C
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.
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.