Information & Training. | Quality Assurance. Quality Management.

The Change Control Board.

In many organizations where there is regular on-going change or where a major change project is in process, a Change Control Board will be established to manage the change.

The purpose of the Change Control Board will be some or all of the following:

– Reviewing and approving change requests,

– Prioritizing change activity,

– Allocation of resources to change projects,

– Provision of unified reporting of all change activity,

– Highlighting and removal of roadblocks to necessary change activity.

In most organizations the primary activity of the Change Control Board is the review and approval of change requests. Depending on the functional make-up of the organization, the Change Control Board will consists of core members made up from areas such as Quality Assurance, Regulatory Affairs, Engineering, Manufacturing, Operations, Research and Development, Marketing. Other roles may sit on the Change Control Board on an as-needed basis depending on if the change affects their area, for example for medical type products there may be a clinical approver on the board. Every organization will uniquely determine the membership of their Change Control Board.

At all stages of the change process, documents supporting the change are created. These documents may relate to test and qualification requests, customer feedback data, risks analysis measures, revised operating procedures, training records, supplier audit reports, etc..

All these records will be available for review by the Change Control Board. In addition all data generated during the change process will become historical records and will be filed and retained as per the records management process within the organization. These records will be necessary to demonstrate compliance with quality or regulatory requirements if and when subject to review by third party auditors. They will also be necessary to maintain a history of change, which can be reviewed at some time in the future, where further change is planned.

Information & Training. | Quality Assurance. Quality Management.

        • The Principles of Quality Management
        • The Quality Manual
        • Quality Standards and Specifications  
        • The Quality Management System
        • Revised requirements of ISO 9001: 2015  
        • Design Quality – Products & Processes  
        • Good Manufacturing Practice (GMP)
        • Documentation
        • CAPA – Corrective And Preventative Action
        • Calibration Certification
        • Change Management and Control  
        • Quality Management Training
        • Product and Process Validation  
        • Supplier Quality Assurance
        • Audits & Auditing
        • Ensuring the Quality Management System is Risk based
        • Etc. …. Etc. …. Etc. …
        • Information & Training presentation   >>>