Engineering Change order vs. Change Control

duff999

Involved In Discussions
#1
Hi Folks

More questions, just looking for a high level of understanding.

I am developing an SOP for the ECO process stating - specifically the ECO process applies to released work instructions, materials, packaging and labeling, production equipment and software and other specific documentation.

In a scenario where a piece of software has a revision update - this SW may be used in production or calculating results, would this fall under the ECO process?

Or

Is it better to create a Change Control SOP - rather than locking it down to just ECO?

Any help is appreciated
 
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Ed Panek

QA RA Small Med Dev Company
Staff member
Super Moderator
#2
If the software could affect product quality the software should be controlled. If you modify it should have a revision level. It should be processed as a change via the ECO process and V&V tested prior to release (similar to the initial release). You should document in the batch record which version(s) of software was used for that batch.


your Change Control SOP will define how changes are managed. Some changes like typos may just require a single signoff. Major ones likely need a lot of testing and Design Review before release.
 

John C. Abnet

Teacher, sensei, kennari
Staff member
Super Moderator
#4
Good day
Is it better to create a Change Control SOP - rather than locking it down to just ECO?
Any help is appreciated
Good day @duff999 ;
In my experience, "degrees" or "categories" of change is never a very effective approach (and generally causes confusion with associates).

A change to a controlled process (how the product is processed) or product (change to the product itself), is generally a good / effective / and all encompassing definition of required change point control.

If we identify what/when/who in regards to that definition, then you've created the mechanism for providing the organization and customer..
a) awareness
b) traceability
c) limited exposure (if/when a problem occurs)

Why would an "engineering change" be treated as one type of change control (and of course , what exactly constitutes an "engineering change" ? [Let's assume that this is a product drawing change.] ) be treated any different than a process change?

Doesn't the organization (and in most cases, the customer), want to know what/when/who ?
Doesn't the organization (and in most cases, the customer), want to ...
a) to be "aware" through the required approvals, notifications, training...
b) have traceability to which product is affected (and which is not)...
c) limit exposure by knowing exactly when a change was applied and to which product has been impacted?...

...regardless of whether it is a product or process change?

While on the subject, does not a change to a controlled product or process generally require a change to documentation? (process standard, work instruction, PFMEA, control plan, product drawing, etc..etc... )? Therefore, does not this approach also apply to those documents associated with a controlled product or process?

Simple and concise is good. My experience.


Hope this helps.
Be well.
 
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