Do "Reference Only" documents have to be physically marked/labeled?

[WNQuality]

We control our technical data in the following way:
Proprietary ? Controlled by Engineering on-line
OEM OHM ? The latest version is controlled by Engineering and stored in a specific type of green binder.
Occasionally the floor may print/copy some or all of a document to mark up. This is now obviously uncontrolled.
My question is does this copy need to be marked as ?Reference Only?? I was thinking of amending my document control SOP, and post some signage to the effect of ?Only the On-line version or copies in the green binders are controlled, all other copies are considered uncontrolled and should be used as Reference Only?.
Is this adequate or do they need to be stamped?
Thanks

 

[Curtis317]

Re: Reference only documents

Yes they should be stamped "For Reference Only" include the date of stamp if you can. That way you will know when the document was printed and know if it hangs around that it is out of date if that applies.

 

[Jim Wynne]

We control our technical data in the following way:
Proprietary ? Controlled by Engineering on-line
OEM OHM ? The latest version is controlled by Engineering and stored in a specific type of green binder.
Occasionally the floor may print/copy some or all of a document to mark up. This is now obviously uncontrolled.
My question is does this copy need to be marked as ?Reference Only?? I was thinking of amending my document control SOP, and post some signage to the effect of ?Only the On-line version or copies in the green binders are controlled, all other copies are considered uncontrolled and should be used as Reference Only?.
Is this adequate or do they need to be stamped?
Thanks

I think it's best to stay away from "Reference Only" in all cases. All documents are for reference only, no?

This problem is often solved by adding a footer to documents that says that printed copies are uncontrolled. If you update your procedure to say that printed copies are uncontrolled, and everyone who might use a printed copy is aware and cognizant, that should be enough.

 

[isoalchemist]

I've always followed Jim's approach.

My question would be why are they getting marked-up? It could be indicative a significant problem with the documentation or that it was just a handy piece of paper. Just make sure they are disposed of and don't become the instruction for the next time

 

[kgott]

?

This problem is often solved by adding a footer to documents that says that printed copies are uncontrolled. .

This is widely done but 4.2.3 states that documents required by the quality management system shall be controlled.

By placing a footer in documents that says 'printed copies are uncontrolled,' we are admitting that in we cannot control hard copy documents and so therefore we are in breach 4.2.3 are we not?

Perhaps we would not be in breach if we put in a footer say something like 'printed copies may be out of date, check online version before use."

 

[dgriffith]

My related problem is that it seems like the manufacturers operating manual must also be controlled. Unless you're stamping the book Ref Only to show it is uncontrolled, how do you REALLY control it. Maybe the latest version isn't on line. Maybe the manufacturer only sends addendums instead of reprinting the whole book. Maybe you don't need a later version as it doesn't apply to the instrument version you have.

 

[AndyN]

Jim and others who agree have it correctly. Not having distribution control over a document and then stamping it "for reference only" is an open invitation to use it - and it may be obsolete! Far better to limit the use for 24 hours and say destroy it. It's a good practice to have people understand "Use it and lose it"...

 

[Jim Wynne]

This is widely done but 4.2.3 states that documents required by the quality management system shall be controlled.

By placing a footer in documents that says 'printed copies are uncontrolled,' we are admitting that in we cannot control hard copy documents and so therefore we are in breach 4.2.3 are we not?

Perhaps we would not be in breach if we put in a footer say something like 'printed copies may be out of date, check online version before use."

Saying that a printed document is not controlled doesn't affect the controlled status of the document, as strange as that might sound. It just means that if the document changes, printed copies won't be automatically updated. The thing to do is to periodically ask users how they know that a printed document they're using is the current version. Internal audit is the way to confirm that users are cognizant of the requirements.

 

[Randy]

Too bad nobody reads and pays attention to the requirement while at the same time engage their reasoning skills.....

The requirement states "...to prevent unintended use of obsolete documents"

1) Requiring and placing the words "For Reference Only" is a method of document control boys and girls

2) Keeping documents "For Reference Only" demonstrates intent to possibly use them "For [future] Reference" therefore requiring them to be controlled


The whole thing revolves around trying to keep documents that are no longer valid from being "accidentally" used or used in error....That's one of the reasons why we have the requirement for "Current Revision Status" ...

This burning desire to put "For Reference Only" on documents is a Pandora's Box and a minefield for disaster that I will find in my 1st 15 minutes during any audit.....Why complicate that which wasn't meant to be complicated?

 

[WNQuality]

A reason for ?Reference Only? documents is that a technician may mark up a schematic to include wave forms at a specific test point; this is not part of the official Technical Data Package, but rather a troubleshooting aid. Once the document is marked up it is no longer controlled.
I agree that we want to minimize reference only documents as much as possible, but in some cases they may be required
I think I have heard that the initial approach ? an SOP, and perhaps signage, that states that any document outside a specific set of circumstances (On-line or in specific type of book), should be considered uncontrolled and is therefore reference only is adequate.
If I?m out to lunch, please let me know ? I would rather hear it here then from registrar