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Wed, 12 Aug 2015 09:35:03 -0700 |
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On Wed, Aug 12, 2015 at 9:11 AM, Herrmann, Lisa <[log in to unmask]>
wrote:
I was in concert with some of the other responses until I saw you add this
piece of info....
> Only difference is it is for the Quality Assurance Department
> (manufacturing world). They just want someone to assign a document control
> number if it is a new document or document the revision dates and changes
> if it is a current document.
THEN, a BIG red flag went up. If this is part of a QAP (Quality Assurance
Program) and it's an ISO related compliance requirement, it should remain
with the organization issuing and managing the documents.
In the "ISO Quality World" document control/document management is a
specialized function that has to answer to quality auditors when that
process occurs. Take a look at Section 4.2 of ISO 9001 on Documentation
Requirements... the necessary specifics for managing "quality related
documents" require VERY SPECIFIC things to take place with HOW and WHERE
the documents are managed, and if they are all being generated by
Manufacturing, they should have the active role in this.
> We used to have a Document Services team that did that and they have those
> people in areas where they could still manage it even though the official
> team has dissolved, but they are choosing Records. I am having a hard time
> understanding their reasoning for doing so, which they haven't told me that
> as of yet either. I just see it right now as time consuming and taking
> time from more important jobs and so have a hard time justifying their
> thinking.
>
You're right in that it's EXTREMELY time consuming and is an exacting
process. As you said "they had a team and dissolved it" and now they're
looking for someone else to take on this non-trivial role. If they expect
RM to take it on, they should provide a similar number of staff and funds
to support the effort.
Larry
--
Larry
[log in to unmask]
*----Lawrence J. MedinaDanville, CARIM Professional since 1972*
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