Reference to an archived template in multiple SOPs

M

MDRepair Canada

Starting to get Involved
#1
#1
Hi all,
I have a question.
We have decided to archive a non conformance template as we are now recording them directly in our IT system.
Problem is that this form is referenced in multiple SOP or Work instructions.
It will take some time for me to update all the documents where is it referenced.
We will be audited by an external auditor in few weeks. Will it be a non conformity if all documents are not updated that day?
There is an action planned to update those.

Thanks in advance for your help!
Regards,
MD
 
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Y

yodon

Leader
Super Moderator
#2
#2
Who knows what an auditor will write you up for! :) It probably would be if there was evidence someone used the old form after the switch-over date. (So you should have a well-defined switch-over date!)

This ties directly to 13485 5.4.2(b) (maintaining the integrity of the QMS). You say you already have a plan (good!) and that's certainly helpful. Be sure to show that you're sticking to your plan.

I suggest you also establish a plan and take actions necessary to ensure that after the switch-over date, there's no possibility for using the old form. This probably involves some bit of training and communications. Again, be prepared to show what those actions were and how they are successful in ensuring no missteps.
 
M

MDRepair Canada

Starting to get Involved
#3
#3
Thanks a lot @yodon for your answer. It helps a lot.
i am the only one using this template so probability that someone is using the wrong one if very low. I will show my plan et cross fingers the auditor doesn’t have anything to say about that :)
 
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