Functional Risk Assessment

Functional Risk Assessment is the structured evaluation of how process or system functions could fail, the impact of those failures, and the controls needed to reduce risk to acceptable levels. 
 
It is aligned with ISO 14971 for medical device risk management and ICH Q9 for pharmaceutical quality risk management, both of which require identifying hazards, estimating risk, and implementing controls based on severity and probability. 
 
Why it matters: weak functional risk assessment leads to hidden failure modes, unsafe products, and regulatory findings.