🛡️ Risk Management
GMP Quality Risk Register
Perform risk assessments using a structured Failure Mode & Effects Analysis (FMEA) register. Define process steps, identify hazards, score initial/residual risk (S, O, D), document mitigations, and export to CSV or print-ready PDF.
0
Low Risks (<50)
0
Medium Risks (50-100)
0
High Risks (101-200)
0
Critical Risks (>200)
| Process Step / System | Potential Hazard / Failure Mode | Potential Failure Causes | Initial Risk (S x O x D) | Mitigations / Planned Controls | Residual Risk (S' x O' x D') | Action |
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ICH Q9 Quality Risk Management:
Quality Risk Management (QRM) is a systematic process for the assessment, control, communication, and review of risks to the quality of the drug product. Severity (S) reflects the impact of the hazard on patient safety or product quality; Occurrence (O) is the probability of the cause happening; Detection (D) is the probability of identifying the failure mode before the product leaves control.
Quality Risk Management (QRM) is a systematic process for the assessment, control, communication, and review of risks to the quality of the drug product. Severity (S) reflects the impact of the hazard on patient safety or product quality; Occurrence (O) is the probability of the cause happening; Detection (D) is the probability of identifying the failure mode before the product leaves control.
Prepared By (Subject Matter Expert):
Date:___________________
Reviewed By (Area Manager):
Date:___________________
Approved By (Quality Assurance):
Date:___________________