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Old 14th September 2006, 01:36 PM
dbellis dbellis is offline
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Question Documenting Revision History - Single “Revision Record” Document

I have recently taken over as Management Representative for my company’s Quality Management System (ISO 9001:2000). Currently we only have a single “Revision Record” document that has columns for date, rev number, section revised, description of change, and authorization (signature). This document seems to be setup for changes to the actual Quality Manual only.

I am looking for recommendations on how to track revision history for the other elements of our Management System (i.e. Procedures, Work Instructions, and Forms). How do your systems track this? Should I create a separate revision record document for each of these other elements? Should all this be tracked on a single document? Or in the case of Procedures and Work Instructions, should I include this information on the documents themselves?

I realize this could probably be done a number of different ways and still satisfy the requirements; however, I would appreciate feedback from those that have experience with this. If possible, examples are always the most helpful.

Thank You,
Don

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Old 14th September 2006, 01:55 PM
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Gmayes Gmayes is offline
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Re: Documenting Revision History

I'm confused at actually what is in place. Is it a record that is created each time the document is changed? Or is it something attached to the document itself that is updated each time a revision is made?

This is what I have in place with my company's QMS.

Each document (SOP, Form, QM, etc.) is assigned a document number. I have a log for each SOPs, Forms, and Manuals. The log contains the document name, number, current revision, revision date, never review date, and document owner. Each time a document goes through the revision process, this log is updated.

Also, I have a Document Change Request form. Its a form that has check boxes and text boxes to capture the following information:

- Is this a revision, creation of new, or retire.
- Document Number
- Revision
- REquestor
- Reason for revision (request)
- Is this a result of a Corrective/Preventive Action? (yes/no)
- Document owner approval
- QMS Manager approval.

After a document is revised, the new revision is submitted to me with the sheet completed. I take this to the document owner for their review and approval. After all approvals have been made, the new document is updated on our server, and the signed form with document is kept as a record.

Our SOPs and Manuals also have a revision history at the end of the document itself. It captures what the revision is, who made the revision, the date, and the reason.

If you'd like to see an example of this Document Change REquest, feel free to send me a PM.

~Gregg

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Old 14th September 2006, 02:01 PM
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Re: Documenting Revision History

You're right there are many ways to satisfy the requirement. You must ask yourself what works best for your company.

I,ve always used a revision history table in each document. This provides the document user easy access to the change history without having to look in another document. Your users may not care about the revision history and use of a separate document of change control database (PDM/PLM) may be easier for you.
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Old 14th September 2006, 03:59 PM
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Thumbs up Re: Documenting Revision History - Single “Revision Record” Document

Quote:
In Reply to Parent Post by dbellis View Post

I have recently taken over as Management Representative for my company’s Quality Management System (ISO 9001:2000). Currently we only have a single “Revision Record” document that has columns for date, rev number, section revised, description of change, and authorization (signature). This document seems to be setup for changes to the actual Quality Manual only.

I am looking for recommendations on how to track revision history for the other elements of our Management System (i.e. Procedures, Work Instructions, and Forms). How do your systems track this? Should I create a separate revision record document for each of these other elements? Should all this be tracked on a single document? Or in the case of Procedures and Work Instructions, should I include this information on the documents themselves?

I realize this could probably be done a number of different ways and still satisfy the requirements; however, I would appreciate feedback from those that have experience with this. If possible, examples are always the most helpful.

Thank You,
Don
Don:
I'd use the same process for all documents. I have used a 'DCN' (document change notice) to accomplish all the things you described. I prefer this approach, because to put all the history in a document (like a WI etc.) eventually becomes a burden. Go with what you've got - it works if you want it to.

Andy

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Old 15th September 2006, 02:28 AM
potdar potdar is offline
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Re: Documenting Revision History - Single “Revision Record” Document

The document control process has its roots in the drawing office. They have been controlling their documents excellently for ages. Just visit them an see if their methods suit you. Or then, many variations have been designed to suit evrybody's situation best. You can design your own.
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