Is it acceptable to add approvers to a document in an ad-hoc manner?

GOOD DOCUMENTATION PRACTICE (GDocP)
1

Hello Experts

I have a question surrounding the approval of documents.

Scenario:

So I’m sending an OQ Protocol around for pre-approval so I can carry out my test execution…my cover page which is based on a template has 6 approvers ranging from Quality to Managerial sign-off.

My question is…is it acceptable to hand write on the cover sheet another approval which is not in the cover page template (which is version controlled).

Hope that makes sense and appreciate any feedback on this.

Regards

2

Wow, 6 signature blocks and you want to add more signatures? Sounds like an issue in and of itself.

I think you get into some dangerous territory there. If you look at, for example, ‘Control of Documents’ in ISO 13485, you’ll see the note:

The organization shall ensure that changes to documents are reviewed and approved either by the original approving function or by another designated function that has access to pertinent background information upon which to base its decisions.

So if you go adding people on approval (ad-hoc), you would have to perpetuate that on future updates.

The regulations / guidance docs don’t prescribe who has to approve documents, that is up to you; but you should have a consistent approach. If you add a signature on one OQ and don’t have that role on other OQs, your whole document approval system may be questioned.

I guess I’d be curious what kind of problem you’re trying to solve by adding approvers (on an ad-hoc basis)?

3

Hi Yodon

Thanks for the comments they have been very helpful…my senior engineer tells me that its ok to add more people to the document for approval even though we have a designated area for approvers.

I guess he wants to be able to add people last minute that he feels needs to see the protocol…personally I have never seen this approach before its seems very uncontrolled.

Rgs

4

Hello,

My only concern would be if the additional signature is not already one of the disciplines signing i would like to know what their responsibilities are.

I guess somewhere in the document there is a roles and responsibility section and assigned to the signatories.

[quote=yodon]Wow, 6 signature blocks and you want to add more signatures? Sounds like an issue in and of itself.

I think you get into some dangerous territory there. If you look at, for example, ‘Control of Documents’ in ISO 13485, you’ll see the note:

The organization shall ensure that changes to documents are reviewed and approved either by the original approving function or by another designated function that has access to pertinent background information upon which to base its decisions.

So if you go adding people on approval (ad-hoc), you would have to perpetuate that on future updates.

The regulations / guidance docs don’t prescribe who has to approve documents, that is up to you; but you should have a consistent approach. If you add a signature on one OQ and don’t have that role on other OQs, your whole document approval system may be questioned.

I guess I’d be curious what kind of problem you’re trying to solve by adding approvers (on an ad-hoc basis)?[/quote]