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
26、Cover1.Training policy2.Training processes3.Critical training documentationPolicyState the policy regarding training for management and staffProcessesDescribe processes and management/staff responsible for:Identifying statutory,regulatory,or professional certifications requiredIdentifying,designing,
27、performing,and documenting trainingTechnicalQualityProject managementDocument TrainingDescribe how staff proficiency in critical technical disciplines is maintained and documentedProcurement of Items and Services Overview:Procurement of Items and ServicesDescribe organizations process for ensuring t
28、hat suppliers provide items and services that:Are of known and documented qualityMeet the technical requirementsFour Areas to Cover1.Review and approval of procurement documents2.Review and approval of QA responses to solicitations3.Objective evidence of adequate quality from suppliers4.QA document
29、review and approval Review and Approval of Procurement Documents Describe process and responsibilities for ensuring that documentation clearly states:Item or service required Technical and quality requirements Quality System elements that the supplier is responsible forHow suppliers conformance to r
30、equirements will be verifiedReview and Approval of QA Responses to SolicitationsDescribe roles,responsibilities,and process for review and approval of responses to solicitations to ensure:That all technical and quality requirements are satisfiedThat there is adequate evidence of suppliers capability
31、 to satisfy EPA Quality System requirementsQuality From SuppliersDescribe process for determining adequate quality from suppliers,including:How procurement sources are evaluated and selectedHow and when source inspections are usedHow deliverables are examined for conformance to specificationsQA Docu
32、ment Review and ApprovalDescribe roles,responsibilities,processes and policies for:Review and approval of mandatory quality related documentationDelegation of review and approval of mandatory quality-related documentationEnsuring that EPA quality-related contracting policies are satisfiedDocuments a
33、nd RecordsOverview:Documents and RecordsDiscuss procedures for documents and records:Timely preparationReviewApprovalIssuanceUseControlRevisionMaintenance DocumentAny compilation of information that:DescribesDefinesSpecifiesReportsCertifiesRecordA completed document that provides objective evidence
34、of an item or process.Identify Documents and RecordsDescribe or reference process for identifying quality-related documents and records requiring version and release controlQA-Related Documents and RecordsDescribe or reference process by which all QA-related documents and records are:AccessibleProte
35、cted from damage and deteriorationSubject to retention requirementsPrepared,reviewed,and approvedIssued and revisedComplianceDescribe or reference process for ensuring compliance with all statutory,contractual,and assistance agreement requirements for records from environmental programs Computer Har
36、dware and SoftwareOverview:Computer Hardware and SoftwareThe QMP must describe QA and QC processes for the use of computer hardware and software to support environmental data operationsGeneral RequirementsComputer hardware must be appropriate for its intended applicationComputer programs must be dev
37、eloped using an approved software development methodologyExamples of Hardware CoveredData acquisition/logging systemsComputers used with analytical instrumentsAutomated sampling systems in which system failure would adversely affect quality and potential usability of collected data for decisionsExam
38、ples of Software CoveredProgramsModelsData basesData analysis systems Hardware QA and QC Processes Describe or reference process for ensuring that computer hardware used in environmental programs meets technical requirements and quality expectationsDescribe or reference how changes to hardware will
39、be controlled to assess impact of change on performanceSoftware Development QA and QC ProcessesDescribe or reference process for:Developing computer softwareValidating,verifying,and documenting software for its useAssuring that software meets requirements of userIRM Policies Describe or reference pr
40、ocess for ensuring:1.That data and information produced and collected by computers meet applicable information resource management requirements and standards IRM Policies 2.That applicable EPA requirements for information resources management are addressed,including:Year 2000 compliance(Chapter 5)Se
41、curity(Chapter 8)Privacy requirements(Chapter 11)PlanningOverview:PlanningDescription of process for planning environmental programsDiscussion of QAPP processDiscussion of organizations secondary data policySystematic PlanningUse systematic planning process based on scientific methodApply the princi
42、ple of graded approach and common sense Systematic Planning RequirementsDescribe process used for general project planning,including:How it is accomplishedHow planning will be documentedWho uses planning toolsRoles and responsibilities of management and staffQuality Assurance Project Plans(QAPPs)Des
43、cribe process for:DevelopingReviewingApprovingImplementingRevising the QAPPSecondary DataDiscuss process for evaluating and qualifying secondary dataDescribe application of any statistical methods used Implementation of Work Processes Overview:Implementation of Work ProcessesDescribe process for imp
44、lementing work within organizationProcedures for ensuring work is performed according to planProcedures for routine,standardized,special,or critical operationsProcedures for controlling and documenting the release,change,and use of planned proceduresDeveloping and Implementing ProceduresDescribe pro
45、cess for:Ensuring that work is performed according to planDeveloping and implementing procedures for appropriate routine,standardized or special operations,including:Identifying operations needing proceduresPreparation of proceduresReviewing and approving proceduresPlanned ProceduresDescribe measure
46、s for controlling planned work processes or procedures:Their releaseTheir changeTheir useControlling MeasuresMeasures should provide for:Necessary approvalsSpecific times and points for implementing changesRemoval of obsolete documentation from work areaVerification that changes are made as prescrib
47、ed Assessment and ResponseOverview:Assessment and ResponseDescribe:How and by whom assessments of environmental programs are planned,conducted,and evaluatedProcess by which management determines:Assessment activities and tools appropriate for a particular project Expected frequency of useExamples of
48、 Assessment ToolsManagement systems reviewsSurveillanceTechnical systems auditsPerformance evaluationsAudits of data qualityPeer reviews and technical reviewsReadiness reviewsData quality assessmentsTwo General Types of Assessment1.Management 2.Technical Assessment ActivitiesDescribe process:For pla
49、nning,conducting,and evaluating assessmentsBy which management chooses the appropriate assessment for a particular projectAssessment Activities(Contd)Describe:How frequency of assessments is determinedProcess for reporting and responding to resultsResponsibilities,levels of participation,and authori
50、ties 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 m
