AOAC SPIFAN Stakeholder Panel Meeting Book (March 12, 2020)

Four steps to evaluate method variability on assessment of product compliance 1. Determination of product specifications based on national regulations. 2. Review analytical method variability of SPIFAN methods. 3. Definition of Method Capability ( C m ). 4. Evaluation of C m and ability of method to demonstrate compliance with regulations.

5

1. Product specification range

Largest possible specification limits defined by using midpoint of regulatory requirements as true value in product and taking the highest possible declared value by setting USL = Max regulatory limits.

Specification range % =

× 200

( + )

6

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