Global system pressures prompt hospitals to consider the risk factors of the healthcare system. The sterilization unit is a focal point of the healthcare system in regards to risk factors, and these units should be properly managed. Therefore, to study risk factors in sterilization units, we utilized failure mode and effects analysis (FMEA), which is a proactive risk assessment method for examining all failure modes and eliminating or reducing the highest risk priority failures. In this study, a 5 x 5 matrix and both classical and fuzzy approaches of FMEA were developed for a sterilization unit to assess and identify the hazards discussed in prior studies and new hazards discovered during this study. The method proposed in this study provided both accurate risk assessments and effective responses to those risks. Finally, a case study of the sterilization unit of a large hospital is presented to demonstrate the effectiveness of the proposed methods. (C) 2016 Elsevier Ltd. All rights reserved.