1.1.1 The degree of agreement described in 1.1 can be either for PPTMRs and PTMRs measured on the same materials, or for PPTMRs measured on basestocks and PTMRs measured on these same basestocks after constant level additivation.

1.1.2 In some cases, a two-step procedure is employed. In the first step, the analyzer and PTM are applied to the measurement of the same blendstock material. If the analyzer employed in Step 1 is a multivariate spectrophotometric analyzer, then Practice D6122 is used to access the agreement between the PPTMRs and the PTMRs for this first step. Otherwise, this practice is used to compare the PPTMRs to the PTMRs measured for this blendstock to determine the degree of agreement. In a second step, the PPTMRs produced in Step 1 are used as inputs to a second model that predicts the results obtained when the PTM is applied to the analysis of the finished blended product. Since this second step does not use analyzer readings, the validation of the second step is done independently. Step 2 is only performed on valid Step 1 results. Note that the second model might accommodate variable levels or multiple material additions to the blendstock.

1.7.1 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.

1.7.2 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.

1.10.1 The line sample procedure is the primary option for when the validation is for (2b) materials including effect from additional treatment to the material.

1.12.1 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.

1.12.2 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.

1.12.3 The validation outcome are considered valid only within the range covered by the validation material Data from several different Validations (general or level-specific) can potentially be combined for use in a General Validation.