Browsing by Author "Quintero Ortiz, Alejandro"
Now showing 1 - 1 of 1
Results Per Page
Sort Options
Item Diseño de un programa de gestión del riesgo aplicable en el proceso productivo en una central de mezclas(Universidad Santiago de Cali, 2025) Cechagua Suarez, María Angelica; Quintero Ortiz, Alejandro; Suarez Osorio, Liseth (Directora); Ruiz Pauly, Nathalie (Codirectora)Risk analysis is a systematic process used in different fields to identify, assess and control risks associated with the execution of processes, usually large-scale and branching. In the pharmaceutical 5 field, risk analysis is essential to ensure the safety and quality of medicines, so professionals in this field must be trained in techniques and methodologies for risk management. In this sense, the objective of this project was to design a risk management program applied to the production process of a mixing plant in Cali, Colombia. This process will identify and assess the risks associated with the processes and products manufactured at the plant. This makes it possible to implement preventive and corrective measures to minimize risks and ensure patient safety. The project was carried out by implementing the Failure Mode and Effects Analysis (FMEA). The risks associated with different stages of the process were identified and classified into three levels according to their severity, occurrence and ability to detect. The results indicated that 56% of risks were acceptable, 39% acceptable under specific conditions and 5% unacceptable. Corrective measures implemented included improved operating procedures, staff training, preventive maintenance and optimization of critical systems such as power supply. The study highlighted the effectiveness of FMEA in mitigating risks in critical pharmaceutical processes and stressed the importance of proactive management that includes continuous training and technological modernization. Although the limitations in infrastructure and financial resources presented challenges, the methodology adopted proved to be adaptable to the Colombian context. This model is a strategic tool for improving product quality and safety, as well as strengthening the competitiveness of pharmaceutical facilities at the national level.