Signature on a Paper Document? Procedure and Work Instruction Approvals

[Mikaela&Eleonor]

This is our first time posting a question to this forum and we look forward to any reply. We are working at a small manufacturing company which is in the process of implementing a QMS according to ISO 9001.

Our question is about the need of a signature on procedures and work instructions. Even if most of the personnel have access to the quality documents on our Intranet some persons don't and our solution to this problem is to give them a folder consisting the quality documents needed. Is it enough to have a signed copy of each document in a master copy folder or does every copy distributed in the organisation have to be signed to ensure that the document is valid. It is a problem for us to get an electronic signature and therefor we wonder if it is OK to do it this way?

We look forward to your reply!

PS. Please excuse our swenglish.

Kind Regards

Mikaela & Eleonor

 

[Jim Biz]

We have a similar situation here -

To solve it we keep a "Master signed copy set" of each procedure & work instruction in the main office and have identified in our 4.5 Doc control procedure 4 additional "series numbered" "Bookset" locations.

Ex. Book# Location Custodian
001 Main office (ISO Mgr.)
002 Inspection office (Insp Mgr.)
003 Weld Office (Weld Mgr.)

The Area office COPIES are just that "copies" (signatures included) -

It was "Suggested" by our auditors to use colored paper. (Available only to the ISO manager)and a Red controlled stamp, to gard against invalid changes, or multiple distribution of obsolete outdated documents.

I don't agree with the use of colored paper or the stamp - but it is currently being done until we can install additional computer stations, post all signed documents on our intranet and update our system to handle them.

Regards
Jim

 

[Al Dyer]

M&E,

Just to add to Jim's points,

I would also have a continuous improvement/preventive action project in place that will document to customers and/or auditors that you are aware of and acting upon the situation.

ASD...

 

[Marc]

This is a 'Blast From The Past'... Does anyone actually sign paper documents any more?

I've started a Public poll in this thread.

Please - Don't just vote - Tell us your experiences and opinions!

 

[Jim Wynne]

This is a 'Blast From The Past'... Does anyone actually sign paper documents any more?

I've started a Public poll in this thread.

Please - Don't just vote - Tell us your experiences and opinions!

All electronic where I work. Too d*mn many approvers, but it's good not to have to chase the paper around, and for everybody to have the same, easily accessible source for the current versions.

 

[Aaron Lupo]

At my last place of employment (Medical Devices) we had to sign all of our procedures. We did not have the money to implement a part 11 compliant system so we were stuck with paper.

Where I am now (again Medical Devices) we use sort of a hybrid system we still sign paper copies of ECR's but they are then scanned into the system.

 

[Kevin H]

We're ISO/TS 16949 & ISO 9001:2000 registered and are running a hybrid system. At the procedure level we have 1 master hard copy that has been approved by the relative copies with actual signatures and stamps. The procedures are then distributed electronically to all other locations. QA is responsible for the administration of the procedure level document system. At the work instruction level, we are running manual systems that are controlled by area managers, not QA.

 

[S. Thompson]

Go electric!

We are mainly electronic - with the Quality Policy & Objectives signed off by MD.

All documents, procedures are controlled by QA and distributed as necessary.

 

[Joe Cruse]

All electronic. We have QWB Pro for document control. While it's a big, cumbersome system, it does a great job of document control. All Managers have electronic access and use the software, or email me to do it for them, for raising change requests. Approval is through the system, as is document issue and all other aspects of control. Pretty good setup. I'd never go back to the old method of manual sign-off.

 

[Scoobz]

Our documentation is generated by electronic systems and the approval of the documents within the systems is electronic (secure signature systems).

These systems generate paper output in most cases and the printed documents are used for recording of information. The approval of the information that has been entered onto the documents is 'by hand' and therefore on paper.

I personally use Achiever Business Solution's 'Quality Suite', SAP and JD.Edwards for a variety of document generation.