Geokad
☆    

Canada,
2009-07-17 00:23
(6184 d 21:00 ago)

Posting: # 3961
Views: 3,568
 

 Incurred Samples Reproducibility (ISR) [Bioanalytics]

Hello,

I would like to know what people in here do if during the ISR, you have one or more samples which don’t confirm the original value even though that the whole test is acceptable (i.e. 2/3 are within ±15.0% but there is a value at +50%).

Does anyone here investigate this value if there is no particular trend?

Regards, Geokad
najatmughrabi
☆    

2009-07-19 10:27
(6182 d 10:55 ago)

@ Geokad
Posting: # 3969
Views: 2,863
 

 Incurred Samples Reproducibility (ISR)

Hello
It all depends upon the number of samples that were outside your acceptance criteria. Yes you need to investigate if your 1/3 OOS values were above the 30%. Good-luck. Najat

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Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Helmut]
P.S.: Do you have a reference for 1/3 > 30%?
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