Rethinking “Human Error” in Biopharmaceutical Manufacturing
Author: Ann Ryan, PhD Researcher, Director of Industry Engagement & Training, Innopharma Education
A recent publication from Ann Ryan, from our PhD research team explores how the biopharmaceutical industry conceptualises human error — and how this influences training, quality investigations, and regulatory responses. Despite frequent attribution of deviations and drug shortages to “human error” this review reveals a deeper issue: an over-simplification that overlooks the surrounding systemic, ergonomic, and organisational factors that shape performance.
Drawing on insights from high-risk sectors such as aviation, nuclear energy, and engineering, the study maps how human factors and production ergonomics are inconsistently understood and applied across the industry. Foundational models like Reason’s Swiss Cheese Model, Rasmussen’s Skill-Rule-Knowledge framework, and the DoD Human Factors Analysis and Classification System (HFACS) are reviewed to highlight how humans interact with complex systems — and how mistakes often reflect system design rather than individual failure.
The article also critiques how investigations, including the FDA’s 2019 Drug Shortages Task Force report, often omit consideration of human factors despite their relevance to over half of reported deviations. By contrast, sectors such as aviation have long integrated ergonomics and system thinking into root cause analysis and operator training.
Finally, the discussion turns to training transfer — the process by which learning from the classroom translates into real-world competence. Using Baldwin and Ford’s model, the article asks whether a more synthesised understanding of human factors and ergonomics could enhance the sustainability and impact of training in biopharmaceutical environments.
This research underscores a key message: improving performance and preventing failure in complex manufacturing systems requires moving beyond the label of “human error” to understand and design for the conditions under which humans work.
