ASTM D 3764 : 2023

1.1This practice describes procedures and methodologies based on the statistical principles of Practice D6708 to validate whether the degree of agreement between the results produced by a total analyzer system (or its subsystem), versus the results produced by an independent test method that purports to measure the same property, meets user-specified requirements. This is a performance-based validation, to be conducted using a set of materials that are not used a priori in the development of any correlation between the two measurement systems under investigation. A result from the independent test method is herein referred to as a Primary Test Method Result (PTMR).

1.2This practice assumes any correlation necessary to mitigate systemic biases between the analyzer system and PTM have been applied to the analyzer results. See Guide D7235 for procedures for establishing such correlations.

1.3This practice assumes any modeling techniques employed have the necessary tuning to mitigate systemic biases between the analyzer PPTMR and PTMR have been applied to the model results. Model form and tuning is not covered by this practice, only the validation of the model output.

1.4This practice requires that both the primary method against which the analyzer is compared to, and the analyzer system under investigation, are in statistical control. Practices described in Practice D6299 should be used to ensure this condition is met.

1.5This practice applies if the process stream analyzer system and the primary test method are based on the same measurement principle(s), or, if the process stream analyzer system uses a direct and well-understood measurement principle that is similar to the measurement principle of the primary test method. This practice also applies if the process stream analyzer system uses a different measurement technology from the primary test method, provided that the calibration protocol for the direct output of the analyzer does not require use of the PTMRs (see Case 1 in Note 1).

1.6This practice does not apply if the process stream analyzer system utilizes an indirect or mathematically modeled measurement principle such as chemometric or multivariate analysis techniques where PTMRs are required for the chemometric or multivariate model development. Users should refer to Practice D6122 for detailed validation procedures for these types of analyzer systems (see Case 2 in Note 1).

1.7Performance Validation is conducted by calculating the precision and bias of the differences between results from the analyzer system (or subsystem) after the application of any necessary correlation, (such results are herein referred to as Predicted Primary Test Method Results (PPTMRs)), versus the PTMRs for the same sample set. Results used in the calculation are for samples that are not used in the development of the correlation. The calculated precision and bias are statistically compared to user-specified requirements for the analyzer system application.

1.8Two procedures for validation are described: the line sample procedure and the validation reference material (VRM) injection procedure.

1.9Only the analyzer system or subsystem downstream of the VRM injection point or the line sample extraction point is being validated by this practice.

1.10The line sample procedure is limited to applications where material can be safely withdrawn from the sampling point of the analyzer unit without significantly altering the property of interest.

1.11Validation information obtained in the application of this practice is applicable only to the type and property range of the materials used to perform the validation.

1.12Two types of validation are described: General Validation, and Level Specific Validation. These are typically conducted at installation or after major maintenance once the system mechanical fitness-for-use has been established.

1.13Procedures for the continual validation of system performance are described. These procedures are typically applied at a frequency commensurate with the criticality of the application.

1.14This practice does not address procedures for diagnosing causes of validation failure.

1.15This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.

1.16This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.