ISO 9001:2000 - Documents Requiring Control - Documents of External Origin

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Phil Schoner

Specification control

I have a special situation regarding specification control when the specifications are not yours. Company A does contract design work for Company B. "B" maintains a website where all specifications are maintained and developed. "A" has access to this site as they perform their contract design service for "B". When a finished design is delivered to "B", it is, of course, on the web site. "A" occasionally prints out hard copies of drawings they have worked on. They file them, scribble notes on them, etc. (You know how engineers can be!). There is no chance that these filed hard copies will be used to produce the part, etc. The controlled drawings are on the web site, and they are controlled by "B". "A's" offices are separate from "B's"

Question: Is "A" required to mark their hard copies of "B's" drawings as "uncontrolled copy"? I think not, but would like to hear some comments and opinions on this.

Phil Schoner
 

CarolX

Trusted Information Resource
Phil Schoner said:
I have a special situation regarding specification control when the specifications are not yours. Company A does contract design work for Company B. "B" maintains a website where all specifications are maintained and developed. "A" has access to this site as they perform their contract design service for "B". When a finished design is delivered to "B", it is, of course, on the web site. "A" occasionally prints out hard copies of drawings they have worked on. They file them, scribble notes on them, etc. (You know how engineers can be!). There is no chance that these filed hard copies will be used to produce the part, etc. The controlled drawings are on the web site, and they are controlled by "B". "A's" offices are separate from "B's"

Question: Is "A" required to mark their hard copies of "B's" drawings as "uncontrolled copy"? I think not, but would like to hear some comments and opinions on this.

Phil Schoner
I don't think so, Phil. Look at it this way... "A" furnishes a product to "B". "A" keeps one part (this case, a drawing) in their part/engineering/sales file.

I work for a sheet metal job shop. We use to keep a sample part from the first production run. We identified it with the part number, revision and customer info, but it was never marked as "uncontrolled".
 
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Wes Bucey

Prophet of Profit
Let's revisit the concepts of
"copy"
"control"
"uncontrolled"
"superseded"
"draft"

In my experience, "copies" are rarely "controlled" - almost by the very nature of any organization, once the copy leaves the "controlled" environment, it has ceased to become a controlled document.

The essence of a document control system is to ensure documents
  • are protected from harm (or unauthorized modification),
  • are "managed" (stored and easily found and retrieved and run through an authorized revision system)
  • are "controlled" (to ensure superseded, obsolete, or unauthorized versions do not find their way into the manufacturing or other process and activities of the organization.)
The situation you describe seems like the only "controlled" documents are those on the customer's website (i.e. they are not approved for release until the customer authorizes their addition to the website.) Similarly, it seems that any document copied from the website is "uncontrolled" by definition (it is NOT on the website.) Therefore, adding the word "uncontrolled" to the copy is superfluous. (copies made before customer adds the authorized version to its website are still "drafts.")

The copy remains or now becomes a "draft" for future work or speculation about working with the document (engineer's notes or machine operator's notes or installer's notes) which are not part of the formal revision process and therefore do not affect the "controlled" document on the customer's website.
 
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James Gutherson

The idea of marking something 'uncontrolled' is to prevent it's inadvertant use instead of the proper 'controlled' document.

In this case the document never goes near the production environment and so could not be used inadvertantly, and so as stated by the other marking it 'uncontrolled' would be superfluous. (Having a document removed from the production area, is a form of control in itself)
 
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MarilynJ6354

Customer Changes To Prints

We have a customer who keeps making changes to prints and doesn't provide a new revision level. In fact, they refuse to. They just keep giving us the same print with handwritten, initialed changes to dimensions. If they date the changes is that all we need?
 

Wes Bucey

Prophet of Profit
MarilynJ6354 said:
We have a customer who keeps making changes to prints and doesn't provide a new revision level. In fact, they refuse to. They just keep giving us the same print with handwritten, initialed changes to dimensions. If they date the changes is that all we need?
The supplier's obligation falls under "care of customer documents" -
supplier documents the receipt of the handwritten changes and makes internal adjustments to prevent use of previous versions (also with handwritten changes)

A customer's lack of rigor in document control is no excuse for the supplier to abandon its own QMS.

This is a concept which carries through in other aspects of Quality besides Document Control. In our high tech machining business, we often made components to tolerances which the customer didn't have instrumentation to check and confirm our readings. That did not release US from the obligation of assuring we met the tolerances.
 

Marc

Fully vaccinated are you?
Leader
I've typically allowed 'redlined' or penned revisions as long as it is acknowledged in an e-mail or such. The it goes into the engineering change system where that fact that you were given an 'initialed' change can be noted.

HOWEVER - Ensure you keep a history of each change so they can be readily compared for contradictions, etc.

AND - Make sure it goes through your engineering change system as it should.
 
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Yvaine

This seems to be an old thread. I found the initial post through Google, and it was really informative. Thanks to whoever posted it! :)

I have a somewhat silly question regarding controlling external documents. I apologize in advance for its silliness, but I figure it's better to be sure than be sorry after the audit. :D Is there a need to control communications (e.g. letters, memos) from external parties?
 
Hello Yvaine, and welcome to the Cove :bigwave:
I have a somewhat silly question regarding controlling external documents. I apologize in advance for its silliness, but I figure it's better to be sure than be sorry after the audit.
Silly? :confused: What's silly about it? Just ask away.

Is there a need to control communications (e.g. letters, memos) from external parties?
: That would basically be records then. Yes, to the extent necessary to "provide evidence of conformity to requirements and of the effective operation of the quality management system" (ISO9001:2000, clause 4.2.4). What it boils down to is that the media used to carry this information is irrelevant. It is up to you to decide which information you need, and you also need to take into account what your procedure for control of records have to say about it.

Also have a look at: Control of documents - Emails - 4.2.3 f

/Claes
 
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