Once all action items have been completed and approved, the assigned reviewer will receive a notification in their Pending Tasks, prompting them to assess the effectiveness and approve the incident report.
Clicking on the subject in Pending Tasks will direct users to the Check Effectiveness and Approve Report form. In this form, users can evaluate the effectiveness of the incident response, examining the root cause analysis and the adequacy of actions taken. Upon concluding their review, users can determine the next course of action.
- 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.
- 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.
- 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.
- 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.
- Selecting this button will conclude the Incident Management workflow and initiate the CAPA Management workflow.
- If QE is selected, it will alter the page in the following way:
- 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.
- 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 Check Effectiveness and Approve Report task, the selected recipient(s) will receive an email including the incident report as an attached PDF.
- Upon closure of the Check Effectiveness and Approve Report task, the selected recipient(s) will receive an email including the incident report as an attached PDF.
- 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.
- 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.
- If selected, the assigned approver will be tasked with reviewing and approving the report.
- 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.
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