34 No. 6
||Recent IUPAC technical reports and recommendations that affect the many fields of pure and applied chemistry.
See also www.iupac.org/publications/pac
Ilya Kuselman et al.
Pure and Applied Chemistry, 2012
Vol. 84, No. 9, pp. 1939–1971
A metrological background for investigating out-of-specification (OOS) test results of chemical composition is discussed. When an OOS test result is identified, it is important to determine its root causes and to avoid reoccurrence of such results. An investigation of the causes based on metrological concepts is proposed. It includes assessment of validation data of the measurement process and its metrological traceability chains, evaluation of measurement uncertainty, and related producer’s and consumer’s risks. This approach allows distinguishing between OOS test results that indicate an actual change in chemical composition of an analyzed object, and OOS test results that are metrologically related with a certain confidence probability. Practical examples illustrating applications of the described approach in environmental and food analysis, as well in drug analysis and stability study of drug products, are described. Acceptance limits, warning and action lines for the test results, and corresponding producer’s and consumer’s risks are discussed.
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