ICH Q9(R1) - Quality Risk Management

What it says

Quality risk management should be applied using a systematic process, with the level of formality proportionate to the level of risk involved, and specific measures must be taken to reduce subjectivity and manage bias in risk assessment outcomes.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• The 2023 revision added two elements not present in the original 2005 guideline: an explicit formality-proportionate-to-risk principle, and specific expectations around identifying and managing subjectivity and bias in risk assessment methodology.
• A risk assessment conducted informally, without a documented methodology, does not satisfy this guideline even if the underlying conclusion happens to be correct.
• Structured methodologies such as FMEA, Ishikawa or a formal risk matrix exist specifically to reduce the influence of a single assessor's individual judgment on the outcome.

What inspectors look for

• Whether the level of documented rigor in a risk assessment is proportionate to the actual risk involved, neither excessive for a low-risk decision nor inadequate for a high-risk one.
• Whether risk assessment conclusions show signs of being reverse-engineered to justify a decision already made, rather than genuinely driving the decision.
• Whether the same individual or small group repeatedly reaches risk conclusions without any structured method or independent challenge built into the process.

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