Serialised Defective Part Replacement

#1
Hi All, I'm looking for a bit of advice.

We manufacture an electronic device which has 2 parts (light array and controller). The two parts are manufactured as one batch and are shipped as one device, both parts are labelled and have the same serial number on (serial number references batch number).

We have some defective parts in the field, affecting just one part (the controller). Currently our policy is to replace the whole device (both parts), however this is not always economically viable. We would like to replace just the defective part then rework the defective part.

Does anyone do anything similar, if so how do you manage the serial numbers for the replacement?

Any thoughts or help appreciated.

Thanks
 
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chris1price

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#2
There is no rule that says you must have matching serial numbers. We used to have different serial number sequences for different parts. It just means you need to keep traceability of an increased number of parts.
 
#3
There is no rule that says you must have matching serial numbers. We used to have different serial number sequences for different parts. It just means you need to keep traceability of an increased number of parts.
Thanks Chris

We started with a single matching serial number as we plan to shortly distribute into the US and thought it would be easier for the UDI.

How do you label the product(s) and its packaging with different serial numbers?
 

shimonv

Trusted Information Resource
#4
I would keep the serial number "as as", and update the device history record with the rework details.
I don't see an issue with this as long as you have good traceability for your devices.

Shimon
 
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