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Confirmation of Non-Standard Methods

Non-standard methods require confirmation; reconfirmation through five methods.

Confirmation can be made using one or more of the following techniques:

a) Calibrate or assess bias and precision using reference standards or standard materials.

b) Conduct a systematic review of factors affecting the outcome;

c) By altering the robustness of the control inspection method, such as the incubator temperature

Sample volume, etc.

d) Compare results with other confirmed methods.

e) Inter-laboratory Comparison

f) Assess the measurement uncertainty of the results based on an understanding of the method's principle and practical experience with sampling or testing methods.

Non-standard methods can be selected from one or all, or they can be determined by the lab itself, but they should be as comprehensive as possible, and records need to be confirmed.

Method performance characteristics may include, but are not limited to: measurement range, accuracy, measurement uncertainty of results, detection limit, quantitation limit, method selectivity, linearity, repeatability or reproducibility, robustness against external influences, or specificity against basic interferences from samples or test substances.

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