Human Errors and Out-of-Specification Test Results

摘要

Out-of-specification (OOS) test results of chemical composition are results that fall outside the specifications of acceptance criteria established in the pharmaceutical industry, or do not comply with regulatory, legislative, or specification limits in other industries and fields, such as environmental and food analysis. Investigation of OOS test results is described in the U.S. FDA (Food and Drug Administration) Guidance 2006.~1 The guidance established an empirical organizational approach to investigation and decisions, which can be utilized at the different stages of investigation. When an OOS test result is identified, it is important to determine the root causes of the event and to avoid reoccurrence of such results. An investigation of the causes based on metrological concepts is proposed in the corresponding IUPAC/CITAC (Cooperation on International Traceability in Analytical Chemistry) Guide 2012.~2 This approach allows distinguishing between OOS test results, which indicate an actual change in chemical composition of an analyzed object, and OOS test results, which are metrologically related with a certain confidence probability (i.e., caused by measurement uncertainty and other metro-logical problems).