We live in a world of uncertainty. Moving forward in this context would be much easier if we could manage to identify, analyse, mitigate, and ultimately accept the most relevant threats, with a deep understanding of the actual significance of such risk(s). Remarkably, this strategy can be applied to any field of interest, from daily life to economics or medicine. Indeed, current quality standards in cellular therapy have already incorporated risk-based management in their guidelines. In this chapter, we present the concept of risk management as part of a quality management program and discuss by whom, why, how, and when this approach should be applied in order to benefit the production and use of safe and effective cell-based therapies in general and hematopoietic stem cell transplantation in particular.
Copyright 2021, The Author(s).