Mapeamento de processo do setor de engenharia de qualificação de uma empresa farmacêutica do norte do Paraná

Abstract

This study presents the process mapping in the qualification engineering sector of a pharmaceutical company, combined with the application of the Hazard Analysis and Critical Control Points (HACCP) tool, aiming to identify Critical Control Points (CCP), standardize and propose improvements the sector's activities, attempting to ensure greater quality and operational efficiency. Thus, the methodology included analyzing the sector's current flowchart, conducting interviews with employees, practical experience, and training in Standard Operating Procedures (SOP) for data collection. The application of HACCP allowed the identification of specific risks in the qualification stages, the establishment of critical limits, and the proposal of corrective and monitoring actions, mitigating recurring failures and reducing the impact of deviations in the processes. Based on the results, an ideal flowchart was developed, reflecting the proposed improvements, optimizing the workflow, and prioritizing activity integration, with greater clarity in handling categorized equipment and executing specific qualifications. However, the implementation of the ideal flowchart was not feasible due to the time required for its adaptation, validation, and staff training. Nevertheless, the proposed model serves as a robust basis for future improvements, standing out as a strategic recommendation to optimize the qualification sector. In that regard, this study emphasizes the importance of process mapping and the application of tools such as HACCP to promote continuous improvement, ensuring regulatory compliance and increasing efficiency in critical sectors of the pharmaceutical industry.