Okay, I can't even believe I'm asking this question, but sometimes I feel so bogged down in the system that I can't see clearly enough to make decisions. Our document control procedure reads:

Any copies printed from the master file will show a watermark saying “DO NOT COPY”. A copy with this watermark indicates it was printed from the master online file, is uncontrolled, and must be verified by the user as being current.

Our TS system shares its document control procedure with the ISO14k1 system, and the EMR has a problem with this watermark. His complaint is that if he wanted to hand out copies of one of his procedures to 20 people, he would have to "print" 20 copies instead of printing one copy and making 19 photocopies.

1. Am I crazy to think it's okay for him to make photocopies of the document? The point is that the watermark indicates it's uncontrolled, not that it can't be photocopied.

2. Does anyone else think it's shady that the watermark says "Do Not Copy" on uncontrolled documents. If I didn't have a copy of the Document Control procedure in my hands (and only a few of us do) I would know I couldn't copy the document, but I wouldn't know I was supposed to verify the latest revision.

3. I'd rather see "Uncontrolled Copy. Verify current revision before use." as our watermark, but I'm afraid that forces us to create a bunch of controlled copies for use throughout the plant instead of having one online master and one controlled hard copy. Or... how do we prove people know they have the latest revisions?

Actually, can somebody post a copy of a bulletproof Document Control procedure for me to look at? I'm afraid I'm trying touch up a system that is deeply flawed.

You are not crazy!

A lot of organizations get their knickers in a twist over issues like this.

Essentially, the problem arises from an incomplete understanding of Document Control. Certain industries are highly regulated (pharmaceuticals, for one) and must adhere to strict and absolute protocols about document control.

The rest of us have a lot of leeway in how we control our documents. The issue of how long a printed copy of a document is valid when the only MASTER is maintained as an electronic file depends on things like

how frequently is the document revised?
what purpose will the printed document be put to?
will the holder of the printed document be trusted to destroy the printed version if an expiration date is provided?
will our infrastructure allow for more than one means of producing "temporary" copies?
The answer rests with the organization. One technique many organizations use for the watermark issue is to print a print date and an expiration date for destruction of the copy. In the case of xerographic copies - someone must have the authority to make an exception and to extract the promise of destruction of copies once the primary purpose is over.

In other organizations, often the control policy is much more rigid and severe than it needs to be. The primary purpose of control is to assure obsolete documents are not relied on to make or inspect products or to perform some other activity which could result in loss or damage.

Therefore, if a document is to be used for a reference guide for "20 people" - the question has to be, "What will these people do with their copies?" Do they intend to take them back to their work stations as permanent references? That's a no-no. Will they be used for a training session to familiarize them with the document, then collected and destroyed with the big part of the lesson being that reference should always be made to the Master document before performing the activity? That's a yes-yes.

In my opinion, the biggest bugaboo with Document Management is organizations adopting someone else's method with no thought as to how that method will work with their organization.

You are not crazy!

A lot of organizations get their knickers in a twist over issues like this.

Essentially, the problem arises from an incomplete understanding of Document Control. Certain industries are highly regulated (pharmaceuticals, for one) and must adhere to strict and absolute protocols about document control.

The rest of us have a lot of leeway in how we control our documents. The issue of how long a printed copy of a document is valid when the only MASTER is maintained as an electronic file depends on things like

how frequently is the document revised?
what purpose will the printed document be put to?
will the holder of the printed document be trusted to destroy the printed version if an expiration date is provided?
will our infrastructure allow for more than one means of producing "temporary" copies?
The answer rests with the organization. One technique many organizations use for the watermark issue is to print a print date and an expiration date for destruction of the copy. In the case of xerographic copies - someone must have the authority to make an exception and to extract the promise of destruction of copies once the primary purpose is over.

In other organizations, often the control policy is much more rigid and severe than it needs to be. The primary purpose of control is to assure obsolete documents are not relied on to make or inspect products or to perform some other activity which could result in loss or damage.

Therefore, if a document is to be used for a reference guide for "20 people" - the question has to be, "What will these people do with their copies?" Do they intend to take them back to their work stations as permanent references? That's a no-no. Will they be used for a training session to familiarize them with the document, then collected and destroyed with the big part of the lesson being that reference should always be made to the Master document before performing the activity? That's a yes-yes.

In my opinion, the biggest bugaboo with Document Management is organizations adopting someone else's method with no thought as to how that method will work with their organization.


I think seeing how other organizations approached document management gives you a framework. Some of us just need to think through what we need for our organizations by seeing someone else's work.

My thoughts would be, how hard is it for the employees to look up the "controlled" version? Why would you need 20 copies? Is it that hard for an average employee to get to the controlled copy?

I do agree with your statement about changing the watermark to read uncontrolled copy as long as it is practical for the employees to get to and verify the rev level. As far as the statement about having to print 20 copies, vs. copying one copy...it's kind of semantics in this day and age. Printers and copiers use pretty much the same technology anymore. As a matter of fact, we just replaced our network printer with a network copier that you can print to. So, in that case, whose to know if it was printed or copied?

Exactly. All our printers are printer/copiers. It's the same darn thing.

And as far as people getting to the network copy to check against the master, even though it's accessible to them, I doubt they actually will, know what I mean?

And as far as people getting to the network copy to check against the master, even though it's accessible to them, I doubt they actually will, know what I mean?

Therein lies the rub:bonk:

if they have access to the network, then I really cannot see why the paper copies are needed except as a training issue/chcklist for jobs not performed often enough to memorize.

Do you actually have a problem with uncontrolled out-of-date documents being used and so causing nonconforming material? If not, then it really shouldn't be a problem for an auditor. As long as all your people have been trained to recite the following: "I wouldn't use this work instruction (fill in that blank with appropriate document) without first checking to make sure that it is the current revision, and I can get that by going to my computer and checking it like this."

No, I doubt we have anyone using the wrong rev level of documents for anything that affects product quality. Our operator instructions, etc... are controlled.

It's more likely that people have out-of-date copies of instructions that they don't refer to. Say, receiving might have an instruction on how to generate a bin label, but the software interface has been updated so the instruction has been updated. Someone in receiving might still be holding on to an outdated copy, but they know how to do the job the right way.

My concern is that an auditor might say "Show me the procedure you follow to do this." and the employee will proudly whip out a copy they haven't even needed to look at in two years.

Maybe I'm nitpicking, but I'm a perfectionist, and while it doesn't necessarily concern me that our document control might not be perfect, it does bug me to write a document control procedure knowing that it isn't airtight.

Our procedure states that documents that the current rev level is only available via the intranet and all employees are trained on how to access the documents and dispose of printed copies unless they are retained as records. This sounds a little more like a training issue than a document control issue.

IMHO

Michelle

HI people,.... im in the process of making my first procedure

control of document. and my question is... can I do only one document reflecting the diferent traitment of the document beginning to the QMS and the document beginning to "engineering specifications"

i hope you understand, my english is not to good

Another question... are the technical specifications controled documents? I recieve. both... some impact in the quality of my products(controled documents) anothers do not (not controled documents)

Are im doing the thing rigth??

thanks you people...

very nice forum you have here

Hello, We ran into some of the same problems here when initiating our doc. system. Some of the ideas that have worked for us:

-We changed from a watermark to a standard footer on all procedures that reads "This document is uncontrolled unless a Controlled Document stamp appears in RED". This eliminated the problem with copiers.
-We utilize read-only access via computers at all possible areas. (The documents are only able to be revised by certain doc. control personnel terminals) All terminals may print an uncontrolled copy but we try to encourage visual only if possible.
-We do keep two sets of Controlled documents in our company, one in Production and in Final QA. These are kept neat and available to all employees and also provide easy revision reference points for uncontrolled docs.
-Our doc. control procedure outlines that the revision of any uncontrolled document must be verified prior to use beyond the initial receipt or printing of the document.
-As far as employees keeping a "stash" of old revision documents, we have only encountered that one time and were informed that it was too far to walk to the printer to get a new one (can you believe that?!) We do have printers throughout the facilities. Our internal auditors are very much on the lookout for old revisions of documents at all times, not only during audits. The best way to prevent stashing is training...training...training!
Best of luck! Lisa

We did much the same as Lisa's company.
- We include a footer on all documents that states, "The (our company name) document control system contains the most current version of this writing. Uncontrolled when printed."
- Our document control system allows all personel read-only access to the most current documentation.
- All personnel were trained on how to access the system and issued a card (that fits in their employee badge holder) with instructions on accessing the documentation.
Good luck with whatever you decide to try.

.....My concern is that an auditor might say "Show me the procedure you follow to do this." and the employee will proudly whip out a copy they haven't even needed to look at in two years. ....

You can even recover from this. Teach your people to just tear up the old doc in front of the auditor, "thank" the auditor for helping them get better, print the current rev, check the rev block for what changed, and then decide what action they have to take based on the extent of the change.

Hopefully it was just a minor change, but once people realize they could be personally responsible for a recall campaign, they usually decide to not keep old hard copies around.

We are fortunate that no one is more than an arms length from a computer and painless access to the current version. But some die hards still love that hard copy!

Good luck - keep it simple. Make the doc holder responsible or your life will be "heck".

control of document. and my question is... can I do only one document reflecting the diferent traitment of the document beginning to the QMS and the document beginning to "engineering specifications"

As long as you address the requirements of the standard (assuming you are going for 9K2K), you can do it however it works for you.

Another question... are the technical specifications controled documents? I recieve. both... some impact in the quality of my products(controled documents) anothers do not (not controled documents)


Are these specifications that you receive from you customers?

If they control the product, then they must be addressed in the doc control procedure.

thanks Carol, yes i recieve these specifications from customers, but they send me some actualizations. and send me to another specifications that i dont need,

we produce exaust system for automoviles then we recieve from our customer some specifications of product that we are actually producing, and send me too another specifications of product that maybe we are gonna produce, maybe not, or specifications of product that we did time ago... and not doing now

hope you could understand me...

One other thought on employees keeping their personal stash of documents. We had a footer print that said the document was good for 24 hours from the date of printing. It could then be photocopied for training.

Then if quality issued a 'controlled' version to a binder, it did not have this 24 hour statement on it. We did have to train over and over again about the 24 hour note vs. the controlled binder (which I did get rid of, and went to an entirely electronic solution).

No, I doubt we have anyone using the wrong rev level of documents for anything that affects product quality. Our operator instructions, etc... are controlled.

It's more likely that people have out-of-date copies of instructions that they don't refer to. Say, receiving might have an instruction on how to generate a bin label, but the software interface has been updated so the instruction has been updated. Someone in receiving might still be holding on to an outdated copy, but they know how to do the job the right way.

My concern is that an auditor might say "Show me the procedure you follow to do this." and the employee will proudly whip out a copy they haven't even needed to look at in two years.

Maybe I'm nitpicking, but I'm a perfectionist, and while it doesn't necessarily concern me that our document control might not be perfect, it does bug me to write a document control procedure knowing that it isn't airtight.

Just a couple of questions:


If the employees truly have been trained, and know the process, why have a document in-place at all?
Could you provide training on the process, and any changes as they come along, and NOT have a document in-place (essentially your'e stating that the documents aren't being used anyway)?