Our Center acquired a mobile electron linear accelerator for intraoperative radiation therapy (IORT) and the clinical activity started at the end of June 2012. The risk assessment performed before the start of clinical activity was integrated with a predictive matrix risk analysis (FMECA). Two years later an analysis of all the relevant criticalities was performed in order to improve quality. The aim of this study is to present the results of the method elaborated by our Working Group and the application of FMECA prospective approach to IORT procedure.