Requirements for Review and Approval of QMS Documents

J

jhinckley

We recently received a minor NC related to the above. The statement of nonconformity was as follows:

Other than the change history and approval of the quality manual there is no evidence of review and approval of quality system documents prior to issuance or revision.

Absent a true document management system, what would be the best way to address this NC?
 

AndyN

Moved On
Re: Review and approval of QMS documents

We recently received a minor NC related to the above. The statement of nonconformity was as follows:

Other than the change history and approval of the quality manual there is no evidence of review and approval of quality system documents prior to issuance or revision.

Absent a true document management system, what would be the best way to address this NC?

What was the reference requirement the NC was made against?
 

Pancho

wikineer
Super Moderator
Re: Review and approval of QMS documents

We recently received a minor NC related to the above. The statement of nonconformity was as follows:

Other than the change history and approval of the quality manual there is no evidence of review and approval of quality system documents prior to issuance or revision.

Absent a true document management system, what would be the best way to address this NC?

Hi again, Jim,

ISO 9001 itself doesn't require "evidence of review and approval". In clause 4.2.3, it requires you to "define the controls needed to (a) approve documents for adequacy prior to use, and (b) to review and update as necessary...".

Does your procedure define any controls at all for approval and review? Maybe you are missing defining such controls, but if so, the wording of the NC seems incorrect to me.

Alternatively, does your procedure for document control require some other evidence? If so, maybe the NC is against your own procedure.
 
K

kgott

Re: Review and approval of QMS documents

ISO 9001 itself doesn't require "evidence of review and approval".
.

I'm misisng something here Pancho. How does a document get approved for either issue or re-issue without some evidence thats its approved?

thanks
 

Pancho

wikineer
Super Moderator
Re: Review and approval of QMS documents

How does a document get approved for either issue or re-issue without some evidence thats its approved?

Evidence is provided by records. If a record isn't kept, then the evidence may be lost.

The OP's auditor did say "other than the change history". Thus there likely is version control in the system and edits are recorded. If the editor can approve, then that does provide evidence of approval, of course. But if in the OP's doc control procedure the approval has to come from another party then the change history may not provide the required evidence.
 
J

Jeff Frost

Re: Review and approval of QMS documents

jhinckley,

The documented procedure must identify the approval process (4.2.3.a) and though a formal record is not required for the review and update (4.2.3.b) there must be some form of evidence that review/update has taken place. The procedure is the document control method for your company, so it should address all requirements of 4.2.3 including what will serve as evidence of review/update approval.
 

Helmut Jilling

Auditor / Consultant
Jhinckley,

I think we need a little more info. You stated the NC, but give us the whole NC statement nad the objective evidence cited. Without seeing what the auditor felt was incorrect, we are limited to guessing as to what to correct.

Cl 4.2.3, like any other clause, does require evidence that the requirements have been met. But, there are many ways to achieve that. It is possible that the auditor was reachiing for more than what is required, but I am inclined to give the auditor the benfit of the doubt until I understand what evidence he saw that led to the nonconformity. Of course, the nature of this finding, the way it was written, could imfer that the auditor was a bit of a rookie and heavily focused on the doc control requirements...

Can you give us the rest of the details, and we'll try to help more specifically.
 
R

Richard Davison

I had a minor NC for exactly the same thing. Our solution (accepted by the auditor) is that I email all new or revised documents to our MD requesting that he review and approve them prior to release. His reply email confirming is sufficient to confirm review and approval.
 

insect warfare

QA=Question Authority
Trusted Information Resource
We recently received a minor NC related to the above. The statement of nonconformity was as follows:

Other than the change history and approval of the quality manual there is no evidence of review and approval of quality system documents prior to issuance or revision.

The way I'm reading this is that (and if I am incorrect let me know) that you have controls in your QM for review and approval of the QM itself, but regarding the rest of your QMS documentation, you have a lack thereof. Sound about right?

Absent a true document management system, what would be the best way to address this NC?

The best way to address it would be to identify what gaps you have and initiate actions in order to achieve whatever it is you need to do to have an "effective" document management system. Depending on how primitive your system is, you may need more planning than you think. BTW, I'm not sure there is such a thing as a "true document management system", so I use the operative word "effective" because what works here does not usually work there, and vice versa.

The worst way to address the NC is to try and circumvent it without giving the PDCA process its due diligence first (not recommended)...

Hope this helps :rolleyes:
Brian
 

Jen Kirley

Quality and Auditing Expert
Leader
Admin
I had a minor NC for exactly the same thing. Our solution (accepted by the auditor) is that I email all new or revised documents to our MD requesting that he review and approve them prior to release. His reply email confirming is sufficient to confirm review and approval.
I would accept that as evidence of approval. I would go on to ask if this person was the only one/last one to approve in all cases, or if others had to be included for various document types and levels.
 
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