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Components of a Quality Assurance Plan for Analytical Methods

Crystal Thomas, HPL-UMCES, cthomas@hpl.umces.edu (Presenting)
Laurie Van Heukelem, HPL-UMCES, laurievh@hpl.umces.edu (Presenting)
Stanford B Hooker, NASA-GSFC, stanford.b.hooker@nasa.gov (Presenting)

A Quality Assurance Plan (QAP) describes a process to ensure that an analytical method fulfills the agreed upon accuracy objectives at all points during the analysis of samples. A QAP includes: a) method validation, b) a description of standardized procedures, c) quality control (QC) measurements, and d) quality assessment (QA). Quality assessment quantitatively describes how results of QC measurements are used to determine whether a method is performing within expectations. A QAP provides knowledge of the uncertainties associated with measured values and, thus, provides confidence in the data products. Using an HPLC pigment analysis method as an example, we describe necessary method validation steps and show how control charts of temporally observed QC measurements are used for quality assessment. Method validation is performed before a method is used for routine analysis of samples and requires an initial understanding of the accuracy required. Thus, the method selected can be evaluated as being suitable, or not, for the intended application.


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