The change process is really when someone identifies an issue that may need to be addressed. In agreement to the post above, there is a cost factor added to any kind of ECO. Therefore, an ECO is reviewed very carefully before signing off since there are many factors attached to it. I worked in the software development side and our client need some changes to the existing program that they had since the client acquired few new companies. We had several meetings before an ECO was issued since as a contractor it would have been an added cost to the company apart from the contract that was in place. ECO went through many approval from top-down when it finally got to us for implementing the change. We did make the changes to the code but it was a lengthy process as it had to go through development,testing, QC, and then deployed it for production.
A particular change order that occurred was that my companies supplier for a certain plastic was changed. The difference was very slight but however, proper protocol is very important. Therefore an ECO was issued due to the change in the product. This lead to every department being notified about the change. Due to the modifications the regulatory depart became heavily involved and were more modifications with SOP changes, additional work in verification, risk analysis and especially testing. Due to the minor change, it was not as extensive, but there was still an overhaul of things needing to be done to accommodate the change.
ECO’s (Engineering Change Orders) are used for changes in components, assemblies, or documents such as processes and work instructions. I have not filed an ECO at work but one of the Sr.Engineers on the team did go through an engineering change request (ECR). ECR s used to describe a suggested enhancement or problem with a product. The form initiates the change process — it promotes discussions within the organization to help determine the impact of a change and the best possible solution. The Sr.Engineer on the team felt that the design of the stitching on the fabric we use to cover our mitral clip could be changed to better help tissue growth while the device is implanted in the body. This request opened up a big discussion between other sr.engineers on the team, stitching specialists and our distributors to see if this is possible.
ECO’s make it possible to accurately identify ,address and implement product change while keepin all key stakeholders in the loop and maintaining a historical record of product.The change process starts when someone identify an issue that need to be addressed with a change to the product.It ends when agreed upon change is implemented.ECO’s are used in between to summarize the modification ,finalize the details and obtain all the necessary approvals.without a clearECO process making a change to product can set off a chain of costly ,time consuming and avoidable events.
