Does "Refurbishment" fall under "Service"?

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yodon

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#2
Since nobody has yet jumped on this, I'll toss in my 2 cents.

I'm on the fence. On the "no" side, the servicing section starts out "If servicing of the medical device is a specified requirement..." so I would think it's unlikely that any refurbishment would be established with specified requirements.

On the "yes" side, you would still need, as that section says, to verify product requirements are met (after refurb) and it would seem wise to analyze the records to see if there was any complaint or opportunities for improvement.

I think I've convinced myself to say "yes" since it would seem to be the most conservative approach and you'd probably be best off following those things anyway.

Interesting question. What are your thoughts? Hopefully others will chime in.
 

Tidge

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#4
I feel like there are subtleties, and that the subject of "refurbishing" IMO falls under both Servicing Activities (7.5.4) and Customer Property (7.5.10).
 
#5
@Tidge are you pointing to these two acts?

Servicing activities (13485:2016 Section 7.5.4)
If servicing of the medical device is an applicable requirement, the organization shall document servicing procedures, reference materials, and reference measurements, as necessary. “The organization shall analyze records of servicing activities carried out by the organization or its supplier: a) to determine if the information is to be handled as a complaint: b) as appropriate, for input to the improvement process”. If it is determined that the information is not to be handled as a complaint, then justification is required.
Customer property (13485:2016 Section 7.5.10)
Does the organization identify, verify, protect, and safeguard customer property provided for use or incorporation into the product while it is under the organization’s control or being used by the organization? If any customer property is lost, damaged or otherwise found to be unsuitable for use, does the organization report this to the customer and maintain records?

I got the refurbishment point under the customer property section. Please help me know it's relevance under the servicing activities. I am not able to place the question of @Ajit Basrur in that context.
 
#6
Thanks for all the answers. In the below scenario, the situation is slightly different.

When the customer complains about a product, he is replaced with a new unit and instructed to send the defective unit to the manufacturer. The manufacturer gathers all these defective units and refurb them with a new identification number (lot number). These refurbished units are sold separately at a discount.

In the above scenario, I do not think it should fall under "Customer Property" but under "Servicing". Am I correct?
.
 
#7
I got the context now. In that case I too don't think it comes under either of the acts. Let's see what other replies we come up with. I am looking forward to it.
 

Tagin

Trusted Information Resource
#8
I got the context now. In that case I too don't think it comes under either of the acts. Let's see what other replies we come up with. I am looking forward to it.
I agree - its nether Servicing nor Customer Property. Instead, I consider it 8.3 N/C Product. The process in my view is:

N/C Product > Rework activity > Secondary sales channel
 
#9
The 8.3.3, Nonconforming detected after delivery, looks appropriate.

In this case, since the defective unit is not going to the "same" customer, it does that not fall under "Servicing" and would fall under 8.3.3 - is my assumption correct?
 

Tagin

Trusted Information Resource
#10
In this case, since the defective unit is not going to the "same" customer, it does that not fall under "Servicing" and would fall under 8.3.3 - is my assumption correct?
That's how I view it. 'Servicing' is not clearly defined in 13485 or 9000. If we take the term 'servicing' as a variant of 'service', then in 9000 3.7.7 definition of 'service' we have:
"Note 4 to entry: A service is generally experienced by the customer".

But again, this is just my interpretation.
 
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