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Thread: SABRE reporting hints, tips and reminders

  1. #1

    SABRE reporting hints, tips and reminders

    Dear Colleagues

    As you know I will contact reporters for further information and clarification on review of a SABRE report either by telephone or email. However, there are occasions where there are minor aspects to reporting where I choose not to make contact.

    Experience shows me that many reporters make similar minor errors, or assumptions, etc etc so I thought I'd start a thread to make general points that have been triggered by recent reviews. The following posts I hope are helpful to all and are not intended to call out any individuals for a recent report.

    Please do feel free to comment or discuss the posts. SABRE reporting continues to be a learning experience for me as well.



  2. #2
    Reporting "As soon as known"

    Please remember the requirement for reporting SABRE reports is to report "as soon as known" to the Competent Authority. In practice this should be within "48 hours" of an error being determined to be a Serious Adverse Event or reaction. Many errors are not discovered at the time they occurred, or have been detected but further investigation is required to determine if they are serious. This is fine with me, and I don't expect you to report things you're not aware of or minor errors in case they become serious later.

    However, we still get reports, often reported as a Notification and a Confirmation at the same time, weeks or often months after the serious adverse event has been detected.

    Please remember to report a Notification as soon as known, then carry out your investigation to determine the Root Cause and CAPA and submit the Confirmation report.

    Furthermore, it is within the BSQR to submit a Confirmation with the proposed CAPA. It is not a requirement to delay Confirmation until after the CAPA has been implemented or determined to be effective.

    Please also remember that changes and update to investigations can be added as Footnotes.

  3. #3
    Second checks as CAPA

    Checking the accuracy and effectiveness of completed work is an important part of any QMS. However, please consider carefully the effectiveness of additional checks and implementing second checks as CAPA.

    For example, I will often see Component labelling errors reported with the RC that the second check was not performed and the CAPA has been a reminder to perform the second check.


    The RC was the error in attaching the labels to the units BEFORE the second check was due to be performed.

    Please investigate why the label was applied incorrectly in the first place and address the root causes of that error.

    If your error was a result of staffing or workload issues, or other distractions, adding the distraction of a second check does not address the problems that were the real RC.

  4. #4
    Avoid stating CAPA that is incomplete

    Sometimes as part of an investigation, the CAPA will require a review of practice, or documentation etc. If it does, please remember that this is an incomplete action. Before you submit your Confirmation report, I will want you to not only have performed that review, but identified the necessary CAPA as a result of that review.

    For example, stating "Review documentation for fitness of purpose" or "Review training records" as CAPA shows me that the investigation hasn't yet been completed. You will need to have determined if the documentation IS fit fit for purpose an the training IS complete, and if not then you can state what the actual RC and CAPA should be.

  5. #5
    In addition to the above post, please also remember that simply stating that staff have performed a reflective statement is also incomplete CAPA. It is essential that you record in the SABRE report what they have reflected on and what staff will do differently to address the identified RC.

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