The Risk Assessment in the CAPA program utilizes the Severity (S) x Occurrence (O) x Detectability (D) matrix to categorize issues into Critical, High, and Medium priorities so that appropriate response actions can be determined.

Upon identification, the GQC shall perform a Risk Assessment using the Severity (S) x Occurrence (O) x Detectability (D) matrix. Critical (Priority 1): RPN ≥ 20. Investigation due in 15 days. Closure target: 60 days. High (Priority 2): RPN 10–19. Investigation due in 30 days. Closure target: 90 days. Medium (Priority 3): RPN < 10. Closure target: 120 days.

legacy import — synthesised from supporting_context_primary