摘要
针对目前国内药品检测实验室在不合格项(OOS)管理中存在的短板,利用示例演示,介绍了OOS管理中常用的2个统计分析工具——控制图和Pareto图。运用控制图,可对同一产品的长期检测结果进行异常趋势(OOT)预测和OOS分析;运用Pareto图可对实验室内众多OOS原因进行主因辨识和分析,从而有的放矢地进行纠正和预防。控制图和Pareto图是实验室质量管理工作所必备的2款简便高效的统计工具。
Aiming at solving the shortcomings existing in out-of-specification(OOS)evaluation in domestic drug testing laboratories,this paper introduces two commonly used statistical tools,control chart and Pareto chart,with examples.Control chart could be used for out-of-trend(OOT)prediction and OOS analysis based on test results of the same product over time.Pareto chart could be used to identify and analyze the main causes of OOS in the laboratory so that corrective and preventive actions may be taken.Control chart and Pareto chart are two simple,efficient,but essential statistical tools for laboratory quality management.
作者
李娜
冯国双
段丽
谭德讲
许卉
LI Na;FENG Guo-shuang;DUAN Li;TAN De-jiang;XU Hui(Yantai University;National Institutes for Food and Drug Control;Center of Clinical Epidemiology and Evidence Based Medicine,Beijing Children’s Hospital,Capital Medical University)
出处
《中国食品药品监管》
2021年第6期40-47,共8页
China Food & Drug Administration Magazine
基金
中国食品药品检定研究院质量安全和能力建设项目。
