亚硝胺污染来源风险评估

ABSTRACT Production lots and tests with a specification range of two standard deviations will produce random rejections five percent of the time, as a result of extreme statistical variation. Techniques based on sound statistical reasoning were developed to deal with out-of-specification (OOS) test results. The temptation to bend the rules and lower the reject rate led to abuses, however. The most common of these was to test a sample repeatedly until a passing result was produced. In 1993, Barr Laboratories lost a lawsuit on this and related points and the judge's decision led to new interpretations of FDA rules, including the requirement that an investigation be initiated before a replicate sample can be tested. These rules and others incorporated into FDA guidance documents reflect a misunderstanding of important statistical principles.

​关于分析方法验证，有各种各样的指南可以参考，但是实际操作过程中，我经常被看到很多同行或者更多是新手吧，把指南中一些语句神圣化，教条化，仿佛不这么做天就会塌下来，地球就会倒回2012毁灭一样。实际这是缺乏对方法验证的基本概念的理解。这种情况在长期做分析实验的QC分析人员上比较少见，反而常见于新手QA管理人员。