6 replies to this topic

[D-D]

Generally speaking (and specifically for ISO and GMP) 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 say), or is it enough just to have one set of signatures on the front page?

[Rosemary4]

IMO it is wise to have all pages signed by the authoriser. This ensures that pages can't be substituted during the life of the document without the authoriser's agreement. I have never seen the requirement in print but was always told to do it that way when I first became involved in Quality systems management. Nowadays the MD signs every page of the top level docs, but I don't bother with signatures on lower level docs.

[john123]

We were told to do the same, every page should be signed. Helps to control the entire document, making sure no one altered page 2 or added an extra page later. Also helps to prove that the authorizer has reviewed the entire document.

[George @ Safefood 360°]

I disagree. I think signing each page is rooted deeply in the old ISO 9000 era when paper work for paper work sake was king. IMO it is necessary only to sign one page - the first page. This first page will also contain the control information such a unique document reference, number of pages in the document and the current issue of the document.

As long as the control information is contained on all pages, I cannot see the point of signing each page. As is best practice, any control document should be supplied and used in its entirety including page 1 with the authorization signature.

This is just my opinion, but i think we all have enough to do in the day without signing each and every page of a control document.

George

[Charles.C]

Dear D-D,

I agree with George however the original post referred to ISO documents. In this regime, the habit may be historically entrenched.

Rgds / Charles.C

[D-D]

Interestingly, I also asked the question on an ISO forum and the consensus was that it is only necessary to sign the first (or last) page. It was also suggested that as long as review and authorisation can be demonstrated, there is no absolute requirement to have any signatures at all...

[PYRPYT]

Correct, signatures are needed only on front page and this must be part of the "Document conrol procedure" if the auditor disagrees... ask where in the Standard requires to sign each page.