Are signatures required on every page of a controlled document?

[dsanabria]

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?

Requirements in the standard is for control of documents / records and aproval - re aproval. You define how, who and when they will be approved.

 

[Helmut Jilling]

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

You are controlling the data and information, not the document only. So, if it is password protected, the data is being entered by an authorized person. The data is being controlled by that individual and signatures are not required.

If you want to go one step further, you can print a template of the spreadsheet, and indicate that this format is correct and controlled, in whatever manner your procedure requires.

 

[drgnrider]

You are controlling the data and information, not the document only. So, if it is password protected, the data is being entered by an authorized person. The data is being controlled by that individual and signatures are not required.

If you want to go one step further, you can print a template of the spreadsheet, and indicate that this format is correct and controlled, in whatever manner your procedure requires.

This pretty much is how our system works. The server is restricted as to who can write to it (ISO rep, Factory Director, Network Admins) everyone else has read-only access. ALL documents are password protected and in either Word, Excel, or PowerPoint format (only ISO rep has password). Servers are backed-up nightly and stored off-site.
The only documents that have signatures, per Factory Director's request, are the master printed Quality and Environmental Manuals (signed by FD and QC or EHS manager). The footer of all printed documents state it is "uncontrolled when printed", revision date, and document title.

This process has passed at least six CB audits.

 

[Helmut Jilling]

This pretty much is how our system works. The server is restricted as to who can write to it (ISO rep, Factory Director, Network Admins) everyone else has read-only access. ALL documents are password protected and in either Word, Excel, or PowerPoint format (only ISO rep has password). Servers are backed-up nightly and stored off-site.
The only documents that have signatures, per Factory Director's request, are the master printed Quality and Environmental Manuals (signed by FD and QC or EHS manager). The footer of all printed documents state it is "uncontrolled when printed", revision date, and document title.

This process has passed at least six CB audits.

I have a problem with last sentence..."uncontrolled when printed." That was a common suggestion invented by auditors, but does not meet the standard which says, "all docs must be controlled." If someone is outing docs, they need to know they are right, correct, current, authorized, etc. I suspect you are controlling that that is happening. In wich case you are in fact controlling them. You might want to rethink that last bit. I know what you are trying to do, but you need to go about it in a different way.

 

[AndyN]

I frequently access a folder of documents which our system makes available as the most recent. I sometimes print them off. Our system makes me aware when they have changed and the obsolete version is removed from my access. The printed one isn't marked "Uncontrolled" or anything else. It works well...

 

[drgnrider]

Not a fan of "uncontrolled when printed", either, but it makes the "old dogs" not want to keep them (their words). Past audit an "old dog" was found using a print he took out of his toolbox, been there for years, "because they don't issue this print with the job"! Apparently nobody, has informed documentation department that they need this print on this, or numerous other, jobs. They don't want to check the system to verify if current.... and 'don't have time to make notification to documentation to fix it'!

Not pushing this too much as I am making some headway with the "old dogs" on higher-priority issues. Some are too stubborn and management doesn't want to start a revolt. So I settle for the "wins" I can get.

 

[Dubai_capi]

I have a problem with last sentence..."uncontrolled when printed." That was a common suggestion invented by auditors, but does not meet the standard which says, "all docs must be controlled." If someone is outing docs, they need to know they are right, correct, current, authorized, etc. I suspect you are controlling that that is happening. In wich case you are in fact controlling them. You might want to rethink that last bit. I know what you are trying to do, but you need to go about it in a different way.

yah i think the same.. no need to write uncontrolled if printed cos its already a controlled document.. so you are misleading ppl when using your documents and making them loose confidence in whatever your staff are printing.. i think you need to re-think aboutthat bit..

 

[Dubai_capi]

I frequently access a folder of documents which our system makes available as the most recent. I sometimes print them off. Our system makes me aware when they have changed and the obsolete version is removed from my access. The printed one isn't marked "Uncontrolled" or anything else. It works well...

yah its a matter about updating documents and making them available for use and removing obsolete ones.. thats it.. also to have a communication thats effective to make ppl aware about changes in docs..

 

[TigerLilie]

My predecessor would print out each SOP and he, as the QA Director, would sign the cover page, along with the process owner. Since his departure, I implemented procedure approvals through Microsoft SharePoint workflows. There is a record of who approved the SOP and when. It makes for a lot less paperwork and provides a thorough history of all the approvals and changes. We haven't had an audit since implementing, but I foresee no issues.

 

[keldez]

This thread has evolved a bit, but reading through it's entirety I find it interesting the amount of folks having signatures on their SOPs and such - as I've never seen this until joining my current company. I agree with the multiple posts that showing/tracing approval is key.
I found this thread, as I'm about to remove signatures from our SOPs and move them to the approval process in something like you would see in an ECN/ECO, but a more simple approval document for document changes (DCN). Maybe this is overkill, as I cringe at seeing signatures in the SOPs themselves. I'm more used to the revision history table within the SOP tracing the document's approval to a record that is solely for the approval of the document change/creation. I find this method cleaner but perhaps more work. If anyone has comments/advice against this approach, I welcome your opinion.