An operator misses a step. The deviation gets written up, investigated and closed out with three familiar words: human error, retraining completed. Six months later, someone else on the same line, performing the same step, makes the exact same mistake.
If that sequence sounds familiar, you’re not the only site where it plays out. The numbers back it up, and they’re worse than most people assume.
80% of process deviations in pharmaceutical manufacturing get labelled “human error.” Looking beyond deviations to the broader category of quality defects, including laboratory errors and complaints, separate research suggests that human error accounts for roughly 25 to 30% of cases. Even then, many investigations provide no clear definition of what “human error” actually means or why a trained, competent person made that particular mistake on that particular day.
A 2025 industry review from PwC adds another important insight. Forty percent of quality professionals say they’re unable to identify the true root cause of an issue and 80% of investigators close an investigation with only a probable cause rather than a definitive one, often defaulting to human error by elimination.
Retraining is the reflex response anyway, and it’s easy to see why. It’s fast. It’s cheap. It produces a signature on a training record that an auditor can point to as “action taken.”
A quick example. An operator transcribes the wrong batch number onto a log sheet. Investigation: human error. Retrained. Three weeks later, a different operator makes the identical error on the identical form. Retrained again. It happens a third time. Only then does someone finally look at the form itself and find two fields, batch number and lot number, sitting side by side in near identical formatting, making them easy to confuse under time pressure at the end of a long shift. The form was the hazard. Three rounds of retraining never touched it because retraining was never designed to.
That’s the blind spot. Most deviations are initially attributed to a knowledge gap. However, when investigations trace the error back to its underlying causes, they often reveal Risk Influencing Factors (RIFs) such as ambiguous SOPs, poorly designed documents, similar-looking labels, understaffed shifts, environmental noise, unrealistic time pressure, and fatigue.
Regulators have caught on to this faster than most shop floors have. FDA, EMA and MHRA inspectors increasingly treat “human error” as an unfinished investigation rather than a completed root cause.
This is the gap Blue Flame Consulting solves. Instead of starting an investigation at “who made the mistake,” our process starts by mapping how the work actually happens, clarifying the process, reviewing where risk sits within it, and identifying the specific Risk Influencing Factors driving recurring deviations.
Ready to move beyond retraining? Get in touch with Blue Flame Consulting.