Hello All,

We have our upgrade audit next week and I have just found a pile of forms that, as yet are not being controlled. Will it be acceptable if the forms have an effective date printed on them that is only a couple of days prior to the audit? Is this within the requirements? Or do we need to have a track record of the forms being controlled?

All your comments are appreciated… I have so much to do before the audit that I am starting to go crazy!!!

Thanks

Crodge

Hello All,

We have our upgrade audit next week and I have just found a pile of forms that, as yet are not being controlled. Will it be acceptable if the forms have an effective date printed on them that is only a couple of days prior to the audit? Is this within the requirements? Or do we need to have a track record of the forms being controlled?

All your comments are appreciated… I have so much to do before the audit that I am starting to go crazy!!!

Thanks

Crodge"A pile of forms"?
Does your organization use these forms?
Do you have them listed in some master index?
Is the data that gets listed on these forms crucial to any activity that relates to product, service, or customer?
When were these forms really created? Why? Who did it? Why did that person or persons think it wasn't important to put them under 'control' when they were created?

IMO, you have a lot more questions to ask and answer before you consider fudging your QMS.

One of those questions has to be: "Exactly what does our organization mean by 'controlled'?"
The simple fact of the matter is those forms may already be controlled according to your organization's practices. (On its most basic level, many organizations work with this definition:
Controlled

Means assuring only the most recent authorized version or revision of a design, document, or part is in process by actively removing all outdated or nonconforming versions, marking them as such, and keeping them segregated from the active design or production process except for archival reference.

When your organization deals with very sensitive security issues, the definition may be enhanced:
Controlled copy

"Control " implies we will keep a register of the authorized holders of any document created by us. When any event occurs related to a controlled document, we notify the registered holders, requiring them to acknowledge the notice. When we change or revise a document, we send registered holders the updated version and require them to return or confirm destruction of the outdated document to us. Compare with "uncontrolled copy" where the holder is responsible for maintaining an updated copy.

[These definitions are from the Glossary of my Q manual.]
Just because my organization follows the second definition does NOT mean it is good business practice for YOUR organization to do anything more than the first definition.

I think you should worry more about how the forms fit into your QMS (if they even belong there) and less about how they may be perceived by an auditor.

I have so much to do before the audit that I am starting to go crazy!!!
Whoa there. Calm down. Take a couple of deep breaths... ;)

The forms: You just found out about them, right? If they need to be controlled, make them controlled. After all, you can't very well go back in time and get a better date. You found them, you fix them, that's all anyone can ask imo.

And hey: Good luck with the upgrade audit :agree:

/Claes

Firstly,

Wes.
1. If my organization didn’t use these forms then I couldn’t give a s##t if they were controlled or not!
2. I didn’t ask for the definition of ‘Document Control’ anywhere in my post
3. I have no intention of “of fudging our QMS”, if I did I wouldn’t be asking for advice would I??
4. Our company has a Document Control procedure, as I am now aware that yours does. Maybe I wasn’t clear in saying that I have now found some forms that do not meet the requirement of our procedure and was wondering if I was to make them meet the requirement even at this late stage, would it be acceptable to our auditor?
5. I would use stronger language if this weren’t a public forum. Sounds like you need a vacation.

Claes.

Thank you kindly for your swift response, this is what I was looking for.

Best Regards

Crodge

http://www.qualitydigest.com/june02/html/doccontrol.html

I really like this article and I've read it from time to time to regain perspective.

Sometimes I get a little stressed by the amount of work I perceive as needed. Generally, I think of much more work than really is needed. I think the wisdom is to do as little work as possible. Best thing to do is make a plan and then nail it.

A whole slew of documents with late effective dates is no problem at all as far as I know. In fact, if the auditor goes through and sees that you can make changes to the quality system and maintain control, that's a good thing (for example you don't have any old versions out there.)

I like to be able to list off all the places where any little document is at. I have a growing Excel spreadsheet that does this. It is my document list and it isn't on a network, and the document controller is the only person who can make changes to it. You see I've defined the controls for this document and I know where it is at, and how to keep it from going astray.

Focus on the first four elements of the 4.2.3 document control clause. They engender the rest of the clause.

We do appreciate your self-control. :>

But hey, seriously.. when I ask questions, well whatever. Check out the article. It's a gooder.

Chill! You did say that -
"All your comments are appreciated… I have so much to do before the audit that I am starting to go crazy!!!"
Ok, so you didn't appreciate Wes' efforts to help out - no need to tell him he needs a vacation! :ko:
As usual, very good sensible & practical advice from Claes.

Well, we all get the pre audit jitters at one time or another... Let's move on, shall we?

/Claes

ACTUALLY

Since I'm SURE one of you is going to be checking back to this thread in the near future, let me ask a question.

How would you handle document control in a small fab shop?

I may be going back to some of the ISO 94 elements but this is how I do it.

Documents are controlled by a maintained list on my computer. It's an excel spreadsheet that lists the number the title the level the date revised, and the locations. it also references a document change request number.

Now, when I make a doc change I also fill out a record of revisions. On my Level II and III I have this at the bottom of the document, a little table for writing the date changed, description, and initialed authorization.

For levels I and IV I have a separate sheet to do this. I create the sheet every time I make a new document, and it goes in one **** of a growing file. Is this sheet necessary for any reason?

Now, when I make a doc change I also fill out a record of revisions. On my Level II and III I have this at the bottom of the document, a little table for writing the date changed, description, and initialed authorization.

For levels I and IV I have a separate sheet to do this. I create the sheet every time I make a new document, and it goes in one **** of a growing file. Is this sheet necessary for any reason?

ISO 9001:2000 4.2.3 c) "...to ensure that changes and the current revision status of documents are identified,"

That's why you have a history of the changes you made. ;) Think of it like this, Erik. Suppose you leave your organization to move on to bigger and better things (okay...stop daydreaming, now. ;) ). John Doe comes in as your replacement and he thinks that he can modify a form that you created to be better. A history of its revision may show that you once had the fields on the form that he wants to add, but you took them off because no one ever used them. Saves time in the long run, if we know what a document used to look like once upon a time. :cool:

If, however, your asking if the sheet itself is necessary, well, what works best for you? My own personal preference is having the revision as a table within the document. One stop shopping, so to speak. Not only can I see, at a glance, what the document used to look like, but for new revisions, people can look at the revision table and see quickly what has changed (rather than reading through the entire document and trying to remember what the previous revision stated).

Pick a system that works for you.

Hello All,

We have our upgrade audit next week and I have just found a pile of forms that, as yet are not being controlled. Will it be acceptable if the forms have an effective date printed on them that is only a couple of days prior to the audit? Is this within the requirements? Or do we need to have a track record of the forms being controlled?

All your comments are appreciated… I have so much to do before the audit that I am starting to go crazy!!!

Thanks

Crodge

This might not be the most popular opinion, but FWIF...

A. I agree with Claes - you found a problem and fixed it. The auditor should be happy about that.

B. For the future, consider whether these forms really need control. IMO if they do not act as a WI as well as a place to record data, and if you do not say in your procedures that all forms must be controlled, then ISO does not require that a form which is only acting a place to record data be controlled at all.

Good luck.

Hello Crodge,

I agree with Claes. If these forms need to be controlled, then just do it.

If you have to classify these forms to be critical, just issue an deviation, inform the involved people and it is corrected.

If the form is used for records desribed in 4.2.4 and required by the standard, you shold look for a "white" solution, otherwise I would not see any problems to fix this thing on the fly.

regards~ghw

Another thing to think about is what type of control do you need? Depending on the form, and its usage, why not place the control at the local level? The system is your system, and you can meet 4.2.3 by allowing the form originator to control the form.

I worked with a company that allowed each department to develop and control their own forms. The forms do not appear on any master list, and the department makes sure they meet the standard. The system works quite well, and they've never had a problem.

:topic: BTW, Wes has a tendency to explain things in detail. Based on other posts, I doubt he was attempting to be condensending or anything like that. You must also remember, that our posts are designed to not only answer your questions, but help those who didn't ask the question. Wes has established his expertise in the Cove, and we all welcome his posts. With only 8 posts, I would hold off in criticising others. :thedeal:

...With only 8 posts, I would hold off in criticising others...

Well then, I'm curious. How many posts does one need to have before becoming offended at someone who accuses one of "fudging their QMS"?

Well then, I'm curious. How many posts does one need to have before becoming offended at someone who accuses one of "fudging their QMS"?

Well, maybe its me, but I didn't read Wes' comment as accusatory. I read it more as a warning against fudging. Once again, I base this partly on past posts. If Crodge read it as an accusation, then it would explain point # 3, but points 1 and 2 seemed to be a bit critical. Make more sense?

Whoa there. Calm down. Take a couple of deep breaths... ;)

The forms: You just found out about them, right? If they need to be controlled, make them controlled. After all, you can't very well go back in time and get a better date. You found them, you fix them, that's all anyone can ask imo.

And hey: Good luck with the upgrade audit :agree:

/Claes

Totally Agree, Claes. :agree: Vini, Vidi, Vici (I think that is what Ceaser said). You found them, you fix them, that's all anyone can ask imo.

:topic: I also agree with Cindy.
Wes (IMO) :truce: I too thought you were a bit strong and db I don't think it matters how many posts anyone has before they can have their say. I have only been here this year and a few people joined after me and have tripled my posts but I don't think they are any better or worse than me. (We are all equal here, justsome more than others :vfunny: )

Greg B

Well then, I'm curious. How many posts does one need to have before becoming offended at someone who accuses one of "fudging their QMS"?

The thread starter was asking for advice. Sometimes, there are those in their quest to demonstrate their knowledge of the field, throw these "little" shots in without stepping back and looking at how it could be perceived. The word "fudging" indicated dishonesty, or at least an attempt to circumvent the rules. That was not the case. There was a possible problem. How can we help fix it? That's all. Everything else is "extras". We had a gentleman here who did this consistantly and he drew the wrath of many members. But, he also had his supporters with similar mannerisms. Fortunately or unfortunately, he is no longer a participant in the Cove. As a Moderator I won't comment any further on the turn of this thread, except to say Claes said it best. "let's move on". :agree:

Post #5
atetsade
Forum Contributor

http://www.qualitydigest.com/june02...doccontrol.html

I really like this article and I've read it from time to time to regain perspective.

atetsade,

I enjoyed the read, "Document Control Made Easy" by Craig Cochran! Thanks!

I do not know if it is appropriate to ask some questions about the article here or not, but I would like to discuss some items from the article. [I'm sure the Moderators will do with this as they see best.]

Under "Reviewing, Updating and Reapproving Documents," I was hit with the statement that "the standard requires an organization to review documents periodically to see if they're still valid. If they are, the organization reapproves them. If they are not, either a revision is made or the document is declared obsolete." Mr. Cochran goes on to suggest there are three ways to handle a document review. A recall on a strictly periodic basis; a review, update as necessary and then reapprove based on business triggers or real-world events that affect a document; and use of the internal audit process to review documents.

To begin with, the standard does not say 'periodically.' That may be implied or inferred, but not stated - right?

I worked in a DoD contractor where they routinely reviewed their Corporate Policies, Departmental Directives, and Sectional Instructions (I particpated in performing reviews), but I have not developed such a system of document control. (Parenthetically, that employment was long before the Process-Based Approach to a Quality Management System.) How do those who have written such a control deal with the reapproved documents? Do you indicate such a status on the document, or maintain evidence of a review in a seperate record system?

Mr. Cochran seems to indicate that all documents must go through this review and reapproval process, "If an organization intends to use its internal auditing process to satisfy this requirement, then extra care must be taken when planning and scheduling audits to ensure that all documents are sampled during an extended period." Is that so, or only those documents that I would designate that need to go through a review and reapproval process?

What approach have you utilized to meet this requirement?

Under "Making Documents Legible and Identifiable," Mr. Cochran states "Legibility means that documents can be read and understood. They should be written in a clear, decipherable manner, in the language spoken by document users." I looked for the word 'legible' in 9000:2000, and did not find it. Is this definition true? Is it stated somewhere in 9000 or 9001 and I missed it? I just do not believe that readability and understooding are criteria for legibility. Have you seen that Email that has gone around where spelling was hardly accurate, but the paragraph with understandable? As for multi-lingual (sp?) process participants, there is a paradigm in language acquisition that states that imitation precedes comprehension which precedes expression. This would indicate that I can comprehend much better than I can speak. Why should readability and undersatnding be a criterian for legibility?

I also found it interesting under "Control of External Documents" that Mr. Cochran makes the observation that "paper-based internal documents should also have their distribution controlled, but this isn't specifically required by ISO 9001:2000." I agree with the observation and that the likely hood of getting a nonconformace while ensuring "that relevant versions of applicable documents are available at points of use" would be greater if I did not have controlled distribution of the internal documents.

Just some thoughts to ponder or discuss.

Doug

Hello all,

I would like to thank you all for your help and assistance over the last few months. We have just been recommemended for Certification with 4 minor non-conformances.( Non related to document control :D )

Being as we are a company with over 2000 employees and 4 very different core processes I am very happy with 4 non-conformance!

Thanks Again

Time for Beer!!!!

Bye

Well done, Crodge :bigwave: Congratulations.

/Claes