Documents not controlled by the ECO (Engineering Change Order) process

#1
I received the following observation from my DNV auditor and I want to address it in the best possible way:
"Assure the procedure for document control addresses control of department documents not controlled by the ECO process like customer profiles utilized in Sales"

I am trying to collect ideas (brainstorm) to come out with the best alternative.

I would appreciate your input.
Thanks.
 
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somashekar

Staff member
Super Moderator
#2
I received the following observation from my DNV auditor and I want to address it in the best possible way:
"Assure the procedure for document control addresses control of department documents not controlled by the ECO process like customer profiles utilized in Sales"

I am trying to collect ideas (brainstorm) to come out with the best alternative.

I would appreciate your input.
Thanks.
Your document control procedure will direct required actions on relevant documents that will need a re-visit and change when an ECO is released.
Your auditor perhaps is asking you to document and make stronger your document control procedure. This is by way of linking ECO process to Document control process (improved process interaction) which is a sign of system maturity, if not done.
 
#4
I added the following paragraph to my procedure but my auditors is saying:

"The revision is not adequate. The requirements of ISO 9001 clause 4.2.3 need to be specifically addressed in the procedure for document control regarding control of documents not controlled by the ECO process"

This is my paragraph:

Documents not controlled by the ECO process
Some departments create other type of controlled documents that
require frequent updates; in this case it would be unproductive to
create an ECO every time, therefore, these documents are controlled
by the head of the department or designees, and should be protected
(as applicable) to prevent unauthorized changes.

Please I need feedback, thanks.
 
Last edited:

yodon

Staff member
Super Moderator
#5
Maybe I'm off base here but the requirement states:

"Documents required by the quality management system shall be controlled." (my emphasis)

Are (Customer Profile and other) documents really *required* by your QMS?

I would agree that if these are required by your QMS then your statement about how they are controlled doesn't come close to meeting the requirement.

If these docs truly are required by your QMS (and need to be), you probably need a work instruction for how all the required controls (a..g) are met (outside of the ECO process).
 
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