Requirements for Review and Approval of QMS Documents

J

jhinckley

#11
Re: Review and approval of QMS documents

I'm sorry I was away for a few days. The clause cited was 4.2.3.
 
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Big Jim

Super Moderator
#14
I'm amused.

Unless your document control procedure says you are going to keep records of document changes he is over-reaching. Nowhere is 4.2.3 is their any mention that records need to be maintained to fulfill 4.2.3 a-g.

You can choose to maintain such records or not. It is your choice, not the auditors. If you choose not to, the auditor has to find another way to determine that you are fulfilling the requirements of 4.2.3 a-f, and that would be to determine your PRACTICE through interview and observation.

The only reference to records in 4.2.3 is in the second sentence where it tells you that records need to be controlled according to 4.2.4. This sentence does NOT impose a requirement to maintain records of document changes.
 
J

jhinckley

#15
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.
As it is currently written, my Control of Documents and Records procedure says that a Document Change Request is directed to the applicable Document Author. The Document Author either creates, revises or retires an existing document among other things including updating the revision history.
Upon completion designated approvers are supposed to receive electronic notification asking them to review the document. At this point the document is either approved or not. If not it goes through a review cycle.

After electronic approval by all listed reviewers, the DMS automatically copies the document to the Approved Document Database and Document Archives Database ensuring that approved changes and current revision are recorded.

The problem is when I first wrote the procedure, I envisioned the implementation of DMS software to handle this. This has not happened. So, to address the NC, I'm thinking of using a Document Change Request form in conjunction with a document matrix listing all documents in the system. It's not ideal, but I believe it will address the NC.
 
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