If the reviewer requests further approval for the incident report, the selected approver will receive a notification in their Pending Tasks, prompting them to review and approve the report.

Clicking on either the subject in Pending Tasks or the button in the email will direct users to the Review and Approve Report form. This form, largely mirroring the Check Effectiveness and Approve Report form, presents all fields in a read-only format. Users can review the incident report, including its root cause analysis and related actions, before providing their approval.

  1. Recommendations for Consideration: This is a rich text field that allows users to provide actionable recommendations or suggestions based on the incident review, aiding in the implementation of improvement measures.
  2. Comment: This field allows users to add comments regarding the incident report. It also allows them to review and respond to comments left by previous stakeholders.
  3. Download PDF: This button allows users to download a PDF copy of the incident report.
    • If selected, the PDF opens in a new tab in the web browser.
  4. Escalate the Issue to QE or CAPA?: This is a single-select dropdown field that determines whether to escalate the issue to a quality event (QE) or CAPA.
    • If QE is selected, it will alter the page in the following way:
      • Quality Event Reviewer: This is a single-select dropdown field that retrieves the list of active users, roles, and groups in the system. It is a mandatory field. It allows for the selection of the party responsible for reviewing the quality event.
      • Escalate the Issue: This button allows users to send the incident to the Quality Event application.
        • Selecting this button will conclude the Incident Management workflow and initiate the Quality Event Management workflow.
    • If CAPA is selected, it will alter the page in the following way:
      • CAPA Reviewer: This is a single-select dropdown field that retrieves the list of active users, roles, and groups in the system. It is a mandatory field. It allows for the selection of the party responsible for reviewing the CAPA.
      • Escalate the Issue: This button allows users to send the incident to the CAPA application.
        • Selecting this button will conclude the Incident Management workflow and initiate the CAPA Management workflow.
  5. Assigned Approver: This is a single-select dropdown field that retrieves the list of active users, roles, and groups in the system. It allows for the selection of the party responsible for providing additional approval for the incident report.
  6. Distribute Incident Report To: This is a multi-select dropdown field that retrieves the list of active users, roles, and groups in the system. It allows for the selection of the recipient(s) for the incident report.
    • Upon closure of the Review and Approve Report task, the selected recipient(s) will receive an email including the incident report as an attached PDF.
  7. Download PDF: This button allows users to download a PDF copy of the incident report.
    • If selected, the PDF opens in a new tab in the web browser.
  8. Close the Incident: This button allows users to close the incident, bringing the workflow to an end.
    • Once selected, no further actions can be taken, and the incident will be officially marked as resolved.
  9. Approved, Additional Approval Required: This button allows users to send the incident report for additional approval.
    • If selected, the assigned approver will be tasked with reviewing and approving the report.

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