If you’re in the market for a Deviation Management System, there are several factors to consider before making the purchase. Read on to learn more.
Root cause determination
Developing a good root cause determination process is an essential part of any Deviation Management System. Failing to identify the exact cause of a deviation can result in massive losses in revenue. Using simple tools such as the fishbone diagram or a more thorough process is necessary to ensure the most appropriate resolution. Contributing factors are elements that were required for the event to occur or that accentuated its impact. For example, a drug may have been out of date for a few weeks, and this was likely a result of a temperature outside of the optimum range.
To identify the real root cause, the investigation team must identify the actual culprit. Human error, for example, may mask the real root cause. If, for example, the second shift manufacturing operator forgot to sign the step in the batch record, the initial investigation determines that this error was a result of human error. Then, the investigation team may look to the second shift operator and their supervisors for input. When human error is the underlying root cause, the supervisors must be aware of this and, if possible, take action to correct the problem.
Automated process
An automated process in a Deviation Management System will allow team members to weigh in on the investigation results and dispositions. It will also include the capability to assign tasks and highlight overdue and upcoming tasks. It will also automatically create CAPAs for deviations. In addition, this process will reduce the time and expense of creating and distributing paper documents. In addition, an automated process will ensure that deviations are dealt with promptly and effectively.
Integration with other control systems
A well-integrated Deviation Management System will provide an effective means of gathering critical quality data on a timely basis. It will provide timely notification of failures, allowing redeployment of resources to problem areas. In addition, it should incorporate risk management principles and the knowledge of conflicting interests among consumer, regulatory, and other interests. In addition, it should provide trending data based on the same parameters across all processes.
Costs
The first step in implementing a deviation management system is understanding its potential costs. Conventional deviation management systems treat all events as equals and require 30-day closure. This practice promotes a “check the box” mentality, resulting in poor behavior and wasteful resources. To overcome these problems, the Deviation Management System Workstream of BioPhorum developed a Guide to Implementing a Risk-Based Deviation Management System. This approach separates data into minor track-and-trend events, which can be managed more easily.
