Control of Documents - When?? Uncontrolled forms identified days before the audit

C

Crodge

#1
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
 
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Wes Bucey

Quite Involved in Discussions
#2
Crodge said:
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the most recent authorized version or revision of a design, document, or part is in process by actively removing all outdated or nonconforming versions, marking them as such, and keeping them segregated from the active design or production process except for archival reference.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.
 
#3
Crodge said:
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
 
C

Crodge

#4
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
 

apestate

Quite Involved in Discussions
#5
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.
 

apestate

Quite Involved in Discussions
#6
We do appreciate your self-control. :>

But hey, seriously.. when I ask questions, well whatever. Check out the article. It's a gooder.
 
T

Teknow

#7
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.
 

apestate

Quite Involved in Discussions
#9
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?
 

RoxaneB

Super Moderator
Super Moderator
#10
atetsade said:
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.
 
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