Our company uses ECOs and refers to them as Change Notices, as these can be originated by non-engineering as well. These CNs serve to make revisions to any document in the Quality Management System, including but not limited to SOPs, device and tooling drawings, manufacturing floor plans, equipment registrations, etc. In order for this to be passed, it must be reviewed and approved by the necessary departments depending on the nature of the change. In general, every CN must be approved by Document Control to check for formatting and consistency across the QMS. Manufacturing Engineering must sign and approve that the changes do not affect the current manufacturing process and if it does, state if it requires a design review. Regulatory, Quality, and Operations must also sign. If one department rejects it, even if the other departments already approved it, the originator of the CN must make the changes and get all of these approvals again. The QMS software we utilize is TrackWise.