> 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.md).
# Creating & Managing Quality Events
Perform tasks assigned to your role to advance reports through the QE Management workflow.
## Workflow Overview
The **Quality Event** (**QE**) application operates through a single, standardized workflow: the **QE Management** workflow. This workflow governs the full lifecycle of a quality event report, from creation through final evaluation and closure.
***
## Interactive Tour
Explore the **QE Management** workflow and learn how each stage works, with key guidance and best practices along the way.
{% @howdygo/embed url="" %}
***
## Workflow Initiation
A quality event can be initiated through any of the following triggers.
{% tabs %}
{% tab title="Triggered by User" %}
A user may manually initiate a quality event when a quality issue is identified that requires formal evaluation and tracking.
{% endtab %}
{% tab title="Triggered by Audit" %}
At the final stage of the **Audit Planning & Execution** workflow, the audit team leader may initiate a quality event for one or more observations associated with the audit plan.
{% hint style="info" %}
Before initiating the quality event, the team leader must assign a party (user, role, or group) to act as the reviewer. This party is responsible for completing the [**Review the Issue**](/interfacing-help-files/quality-managers/quality-event-application/creating-and-managing-quality-events/review-issue.md) task. This task includes details of the audit plan and the selected audit observations.
{% endhint %}
{% endtab %}
{% tab title="Triggered by MR" %}
At the **Execute MR** stage of the **Management Review** workflow, an administrator may escalate the management review to a quality event.
{% hint style="info" %}
Before initiating the quality event, the administrator must assign a party (user, role, or group) to act as the reviewer. This party is responsible for completing the [**Review the Issue**](/interfacing-help-files/quality-managers/quality-event-application/creating-and-managing-quality-events/review-issue.md) task, which includes details of the management review.
{% endhint %}
{% endtab %}
{% tab title="Triggered by Incident" %}
At various stages of the **Incident Management** workflow, users may escalate an incident to a quality event.
{% hint style="info" %}
Before initiating the quality event, the user must assign a party (user, role, or group) to act as the reviewer. This party is responsible for completing the [**Review the Issue**](/interfacing-help-files/quality-managers/quality-event-application/creating-and-managing-quality-events/review-issue.md) task, which includes details of the incident.
{% endhint %}
{% endtab %}
{% endtabs %}
***
## Workflow Stages
The workflow is organized into **eight key stages**, each with specific roles and responsibilities.
{% hint style="success" %}
For detailed instructions on any stage, click the corresponding button.
{% endhint %}
{% stepper %}
{% step %}
### Create New Quality Event
> **Performed By:** Report Creator (e.g., Operator, QA Representative, Department Manager)
**Responsibilities**:
* Identify the need for a quality event.
* Provide the necessary details to describe and classify the event.
* Define actions to address the issue.
* Submit the report to initiate the workflow.
***
{% endstep %}
{% step %}
### Review Issue
> **Performed By:** Assigned Reviewer (e.g., QA Manager, Department Manager, Compliance Officer)
**Responsibilities**:
* Evaluate the submitted quality event for clarity, accuracy, and relevance.
* Assess the classification, context, and proposed actions of the event.
* Provide feedback if revisions are needed.
* Take appropriate action:
* Return the event to the creator for modification.
* Submit the event for further investigation.
* Initiate immediate correction or containment of the issue, with or without defined actions.
* Close the quality event if no underlying issue is found.
{% hint style="warning" %}
This stage is triggered only if the report is returned for modification after the initial review.
{% endhint %}
***
{% endstep %}
{% step %}
### Contain / Correct Issue
> **Performed By:** Report Creator (e.g., Operator, QA Representative, Department Manager)
**Responsibilities**:
* Document immediate containment or correction measures taken to stabilize the quality issue.
* Submit the issue for further investigation or close the quality event.
{% hint style="warning" %}
This stage is triggered only if the report is submitted for immediate containment or correction after the initial review.
{% endhint %}
***
{% endstep %}
{% step %}
### Gather Details
> **Performed By:** Report Creator (e.g., Operator, QA Representative, Department Manager)
**Responsibilities**:
* Conduct a thorough investigation of the quality event, including root cause analysis.
* Define actions to address, mitigate, or prevent recurrence of the issue.
* Identify and document associated risks.
* Submit the quality event for formal CAPA assessment or close the event if no further action is required.
{% hint style="warning" %}
This stage is triggered only if the report is returned for further investigation after the initial review or immediate containment.
{% endhint %}
***
{% endstep %}
{% step %}
### Review Issue – Escalate to CAPA?
> **Performed By:** Assigned Reviewer (e.g., QA Manager, Department Manager, Compliance Officer)
**Responsibilities**:
* Evaluate the quality event investigation, including root cause analysis, associated risks, and proposed actions.
* Determine whether unresolved issues or high-impact risks warrant escalation to CAPA.
* Submit the issue to the CAPA application or submit it for immediate correction through defined actions.
{% hint style="warning" %}
This stage is triggered only if the report requires CAPA assessment after investigation.
{% endhint %}
***
{% endstep %}
{% step %}
### Execute Action(s)
> **Performed By:** Assigned Action Owners
This stage includes the **Execute Action(s)** subprocess, which manages all actions required to address the quality event. It integrates with the [Action Item Management](/interfacing-help-files/quality-managers/action-item-application/creating-and-managing-action-items.md) workflow.
**Responsibilities:**
* Accept or decline assigned action(s).
* Execute assigned items according to instructions.
* Document progress and provide evidence of completion.
* Report any issues or deviations from the plan.
* Submit completed work for approval.
{% hint style="warning" %}
This stage is triggered only if specific actions were defined during the workflow.
{% endhint %}
***
{% endstep %}
{% step %}
### Check Issue Correction
> **Performed By:** Assigned Reviewer (e.g., QA Manager, Department Manager, Compliance Officer)
**Responsibilities:**
* Review completed actions and verify that the quality issue has been resolved.
* Ensure all corrective and preventive actions are complete.
* Confirm that documentation is accurate and compliant.
* Close the quality event once all corrections are validated.
***
{% endstep %}
{% endstepper %}
***
---
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