GUIDELINESNonCorrectiveCorrectiveAction.pdfVIP专享VIP免费原创优质

GUIDELINESFORNON-CONFORMITIESANDCORRECTIVEACTIONSPURPOSEThisguidelineshallestablishtherequirementsfor:1.Reviewingnon-conformities;2.Determiningthecausesofthediscoverednon-conformities;3.Determiningandimplementingactionneededtopreventtheexistenceandrecurrenceofanon-conformity;4.Recordsoftheresultsofaction/staken;5.Reviewingtheeffectivenessofthecorrectiveactionstaken;6.Definingthecontrolsandrelatedresponsibilitiesandauthoritiesfordealingwithnon-conformingservices.SCOPEThisprocedureshallcoverallcorrectiveactionsthatcanbedonetoaddressanonconformitywhichcanaffectthePRAQualityManagementSystem.POLICYThedeliveryofPRA’sservicesshouldalwayssatisfycustomer’srequirementsinaccordancewiththeserviceagreement.Itisthepolicyofthecompanytoidentify,controlandpreventoccurrence/recurrenceofservicesthatdonotconformtospecifiedrequirements.Inaddition,PRAmustimplementcorrectiveactionstoimprovetheeffectivenessoftheestablishedQualityManagementSystem.DEFINITIONOFTERMSCorrection–actiontoeliminateadetectednon-conformity.CorrectiveAction-actiontoeliminatethecauseofanon-conformityandtopreventrecurrence.Conformity–fulfillmentofarequirement.Nonconformity(NC)-failuretocomplywitharequirementOpportunityforImprovement(OFI)-anobservedsituationwhichisnotanon-conformitybutwheretheresultsachievedmaynotbeoptimal,lessthanwell-organized,orovercomplicated.RequestforAction(RFA)-documentusedto:-Recordanon-conformityoranopportunityforimprovement;-Identifytheroot-causeofthenon-conformity;-Determinecorrectionandcorrectiveaction.RESPONSIBILITIES1.QMSLeader/Head-ensurethatthisprocedureisproperlyimplemented.2.Heads/ProcessOwners-ensurethatcorrectionsandcorrectiveactionsarecarriedoutwithoutunduedelay-ensurethatallRFAsreceivedareproperlyrespondedandsubmittedtotheIQA,andthatdocumentedinformationisretained.-ensuretheeffectivenessofactionstaken.3.InternalQualityAuditTeam-verifyifthecorrectionsandcorrectiveactionshavebeeneffectivelycarriedout.PROCEDUREDETAILS1.Identificationofnon-conformingservicesNonconformingservicesmaybedetectedthroughorasaresultof(butnotlimitedto)thefollowing:1.StatutoryandRegulatoryRequirements2.ClientFeedback3.AuditActivities4.ManagementReviews2.Whenanon-conformityisdetected,implementthefollowingprocedure:1.Documentthenon-conformitybyaccomplishingtheappropriatepartoftheRFA;2.SubmittheRFAtotheInternalQualityAuditTeamforreviewandcontrolnumberassignment.TheIQATeamshallberesponsibleinforwardingtheRFAtotheconcernedunit;3.TheinitiatorandtheIQATeamshallcoordinateonthestatusofactions,anduntilthenon-conformityisresolved;4.Inthecaseofnon-conformityfromnon-achievementofaUnit’sobjectiveortarget,the“ActionPlanforUnmetTargets”formcanbeusedtodocumenttheNC.Thisdocumentisdecentralized.3.WhenanRFAisreceived,implementthefollowingprocedure:1.UnitHeadshouldacknowledgetheRFAbysigningonthe1stpage(spaceprovided);2.PerformaRoot-CauseAnalysis(RCA).3.UsingtheresultsoftheRCA,formulateacorrectionandacorrectiveaction.Theactionstobetakenshouldaddresstheidentifiedcause/softheNC.4.Provideaspecificimplementationdateforboththecorrectionandcorrectiveaction;5.SecuretheapprovaloftheUnitHead;6.SubmittheRFAtotheIQATeamwithinfifteen(15)workingdaysuponreceipt.4.DispositionandMonitoringofCorrectionandCorrectiveAction1.TheconcernedUnitHeadshallberesponsibletocarryoutthenecessarycorrectiveactions.TolowertheriskofrecurrenceofdetectedNCs,andtheriskofoccurrenceofpotentialNCs,theUnitHeadshall:a.ReviewandapprovetheRCA,thecorrection,andthecorrectiveactionthathavebeenidentifiedintheRFA;b.Monitorifactionsarecarriedoutaccordingtothetargetedimplementationdate;c.ConductaregularmeetingregardingtheUnit’simplementationofthePRA-QMS,theresultsofactionstakenintheRFAs,andotherQMSconcerns.2.TheUnitheadsshallbeprimarilyresponsibleinensuringtheeffectivenessoftheirownactions.5.CONTROLOFNONCONFORMITYMATRIXNatureofNCAction/DispositionResponsibilityDelayintheperfectionofprojectSeekapprovalfromauthority;ReviseWorkplanProjectManagerChangeinProjectDurationReviseProjectImplementationPlanProjectManagerExceedingtheallottedprojectbudgetMonitorsucceedingprojectdisbursementsRe-alignbudgetitemsProjectManagerFinanceStatementofAccounterrorsRetrievetheStatementofAccountsRe-issueStatementofAccountswithcoveringexplanationProjectManagerFinanceDeviationfromestablishedCodeofConductInvestigateRefertosuperior/managerforimmediateappropriateactionHumanResourceDivisionEquipmentmalfunctionReplacewithspareequipmentRentequipmentfromexternalserviceproviderGeneralServicesDivisionProblemswithutilities/facilitiesSecureremedialimmediateactionfromconcernedutility/facilitiesproviderGeneralServicesDivisionREFERENCENonconformityandCorrectiveAction-Clause10.2ISO9001:2015