OOS的统计判定策略及国内常见问题探讨

Discussion on the statistical decision strategy of out-of-specification(OOS) and the common problems in China

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.