Methodology in internal quality control of chemical analysis

Abstract

Internal quality control (IQC) is an essential feature of routine analysis, serving to ensure that the uncertainty of results found during the validation of a procedure is maintained over long periods of time. The primary method of IQC is to analyse a surrogate material alongside the test materials in every run of analysis and thus address run-to-run precision (a subset of VIM3-defined ‘intermediate conditions’). This ‘control material’ must be as similar as practicable in composition to the routine test materials, although there are always some differences. Results from the control material (control values) are plotted on a control chart, and out-of-control results have to be investigated and problems rectified. Considerable care is needed in obtaining correct values of the parameters for determining statistical control limits, and these can be adequately estimated only during routine use of the analytical procedure. In contrast, target control limits have to be set on a fitness-for-purpose basis and are necessarily wider that statistical control limits. An additional type of internal quality control can be executed by the analysis of duplicate test portions of some of the actual test samples. This provides a realistic dispersion, but addresses only repeatability precision. A further complication of duplication is that the precision of results typically varies with concentration of the analyte.