Document Control and Identifying Distribution

[kgott]

Re: Document Control and Distribution

We state in our procedures that all controlled documents are in the mainframe. Once a document is printed out it becomes a reference document and is no long controlled. After it is filled out and put away it is a record. I haven't had anyone complain on this so far.

This approach is very common but in my expereince documents dont change that often other than early in the development of the system, so in a sense I think this statement is untrue. I prefer to say that "printed documents may not be current, check revision status with the online doc."

Maybe this is merely a play on words but in my view considering hard copy documents as uncontrolled, not only just generates a lot of wasted paper but creates the idea that we cannot act on any printed document and I think this is going a bit overboard.

Is there something I am not aware of here??

 

[Helmut Jilling]

Re: Document Control and Distribution

If it's a small organization (small enough to go out and find all the blank copies of a given form), have the operator request a form from Doc Control or have a .pdf available on a computer that can be printed with a watermark.

If you are adamant that you want to state your desired method under Distribution, then just state it: something like "We will print multiple copies of forms and place them on the floor. If the forms are revised we will collect all obsolete copies." Let me be clear, I'm not giving you any assurances that this will be satisfactory.

4.2.3 (g) might appear to be satisfied superficially, but the auditor will make a determination if it's effective or not. It may look simple on paper, but.....

Observations of an auditor:

1. Electronic documents are much easier to control. Try to use an many docs electronically as practical.

2. Some docs of course, do need to be printed. But, the less copies you print, the easier it is to control.

3. When you do print some forms for use, only print a small amount, and store them in as few locations as practical. Then, if it changes, go fetch the old ones and replace with the new ones.

4. Put revision dates on every document and form, as a matter of good practice. It makes managing them easier.

5. To SilentRunning - declaring that paper copies are "Uncontrolled" is very outdated and noncompliant. Shame on your auditor for accepting that.

The standards say all documents must be controlled. It does not differentiate between paper or electronic. refer to # 1, 2, 3 and 4 above to describe ways to simplify that control.

 

[silentrunning]

Helmut, could you please elaborate on #5. This is the first time I have had a negative comment. I would like to rectify the situation if I am doing it wrong.

 

[steve hussain]

Re: Document Control and Distribution

What if someone photocopies these printed work instructions. We do both Pdf files on the intranet and hard copies. the hard copies are first approved by signature, then photocopied, stamped and distributed. control copies carry a red revision date. so if you attemp to copy from the net, it will be uncontrolled since it will not have the signature (ones on the intranet is typed in) and the red revision date.

 

[Helmut Jilling]

Helmut, could you please elaborate on #5. This is the first time I have had a negative comment. I would like to rectify the situation if I am doing it wrong.

The standards say all documents must be controlled. Does not differentiate between paper or electronic documents, they must be controlled to make sure people are using the correct versions.

Declaring that the main file on the server is controlled and that paper copies are "Uncontrolled" is noncompliant. All copies must be controlled to make sure people are using the correct versions.

The standards want your documents controlled to ensure they are accurate, up-to-date, and authorized or approved for use.

It was a frequent practice back in the 90's, but was not compliant regardless. Some auditors may not make a fuss about it, but it it not confirming. There is nothing in the standard that says that is OK.

Shame on your auditor for accepting that. Very outdated practice.

For tips how to do that in an easy manner, review the 4 points in my previous reply.

 

[kgott]

Helmut, could you please elaborate on #5. This is the first time I have had a negative comment. I would like to rectify the situation if I am doing it wrong.

Helmut is referring to clause 4.2.3 Control of documents of ISO 9001 - Documents required by the quality management system shall be controlled.

The key here is:
1. - to think in terms of the quality management system documentation

and

2. 4.1 General requirements - The organization shall determine the processes (and documentation) needed for the quality management system and their application throughout the organization.

hope this helps