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Rework, Reprocess, or Correction - A simple blurred letter on the legible etching

#1
We received a NC from an Internal Audit because an employee was checking for cosmetics before the device was packed and shipped and it was not labeled "non-conforming" and segregated from the rest of the shipment.

If the employee finds blurred etching (but still legible), or the color coding is uneven they will give it back to the technician to fix. This is not new product, it is a repaired product that has been in the field for years.

One quality person says its Non-conforming when it comes in and that is why we repair it so it can't be considered non-conforming before its packed and shipped. Another quality person says, it doesn't meet our standard of high quality so it should be considered rework and follow the rework process.

My question is, can a product be considered Non-conforming if its already been manufactured and we are just repairing it back to the manufacturer's specs? Can a simple blurred letter on the legible etching be reason enough to go through the rework process with manager approvals and extra documentation?
 
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John C. Abnet

Teacher, sensei, kennari
Staff member
#2
My question is, can a product be considered Non-conforming if its already been manufactured and we are just repairing it back to the manufacturer's specs? Can a simple blurred letter on the legible etching be reason enough to go through the rework process with manager approvals and extra documentation?
Good day @gemsmom ;
Please help us understand. Is your business model ONLY the rework/refurbish of items or do you also manufacture new?
 
#3
Q: Can a blurred letter be a NC?

A: If it is a 'required marking' ie a safety marking or, even a manufacturers address then yes it could be an NC.
If it does not in anyway provide information that forms part of the Essential Requirements then it is not an NC and is cosmetic.
 
#4
Good day @gemsmom ;
Please help us understand. Is your business model ONLY the rework/refurbish of items or do you also manufacture new?
We are a contract manufacturer. 90% of our service is the repair of instruments, the other 10% is contract manufacturing (to our customer's specs). The part of the business in question is the 90% repair (which is also to our customer's specs).
 

John C. Abnet

Teacher, sensei, kennari
Staff member
#5
We are a contract manufacturer. 90% of our service is the repair of instruments, the other 10% is contract manufacturing (to our customer's specs). The part of the business in question is the 90% repair (which is also to our customer's specs).

Thanks for the additional information. So, a few considerations...
1- I see this is an "internal audit" finding. That does not necessarily diminish the result, but I'm curious as to how your 3rd party auditor views it. Has the registrar ever written this up as a nonconformance?
2- Remember the purpose and requirements of clause 8.3 (control of nonconforming product). Shall...
- ensure product which does not conform...

[I assume since you manufacture new, that the repair product as received "does not conform" to the comparable new requirements. Is that correct?]
- identified and controlled to prevent its unintended use
[is it possible for the to "yet to be repaired" or "already repaired" product to be commingled with "new" product?]
[is it possible for the "yet to be repaired" product to be commingled with the "already repaired" product]?

So for a moment, "forget" about the requirements of the standard. If the answer to any of my questions above is "yes", then SHOULD your organization "..identify and control to prevent its unintended use" to prevent risk to your organization?? If there is risk associated with any "yes" answers to my questions above, then it appears your internal auditor may indeed be making an astute observation.


What do you think?
 
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