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Assigning Serial number at final QC check

Discussion in 'ISO 13485 and ISO 14969 – Medical Devices QMS' started by ChuckD, Sep 1, 2017.

  1. ChuckD

    ChuckD New Member

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    Hey all,

    My company is implementing a new line with fully electronic traveler/device history record. The system is 100% validated. However, the system is being programmed 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. 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? Does anyone have any experience with a similar situation?
     
  2. hogheavenfarm

    hogheavenfarm Well-Known Member

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    What do you do now, with the paper system? Does a traveler accompany each piece? I assume it has no serial number then either. I take it the problem is one of identification during stages of assembly, and that the "new" system would simply be programmed sequentially, so removing a bad part from the line would mismatch the traveler with the part.
     
  3. indicator

    indicator Member

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    Do you manage manual good received number for all your raw materials? I presume you have the batch number too that is allocated at the time of device assembly. I believe that this serial number is assigned at the final inspection check mainly for post market activities and traceabilities.
    Interested to see other's opinions.
     

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