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    Quality Notification CAPA

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    indravathi
    1) Many SAP sites only use the defect recording portion of Quality Notifications and not the full closed-loop functionality, missing out on ensuring defects do not reoccur. 2) Current CAPA processes at most sites are complex and involve emails and calls, leaving loose ends and reoccurring defects. 3) Using the full SAP QM Quality Notification functionality ensures notifications are not closed until all corrective actions are performed and approvers are satisfied, with all processes tightly integrated in SAP.

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    Quality Notification CAPA

    Uploaded by

    indravathi
    649 views3 pages
    1) Many SAP sites only use the defect recording portion of Quality Notifications and not the full closed-loop functionality, missing out on ensuring defects do not reoccur. 2) Current CAPA processes at most sites are complex and involve emails and calls, leaving loose ends and reoccurring defects. 3) Using the full SAP QM Quality Notification functionality ensures notifications are not closed until all corrective actions are performed and approvers are satisfied, with all processes tightly integrated in SAP.

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    1) Many SAP sites only use the defect recording portion of Quality Notifications and not the full closed-loop functionality, missing out on ensuring defects do not reoccur. 2) Current CAPA processes at most sites are complex and involve emails and calls, leaving loose ends and reoccurring defects. 3) Using the full SAP QM Quality Notification functionality ensures notifications are not closed until all corrective actions are performed and approvers are satisfied, with all processes tightly integrated in SAP.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as DOC, PDF, TXT or read online from Scribd
    Download as doc, pdf, or txt
    649 views3 pages

    Quality Notification CAPA

    Uploaded by

    indravathi
    1) Many SAP sites only use the defect recording portion of Quality Notifications and not the full closed-loop functionality, missing out on ensuring defects do not reoccur. 2) Current CAPA processes at most sites are complex and involve emails and calls, leaving loose ends and reoccurring defects. 3) Using the full SAP QM Quality Notification functionality ensures notifications are not closed until all corrective actions are performed and approvers are satisfied, with all processes tightly integrated in SAP.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as DOC, PDF, TXT or read online from Scribd
    Download as doc, pdf, or txt
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    At a glance
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    The key takeaways are that SAP Quality Notifications can help companies fully integrate their corrective action processes, ensure issues don't reoccur, and gain benefits over manual systems. However, many companies only use the defect reporting portion of Quality Notifications.

    The steps described include defect identification, entering details, assigning tasks to investigate, completing tasks, identifying root causes and corrective activities, approval and closure.

    Implementing SAP Quality Notifications involves significant change management since it touches many parts of the business. Ensuring commitment across impacted teams and proper training is important for success.

    Quality Notification CAPA

    There are many existing SAP sites that are doing Defects Recording but only
    a few that are really using the full closed loop functionality (Defect
    Locations, Tasks, Causes and Activities). The key to the Quality
    Notifications are to correct processes that are out of control or are trending
    in that direction. When companies only use the Defect portion they can
    only do defect reporting which might look good for meetings and graphs but
    it does nothing to ensure the defects/issues do not occur again. So in most
    cases the sites are entering defects in SAP but are also still using the manual
    or non integrated corrective action systems. So they never really reap the
    full benefits of SAP Quality Notifications.

    The actual CAPA processes are in most cases complex, involving many
    people. Their current processes involve a lot of e-mails and phone calls to
    try to ensure the processes are followed through. But these types of
    systems inherently are flawed with a lot of loose ends that do not get
    filled. Consequently the same types of defects/issues reoccur because of
    poor follow through.

    When using the full SAP QM Quality Notification functionality you can
    ensure the notification is not closed out until all the corrective actions have
    been performed and the approvers are satisfied with the results. Also, all
    the processes are tightly integrated with the rest of the SAP system. For
    example, if a defect is recorded against a material received from a vendor
    then the notification has the key purchase order information linked to the
    notification.

    Following is an example of a full QM Quality Notification lifecycle:

    1. Defect is identified, can come from various sources:


    • Customer Complaints
    • Internal Unplanned Deviations
    • External Unplanned Deviations
    • Customer Audits
    • Vendor Audits
    • Internal Audits
    • Annual Product Reviews
    • Quality Out of Specifications
    • Trending Analysis
    2. User enters the defect information into SAP Quality Notification
    summary screen. The end user needs to provide the details of the
    incident.
    3. Notification Coordinator is monitoring existing and new notifications,
    they see the new notification
    4. Notification Coordinator does an immediate assessment to determine
    what type of action needs to be taken. Also, they fill out more of the
    notification from the entered summary information:
    α. Priority
    β . Defect codes
    χ . Defect Locations
    δ . Contact Persons
    2. If the defect requires corrective action then the Notification
    Coordinator assigns Tasks to applicable departments that need to
    investigate. These tasks will have due dates which will help the
    departments manage their work load.
    3. The departments are running the Notification Tasks Work List
    periodically throughout the day. When they find a new task they set
    its status to “In Process” and assign it to a person.
    4. As each task is complete the department will enter what they found
    during their investigation into long text and set the task User Status
    to Complete.
    5. The Notification Coordinator is monitoring tasks that are complete.
    When they pick up the task they will look for completeness, if it is
    not complete they will set the User Status to “Rework” and push it
    back to the department. If it is complete they will set the task
    System Status to “Complete”.
    6. The Notification Coordinator reads the long text and extracts the
    Root Cause information. Also, the Activities that were performed to
    correct the process are identified. This information is translated into
    Catalog Codes so the information can be reported against for trending
    analysis.
    7. If the immediate problem has been fixed but their needs to be a long
    term investigation, the Notification Coordinator can open up a Long
    Term Notification that is linked to the initial notification. This allows
    the initial notification to be closed but the Long Term can now be
    managed separately, which may involve a different group.
    8. When all the tasks for a notification have been completed and the
    Notification Coordinator is satisfied, the coordinator will send a Task
    to the Approver for final review and closure.
    9. The Approver periodically through the day runs the Task Work List to
    see if there are new task for notification review. When satisfied they
    will set the notification to “Closed”.
    This is just one example of a full SAP Quality Notification lifecycle. SAP
    Quality Notifications has a lot of flexibility to meet various business models.
    In most cases it is the Change Management piece that is the hardest part of
    the implementation, not the SAP notification functionality. Because CAPA
    systems touch so many people and business scenarios within a company it is
    a big stretch to get them to all commit to the new processes. So we manage
    early on the Change Management portion to ensure everyone is on board
    and the proper amount of training has been planned for.

    It is crucial to have the right person on board to design and implement SAP
    Quality Notifications to meet the business requirements and to ensure
    successful project lifecycle management.

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