Conventional 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 a number of years, experienced operations and quality management representatives from nearly 20 companies 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 changes at one level are 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. This risk based approach is based on dropping the investigation of each minor, low-risk events but effectively track and trending them, to free up significant resources to work on prevention, and 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.
This article published in the BioProcess International, proposed this risk based approach and provides guidance on how to make track and trend work in away that is consistent with other companies involved in the program.