Over deze norm
1.1 This 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).
1.2 This 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.
1.3 This 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.
1.4 This 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).
1.5 This 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).
1.6 Performance 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.
1.6.1 For analyzers used in product release or product quality certification applications, the precision and bias requirement for the degree of agreement are typically based on the site or published precision of the Primary Test Method.
1.6.2 This practice does not describe procedures for establishing precision and bias requirements for analyzer system applications. Such requirements must be based on the criticality of the results to the intended business application and on contractual and regulatory requirements. The user must establish precision and bias requirements prior to initiating the validation procedures described herein.
1.11 Two 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.
1.11.1 General Validation is based on the statistical principles and methodology of Practice D6708. In most cases, General Validation is preferred, but may not always be possible if the variation in validation materials is insufficient. General Validation will validate analyzer operation over a wider operating range than Level Specific Validation.
1.11.2 When the variation in available validation materials is insufficient to satisfy the requirements of Practice D6708, a Level Specific Validation is done to validate analyzer operation over a limited range.
|Engelse titel||Standard Practice for Validation of the Performance of Process Stream Analyzer Systems|