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产品质量回顾按时完成率作为质量量度之一,将成为美国食品药品监督管理局(FDA)《质量量度要求》指南(草案)的规范。为强化质量监控,向顾客提供安全有效的产品,上海海尼药业决定将产品质量回顾按时完成率纳入公司关键绩效指标,开展QC活动。这项QC活动极大地提高了效率,报告平均完成时间缩短了一半多。而且他们采取的对策非常“接地气”。该案例对开展QC活动的小组有一定的借鉴。有兴趣的读者,不妨一读。
Product Quality Review On-time completion rates, as one of the quality measures, will be the norm for the FDA’s “Guidelines for Quality Measurement Requirements” (Draft). In order to strengthen the quality control and provide the safe and effective products to the customers, Shanghai Hainipp Pharmaceutical Co., Ltd. decided to incorporate the time completion rate of the product quality review into the key performance indicators of the company and carry out the QC activities. This QC activity has greatly increased efficiency, reducing the average reporting time by more than half. And their response is very “ground gas”. This case has some reference to the team that conducts QC activities. Interested readers, may wish to read.