Document Control ISO and FDA

[MedicalDevicequestion]

I have a question about document control.

If you have a document you send around for a business for approval signatures, but it gets half way around those people but then requires changes, should it go to revision 2.

For example, suppose Mary, Ben, Carol and Anne are to approve a document created by Brandon (all not real names).

Mary and Ben sign the revision 1 document, but carol requires the colour to be blue instead of green. The document is changed accordingly.

Should it go to revision 2 of the document showing a history of the change to blue from green

Or

Can it still be revision 1, with no document change history showing the change from blue to green.

I can see an argument it could be revision 1 because it did not get all signatures (i.e. Carol ans Anne did not sign).
However, without the change history Mary and Ben may not know what has changed. Additionally, without going to revision 2 Bendon sometimes makes changes without getting Mary and Ben to resign the approval sheet because he already has their signature on the approval sheet when it went around originally for signature before the change (i.e. when Carol requests a change, he makes the change but isnstead of sending it around for all the signatures again, he passes it only to Carol and then Anne, because he has signatures for a revision 1 document from Mary and Ben from before the changes were made).

Should the document have gone to revision 2, and if yes is there anywhere I can 'point to' to show this is what should happen?

 

[indubioush]

A document must not be released until all appropriate individuals have approved all significant changes. If additional changes are made during the review process, the document should be kicked back to document control and then re-routed so that the people who already reviewed the change order are made aware of the new changes. A document does not undergo multiple revisions when it is on a change order. It moves to the next revision upon official document release.

Additional note: There should be protections in place that prevent the originator from slipping in additional changes while a document is on change order.

 

[Tidge]

I would prefer the document NOT up-revise just because someone required a change prior to approval. I used to know someone who made quite a fuss about the difference between versions and revisions and while I understand the point they were trying to make, the argument ignore the core issue that there can only be one currently released instance of a document at any time, no matter how many corners people try to imagine.

 

[Enternationalist]

Maintaining that level of detail is usually unnecessary and burdensome. When a document is finished and approved, give it its version/revision number. It adds no value to track every single alteration made on the way; you only need a record of what actually got used in practice.

 

[ChrisM]

If not all the approval signatories sign the first version, then it never got approved so there is no need to revise it yet again before circulating it for signature by all parties.

What you should be aiming for is an approval system where, after drafts have been circulated for comment, only 2 signatures are required for formal issue.

 

[Billy Milly]

I agree with Chris. It is good to diferentiate between review (consultation...) and approval. It seems you are now treating them as one.

 

[FRA 2 FDA]

Exactly what others have said. If we get part of the way through the approval process and someone makes a change, it just goes back to the beginning of approvals with an explanation of what changed to save the people who already approved from having to reread the whole thing. If they have no objections, they just sign again and send it to the next person. The revision doesn't change because it was never released during the initial approval round.

 

[blackholequasar]

To me, the reason we are routing the document for approvals is to get input/feedback from process owners to ensure that the current revision is complete and cohesive. I anticipate changes through the approval process, so there is NO need to up-rev during this as the official revision has not yet been approved and released from document control. I can't imagine redlining something and up-revving it over and over again, that seems far too tedious and repetitive!