4 replies to this topic

[po6ito23]

Hi all. Can you please help me on this problem. I have system manual, at the end of this manual; I have list of annexes: FS Control Plan, Food Defense Plan, Process Flow Diagram, etc. These annexes need to be controlled and distributed to interfacing department, but the problem is how will I control the annexes since each document has "Update as of" and the system manual has "Effective Date". Thank you in advance for the help.

[rmssan]

Hello, how do you mean by how will you control these documents? Even annexes fall under controlled documents as these are part of the system manual.

 

If you are asking specific details to log: the annex title, annex code, revision date, originator, and document controller signature are typical details needed in the logbook.

 

Depending on your system, sending out copies make the copies "uncontrolled" copies, and the receiving department may received these "uncontrolled" copies and log them into their department's uncontrolled documents logbook and thereby adapt these as the up-to-date documents in use. Typically only those with authority to change these documents have the "controlled" copy meaning the receiving department may only refer to them and not revise them.

 

The creators of the document will retain the "controlled" copy - this must be logged in the document controller's logbook, stamped or otherwise marked as controlled, and duly signed. Number of copies of the controlled document and to whom these will be sent will also have to be logged. Make sure these copies have records of receipt to document that these copies have indeed been received by the relevant departments and to serve as proof that the controlling department have indeed issued out and made sure that only relevant copies of the document are in use.

[po6ito23]

Thank you for giving me an idea. 

Do you mean, I need to provide logbook for uncontrolled copies for each department?
Since then, "reference copy" is the term we used instead of "Uncontrolled Copy". We still record document requested by accomplishing "Request for Reference Copy". Once requested, we photocopy the master copy, stamp with "Reference Copy", then sign by DCC.

For Document Annexes, our practice to date, once the annex is revised, it should be reflected on the revision history of the mother document, and the list of annexes (found at the end of the mother document, last page) will be revised as well.

[rmssan]

No, not per department, just one logbook for uncontrolled copies, then just put a field to whom the copies will be sent. This is just a practice we have done to trace our document recipients and prove that we have indeed made copies and sent them out. You may incorporate these information in your existing logbooks or records such as the revision history (if receiving departments do not change is already part of your SOP in the QMS then no need to specify).

 

The important point here is that you can provide evidence that changes done on the mother document are effectively cascaded onto the pertinent departments to ensure that everyone is using up-to-date information. This could be your "request for reference copy" forms with corresponding receiving slip from the other departments.

 

From your response, it seems that you are already controlling your annexes. If creating copies of new annexes are already in your existing manual, then only the proof that these copies are indeed received by the departments would be necessary.

[Scampi]

It seems to me those documents SHOULD NOT be annexes......those are stand alone documents no?

 

The food safety plan is the heart of your program and I would never list it as an annex  but that's just my opinion

 

Annexes still need document names/numbers and revision dates no matter the content