Definition

A systematic investigation method to identify the fundamental underlying reason(s) for a deviation, error, or quality issue.

Example

Three late submissions occurred. Root cause analysis using '5 Whys' reveals: Why late? → Processor was on vacation → Why no backup? → Training not complete → Why? → Resource constraints. Root cause: staffing/training.

Regulatory source

ICH Q10, Quality Management

Common mistakes

Stopping at surface-level causes rather than drilling down to true root causes that can be systematically addressed.

Inspector question

Show me a root cause analysis you performed. How did you verify you reached the true root cause?

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