Association of Analytical Communities validation study data - How deep should I go?

jbreen said:

We have recently established a quality system in our R&D Lab (Brown Forman, alcoholic beverage production) which is modeled after ISO17025. I am currently considering the extent to which our lab should "validate" or "verify" the methods/testing that our quality system covers.

For the in-house methods that reference AOAC methods, my initial intention was to rely on the AOAC validation study results thereby needing no further validation to be performed here in our lab. We did perform repeatability (4 analysts analyzing 6 reps of 4 sample types for each method) and reproducibility (1 analyst performing 30 reps for each method) studies. We are also currently coordinating a co-lab study with some of our QC Labs.

I have requested copies of the JAOAC journals referenced which I am assuming will hold the AOAC validation study data.

I am considering the need to perform verification studies. In that way we could cover for the slight modifications we made to the official AOAC methods in some cases and we would have evidence that the method is valid for the matrices and concentrations we are testing.

How deep should you go to prove that a method is suitable for the intended purpose?

Thanks,
Jenny Breen
Brown-Forman
R&D Quality Manager

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