已确定生产偏差，是否还需要发起OOS调查？

Does an OOS (OOX) examination have to be triggered if alaboratory error is ruled out and a production error has already been found anddocumented?

如果排除了实验室错误, 并且发现并记录了生产错误, 是否必须触发OOS(OOX) 检查？

If an error has occurred during production and has beendocumented, this should be recorded using the deviation system. Obviously,however, the product was still analysed - possibly with the expectation thatthe production error would not lead to an OOS. But if a (release) analysis isperformed and one result is an OOS, you need in any case to perform an OOSinvestigation. After all, there is also the possibility that the OOS result isdue to a laboratory error and your batch is within the specification despitethe production deviation!

如果在生产过程中发生了错误, 并已记录在案, 则应使用偏差系统进行记录。但是，怀着生产偏差不一定导致OOS结果的期望，仍对该产品进行了检验。但是, 如果执行了 (放行) 检验, 并且有一个结果是OOS，则在任何情况下都需要执行OOS调查。毕竟, 也有可能OOS结果是由于实验室错误, 而你的批次是合格的, 尽管有生产偏差!

OOS调查流程：