年度質(zhì)量管理計(jì)劃(很有參考價(jià)值)-wenkub
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【正文】 Quality System implementation QA Policy A statement of the anization39。 QUALITY MANAGEMENT PLAN OVERVIEW Course Goals At 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 – Explain the graded approach to designing a QMP Why Are You Here? ? Any anization conducting environmental programs by or on behalf of EPA must have a documented quality system ? The QMP documents that quality system You help develop a QMP. How is an anization vulnerable if inadequate data are collected? What 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 purpose ? Defensible C o m p u t e r H a r d w a r e / S o f t w a r eP e r s o n n e l Q u a l i f i c a t i o n s / T r a i n i n gQ u a l i t y I m p r o v e m e n tA s s e s s m e n tI m p l e m e n t a t i o n o f W o r k P r o c e s s e s P l a n n i n gP r o c u r e m e n tR e c o r d s / D o c u m e n t a t i o nQ u a l i t y S y s t e m D e s c r i p t i o n M a n a g e m e n t / O r g a n i z a t i o nE n v i r o n m e n t a l D a t a O p e r a t i o n sA d e q u a t e D a t a Q u a l i t y Common Steps in Quality System Design ? Prepare an overview of the current anization and its environmental data operations ? Identify existing Quality System ponents or tools ? Document existing procedures as appropriate ? Develop procedures where necessary ? Document the Quality 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。s policy on quality assurance, including: –Importance of QA and QC to anization and why –General objectives/goals of Quality System ? Policy for resource allocation for the Quality System Organization Chart ? An anization chart must: –Identify all ponents of the anization –Identify the position and lines of reporting for QA Manager and any QA staff –Show independence of the QA Manager from groups generating, piling, and evaluating environmental data Responsibilities and Authorities Discuss the responsibilities and authorities of: ? QA Manager ? Any other QA staff Technical Activities ? Discuss the technical activities or programs supported by the quality system – Specific programs that require quality management controls – Where oversight of extramural programs is needed to assure data quality – Where internal coordination of QA and QC activities needs to occur Process for Resolving Disputes Internal Only Discuss the anization39。s process for ensuring that suppliers provide items and services that: – Are of known and documented quality – Meet the technical requirements Four Areas to Cover 1. Review and approval of procurement documents 2. Review and approval of QA responses to solicitations 3. Objective evidence of adequate qual
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