首先 翻译成 质量量度 就不确切。应该是 “质量符文”。 其次，量度核心 是 卡方检验。

个人认为：OOS是指超标结果，有效的超过结果是指 样品实际就是超标的。所以无效的OOS超标率应为：无效的OOS（非样品问题造成的）/发生的OOS总数。

Invalidated Out-of-Specification (OOS) Rate = the number of OOS test results for the finished product invalidated by the establishment divided by the total number of OOS test results divided by the total number of tests performed by the establishment in the same timeframe. See FDA Guidance Request for Quality Metrics - Quality Metrics that FDA Intends to Calculate