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1·Setting data-driven OOT alert limits in such situations may not be possible.

在这种情况下，不可能设置数据驱动的OOT警戒线。

2·The methods for detecting OOT results may vary depending on the type of OOT alert.

确定OOT结果的方法可以根据OOT警戒类型的不同而有所不同。

3·Periodic review of limits. SOPs may specify a periodic review process for OOT alert limits.

限度的周期审核：SOP可以规定OO T警戒限的一个周期性审核程序。

4·A conclusion can only be reached after the investigation of OOT stability data that follows.

只有接下来对OOT稳定性数据进行调查以后才可以做出结论。

5·A review of the OOT alert procedures' performance might coincide with the annual product review.

OOT警戒程序执行情况的审核可能符合年度产品审核。

6·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。

7·The investigation's depth required for each OOT alert will depend on potential risks to product quality.

每个OOT警戒调查的程度取决于对产品质量的潜在风险。

8·This assessment can involve identifying a previous result that was once within trend but is now an OOT result.

这个评估包括识别一个以前的结果，该结果曾经符合趋势，但现在是OOT。

9·OOT alerts can be classified into three categories to help identify the appropriate depth for an investigation.

OOT警戒可以分为三种类型，用来确定调查的适当程度。

10·It is natural that earlier conclusions be revised in light of new information because developing OOT alert criteria is an active and continuing process.

早期的结论根据新的标准被修订是很自然的事情，因为OOT警戒标准的开发是一个主动持续的过程。