Risk Analysis and Process Improvement for Medical Devices with Integrated Method DEA and FMEA

Abstract

Risk analysis is the identification of factors, conditions, activities, systems, components that are important concerning risk. Evaluating the systems in terms of risk plays a critical role in the production of products that are especially important for human health. The washing process of the medical devices at the production stage is important in terms of ensuring the acceptable sterility assurance level of the product before sterilization. In this process, the risk factors that may affect human health emerge. Risk Priority Number (RPN) which is used in the Failure Mode and Effect Analysis (FMEA) is calculated for each factor and it is considered to be equally important in general. Sometimes it can be difficult to clearly show the importance of these effects. These invisible effects cause great costs for companies, and they can also affect human health at risk. In this study, risk analysis of the washing process in a company producing medical devices is performed. Risk prioritization is made by scaling risk types and their effects by Data Envelopment Analysis (DEA) method to eliminate the disadvantages in question. As a result of the study, the prioritization of risk types with different methods is compared.