Controlled Setup Sheets for a production line

pammesue

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#1
I have a question about controlled documents. We have a document control procedure for all of our documents--work instructions, quality procedures etc. We also have some documents that are essentially setup sheets for a production line.

These setup sheets have a footer at the bottom with a date of last change. However the setup sheets have never gone through the document change procedure, where everyone signs off and the original is stored with all the other work instructions etc.

Engineering has always "controlled" the setup sheets as these sheets can change somewhat frequently. Do you think these setup sheets need to fall in line with the rest of the work instructions/procedures in regards to change review signoffs?

I had never noticed that this was an issue before, but lo and behold, an auditor saw a setup sheet printed on the floor. He wanted to verify that it was the correct revision and i went to the folder where the originals are kept and printed it off and the footer was wrong and contained the function of "today", meaning it printed the date that the sheet was actually printed and it didnt match the date of the one on the floor, even though the setup sheet contents were exactly the same.

We have all been fighting over having to control these setup sheets. There are MANY and we would have alot of work going through the revision process with getting the necessary signatures for any change that occurs.

what do yall think?

Im contemplating writing in our control of document procedure that setup sheets are for reference only and are controlled by engineering and do not require the usual signoffs. I think I will also remove the footer with any revision/date reference and add to the setup sheet the words reference only.

thanks!
 

Ninja

Looking for Reality
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#2
Question and answer:

Does the company care if the setup sheet is actually followed by the person setting the equipment up?

If the answer is "Yes"...it's pretty much a work instruction, isn't it? Thus control is needed.

If the answer is "No"...trash them all.
 
#3
Local control is fine.

They don't have to go through the same approval procedures as your other documents.

So it sounds like these are all saved on a computer and printed as needed. If so, and you have reasonable control of access to make changes, I think your fine. If you have the ability to recall and update you should be fine.

In our system everything is printed out of our erp system. It contains the latest versions. if there are any changes during production the paperwork is recalled and updated as applicable.
 

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