When To Change Revisions on Documents

[Quality_Goblin]

Hi All,

We are currently reformatting our QMS and I have a couple questions on if/when it would be necessary to change the revision number on documents. Since we are in the process of reformatting and renumbering the system of controlled documents, we have SOPs and WIs that are using both old and new numbering systems:

1) When you change the document number to the new system and new template, and it is at Rev 5. Would you start from Rev 1 with the new document number, or would you continue and go to Rev 6? My thought is that you would start at Rev 1 since the QMS has a new numbering system, but I just wanted to see what others have done.

2) In a new document, when you have referenced (now obsolete) document #s based on the previous QMS format and you need to update the reference document # to match the current QMS system, does this require a revision change on the new document? In our current Document Control SOP things like typos and formatting don't require revision changes. But what about when a reference document number has changed?

Thanks!

 

[lianayada]

In my experience (and will be experiencing this same issue later this year):
1. Yes, revisions go back to Rev. 1 with new document number.
2. Updating the referenced document numbers (assuming that is the only change being made) requires no revision update.

 

[Quality_Goblin]

In my experience (and will be experiencing this same issue later this year):
1. Yes, revisions go back to Rev. 1 with new document number.
2. Updating the referenced document numbers (assuming that is the only change being made) requires no revision update.

Thank you! You confirmed what I was already thinking. I appreciate your response.

 

[Michael_M]

2) In a new document, when you have referenced (now obsolete) document #s based on the previous QMS format and you need to update the reference document # to match the current QMS system, does this require a revision change on the new document? In our current Document Control SOP things like typos and formatting don't require revision changes. But what about when a reference document number has changed?

My view on this: the document changed (even if only a reference value) so would need a new revision. If I understand your question correctly, Document A calls to reference Document "Old Document Name" and now calls to "New Document Name". If this is the case, a new revision should be issued as someone could still have the "old document name" copy and since there is no revision update could lead to having two different primary documents using the same revision level.

Note: My document control is very small, but if I hit the 'save' button on a document, I treat it as an updated revision level even if nothing changed, otherwise, why did I hit the 'save' button?

 

[Quality_Goblin]

My view on this: the document changed (even if only a reference value) so would need a new revision. If I understand your question correctly, Document A calls to reference Document "Old Document Name" and now calls to "New Document Name". If this is the case, a new revision should be issued as someone could still have the "old document name" copy and since there is no revision update could lead to having two different primary documents using the same revision level.

Note: My document control is very small, but if I hit the 'save' button on a document, I treat it as an updated revision level even if nothing changed, otherwise, why did I hit the 'save' button?

I think I see what you're saying. So in my example DOC-10.0-001 Improvement Process is now changed to DOC-3.2-001 Improvement Process. In both versions we reference DOC-8.5-003 Manufacturing Process, but now we have changed Manufacturing Process to DOC-5.3-001. If I update DOC-3.2-001 to now reference DOC-5.3-001, you're saying that I need to uprev Doc-3.2-001?

 

[Mike S.]

1. I'd probably go to new document number rev 1 and in my revision table I'd explain that it is replacing old doc number rev 5.

2. I would change the revision.

 

[Randy]

I'd go with whatever makes the best sense and is easiest to manage for you and poop on everyone else.

 

[Michael_M]

I think I see what you're saying. So in my example DOC-10.0-001 Improvement Process is now changed to DOC-3.2-001 Improvement Process. In both versions we reference DOC-8.5-003 Manufacturing Process, but now we have changed Manufacturing Process to DOC-5.3-001. If I update DOC-3.2-001 to now reference DOC-5.3-001, you're saying that I need to uprev Doc-3.2-001?

I say yes, not knowing your document controls system like you do, you may find this does not work for you. Like I said, if I click the 'save' document button, I update the revision. This prevents having two documents with the same revision having different instructions (a previous finding for me).

 

[Ampein]

1) Yes, start from new revision.
2) Revision of the document is required as the material content (new number referenced) is different form current revision.

 

[cztony]

old revision is needed if you want keep the change history for further reference, if you change to Rev.1, the history will be lost. depend on your situation.