Site using "reference only" stickers and stamps on WI and tools.

FRA 2 FDA

Involved In Discussions
If something in one of the work instructions changes, how is that change communicated to the employees using them? Do they get new WIs? How? What happens with the old ones?
 

dwperron

Trusted Information Resource
If something in one of the work instructions changes, how is that change communicated to the employees using them? Do they get new WIs? How? What happens with the old ones?
If you post work instructions then you need to have established policies. If you are just passing them out to workers..... that is such a dangerous practice. They will squirrel away copies, work from their old marked up copy, all the things that auditors find. You are much better off with electronic copies, at least there you have real document control. If you need physical copies then they need to be date / revision controlled, and you need to have a record of where they are posted so you can be sure to find all the copies when changes are made. Numbering the copies makes sense because that will let you know that you have recovered all the old copies. As for the old copies, you need to retain one for your records, destroy the rest.
 

Quality-Nation

On Holiday
Hello all,
I am in process of performing an internal audit for a site. The site is using "reference only" stamps and stickers on tools, work instructions, and procedures to try to get around the need for calibrated equipment and make old documents in the work area not a finding.
Has anyone run into this or used this method? The claim is this is something the operations manager picked up from aerospace.

Thanks,
John
Yes, all the time, in one degree or another. It has worked for many years because (some) external auditors don’t actually know what “control” of such things means. Of course, it’s a complete abdication of control. It’s easy to demonstrate why/how it doesn’t work. But the real question is, what made them think this was a thing to do?
 
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