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Batch Record Error

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  • November 7, 2003 at 2:08 am #24970

    Aidan
    ★ 10 Years ★
    Participant

    I work in a pharmaceutical company, which is highly regulated by FDA. Recently we have lots of scrap due to batch record error such as actual quantity do not match accepted quantity in the batch record, etc. Other than performing a re-train on operator, anyone has experience in improving the accuracy of batch record error?
    Thank you, in advance,
    Aidan

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    November 7, 2003 at 2:55 pm #59966

    DaveG
    ★ 10 Years ★
    Participant

    Forget re-training.  Do root cause analysis, then fail-safe the process.

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    November 14, 2003 at 1:02 pm #59973

    David Oakley
    ★ 10 Years ★
    Participant

    Aidan
    My first question would be did you just start discovering that you had batch record errors or did the rate suddenly go up. If it suddenly went up, I would determine what changed that casued it to go up.
    In my opinion, it is always better to go after the procedures rather than the people. As an example, there was a case where certain people started having a high rate of errors reading numbers printed by a printer. The people that were having the problem were being disiplined and taken off of the job. When I investigated, I found that it was only men that were having problems. Color blindnes is more common in men than in women and red is the most common color that can’t be seen. Sure enough, the problem had started when they had changed to a new printer and the new ink had a red component to it. Changed to an ink that didn’t have so much red in it and the problem went away.
     
    David

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