ECO (Engineering Change Order) process questions

duff999

Involved In Discussions
#1
Hi All

I am developing our ECO process SOP and could use some input if you can.

I typically have used the ECO process for product that have been released to production, and not R&D work. Is this the correct worklow?

Thanks in advance
 
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shimonv

Trusted Information Resource
#2
Yes. Major changes go through the design and development process (plan, input/output, V&V, etc.).
Minor changes (sustaining engineering) goes through ECO process. That is the common industry practice.
 

William55401

Involved In Discussions
#3
As design and development progresses (typically defined phases per a plan), the level of rigor (including document control) increases. I am not sure the answer is as simple as above. For example, when are material specifications frozen so that they are in a condition to be approved and purchased for human use product? The approval of those specifications via an ECO process will occur during Design and Development. As you work on change control / ECO process, ensure that it complementary to your Design and Development for new products. As you think about ECO for released products, ensure the result of each ECO are records that maintain the Design History File (look out for Risk Mgmt) in real time. I agree that there are documents that do not require engineering change order rigor. Things like protocols, plans and reports can be simply approved and filed. HTH.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#4
and not R&D work. Is this the correct workflow?
To stifle a PURE RESEARCH work with ECO bureaucracy would be nuts, in my opinion.

When it comes to product DEVELOPMENT, from concept to volume production, I would think that, as you release products for prototyping, alpha and beta testing, the ECO protocol rigor should be carefully introduced. Some product development cycles, including V&V might take years to accomplish. The closer you are to formal release, the more sense to make ECO being followed.

Good luck.
 

Ed Panek

QA RA Small Med Dev Company
Trusted Information Resource
#5
We used the concept of a "Project Proposal" at the very start. A very loose idea of what we wanted this design to accomplish. Once it was delivered to Engineering they determined the major obstacles to determine feasibility. For the Engineering staff, we initially provide the sandbox and get out of the way during feasibility (is this idea even possible). They are free to iterate until they have a releasable candidate test solution. Once they are at this point and a budget for further development is created we introduce more controls. Once we were confident we could do this, we started a design plan based on the early feasibility results.
 

yodon

Staff member
Super Moderator
#6
Without intending to pour gas on myself and wait to be flamed (not that anyone here would do that), there does come a time in the Design process where *change control* is needed. I would tend to agree that a full-blown ECO system probably introduces too much overhead, though. If something has been used in design verification, subsequent changes need to be controlled.
 

guna8184

Starting to get Involved
#7
Are you the design owner of the product if you are than its easy to control.
You should consider to add in your flow the disposition of the old part prior use of new part.
Is it immediate change or running change (deplete old part) before use new part.
I hope this information is useful
 

Tidge

Quite Involved in Discussions
#8
(pours gasoline on self, lights cigarette, passes to @yodon )
there does come a time in the Design process where *change control* is needed. I would tend to agree that a full-blown ECO system probably introduces too much overhead, though. If something has been used in design verification, subsequent changes need to be controlled.
During development, the bare minimum is to have an process for controlling/establishing design outputs that are to be used for verification. I believe the minimum number of 'independent reviewers' for such a change is one (an independent 'quality' representative). I want to note that even in development (typically later in that phase, after verification activities have begun) an established change order process will be necessary so as to not jeopardize previously collected verification data.

As design outputs are intended to satisfy more stakeholders, the review and approval process will naturally involve more people, even if the product is still in development.
 
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