年度质量管理计划(很有参考价值).ppt

,QUALITYMANAGEMENTPLANOVERVIEW,CourseGoals,Attheconclusionofthistraining,youwillbeableto:ExplainthebasicconsiderationsforQualitySystemdesignExplainwhataQualityManagementPlan(QMP)isandwhyitisrequiredDiscussthetenelementsofaQMPandthetopicstocoverineachExplainthegradedapproachtodesigningaQMP,WhyAreYouHere?,AnyorganizationconductingenvironmentalprogramsbyoronbehalfofEPAmusthaveadocumentedqualitysystemTheQMPdocumentsthatqualitysystemYouhelpdevelopaQMP.,Howisanorganizationvulnerableifinadequatedataarecollected?,WhatIsAQualitySystem?,Aframeworkofmanagementandtechnicalpracticesthatassurethatenvironmentaldatausedtosupportdecisionsare:OfadequatequalityandusabilityfortheirintendedpurposeDefensible,CommonStepsinQualitySystemDesign,PrepareanoverviewofthecurrentorganizationanditsenvironmentaldataoperationsIdentifyexistingQualitySystemcomponentsortoolsDocumentexistingproceduresasappropriateDevelopprocedureswherenecessaryDocumenttheQualitySystemdesign,SystemOverview,QuestionstoAsk,Howdoesyourorganizationusedata(datagenerator,decisionmaker,regulatory)?Whatisthescopeoftechnicalactivitieswithinyourorganization(monitoring,regulatoryactions,inspections,characterizations,programoversight)?Whoisresponsibleforplanning,implementing,andassessingthesetechnicalactivities?Whattoolsarealreadyinuseoraremandated(QAPPs,SOPs,TSAs)?,GradedApproach,QAandQCrequirementscommensuratewith:ImportanceofworkAvailableresourcesUniqueneedsoforganizationConsequencesofpotentialdecisionerrors,TipsforDesignandImplementation,DontdelegateresponsibilityforsuccessoftheQualitySystemtoolowinorganizationInlargerorganizations,avoidcommunicatingQMPrequirementstoeveryoneallatonceUsevalueaddedassessmentsratherthanrigidauditsBuildsuccessmeasuresintothesystemsothatyouwillknowwhenitisworkingwell,QMPRequirementsOverview,QMPRequirement,AllworkperformedbyEPAorganizationsandbyexternalorganizationsfundedbyEPAthatinvolvesacquisitionofenvironmentaldatageneratedfromdirectmeasurementactivities,collectedfromothersources,orcompiledfromcomputerizeddatabasesandinformationsystemsshallbecoveredbyanAgency-approvedQMP.,InternalandExternalRequirements,Internal:EPAOrder5360.1A22000External:48CFRPart46(contracts)40CFRPart30,31,and35(assistanceagreements)Other(e.g.,consentagreementsinenforcementactions),QMPPurpose,TheQMPdocumentswhatyouaregoingtodo,howyouaregoingtodoit,andhowyouknowyoudidit.,ImportantTerms,QualityManagementQualityAssuranceQualityControl,ScopeofQMP,Mustreflectoremphasizeactualpractices,notplannedpracticesShouldusethegradedapproachShouldbeconstructedandwrittensoitseffectivenesscanbeassessed,Revision,QMPmustbekeptaccurateandup-to-dateinaccordancewithchangesinQApolicyandproceduresNotifyallappropriatepersonnelaboutchangestoqualitysystemandQMP,Revision(Contd),Internal:SubmitrevisionsmadeduringyeartotheQualityStaffwithQAAnnualReportandWorkPlan.External:SubmitrevisionstothedesignatedEPAofficialasareportwhentheyoccur.Ifchangesaresignificant,submitentireQMP.,GeneralRequirements,10QMPRequirements,ManagementandOrganizationQualitySystemComponentsPersonnelQualificationsandTrainingProcurementofItemsandServicesDocumentsandRecords,10QMPRequirements(Contd),ComputerHardwareandSoftwarePlanningImplementationofWorkProcessesAssessmentandResponseQualityImprovement,ApprovalPage,ApprovalpagesignaturesManagementQAManageroforganizationQualityStaffDirector(internal)SeniorEPAOfficialforQuality(internal)ResponsibleEPAofficial(external)Maybeeitherpartoftitlepageorseparatesheetfollowingtitlepage,IfNotApplicable,Ifelementisnotapplicabletoanorganizationsqualitysystem,astatementaboutwhyitisnotmustbeincludedinQMP,ManagementandOrganization,Overview:ManagementandOrganization,Adescriptionof:QAPolicyOrganizationalstructureStaffroles,responsibilities,andauthorities,TechnicalactivitiesDisputeresolutionQualitySystemimplementation,QAPolicy,Astatementoftheorganizationspolicyonqualityassurance,including:ImportanceofQAandQCtoorganizationandwhyGeneralobjectives/goalsofQualitySystemPolicyforresourceallocationfortheQualitySystem,OrganizationChart,Anorganizationchartmust:IdentifyallcomponentsoftheorganizationIdentifythepositionandlinesofreportingforQAManagerandanyQAstaffShowindependenceoftheQAManagerfromgroupsgenerating,compiling,andevaluatingenvironmentaldata,ResponsibilitiesandAuthorities,Discusstheresponsibilitiesandauthoritiesof:QAManagerAnyotherQAstaff,TechnicalActivities,DiscussthetechnicalactivitiesorprogramssupportedbythequalitysystemSpecificprogramsthatrequirequalitymanagementcontrolsWhereoversightofextramuralprogramsisneededtoassuredataqualityWhereinternalcoordinationofQAandQCactivitiesneedstooccur,ProcessforResolvingDisputes-InternalOnly,Discusstheorganizationsprocessforresolvingdisputesregarding:QualitysystemrequirementsapplicabilityQAandQCproceduresapplicationAssessmentsCorrectiveactions,QualitySystemImplementation,DiscusshowmanagementwillensurethatapplicableelementsoftheQualitySystemareunderstoodandimplementedinallenvironmentalprograms,QualitySystemComponents,Overview:QualitySystemComponents,DiscussprincipalcomponentsofQualitySystemandtoolsusedtomanagethesystemWhatcomponentscompriseQualitySystemWhattoolsareusedtomanageQualitySystemWhousesthemandhow,QualitySystemComponents(Contd),ListpartsoftheorganizationthatarerequiredtoprepareQMPsDiscussthereviewandapprovalprocessforQMPsfromexternalorganizations,QualitySystem“Tools”,QMPsManagementAssessments-SelfandIndependentTechnicalAssessmentsSystematicPlanningStandardOperatingProcedures(SOPs)QualityAssuranceProjectPlans(QAPPs)DataQualityAssessments,PersonnelQualificationsandTraining,Overview:PersonnelQualificationandTraining,Describeorganizationsprocessfor:EstablishingtrainingrequirementsIdentifyingtrainingneedsAssigningtrainingprioritiesMeetingtrainingneeds,ThreeAreastoCover,TrainingpolicyTrainingprocessesCriticaltrainingdocumentation,Policy,Statethepolicyregardingtrainingformanagementandstaff,Processes,Describeprocessesandmanagement/staffresponsiblefor:Identifyingstatutory,regulatory,orprofessionalcertificationsrequiredIdentifying,designing,performing,anddocumentingtrainingTechnicalQualityProjectmanagement,DocumentTraining,Describehowstaffproficiencyincriticaltechnicaldisciplinesismaintainedanddocumented,ProcurementofItemsandServices,Overview:ProcurementofItemsandServices,Describeorganizationsprocessforensuringthatsuppliersprovideitemsandservicesthat:AreofknownanddocumentedqualityMeetthetechnicalrequirements,FourAreastoCover,ReviewandapprovalofprocurementdocumentsReviewandapprovalofQAresponsestosolicitationsObjectiveevidenceofadequatequalityfromsuppliersQAdocumentreviewandapproval,ReviewandApprovalofProcurementDocuments,Describeprocessandresponsibilitiesforensuringthatdocumentationclearlystates:ItemorservicerequiredTechnicalandqualityrequirementsQualitySystemelementsthatthesupplierisresponsibleforHowsuppliersconformancetorequirementswillbeverified,ReviewandApprovalofQAResponsestoSolicitations,Describeroles,responsibilities,andprocessforreviewandapprovalofresponsestosolicitationstoensure:ThatalltechnicalandqualityrequirementsaresatisfiedThatthereisadequateevidenceofsupplierscapabilitytosatisfyEPAQualitySystemrequirements,QualityFromSuppliers,Describeprocessfordeterminingadequatequalityfromsuppliers,including:HowprocurementsourcesareevaluatedandselectedHowandwhensourceinspectionsareusedHowdeliverablesareexaminedforconformancetospecifications,QADocumentReviewandApproval,Describeroles,responsibilities,processesandpoliciesfor:ReviewandapprovalofmandatoryqualityrelateddocumentationDelegationofreviewandapprovalofmandatoryquality-relateddocumentationEnsuringthatEPAquality-relatedcontractingpoliciesaresatisfied,DocumentsandRecords,Overview:DocumentsandRecords,Discussproceduresfordocumentsandrecords:TimelypreparationReviewApprovalIssuanceUseControlRevisionMaintenance,Document,Anycompilationofinformationthat:DescribesDefinesSpecifiesReportsCertifies,Record,Acompleteddocumentthatprovidesobjectiveevidenceofanitemorprocess.,IdentifyDocumentsandRecords,Describeorreferenceprocessforidentifyingquality-relateddocumentsandrecordsrequiringversionandreleasecontrol,QA-RelatedDocumentsandRecords,DescribeorreferenceprocessbywhichallQA-relateddocumentsandrecordsare:AccessibleProtectedfromdamageanddeteriorationSubjecttoretentionrequirementsPrepared,reviewed,andapprovedIssuedandrevised,Compliance,Describeorreferenceprocessforensuringcompliancewithallstatutory,contractual,andassistanceagreementrequirementsforrecordsfromenvironmentalprograms,ComputerHardwareandSoftware,Overview:ComputerHardwareandSoftware,TheQMPmustdescribeQAandQCprocessesfortheuseofcomputerhardwareandsoftwaretosupportenvironmentaldataoperations,GeneralRequirements,ComputerhardwaremustbeappropriateforitsintendedapplicationComputerprogramsmustbedevelopedusinganapprovedsoftwaredevelopmentmethodology,ExamplesofHardwareCovered,Dataacquisition/loggingsystemsComputersusedwithanalyticalinstrumentsAutomatedsamplingsystemsinwhichsystemfailurewouldadverselyaffectqualityandpotentialusabilityofcollecteddatafordecisions,ExamplesofSoftwareCovered,ProgramsModelsDatabasesDataanalysissystems,HardwareQAandQCProcesses,DescribeorreferenceprocessforensuringthatcomputerhardwareusedinenvironmentalprogramsmeetstechnicalrequirementsandqualityexpectationsDescribeorreferencehowchangestohardwarewillbecontrolledtoassessimpactofchangeonperformance,SoftwareDevelopmentQAandQCProcesses,Describeorreferenceprocessfor:DevelopingcomputersoftwareValidating,verifying,anddocumentingsoftwareforitsuseAssuringthatsoftwaremeetsrequirementsofuser,IRMPolicies,Describeorreferenceprocessforensuring:Thatdataandinformationproducedandcollectedbycomputersmeetapplicableinformationresourcemanagementrequirementsandstandards,IRMPolicies,ThatapplicableEPArequirementsforinformationresourcesmanagementareaddressed,including:Year2000compliance(Chapter5)Security(Chapter8)Privacyrequirements(Chapter11),Planning,Overview:Planning,DescriptionofprocessforplanningenvironmentalprogramsDiscussionofQAPPprocessDiscussionoforganizationssecondarydatapolicy,SystematicPlanning,UsesystematicplanningprocessbasedonscientificmethodApplytheprincipleofgradedapproachandcommonsense,SystematicPlanningRequirements,Describeprocessusedforgeneralprojectplanning,including:HowitisaccomplishedHowplanningwillbedocumentedWhousesplanningtoolsRolesandresponsibilitiesofmanagementandstaff,QualityAssuranceProjectPlans(QAPPs),Describeprocessfor:DevelopingReviewingApprovingImplementingRevisingtheQAPP,SecondaryData,DiscussprocessforevaluatingandqualifyingsecondarydataDescribeapplicationofanystatisticalmethodsused,ImplementationofWorkProcesses,Overview:ImplementationofWorkProcesses,DescribeprocessforimplementingworkwithinorganizationProceduresforensuringworkisperformedaccordingtoplanProceduresforroutine,standardized,special,orcriticaloperationsProceduresforcontrollinganddocumentingtherelease,change,anduseofplannedprocedures,DevelopingandImplementingProcedures,Describeprocessfor:EnsuringthatworkisperformedaccordingtoplanDevelopingandimplementingproceduresforappropriateroutine,standardizedorspecialoperations,including:IdentifyingoperationsneedingproceduresPreparationofproceduresReviewingandapprovingprocedures,PlannedProcedures,Describemeasuresforcontrollingplannedworkprocessesorprocedures:TheirreleaseTheirchangeTheiruse,ControllingMeasures,Measuresshouldprovidefor:NecessaryapprovalsSpecifictimesandpointsforimplementingchangesRemovalofobsoletedocumentationfromworkareaVerificationthatchangesaremadeasprescribed,AssessmentandResponse,Overview:AssessmentandResponse,Describe:Howandbywhomassessmentsofenvironmentalprogramsareplanned,conducted,andevaluatedProcessbywhichmanagementdetermines:AssessmentactivitiesandtoolsappropriateforaparticularprojectExpectedfrequencyofuse,ExamplesofAssessmentTools,ManagementsystemsreviewsSurveillanceTechnicalsystemsauditsPerformanceevaluationsAuditsofdataqualityPeerreviewsandtechnicalreviewsReadinessreviewsDataqualityassessments,TwoGeneralTypesofAssessment,ManagementTechnical,AssessmentActivities,Describeprocess:Forplanning,conducting,andevaluatingassessmentsBywhichmanagementchoosestheappropriateassessmentforaparticularproject,AssessmentActivities(Contd),Describe:HowfrequencyofassessmentsisdeterminedProcessforreportingandrespondingtoresultsResponsibilities,levelsofparticipation,andauthoritiesforallmanagementandstaffparticipatinginassessmentprocess,AssessorQualifications,AssessorqualificationsTechnicallyknowledgeableNorealorperceivedconflictofinterest,AssessorAuthority,Describehowpersonnelconductingassessmentswillhave:SufficientauthorityAccesstoprogramsandmanagersAccesstodocumentsandrecordsOrganizationalfreedom,AssessmentResults,Describeprocessforreviewofasse