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View Full Version : Control of Documents - Is a unique format required?


Chaos
7th July 2009, 02:05 PM
Hello,

We got audited a couple of weeks ago, and the Auditor found 3 minor no conformities. One of them caught my attention, because the first part is OK, but the additional comment I find no rule to back it up.

Here is the NC:
Non Conformance: Some documents were found without evidence of document control in the QMS, also 4 different types of "control templates" were coexisting in the system.

:whip:
The first part was negligence on some areas, that's OK, and easily fixed.
The second one, is that some documents were hard to format using the nice layout we had for the standard procedures, so we just created a footnote, or a small "box" quoting all the required info, version, author, revisor, etc.

Is this an ISO requirement? Can we use different formats for document control or are we bound to use only one? Should all standard formats be explained somewhere, or if we just present the data required by 4.2.3 we are ok?

Thanks a lot and sorry for the raw english, it's not my native language.

somashekar
7th July 2009, 02:33 PM
The NC wordings do not suggest that you refer to a certification body audit. Are you ?
If you are missing the contents and looking at the borders and designs, perhaps the audit is at an infant stage. This could at best be an observation made to the attention of the document control process.

Randy
7th July 2009, 02:55 PM
Is this an ISO requirement? No, absolutely not!:nope:

Can we use different formats for document control or are we bound to use only one? You can use 100 different formats if they suit your needs and you can effectively control them.

Should all standard formats be explained somewhere, or if we just present the data required by 4.2.3 we are ok? This isn't a requirement either. All you have to be able to do is identify them, control them effectively and be able to verify revision status.

Ertai
7th July 2009, 03:02 PM
No, absolutely not!:nope:

You can use 100 different formats if they suit your needs and you can effectively control them.

This isn't a requirement either. All you have to be able to do is identify them, control them effectively and be able to verify revision status.

Thanks a lot for your answer, we've been really wondering about this.

Regards,

Robert Broughton
7th July 2009, 10:36 PM
Was the nonconformance for 4 different types of control methods? For example on some documents you use rev level, on some you use control stamps, on others you use dates etc... Does the "small box" contain the same information for all controlled documents?

Jim Wynne
8th July 2009, 12:36 AM
Was the nonconformance for 4 different types of control methods? For example on some documents you use rev level, on some you use control stamps, on others you use dates etc... Does the "small box" contain the same information for all controlled documents?

None of those should make any difference so long as control itself is consistent across the different methods. In the case of document control, the product (control) is more important than the process (how control is achieved).

SpongeMouse
8th July 2009, 01:32 AM
this should not be an NC, its only observation.

as said by the covers, its not mandatory.

but just remember, NC or observations is always = improvements :cool:

TamTom
8th July 2009, 03:05 AM
Hi,

I think the auditor put an obersevation together with the nonconformance, if there were documents not controlled (that should be), then the first part of the auditor statement was right, and he added the overervation.

I have seen this behavier from time to time, by some (German) auditors, I think they mostly doing these kind of statement, when they not finding any other major failures.


Greetings,

TamTom

harry
8th July 2009, 04:59 AM
What does your procedure say. I had seen many cases of people registering their blank form/template and say - this is template that we are using.