Are signatures required on every page of a controlled document?

[AndyN]

Andy,

My lab falls under several different regulatory requirements and expectations of various client/third party auditors to show final official approval of any document (SOP, master form, quality or safety manual). Our tracking form used for initiation and review process is insufficient for formal approval.

If electronically approved, I'm looking for a solid compliant process to document initiation of the document, internal review and final approval. Anything else would be counter productive to an effective document control process.

I see final approval sign off as official authorization of that version of the document. Hoping to move toward electronic approval to comply with our paper-reduction and process streamlining plans.

Glad for the clarification, thank you so much. It's important to understand influences on your particular business are in play here, not what ISO 9001 requires - for clarification with other readers.

 

[Ettore]

Quick question: When preparing a controlled document such as an SOP, is it necessary for each and every page to be signed by the originator and authorizer (in a standard footer/header say with all the document control info), or is it enough just to have one set of signatures on the front page?

From p. 4.2.3 of ISO 9001 there are no evidence that the signatures for reviews and approval a documents is necessary.
Document have just to be "approved for adeguacy" prior to be issued and have to be reviewed as necessary. A Signature on the document is just one of the easy way to document it.
Making sure that who have the responsability to approving the contest of the document have read it before approving is another story, expecially when the CEO have this responsability.
Your CEO, have undertood and believe on the importance of Quality System Procedure?
If yes you are working in a luck company.

 

[isoalchemist]

Loose language. They require review and approval as every agrees. "signature" was just demonstration of approval however your system handles it.

 

[pearson114]

Andy,

My lab falls under several different regulatory requirements and expectations of various client/third party auditors to show final official approval of any document (SOP, master form, quality or safety manual). Our tracking form used for initiation and review process is insufficient for formal approval.

If electronically approved, I'm looking for a solid compliant process to document initiation of the document, internal review and final approval. Anything else would be counter productive to an effective document control process.

I see final approval sign off as official authorization of that version of the document. Hoping to move toward electronic approval to comply with our paper-reduction and process streamlining plans.

We were a small machining company approved to AS9100. Our system (Proquis) was used to hold all current copies of documents, despite not being completely accessible to all who required it, therefore hard copies were needed too.

The previous QM set up the system and I inherited it, he took responsibility for all documents (which I didn't agree with, I believe the Process Owner should be responsible for the relevant documents). As mentioned there would be a footer at the bottom of each document with went along the lines of:

- Control of Records
- SQAP4.2.4
- Issue No: 3
- Approved By: Joe Bloggs, Quality Manager
- Issue Date: 12/12/2012

Each document which required approval would have the above, he then held a list of all documents with their issue status. Each time a document was updated, he would update the list to reflect the correct issue of the doc, print it and sign in a provided space to show that he was approving all documents on the list at the issue shown.

Personally, I didn't like the system, I got through the audit a couple of months into my role as QM then changed the system into a more conventional one, where documents were approved (by the Process Owner), scanned back in as a PDF and uploaded onto an intranet system.

Others may like the 'electronically approved' method, and despite the auditor not particularly liking the idea, the system conformed to requirements and couldn't raise it as a non-conformance.

Hope this helps!

 

[Taliesyn]

I've just taken over a QMS where the same thing has been done. Work instructions for the shopfloor had 3 signatures on every page - which in some cases meant 57 signatures on a complex assembly instruction. To me, it's a recipe for disaster as, unsurprisingly, I found pages not signed at all - or with only 2 out of the 3 signatures.
It's up to you how you approach it but I favour a single "update" or "change history" page for documents where the content is controlled.
If the format is controlled - such as a data collection form - just have a pdf file on the server for everyone to print & write on. That way there won't be any "uncontrolled changes" and the control of the document becomes that much easier. Actually, we use Lotus Notes but the principle is the same.
As I said, it's "your" QMS so do what works best for you - but be prepared to argue your case cos some CB's come in with some damned strange ideas about document control!!

 

[Randy]

You will not find the word "signature" anywhere in ISO 9001, so requiring it becomes a self inflicted wound that is easily avoided by not doing so

 

[zancky]

imho

I suppose the thread was not started for a strict ISO 9000 compliance, but when customer or the standard is under GMP/GDP scheme where the story is completely different.

from my short experience and some request from very big GMP related companies:
in such a case if there is paper master, each page has to be signed and dated by the author while in the first or on the last you can find approvals and reviewers. some customer pretend that every year (or something similar) an authorized people review the document in order to confirm the validity against the possible happened law organization requirements improvements changes.
the master document may be in electronic format with electronic signature provided that the electronic signatures give the same assurance of handwriting signature (i.e. personal password, document md5 (or sha))
whenever a paper copy is needed, only an authorized people can print the document and he has to made a signature on each footer with date. At least on the first page he has to write the reason for such print and how long the copy is valid (no more then few month or the end of document revision time (see above or the issue of a new revision whichever occurs first).
the system has to avoid, in addition to old version use prevention etc: any uncontrolled photocopy, substitution or missing of part of the document.

 

[Randy]

imho

I suppose the thread was not started for a strict ISO 9000 compliance, but when customer or the standard is under GMP/GDP scheme where the story is completely different.

from my short experience and some request from very big GMP related companies:
in such a case if there is paper master, each page has to be signed and dated by the author while in the first or on the last you can find approvals and reviewers. some customer pretend that every year (or something similar) an authorized people review the document in order to confirm the validity against the possible happened law organization requirements improvements changes.
the master document may be in electronic format with electronic signature provided that the electronic signatures give the same assurance of handwriting signature (i.e. personal password, document md5 (or sha))
whenever a paper copy is needed, only an authorized people can print the document and he has to made a signature on each footer with date. At least on the first page he has to write the reason for such print and how long the copy is valid (no more then few month or the end of document revision time (see above or the issue of a new revision whichever occurs first).
the system has to avoid, in addition to old version use prevention etc: any uncontrolled photocopy, substitution or missing of part of the document.

Nowhere do you find this in clause 4.2.3, NOWHERE!

 

[Mikishots]

Actually, signatures aren't required of ISO 9001 (you are posting in the ISO 9001 forum so am basing it on this). What is required is that they are approved. If you choose to do this with a signature, that is up to you. Seems that it is the accepted method of showing approval, but again, it isn't required. You just need to be able to show that the documents have been approved.

Now, if your internal procedures state that you approve documents by placing a signature on the document you do need to sign them. Signing the front page only would be acceptable as long as your procedure doesn't state otherwise. What does your procedure call out?

Ahh...I was hoping someone would say this.

 

[Dubai_capi]

hi

i was thinking of controlling all excel sheet we are using for reconcilation of accounts, preparation of financial revenues.. can we control excel sheet.. i mean are there any constraints, recommandations from professional here to do this or how to approach it..thanks