Current methodologies which conduct check-the-box “investigations” for every minor deviation, can lead to companies unintentionally instilling an over reliance on basic tools and running the risk of losing the point as to why deviation management is performed — to find and fix problems. They do little to help companies understand minor slips/lapses, nor do they enhance product quality or assure patient safety.
Over the past year, experienced operations and quality management representatives from nearly 20 companies have collaborated within the Deviation Management workstream to evaluate how the industry’s ingrained habits and thinking around deviation management can be changed using a risk-based approach.
While the change at one level is simple to make, it requires a major shift in custom and practice, a new way of thinking and emphasis on quality rather than focusing solely on compliance. The new approach is based on no longer investigating each minor, low-risk events but effectively track and trending, freeing up significant resources to work on prevention, driving improvement of quality at source.
Companies will free up time wasted on low risk events, enabling trained and qualified investigators to develop more effective tools, techniques, and competencies for comprehensively evaluating significant events and building smarter investigations. This has been implemented successfully by early adopters and they have had successful inspections from multiple authorities.
The workstream has recently published an article describing their approach in Bioprocess International. To read the article in full click on the link below: