Change Control is an area where critical items often “fall through the cracks”, much to your detriment when an FDA inspector comes knocking or when you’re trying to identify the root cause of a product failure or deviation.
Here are some Best Practices for assigning responsibilities to all those involved in Change Control:
- Initiates the Change request
- Sends to Quality personnel for their concurrence
- Assures Approver’s actions are carried out
- Implements production or design Change through the Engineering Change Order (ECO) process
- Distributes the Change request and any associated documents to the Approver(s)
- Transmits the Approver’s decision (acceptance or rejection) to the Originator
Change Request Approver(s):
- Reviews Change requests for accuracy and completeness
- Recommends the proper course of implementation
- Recommends all actions needed to effectively complete and implement the Change
- Assures request is completed in compliance to the Change Procedure
In addition, full completion of a Change request should include:
- Supporting documentation for the original request and the decision for acceptance or rejection
- Detailed description of the action needed to make the Change and the reason for the action
- Identification of all appropriate areas impacted by the Change — such as equipment, materials, testing, purchasing, labeling, legal, etc.
For additional training on best practices in Change Control and improving your overall Quality System, attend EduQuest’s 1.5-day face-to-face class, The CAPA Clinic: Effective CAPA Systems, Failure Investigations, and Complaint Management.