Serialization at Final Quality Check

[ChuckD]

The company I work for is implementing a new line with fully electronic traveler/device history record. The system is 100% validated. However, there is discussion of programming it to assign the serial number to the device at the final inspection check. The argument being that this is done electronically and 100% verified by the system and not impacted by the final quality associate so there is no issue. My understanding has been that the quality check is just that - a check - and nothing related to building the device should be happening at that point.

My concern here is that this seems late in the process to assign the serial number. On the paper records, the serial number is assigned at the beginning by the ERP system. What if there is an issue prior to the QC step and the assembly gets taken off the line and segregated? Without a serial number, how is it identified? Wanted to get some input from you all to see if there is a concern with this approach or if the fact that the system is validated makes this ok. Thanks in advance for your input.

 

[Ronen E]

Hello and welcome to the Cove

I think that your concerns are justified. Validation of the electronic system has nothing to do with how the process should be structured.

Cheers,
Ronen.

 

[yodon]

Agree with Ronen. In your scenario about segregating; what if it's properly segregated and then a few days later QC assesses and says it's ok to continue. The item is put back in for serialization (and packaging or whatever). How do you ensure sufficient traceability?

Consider doing maybe a pFMEA type exercise on it to find similar fault cases. That should give you better ammo when raising it. It would at least provide good discussion fodder.

 

[ChuckD]

Thanks for the input. I've brought these points up to the team and we are working on a solution.