{"id":6040,"date":"2026-01-22T13:07:04","date_gmt":"2026-01-22T13:07:04","guid":{"rendered":"https:\/\/www.innopharmaeducation.com\/?p=6040"},"modified":"2026-01-22T13:07:06","modified_gmt":"2026-01-22T13:07:06","slug":"rethinking-human-error-in-biopharmaceutical-manufacturing","status":"publish","type":"post","link":"https:\/\/www.innopharmaeducation.com\/blog\/rethinking-human-error-in-biopharmaceutical-manufacturing","title":{"rendered":"Rethinking \u201cHuman Error\u201d in Biopharmaceutical Manufacturing"},"content":{"rendered":"\n<p class=\"has-small-font-size\">Author: <strong>Ann Ryan<\/strong>,<strong> <\/strong>PhD Researcher, Director of Industry Engagement &amp; Training, Innopharma Education<\/p>\n\n\n\n<p>A recent publication from Ann Ryan, from our PhD research team explores how the biopharmaceutical industry conceptualises human error \u2014 and how this influences training, quality investigations, and regulatory responses. Despite frequent attribution of deviations and drug shortages to \u201chuman error\u201d this review reveals a deeper issue: an over-simplification that overlooks the surrounding systemic, ergonomic, and organisational factors that shape performance.<\/p>\n\n\n\n<p>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\u2019s Swiss Cheese Model, Rasmussen\u2019s Skill-Rule-Knowledge framework, and the DoD Human Factors Analysis and Classification System (HFACS) are reviewed to highlight how humans interact with complex systems \u2014 and how mistakes often reflect system design rather than individual failure.<\/p>\n\n\n\n<p>The article also critiques how investigations, including the FDA\u2019s 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.<\/p>\n\n\n\n<p>Finally, the discussion turns to training transfer \u2014 the process by which learning from the classroom translates into real-world competence. Using Baldwin and Ford\u2019s 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.<\/p>\n\n\n\n<p>This research underscores a key message: improving performance and preventing failure in complex manufacturing systems requires moving beyond the label of \u201chuman error\u201d to understand and design for the conditions under which humans work.<\/p>\n\n\n\n<p><a href=\"https:\/\/arrow.tudublin.ie\/level3\/vol20\/iss1\/7\/\" target=\"_blank\" rel=\"noopener\">Read the full paper here &gt;&gt;<\/a><\/p>\n\n\n\n<h4 class=\"wp-block-heading\"><a id=\"_msocom_1\"><\/a><\/h4>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:33.33%\"><\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Author: Ann Ryan, PhD Researcher, Director of Industry Engagement &amp; Training, Innopharma Education A recent publication from Ann Ryan, from our PhD research team explores how the biopharmaceutical industry conceptualises human error \u2014 and how this influences training, quality investigations, and regulatory responses. Despite frequent attribution of deviations and drug shortages to \u201chuman error\u201d this [&hellip;]<\/p>\n","protected":false},"author":11,"featured_media":5099,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[25],"tags":[38,61,37,36],"class_list":["post-6040","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blog","tag-ai","tag-pharma","tag-pharmaceuticals","tag-research"],"_links":{"self":[{"href":"https:\/\/www.innopharmaeducation.com\/wp-json\/wp\/v2\/posts\/6040","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.innopharmaeducation.com\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.innopharmaeducation.com\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.innopharmaeducation.com\/wp-json\/wp\/v2\/users\/11"}],"replies":[{"embeddable":true,"href":"https:\/\/www.innopharmaeducation.com\/wp-json\/wp\/v2\/comments?post=6040"}],"version-history":[{"count":3,"href":"https:\/\/www.innopharmaeducation.com\/wp-json\/wp\/v2\/posts\/6040\/revisions"}],"predecessor-version":[{"id":6046,"href":"https:\/\/www.innopharmaeducation.com\/wp-json\/wp\/v2\/posts\/6040\/revisions\/6046"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.innopharmaeducation.com\/wp-json\/wp\/v2\/media\/5099"}],"wp:attachment":[{"href":"https:\/\/www.innopharmaeducation.com\/wp-json\/wp\/v2\/media?parent=6040"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.innopharmaeducation.com\/wp-json\/wp\/v2\/categories?post=6040"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.innopharmaeducation.com\/wp-json\/wp\/v2\/tags?post=6040"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}