年度质量管理计划(很有参考价值).ppt
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- 年度 质量管理 计划 参考 价值
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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 required Discuss the ten elements of a QMP and the topics to cover in each Expla
2、in 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?Wha
3、t 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 purposeDefensibleComputer Hardware/SoftwarePersonnel Qualifications/TrainingQuality ImprovementAssessmentImpl
4、ementation of Work Processes PlanningProcurementRecords/DocumentationQuality System Description Management/OrganizationEnvironmental Data OperationsAdequate Data QualityCommon Steps in Quality System DesignPrepare an overview of the current organization and its environmental data operationsIdentify
5、existing Quality System components or tools Document existing procedures as appropriateDevelop procedures where necessaryDocument the Quality System designSystem OverviewOrg.Data Use Technical ActivitiesResponsibilityQuality System Tools Used Notes Questions to AskHow does your organization use data
6、(data generator,decision maker,regulatory)?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
7、 use or are mandated(QAPPs,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
8、too low in organization 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 perfo
9、rmed by EPA organizations 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.
10、Internal and External 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 y
11、ou did it.Important 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
12、in accordance 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 a
13、s a report when they occur.If changes are significant,submit entire QMP.General Requirements 10 QMP Requirements1.Management and Organization2.Quality System Components3.Personnel Qualifications and Training4.Procurement of Items and Services5.Documents and Records 10 QMP Requirements(Contd)6.Comput
14、er Hardware and Software7.Planning8.Implementation of Work Processes9.Assessment and Response10.Quality Improvement Approval PageApproval page signaturesManagement QA Manager of organizationQuality Staff Director(internal)Senior EPA Official for Quality (internal)Responsible EPA official(external)Ma
15、y be either part of title 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 PolicyOrgan
16、izational structureStaff 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 Syst
17、emPolicy for resource 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 evaluat
18、ing environmental 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
19、 of extramural programs 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 appl
20、icationAssessmentsCorrective 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 Components1.Discuss principal components of
21、 Quality System 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)2.List parts of the organization that are required to prepare QMPs3.Discuss the review and approval process for
22、QMPs from external organizationsORGANIZATION/PROGRAMPROJECTPOLICY/REGULATIONSDefensible Products and DecisionsEPA Program&Regional PolicyExternal PoliciesContracts-48 CFR 46Assistance Agreements-40 CFR 30,31,and 35Internal EPA PoliciesEPA Order 5360.1EPA Manual 5360Consensus StandardsANSI/ASQC E4ISO
23、 9000 SeriesAnnual Review and Planning(e.g.,QAARW P)System sAssessm ents(e.g.,QSAs)Quality SystemDocum entation(e.g.,QMP)Training/Communication(e.g.,Training Plan,Conferences)Supporting System Elements(e.g.,Procurements,Computer Hardware/Software)TechnicalAssessmentsIMPLEMENTATIONPLANNINGASSESSMENTC
24、onduct Study/ExperimentQA Project PlanSystematicPlanning(e.g.,DQO Process)StandardOperatingProceduresData QualityAssessmentData Verification&ValidationQuality System“Tools”QMPsManagement Assessments-Self and IndependentTechnical AssessmentsSystematic PlanningStandard Operating Procedures(SOPs)Qualit
25、y Assurance Project Plans(QAPPs)Data Quality AssessmentsPersonnel Qualifications and TrainingOverview:Personnel Qualification and TrainingDescribe organizations process for:Establishing training requirementsIdentifying training needsAssigning training prioritiesMeeting training needs Three Areas to
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