A review of process deviations caused by human error in Rottapharm Ltd. from 2006 to 2008

Abstract

The objective of this project is to examine Process Deviation Reports (PDRs) generated from 2006 to 2008 for Sachet Products where “Human Error” has been identified as the primary root cause. Sachet Products were chosen for this review as they represent the largest volume output, and the production process involves the largest number of employees compared to other processes in Rottapharm Ltd. e.g. capsule or tablet production processes. For that reason, it was considered that Human Error PDRs generated during Sachet production represents the “worst-casescenario” for Human Error PDRs reported at Rottapharm Ltd. From this review, it is intended that trends in Sachet Human Error PDRs will be identified and the effectiveness of corrective actions implemented will be assessed. Sachet PDRs reported in 2006, 2007 and 2008 were reviewed. The project reports encouraging trends, with the number of PDRs per Sachet output seen to be decreasing from 2006 to 2008. Retraining and document update (e.g. standard operating procedures, checklists, training manuals etc.) were the primary corrective actions implemented in the period under review. While retraining sessions appear to be effective in the short-term, it is recommended that further medium- and long-term solutions must be found to address Human Error PDRs, e.g. control and monitoring of processes utilising Manufacturing Execution Systems and Process Analytical Technology. Additional recommendations from this project include increased communication with different departments to highlight Human Error trends to improve awareness and vigilance to these issues. In addition, the approaches of other Irish Healthcare companies in managing Human Error PDRs were reviewed. This concluded that the approach in Rottapharm Ltd. is comparable to that of other companies in the Irish Healthcare Industry.