Managing Workplace
Error Part 1: Unpicking Patterns Of Human Error
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).
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 actions from being formulated. As an adjunct to this, this article
looks more closely at why human error may occur.
Sandle,
T. (2022) Managing Workplace Error Part 1: Unpicking Patterns Of Human Error, IVT
Network, at: https://www.ivtnetwork.com/article/managing-workplace-error-part-1-unpicking-patterns-human-error
Managing Workplace
Error #2: Getting to the Heart of the Matter Through Human Error Checklists
In terms of how
human error can be defined, then one potentially useful definition of human
errors is as “any member of a set of human actions that exceed some limit of
acceptability, i.e., an out-of-tolerance action, where the limits of tolerable
performance are defined by the system”. In other words, an outcome that was not
intended or desired. At first glance the cause of a human error may seem
straightforward, all too often followed by the hasty conclusion that training
or retraining can fix the issue. However, ‘human error’ is very rarely the root
cause and instead a more detailed and iterative human error root cause analysis
investigation will more often reveals a deeper issue at the heart of the matter
and allows for an appropriate preventative action to be set.

This article looks
at a process of defining human error and provides some guidance on constructing
a checklist for getting to the root of the error. In following this method,
there are very few cases of actual human error; instead, there is typically a
fault with a system, procedure, knowledge, or with the environment within which
the error occurred.
Sandle,
T. (2022) Managing Workplace Error #2: Getting to the Heart of the Matter
Through Human Error Checklists, IVT Network, at: https://www.ivtnetwork.com/article/managing-workplace-error-2-getting-heart-matter-through-human-error-checklists
Managing Workplace
Error #3: Dissecting Reasons and Causes of Laboratory Error
This article looks
at some of the reasons for, and patterns behind, laboratory errors. The article
represents a brief look into the subject area, drawing on some of the issues
that the author is aware of. Generally, laboratory errors should not be
categorized as "human error" since these are not the problem but
generally a symptom of a system or facility or operation. By delving deeper
into the nature of the event (using techniques to get to the real cause of the
problem) more meaningful CAPAs can be developed, CAPAs with a stronger chance
of remedying the problems first time. Hence an important focus is to seek a
significant reduction of repeat observations. This should lead to improved laboratory
efficiency supported by right first-time testing and control.
Sandle,
T. (2022) Managing Workplace Error #3: Dissecting Reasons and Causes of
Laboratory Error, IVT Network, at: https://www.ivtnetwork.com/article/managing-workplace-error-3-dissecting-reasons-and-causes-laboratory-error
Posted by Dr. Tim Sandle,
Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)