Strategies for Addressing the Problems of Subjectivity and Uncertainty in Quality Risk Management Exercises Part I—The Role of

Problems of subjectivity and uncertainty can arise during the execution of risk management and quality risk man- agement exercises, but many existing risk management tools do not provide formal strategies for addressing such problems. The influences of what are known as human heuristics during quality risk management-related activi- ties (such as brainstorming and probability of occurrence estimation) can add to those problems. Heuristics are cognitive behaviours that can influence how individuals make judgments in the face of uncertainty, and they can be a source of significant bias and errors in judgment. The potential adverse effects of such heuristics when iden- tifying potential negative events and their probabilities of occurrence should be counteracted so that the best judgments may be made in relation to these. This paper discusses some of the most important human heuristics and how the good manufacturing practice (GMP) environment might benefit from the peer- reviewed research that has been performed in various fields on those heuristics. In this way, design elements can be incorporated into quality risk management tools that may help counteract the adverse effects of human heuristics. This has the potential to reduce the extent of guesswork in some current quality risk management activities. Several simple, practical strategies are presented that are designed to improve the outcomes of quality risk management exercises with respect to problems of subjectivity and uncertainty. Other cognitive approaches to maximize good judgments are also described. These should be useful to session facilitators to help yield more accurate analyses of risk situations.