"Human error" is a misleading term. Focus on the real cause of errors.

View profile for Ahmed Gamal

QA Senior Section Head at DELTAPHARMA GMP WHO ISO 9001 , 14001 , 45001

“Human error” is never the real root cause NOW NOT Valid. “Human error” puts blame on individuals. “Use error” focuses on the context: → Was the procedure usable? → Were resources available? → Did the system align with human limits? Because most errors stem from things like: → Overload → Poorly written SOPs → Ambiguous instructions → Environments full of distractions → A culture where people can’t speak up And if your root cause analysis ends with “human error,” you’ve probably only gone halfway. The real cause is often deeper: → A design flaw → A broken process → An unrealistic workload And let’s be clear: “retraining” is rarely the right corrective action. Sending someone back to read the same flawed procedure? That’s not solving the issue. Instead, ask: → Was the information accessible? → Was the tool usable? → Was the task even doable in the real world? Then look at the type of use error: → Knowledge-based mistake? → Rule-based mistake? → Action-based slip? → Memory-based lapse? → Routine violation? Now you can act: → Rewrite the SOP → Add checklists → Adjust the environment → Redesign the tool → Supervise better Not Valid close CAPA as Human Error 👍

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