Approval of Electronic Documents - How do we indicate "document approval"?

[Willb]

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

 

[donnammurphy]

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]

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 Drive” 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 “approved”. 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.

 

[Willb]

Thanks to donnammurphy and energy!

Your comments are helpful.

Willb

 

[Russ]

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

 

[CarolX]

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

 

[E Wall]

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).]

 

[ISO Chick]

Hi there
Just throwing in my two cents worth. My company has all it's "Master files" electronic with "Controlled Working paper copies" Approval is noted on the Change Log (which is also electronic) and only the current issues are available as read only documents on line. Editing is restricted to me and my boss. Archive files hold all the previous copies and draft files hold things that I am working on before issue.

The register have been happy that all the documents are controlled and that everything is communicated and available throughout the company which makes everyone happy

 

[E Wall]

Forgot to mention that we also have a backup procedure:

DAILY: Any updated file - [7 tapes rotated & reused]

WEEKLY: Complete b/u all network drives - [5 tapes rotated & reused]

MONTHLY: Complete b/u all network drives - [single use tape - stored for 3 years]

That way even if a virus wipes us out, we won't have to recreate everything.

 

[Carl-]

Just my thoughts:
I have worked with 2 fully electronic systems, neither of which used an electronic signature. As long as access is restricted to the Document control coordinator or Q Manager and you have an established procedure for approving documents, I don't think you would have a problem. Actually, keeping one hard copy log with actual signatures is less control in my mind. Who is to say the signatures are not forgeries? If you limit access electronically, at least you would know exactly where to point if something did not match up! In any case, I think as long as you have limited access and a reasonable backup for the files, any reasonable registrar will not have a problem with it. If they do have a problem, get another registrar, they are a dime a dozen these days.
Best of luck!
Carl-