Document Control

Hi,
Please can you help. We have a number of controlled documents that form part of our contracts sent out to clients. These are our template documents. If someone decides to add an additional to column to one controlled document, without it being a documented change and sends it out to the customer - would this be classed as a non-conformance?
I keep having the same argument at work about this. Help!

 

Good day @Natalie9289 ;
The short answer is "no". This assumes that the intent and the required completion information is not lost by allowing modifications. If the 3rd party auditor writes up this type of stuff, then he/she is missing the intent.

However, your organization DOES need to consider the precedent that allowing "modifications" can set....
* Do the individuals accessing have write permissions and are they changing (without proper change point control), the template, which it sounds like your organization wishes to control"?
* Why is it necessary for the user to add columns? Can the sometimes required columns and/or generic columns be added to the template, which would meet individual unique requirements?
* If there is always the potential for modifications to the "used" version of the template, then in order to send the correct message to the organization team members you may wish to consider adding a boiler plate to the template that states something like...
"In use modifications which add to this template are permitted, however, no elimination of template required fields is permitted."

I would not be as worried about what allowing modifications says to your 3rd party auditor, as I would about how you allow modifications while continuing to managing/,maintaining your organization's culture

Hope this helps.

Be well.

 

Thank you for your replies.
I am asking from the view point of an internal auditor. But also as someone who manages the QMS.
I have several occurances where forms are overwritten and changed without formally being signed off.
I always see it that we use the forms to ensure that each customer receives the same treatment. If a change is to be made to improve that experience, let's document it. Make it an approved changed. Not just change documents where someone sees fit?
We have our recertification coming on shortly and I am rather concerned.

 

Consistent with the concerns @Andy Nichols raised, it sounds like you may indeed have room for concern as the original question does not seem to be an isolated event. As I pointed out previously, it is important that the organization culture understands and respects (and BENEFITS from !) the necessary change point control.

How is top management involved and supporting your efforts. Remember, by rule, this is not YOUR management system, but Top Management's"

Hope this helps.

Be well.

 

To answer both questions.
Top management don't get too involved until an issue arises. They also do not follow processes set. And see no harm in saving documents outside of the system. This has resulted in the MD using old documents!
It has always been said, any change should be documented.