4.1 The analyzer site precision is an estimate of the variability that can be expected in a UAR or a PPTMR produced by an analyzer when applied to the analysis of the same material over an extended time period.
4.2 For applications where the process analyzer system results are required to agree with results produced from an independent PTM, a mathematical function is derived that relates the UARs to the PPTMRs. The application of this mathematical function to an analyzer result produces a predicted PPTMR. For analyzers where the mathematical function, that is, a correlation, is developed by D7235, the analyzer site precision of the UARs is a required input to the computation.
4.3 After the correlation relationship between the analyzer results and primary test method results has been established, a probationary validation (see D3764 and D6122) is performed using an independent but limited set of materials that were not part of the correlation activity. This probationary validation is intended to demonstrate that the PPTMRs agree with the PTMRs to within user-specified requirements for the analyzer system application. The analyzer site precision is a required input to the probationary validation procedures.
4.3.1 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 PTM then validation is done via D3764. Practice D3764 also applies if the process stream analyzer system uses a different measurement technology from the PTM, provided that the calibration protocol for the direct output of the analyzer does not require use of the PTM.
4.3.2 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 development of the chemometric or multivariate model, then validation of the analyzer is done using Practice D6122.
4.4 The procedures described herein also serve as the basis for a process analyzer quality cont......<......
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