BRC 3.2 Documentation Control
Hi All,
I know this is (supposed to be) a simple topic, and I've read other threads on this topic, but can't seem to find the answer I'm looking for.
We have already been through 2 BRC audits (obtained A rating), and the auditor has never brought this up, but I'd rather be safe than sorry on this point.
The BRC interpretation guideline (not the code itself - version 7) states:
Where controlled documents are all contained on an electronic system, it is usual for printed versions to be marked uncontrolled. Each copy must be authorised (e.g. with a signature or stamp) to show it is for use, and each must be given a version number so that out-of-date documents can be identified and removed.
Here is an outline of our documentation control policy:
- all documents have a header/footer with company name, page # of #, revision date, version number, form #, written/revised by and authorized by
- all new and revised forms are reviewed and initialed by the quality coordinator or quality director and kept in a log book (with previous version showing changes)
- our "original copies" are maintained electronically
- a register is maintained showing form #, title, revision date, version #, and location in facility
- only QC can modify documents, and must replace old versions when there are revisions
Currently, we do not sign or stamp each form that is printed, and we do not mark printed copies "uncontrolled".
My question is: since all forms are to be the current version, and forms are only to be in locations listed on the register, must all printed copies of documents (SOP's, policies, check sheets, etc.) to be signed or stamped and marked "uncontrolled"? Or if I state in our procedure that all printed copies are uncontrolled is that sufficient? I just don't want to receive a non-conformance on a future audit, but I also don't want to cause unneeded work.
Also, does that mean daily check sheets are to be marked "uncontrolled"?
We are a small company, with management directly involved in production, and a lot of management commitment, so the current policy has been followed very well.
Thanks in advance for your help with this.
WowQC
Hello WowQC:
I think this is the crux of the issue:
"Where controlled documents are all contained on an electronic system, it is usual for printed versions to be marked uncontrolled."
I would interpret the words "electronic system" to mean a document control system/program/database, not just keeping it electronically on a cloud, for example. Most of those document control systems do print it out with the watermark of "uncontrolled" across each page, which is annoying BTW. But if you are only keeping your documents on your server and having them as read-only, then I think you don't need to go around and stamp all of the printed copies, it is understood that they are uncontrolled unless they are initialed by your QC director. You may want to put that into your document control policy, spelled out that all printed docs are uncontrolled unless they have the initials, and I think it will work. You should be able to defend that in case an auditor asks in the future. If that is already there, maybe that's why they never brought it up. :)
Martha
You may add this to your document control procedure that "all records are un-controlled" and all sops are controlled, so by doing this way u only need to put the stamps on sops and not on the all documets, so orignal copy retained by the office distributions is done accordingly, also dont forget to get aknowledement slips when u distributes across the departments
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Rani
You may add this to your document control procedure that "all records are un-controlled" and all sops are controlled, so by doing this way u only need to put the stamps on sops and not on the all documets, so orignal copy retained by the office distributions is done accordingly, also dont forget to get aknowledement slips when u distributes across the departments
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So what do you think an auditor will say when a CCP record is 'un-controlled'?
Wouldn't it be better to have a master list of authorized records with pertinent information like issue number and date to cross check against?
Regards,
Tony
So what do you think an auditor will say when a CCP record is 'un-controlled'?
Wouldn't it be better to have a master list of authorized records with pertinent information like issue number and date to cross check against?
Regards,
Tony
Agree with tony, we have all the records with page number revision number header footer etc but in our DC procedure CCPs comes under controlled documents
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We do have a printed FSQM, and printed SOP's are in binders in production areas, or posted by equipment. Basically, we don't have any "uncontrolled" documents, if I understand that term correctly. All documents in the facility are printed and placed by QC, and are thus controlled by QC. Would they all then require a signature or stamp? Do daily production check sheets also require this?
I guess my understanding of uncontrolled document is one printed by an employee and taken into production for reference without permission from QC.
BRC defines a Controlled Document as:
A document which is identifiable and for which revisions and removal from use can be tracked. The document is issued to identified individuals and their receipt of the document is recorded.
By this definition, all our documents are controlled (tracked).
Since the main point of this is to ensure no out-of-date versions are in circulation, including signed/stamped copies, can we risk assess (as BRC loves!) and say why a signature/stamp or labeling "uncontrolled" is not required (if we add this to our policy as well)? I'm just trying to avoid having to sign/stamp all our documents currently in use, or revise every document to say "uncontrolled if printed".
Thanks!