Human error, human factors and production ergonomics. A discussion from the perspective of biopharmaceutical manufacturing

Abstract

This article is drawn from a literature review into aspects of training for the biopharmaceutical manufacturing sector. One aspect explored is the apparent neglect of human factors and of production ergonomics in relation to investigations into adverse events, drug shortages and withdrawals, with an over-emphasis on human error and on inadequate training as root causes. The article is discursive in intent, drawing upon literature from other high-risk sectors such as aviation, nuclear energy and engineering. It outlines how concepts of human error, human factors and ergonomics have been differently defined and applied resulting in a dispersed understanding of how best to include them in initial and continuous training. The article ends with a brief discussion around transfer of training and asks if this concept could somehow lead to a more synthesised application of what has been learned about human factors and about ergonomics in investigations into adverse events in high-risk sectors.