FDA质量体系检查指南培训

TheQualitySystemInspectionTechnique(QSIT)PaulR.WhitbyCONSUMERSAFETYOFFICERFDA/ORA/LOS-DOREGULATIONS
QualitySystemRegulation21CFRPart820codeoffederalregulationsFoodandDrugs21PARTS800to1299RevisedasofApril1,1998QSITisanInspectionTechnique
QSITGuideִPurposeandImportanceִObjectivesִFlowchartsִNarrativesִSamplingPlansGGUIDEUIDETOTOIINSPECTIONSNSPECTIONSOFOFQQUALITYUALITYSSYSTEMSYSTEMSFOODANDDRUGADMINISTRATIONAugust1999August1999TheQSITApproach
QSITfocusesonevaluatingwhethertheQualitySystemandsubsystemshavebeenimplementedeffectively.
QSITacknowledgesthatnonconformingproductandqualityproblemshappen.
Whatisimportantis:ִDidthemanufactureridentifythenonconformingproductorqualityproblem?ִDidthemanufacturertakeeffectivecorrectiveandpreventiveaction?QSIT
QSITisaTopdownapproach
Keyqualitysystemsub-systemsareaudited
QSITprovidesdirectionsforsamplingofrecords
ThebinomialstagedsamplingplansoutlinedintheQSITguidehelptoindicatewhattheextentofanydeficienciesmaybeMANAGEMENTMANAGEMENTCorrective&PreventiveActionsMaterialControlsRecords/Documents/ChangeControlsProduction&ProcessControlsDesignControlsFacility&EquipmentControlsSterilizationProcessControlsMedicalDeviceTrackingReportsofCorrectionsandRemovalsMedicalDeviceReportingQSITFocusesonFourMajorSubsystems
ManagementControls
DesignControls
Corrective&PreventiveActionControls
Production&ProcessControlsTheThreeOtherSubsystems
Facility&equipmentcontrols
Productcontrols
Documents,records&changecontrolsSatellites
SterilizationProcessControlsareinspectedasasatellitesystemtotheProductionandProcessControlsSubsystem
MedicalDeviceReporting,ReportsofCorrectionsandRemovals,andMedicalDeviceTrackingaresatellitesofCAPADesignControlsDesignControlsMaterialMaterialControlsControlsRecords,Records,Documents,&Documents,&ChangeControlsChangeControlsEquipment&Equipment&FacilityControlsFacilityControlsProduction&Production&ProcessControlsProcessControlsCorrective&Corrective&PreventivePreventiveActionsActionsManagementControlsManagementControls-Purpose
Provideadequateresourcesfordevicedesign,manufacturing,qualityassurance,distribution,installationandservicing
Assureproperfunctionofqualitysystem
Monitorqualitysystem
MakenecessaryadjustmentsManagementControls-InspectionalObjectives
1.Verifythataqualitypolicy,managementreviewandqualityauditprocedures,qualityplan,andqualitysystemproceduresandinstructionshavebeendefined&documented.
2.Verifythataqualitypolicyandobjectiveshavebeenimplemented.ManagementControls-InspectionalObjectives
3.Reviewthefirm’sestablishedorganizationalstructuretoconfirmthatitincludesprovisionsforresponsibilities,authoritiesandnecessaryresources.
4.Confirmthatamanagementrepresentativehasbeenappointed.Evaluatethepurviewofthemanagementrepresentative.ManagementControls-InspectionalObjectives
5.Verifythatmanagementreviews,includingareviewofthesuitabilityandeffectivenessofthequalitysystemarebeingconducted.
6.Verifythatqualityaudits,includingre-auditsofdeficientmatters,ofthequalitysystemarebeingconducted.DesignControls-Purpose
Controlthedesignprocesstoassurethatdevicesmeet:ִuserneedsִintendedusesִspecifiedrequirementsFocusingtheInspectionofDesignControls...15Objectives(QSIT)52Objectives(DesignControlInspectionalStrategy)36Objectives(DesignControlReportandGuidance)DesignControls-InspectionalObjectives
1.Selectasingledesignproject.
2.Forthedesignprojectselected,verifythatdesigncontrolproceduresthataddresstherequirementsofSection820.30oftheregulationhavebeendefinedanddocumented.DesignControls-InspectionalObjectives
3.Reviewthedesignplanfortheselectedprojecttounderstandthelayoutofthedesignanddevelopmentactivitiesincludingassignedresponsibilitiesandinterfaces.
4.Confirmthatdesigninputswereestablished.DesignControls-InspectionalObjectives
5.Verifythatthedesignoutputsthatareessentialfortheproperfunctioningofthedevicewereidentified.
6.Confirmthatacceptancecriteriawereestablishedpriortotheperformanceofverificationandvalidationactivities.ִsamplingtablesareusedDesignControls-InspectionalObjectives
7.Determineifdesignverificationconfirmedthatdesignoutputsmetthedesigninputrequirements.ִsamplingtablesareused
8.Confirmthatdesignvalidationdatashowthattheapproveddesignmetthepredetermineduserneedsandintendeduses.DesignControls-InspectionalObjectives
9.Confirmthatthecompleteddesignvalidationdidnotleaveanyunresolveddiscrepancies.
10.Ifthedevicecontainssoftware,confirmthatthesoftwarewasvalidated.
11.Confirmthatriskanalysiswasperformed.DesignControls-InspectionalObjectives
12.Determineifdesignvalidationwasaccomplishedusinginitialproductiondevicesortheirequivalents.
13.Confirmthatchangeswerecontrolledincludingvalidationorwhereappropriateverification.DesignControls-InspectionalObjectives
14.Determineifdesignreviewswereconducted.
15.Determineifthedesignwascorrectlytransferred.UsingQSIT-
Sample
Review
Confirm
VerifySamplingforConfidence
UsingTable1andreviewingapopulationof35randomlyselectedrecordsofonetype(DHR)andfindingjustonedeviation.
Theinvestigatorcanbe95%certainthatlessthanorequaltoonly15%percentofthesetofrecordsco