9.3 : 品質保証

Quality assurance is the collective term for the series of activities implemented to ensure the proper performance of a method.

Quality assurance comprises three types of cyclical activities: quality control, quality assessment, and internal corrective measures.

While quality control is performed before and during the analysis, quality assessment is performed during and after. The outcome of the quality assessment decides whether an analysis modification is required. These internal corrections are done after or before the analysis.

The quality assurance processes begin with making clear and concise use objectives for which the analysis result will be used.

The second process is drafting the analysis specifications and expected results. This includes details on sampling, blank tests, calibration checks, quality control checks, accuracy, precision, detection limit, selectivity, sensitivity, robustness, and the rate of false results.

The final process involves assessing whether the results meet the specifications and use objectives.