OOS重新取样

土豆炖西红柿

水系统OOS，根据初步调查为取样的环境问题。计划打扫环境后重新取样。各位大佬请问重新取样的计划因该如何制定。是由同一个人取样还是换另一个人取样。

留言1

5.2.3.3.5  为更好的辅助调查，推荐测试方案设计时每次检验尽可能少的改变试验影响因素，例如，为了确认试剂的影响因素，则在测试中改变试剂的同时，尽可能保持其他试验因素与首次检验相同，如，同样的样品、人员、仪器等。
For better supporting the investigation, it is recommended to change the effect factors of the test as little as possible in each test when establishing the test protocol. For example, in order to confirm the effect factors of reagents by changing reagents in the test, while the other test factors should be kept the same as the initial test as far as possible, such as the same samples, personnel, instruments etc..


5.2.5  重新取样 Re-sampling
只有在下述情况可以申请按取样规程进行重新取样。
Re-sampling  can be applied only in the following cases:
5.2.5.1  样品被全部消耗或不够复验.重新检验，重新取样应执行已批准的原取样规程。
The sample is completely consumed or insufficient for retesting. replacement testing. Re-sampling should be performed as per approved sampling procedure.
5.2.5.2  取样方法存在问题或证明先前样品不具有代表性，若原取样方法不适合，须调查该取样规程对其它批次的影响，且新的取样方法应建立、确认并形成操作规程。
The sampling procedure is found to be insufficient or there is adequate evidence that the previous samples are not representative. The impact on other batches of the sampling procedure should be investigated, and new sampling procedure should be established, verified and documented as an operation procedure.
5.2.5.3  如果仅是全部消耗或不够复验.重新检验，重新取样后，仅检验出现OOS的项目。
If re-sampling is conducted due to consumed or insufficient of sample for retesting.replacement testing, only the OOS items should be retested.
5.2.5.4  如果取样方法存在问题或证明先前样品不具有代表性，重新取样应进行所有项目的检验。
If re-sampling is conducted due to the insufficient sampling procedure or unrepresentative previous samples, the all test items should be retested.
5.2.5.5  复验.重新检验过程所需重新取样时，实验室必须说明重新取样理由，并填写《重新取样申请单》，经部门负责人进行审核，报QA经理进行审核和批准。
If re-sampling is needed during retesting.replacement testing, QC shall explain the reason for re-sampling, fill in <Re-sampling Application Form>, and submit it to QC director for review and report to QA manager for review and approval.

土豆炖西红柿

个人认为应该是控制变量。既然怀疑是环境问题。就应该是清洁后由同一人取样。但因为水样只能当天取又有点拿不准是否需要再有另一个人取样。形成对照？

有个性的乡巴佬

这个没要求吧，就算是人的问题 你这个水取样，人还能怎么乱取？往水里吐痰再取？

青水独客

两个人取，看到底是环境原因还是人，一举两得

留言1

如果确定不是人的原因，不需要更换人员取样。

晴天°皓月

既然初步调查的是取样环境问题，那就不需要换人取样了

狐年少

搞一个变量就好了，搞两个你怎么判定。

猫咪特工

同一人合适，但其实也无所谓

wood295

不需要换人取样吧

mary.ma

留言1 发表于 2022-6-3 16:24
5.2.3.3.5  为更好的辅助调查，推荐测试方案设计时每次检验尽可能少的改变试验影响因素，例如，为了确认试 ...

这段的出处在哪里

孙红红

留言1 发表于 2022-06-03 16:24
5.2.3.3.5&nbsp;&nbsp;为更好的辅助调查，推荐测试方案设计时每次检验尽可能少的改变试验影响因素，例如，为了确认试剂的影响因素，则在测试中改变试剂的同时，尽可能保持其他试验因素与首次检验相同，如，同样的样品、人员、仪器等。
For better supporting the investigation, it is recommended to change the effect factors of the test as little as possible in each test when establishing the test protocol. For example, in order to confirm the effect factors of reagents by changing reagents in the test, while the other test factors should be kept the same as the initial test as far as possible, such as the same samples, personnel, instruments etc..


5.2.5&nbsp;&nbsp;重新取样 Re-sampling
只有在下述情况可以申请按取样规程进行重新取样。
Re-sampling&nbsp;&nbsp;can be applied only in the following cases:
5.2.5.1&nbsp;&nbsp;样品被全部消耗或不够复验.重新检验，重新取样应执行已批准的原取样规程。
The sample is completely consumed or insufficient for retesting. replacement testing. Re-sampling should be performed as per approved sampling procedure.
5.2.5.2&nbsp;&nbsp;取样方法存在问题或证明先前样品不具有代表性，若原取样方法不适合，须调查该取样规程对其它批次的影响，且新的取样方法应建立、确认并形成操作规程。
The sampling procedure is found to be insufficient or there is adequate evidence that the previous samples are not representative. The impact on other batches of the sampling procedure should be investigated, and new sampling procedure should be established, verified and documented as an operation procedure.
5.2.5.3&nbsp;&nbsp;如果仅是全部消耗或不够复验.重新检验，重新取样后，仅检验出现OOS的项目。
If re-sampling is conducted due to consumed or insufficient of sample for retesting.replacement testing, only the OOS items should be retested.
5.2.5.4&nbsp;&nbsp;如果取样方法存在问题或证明先前样品不具有代表性，重新取样应进行所有项目的检验。
If re-sampling is conducted due to the insufficient sampling procedure or unrepresentative previous samples, the all test items should be retested.
5.2.5.5&nbsp;&nbsp;复验.重新检验过程所需重新取样时，实验室必须说明重新取样理由，并填写《重新取样申请单》，经部门负责人进行审核，报QA经理进行审核和批准。
If re-sampling is needed during retesting.replacement testing, QC shall explain the reason for re-sampling, fill in &lt;Re-sampling Application Form&gt;, and submit it to QC director for review and report to QA manager for review and approval.

这个是法律法规上的规定吗？如果是，请告知是什么法律法规为谢。

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小金库

谢谢分享。