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View Full Version : Identifying Changes to Documentation - ISO9001 Clause 4.2.3 c


stephenh
11th January 2008, 10:56 AM
Hi everyone,

I have a query over 4.2.3 c) to ensure that changes and the current revision status of documents are identified.

Revision status is no problem, all documents have a code with the current revision status and the document register is updates accordingly. However we do not have a system in place for identifying changes.

Design files e.g. artwork is stored in a job file with the version number so I guess a progression could be seen from version 1 to version 5.

However, with regards to QMS documents we do not have a way of identifying changes. I'm not even sure why this is necessary as long as the latest version is available. Any updates to procedures /forms / manual, at present the new version just replaces the old version and revision status updated?

Is there anything I should be doing?

AndyN
11th January 2008, 11:07 AM
Stephen:
It's often helpful to a document user to know what has changed to stop them from having to read through a document (often lengthy and boring!) to find a simple reference or typo or responsibility etc has changed.

I'd suggest that if you're not using one, a document change notice is a good way to communicate changes, why they occured and what was changed, for the benefit of the users.....

When I help people put together documentation control systems, that's one of the first thigns we do and no-one has ever said anything against it - they have all they need at their finger tips when they read it.....

Ajit Basrur
11th January 2008, 11:16 AM
Hi everyone,

I have a query over 4.2.3 c) to ensure that changes and the current revision status of documents are identified.

Revision status is no problem, all documents have a code with the current revision status and the document register is updates accordingly. However we do not have a system in place for identifying changes.

Design files e.g. artwork is stored in a job file with the version number so I guess a progression could be seen from version 1 to version 5.

However, with regards to QMS documents we do not have a way of identifying changes. I'm not even sure why this is necessary as long as the latest version is available. Any updates to procedures /forms / manual, at present the new version just replaces the old version and revision status updated?

Is there anything I should be doing?

Change History is required for easy traceability of changes through the different versions. I am attaching a very good Change Management Procedure (http://www.tbs-sct.gc.ca/emf-cag/chgemgmt/cmgtproc_e.asp) for your information which details various aspects of Change Management for documents.

Hope this will clarify.

SteelMaiden
11th January 2008, 11:20 AM
I find it much easier to "get to the meat" if a revised document has some sort of indicator inserted where the revision took place. You can do something quite simple, you do not have to write a new paragraph stating "this is where something was added, subtracted, changed" you can just put in some symbol that is not typically used within your documentation.

There are many "symbols" available within word processers, or use a key from the keyboard that doesn't get used...how about the pipe symbol (|) inserted with a color change and/or bolded? Use a delta symbol from the symbol sets, or some other unique identifier. It is a simple thing to do and will help your employees cut through a lot of stuff. You can than document a thorough explanation of the change in your document control database, revision info within the document or however you do this. But, unless you are a technical person, all you really want is to know where the change was so you make sure you change your practice.

How many times have you looked at two documents that appear to be identical, trying to figure out what changed? I hate when that happens. It wastes my time, and after awhile you feel like you are searching for a needle in a haystack.

stephenh
11th January 2008, 11:22 AM
It just seems unneccesary effort if for example, a process owner slightly modifies a process flowchart, the only people who need to know are the quality manager (to update the register) and the process owner. As long as the latest flowchart is correct and up to date, why would either of us need to see the previous version?

michellemmm
11th January 2008, 11:37 AM
It just seems unneccesary effort if for example, a process owner slightly modifies a process flowchart, the only people who need to know are the quality manager (to update the register) and the process owner. As long as the latest flowchart is correct and up to date, why would either of us need to see the previous version?

:2cents:

If your Continual Improvement System is active, growing and formal, you need to have records and achieves that shows "what went right" and "what went wrong". Yes, you need a record of the "lessons learned." It may look as waste of time for you right now, but it is one of the ways of passing tribal knowledge to the new generation.

ScottK
11th January 2008, 12:00 PM
I use a Document Change Request or "DCR" to track the changes. The details of the changes are located there.
There's a rev history in each document saying what changed and a reference to the DCR.

I don't put change indicators in the document body because we use a heck of a lot of visuals - photos and flow charts - that are harder to annotate than a straight MS Word document.

Drawings are handled differently. They do show the changes and rev'd dims are marked.

All of this is documented in our document control procedure.

JaneB
14th January 2008, 08:39 PM
Stephen:

I'd suggest that if you're not using one, a document change notice is a good way to communicate changes, why they occured and what was changed, for the benefit of the users.....

That's usually all I do. Plus keep previous versions, just in case one needs to go back to them.

I can say that in over 20 years, the number of times that's been required is... hmm, once maybe? So I don't spend a lot of time on this part these days. But that's also likely to be a function of the types of systems and organisations involved, & the circumstances.

Examples: Projects are usually moving forward, moving forward, so any documents updated on those often change a lot and the old version is old history. A procedure document may just warrant a brief note to say that a section was added/titles updated, etc.
Whereas manufacturing engineering drawings often need detailed info on exactly what changed from one revision to another.

It all depends.