Monday 22 March 2021

Case studies in error risk reduction


This article is concerned with error risk reduction, centered on illustrative case studies. Human error has long been identified as a contributing factor to incident causation, and pharmaceuticals and healthcare is no exception. Human error is a cause of substantial variation across the pharmaceutical and healthcare sectors. To a degree it can be prevented by analyzing process for failure modes and implementing better training, clearer documentation and by increasing automation. To do so requires an understanding of human behaviors and motivations, and ensuring that the 'human factor' is adequately assessed in the design of systems and processes. Human error is frequent topic of regulatory inspections.



Error risk reduction is associated foremost with human error and the ways to reduce the impact of human error on procedures and processes. With this approach, it is important that the people carrying out the assessment should have an understanding of the different types of failure and the factors that make them more or less likely to occur.




Sandle, T. (2020) Error Risk Reduction: Concept and Case Study, Journal of Validation Technology, 26 (6) at:


Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (


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