Standard Guide for Evaluating Test Method Capability and Fitness for Use

Importancia y uso:

4.1 This guide provides the developers of test methods with systematic approaches to evaluate the inherent adequacy (capability) of the precision and the adequacy of between-laboratory standardization as determined by interlaboratory testing in accordance with Practice D6300 for a new or modified test method.

4.1.1 The tools presented in this guide can be used to assess the adequacy of the repeatability and reproducibility determined for a given test method relative to their intended applications. For those test methods with less than optimal precision, the responsible subcommittees would have an opportunity to investigate, suggest improvements in the procedure, and design an interlaboratory study as necessary. It is important to note that non-optimal precision does not necessarily imply that the test method is invalid, but that the test method may be less capable for an intended application.

4.2 This guide is applicable to test method users to evaluate the relative performance of different test methods that purport to measure the same property as applied to a specific application of the test methods.

4.3 This guide can be used to evaluate the fitness for use of a test method reproducibility relative to its intended use in specifications.

4.3.1 When test method results are intended to be compared against specification limits, this guide provides the tools to assess whether the test method’s reproducibility is expected to be fit for use relative to the stated limits.

4.4 This guide is most effective when used in conjunction with sufficient knowledge of the chemistry, instrumental technology, metrology principles, sample characteristics, and a fundamental understanding of statistical meaning and implications associated with repeatability and reproducibility of the test method being evaluated.

4.5 This guide does not cover the qualitative and business factors that might also be considered in judging a test method’s capability or fitness for use versus a specific application.

Subcomité:

D02.94

Referida por:

D6349-21, D7348-21, D4326-21, D8339-20, D6357-21B

Volúmen:

05.05

Número ICS:

75.080 (Petroleum products in general)

Palabras clave:

capability; fitness for use;