年度質(zhì)量管理計劃(很有參考價值)

1、 QUALITY MANAGEMENT PLAN OVERVIEW Course GoalsAt the conclusion of this training, you will be able to:Explain the basic considerations for Quality System design Explain what a Quality Management Plan (QMP) is and why it is requiredDiscuss the ten elements of a QMP and the topics to cover in eachExpl

2、ain the graded approach to designing a QMPWhy Are You Here?Any organization conducting environmental programs by or on behalf of EPA must have a documented quality systemThe QMP documents that quality system You help develop a QMP.How is an organization vulnerable if inadequate data are collected?Wh

3、at Is A Quality System?A framework of management and technical practices that assure that environmental data used to support decisions are:Of adequate quality and usability for their intended purposeDefensibleCommon Steps in Quality System DesignPrepare an overview of the current organization and it

4、s environmental data operationsIdentify existing Quality System components or tools Document existing procedures as appropriateDevelop procedures where necessaryDocument the Quality System designSystem OverviewQuestions to AskHow does your organization use data (data generator, decision maker, regul

5、atory)?What is the scope of technical activities within your organization (monitoring, regulatory actions, inspections, characterizations, program oversight)?Who is responsible for planning, implementing, and assessing these technical activities?What tools are already in use or are mandated (QAPPs,

6、SOPs, TSAs)? Graded ApproachQA and QC requirements commensurate with: Importance of work Available resources Unique needs of organization Consequences of potential decision errorsTips for Design and ImplementationDont delegate responsibility for success of the Quality System too low in organization

7、In larger organizations, avoid communicating QMP requirements to everyone all at onceUse value added assessments rather than rigid audits Build success measures into the system so that you will know when it is working wellQMP Requirements Overview QMP RequirementAll work performed by EPA organizatio

8、ns and by external organizations funded by EPA that involves acquisition of environmental data generated from direct measurement activities, collected from other sources, or compiled from computerized data bases and information systems shall be covered by an Agency-approved QMP. Internal and Externa

9、l RequirementsInternal: EPA Order 5360.1 A2 2000External:48 CFR Part 46 (contracts)40 CFR Part 30, 31, and 35 (assistance agreements)Other (e.g., consent agreements in enforcement actions)QMP PurposeThe QMP documents what you are going to do, how you are going to do it, and how you know you did it.I

10、mportant TermsQuality ManagementQuality AssuranceQuality ControlScope of QMPMust reflect or emphasize actual practices, not planned practicesShould use the graded approachShould be constructed and written so its effectiveness can be assessedRevisionQMP must be kept accurate and up-to-date in accorda

11、nce with changes in QA policy and proceduresNotify all appropriate personnel about changes to quality system and QMP Revision (Contd)Internal: Submit revisions made during year to the Quality Staff with QA Annual Report and Work Plan.External: Submit revisions to the designated EPA official as a rep

12、ort when they occur. If changes are significant, submit entire QMP.General Requirements 10 QMP RequirementsManagement and OrganizationQuality System ComponentsPersonnel Qualifications and TrainingProcurement of Items and ServicesDocuments and Records 10 QMP Requirements(Contd)Computer Hardware and S

13、oftwarePlanningImplementation of Work ProcessesAssessment and ResponseQuality Improvement Approval PageApproval page signaturesManagement QA Manager of organizationQuality Staff Director (internal)Senior EPA Official for Quality (internal)Responsible EPA official (external)May be either part of titl

14、e page or separate sheet following title pageIf Not ApplicableIf element is not applicable to an organizations quality system, a statement about why it is not must be included in QMPManagement and Organization Overview: Management and OrganizationA description of:QA PolicyOrganizational structureSta

15、ff roles, responsibilities, and authorities Technical activities Dispute resolution Quality System implementationQA PolicyA statement of the organizations policy on quality assurance, including:Importance of QA and QC to organization and whyGeneral objectives/goals of Quality SystemPolicy for resour

16、ce allocation for the Quality System Organization ChartAn organization chart must:Identify all components of the organizationIdentify the position and lines of reporting for QA Manager and any QA staffShow independence of the QA Manager from groups generating, compiling, and evaluating environmental

17、 dataResponsibilities and AuthoritiesDiscuss the responsibilities and authorities of: QA Manager Any other QA staffTechnical ActivitiesDiscuss the technical activities or programs supported by the quality systemSpecific programs that require quality management controlsWhere oversight of extramural p

18、rograms is needed to assure data qualityWhere internal coordination of QA and QC activities needs to occur Process for Resolving Disputes - Internal OnlyDiscuss the organizations process for resolving disputes regarding:Quality system requirements applicabilityQA and QC procedures applicationAssessm

19、entsCorrective actionsQuality System ImplementationDiscuss how management will ensure that applicable elements of the Quality System are understood and implemented in all environmental programsQuality System Components Overview: Quality System ComponentsDiscuss principal components of Quality System

20、 and tools used to manage the system What components comprise Quality SystemWhat tools are used to manage Quality SystemWho uses them and howQuality System Components (Contd)List parts of the organization that are required to prepare QMPsDiscuss the review and approval process for QMPs from external

21、 organizationsQuality System “Tools”QMPsManagement Assessments - Self and IndependentTechnical AssessmentsSystematic PlanningStandard Operating Procedures (SOPs)Quality Assurance Project Plans (QAPPs)Data Quality AssessmentsPersonnel Qualifications and TrainingOverview: Personnel Qualification and T

22、rainingDescribe organizations process for:Establishing training requirementsIdentifying training needsAssigning training prioritiesMeeting training needs Three Areas to CoverTraining policyTraining processesCritical training documentationPolicyState the policy regarding training for management and s

23、taffProcessesDescribe processes and management/staff responsible for:Identifying statutory, regulatory, or professional certifications requiredIdentifying, designing, performing, and documenting trainingTechnicalQualityProject managementDocument TrainingDescribe how staff proficiency in critical tec

24、hnical disciplines is maintained and documentedProcurement of Items and Services Overview: Procurement of Items and ServicesDescribe organizations process for ensuring that suppliers provide items and services that:Are of known and documented qualityMeet the technical requirementsFour Areas to Cover

25、Review and approval of procurement documentsReview and approval of QA responses to solicitationsObjective evidence of adequate quality from suppliersQA document review and approval Review and Approval of Procurement Documents Describe process and responsibilities for ensuring that documentation clea

26、rly states:Item or service required Technical and quality requirements Quality System elements that the supplier is responsible forHow suppliers conformance to requirements will be verifiedReview and Approval of QA Responses to SolicitationsDescribe roles, responsibilities, and process for review an

27、d approval of responses to solicitations to ensure:That all technical and quality requirements are satisfiedThat there is adequate evidence of suppliers capability to satisfy EPA Quality System requirementsQuality From SuppliersDescribe process for determining adequate quality from suppliers, includ

28、ing:How procurement sources are evaluated and selectedHow and when source inspections are usedHow deliverables are examined for conformance to specificationsQA Document Review and ApprovalDescribe roles, responsibilities, processes and policies for:Review and approval of mandatory quality related do

29、cumentationDelegation of review and approval of mandatory quality-related documentationEnsuring that EPA quality-related contracting policies are satisfiedDocuments and RecordsOverview: Documents and RecordsDiscuss procedures for documents and records:Timely preparationReviewApprovalIssuanceUseContr

30、olRevisionMaintenance DocumentAny compilation of information that:DescribesDefinesSpecifiesReportsCertifiesRecordA completed document that provides objective evidence of an item or process.Identify Documents and RecordsDescribe or reference process for identifying quality-related documents and recor

31、ds requiring version and release controlQA-Related Documents and RecordsDescribe or reference process by which all QA-related documents and records are:AccessibleProtected from damage and deteriorationSubject to retention requirementsPrepared, reviewed, and approvedIssued and revisedComplianceDescri

32、be or reference process for ensuring compliance with all statutory, contractual, and assistance agreement requirements for records from environmental programs Computer Hardware and SoftwareOverview: Computer Hardware and SoftwareThe QMP must describe QA and QC processes for the use of computer hardw

33、are and software to support environmental data operationsGeneral RequirementsComputer hardware must be appropriate for its intended applicationComputer programs must be developed using an approved software development methodologyExamples of Hardware CoveredData acquisition/logging systemsComputers u

34、sed with analytical instrumentsAutomated sampling systems in which system failure would adversely affect quality and potential usability of collected data for decisionsExamples of Software CoveredProgramsModelsData basesData analysis systems Hardware QA and QC Processes Describe or reference process

35、 for ensuring that computer hardware used in environmental programs meets technical requirements and quality expectationsDescribe or reference how changes to hardware will be controlled to assess impact of change on performanceSoftware Development QA and QC ProcessesDescribe or reference process for

36、:Developing computer softwareValidating, verifying, and documenting software for its useAssuring that software meets requirements of userIRM Policies Describe or reference process for ensuring:That data and information produced and collected by computers meet applicable information resource manageme

37、nt requirements and standards IRM Policies That applicable EPA requirements for information resources management are addressed, including:Year 2000 compliance (Chapter 5)Security (Chapter 8)Privacy requirements (Chapter 11) PlanningOverview: PlanningDescription of process for planning environmental

38、programsDiscussion of QAPP processDiscussion of organizations secondary data policySystematic PlanningUse systematic planning process based on scientific methodApply the principle of graded approach and common sense Systematic Planning RequirementsDescribe process used for general project planning,

39、including:How it is accomplishedHow planning will be documentedWho uses planning toolsRoles and responsibilities of management and staffQuality Assurance Project Plans (QAPPs)Describe process for: DevelopingReviewingApprovingImplementingRevising the QAPPSecondary DataDiscuss process for evaluating a

40、nd qualifying secondary dataDescribe application of any statistical methods used Implementation of Work Processes Overview: Implementation of Work ProcessesDescribe process for implementing work within organizationProcedures for ensuring work is performed according to planProcedures for routine, sta

41、ndardized, special, or critical operationsProcedures for controlling and documenting the release, change, and use of planned proceduresDeveloping and Implementing ProceduresDescribe process for:Ensuring that work is performed according to planDeveloping and implementing procedures for appropriate ro

42、utine, standardized or special operations, including:Identifying operations needing proceduresPreparation of proceduresReviewing and approving proceduresPlanned ProceduresDescribe measures for controlling planned work processes or procedures:Their releaseTheir changeTheir useControlling MeasuresMeas

43、ures should provide for:Necessary approvalsSpecific times and points for implementing changesRemoval of obsolete documentation from work areaVerification that changes are made as prescribed Assessment and ResponseOverview: Assessment and ResponseDescribe:How and by whom assessments of environmental

44、programs are planned, conducted, and evaluatedProcess by which management determines:Assessment activities and tools appropriate for a particular projectExpected frequency of useExamples of Assessment ToolsManagement systems reviewsSurveillanceTechnical systems auditsPerformance evaluationsAudits of

45、 data qualityPeer reviews and technical reviewsReadiness reviewsData quality assessmentsTwo General Types of AssessmentManagement Technical Assessment ActivitiesDescribe process:For planning, conducting, and evaluating assessmentsBy which management chooses the appropriate assessment for a particula

46、r projectAssessment Activities(Contd)Describe:How frequency of assessments is determinedProcess for reporting and responding to resultsResponsibilities, levels of participation, and authorities for all management and staff participating in assessment processAssessor Qualifications Assessor qualificationsTechnically knowledgeableNo real or perceived conflict of interestAssessor AuthorityDescribe how personnel conducting assessments will have:Sufficient authorityAccess to programs and managersAccess to documents and recordsOrganizational freedomAssessment ResultsDescribe process for review of