年度质量管理计划(很有参考价值)

QUALITYMANAGEMENTPLANOVERVIEWCourseGoalsAttheconclusionofthistraining,youwillbeableto:–ExplainthebasicconsiderationsforQualitySystemdesign–ExplainwhataQualityManagementPlan(QMP)isandwhyitisrequired–DiscussthetenelementsofaQMPandthetopicstocoverineach–ExplainthegradedapproachtodesigningaQMPWhyAreYouHere?•AnyorganizationconductingenvironmentalprogramsbyoronbehalfofEPAmusthaveadocumentedqualitysystem•TheQMPdocumentsthatqualitysystemYouhelpdevelopaQMP.Howisanorganizationvulnerableifinadequatedataarecollected?WhatIsAQualitySystem?Aframeworkofmanagementandtechnicalpracticesthatassurethatenvironmentaldatausedtosupportdecisionsare:•Ofadequatequalityandusabilityfortheirintendedpurpose•DefensibleComputerHardware/SoftwarePersonnelQualifications/TrainingQualityImprovementAssessmentImplementationofWorkProcessesPlanningProcurementRecords/DocumentationQualitySystemDescriptionManagement/OrganizationEnvironmentalDataOperationsAdequateDataQualityCommonStepsinQualitySystemDesign•Prepareanoverviewofthecurrentorganizationanditsenvironmentaldataoperations•IdentifyexistingQualitySystemcomponentsortools•Documentexistingproceduresasappropriate•Developprocedureswherenecessary•DocumenttheQualitySystemdesignSystemOverviewOrg.DataUseTechnicalActivitiesResponsibilityQualitySystemToolsUsedNotesQuestionstoAsk•Howdoesyourorganizationusedata(datagenerator,decisionmaker,regulatory)?•Whatisthescopeoftechnicalactivitieswithinyourorganization(monitoring,regulatoryactions,inspections,characterizations,programoversight)?•Whoisresponsibleforplanning,implementing,andassessingthesetechnicalactivities?•Whattoolsarealreadyinuseoraremandated(QAPPs,SOPs,TSAs)?GradedApproachQAandQCrequirementscommensuratewith:•Importanceofwork•Availableresources•Uniqueneedsoforganization•ConsequencesofpotentialdecisionerrorsTipsforDesignandImplementation•Don'tdelegateresponsibilityforsuccessoftheQualitySystemtoolowinorganization•Inlargerorganizations,avoidcommunicatingQMPrequirementstoeveryoneallatonce•Usevalueaddedassessmentsratherthanrigidaudits•BuildsuccessmeasuresintothesystemsothatyouwillknowwhenitisworkingwellQMPRequirementsOverviewQMPRequirementAllworkperformedbyEPAorganizationsandbyexternalorganizationsfundedbyEPAthatinvolvesacquisitionofenvironmentaldatageneratedfromdirectmeasurementactivities,collectedfromothersources,orcompiledfromcomputerizeddatabasesandinformationsystemsshallbecoveredbyanAgency-approvedQMP.InternalandExternalRequirements•Internal:EPAOrder5360.1A22000•External:–48CFRPart46(contracts)–40CFRPart30,31,and35(assistanceagreements)–Other(e.g.,consentagreementsinenforcementactions)QMPPurpose•TheQMPdocumentswhatyouaregoingtodo,howyouaregoingtodoit,andhowyouknowyoudidit.ImportantTerms•QualityManagement•QualityAssurance•QualityControlScopeofQMP•Mustreflectoremphasizeactualpractices,notplannedpractices•Shouldusethegradedapproach•ShouldbeconstructedandwrittensoitseffectivenesscanbeassessedRevision•QMPmustbekeptaccurateandup-to-dateinaccordancewithchangesinQApolicyandprocedures•NotifyallappropriatepersonnelaboutchangestoqualitysystemandQMPRevision(Cont’d)•Internal:SubmitrevisionsmadeduringyeartotheQualityStaffwithQAAnnualReportandWorkPlan.•External:SubmitrevisionstothedesignatedEPAofficialasareportwhentheyoccur.Ifchangesaresignificant,submitentireQMP.GeneralRequirements10QMPRequirements1.ManagementandOrganization2.QualitySystemComponents3.PersonnelQualificationsandTraining4.ProcurementofItemsandServices5.DocumentsandRecords10QMPRequirements(Cont'd)6.ComputerHardwareandSoftware7.Planning8.ImplementationofWorkProcesses9.AssessmentandResponse10.QualityImprovementApprovalPage•Approvalpagesignatures–Management–QAManageroforganization–QualityStaffDirector(internal)–SeniorEPAOfficialforQuality(internal)–ResponsibleEPAofficial(external)•MaybeeitherpartoftitlepageorseparatesheetfollowingtitlepageIfNotApplicableIfelementisnotapplicabletoanorganization'squalitysystem,astatementaboutwhyitisnotmustbeincludedinQMPManagementandOrganizationOverview:ManagementandOrganizationAdescriptionof:•QAPolicy•Organizationalstructure•Staffroles,responsibilities,andauthorities•Technicalactivities•Disputeresolution•QualitySystemimplementationQAPolicyAstatementoftheorganization'spolicyonqualityassurance,including:•ImportanceofQAandQCtoorganizationandwhy•Generalobjectives/goalsofQualitySystem•PolicyforresourceallocationfortheQualitySystemOrganizationChart•Anorganizationchartmust:–Identifyallcomponentsoftheorganization–IdentifythepositionandlinesofreportingforQAManagerandanyQAstaff–ShowindependenceoftheQAManagerfromgroupsgenerating,compiling,andevaluatingenvironmentaldataResponsibilitiesandAuthoritiesDiscusstheresponsibilitiesandauthoritiesof:•QAManager•AnyotherQAstaffTechnicalActivities•Discussthetechnicalactivitiesorprogramssupportedbythequalitysystem–Specificprogramsthatrequirequalitymanagementcontrols–Whereoversightofextramuralprogramsisneededtoassuredataquality–WhereinternalcoordinationofQAandQCactivitiesneedstooccurProcessforResolvingDisputes-InternalOnlyDiscusstheorganization'sproc