年度質(zhì)量管理計劃(很有參考價值)(文件)
【正文】 ity from suppliers 4. QA document 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 for – How supplier39。d) ? Describe: – How frequency of assessments is determined – Process for reporting and responding to results – Responsibilities, levels of participation, and authorities for all management and staff participating in assessment process Assessor Qualifications ? Assessor qualifications – Technically knowledgeable – No real or perceived conflict of interest Assessor Authority ? Describe how personnel conducting assessments will have: –Sufficient authority –Access to programs and managers –Access to documents and records –Organizational freedom Assessment Results ? Describe process for review of assessment results ? Include: – Documentation of results – Reports to management – Management review procedures Response Actions ? Describe process for responding to findings: – How corrective actions will be taken – When they will be taken – By whom they will be taken ? Describe how effectiveness of response will be determined and documented Quality Improvement Overview: Quality Improvement ? Describe: – How anization will detect and prevent quality problems and ensure continual quality improvement – Communication of expectations about quality improvement to staff Quality Problems ? Often inherent in existing management and technical systems ? Workers by themselves have little control over eliminating these problems or improving performance ? Action is required from management to mit to quality improvement Quality Improvement Activities ? Describe management process and responsibilities for: –Identifying, planning, implementing, and evaluating quality improvement activities –Ensuring that conditions adverse to quality are identified promptly and corrected Communicating Quality Improvement ? Describe how expectations for quality improvement are municated Implementing Quality Improvement ? Identify process improvement opportunities ? Identify problems ? Offer solutions to problems Now You Can ... ?Explain what a Quality Management Plan (QMP) is and why it is required ?State the benefit of the QMP ?Describe the process and responsibilities for developing QMP within your program Now You Can Also ... ?List 10 requirements for the QMP ?Describe what must be included in each requirement Remember Use the graded approach! 。s capability to satisfy EPA Quality System requirements Quality From Suppliers ? Describe process for determining adequate quality from suppliers, including: – How procurement sources are evaluated and selected – How and when source inspections are used – How deliverables are examined for conformance to specifications QA Document Review and Approval ? Describe roles, responsibilities, processes and policies for: – Review and approval of mandatory quality related documentation – Delegation of review and approval of mandatory qualityrelated documentation – Ensuring that EPA qualityrelated contracting policies are satisfied Documents and Records Overview: Documents and Records Discuss procedures for documents and records: – Timely preparation – Review – Approval – Issuance – Use – Control – Revision – Maintenance Document Any pilation of information that: –Describes –Defines –Specifies –Reports –Certifies Record A pleted document that provides objective evidence of an item or process. Identify Documents and Records Describe or reference proc
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