质量体系的分析研究

ImplementingaHolisticApproachtoyourQualityManagementSystemStevenR.CagleV.P.ofMarketing&ProductDevelopmentSpartaSystems,Inc.2AgendaSessionObjectivesQualityManagementSystemOverviewTraditionalChallengesRe-definingCAPAImplementingaQualityManagementSoftwareSolutionConclusionQ&A3SessionObjectiveDiscusscriticalcomponentsofaneffectiveQualityManagementSystem(QMS),challengeswithcurrentsystems,andsolutionstoovercomethesechallengesbyimplementingaholisticQualityManagementSoftwaresolution.GeneralIntroduction5DefiningCAPA–ISO13485:20038.5.2CorrectiveAction–Correctiveactionsshallbeappropriatetotheeffectsofthenonconformitiesencountered.Adocumentedprocedureshallbeestablishedtodefinerequirementsfora)reviewingnonconformities(includingcustomercomplaints)b)determiningthecauseofnonconformitiesc)evaluatingtheneedforactiontoensurethatnonconformitiestonotrecurd)determiningandimplementingactionneeded,including,ifappropriate,updatingdocumentatione)recordingoftheresultsofanyinvestigationandofactiontaken,andf)reviewingthecorrectiveactiontakenanditseffectiveness6DefiningCAPA–ISO13485:20038.5.3Preventiveaction–Theorganizationshalldetermineactiontoeliminatethecausesofpotentialnonconformitiesinordertopreventtheiroccurrence.Preventiveactionsshallbeappropriatetotheeffectsofthepotentialproblems.Itisalsodeterminepotentialnonconformitiesandtheircausesa)evaluatingtheneedforactiontopreventoccurrenceofnonconformitiesb)determiningandimplementingactionneededc)recordingoftheresultsofanyinvestigationsandofactiontaken,andd)reviewingpreventiveactiontakenanditseffectiveness7QualityRegulation21CFR820.100U.S.FoodandDrugAdministration’sregulationgoverningmedicaldevicemanufacturersqualitysystems:(a)Eachmanufacturershallestablishandmaintainproceduresforimplementingcorrectiveandpreventiveaction:(1)analyzingprocesses,workoperations,concessions,qualityauditreports,qualityrecords,servicerecords,complaints,returnedproducts,andothersourcesofqualitydatatoidentifyexistingandpotentialcausesofnonconformingproduct,orotherqualityproblems(2)investigatingthecauseofnonconformitiesrelatingtoproduct,processes,andthequalitysystem(3)identifyingtheactionsneededtocorrectandpreventrecurrenceofnonconformingproductandotherqualityproblems(4)verifyingorvalidatingthecorrectiveandpreventiveaction(5)Implementingandrecordingchangesinmethodsandproceduresneededtocorrectandpreventidentifiedqualityproblems(6)Ensuringthatinformationrelatedtoqualityproblemsornonconformingproductisdisseminatedtothosedirectlyresponsibleforassuringthequalityofsuchproductorthepreventionofsuchproblems;and(7)Submittingrelevantinformationonidentifiedqualityproblems,aswellascorrectiveandpreventiveactions,formanagementreview8QualityRegulation21CFR211.22VerysimilaristheU.S.FDA’sregulationforpharmaceuticalmanufacturers21CFRPart211.22(QualityControlUnit)…responsibilitiesofaqualitycontrolunit...toassurethatnoerrorshaveoccurredor,iferrorshaveoccurred,thattheyhavebeenfullyinvestigated.Thequalitycontrolunitshallhavetheresponsibilityforapprovingorrejectingallproceduresorspecificationsimpactingontheidentity,strength,quality,anpurityofthedrugproduct…andinPart211.92(ProductionRecordReview)Anyunexplaineddiscrepancy…orthefailureofabatchoranyofitscomponentstomeetanyofitsspecificationsshallbethoroughlyinvestigated…Theinvestigationshallextendtootherbatchesofthesamedrugproductandotherdrugproductsthatmayhavebeenassociatedwiththespecificfailureordiscrepancy.Awrittenrecordoftheinvestigationshallbemadeandshallincludetheconclusionsandfollow-up.9QuotesfromCurrentFDAWarningLettersEachmanufacturershallestablishproceduresforqualityauditsandconductsuchauditstoassurethatthequalitysystemisincompliancewiththeestablishedqualitysystemrequirementsandtodeterminetheeffectivenessofthequalitysystem.Qualityauditsshallbeconductedbyindividualswhodonothavedirectresponsibilityforthemattersandshallbetakenwhennecessary.Areportoftheresultsofeachqualityaudit,andreaudit(s)wheretaken,shallbemadeandsuchreportsshallbereviewedbymanagementhavingresponsibilityforthemattersaudited.Thedatesandresultsofqualityauditsandreauditsshallbedocumentedasrequiredby21CFR820.22.internalqualityauditsconductedbyyourfirmfailedtoverifythatthequalitysystemwaseffectiveinfulfillingqualitysystemobjectives(FDA483,Item#2).10QuotesfromCurrentFDAWarningLettersYourfirmfailstoimplementandmaintaincorrectiveandpreventiveaction(CAPA)proceduresthatincluderequirementsforanalyzingprocesses,workoperations,concessions,qualityauditreports,qualityrecords,servicerecords,complaints,returnedproduct,andothersourcesofqualitydatatoidentifyexistingandpotentialcausesofnonconformingproduct,orotherqualityproblemsasrequiredby21CFR820.100(a)(1).Yourfirmfailstoestablishandimplementcorrectiveandpreventiveaction(CAPA)proceduresthatincluderequirementsforidentifyingtheaction(s)neededtocorrectandpreventrecurrenceofnon-conformingproductandotherqualityproblemsasrequiredby21CFR820.100(a)(3)Allactivitiesrequiredby21CFR820.100mustbeverifiedorvalidatedtoensurethatsuchactioniseffectiveanddoesnotadverselyaffectfinishedd