Controlled Documents - How many copies can be stamped "Controlled Document"?

A question was brought up today on the subject of how many copies of a controlled document a person can have that is stamped "Controlled Document".All the copies are of the same document.
Our policy does not cover this nor can we find anything mentioned in the QS-9000 3rd edition QSR.
Anybody know?
One person here says he can have as many copies as he wants all stamped "controlled".
and only he can make changes.

[barb butrym]

what is your definition of control? Typically it means that if a change is made, the "copy" is retrieved and replaced...or some variation of that.

so ...the answer then becomes,,,,as many copies as he needs, as long as they are retrieved and replaced when updated...so that would have to be noted somewhere....perhaps a master distribution list? Potentially dangerous ....a 'gimme a nonconformance' situation.

[Marc]

Originally posted by roadrunner5_2000:

A question was brought up today on the subject of how many copies of a controlled document a person can have that is stamped "Controlled Document". All the copies are of the same document.

True - you can have as many as you want.

Our policy does not cover this nor can we find anything mentioned in the QS-9000 3rd edition QSR. Anybody know?

One person here says he can have as many copies as he wants all stamped "controlled" and only he can make changes.

The key is that every 'controlled' copy, whether 1 or 1000, has to be identified - there has to be a distribution list or other mechanism to ensure that every copy is defined and accounted for and that when a change is made to the master document each 'controlled' copy is addressed.

How you address the change is up to the company. You can send each 'owner' a memo which advises them of the change and says something like "It is your responsibility to remove the prior version from your manual and destroy it". I have also seen some companies that require that the old version be returned to the document owner/distributor or that a signed form be returned where the recipient 'swears' that s/he understands the change, has removed and replaced the old version. In extreme situations (I used to see this in my military manufacturing days) you send someone out to physically take the old document and replace it with the new document. In those days if you 'lost' a controlled document that was issued to you, you had to sign a statement to that affect before you got your copy of the latest revision.

The question is, how many controlled copies do you need?

Also - don't forget that often a document change requires training on the document revision(s).

Much of this is becoming moot by electronic control and distribution.

[This message has been edited by Marc Smith (edited 08 April 2000).]

We've moved to an electronic drawing database for most of our controlled documents, which simplifies paper control.
However, everyone who actually works with the product likes a paper copy of the product in front of them.
Our ISO auditor said all data used to perform a job must be controlled, and our printouts are not.
We've talked about putting expiration dates on the printouts or a datestamp and a procedure stating that X# of days after the printing the document has expired.
This doesn't seem to cover ISO 4.5.2 "Invalid and/or obsolete documents are promptly removed from all points of issue or use, or otherwise assured against unintended use".
How much do we have to do to satisfy our auditor that we're "assuring against unintended use"? Do we have to do daily sweeps of the work areas to pick up expired documents?

Thanks,

AJP

[Marc]

Originally posted by AJPaton:

We've talked about putting expiration dates on the printouts or a datestamp and a procedure stating that X# of days after the printing the document has expired

This should satisfy the '...or otherwise assured against unintended use..." requirement. I would stamp each document footer.

[Jim Biz]

I have observed similar instances where documents are controlled mainly in electronic databases > what was done was to insert at the top of the document "valid on print date XX/XXx only"
(But I wouldn't be real sure that some external auditors would allow it.)

[David Mullins]

ROADRUNNER: Anyone can make changes to this guys documents, not just him, but they do have to go through the review and approval cycle. If he has multiple copies of the same documents (and same versions) find out WHY, or is he simply off his medication.

AJP: It sounds like you still have a hard copy drawing system with electronic file backup. If that's what they want, then I'd describe the system that way. Hard copies = controlled documents (no expiry dates), and electronic back-up of files is provided for safeguarding data, and for future revisions. In a conventional QMS it's just like having hard copy documents distributed, while the original WORD file (or whatever) is kept on your PC - no different.



------------------

Nope, we have a electronic drawing system, controlled by our off-site design center (with their own ISO certification). We're registered to ISO 9001 through their design activities. No design in our plant.
They control the design, we provide computers in each assembly area with access to the electronic drawings.
Problem 1 - the computers don't move to the components being installed so people like a hard copy of what they're building, for occasional reference.
Problem 2 - there's been considerable expense for this system, and it's being considered in other locations.
Summation: we're looking for a simple way to control the printouts and encourage a paperless facility.

AJP