posted 23 November 2000 08:22 AM               

Which part of the ISO Standard is driving this? Is it not possible to circulate copies of documents as and when required, and simply state in your Documentation Guidelines that all documents have to be presumed to be uncontrolled and that if they want an original they have to go to the either the EDP server if it is a EDP file, or to the Drawing Cupboard if it is for example a hardcopy.

The alternative seems to be to stamp on the offending document 'Uncontrolled Copy', and the result is that theoretically nobody could or should work from such documents.

Regards

Andy Bassett

posted 23 November 2000 10:41 AM               

So - document control drives it in some companies with old ideas - my opinion. It is important that everyone know what is controlled and why.

posted 18 December 2000 09:13 AM               

Level I and II documents submiited to a customer for review.

All documents/drawings/literature that effect the quality of the product during the decision making/verification/validation process are required to be controlled copies.

posted 13 February 2001 05:02 PM               

A simple definition of an "Uncontrolled Document":

A document that is not maintained or updated. Uncontrolled documents do not have a traceable distribution. Uncontrolled documents should be current at the time of issue and marked appropriately, at least with the words ãuncontrolledä.

posted 29 March 2001 06:01 PM               

I would just like to add that there are different requirements in the various standards/specifications.

As an example, if you are automotive and QS or TS, it is required that the business plan shall be a controlled document which is not a requirement of ISO-9k:1994. I'm not sure about ISO-9k:2000.

posted 30 March 2001 08:13 AM            

Any "living" document, business plans, FMEAs PPAP's, Control Plans and the like. Basically any document we could generate and update in a spreadsheet, database or word processor, I have defined in systems as Living Documents. In our quality systems we have stated that these computer files are the only controlled copy, I note in the master lists who or where files are maintained. i.e. the business plans were on the secure drive belonging to the Operations Manager, APQP stuff was saved on a secure network drive accessible only to the core team.

A statement showed that hard copies were not controlled but might be used as reference material as needed. Each person knows how to check the latest revision date to tell if the copy is the most current. This worked for my first ISO 9002:94 system, it worked for my next system which was QS third edition, and now in my current plant, I expect that it will work for ISO 9000-2000.

I have also helped several of our other divisions set up their own quality systems, and those that had computer literate persons on board have used this or variations of it for themselves. The only thing you need to make sure of is that if you go electronic, you need people who are not afraid of computers and some extra time spent in training and setting up secure drive folders for ALL the committees and task groups.

The cool thing about computers is that you can schedule meetings, you can send agendas and minutes, you can document approvals and very seldom print anything out plus, it doesn't take very long before that one person who ALWAYS uses the excuse that they did not know about it figures out he'll/she'll get nailed by the other members of the committee when they all say "Your name was on the e-mail just like the rest of ours." Peer pressure is a very good motivator.