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1、FOODANDDRUGADMINISTRATIONGUIDETOINSPECTIONSOFQUALITYSYSTEMS1August199912GuidetoInspectionsofQualitySystemsThisdocumentwasdevelopedbytheQualitySystemInspec-tionsReengineeringTeamMembersOfficeofRegulatoryAffairsRobRuffGeorgiaLayloffDeniseDionNormWongCenterforDevicesandRadiologicalHealthTimWellsT
2、eamLeaderChrisNelsonCoryTylkaAdvisorsChetReynoldsKimTrautmanAllenWynnDesignedandProducedbyMalakaC.Desroches3ForewordThisdocumentprovidesguidancetotheFDAfieldstaffonanewinspectionalprocessthatmaybeusedtoassessamedicaldevicemanufacturer’scompliancewiththeQualitySystemRegulationandrelatedregulati
3、ons.Thenewinspectionalprocessisknownasthe“QualitySystemInspectionTechnique”or“QSIT”.Fieldinvestigatorsmayconductanef-ficientandeffectivecomprehensiveinspectionusingthisguidancematerialwhichwillhelpthemfocusonkeyelementsofafirm’squalitysystem.Note:Thismanualisreferencematerialforinvesti-gatorsa
4、ndotherFDApersonnel.ThedocumentdoesnotbindFDAanddoesnotconferanyrights,privi-leges,benefitsorimmunitiesfororonanyperson(s).4TableofContentsPerformingSubsystemInspections...............7Pre-announcedInspections.....................13GettingStarted..............................15ManagementContro
5、ls........................17InspectionalObjectives18DecisionFlowChart19Narrative20DesignControls............................31InspectionalObjectives32DecisionFlowChart33Narrative34CorrectiveandPreventiveActions(CAPA)........47InspectionalObjectives48DecisionFlowChart49Narrative50MedicalDeviceR
6、eporting61InspectionalObjectives62DecisionFlowChart63Narrative64Corrections&Removals67InspectionalObjectives68DecisionFlowChart69Narrative70MedicalDeviceTracking73InspectionalObjectives74DecisionFlowChart75Narrative76ProductionandProcessControls(P&PC)........79InspectionalObjectives80DecisionF
7、lowChart81Narrative82SterilizationProcessControls91InspectionalObjectives92DecisionFlowChart93Narrative94SamplingPlans...........................103Instructions104Tables(Backpage)1075Thisreferenceisintendedtobeusedinconjunctionwiththe:r
