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Document Control Policy


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#1 DuckMan

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Posted 09 January 2014 - 08:51 PM

Hello my international friends!

 

It's a "shout out" from Dallas Texas over here in the US where we are going through an "Arctic Blast" of the century........at least according to the media. :yeahrite:

 

I have a question and need your help.

 

I am in the process of creating a Policy to help demonstrate document control in a Distribution Warehouse.

 

I have read most of the threads in the forums on this topic and maybe I missed this info but I will ask anyway;

 

 

What information must be communicated in such a policy to ensure Document Control?

 

I was thinking a breakdown would provide the following;

  1. Distinction between different documents (ie. Records vs Documents)

  2.  How these items get validated prior to issue or use and who has the ability to do such

  3.  Retention time frames.

 

I was thinking something like this combined with a master document register that only myself (GMP Coordinator ) would have access too would be sufficient.

 

The only standard we must meet are local, FTC, FDA

 

Is there more to this and I am missing it? Previous threads noted the need to actually control the printing of documents to specific people, is this really necessary? In my experience, a document that has been locked for viewing only, can simply be copied into another folder where the copy can in fact be altered so it seems like a superficial control at best.

 

Another thread mentioned a need to actually control how many copies are currently printed out. Almost like as astringent controls on the copies as you would see on "Label Control" procedures for BRC. That seems way over the top to me, since employees here could simply run it off the copy machine rather than come talk to me about needing more copies.  Any and all feedback/thoughts on this subject will be appreciated.

 

 

Your Friend From the land that Brought You Jerry Springer, Coca Cola & Denis Rodman! :rock:

 

 

The Duck Man



#2 zac2944

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Posted 09 January 2014 - 09:09 PM

Love this subject.

 

Like you say, it is pretty much impossible to stop someone from printing/copying a document, so I don't recommend going down that road.

 

Simple solution is to have master copies for all docs, either hardcopy or electronic, and everyone ensures that they only access from the master copy.  You can have a master document list too (which you'll need for SQF) that lists rev level, and people can also check any copies they may have against that. 

 

If you go with printed masters, then use a binder or binders and only those binders are the "controlled" versions.  You can have a binder for each department, or just one binder with all docs, up to you.  In you doc control procedure have a distribution list that says what docs are stored in what binders.  Now any time you make a revision you have to go out and update all binders.  Copies are not controlled and employees should not make copies. You have to train them on this and audit.  If they do make copies those would be considered uncontrolled. You can still use this uncontrolled version, but employees should always check an uncontrolled version against the master to master list to ensure they are using the latest version.  For forms, where you need many printed copies, you need to document where you store the printed forms and have a system to recall the old blank ones when you revise a form.  You print a stack of blank forms for the week on Monday; better know for sure that it hasn't changed when you go to use one on Friday.  You can have a system to inform users of changes, and train everyone to check for changes against the masters.

 

If you go with electronic masters, then any printed document is considered uncontrolled.  Once printed you must check against master or list to verify that you've got the latest version.  As long as people only work off of electronic version, then they always have the latest.  Forms should be printed as needed, or have a system to recall printed ones if there is a change as mentioned above.  That's what I do.  We keep stacks of printed forms in each department on a big document holder mounted to the wall by the area manager's office.  If one changes, then area manager is notified and replaces the old forms.  If he's really smart he will comb his area for any that may be squirreled away in an operators desk.

 

Hope that helps.



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#3 DuckMan

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Posted 09 January 2014 - 10:19 PM

Thank you Zac2944!

 

Your response has given me all the info I think I will need to create the register and policy!

 

I love this forum!   :wub:



#4 Charles.C

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Posted 10 January 2014 - 03:08 AM

Dear Duckman,

 

The only thing I guarantee about printed systems is that auditor detectable errors will occur.

 

So the principles which you somewhat disparaged are intended to minimise these errors.

 

It then becomes a question of your internal tolerances.

 

Rgds / Charles.C


Kind Regards,

 

Charles.C





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