Risk assessment of the polishing department in A company that manufactures orthopedic implants in the medical device industry

In the developing and changing world, the business world and production techniques are also changing rapidly. This change has also increased awareness in the field of occupational health and safety. Companies are not only concerned with the quality of their products, but also with the production conditions and the health of their employees. Therefore, more studies and investments are made in this field. Risk assessment methods are also a result of these studies. The medical device sector, which is one of the areas most affected by technological developments, is very important in the development and development of the country due to both the production technology and the high quality standards of the products produced. It is extremely important for companies working in this field to use the necessary technology in terms of both product and employee health. In this study, sources of danger in terms of occupational health and safety of a company that produces orthopedic implants were determined and a risk assessment was made. In this context, first of all, the sources of danger in the orthopedic implant production sector were determined, and then the possible risks caused by these sources of danger were calculated and a risk assessment was made. Failure Modes and Effects Analysis (FMEA) method was used in risk assessment. The sources of danger in the polishing department have been determined to be mainly caused by the machine, the wrong equipment used, and the working environment. As a result of the risk assessment, the possible risks that these danger sources may cause have been reduced to an acceptable level. As a result of the risk assessment made with the FMEA method of the 10 most important sources of danger identified within the scope of this study, an improvement between 20% and 75% was achieved in the risks, depending on the type of hazard. According to the results obtained in the evaluation of the risk analysis of the sources of danger in the polishing department, incomplete or incorrect use of personal protective equipment, lack of on-the-job training, and irregularity of the workplace environment were observed. These problems are common problems for many businesses, often called SMEs, and if precautions are taken, these businesses will become a much safer and more efficient workplace. Keywords: Medical Device Industry, Orthopedic Implant, Hazard Sources, Risk, FMEA, Risk Assessment