Failure mode and effects analysis (FMEA) breaks a process, product or system into steps and asks, for each one, how it could fail (the failure mode), what the consequence would be (the effect) and why it could happen (the cause). Each failure mode is scored, typically on a scale of 1 to 10, for severity, likelihood of occurrence and the chance that existing controls will detect it.
Multiplying the three scores gives a risk priority number (RPN). Failure modes with the highest RPNs, or with high severity whatever their RPN, get mitigation actions — design changes, additional controls, better detection — and are then re-scored to show the residual risk.
Why it matters in GMP
FMEA is one of the tools named in ICH Q9 and is widely used in pharma for process risk assessments, change control impact assessments, equipment and computerised system validation and contamination control strategies. Its strength is that it makes reasoning visible; its weakness is that scores can be subjective, which is why scoring scales and acceptance criteria should be defined in advance.
- Agree scoring definitions and risk bands before the workshop.
- Involve people who know the process from different angles.
- Track every mitigation to completion and re-score the residual risk.
How Swat iQua Suite handles it
Swat iQua Suite keeps FMEA registers as controlled records. The server always computes the RPN as severity × occurrence × detection, each from 1 to 10, so nobody can type in their own number, and recalculates residual RPN after mitigation. Risk bands are configurable — by default low up to 40, medium up to 100, high up to 200 and critical above that — and registers are approved by QA with an e-signature.