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Control of Documents or Control of Records?

Wes Bucey

Prophet of Profit
#21
I also agree - the auditor is confused if you have reported things accurately. Perhaps he was kind silly enough to write his comment?
 
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#24
I also agree - the auditor is confused if you have reported things accurately.
Yes, I've reported 100% accurate. I myself couldn't believe also. You would be surprised of what you can all hear during outsourced internal audits. Unfortunately, we have legal limitations on how to choose (public/open purchase) internal auditors. The lowest price wins :(

Indirectly, the reasons why I registered here is to learn from professionals, not amateurs I meet on similar occasions.

Amateurs generally fail on this (0.1 / ISO 9001):
"It is not the intent of this International Standard to imply uniformity in the structure of quality management systems or uniformity of documentation."
 
J

JayDeeJay

#25
Hopefully this isn't too far off topic. One of the areas of concern at our recent Readiness Evaluation was with regard to forms and records. All of our forms that are linked to procedures are uniquely identified and rev controlled. The Form number, name, rev and date are recorded on the form. However the auditor pointed out that as soon as that form is filled out, it becomes a record and can no longer be identified as a form. This seems like an astronomical task to manually change each and every form that gets filled to a record number. I know there has to be an easier way to do this. Help!
 

John Broomfield

Staff member
Super Moderator
#26
Hopefully this isn't too far off topic. One of the areas of concern at our recent Readiness Evaluation was with regard to forms and records. All of our forms that are linked to procedures are uniquely identified and rev controlled. The Form number, name, rev and date are recorded on the form. However the auditor pointed out that as soon as that form is filled out, it becomes a record and can no longer be identified as a form. This seems like an astronomical task to manually change each and every form that gets filled to a record number. I know there has to be an easier way to do this. Help!
Jay,

Your records already have a unique identifier as a result of each form's design.

For example:

A. Purchase Order has a PO Number
B. Corrective Action Request has a CAR Number
C. Calibration Record has the Device ID

You documented filing and archiving procedure should already refer to these unique identifiers to make your records retrievable.

John
 
J

JayDeeJay

#27
Thanks for the reply John. The auditor referenced our Supplier Survey form and the Record Control Review form we use. We do not have a consistent identifier when these forms are filled out. I guess I could just add a numbering system? Seems like just another log to maintain...
 

John Broomfield

Staff member
Super Moderator
#28
Thanks for the reply John. The auditor referenced our Supplier Survey form and the Record Control Review form we use. We do not have a consistent identifier when these forms are filled out. I guess I could just add a numbering system? Seems like just another log to maintain...
Jay,

Your a Supplier Survey form is uniquely identified by the Supplier's Name and you have no need to log these if filed in each current Supplier's file.

I do not understand what a Record Control Review form is.

John
 
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