posted 17 November 1998 09:13 AM               

It sounds to me that you have chosen to place revisional change history directly into your documents. That is fine. The description of the change should be as specific as it needs to be. For instance: if you go back to a document in a year's time, will you have trouble figuring out why you revised the document? You shouldn't.

Hand written changes are also acceptable provided that they are identical in all distributed copies and are legible. Neatness counts here and for all quality records.

Your revision history categories are fine.

As far as what others include in revision history I can't say.

posted 17 November 1998 05:04 PM               

I have seen all sorts of ways to show revision history and have implemented several different methods myself. It doesn't matter if its computerized or manual, in the document or in a separate location. All that does matter is that you can track the changes from revision to revision and that the information is accessable to the user.
A method I tend to like is a limited history in the document, like the last 3 revisions, and the rest on saved files of the old document. This works when you have the document history saved electronically. You can leave only the most recient changes on the latest document and earlier changes are found by looking up the obsoleted past revisions on the system in a history file.

posted 20 November 1998 11:20 AM               

The posts thus far are examples of very good suggestions for compliance. I will just toss in my two cents worth anyway.

The system I use is basically a hybrid of the above. Each document change is recorded on a Document Change Notice (DCN). The DCN details the nature and reason for the change. The document and DCN are circulated for approval by affected parties. Once approved, the obsolete documents are removed and replaced by the revised documents at all points of issue. The DCN remains in the Document Master Record (DMR) to maintain the history. An example would be: Procedure XYZ is at revision D. Revision D is issued and maintained in the DMR and all previous revisions are removed and destroyed. The DCN's for Revision A, B and C are also maintained in the DMR. The DMR contains a master list of all documents pertinent and the latest revision number of the document. As a redundant (sort of) backup, all changes and the reasons for the change are maintained in the MS Word document via the Track Changes tool and comment fields.

This is sorta overkill in some aspects, but my company is also FDA regulated, and some (not all) Government auditors can be such ( o )'s.

I try to avoid placing revision history and reasons on the document itself. Tends to clutter it. There is nothing wrong with this method. I just try to avoid it as a personal preference.