Is this procedure ISO 9001 Clause 4.2.3 Compliant?

[EDH05]

My second effort. Thanks for all the suggestions.

 

[treesei]

A quick comment:

"Approvals are required from: Design Engineer Document Control
Manufacturing Purchasing
Production Engineer Marketing
Materials
Once all parties have signed off on a change the DCS will execute the change."

Are you sure each and every document change will need the approval of all seven departments above?

 

[EDH05]

Are you sure each and every document change will need the approval of all seven departments above?

They will not. I suppose it should read: Once all necessary parties have signed off on a change the DCS will execute the change. However, do I then have to have something included about who is required for what, or who determines who the necessary approvals are?

 

[treesei]

However, do I then have to have something included about who is required for what, or who determines who the necessary approvals are?

I would recommned one. I don't know how your QMS document structure is, but usually a simple matrix (as part of the procedure or a child document) will do the trick. This matrix determines who the necessary approvals are.

 

[Kirin]

Hello All,

I'm new to the forum and have been reading through the thread as it is relevant to some work that i'm currently undertaking.

Not wanting to hijack the thread , but I was wondering if any of you would be able to provide some criticism on the first draft of my document control procedure? I was going to start a fresh thread, but didn't want to clog up the board with similar topics, plus I thought that it might be more useful for future readers to have relevant content grouped in the same thread.

I realise that it is not necessary to formally address each section of the document control requirements of the standard as I have done, I just felt that for the first draft it helped to keep me on track.

Is it necessary to add 'Scope' and 'Purpose' sections, or is that considered a little old hat now?

Thanks in advance!

 

[AndyN]

Welcome to the Cove! I'm sure you'll get good responses.

From a format point of view, you may wish to de-couple the document from the ISO numbering. In 2000, a lot of companies had the exact problem because they had their procedures numbered as 4.5 - the doc control requirement of ISO 9001 1994. It's just work that doesn't need doing!

I prefer to kick the old school formats so yours is fine by me!

 

[treesei]

Is it necessary to add 'Scope' and 'Purpose' sections, or is that considered a little old hat now?

From my regulatory background, to me it is very important that a document clearly have two elements, either as part of it or referred to somewhere else: The exact application (the scope) and the definitions of important terms.

Another minor comment: In a document, any activity that "should" be done may not be done while that "shall" be done must be done.

 

[Stijloor]

Another minor comment: In a document, any activity that "should" be done may not be done while that "shall" be done must be done.

I don't care what should or shall happen. I am more concerned with what IS happening. Write active voice, present tense.

Stijloor.

 

[treesei]

I don't care what should or shall happen.
Stijloor.

I am afraid that in an audit, you have to care. All laws/egulations/guidances are written with careful use of these two words. A deviation from "shall" will cost you an NC. A deviation from "should" may not if you know how to handle the situation. The former is a requirement; the latter, a suggestion/recommendation.

 

[Stijloor]

I am afraid that in an audit, you have to care. All laws/egulations/guidances are written with careful use of these two words. A deviation from "shall" will cost you an NC. A deviation from "should" may not if you know how to handle the situation. The former is a requirement; the latter, a suggestion/recommendation.

I am referring to internal documents. BTW, I am an auditor...

Stijloor.