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  ISO 9001/4:2000
  Approval of Electronic Documents

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Author Topic:   Approval of Electronic Documents
Willb
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posted 23 May 2001 10:21 AM           Edit/Delete Message   Reply w/Quote
Help anyone!!!

When our company makes the transition to ISO 9001:2000 we intend to maintain controlled documents on the intranet only. Printed copies will be marked "uncontrolled".

My question...How do we indicate "document approval"? I'm sure there is an acceptable way but I haven't discovered it.

Thanks,

Willb

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donnammurphy
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Posts: 18
From:Athens, GA, USA
Registered: Dec 2000

posted 23 May 2001 01:40 PM     Click Here to See the Profile for donnammurphy   Click Here to Email donnammurphy     Edit/Delete Message   Reply w/Quote
My documentation is entirely electronic. I have 2 databases. The first database has controlled documents. These documents have gone throught the approval process and are issued electronically to the appropriate personnel. Anyone wanting to print from this database can, but the document will print out as a for reference only copy. The second database has pending documents. I call this my changes database. When a document needs to be revised or is new, this is where it will reside. Once the document is completed and all vested personnel have approved the document, it automatically goes into the controlled documents database. I house all the documentation in this database sorted by procedures, work instructions, detail instructions and forms. Hope this helps.

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energy
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Posts: 228
From:New Britain, CT
Registered: Nov 2000

posted 23 May 2001 02:26 PM     Click Here to See the Profile for energy   Click Here to Email energy     Edit/Delete Message   Reply w/Quote
After reading Laura M‚s post on creating hyper linked word document procedures, somewhere on this site, I had our MIS person establish a place on our „Shared Driveš on the server. Approved documents will be available with read only rights for users. The MIS person and myself will have edit rights. He is my back up and will not edit documents. Our procedure says that any documents on the secure shared drive are considered „approvedš. For documents that are in transition, they reside on my personal drive that is password protected. Once approved, they are placed on the shared drive. We also treat printed copies as uncontrolled documents. The one exception will be a Master Book, maintained in a secure cabinet in the Quality Assurance Manager‚s Office, that contains originals with the approval signatures on them. I feel that as long as all this is detailed in our Document and Revision Control Procedure, the Auditor will find it difficult to tell us it is inadequate. Of course, we are a ways off before we face external auditors. But, I‚m comfortable enough to resist any interpretation that our document control system is inadequate.

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Willb
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posted 25 May 2001 09:27 AM           Edit/Delete Message   Reply w/Quote
Thanks to donnammurphy and energy!

Your comments are helpful.

Willb

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Russ
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Posts: 17
From:Tipton, IN
Registered: Apr 2001

posted 31 May 2001 09:39 AM     Click Here to See the Profile for Russ   Click Here to Email Russ     Edit/Delete Message   Reply w/Quote
I agree, energy your method for electronic documents is just what I needed. It answers most of my questions on how I was going to control my manual that I almost have ready for our intranet. Thanks

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CarolX
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Posts: 108
From:Illinois, USA
Registered: Jun 2000

posted 31 May 2001 10:51 AM     Click Here to See the Profile for CarolX   Click Here to Email CarolX     Edit/Delete Message   Reply w/Quote
We plan to go intranet with our system in the near future. My approval system is set-up in this fashion. Each procedure has the name of the approving authoirity typed on the form. Before any new/revised procedures are released, the approver signs a cover page indicating approval of the documents. That cover page is maintained in the quality office.

CarolX

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E Wall
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Posts: 45
From:Columbus, GA USA
Registered: Jun 2001

posted 12 June 2001 05:00 PM     Click Here to See the Profile for E Wall   Click Here to Email E Wall     Edit/Delete Message   Reply w/Quote
It's been my dream to launch our procedures on the intranet for 3 years. Unfortunately, it's low priority to mgmt, so...I'm still waiting.

While I still issue out 'paper' documents, the system we use for approvals would work for you too. We have ECO's (Engineering Change Order) and DCR's (Document Change Request) depending on if it is a Corporate document or Plant document. Either way in the document header the Approval: is listed as the ECO or DCR # used to route the change.

We print up the 'controlled copy' on blue paper, so any other copy is uncontrolled, and doesn't require stamping (you can't possibly control who uses the copier).

With an electronic system, I would think keeping a 'master' paper copy or stored backup of the e-file will be available even if the system goes down. Then any 'printed' copy is uncontrolled.

Save as much work as possible. We do have an 'Uncontrolled Copy Current When Issued' stamp if needed, but rarely use it.

[This message has been edited by E Wall (edited 12 June 2001).]

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