Quality Risk Management — ICH Q9

Risk Assessment Matrix (Likelihood × Severity)

A qualitative 5×5 risk matrix for assessing deviations, change controls, and quality events — quicker to apply than full FMEA when a rapid risk classification is needed.

How the Matrix Works

Unlike FMEA's numeric RPN (S × O × D), a risk matrix classifies risk qualitatively by plotting Likelihood against Severity on a grid, with each cell pre-assigned a risk band. This approach is fast, visual, and well suited to change control and deviation risk classification where a quick, defensible categorization is needed.

Rating	Likelihood Meaning	Severity Meaning
1	Rare — unlikely to ever occur	Negligible — no meaningful impact
2	Unlikely — occurs occasionally	Minor — limited, recoverable impact
3	Possible — occurs sometimes	Moderate — noticeable impact, contained
4	Likely — occurs often	Major — significant quality/compliance impact
5	Almost certain — expected to occur	Critical — direct patient safety/product impact

Interactive Matrix

Likelihood (1–5) 1 — Rare 2 — Unlikely 3 — Possible 4 — Likely 5 — Almost Certain

Severity (1–5) 1 — Negligible 2 — Minor 3 — Moderate 4 — Major 5 — Critical

Current classification: —

Risk Log

Item / Description	Likelihood	Severity	Risk Level

Typical Response by Risk Level

Risk Level	Typical Response
Low	Accept; routine monitoring, no formal mitigation required
Medium	Consider mitigation; document rationale if accepted as-is
High	Mitigation generally required before proceeding
Critical	Immediate action required; escalate per QRM procedure

Matrix bands shown are a common illustrative configuration. Your site's Quality Risk Management procedure should define its own approved matrix, risk bands, and required actions per ICH Q9 — use this tool as a quick reference, not a substitute for your formal QRM documentation.

Recommended Reading

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Quality Risk Management in the FDA-Regulated Industry, 2nd Ed. José Rodríguez-Pérez — a comprehensive guide to ICH Q9 risk tools, including likelihood/severity matrices alongside FMEA.	View on Amazon →
Foundations of Quality Risk Management Jayet Moon — a practical grounding in risk-based thinking (ISO 31000/ISO 9001-aligned) behind qualitative matrix tools like this one.	View on Amazon →

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