BioPhorum has developed a risk-based deviation management system (DMS). 13 member companies have implemented this approach, and summary data from these companies shows improved quality performance plus an average time saving of 22,200 work hours per site per year, which is equivalent to a $888k cost saving.
An effective deviation management process is one that identifies and removes risk from processes using root cause analysis (RCA) principles and a corrective and preventive action (CAPA) programme. The current model used by many biopharmaceutical companies considers all deviations or events are equal and require a 30-day closure, known as the ‘30-day rule’1. Treating all events as equal and following the ‘30-day rule’ drives an inefficient process and wasteful behaviours.
This guide outlines the work of the BioPhorum DMS Workstream in defining and creating a simplified and effective risk-based deviation management system with advanced RCA methodologies, and a track-and-trending process of low-risk events. It includes everything required to build a risk-based approach to DMS, including the business case for change, the new process, risk-based tools, and a detailed sharing of post-implementation benefit.