Impact of Root cause analysis in reducing Human error in the Pharmaceutical Industry
Root cause analysis is a problem-solving technique using various tools which aim to identify the main root cause of a problem and its contributing factors. An effective RCA identifies the underlying causes of a problem rather than concluding at symptoms level. In the pharmaceutical industry, when deviations or non-conformances arise, efforts are made to identify the underlying causes of these events. This study focused on events caused by “Human error.” Human error is inevitable and it is widely accepted. Identifying the real causes of error can reduce human error. The main objective of the study is to demonstrate the effectiveness of RCA in reducing human error in the pharmaceutical industry and to propose improvement suggestions for more effective RCA implementation. Familiarization of RCA tools can increase the knowledge and skills in usage of RCA tools. The objectives of the study are to determine whether pharmaceutical industry employees are aware of various RCA tools and to identify the common RCA tools used during human error events. Conducting RCA is a time consuming and resource intensive. The challenges associated with the effective RCA implementation was found to be time consuming, resource intensive and management pressure. Studies have been conducted on the improvement of failure investigation process in the pharmaceutical industry. These studies revealed that the implementation of effective RCA for human error can be improved by improving organizational culture and involving human factor experts in the RCA team.
This study used mixed method research design by conducting survey and collected data from the pharmaceutical industry employees around the world. A total of 100 participants responded to the survey. The study identified that the pharmaceutical industry employees are well aware of the various RCA tools and the common RCA tools used were found to be (but not limited to) 5Whys, Brainstorming, Process mapping and fishbone analysis. In addition, this study identified that respondents felt 5 Whys is the most effective RCA tool used during human error events in the pharmaceutical industry. Several challenges to implement effective RCA were found as lack of time and resources, lack of training on RCA methodologies, management support and, insufficient data availability. This study recommended that Improvement in organizational culture adopting no blame culture, management support in providing sufficient allocation of time, providing extensive training in RCA methodologies and improvement in processes can contribute to effective RCA following human error events