> For the complete documentation index, see [llms.txt](https://interfacing.gitbook.io/interfacing-help-files/llms.txt). Markdown versions of documentation pages are available by appending `.md` to page URLs; this page is available as [Markdown](https://interfacing.gitbook.io/interfacing-help-files/quality-managers/incident-application/creating-and-managing-incidents/check-effectiveness-and-approve-report.md).

# Check Effectiveness & Approve Report

Verify that the incident has been effectively addressed and determine whether the report can be approved and closed.

## Workflow Overview

<i class="fa-location-dot">:location-dot:</i> **Current Task:** Check Effectiveness & Approve Report

<i class="fa-user">:user:</i> **Performed By:** Assigned Reviewer (e.g., Incident Manager, Department Manager, Compliance Officer)

<p align="center"><kbd><strong>IMAGE</strong></kbd></p>

***

## Accessing the Task <a href="#accessing-the-task" id="accessing-the-task"></a>

The **Check Effectiveness & Approve Report** task can be accessed through any of the following:

* The **To Do** module.
* The **Notification Panel** (via the **Notification Bell**).
* The **direct link** provided in the email notification.

***

## Completing the Task <a href="#completing-the-task" id="completing-the-task"></a>

After all defined actions have been completed and approved, review the incident to confirm that the response effectively resolved the issue and meets organizational requirements.

<p align="center"><kbd><strong>IMAGE</strong></kbd></p>

{% hint style="warning" %}
To download a PDF copy of the incident report, click **Download PDF** at the bottom of the form.
{% endhint %}

{% hint style="success" %}
For guidance on common form features and functions, see [**Working with Forms**](/interfacing-help-files/end-users/exploring-apps/working-with-forms.md).
{% endhint %}

{% hint style="info" %}

#### Saving Your Work

To save progress without submitting, click **Save** in the top-right corner of the panel.&#x20;

* The task remains in the **To Do** module for you to revisit and complete later.
  {% endhint %}

***

{% stepper %}
{% step %}

### Evaluate Effectiveness

Review the incident outcome to confirm that the issue has been appropriately addressed and that the report is ready for closure. Consider the following:

<table data-card-size="large" data-view="cards"><thead><tr><th></th><th></th></tr></thead><tbody><tr><td>✅ <strong>Resolution Effectiveness</strong></td><td>Did the implemented measures effectively address the incident and resolve the identified issue?</td></tr><tr><td>✅ <strong>Root Cause &#x26; Risk Mitigation</strong></td><td>If a root cause analysis was performed, do the implemented measures appropriately address the identified root cause(s) and contributing factors?</td></tr><tr><td>✅ <strong>Residual Risk</strong></td><td>Are there any remaining risks, unresolved issues, adverse impacts, or follow-up activities requiring additional attention or escalation?</td></tr><tr><td>✅ <strong>Overall Readiness for Closure</strong></td><td>Does the report contain sufficient documentation, approvals, evidence, and outcomes to support formal closure?</td></tr></tbody></table>

***

{% endstep %}

{% step %}

### Provide Feedback

Use the available fields to document your assessment and communicate next steps.

<p align="center"><kbd><strong>IMAGE</strong></kbd></p>

* **Recommendations for Consideration:** Document any improvement suggestions, corrective insights, or preventive measures identified during the review.
* **Comments:** Add clarifications, questions, or discussion points to support collaboration.

{% hint style="info" %}

#### Commenting Guidelines

* You can **edit**, **delete**, or **reply** to your own comments.
* You can **reply** to others' comments but cannot edit or delete them.
  {% endhint %}

***

{% endstep %}

{% step %}

### Escalate to QE or CAPA (Optional)

If the incident requires further review and processing beyond standard incident handling, escalate the issue to a quality event (QE) or CAPA.

<p align="center"><kbd><strong>IMAGE</strong></kbd></p>

* **Escalate the Issue to QE or CAPA?:** Select the appropriate escalation path.
  * In the field that appears, select the user, role, or group responsible for reviewing the report.

***

{% endstep %}

{% step %}

### Request Additional Approval (Optional)

If additional review or approval is required before the incident can be closed, select the responsible user, role, or group.

<p align="center"><kbd><strong>IMAGE</strong></kbd></p>

***

{% endstep %}

{% step %}

### Distribute Incident Report (Optional)

If the finalized incident report should be shared, specify the intended recipients.

<p align="center"><kbd><strong>IMAGE</strong></kbd></p>

* [**Distribute Incident Report To:**](#user-content-fn-1)[^1] Select one or more users, roles, or groups.
  * 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.

***

{% endstep %}

{% step %}

### Finalize Assessment

From the **Task Resolution** dropdown, select one of the following actions:

* **Approved, Additional Approval Required**

  Approve the incident report and route it for an additional level of review or approval.

  → Next Step: [Review & Approve Report](/interfacing-help-files/quality-managers/incident-application/creating-and-managing-incidents/review-and-approve-report.md)

{% hint style="danger" %}
In the **Review & Approve Report** task, the assigned approver can either close the incident or assign another approver for further validation. This process will continue until an approver chooses to close the incident.
{% endhint %}

* **Approved, Close the Incident**

  Approve the report, concluding the workflow.
* **Escalate the Issue**

  Escalate the incident to a quality event or CAPA for further processing.

{% hint style="warning" %}

#### How Escalation Works

Based on the selected escalation path, the issue is automatically routed to the appropriate workflow:

* **Quality Event**

  → Workflow: [**Quality Event Management**](/interfacing-help-files/quality-managers/quality-event-application/creating-and-managing-quality-events.md)

  → Task: [**Review Issue**](/interfacing-help-files/quality-managers/quality-event-application/creating-and-managing-quality-events/review-issue.md)
* **CAPA**

  → Workflow: [**CAPA Management**](/interfacing-help-files/quality-managers/implementing-capas-apps/navigating-the-capa-management-workflow.md)

  → Task: [**Review CAPA**](/interfacing-help-files/quality-managers/implementing-capas-apps/navigating-the-capa-management-workflow/review-capa.md)
  {% endhint %}

After selecting the appropriate resolution, click **Submit** to finalize your assessment and advance the workflow.

***

{% endstep %}
{% endstepper %}

***

## See Also

<table data-view="cards"><thead><tr><th></th><th></th><th data-hidden data-card-cover data-type="image">Cover image</th><th data-hidden data-card-target data-type="content-ref"></th></tr></thead><tbody><tr><td><strong>Tracking &#x26; Monitoring Incidents</strong></td><td>Monitor the status and progress of incidents using lists and dashboards.</td><td><a href="https://1488562728-files.gitbook.io/~/files/v0/b/gitbook-x-prod.appspot.com/o/spaces%2FTx7AmE0d2Q4ja20EYjF5%2Fuploads%2FNZOvD3ldHJ3i1zsvDksS%2FCR-V16-Icons-1.png?alt=media&amp;token=7c420cc4-9abf-4601-8fc3-8e9769771b27">App-V16-Icons-1.png</a></td><td><a href="/interfacing-help-files/quality-managers/incident-application/tracking-and-monitoring-incidents.md">Tracking &amp; Monitoring Incidents</a></td></tr></tbody></table>

[^1]: 💡 **For Administrators:**

    * Manage the options that populate the **Distribute** dropdown in:
      * **Library** > [**Organization**](/interfacing-help-files/process-analysts/organization-management.md).
    * Only **active** users, roles, and groups will appear in the dropdown.


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