Uncontrolled Hard Copy (Paper) Document Validity Period

[quality1984]

Hi All,

I was wondering if I could get some opinions on an issue regarding uncontrolled hardcopies.

I work in a manufacturing plant and we do have controlled hardcopy folders etc but this is in regards to people printing copies off the controlled system and distributing them to Contractors.

I have made the rule that the printed uncontrolled copy is valid for 24 hours from the date of print only but the maintenace planners print copies 7-14 days in advance when they plan jobs. They state that they can't print on the day because there is just too much paperwork and it wouldn't be practical. They are concerned that if a validation period is only 24 hours then some Contractors would demand that they print off a fresh copy.

Most procedures don't change and the maintenance planners are the ones that change them anyway if they were to so they are aware of which procedure is up to date.

My question is, could I scrap the validation period altogether and just simply write a statement on the uncontrolled copy - ONCE PRINTED THIS DOCUMENT BECOMES UNCONTROLLED - If I do this am I opening myself up to a gap in the future? Could an Auditor fault this statement and ask for it to be changed?

Your help is greatly appreciated and I apologise if this has been asked before. I have tried to search previous threads but none really match this situation I am in.

Regards,

Kristina

[Randy]

Very common practice, I see it all the time

[harry]

In Reply to Parent Post by quality1984

Hi All,

I was wondering if I could get some opinions on an issue regarding uncontrolled hardcopies.....................................

Welcome to the Cove.

'Uncontrolled' means you are not going to control or unable to control. Hence, setting validity period after it was printed is contradictory and may even land you in trouble with auditors.

ONCE PRINTED THIS DOCUMENT BECOMES UNCONTROLLED

This is correct. Once printed, it is outside your control because you simply do not know what is going to happen next.

[somashekar]

In Reply to Parent Post by quality1984

Hi All,

I was wondering if I could get some opinions on an issue regarding uncontrolled hardcopies.

I work in a manufacturing plant and we do have controlled hardcopy folders etc but this is in regards to people printing copies off the controlled system and distributing them to Contractors.

I have made the rule that the printed uncontrolled copy is valid for 24 hours from the date of print only but the maintenace planners print copies 7-14 days in advance when they plan jobs. They state that they can't print on the day because there is just too much paperwork and it wouldn't be practical. They are concerned that if a validation period is only 24 hours then some Contractors would demand that they print off a fresh copy.

Most procedures don't change and the maintenance planners are the ones that change them anyway if they were to so they are aware of which procedure is up to date.

My question is, could I scrap the validation period altogether and just simply write a statement on the uncontrolled copy - ONCE PRINTED THIS DOCUMENT BECOMES UNCONTROLLED - If I do this am I opening myself up to a gap in the future? Could an Auditor fault this statement and ask for it to be changed?

Your help is greatly appreciated and I apologise if this has been asked before. I have tried to search previous threads but none really match this situation I am in.

Regards,

Kristina

You are quite OK, exept that you can say ...
"UNCONTROLLED WHEN PRINTED, CHECK VALIDITY BEFORE USE"

and you can have the 'Printed on date: ' also appearing as a footer.

[SteelMaiden]

In Reply to Parent Post by somashekar

You are quite OK, exept that you can say ...
"UNCONTROLLED WHEN PRINTED, CHECK VALIDITY BEFORE USE"

and you can have the 'Printed on date: ' also appearing as a footer.

That is an acceptable method, but by no means the only one. We just use "uncontrolled when printed". I've seen systems that say uncontrolled after xx/xx/xxxx" with the date the copy came off the printer inserted. (I don't like that one, how do you know someone didn't issue a new one five minutes later?) And, I've seen the statement that you suggest also. In all actuallity, if you make that statement in your manual or procedures for your document control and your folks are trained, you don't have to have a statement at all.

[quality1984]

Great! Thank you to all for your help, I really appreciate it

[Helmut Jilling]

...ummm...interesting comments, boys and girls...but, let's see what the "good book" says...shall we..?

4.2.3 Control of documents
Documents required by the quality management system shall be controlled...
a) to approve documents for adequacy prior to issue,
c) to ensure that changes and the current revision status of documents are identified,

g) to prevent the unintended use of obsolete documents...

So, though some of these methods are "common," they are only compliant if they meet these requirements. If you do it carefully, it can meet the requirements. If you just stamp your documents, it might not meet the requirements.

The purpose is simply to ensure that information is up-to-date, accurate, approved and authorized.

So, in the case of the maintenance docs printed days in advance, are they still the same revision? If so, if they didn't change, then the printed copies are the same as the approved copy, they can meet the requirement. Though, I'm not sure why they can't be printed 2-3 days before.

In the case of stamping them "Valid for one day when printed," if they don't change during that day, then they can meet the requirement.

In the case of stamping them "Uncontrolled if printed, verify before use," if you can't be certain people are actually verifying them, then they probably won't meet the requirement to "control." Besides, do you really want everyone in your company to take time to verify all the docs before use? Doesn't that sort of defeat the purpose of doc control in the first place?

Try to get peopl to use docs electronically, off your master. Then, doc control is most simple. In many cases, printing is just a habit. In the case of "valid for 24 hrs,' usually doc chnages take longer than that to approve anyway, so it probably won't be an issue.

The point of my post, is we were discussing methods, without linking to the requirment and the intent of the requirement. I am tired of people saying "well, they other auditor said it was ok..." Don't forget to make sure your methods meet the requirements.

[quality1984]

Thank you for your comments.

The documents have to be printed in this case and cannot be electronically accessed by Contractors.

Due to the 10,000 + documents that I have to control it is not possible to have an inflexible system. I cannot control people printing documents even though they are discouraged to. I've even set up controlled hardopies of documents but in this case with maintenance that cannot be possible.

The documents within the electronic system are approved and adequately controlled. Official controlled hardcopies are approved and adequately controlled. Anything else outside of that would be virtually impossible to police.