Questionable Audit Finding about Revision Levels of Product Manual CD's

[Janselm]

We recently had our external audit and our auditor came up with a finding that I personally do not believe is a real non-conformance or problem.

Our shipping department keeps CD copies of all documentation (product manuals, spec sheets, etc.) for each product. Each of the documents on the CD has its own revision level. Each CD is named in accordance to their respective product. When shipping goes to package a product, the correct CD is placed in the shipping container. Our documentation department keeps track of what is on the CD's and in the event that one of the documents is revised they personally go to shipping, dispose of the old CD's and give them new ones.

Our auditor claims that this is a non-conformance because the CD's themselves are required to have their own revision level.

Here is the exact finding:

[FONT=&quot]Requirement:[/FONT][FONT=&quot] Section 6.3.2 of Procedure 7 states documents are controlled by a revision number.[/FONT]
[FONT=&quot]Non Conformance: [/FONT][FONT=&quot]Documents used were not controlled as required by the procedure. There was no revision indicator.[/FONT]
[FONT=&quot]Evidence: [/FONT][FONT=&quot]Product manual CD's in shipping.[/FONT]

To me, since the documents on the CD's themselves contain a revision number, the CD itself does not need one. I don't believe there is any need for the CD's to have a revision number since
1: They are not documents so the procedure doesn't really apply
2: The content of the CD's is controlled in a fashion that will prevent obsolete documents to be shipped out with the product.

Any suggestions on what I should do?

 

[Reg Morrison]

Re: Bupkis Audit Finding about Revision Levels of Product Manual CD's

Any suggestions on what I should do?

Yes, drop the CD's altogether and let customers know where (online) they should go to download any document they need. IMHO, a much more elegant, cost-effective, modern and environmental-friendly solution.

 

[Bev D]

Re: Bupkis Audit Finding about Revision Levels of Product Manual CD's

Yes, drop the CD's altogether and let customers know where (online) they should go to download any document they need. IMHO, a much more elegant, cost-effective, modern and environmental-friendly solution.

A great long term solution unless your customer base is not fully up on the latest technology like an internet connection.

The OP's issue is that their internal procedures require documents to have a revision number. The auditor interpreted the CD as a document. In reality, the CD is not in and of itself a document. It contains (electronic) documents that do have . The CD is a delivery and storage device and that doesn't require version control per their internal procedures. The gap lies in the interpretation of what the CD is.

The standard of course only requires version control such that outdated versions are not inadvertantly used. The OP can demonstrate that they meet this requirement.

there are a few options here

• argue with the auditor
• chagne the internal procedure to better define what a document is (my personal preference)
• agree with the auditor and put a version number on the CD

yes its a picky finding. It should have been a point of rational discussion. but it wasn't

 

[Marc]

Re: Bupkis Audit Finding about Revision Levels of Product Manual CD's

<snip> Our documentation department keeps track of what is on the CD's and in the event that one of the documents is revised they personally go to shipping, dispose of the old CD's and give them new ones. <snip>

I have to agree with the auditor if the CD has manuals and/or other controlled documents on it. How else do you know what revision document(s) are on the CD?

If they personally do this and have records of having done it, you can call the auditor on it. But...

I have gone through that route where I have gotten outdated documents on CDs that didn't have a revision date or other way to tell what was on the CD.

I do agree with Reg - Put them on the internet and put something in or on the box with the URL to the documents. My last 2 computers do not even have CD/DVD drives.

I do understand Bev's comment - That your customer base may not be fully up on the latest technology like an internet connection, but in that case... There's no guarantee they have a CD drive to begin with.

My opinion - Paper or internet URL. CDs and DVDs are dinosaurs. Remember floppy disks? I still have an 8" floppy around here somewhere as a "momento" of the 1980's...

 

[normzone]

Re: Bupkis Audit Finding about Revision Levels of Product Manual CD's

Some of our end users (military folks in the field) may not have reliable access to the web. For that reason we periodically choose to maintain both online and CD versions.

" If they personally do this and have records of having done it, you can call the auditor on it. But...

I have gone through that route where I have gotten outdated documents on CDs that didn't have a revision date or other way to tell what was on the CD. "

My experience as well. Doing that purge of obsolete CDs I believe, maintaining records to prove it is unlikely.

Besides, how much burden does it add to put a rev level on the CD ? Assuming, of course, that the artwork for the CD label is already tracked.

 

[Janselm]

Unfortunately, putting it up on the internet is not an option for us. Our management is very "cautious" of who can get our documentation and how they can get it. With only a few real competitors in our business (RF Matrices) they are worried that having our manuals on the internet may expose them to our competitors.

What we ended up doing is giving the CD's rev levels and each one will have a log of exactly what documents and what revision levels of those documents are contained on the CD's. The log rev level and the CD rev level will always match. Our shipping personnel will compare the revision of the CD with the electronic revision of the log each time before shipping to assure they match. We submitted the action plan and our auditor accepted it.

Thanks everyone for your help.

 

[normzone]

Good choice. Only today we were discussing a disk we received from a large computer equipment manufacturer that was made up of a random collection of uncontrolled files.

 

[dgriffith]

Unfortunately, putting it up on the internet is not an option for us. Our management is very "cautious" of who can get our documentation and how they can get it. With only a few real competitors in our business (RF Matrices) they are worried that having our manuals on the internet may expose them to our competitors.

Depending on the size of the company, a firewalled intra-net would work. It's what we use. Then, the official copy is on-line, and anything printed for use becomes uncontrolled--just tell the auditor that the controlled version is located on-line and be able to demonstrate that you can find it.