By Tim Sandle

Published in: IVT Blog

Published on: January 12, 2022

INTRODUCTION It is well established that regulators do not like the root causes of deviations to conclude ‘human error’ and for the resultant corrective or preventative action (CAPA) to recommend additional training. Instead, regulators expect organizations to go deeper and to unpick the underlying reasons as to why a person made an error and, from this, error risk reduction actions can be initiated. Probing the cause of human error can be achieved through an interactive process, such as by asking ‘why’ multiple times until the answer emerges (this parallels the 5-whys technique or the repetitive questioning of a recalcitrant child).

In a paper published in the Journal of Validation Technology (“Error Risk Reduction: Concept and Case Study”) this author presented risk reduction processes centered on two case studies. The paper demonstrated why simply resorting to ‘human error’ as the root cause of an incident is often inaccurate and generally prejudicial; it also hides too much about how a system functions or malfunctions and hence prevents an appropriate preventative action from being formulated. As an adjunct to this, this article looks more closely at why human error may occur.

This article is part one of a three-part IVT series: Managing workplace error #1: Unpicking patterns of human error. Managing workplace error #2: Getting to the heart of the matter through human error checklists. Managing workplace error #3: Dissecting reasons and causes of laboratory error.

These articles are designed to help organizations to beyond the simplification of a cause as ‘human error’ and to reveal the deeper systematic underpinnings that cause things to go wrong.

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