganizationisaCAPA!

12,HolisticQMSDefinesCAPASources,Complaints,InternalInspections,SupplierAudits,RegulatoryAudits,Non-conformance,Deviations,OutofSpecification,OutofSpecification,AdverseTrends,AdverseEvents,IncomingInspections,Andmore,NumeroussourceareasforCAPAScopeof“problems”thatdriveCAPAsgobeyondnonconformingproductAnyprocessthataffectsproductqualityisincluded,13,CAPAProcessbestpractices,VerifyEffectiveness,ImplementActions,Review&ApprovePlan,Investigate,RootCause,ActionPlan,Identify&Triage,Regardlessofwheretheproblemoriginates,orwhattypeitis,itmustfollowaprocess,IdentifyproblemAssessimpactQuality/Regulatory/ManagementNotificationInvestigationProcess?

CompleteInvestigationDetermineRootCauseProposedCorrective/PreventiveActionsPlaneffectiveness,AssesschangesEnsurenoimpacttoproductqualityConsensusfromSMEsApproval,ImplementActionsVerifycompletedInformstakeholders,MeasuretoensureproblemhasbeenresolvedMonitortoensureitisnotre-occurring,ChangeControl,MetricsandReporting,14,AddressingQMSChallenges,TypicalQMSChallenges,ChallengesinProblemIdentificationMissingviewofthebigpictureLackofownershipandaccountabilityInabilitytolinkrelatedproblemsInsufficienttoolsfortrendingandanalysis,ChallengesinInvestigationQualityofinvestigationsispoorMissing&incompleteinformationInabilitytoeasilyreviewsimilarpastinvestigationsInconsistentinvestigationprocess&RootCauseNotdeterminingrootcausePastdueinvestigations,notbeingclosed,getlost,ProblemIdentification,Identify&InvestigateRootCause,CreateActionPlan,ChallengesinPlanningVaguerootcauseanalysisConfusionoverwhatis“corrective”andwhatis“preventive”actionInabilitytorelatecorrectiveactionstosourceproblemsLackofintegrationtoChangeControlSystem,16,TypicalQMSChallenges（cont.）,VerifyEffectiveness,ImplementActions,ChallengesinImplementationNowaytotrackissuesthroughworkflowLackofvisibilitytoopenitemsLackofvisibilitytorelateditemsChangestoplanmid-streamCompliancerisk,ChallengesinEffectivenessEasyto“forget”tomeasureeffectivenessDifficulttogathernecessarymetricsNomeanstogeneratemetricsInabilitytomeasureeffectivenessdoesnotgiveusanyassuranceifweareaddressingtherootcauseoftheproblems,Review&ApprovePlan,ChallengesinReview&ApprovalNotsurewhoneedstoapproveApprovalsinserial,notparallelApprovalprocesstakeslongtimeLackofkeystakeholderinput,17,Solution,HolisticApproachtoQualityManagementGlobalize（harmonize）aroundacommonphilosophyandapproachtoCAPAandsourceEventsObtainfullcompliancewithcGxPs,aswellasregulatory&customerexpectationsUsequalitymetricsasabasisforcontinuousimprovementsTrendingProblemAnalysisThoroughInvestigationsandRootCauseAnalysisEnsuringCAPAeffectivenessBringattentiontoriskareastopreventproblemsImplementacentralizedQualityManagementSystem:

ManagesallinputsandoutputsaswellastheactualactionsScalabletobedeployedonaglobalbasisFunctionality/Flexibilitytomeetbusinessrequirements,18,Re-definingCAPA,Re-definingCAPA,DefinitionsStanda