生产商要设置警戒限度和措施限度。

The manufacturer should establish alert and action limits.

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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。

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

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一旦指定了方法，SOP应包含以下潜在内容：数据要求，负责设定限度的人员，用来测定每种OOT警戒的方法。

Once an approach is identified, some potential topics to be included in the SOP are data requirements, personnel responsible for setting the limits, and methods used to detect each type of OOT alert.

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