Human Heuristics: Understanding the Impacts for Pharmaceutical Quality Risk Management

This paper addresses the influence of human heuristics (Biases) on the assessment of risk. A core principle underpinning effective Risk Management is the principle that Risk Management explicitly addresses uncertainty i.e., that it explicitly takes account of uncertainty, the nature of that uncertainty, and how it can be addressed. Heuristics are cognitive behaviours which come into play when we make judgements in the presence of uncertainty. How these behaviours are manifested is still the subject of much research, but there is evidence in the literature that heuristics are a source of significant bias and errors in judgement. Awareness of the potential adverse influences of human heuristics on the outcomes of QRM exercises, e.g., during brainstorming and other team-based decision-making activities is key to designing and implementing your QRM tools successfully.