Change Control Form - Approval process for cross departmental communication

M

mhunter - 2009

#1
I have a question regading control of documentation. I am in the process of putting together a procedure for change control. I have created a document to help the approval process to incorporate cross departmental communication if need be. My question is, if this form is not used for all offical document changes, then a rev block must be used for history purposes correct?:bonk: Thanks for any assistance you can provide!!
 
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Jen Kirley

Quality and Auditing Expert
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#2
Welcome to The Cove!

I am not sure I completely understand you, but I will try to give you a straight answer.

At minimum, controlled documents need to have some way for the reader to know their version is the most recent available. That usually happens with a revision number, but a date might serve too. The archived old copy should be plainly marked "Obsolete" or some such.

These documents will, according to their sensitivity, need change approvals from authorized people who represent the people who use, or will be affected by the process being changed.

If a change form is separate from the document itself, it needs to identify which revision it is for. So, one could argue that both have a revision number. But if a change form is separate from the document it is collecting approvals for, its revision number isn't adequate. The document itself needs this revision information. I like to see it on the front page, as well as the header or footer of every page.

There will be some documents that arguably don't need this kind of change control. Equipment manuals from the manufacturer might not need revision controls if a performance check is done after each repair/PM. A blank requisition form might not need any revision control unless it was getting a critical change and you want to be sure the old version never gets used again.

I hope this helps!
 
M

mhunter - 2009

#3
Thanks for the reply. I guess I should of explained it a little better. Sorry!! I understand the revision on every official doc but, my question pertains to the history of the doc. When you rev up a document, do you have to have the "rev history box"? To specify who, what, when? I can see if you have a seperate form for the approval process, you have your history. However, if you don't have a seperate form for the approval process, it appears you would be lacking the revision history??? Thanks for any help you can provide.:)
 
R

Roland Cooke

#4
The issued document needs a revision number, to enable doc control. The details of the revision, and any previous histories, do not need to be explained on the actual issued document (though they can be). As long as they are detailed somewhere, that's the only requirement IMO.
 
#5
Usually a Doc change notice is used, which when signed off by all related process heads will authorise the release of the next version of pertinent document. This Doc change notice captures the history (what led to the change and where) like audit CA / Customer complaint / CAPA / Any other related process modification and such things .... The Doc change notice number is captured in the new release of the document in question. One such notice could be a lead to several document changes. (Very similar to an ECR ECN process) This works well and is a proof for good process interactions too.
Somashekar
INDIA
 
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