Approvals for Obsoleting QMS Documents

#1
Hello Everyone,

If anyone has some thoughts on this, we would appreciate some feedback.

We have recently implemented QMS software which does not require approval of the original parties to obsolete a QMS document. It has always been my experience that this is required when obsoleting a document, not just requesting a rev. change. We are now debating as to whether this is required or not because the standards indicate that these approvals are required for changes to documents. It is my opinion that obsoleting a document is a change and should be approved by the affected parties.

The software does allow us to archive if we want to obsolete something, but there is no workflow set up to get approvals. All it takes is an e-mail request from someone requesting that our Doc Admin person obsolete the document (though she would question the person on why they wanted it obsoleted and comment in the document why it is being removed). I do not feel comfortable with this (I am lead auditor). Am I crazy or do any or your companies submit offical approval requests to obsolete something?

We have a surveillance audit coming up next month, just CYA'ing

Thoughts?

Thanks!
Laura
 
Elsmar Forum Sponsor
#2
I tend to agree with you, Laura.

On the principle that this is a management system, documents which form part of it should be not only approved for use, but someone should approve their removal (obsolescence). It's true that many documents are obsoleted by subsequent revisions, and the approval of a revision is also the approval to obsolete (as it were), but as you point out, not all documents are removed from the system by revision.

One good example of where the people who write the software don't always have a good grasp of many facets of implementation.......thanks for posting that here!

Good luck at the surveillance!
 

jkuil

Quite Involved in Discussions
#3
The purpose of having approvals in the document control process is to assure that changes to any document do not negatively affect the integrity and consistency of the documented quality system (thus not only of a single document). Obsoleting a document could affect the QMS by inducing gaps. The reason for obsoleting the document and the risk for becoming incompliant with regulatory requirements should be evaluated in the change request. Acceptable reasons are:
  • the requirements in the document have become inapplicable as the associated processes have been stopped
  • the requirements were/are specified in other quality system documents
  • the requirements are not warranted by any regulatory requirement, customer requirement or quality objective
 

SteelMaiden

Super Moderator
Super Moderator
#5
You aren't crazy Laura, it makes sense that someone "in the know" would be the one to say "this document is not any good anymore, get rid of it". Otherwise, even I could say "I don't use that, get rid of it." and bring everything to a screeching halt because I got rid of the information needed to do the most important process.:bonk:
 
M

Mengelbrecht

#6
Hi Laura,

I would say that any document, whether in draft, final approved or obsolete must be reviewed and authorized by the custodian of that document.

In my mind, evidence of a document that is not in use anymore, must be either show that the document is revised and you will then reference to the revision nr. or declared obsolete.

An obsolete document is obsolete because somebody decided that it is not applicable anymore. Therefore proof of somebody that authorised it must be shown.

In our process, obsolete documents is going through the normal authorisation process.

Hope this help,

Marianne



Hello Everyone,

If anyone has some thoughts on this, we would appreciate some feedback.

We have recently implemented QMS software which does not require approval of the original parties to obsolete a QMS document. It has always been my experience that this is required when obsoleting a document, not just requesting a rev. change. We are now debating as to whether this is required or not because the standards indicate that these approvals are required for changes to documents. It is my opinion that obsoleting a document is a change and should be approved by the affected parties.

The software does allow us to archive if we want to obsolete something, but there is no workflow set up to get approvals. All it takes is an e-mail request from someone requesting that our Doc Admin person obsolete the document (though she would question the person on why they wanted it obsoleted and comment in the document why it is being removed). I do not feel comfortable with this (I am lead auditor). Am I crazy or do any or your companies submit offical approval requests to obsolete something?

We have a surveillance audit coming up next month, just CYA'ing

Thoughts?

Thanks!
Laura
 
W

Watchwait

#7
We're all on the same page here. When in doubt, I always invoke the "reasonable person" concept. In this case, would a reasonable person expect that the original approvers of a controlled document be required to obsolete this same document? I'm also quite certain that a typical FDA Investigator would also make this same assumption. BTW...just why would anyone OBJECT to this interpretation of the regulation? Since this does not seem to be a particularly burdensome requirement I'd tend to err to the conservative.:2cents:
 
#8
..... BTW...just why would anyone OBJECT to this interpretation of the regulation? Since this does not seem to be a particularly burdensome requirement I'd tend to err to the conservative.:2cents:
Appreciate everyone's feedback on this and we are all on the same page with this. The objection is from the person setting up the doc control module in our QMS software. She is still pretty green in the Quality field as far as I am concerned, but thinks she knows all.... All I'm sayin' about that one.

Anyway, I have approached my boss in regard to this and he is in agreement that obsolete documents need to go through the original approval process. The person who is dealing with the workflow has been told to contact the software manufacturer to determine how to develop this routing.

Thanks again everyone for your feedback!
Laura
 
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