<![CDATA[This research aims to analyze occupational safety risks in the Infusion Set Division using the HIRARC (Hazard Identification, Risk Assessment, and Risk Control) and FMEA (Failure Mode and Effects Analysis) methods. The background of this research is based on the high rate of workplace accidents occurring in the medical device manufacturing sector, particularly in the production process of infusion sets that involve automated machines, chemicals, and repetitive activities that pose a risk to worker health. This study was conducted through field observation, questionnaires to 80 respondents, and in-depth interviews in eight main work areas. Based on the discussion results, it was found that out of the eight work areas analyzed, the extrusion, assembly, and electrical areas are locations with the highest risk levels. Through the HIRARC method, It was found that activities such as operating hot machines, direct contact with electricity, and repetitive work provided a Risk Level value of ≥ 12, which is classified as high risk. Meanwhile, using the FMEA method, the highest risk was recorded in Raw Material Loading with a Risk Priority Number (RPN) of 263,494, as well as in the electrical area and Extrusion, both with an RPN of 236,118. The discussion results indicate that the main risks arise from a lack of early hazard detection, suboptimal OHS training, and production target pressures. The recommended control strategies include disciplined use of personal protective equipment (PPE), enhanced safety training, improvements in workplace design, and regular evaluations of the OHS system. The application of HIRARC and FMEA has proven to provide a deeper understanding in identifying risk priorities and formulating effective mitigation steps.]]>
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