Human Error: What Pharma Should Know And Do About It — Part One


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By Anna Rose Welch, Editor, Biosimilar Development
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Human Error: What Pharma Should Know And Do About It — Part One

When it comes to determining the underlying cause of a breach in good manufacturing practices, industry often falls back on human error and looks no farther into the matter. However, as Life Science Training Institute’s expert Joanna Gallant describes, retraining employees is only going to go so far and, more often than not, will not even be the appropriate CAPA for the issue. In part one of this four-part series, Gallant discusses where the industry currently stands in identifying the root cause of a problem, as well as the extent to which industry turns to human errors as an explanation.

ARWelch: Have there been changes in how industry is viewing/defining/addressing human error? Has this affected the number of cases?

Joanna Gallant: As an industry, we’re starting to make some headway into looking deeper into human error situations, but it’s still a challenge.

Over the years, many processes that had seen deviations were “band-aided” repeatedly instead of being assessed and reworked. The patches hide the fact that there’s still a problem, serving to complicate the process while allowing the issues to continue. Eventually, the situation worsens; the “band-aid” no longer works or the process gets very complex, causing additional errors and making it an even more complex problem to fix.

Sometimes it’s done as a business decision, for instance deciding to run a piece of equipment to failure before replacing it. Other times, we implement a short-term solution in order to continue a process, intending to revisit the situation after the crisis is averted. However, too often something else takes its place as a priority and that follow-up doesn’t occur. The short of it is that the appropriate CAPA isn’t identified.

Worse, the situation often gets attributed to “human error,” claiming it must have simply been the operator who made the mistake, because others have been able to execute the process correctly before them. We view this as an easier fix — retraining, anyone? — and it keep us from having to admit that other resources are an issue.

This is why regulatory agencies are now pushing industry to do better with identifying and fixing the issues versus calling every issue that involves a person a “human error”. Along with evaluating the effectiveness of our CAPAs, this mindset is intended to drive the reduction of human error situations.

Despite this, I’m not sure we’re seeing a significant reduction across the industry. For instance, in my root cause course, one of the questions I ask is how many “human error” root causes each attendee sees in their system. Most respondents fall between 20 percent and 75 percent. While this alone is not enough to make a definitive assessment, it does lead me to believe that we’re still not where we need to be.


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