Using Scrapped NC items for training

R

Renea Koski QSM

Starting to get Involved
#1
#1
I have an ISO 13485:2016 audit in a few months and I was wondering what others do with their "NC Scrapped" materials/products that they then use for training purposes. Do you label them "FOR TRAINING USE ONLY," or just HIDE them for when the auditors come by??
 
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malasuerte

malasuerte

Quite Involved in Discussions
#2
#2
You label them or do something to visually ensure it is clear they are 'scrapped'. Of course, you should be able to prove that they have been removed from your system (electronically) and cannot return (or be mistaken for actual functioning product).

Nothing wrong with having them there - I would see it as a positive that you can use actual real material to train with.
 
R

Renea Koski QSM

Starting to get Involved
#3
#3
Thank you. Each item has gone through the NC process and it is in a bin marked for training only. Just wondered if anyone else had other ideas for when the auditors come by. . .
 
Sidney Vianna

Sidney Vianna

Post Responsibly
Leader
Admin
#7
#7
Johnnymo62 said:
How do you prevent someone from removing the label and shipping them to a customer?
Click to expand...
No system in the world will be robust enough to prevent people intended to bypass controls from doing so, if the corporate culture would even allow and/or foster such behavior.

As @optomist1 mentioned, mutilating the parts in a way that render them unusable is also a potential solution.
 
R

Renea Koski QSM

Starting to get Involved
#8
#8
I don't have a problem in house of people un-intentionally processing these tools. . . we are small and everyone knows the drill here. (Plus, they would pass the shipper's checkpoint without the proper paperwork (work order, inspections, etc . . )
I just was wondering what is acceptable to an Auditor. A bin of used parts/tools. Is being marked "for training only" enough to pass??
 
Scanton

Scanton

Wearer of many hats
#10
#10
As long as they are clearly identifiable as "training pieces" and not "product" there should be no problem.

I paint mine with Day-Glow Orange paint on surfaces that don't affect their function, so that anyone with eyes can see they are not a standard components waiting to be shipped to a customer, even if they did find their way out of the training room.
 
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