OOS-OOT

Submitted by atulvek on Thu, 07/02/2009 - 10:46
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What is an OOT results?
What is the difference between OOS and OOT result?
How to handle OOT results vs. OOS investigation?
Can we release a batch even if the OOT result can not be resolved?

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OOS-OOT

Submitted by sekharnchandra on Thu, 07/02/2009 - 12:00.

OOS -Out of Specification, OOT- Out of Trend.
Eg:
The specification limit of an impurity is : Not More than 0.1%,
Case-1: For a particular batch, the result obtained 0.11% ----This result is out of the specification limit. This is called OOS. Investigation is required. Fish bone diagram is used for OOS investigation. After identification of the root cause, corrective and preventive measures to be taken.

Case-2: The result obtained 0.08%. Although the results is well within the specifications, we should compare the result with the previous batches trend. If we found the average value of the trend as 0.05%, then this batch result (0.05%) is called out of trend.
After identifying the root cause, we can approve the batch.
OOT to be dealt on case-by-case approach. We need to have an understanding and control on the process.

Please feel free for any questions.

Thanks
Chandra Sekhar
ASQ-Certified Quality Auditor
Manager.