2 replies to this topic

[Qasim Abbasi]

I have been asked by auditor that how do You validate your method .i have told him we use AOAC method and i thing AOAC methods do not need validation but auditor give me Observation that there is no formal procedure of validation. could someone guide me how to validate the AOAC method

[Charles.C]

I have been asked by auditor that how do You validate your method .i have told him we use AOAC method and i thing AOAC methods do not need validation but auditor give me Observation that there is no formal procedure of validation. could someone guide me how to validate the AOAC method

Dear gasimabbasi,

I agree with you that normally A.O.A.C. methods are regarded as a primary reference. IMO yr auditor is nitpicking.

It may depend on the specific procedure but I think many of the listed methods in the main manual include a reference (after the method) to the work which established the item, especially if it's their own data when an article in their own journal J.O.A.C. will be linked.

From memory, AOAC also publish standard generic procedures for use in validating their published methods. For example, the one for recommended microbiological, pathogen detection media is on this forum (somewhere).

Rgds / Charles.C

[RAJEEV SANKAR]

Dear Qasim,

Though an international method like AOAC doesn't require a validation, one can prepare an internal validation report for presenting to an auditor. You can conduct the repeatability, reproducibility, spike recovery test etc. to assess the precision and accuracy of a test result based on the AOAC method.

Repeatability ---> Same test conducted by multiple analyst and values are correlated for closeness
Reproducibility ----> Same test conducted multiple times by the same analyst.
Precision ------> Degree of closeness of a set of results. More closer the set of values of a test, more the precision.
Accuracy --------> Degree of deviation from the true value. Lesser the variation from the true value, more accurate the result is

An accurate result doesn't need to be precise and viceversa.


Thanks & Regards
Rajeev Sankar

I have been asked by auditor that how do You validate your method .i have told him we use AOAC method and i thing AOAC methods do not need validation but auditor give me Observation that there is no formal procedure of validation. could someone guide me how to validate the AOAC method