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QM - Defect recording setup in a way to block UD

Dear all

There are deviations recorded during the storage or manufacturing process, that do not necessarily affect the results recording of a batch.

Nevertheless, these deviations are recorded as defects in SAP and it has to be stated that CAPA actions are envisaged.

The requirement is that usage decision cannot be performed if there are defects open for deviations created manually, even if results recording are OK and technically we could proceed to accept the batch.

So, how to set it up in a way that an open Defect, blocks the UD?

Thank you

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1 Answer

  • Best Answer
    Aug 06, 2018 at 02:17 PM

    The defects can be assigned a severity. Defects are set up to create a quality notification.

    There are major and minor defects.

    A notification with an open minor defect which has not been "activated" is automatically closed when the UD is done.

    A notification with an open major defect or an open minor defect that has been activated, has to have the notification addressed and closed by some before the UD can be done.

    Standard functionality.


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