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1·Data handling procedures, calculation checks, OOS.

数据处理程序，计算复核，OOS。

2·Do you start the OOS investigation immediately after its happening?

您是在检验数据超标情况发生之后就马上开始调查吗？

3·The AP must be in an OOS state for the initialization to be allowed.

ap必须处于oos状态才能允许对其进行初始化。

4·There should be no preconceived assumptions as to the cause of the OOS result.

不应该对OOS结果的原因进行预想的假定。

5·When an OOS happens, do you review and check if it would impact other batches?

检验数据超标情况发生时，您是否回顾并核实它会不会影响到其它批次？

6·An OOS result does not necessarily mean the subject batch fails and must be rejected.

一个OOS结果不一定就意味着批产品不合格和必须拒绝使用。

7·Appropriate testing is needed to ensure that no blending of OOS material is occurring.

合适的测试是为了确保不发生超标批次参与混粉。

8·How does your SOP for OOS define that under which conditions an averaging of results is allowed?

对于在什么情况下可对(检验)结果取平均值，您的超标检验数据(处理)程序中是怎么规定的？

9·Report to Supervisor in time when OOT & OOS were found and do further investigation if necessary.

发现OOT和OOS时，及时向领导报告，必要时作进一步的调查。

10·You did not investigate this OOS result or explain why you excluded the failing result from the official record.

你们没有对此OOS结果进行调查，也没有解释为什么你们在正式记录中排除了该不合格结果。