How to Make Investigations More Effective.
In 2016 BioPhorum members came together to consider how to improve the efficacy of their investigation and root cause analysis approaches.
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 state of investigations was limited not only in its scope but also its ability for self-improvement. The team’s belief was that addressing these issues would result in better use of limited resources within organizations and also aid the adoption of HuP practices within biopharma businesses.
Following the internal release of the report, this article this written by Clifford Berry and published in BioPharm International to socialize the recommendations to a wider audience
See page 35 of the ‘Trends’ ebook