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  • srg36 replied to the topic Design Change Request in the forum Project Management Process and Medical Device Development 7 years, 5 months ago

    In my company, the first step in performing a change is to submit a change request via our Windchill software. This request goes to the change administrator who either approves or reworks the change request. Once approved, a request goes out to all the managers of each department asking them to assign a person from their department to join the team performing the change. The type of change determines which departments need to be involved. The team who is selected then works together to fill out a Change Control Form (CCF) which is then presented to a Change Control Board (CCB). the CCB determines whether to approve the Change Request or rework it. Once it is a approved, a Change Notice is initiated, and an Implementation Plan (IP) is put together detailing all tasks required to be completed in order for the change to be finalized and signed off on. Once all tasks in the IP are complete, the change administrator audits the completed CCF and if everything looks good the change is finalized. The Windchill software automates the workflow of this entire process, which seems like it may might make things more efficient. However, i have found our change control process to be very burdensome.