摘要
对产品是否为不合格项(OOS)的准确判定,特别是对其测量属性接近其质量限的边缘产品的判定,是非常具有挑战性的问题。它不仅是质量控制中不可或缺的内容,更是检测实验室的能力体现。本文结合国际上合格性判定的相关法规和指导原则,从统计的不确定度和风险评估等角度,探讨了判断边缘产品是否属于OOS的几个基本前提要素,分析了目前国内在边缘产品的OOS判定中存在的常见问题,并用实例系统地阐述了相关判定策略,以期为今后OOS的科学判定提供依据。
Accurate determination is a particularly challenging issue whether a product is an OOS or not,especially when it is an edge product which the measurand is close to the specification limit. It is not only an indispensable part in quality control system,but also an indicator showing the ability of the testing laboratory. Based on the relevant regulations and guiding principles of international conformance decision,this paper discusses the premise elements to judge whether edge products belong to OOS or not from the perspectives of statistical(measurement uncertainty) and risk assessment,the common problems existing in the OOS decision of edge products in China,and also the systematically expounds the relevant decision strategies with examples,so as to provide the basis for the scientific decision of OOS in the future.
作者
李娜
马莉
谭德讲
许卉
LI Na;MA Li;TAN De-jiang;XU Hui(National Institutes for Food and Drug Control,Beijing 102629,China;Yantai University,Yantai 264003,China)
出处
《药物分析杂志》
CAS
CSCD
北大核心
2019年第10期1915-1920,共6页
Chinese Journal of Pharmaceutical Analysis
基金
北京市科技计划课题资助项目(Z151100000115013)
关键词
不合格项(OOS)
质量限
警戒区间
测量不确定度
严格接受标准
宽松接受标准
决策规则
out-of-specification(OOS)
specification limit
guard band
measurement uncertainty
stringent acceptance standard
relaxed acceptance standard
decision rule