BPOG members are now considering the recommendations of a report made available internally in May 2016, to improve the efficacy of their investigation and root cause analysis approaches. The team will be meeting at Biogen in North Carolina over 21-23 March, 2017 to discuss the impact of the 14 recommendations made in the initial report to assess which member companies have changed their operations as a result. The report is available for members here.
The major report titled: ‘Investigation and Root Cause Analysis and Best Practices’ showed considerable scope for improvement in the industry. Based on research into current practices and comparisons with high reliability organisations in other regulated industries, the report made recommendations for change.
In its conclusions, the team discovered that a lack of training was impacting the ability of investigators and that the tools in existence to perform these analyses were not appropriate for the complex problems presented. The current state of investigations is limited not only in its scope but also its ability for self-improvement. The team believe that addressing these issues will result in better use of limited resources within our organizations and also aid the adoption of HuP practices within our businesses.
Following the internal release of the report, an article has been written by Clifford Berry and published in BioPharm International to socialize the recommendations to a wider audience. This can be accessed here.