This paper presents an application of FMEA (Failure Mode and Effects Analysis) on the manufacturing process of piroxicam 20mg capsules, with the objective of identifying possible failures and create subsidies for improvement of the production stages. Brainstorming or Collaborative critical analysis was used as a tool to collect information and support FMEA’s application. After the risk analysis, evaluation of the production process using FMEA, manipulation and secondary packaging were found to be the critical stages in the production process necessary for implementation of actions in order to mitigate the risks.