Getting ready for my readiness review in 3 weeks...and was wondering about this....

now my customer supplied or external documents I have a system for....but what about internal documents..not doc's I use for the floor.. I'm talking about specifically b/p for fixturing or projects for improvements....non part specific....

We have b/p of these and they have rev levels and dates on them...but there is not a specific list that is controlled. Its really up to the process eng that if he got hit by a bus tomorrow I guess we'd be scrambling to figure out what was his system....

is it correct to state that all documents if they are process related need to be controlled?:confused: even machine b/p?

Is it correct to state that all documents if they are process related need to be controlled?:confused: even machine b/p?
Yes, for the reason you stated, among others.

what about documents that come from a company we bought a license for...b/p's...and we made our own b/p's from them.....can't they be reference doc's?

or is it just simply...any document that is process oriented whether its ours or not....should be controlled.....even doc's that are for improvements for fixtures....

what about documents that come from a company we bought a license for...b/p's...and we made our own b/p's from them.....can't they be reference doc's?

or is it just simply...any document that is process oriented whether its ours or not....should be controlled.....even doc's that are for improvements for fixtures....
You've lost me now, I'm afraid. Can you be more specific about "documents..from a company we bought a license for...and we made our own b/p's..."? And "...docs that are improvements for fixtures"?

Look. Here's a simple rule of thumb.
If the document is used to provide a product or service, it should be controlled and under configuration management to assure no obsolete document gets into the mix and that none are lost or none modified without due approval. With this definition, every blueprint used in reference or actual production of a product MUST be controlled, regardless if it comes from customer, supplier, or in-house. I can't think of any exception to this rule.

I understand all about making products based on a license purchased from another company. The original blueprint MUST be controlled as part of controlling the license agreement. You can't unilaterally modify the license agreement, so it is controlled as well. Obviously, if you make any adaptations, you need to assure they conform to the license. If not, maybe you no longer need the license.

I swear to you it is not difficult to manage and control documentation related to production and quality of products. You are trying to avoid doing something you should want to do regardless if you are trying to adhere to a Standard or not. It is just good business to control documents related in any way to producing products.

I am currently revising our QMS to get where I would like it to be. As one improvement, I am using MS Visual SourceSafe (VSS) to control all of my QMS documentation. I have used VSS many times in the past and it seems to be working out quite well. I formally check in and check out documents as needed. It might seem like "overkill" but it works well for me and it ensures that all of our QMS documentation is well-controlled and maintained.

Question to Wes: Is my VSS approach to document control using formal CM adequate enough for covering ISO requirements in this area? I would think so as it provides an excellent , formal control mechanism for the development, revision and update of procedures, forms, etc.

As another continuous improvement, I am also working to create a "virtual" QMS and automating it as much as possible. Do you have any recommendations on commercial software related to such an effort?

:thanx:

The beauty of the current version of ISO9k2k is that it does NOT dictate what an organization must use or do beyond the functions of following government regulations, customer requirements, and good business practices suitable for that business. Therefore, a mom and pop shop can comply with all their paperwork in a cigar box (if the quantity of paperwork fits), while a megacorporation may need computers, scanners, padlocks, and platoons of caretakers to manage their documents.

As long as you don't set yourself up to be a "choke point" in your document flow, any system should be fine. A choke point occurs when EVERY piece of paperwork has to go through one person regardless if that person is otherwise involved in the activity related to the paper. An extreme example might involve a work instruction for polishing a product. If the worker had to come to the quality manager each shift, collect the most recent version of the work instruction (to have available at work station - not to use to actually perform the activity), perform the activity, and return the work instruction to the QM for safekeeping every time the worker took a "nature break," you can see the concept of "choke point."

It sounds silly, but there have actually been organizations that did something very similar in a burst of obsessive zeal to "control" documents.