Quality risk management is a central component of the pharmaceutical quality system. All quality-critical decisions should be made on a risk-based basis. This can be done both prospectively (e.g., to determine the scope of a qualification) and retrospectively (e.g., to assess the consequences of a deviation) . QRM is closely interlinked with many other processes in the pharmaceutical quality system. The application of quality risk management requires not only technical expertise but also methodological competence and must be described in an SOP. This should also be suitable for user training. We will show you how to develop an SOP for quality risk management and discuss the content aspects.