Reduction of Human Errors Investigations Related to Documentation in Manufacturing Areas

Abstract

The human error has become an issue in the pharmaceutical companies. The biggest challenges throughout times have been detection and prevention of the human errors. An example of this situation occurred in BMS, Manati plant. BMS is a site where parenteral and oral products are manufactured. Since January to October of 2019, it was observed an increase of human error investigations related to documentation of manufacturing processes. A comprehensive study was performed to evaluate variables for the human error in order to provide alternatives to simplify the documentation and identify actions to reduce the documentation errors. The analysis for this study was quantitative using root cause analysis as methodology. The thesis was based on the perception that the human is a most contributing factor of errors. The investigations’ increase was attributed to the changes in policies related of when is required an investigation. In order to mitigate documentation events, an annual cGMP training with emphasis to good manufacturing practices was provided to the population. It was observed a reduction of investigations after implementation and monitoring of multiple effective preventive and/or corrective actions. Key Terms ⎯ Corrective and Preventive Actions, Human Error, Manufacturing investigations, Root Cause Analysis.