WHO (World Health Organization) has published a revised draft for final comment. The document is similar to the ICH Q9, Risk Management. It does proceduralize a quality risk management process in Section 2. Section 3 addresses training, responsibilities and discusses the QRM (quality risk management) application relative to product development, validation and qualification, and commercial manufacturing. Chapter 4 sets out the expectations of QRM from an inspection strategy while Section 5 identifies appropriate risk management tools.
In summary, ensure the following:
- You have a formal risk management procedure
- Your key personnel are trained in risk management techniques like flowcharts, decision trees, fault tree analysis, cause and effect diagrams
- You have a quantifiable way of measuring risk based on patient impact and probability
- Your documentation is scientific and supports the quality decisions that you have made regarding risk.