4.5 Description of the phases in the risk management process
The next paragraph describes more into detail which steps are to be taken in the risk management process.
Risk management can be performed in all (primary) processes of tissue establishments.
It can be used for distribution, storage, recovery but also for medical risk assessment in the donorscreening process.
Risk management is best performed by a team consisting of at least:
- one or more process owner(s)
- quality assurance manager
If the risk management process should spread over more than one process, there should be participants of all involved processes present.
To initiate a risk management process, choose a process in which you would like to perform a risk assessment or define a problem description for your risk management process. For example: distribution of tissues by courrier in your country (process) or how can we organise our procurement checklist so that it will be followed precisely by the recoveryteams and will protect the safety and quality of the explants or how we can reduce the risks during processing Some of these examples will be used in the training model of this GTP, to clarify the risk management process.