Roxane Napoli, Marketing Manager, Pilgrim Quality Solutions
Like the corrective action process, the change management process is a central part of your quality management system. Change is difficult to manage because it touches every area of your business (including suppliers) because it is constant, and because the process to manage it needs to be compliance-driven. If you already have a change management process in place, here are some resources to help you understand areas where your process can be more harmonized, compliant, and efficient.
Tell the whole story about each change.
This Q&A on FDA compliant change management provides insight into better managing impact assessment and documentation of a change. These areas are typically weak in most change management processes. The article points out that change documentation is often weak or incomplete because there is an internal assumption that “everyone knows what is going on.” When an auditor or other third party later reviews the change, the record seems incomplete because it doesn’t tell the full story. This can make the process seem less thorough or compliant than it actually is.