Mejoramiento del proceso de actualización de diseños para materiales impresos usados en trámites regulatorios en Laboratorios Bussié S.A.

Abstract

This report addresses the improvement of the design process for regulatory submissions at Laboratorios Bussie, highlighting the importance of optimizing this process to ensure efficiency and quality in product delivery to the market. Through a detailed analysis, several critical shortcomings were identified, such as inadequate document handling and the underutilization of available technological tools within the company. One of the main deficiencies is the use of handwritten forms, which not only slows down the process but also increases the risk of human error. Additionally, the documentation lacks a systematic order, making traceability and efficient information management difficult. The involvement of multiple managers in the process, without proper coordination, further complicates communication between the areas involved, causing delays and confusion. The lack of control in the process directly affects the availability of designs for regulatory submissions, which in turn negatively impacts product availability in the market. This situation underscores the urgent need for a comprehensive transformation of the process. The Production Engineer proposes to lead this transformation by applying academic knowledge and leveraging available technological tools. Implementing an optimized system of document flows and using collaborative platforms will enable more efficient and coordinated process management. This approach will not only resolve current issues but also establish a solid foundation for continuous process control and improvement. For the reader of this report, the importance of adopting new development methods in processes is emphasized, as they significantly contribute to control and continuous improvement, thereby ensuring the company’s competitiveness and efficiency in the market.