Gerenciamento de risco em um projeto de transferência de tecnologia intracompanhia farmacêutica

Abstract

This research deals with a quantitative and qualitative case study aimed at the critical analysis of the contribution of risk management in projects of pharmaceutical intracompany technology transfer. It was considered a project to change the location of manufacturing, packaging and quality control of a solid oral medicine performed at a regional level, between sites located in different municipalities of the state of São Paulo to meet the commercial strategy of a multinational pharmaceutical company. This project began in 2013, including planning, organization and execution with completion expected in 2015. A qualitative assessment of the risks related to the scope and quality requirements of the project was performed, as well as a quantitative assessment of the risks related to compliance with the project deadline. In order to confirm or refute the six research propositions presented, it was conducted semi-structured interviews and direct observation in the unit of analysis, bibliographic review and data analysis. The results show that after qualitative analysis of the project risks related to the scope and quality requirements using the Failure Mode and Effect Analysis - FMEA tool, 39 failure modes were identified, with Priority Risk Number - PRN values varying from 70 to 288, the failure modes of greater severity and therefore, priority, it was the quality requirement for health regulations. They also indicate that from the Monte Carlo Simulation the maximum expected time for the project is 1841 days and the minimum of 1473 days. The conclusion of the research shows that the propositions are not fully confirmed. An action plan was proposed to mitigate the risks analyzed.