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  • hc255 replied to the topic Engineering change order in the forum Project Management Process and Medical Device Development 7 years, 3 months ago

    Engineering change orders allow engineers and others to make changes to documents, parts, etc. Typically one or more potential changes are discussed in a meeting or in a brief conversation. Then the person who becomes responsible for making the changes needs to discuss the changes with the applicable departments to speed up the Change Request process. After that, a change notice is created with the applicable documents and approvers attached to the CN. The CN is then routed to the approvers and document services to ensure that all departments agree and that the changes comply. A final review of the changes is done then the change is implemented into the document. Lastly, all those within the scope of the procedure changes are to train to the new changes made.