With my current position I deal with a lot of ECO since the product line I work with was from an acquired company and currently out in the market. The ECO was initiated after staining was observed on one of the components within the kit. That was the justification for the change request. The solution did indeed change the design and as a result the manufacturing process as well. The proposed change was presented to an ECO board for initial plan approval after input from regulatory, R&D, quality, and manufacturing. They assessed the change and the impact it had on the product line. After these groups provided their deliverables, the plan was presented and approved. From there the deliverables were performed and the ECO then effectively closed out.