FDA-QSR820培训教材（经典）.pptVIP

章节O 统计技术 Sec.820.250 统计技术 （a） 适用时，组织应建立并实施程序，识别适当的统计技术要求，以建立、控制和验证过程能力和产品特性的可接受性。 （b） 抽样计划。适用时，基于某个适用的统计原理建立抽样计划。组织应建立并实施程序，以确保抽样的方法满足其预期的用途，并确保抽样计划更改时经评审，这些活动应形成文件。 QSIT 质量管理体系审核技术 MANAGEMENT Corrective Preventive Actions Material Controls Records/ Documents/ Change Controls Production Process Controls Design Controls Facility Equipment Controls Sterilization Process Controls Medical Device Tracking Reports of Corrections and Removals Medical Device Reporting 核心子系统 管理 设计控制 纠正与预防 MDR 纠正报告 追溯 生产过程控制 灭菌 管理子系统审核 1. Verify that a quality policy, management review and quality audit procedures, quality plan, and quality system procedures and instructions have been defined and documented. 2. Verify that a quality policy and objectives have been implemented. 3. Review the firms established organizational structure to confirm that it includes provisions for responsibilities, authorities and necessary resources. 4. Confirm that a management representative has been appointed. Evaluate the purview of the management representative. 管理子系统审核 5. Verify that management reviews, including a review of the suitability and effectiveness of the quality system, are being conducted. 6. Verify that quality audits, including re-audits of deficient matters, of the quality system are being conducted. At the conclusion of the inspection.... 7. Evaluate whether management with executive responsibility ensures that an adequate and effective quality system has been established and maintained. 设计开发子系统审核 1. Select a single design project. Note: If the project selected involves a device that contains software, consider reviewing the softwares validation while proceeding through the assessment of the firms design control system. 2. For the design project selected, verify that design control procedures that address the requirements of Section 820.30 of the regulation have been defined and documented. 3. Review the design plan for the selected project to understand the layout of the desi