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2025-04-04 11:48本頁面
【正文】 uality System design System Overview O r g . D a t a U s e T e c h n i c a l A c t i v i t i e sR e s p o n s i b i l i t y Q u a l i t y S y s t e m T o o l s U s e d N o t e s Questions to Ask ? How does your anization use data (data generator, decision maker, regulatory)? ? What is the scope of technical activities within your anization (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, SOPs, TSAs)? Graded Approach QA and QC requirements mensurate with: ? Importance of work ? Available resources ? Unique needs of anization ? Consequences of potential decision errors Tips for Design and Implementation ? Don39。t delegate responsibility for success of the Quality System too low in anization ? In larger anizations, avoid municating QMP requirements to everyone all at once ? Use value added assessments rather than rigid audits ? Build success measures into the system so that you will know when it is working well QMP Requirements Overview QMP Requirement All work performed by EPA anizations and by external anizations funded by EPA that involves acquisition of environmental data generated from direct measurement activities, collected from other sources, or piled from puterized data bases and information systems shall be covered by an Agencyapproved QMP. Internal and External Requirements ? Internal: EPA Order A2 2023 ? External: –48 CFR Part 46 (contracts) –40 CFR Part 30, 31, and 35 (assistance agreements) –Other (., consent agreements in enforcement actions) QMP Purpose ? The QMP documents what you are going to do, how you are going to do it, and how you know you did it. Important Terms ? Quality Management ? Quality Assurance ? Quality Control Scope of QMP ? Must reflect or emphasize actual practices, not planned practices ? Should use the graded approach ? Should be constructed and written so its effectiveness can be assessed Revision ? QMP must be kept accurate and uptodate in accordance with changes in QA policy and procedures ? Notify all appropriate personnel about changes to quality system and QMP Revision (Cont’d) ? 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 report when they occur. If changes are significant, submit entire QMP. General Requirements 10 QMP Requirements 1. Management and Organization 2. Quality System Components 3. Personnel Qualifications and Training 4. Procurement of Items and Services 5. Documents and Records 10 QMP Requirements (Cont39。s quality system, a statement about why it is not must be included in QMP Management and Organization Overview: Management and Organization A description of: ? QA Policy ? Organizational structure ? Staff roles, responsibilities, and authorities ? Technical activities ? Dispute resolution ? Quality System implementation QA Policy A statement of the anization39。s process for resolving disputes regarding: – Quality system requirements applicability ? QA and QC procedures application ? Assessments ? Corrective actions Quality System Implementation Discuss how management will ensure that applicable elements of the Quality System are understood and implemented in all environmental programs Quality System Components Overview: Quality System Components 1. Discuss principal ponents of Quality System and tools used to manage the system – What ponents prise Quality System – What tools are used to manage Quality System – Who uses them and how Quality Sys
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