Posting Non-Quality System instructions on the Production Floor

#1
Medical Device industry. Thoughts on how to post instructions on the Production Floor that are for processes outside the Quality System. Processes such as how to scan a kanban card. Or instructions for using the Fastenal vending machine (gloves, masks, etc.)

we don’t want to make them controlled work instructions.

We are considering stamping the document but are unsure how to stamp… “For Reference Only” isn’t really applicable and “Uncontrolled” seems triggering in an audit situation.

thoughts? Suggestions?
 
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Randy

Super Moderator
#2
Or instructions for using the Fastenal vending machine (gloves, masks, etc.)
Let me get this straight........You've gotta have written instructions on how to use a "vending machine"?

Processes such as how to scan a kanban card.
What are the "kanban " cards to be used for? Something tells me that without them you've an expectation of problems cropping up.
 
#3
It’s not a snack machine. It’s a vending machine for shop supplies. And there are inputs into the machine to work the machine. The instructions are from Fastenal, the supplier who owns the machine (and fills it).

Kanban is an inventory control system. When the inventory hits a certain level, the kanban card is pulled and scanned notifying purchasing that they need to place an order.
 

Steve Prevette

Deming Disciple
Leader
Super Moderator
#4
In my line of work (not medical) we called those "operator aids" and there were specific requirements:

Operator aids should be viewed as a convenience to the individual using them, not a requirement. Although copies of procedures or portions of procedures can be used as operator aids, the requirement is to follow the procedure. The operator aid makes it easier for the operator to follow the procedure, because the procedure is conveniently posted, but there should be no requirement to use operator aids instead of the procedure in the manual. All personnel should be trained on the need for controlling posted information. This training should cover why it is important to use only approved operator aids, how to tell if an operator aid is approved, what to do if it is not approved, and how to verify that an operator aid is current. When an operator aid is used, the user should verify that it is approved. If the posted information is not approved, the person should not use it and should notify the supervisor. A decision should be made whether to submit the operator aid for approval or remove it. If the operator aid is unusable because of wear or dirt, the operator should obtain a new copy of the operator aid. When the need for an operator aid no longer exists, an operator or the developer/organization originating the operator aid should notify the appropriate supervisor and ensure that the operator aid is disposed of in accordance with facility policies and procedures.

Conduct of Operations Handbook (doe.gov)
 
#5
Thank you! Very helpful! We do have a “Job Aid” Process and it is on the table as a potential solution. It is not our preferred path because while they live outside our Quality system, they are still controlled. Hoping to find a solution to prevent over complicating such a simple thing.
 

Steve Prevette

Deming Disciple
Leader
Super Moderator
#6
You are welcome. I would suggest that SOME degree of control is needed, been there done that. Warning signs of problems are

operator aids that may be valid, but override formal procedures that are in dire need of revision;

operator aids that "cut corners" intentionally or unintentionally;

operator aids that contain out of date guidance; or

operator aids that are a work-around for a safety or quality condition.
 

Randy

Super Moderator
#7
Kanban is an inventory control system. When the inventory hits a certain level, the kanban card is pulled and scanned notifying purchasing that they need to place an order.
Then it's not a "for reference document" therefore control would be an expectation if I were doing your 3rd party audit (which is all I do)

It’s not a snack machine. It’s a vending machine for shop supplies. And there are inputs into the machine to work the machine. The instructions are from Fastenal, the supplier who owns the machine (and fills it).
No kidding, not a snack machine..........The process is essentially the same. The Fastenal instructions are documents of external origin that have been determined to be necessary and yep, pretty much not "for reference" as well if you deem them "necessary" to achieve a desired result.
 
#10
Randy… thanks for the reply. 9 times out of 10 my kind of question arises because someone is trying find a path around the process. Shortcuts always become problems later on. Better to bite the bullet. But as Sidney’s cartoon reflected sometimes it’s just stupid! :cool:
 
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