Evaluate the impact of proposed changes to configuration items (possibly delegated to development team). 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 govern the change process.
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. The BEACON Change Control team will post relevant information to this page as it is developed.


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. These documents may relate to test and qualification requests, customer feedback data, risks analysis measures, revised operating procedures, training records, supplier audit reports, etc.. In addition all data generated during the change process will become organization records and will be filed and retained as per the records management process within the organization. Other roles may sit on the change control board on an as-needed basis depending if the change affects their area, for example for medical type products or process there may be a clinical approver on the board. 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.



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