What Is A Controlled Document?

[George Trybulski]

How and when is a controled document a controled document? We have Process Conformance Sheets that we use to gather variable and attribute data for inspection. We have this form pre filled out as to individual inspection criteria for each of our approx. 1000 jobs in Microsoft Word and have a footer note stating the "form identifier" (mm3000-001)and the revision date. We are deciding to change the form identifier however we have to go into each individual form and change the footer if we decide that. The question is- quality records have to be "controled". Can we just call the form the "Process Conformance Sheet" and just write a procedure on how the completed forms are controlled as to retrivel,use,storage,and disposal ?

 

[CarolX]

George,

I assume you print this out with each job you run. Why not set the footer to print the current date, and thus give you an method to trace your revision history.

Good Luck, Carol

 

[Greg Mack]

Hi George,

I posted this morning a definition I use for "Uncontrolled Documents" so I guess I could provide some assistance by giving you my definition of a "controlled document" and here it is:

"A document that is maintained and updated. Controlled documents are formally approved and their distribution is traceable to enable changes to be executed".

Hope that helps.

 

[Marc]

A couple of other thoughts:

A controlled document is typically one that is Revision sensitive - BUT - Not always!!

If a controlled document is changed, a record of the change has to be made. This means we must have a History of Changes.

If a document is changed, people who use it must know about the change. This means there has to be a distribution list or other effective way to let everyone who uses it know the document has changed.

Every employee must know how to check to see if documentation they are using is the most current version.

 

[Dan Larsen]

"To control or not to control...that is the question" I've had so many discussions with clients on this and it keeps coming up.

I suggest they use this test. Is the item you're considering for control significant enough or used somewhere in the system that if an old (out of date) item is used to perform the work, there is a possibility the work could be performed wrong? If the honest answer is "yes", then the item should probably be controlled.

This still doesn't take care of all the questions, but it does prevent a few. And, of course, I'm constantly trying to refine "the test", so any other thoughts are welcome!

 

[Kelly DiMare]

These descriptions of controlled documents are really helpful to us as we undergo our ISO implementation. What about email though? Frequently we receive information from customers or internal contacts via email, and it may get printed by several different people. If questioned about revision control of the printed copies, is it sufficient to point to the subject title and sent date? Or must we start using "Received"/"Copy" stamps?

 

[SteelMaiden]

Oh, that dreaded e-mail!

I have seen and heard so many LONG discussions about e-mail and I'd like to hear what everyone else is doing.

We have set up our systems to treat e-mails like a phone conversation where the e-mail will be confirmed via our regular systems (such as an order placed by e-mail would be treated like a verbal order and a confirmation of the order sent). Where an e-mail documents a change to a customer specification, by the customer or shows that a customer has agreed to accept an alternate product in lieu of his original requirements, etc., the e-mail is then treated like a letter from the customer and attached/filed per standard practice.

I have talked to some people who feel that every e-mail should be saved electronically as well as printed and filed, but to me that seems to pretty much negate the whole concept of electronic mail?

 

[energy]

If the accidental deletion of an important e-mail causes a break down in the system, results in a lost document or some other snafu, it should be printed. I view it only as a convenience between two or more parties. The tracking feature is important when sending out directives or important messages. But,it all should be printed and treated like hardcopy correspondence.
My opinion.

 

[Kelly DiMare]

Good points...

I agree that printing everything will contradict the purpose and convenience of email, and hope to avoid that. A good rule of thumb seems to be the question posed by Energy- will the accidental deletion cause the breakdown of the system.

A specific scenario comes to mind, however:

Say 3 employees receive the same data from a customer via email- and print it, use it, etc. - but subsequent changes are made to the data. How do we ensure that all 3 employees are aware of a newer version of the data?

The answer I like is to make sure the same 3 people are copied on any future messages regarding the topic. But I was wondering if anyone has been questioned on something like this during an audit...

 

[SteelMaiden]

Kelly,

At the risk of asking a dumb question, what kind of information would the three employees get that would not be recorded in some form such as an addendum to the order, change orders to the work order or traveller or whatever your system calls them, or changes to customer's specs/requirements/base files.

I am sure that I haven't thought this question through completely, but off the top of my head I cannot think of anything that would come from the customer and be implemented and produced without some sort of system wide documentation that would show everyone that the change was made. Now you have me wondering what I might have missed, please fill me in further!