Moving Beyond Human Error: The True Value of Root Cause Analysis

In pharmaceutical manufacturing, deviations are too often attributed to “human error”—someone misread, forgot, or failed to follow a procedure. The case is closed with retraining, but real risks remain unaddressed. This overreliance on human error reflects a deeper weakness: ineffective Root Cause Analysis (RCA).

RCA should uncover why an error occurred, under what conditions, and how systems contributed. Was the process overly complex? Were SOPs unclear? Did time pressure, distractions, or poor resources play a role? Tools like the 5 Whys or Fishbone Diagrams, when rigorously applied, reveal interrelated causes and drive meaningful insights.

Human error is not an endpoint—it is a signal to evaluate processes, systems, and culture. Strong RCA leads to effective CAPAs, addressing root causes rather than symptoms. Organizations that integrate RCA as a mindset foster learning, accountability, and trust, shifting from blame to system improvement—the foundation of a mature quality culture.

05-09-2025