> 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/quality-event-application/creating-and-managing-quality-events/review-issue-escalate-to-capa.md).

# Review Issue – Escalate to CAPA?

Evaluate the quality event to determine whether it should be escalated to a CAPA.

## Workflow Overview

<i class="fa-location-dot">:location-dot:</i>  **Current Task:** Review the Issue – Escalate to CAPA?

<i class="fa-user">:user:</i>  **Performed By:** Assigned Reviewer (e.g., QA 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 **Review the Issue – Escalate to CAPA?** 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>

If the quality event is submitted for CAPA assessment, review the investigation and determine whether the issue should be escalated to CAPA or submitted for immediate correction.

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

{% 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.

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

***

{% stepper %}
{% step %}

### Review Quality Event

When reviewing, consider the following:

<table data-card-size="large" data-view="cards"><thead><tr><th></th><th></th></tr></thead><tbody><tr><td>✅ <strong>Root Cause Analysis</strong></td><td>Does the investigation clearly identify the root cause of the issue?</td></tr><tr><td>✅ <strong>Associated Risks</strong></td><td>Are all relevant risks identified and assessed accurately?</td></tr><tr><td>✅ <strong>Actions</strong></td><td>Are the proposed actions appropriate and sufficient to address the issue and prevent recurrence?</td></tr><tr><td>✅ <strong>CAPA Escalation</strong></td><td>Are there unresolved issues, high-impact risks, or gaps in the investigation or proposed actions that warrant formal escalation to CAPA?</td></tr></tbody></table>

***

{% endstep %}

{% step %}

### Provide Feedback

Use the **Comments** field to share feedback, ask questions, or collaborate with others.

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

{% 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 CAPA

Select **Yes** or **No** in the **Send the Issue to CAPA?** field.

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

* If <mark style="color:blue;">**Yes**</mark>, select the user, role, or group responsible for reviewing the report in the designated field.

***

{% endstep %}

{% step %}

### Finalize Assessment

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

* **Send to CAPA**

  Send the quality event to the **CAPA** application, concluding the **QE Management** workflow and initiating the **CAPA Management** workflow.

{% hint style="info" %}
The assigned reviewer will automatically receive the **Review CAPA** task, which includes details about the quality event.

* For more information on the **CAPA Management** workflow, refer to the [corresponding documentation](/interfacing-help-files/quality-managers/implementing-capas-apps/navigating-the-capa-management-workflow.md).
  {% endhint %}

* **Correct Issue Immediately with Actions**

  Submit the issue for immediate correction through defined actions.

  → Next Step: [Execute Action](/interfacing-help-files/quality-managers/quality-event-application/creating-and-managing-quality-events/execute-action-s.md)

{% hint style="warning" %}
At least **one** action must be defined for execution to proceed; otherwise, the event is closed automatically.
{% 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>Quality Event List</strong></td><td>Browse and filter all submitted quality event reports across the organization.</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/quality-event-application/tracking-and-monitoring-quality-events/quality-event-list.md">Quality Event List</a></td></tr><tr><td><strong>Quality Event Reminder</strong></td><td>Notify responsible users about pending tasks, helping ensure timely completion.</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/quality-event-application/tracking-and-monitoring-quality-events/quality-event-reminder.md">Quality Event Reminder</a></td></tr></tbody></table>


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