ICH Q9(R1): quality risk management

Start with the patient and the evidence

ICH Q9(R1) links quality risk evaluation to scientific knowledge and patient protection. The effort, documentation and formality should match the risk.

Choose the method for the question

The guideline describes several methods, including FMEA. No single tool fits every situation. Define the question, the available information and the limits of the assessment before scoring.

For a software workflow, agree intended use and review responsibilities with your quality team. Record assumptions and uncertainty so reviewers can challenge the result.

Use scores with care

Our RPN calculator supports arithmetic on a 5-point or 10-point scale. These are configurable examples, not an ICH-prescribed scoring system or a compliance decision.

This is a short orientation, not a replacement for the guideline or your quality procedures.

Primary sources: ICH Q9(R1) guideline and ICH briefing pack.