Document Control - Document Revision History Question

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irish634

I've been reading threads for a while but haven't really come across the answer I am looking for.

We are implementing our ISO QMS. For "Control of Documents" we have "to ensure that changes and the current revision status of documents are identified."

Most SOP and Work Instruction examples found on the net have a "revision table" of sorts embedded within the document.

However, in reviewing the IPC documents (ipc.org) (Standards and test methods) they do not include a revision table or revision history in the documents themselves. They do of course have revision letters. I presume they keep a separate document/database that keeps these revisions available.

I also presume an auditor/evaluator would question if we kept them apart from the documents. But for documents like forms, I don't think I have come across one with a revision history table. Revison status yes, table no.

So my question: Is the IPC incorrect in their method? I don't see where they are ISO certified, but reviewing document samples it was something I picked up on.

Are we likely to get 'dinged' if we keep the revision table separate?
Thoughts please and thank you.
 
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Joe Cruse

Re: Revision History Question

I have seen customers do what I believe you are talking about, i.e. the document/forms having a revision status on it somewhere, and then a table at the very end that has a full revision history for that document/form. We especially see them with regards to purchase material specifications.

We do not handle documents that way, and have never been given any hassles about it. In our system, we have a document header, with the title of the doc and its revision status, among other things. We use a database to keep up with the revisions and status of all documents, and can produce a revision history of any document, when needed. I don't know how some of the other business systems like TS work, so maybe under others, putting a full revision history is necessary. Most of the time that I see this, the company has TS certification, not ISO9001.
 

Eredhel

Quality Manager
Re: Revision History Question

Our documents have a header with the doc # and rev, who its owned by, who approved it, and what its title is. Then separately we have a master list that lists every document with its # and rev, date entered/revised, and ownership. I have one master list for docs and one master list for records. I have also hyperlinked the headers and master lists so I can easily go to either with a mouse click. Makes it easy to note rev changes.

Our system is new so I can't say it's great for the long haul. But we did pass our ISO certification handily recently.
 

Miner

Forum Moderator
Leader
Admin
Re: Revision History Question

Revision history may be handled many different ways. A table in the document is just one way, a database is another. Both are acceptable.

Keep it as simple as will work for you. Also, keep it lean. A revision letter, OR number, OR date is fine. No need to have rev letters AND a date.
 

Mark Meer

Trusted Information Resource
I don't believe there's an explicit requirement to maintain revision history in ISO quality system standards (at least not, as far as I know, in 9001 or 13485). ISO 13485, for example, only requires maintaining "at least one copy of obsolete controlled documents"...no mention of revision history.

Certainly, there is no requirement to have revision history printed on every controlled document!

That being said, standards' requirements aside, I do think it is appropriate and valuable to maintain revision history summaries. ...but as already suggested, how you do this is entirely up to you...
 
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irish634

Thanks for the replies.

The clause in question that I am referring to is 4.2.3 line C (ISO 9001:2008)
"To ensure that changes and and the current revision status of documents are identified"

I guess I get hung up with "Ensuring changes are identified." To me, that means maintaining a revision history. Maybe I am wrong.

But I agree, no place does it state we need to maintain a history within the document itself.

I was only curious because the majority of the examples I find online have a revision history as a section within the document. I have found examples, like the IPC documents, that don't have a revision history within the document.
 
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Miner

Forum Moderator
Leader
Admin
The clause in question that I am referring to is 4.2.3 line C (ISO 9001:2008)
"To ensure that changes and and the current revision status of documents are identified"

I guess I get hung up with "Ensuring changes are identified." To me, that means maintaining a revision history. Maybe I am wrong.
Using change bars in the margin, underlining or using color also would identify changes.
 
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Tara Monson

We also keep an excel file with document revision history. No changes are ever noted on the document itself - only the current revision.

This works well for us. If we did keep a history on the document, some of the histories would be pages long. And that's just not worth it for us.

Good luck!
 
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PaulJSmith

To date, we've been keeping notes in the (electronic) document properties comments section of changes made, date, and person making the change.

We're currently looking to transition to a control software, which will make that unnecessary.
 

Jen Kirley

Quality and Auditing Expert
Leader
Admin
If, by IPC.org documents and standards you are referring to things like IPC-TM-650 test methods, I would consider them documents of external origin and as such the revisions are not controllable in the same way as your internal procedures.

I have seen many ways for ensuring changes are identified, including bold, colored or italics text, highlights, a summary in a revision history and a revision page like MIL-STDs used to have.

When considering making revision status known, I have been applying risk principles for a long time. That is,

- "How will the user know if this is the latest version?"
- "How do you make sure the user only accesses the correct version?"
- "How will the user know what has changed?"
- "If this page falls out of the binder and gets picked up, how would a person know what it belongs to and if it is current?"
- "If you need to research what used to be done, how would you do that?"

These are questions the organization can address to help make sure the right thing happens when and where it needs to. How you do it is up to the organization; an auditor should have an open mind as to options.
:2cents:
 
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