Document History - Where and When


Brenda Mundroff

There is a heated controversy here over when to add document history to our controlled online documents. The ISO9002 standard states:
"Where practicable, the nature of the change shall be identified in the document or the appropriate attachments."

Do the following fit this requirement:
a.) include a detail of who, what, when within the document,
b.) include a date/time stamp of the last change, or
c.) have a separate on-line document that shows all documents that have changed and the specifics and nothing within the updated document itself?

Any opinions?

barb butrym

Quite Involved in Discussions
they all work.....

but what works for you? Personally I like the change # referenced...and you can access that record for details...also like an * in margins for paragraghs that change...Or a listing of page #s on the front cover/or back sheet that changed....

there are many many options, and as many opinions. Bottom line, who will actually use that information, how often....and what works for them? My experience? the owner of the procedure is typically the one who would check out the changes to see if training is needed...So an * gives him the new stuff, and he bounces that against the old stuff...does he still have access to an old copy or the change document?...Anyway...thats where i would start.

The Fixer

My company has been registered since 1994. Via numerous audits, we have refined our document change system as follows:
Each document is identified with an overall date or letter sequence revision level on the Cover Page. Each individual page also has it's own rev level in the header. When new changes are made to a document, the changed word, sentence, paragraph is printed in bold italics so it can be easily identified by the user.

We have two document indexes (quality and technical) which are published monthly. All documents and revision dates/letters are displayed. Any documents which have been changed since the last index release is marked with an asterisk in the margin.

Now, to document proof of implementation, each employee has a "Documetation Training Log". Anytime a document is changed which affects an employee's job function, that employee's training log must be updated to reflect that they have received training on the revised procedure.

Obviously, I've left out a little detail as to the control mechanics of all this but I think you get the idea. We've had two different registrars and, other than human beings making individual errors, the "system" itself seems to be audit proof.
Glenn Deka


We use an access database to control all revisions to a document and put the document revision level and date on the actual document. Then it can be looked up in the DB by level. We also put a signoff sheet directly behind the document which states the revision level, date and change description. Not quite sure yet how to handle that signoff with online documents, which we will be implementing real soon. Fixer, I like your idea of putting the changed text in italics or bold. Also Barb the asterik is a great idea too. We have no numbering in our instructions, so it is hard to show in a document or explain in a history where it has changed.
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