Fuzzy FMECA Process Analysis for Managing the Risks in the Lifecycle of a CBCT Scanner

The Failure Mode, Effects, and Criticality Analysis (FMECA) is one of the risk analysis techniques proposed by ISO 14971 Standard. This allows to identify assess consequences faults that affect each component a complex system. FMECA forward-type technique used for highlighting critical points classifying them priority. It also makes it possible evaluate extent failures means numerical indices. can be applied product or work process. In latter case we talk about Process-FMECA. application Process-FMECA bioengineering particular interest because this procedure provides an related management during all different phases medical device life cycle. However, practical applications method have revealed some shortcomings lead inaccuracies inconsistencies regarding consequent prioritization. paper presents example Fuzzy Process-FMECA, improved based on fuzzy logic, small computerized tomography (CT) prototype designed studying extremities human body. CT uses Cone Beam (CBCT) technology. has made produce table risks, are quantified according specifications method. shown phase activity fundamental guarantee correct functioning device. methodology specific paradigmatic analyzing process risks any other