Though I have not came across any but according to my knowledge ECO is a documentation packet that outlines the proposed change, lists the product or parts that would be affected and requests review and approval from the individuals who would be impacted. ECO mainly makes modifications to components, assemblies, associated documentation. ECO gives us information that manages delays and makes easy inputs.

I have had to modify CAD drawings to accommodate new design changes. This involved changing the rev number, adding redlines, and adjusting the bill of materials (BOM). Once the redlines drawing was approved, I had to go back and remove all strike-throughs and red font text and replace it with all black font with the final revision indicated in a table that's usually on the bottom right hand corner of the drawing. I have not dealt with engineering change order yet, but I'm sure I will as I gain more industry experience. My understanding of an engineering change order is that it is initiated when an issue is pointed out and the solution leads to changing the product slightly or significantly, depending on the issue. Once the change is approved, the physical product change is executed and the ECO is used to throughout the process to sum up what the modifications need to be made, finalize the details, and obtain all the approvals needed to implement the change order.

I don't have much experience in Engineering change order. Thank you SMK45 for sharing your experience.From my research i found the stages of the engineering change process are
1. Issue identification & scoping
2. ECR creation: An engineering change request (ECR) is created to examine the necessity and feasibility of the change, to identify parts, components and documentation that might be affected, to estimate costs and list the resources required to implement change.
3. ECR review: Review and discussion among key stakeholders and is modified as needed.
4. ECO creation: Once the ECR is approved, and ECO is generated, which list the items, assemblies and documentation being changed including any updated drawing, CAD files , SOP, MWI(Manufacturing work instruction) required to make a decision about the change
5. ECO review: ECO is circulated to change review board made up of all stakeholders who need to approve the changes
6. ECN circulation : Once the ECO has been approved, an Engineering change notification/notice is sent to affected individuals to let them know.

7. Change implementation: Those responsible for implementation use the information in ECO and ECN to make the make the requested change.

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.

I haven't personally worked with an ECO, but I have seen plenty of them in my current position. I have only noticed our company producing ECOs for product in the validation and post validation stages (once the design input and verification are completed). We implement ECOs for design/hardware changes and for packaging/labeling changes of our launched products. Depending on the complexity of the change request, ECOs typically take between 4-6 weeks to complete.

For example, currently one of the components in one of our products is reaching its end of life (EOL), meaning the manufacturer isn't producing the product any longer (can be due to error or newer versions that are available). So after validating the new part will be equivalent to the part we currently use (which is reaching EOL), an ECO must be produced for that product. The ECO is completed by the legal manufacturer of the product. I say this because we have shared rights on some products with our partners, and if they are the legal manufacturer for some of the country registrations then they will need to complete the ECO process. Even when that occurs though, we always write our own ECO for our records parallel to our partner's ECO, it just isn't a critical path in the schedule.

Another example I have seen is for packaging and labeling changes. ECOs are needed each time a large packaging/labeling change is made. This can be for updating manufacturing addresses, customer service information, content and the addition of translations (typically caused from the addition of a country on a SKU or content changes).

Similar to aij5, I have had quite a bit of experience working on ECO's (my company calls them CCFs (Change Control Form)) for a product that my company acquired and it was already on the market. Unfortunately, it was a very cumbersome process, because in reality we were doing an NPD project under the realm of ECOs. We were creating new prints, and redefining all the specifications and tolerances, changing suppliers and going through process development with our suppliers, and it became very difficult to work within the constraints of the ECO process, but we had no choice since the product was already on the market.

I've experienced several different kinds of changes. One change I've implemented several times was the change of requirements listed in our CAD drawings. I also had to change document policies within SOPs to reflect current practices. These two changes would be considered Non-essentials design change.

Project changes, change within the context of project management is anything that transforms or impacts projects, tasks, processes, structures, or even job function. Therefore change management refers to the tools and processes you use to manage change within a project and its project team. Change requests are inevitable in any project. Successful project managers effectively manage changes through the use of change control boards. Project change management includes analyzing change order requests for their impact on the projects scope, schedule, budget, risk, quality.

For the changes to be managed in a correct and effective manner to be used in determining the steps they must undertake to study and evaluate each change to take the right decision.

These steps include submitting the request for change in a formal manner, through which the required change and the reasons for it and its impact on the duration of the project and the entire project, if it is negative or positive, and provided with the presentation of all documents.

After that, the project manager evaluates the change, indicates its degree of importance to the project, compares it to the impact that the project might have if the change was approved or rejected, and made a recommendation to do so to the party authorized with final approval.

If the decision is to approve the change, then the project manager must issue a change order to the parties that will be responsible for carrying out the work included in that order and which may result in an extension or reduction of the project’s implementation period, and an increase or decrease in the cost of the project.

Posted by: @hc255

I've experienced several different kinds of changes. One change I've implemented several times was the change of requirements listed in our CAD drawings. I also had to change document policies within SOPs to reflect current practices. These two changes would be considered Non-essentials design change.

I have never experienced changes in a work setting but I did experience changes during my capstone project. My project depended on a lot of CREO work. Like hc255 there were many changed to our CAD drawings which then had to be updated in other documents as well. Since the CAD designs changed frequently we had to change our requirements document every time there was an update or change to our CAD designs. 

Project changes refer to change within the context of project management anything that transforms or impact project tasks, processes etc. It refers change inside a project and its team. Like as how dfn3 told, my project too consisted of ANSYS work which has to be modified in other documents as well, whenever there is an update.

 I have not come across any to my knowledge, however, from what I read, ECO is a document that outlines suggested changes, lists parts and details that would affect the design, and the overall request for review and approval from the individuals who it will impact. ECO basically modifies components and assemblies in the documentation and it gives us information that manages delays and makes easy inputs.

I worked on a project at my company involving a product that varied in design depending on the hospital's preferred configuration, so there were hundreds of components in our catalog for this product. Several times during the course of the project the design of a certain component had to be changed, for example, text on a label located on the inner packaging. This would result in a Design Change, which involved meetings and lots of paperwork in order to justify that the change in design would not introduce more risk to the product. Even certain changes to one of the component's specification documents such as dimensions or functional requirements was considered a Design Change, because you were changing what features were documented as critical. However, I don't think my company distinguishes between different types of design changes - they're all referred to as just "Design Change". But because this was a product already on the market, according to the definitions we used in class these changes would be considered Engineering Change Order (ECO).

After reading many of these replies, it seems as if these changes occur frequently, especially ECO. I wonder what the ratio would be if we compared projects that did not need a change compared to ones that went through one of the three processes. I’d imagine it would weigh more towards implementing a change because creating a perfect product on the first try is almost unheard-of in the medical device field. NDC’s, DCN’s, and ECO’s are probably so common that time has to be allotted for so the project can stay on schedule.

Feel free to agree or disagree with me, as I would love to hear other’s thoughts. I don’t have experience with any of these changes, this is some information I have gathered after reading the above posts.