1. OOS (out of specification) is the comparison of one result versus predetermined specification criteria while OOT (Out of Trend) is the comparison of many historical data values versus time.
2. OOS investigations focus on determining the truth about that one value while OOT investigations focus on understanding non-random changes.
Example:
Case-2: The result obtained 95.8 % w/w. Although the results are well within the specifications, we should compare the result with the previous batches trend. If we found the average value of the trend as 99.0 % w/w then this batch result (95.8 % w/w) is called out of trend.
2. OOS investigations focus on determining the truth about that one value while OOT investigations focus on understanding non-random changes.
Example:
The specification limit for assay is: 95.0-105.0 % w/w of label claim
Case-2: The result obtained 95.8 % w/w. Although the results are well within the specifications, we should compare the result with the previous batches trend. If we found the average value of the trend as 99.0 % w/w then this batch result (95.8 % w/w) is called out of trend.
Also see:
how to prepare OOT SOP
ReplyDeletehow i can make a report of OOT
ReplyDeletevery nice explain
ReplyDeletehow far is it from trend average to be concluded as OOT? 5%? 10%? thanks.
ReplyDeleteYes nice explain
ReplyDeleteSUPERB BLOG APPRECIATE THE EFFORTS
ReplyDeleteHi oos is rised when only based on one time test result of an analyst of a sample
ReplyDeleteGood explanation
ReplyDelete