Methods in validating tests

The validity of a specific method should be demonstrated in laboratory experiments using samples or standards that are similar to unknown samples analyzed routinely.

The preparation and execution should follow a validation protocol, preferably written in a step-by-step instruction format.

This primer gives a review and a strategy for the validation of analytical methods for both methods developed in-house as well as standard methods, and a recommendation on the documentation that should be produced during, and on completion of, method validation.

It also describes what is important when transferring a method.

Possible steps for a complete method validation are listed in Table 1.

This proposed procedure assumes that the instrument has been selected and the method has been developed.

The AOAC (15) has developed a Peer-Verified Methods validation program with detailed guidelines on exactly which parameters should be validated.

ASTM test methods are petroleum industry standards, accepted worldwide for quality and reliability.

ASTM test methods for petroleum and refined products include: Intertek fully supports ongoing ASTM petroleum test method standard efforts, helping ensure the consistency and reliability of industry quality and testing standards. Intertek petroleum labs participate in a variety of ASTM focused round-robin testing programs worldwide, helping ensure analytical method quality and reliability.

His framework involves four decisions to consider and six strategies.

Four Decisions for Mixed Method Designs (Creswell, 2003, p.

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