Motivational mechanisms at the origin of control task violations: An analytical case study in the pharmaceutical industry

Abstract

The introduction of rules and procedures to guide front-line operators' behaviour and to decrease the frequency of errors is a growing safety strategy in complex risk systems. It is thought to be a useful way of controlling and standardising human practices and of increasing safety and quality. However, merely developing procedures does not ensure that they are followed. In this study, observation was used to collect information on procedural violations in a pharmaceutical company. Interviews were conducted with the operators and the prescriptors to better understand how and why these violations were occurring. Results showed that a small number of procedures were breached by the majority of operators and that the rules that were violated were the ones associated with a perception of minimum risk. Results suggest the rationality of operators is a response to cognitive and social influences, which must be taken into account when designing procedures. STATEMENT OF RELEVANCE: This paper is about violation and risk perception. This focus is relevant for ergonomic research and practice, taking into account the accumulation of rules and procedures that are found in work in order to improve safety. The results help to better understand the cognitive and social mechanisms underlying violations and give some insights for designing procedures.

Standard deviation? The role of perceived behavioural control in procedural violations

“…Their occurrence has been noted in a range of highrisk industries, including amongst others aviation (English and Branaghan, 2012;Wiggins et al, 2012), rail transport (Lawton, 1998), pharmaceutical manufacture (Nyssen and Côte, 2010) and medicines administration (Alper et al, 2012). Violations are rarely committed with the intention of causing harm; however, they can lead to an erosion of safety margins, thus indirectly increasing the risk of harm occurring (Reason et al, 1998;Amalberti, 2001).…”

A naturalistic decision-making perspective on anaesthetists’ rule-related behaviour

“…Procedural violationsactions that breach established working protocols or ruleshave been studied in a range of occupations (Alper & Karsh, 2009). These include aviation (English & Branaghan, 2012;Wiggins et al, 2012), rail transport (Lawton, 1998), driving (Reason et al, 1990), pharmaceutical manufacture (Nyssen & Cote, 2010) and medicines administration (Alper et al, 2012). Few violations are intended specifically to cause harm, or are a direct cause of accidents; however they can serve to reduce the operational safety margin (Reason et al, 1998).…”

The integrated assessment of occupational risks in a pharmaceutical manufacturing plant

“…Moreover because of the potential risks, safety has been the primary concern in the pharmaceutical sector, but the rash of accidents could be largely a result of smaller, less well-regulated producers appearing in the field [1].…”