SOP-Q00029.03 产品质量年度审核 （联邦）.pdfVIP

文件名称 产品质量年度审核规程 文件编号 SOP-Q00029.03 /File Name Product quality annual review procedure /File No. 起草人/ 日期 审核人/ 日期 批准人/ 日期 执行/ 日期 Prepared By/Date Reviewed By/Date Approved By/Date Effective Date 1 目的 建立产品质量年度审核规程，评价产品质量的符合性，工序质量的符合性及质量 体系的符合性。 Propose: to establish an annual product quality review procedure, evaluate conformity of product quality, process steps and quality system. 2 范围 适用于公司所有生产品种。 Scope: apply to all products manufactured by the company. 3 责任 产品质量年度审核由质量管理部QA 负责； 质检部、生产车间配合年度质量审核工作； 质量管理部经理负责产品年度质量审核报告的批准。 Responsibility: QA department responsible for organizing product quality annual review; QC department and production units assist in product quality annual review; QA manager responsible for approving the product quality annual review report; 4 产品年度质量审核一年开展一次，在每年度的一月份审核上个年度的产品质量。车间QA 应 于每年2 月15 日前，汇总产品稳定性数据和有关趋势图，偏差处理与分析，台账等资料。 Quality annual review should be conducted once a year, looking through the product quality of last year in January every year. Site QA should collect stability data and trend charts, deviation handling and analysis, checklist, etc, before Feb.15th every year. 5 车间QA 汇总所有资料编制年度质量审核报告，3 月30 前完成，交质量管理部经理审批， 质量管理部经理在10 个工作日完成审批。 th Site QA should prepare the annual quality review report before Mar.30 , and then submit it to QA manager. QA manager should review and approve it within 10 workdays. 6 产品年度质量审核工作方式/ Product quality annual review method 产品年度质量审核工作应在有关资料汇总与统计的基础上，由车间QA 汇同生产车间、质 检部分析存在的问题，查找原因，针对主要原因制定措施，做好整改落实工作。 Product quality annual review should be based on gathering and statistic of relevant data. Site QA s