Nonconformance on document control - Unapproved document on production server

Dr RA

Involved In Discussions
#1
Hi All

A document that has not been approved was available in the production drive. The production has not used the document, but had access to the unapproved document. This manufacturing requires validation due to formulation change and has not been validated and approved yet. Production has enquired about this unapproved document and if this can be used as the current version(approved) has been removed from manufacturing access and also attached this document(unapproved) in electronic format..

Due to recent developments on electronic management system, the SOP does not mention of the electronic access to the documents and at the same time does not mention of the copies only available as hard copy. It clearly mentions the current version of documents will be approved and distributed and a master copy will be retained.

A NC has been raised on clause 4.

Do you agree this a non conformance - if yes under what basis?
 
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somashekar

Staff member
Super Moderator
#2
Re: Non conformance on document control

Hi All

A document that has not been approved was available in the production drive. The production has not used the document, but had access to the unapproved document. This manufacturing requires validation due to formulation change and has not been validated and approved yet. Production has enquired about this unapproved document and if this can be used as the current version(approved) has been removed from manufacturing access and also attached this document(unapproved) in electronic format..

Due to recent developments on electronic management system, the SOP does not mention of the electronic access to the documents and at the same time does not mention of the copies only available as hard copy. It clearly mentions the current version of documents will be approved and distributed and a master copy will be retained.

A NC has been raised on clause 4.

Do you agree this a non conformance - if yes under what basis?
Yes I agree :yes:
If I say per the ISO13485, then the clause 4.2.3 a) To review and approve documents for adequacy prior to issue is violated.
4.2.3 d) To ensure that relevant version of applicable documents are available at the point of use. is also violated
 

Dr RA

Involved In Discussions
#3
Re: Non conformance on document control

Thanks Somasekhar,

Will argument that production has not manufactured a batch using this form waive this clauses?

Also the SOP not mentioning availability of the documents in electronic format with controlled access make the NC invalid?

Thanks again

RA
 

somashekar

Staff member
Super Moderator
#4
Re: Non conformance on document control

Thanks Somasekhar,

Will argument that production has not manufactured a batch using this form waive this clauses?

Also the SOP not mentioning availability of the documents in electronic format with controlled access make the NC invalid?

Thanks again

RA
Consequences of the NC can only add to the NC criticality rating.
Flaws within your setup can be part of your RC analysis.
The NC stays
 
P

PaulJSmith

#5
Re: Non conformance on document control

If you caught it internally and not by some external auditor, I would worry less about what standard clause may have been violated, and worry more about how your own internal procedures may have failed. That's the real issue here. Somehow, an unapproved document made it into your approved documents. Whether or not it was used is almost irrelevant. This is most definitely worthy of a Non-Conformance. Find the flaw in your approval process and fix that.
 
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