3 replies to this topic

[D-D]

Typically I create a Record form that needs to be a controlled document with a footer containing the signatures and document control information plus a table at the end showing the dates of different revision numbers and short summaries of the changes made each time. Usual stuff.
From that I then generate a working form for issue and practical use as a nice looking "Template", which is the same document but with the change control table deleted (this usually makes it a one page form) and without signatures. In the footer there is a statement "Authorized template issued by QA for use without signatures – check Quality Manual for signed original".
This seems to work pretty well and is the best solution I have thought of so far but of course I have two documents on the go - the controlled "Master" document and the usable "Template". Just wondering if anyone has a more elegant way of managing controlled record forms?

[john123]

Are people filling out these documents electronically or by hand? I only ask because I'm encountering problems in using documents electronically because of our current system and I'm considering a solution along your lines.

Because our forms are not electronic, and filled out by hand only, we create templates that are signed off by three members of management and then stamped "Official Document". Those original templates are kept in a binder for employee use, and any photocopies made and stored in a file cabinet in labeled folders. When we make a change, the photocopies are pulled and destroyed, and the original is stamped "Obsolete" and stored. We do not keep the revision history on actual forms, we detail that information on the Management of Change forms used to create updated versions. (Policies, procedures and programs do have the revision history, but are not used as Forms, if that makes sense).

I'm not sure the " for use without signatures" part of your QA statement is necessary. If you have the "Authorized template issued by QA – check Quality Manual for signed original" I think that should be sufficient. I've considered something like that if we were to add electronic copies of our controlled forms for management use.

The only potential gap I see is making sure you have a way to control the documents and prevent employees from using an old version or an unauthorized version. If you already have that addressed somewhere, then you should be golden.

[trubertq]

I have a neat wee piece of software that allows me to control the docs electronically, records amendments revision numbers etc..
I save obsolete documents into a rescinded doc folder and link them to it. The 'live' docs are only available through the software and only through 3 people, the Quality manager, The Production Manager and Me. It has worked so far and I can print out a report for the auditor showing amendments, dates, revision numbers etc... it's much tidier than trying to keep hard copies of rescinded documents.

[D-D]

Are people filling out these documents electronically or by hand?

Could be both. Paper forms are issued via a central filing cabinet that is monitored by QA in the same you do it by the sound of it.

As an aside for electronic documents such as risk assessments or logs in Excel, I tend to approve the control of the format by copying the spreadsheet to a document for sign off but then use the electronic spreadsheet in practice. Seems to be okay as long as it is not fiddled with...

I'm not sure the " for use without signatures" part of your QA statement is necessary.

I actually added that bit recently but will revert if it is thought to be overkill and clear enough without it.

The only potential gap I see is making sure you have a way to control the documents and prevent employees from using an old version or an unauthorized version. If you already have that addressed somewhere, then you should be golden.

As above - controlled forms issued to one location for use by QA; the rest comes down to training.
Thanks for your input; sounds like it is pretty much a reasonable approach that can't be simplified much more.

Trubertq - what is the software called? I looked at Entropy from BSI for a short time but it was not that easy to use and lacked buy-in from the managers that were required to use it so went with a simple intranet system in the end with hard copy support.