The purpose of an ECO is to provide a framework for making a change to a product once it is already released to the market. Going through the ECO process makes sure that you check everything that was checked during the design of the product to ensure that the changes you are making will not negatively impact the safety of the product. Sometimes ECOs can be so involved that they are almost like a mini-project, especially when it involves a regulatory submission. Also, Dr. Simon mentioned in his lecture that determining product disposition is a very important part of an ECO, and I would definitely agree with him. There is a lot of time and discussion that goes into determining the disposition of WIP, stock, and product in the field. If it is determined that there is an impact to product in the field it means a much bigger impact and definitely a regulatory impact, as a “market withdrawal” or recall may need to be issued.