09.05.2022

What has to be considered in risk management?

Risk management is carried out in 2 stages: first, it is examined whether and how the identified risks can be reduced or eliminated. Then it must be decided whether the remaining residual risks are acceptable. At this stage of the QRM process, it is important on the one hand to keep a sense of proportion between effort and benefit. On the other hand, QRM must not be misused to "discuss away" existing risks.

[GMP Compliance Adviser, Chapter 19.C]