Administration
Risk Methods
Select a method proportionate to the validation question; a full FMEA is not forced for every discrepancy.
Documented qualitative assessment
Low-complexity, well-bounded matters where narrative justification is proportionate.
Probability-impact assessment
Operational decisions requiring consistent severity and likelihood ranking.
Risk ranking and filtering
Prioritising inventory, periodic review or qualification activity.
FMEA / FMECA
Complex systems or process failure modes where structured control analysis is justified.
HACCP
Process hazards with defined control points and monitoring.
Fault-tree analysis
Top-event analysis requiring causal decomposition.
Preliminary hazard analysis
Early lifecycle scoping before detailed design information is available.