Why Human Error is not the End but the Beginning: Rethinking Deviation Management

In pharmaceutical industry, the pressure to respond quickly to deviations unfortunately still leads to a familiar conclusion: human error. It seems clear, straightforward, and manageable-someone didn't follow a procedure, someone misread a value, someone simply forgot, someone made a mistake. The mistake is logged, retraining is prescribed, and the case is closed. But in reality, nothing meaningful has changed.

This overreliance on "human error" as a root cause reflects a deeper issue in deviation management-namely, the failure to fully engage with the purpose and power of Root Cause Analysis (RCA). RCA is not a formality; it is the linchpin of a functioning deviation management system. Without it, corrective and preventive actions (CAPAs) risk missing the mark.

Human error may be the most visible part of a deviation, but rarely is it the actual root cause. It is often a symptom-one that points to weaknesses in process design, workplace environment, or resource availability.

A well-executed RCA explores what made the error possible. It asks not only who made the mistake, but why it occurred, under what conditions, and how the system contributed. These are not abstract questions. They are practical: was the process unnecessarily complex or poorly documented? Were there distractions, time pressure, or equipment failures involved?

What makes RCA efficient is its structured approach to complexity. Tools like "5 Whys", Fishbone Diagrams and comparative analyses don't just organise and visualise thinking, they encourage teams to compare facts and reflect before drawing conclusions. They allow an investigation to unfold in layers, revealing interrelated causes that might otherwise be overlooked. These tools work only if we commit to using them rigorously, and not just as templates to satisfy documentation requirements.

In this context, identifying human error is not a conclusion, but a starting point. It signals a need to examine processes, quality systems, shift structures, SOP clarity, and even workplace culture. Each of these aspects can create conditions where errors are more or less likely to happen. Human performance is not isolated from the system, it is shaped by it.

Moreover, the quality of RCA directly affects the strength of CAPAs. Corrective actions must do more than address the immediate failure. They must eliminate the root cause. Preventive actions, in turn, should go further and reinforce system-level improvements that reduce the risk of recurrence across processes, systems or departments. But this level of impact is only possible if the root cause is correctly and thoroughly identified.

The best organizations embed RCA into their daily operations, not just as a compliance tool, but as a mindset. They view deviations as opportunities for learning. When teams stop treating human error as a convenient explanation and start treating it as a window into system performance, the culture begins to shift. Reporting increases, ownership improves, and trust builds between teams and leadership.

Ultimately, a mature quality culture doesn't ask whether someone made a mistake. It asks what the system allowed, enabled, or failed to prevent. That shift from blaming people to investigating systems is where meaningful improvement begins. And that's where the real value of Root Cause Analysis is found.