_纠正和预防措施Corrective_and_Preventative_Action.pdf

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1、ProcedureCorrectiveandPreventiveActionP8.5.2/3-1Rev.HApprovedBy:MikeOrsini,QualityManagerDate:10/29/2002Purpose:Todocumentprocedureforcorrectiveandpreventiveaction.Scope:Allcorrectiveandpreventiveactionforcustomercomplaints,auditfindings,andproductnon-conformity.Authority:TheQualityM

2、anagerhastheauthoritytochangeormodifythisprocedure.ReferenceDocumentsandRecords•PolicyElement8.5.2Correctiveactionand8.5.3Preventiveaction•DMRProcedureP8.5.2/3-3•QualityRecordsProcedureP4.2.4ChangeHistoryDateChangeRevBy12/01/96RevisedtyposBMO12/10/96RevisedfortyposCMO12/12/96Updatedt

3、oreflectallCARSforDMOpreventativeaction.03/03/97RemovedLowRiskLog.AddeduseofEMOdatabaseQCICAR.MDB11/13/98Revisednameofdatabase.AddedformsFMOandreportsgeneratedbyHarringtonGroupSoftware.RevisedmethodofinitiatingaCPAFrequest.RevisedmethodofclosingCAR's.RevisedinitialfilingmethodforCAR'

4、s.AddedreviewofopenCAR'stostep9.AddeddatabasestoPreventiveActionsection.10/29/2002UpdatedtotheISO9001:2000GMOrequirementsandflowcharted.Definedtwotypesofpreventiveactions.8/27/2003AddedmethodfortrackingPreventiveHMOActions.UseofcategoryfieldinCARprogramtoidentifyPreventiveActions.Pag

5、e1of3CorrectiveandPreventiveActionP8.4.2/3-1Rev.H-CorrectiveActionSupervisor,QMRBResponsiblePerson/ManagementorQualityManagerMemberTeamAuditorReviewneedforcorrectiveandAddressproblemInvestigatethecauseofpreventiveaction.Opinion:HighmagnitudeorNothenon-conformitiesDeterminetherisk?rel

6、atingtoproduct,magnitudeoftheprocess,andqualityproblemandEndsystem,andrecordtheamountofrisk.YesresultontheSummaryCustomerandNotessectionoftheRequestforEntertheproblemintotheCorrectiveActionSoftwareforCorrectiveProblemandActionCorrectiveActionsandPreventiveActions.ThedatabaseusedforCA

7、Riscalled“InternalDetailReports.(CAP-XXXshallalsobeCAR's”.&CAI-XXX)UseallcauseforappropriatesourcesofimplementingtheinformationsuchasCPAFprocedure.IfDMRisreasonforcorrectiveorpreventiveactionthendocumenttheprocessandworkDMRnumberaspartofthereferencematerialtobeusedbytheCARoperationsw

8、hichaffectPr