Risk management and change control in the supplier qualification process is difficult and tenous part of necessary relationship. Pre-qualification activities involve specification, obtaining and assessing data, and supplier audits. Next, the change control process involves change notification, a mechanism for change, execution and evaluation of change, and closure of the change control process. After that, change control, monitoring, and requalification is expected of a healthy vendor relationship.
This sample change control report and supplier quality agreement will help to ensure that a manufacturing facility remains compliant with US Food and Drug Administration and International Conference for Harmonisation guidances.
Download the accompanying presentation, "Change Control: Evaluate Suppliers on their Process," presented at IVT's Risk Management/Change Control Conference on January 2013, San Francisco, CA.