2019 HPRCT Conference

The purpose of this talk will be to describe Biogen’s journey of integrating Human Performance principles into the investigation process in the biotechnology industry; from initially walking in the footsteps of the “Old View,” to blazing a new path based on the “New View.” This presentation will describe the path taken by Biogen starting in 2015 with an overemphasis on “human error” to a systematic approach in investigations. Advancing to a systematic approach led to identifying causes at the organizational level as opposed to only uncovering causes at the local level. In addition to the above, organizational analysis presented challenges to the biotech industry, which led to confusion about the application of Human Performance principles into the investigation process. The state of investigations at Biogen in 2019 is quite different from 2015. The integration of the systems approach, use of multi-causal causal analysis methods, delineation of local and organizational factors, evaluation of extent of condition and cause, and learning teams have defined excellence in investigations and established a framework for resilience.