This chapter on Risk management presents an overview of a formal risk management process for application in a Tissue Establishment (TE). The aim of the chapter is not to introduce new guidance; all the information is available within already existing legislation and guidelines. The objective is to provide practical directions for the performance of a risk analysis in a Tissue Establishment.
It is possible and acceptable within Good Manufacturing Practices (GMP) for risk assessment to be informal, using empirical tools and experience to estimate and mitigate risks instead of a formal method. This type of risk assessment is not included in this GTP Risk management chapter.
The ultimate goal of the risk management process in Tissue Establishments is to enhance the quality and safety of tissues for the patient. However, the level of effort, formality and documentation of the risk management process should be commensurate with the level of risk.