> 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.md).
# Creating & Managing Incidents
Perform tasks assigned to your role to advance reports through the Incident Management workflow.
## Workflow Overview
The **Incident** application operates through a single, standardized workflow: the **Incident Management** workflow. This workflow governs the full lifecycle of an incident report, from creation through final evaluation and closure.
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## Interactive Tour
Explore the **Incident Management** workflow and learn how each stage works, with key guidance and best practices along the way.
{% @howdygo/embed url="" %}
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## Workflow Stages
The workflow is organized into **seven 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 Incident
> **Performed By:** Report Creator (e.g., Employee, Team Lead, IT Support Specialist)
**Responsibilities**:
* Identify the occurrence of an incident.
* Provide the necessary details to accurately describe, classify, and contextualize the incident.
* Document immediate response measures taken to contain, mitigate, or stabilize the incident.
* Submit the report to initiate the workflow.
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{% endstep %}
{% step %}
### Review Incident Report
> **Performed By:** Assigned Reviewer (e.g., Incident Manager, Department Manager, Compliance Officer)
**Responsibilities**:
* Evaluate the submitted incident for clarity, completeness, and accuracy.
* Assign an investigator if further analysis is required.
* Provide feedback and recommendations for improvement.
* Take appropriate action:
* Return the report to the creator for modification.
* Request a root cause investigation.
* Escalate the incident to a quality event (QE) or CAPA.
* Close the incident if no issue is identified.
{% hint style="warning" %}
This stage is triggered only if the report is returned for modification after the initial review.
{% endhint %}
***
{% endstep %}
{% step %}
### Execute Root Cause Investigation & Create Actions
> **Performed By:** Assigned Investigator (e.g., Subject Matter Expert, QA Specialist, Process Owner)
**Responsibilities**:
* Conduct a root cause analysis to determine underlying causes of the incident.
* Define actions to address root causes, mitigate risks, and prevent recurrence.
* Take appropriate action:
* Initiate actions based on investigation findings.
* Close the incident if no further action is required.
* Escalate the incident to a quality event (QE) or CAPA.
If investigative work is delegated to relevant personnel, the **Additional Investigation** workflow is initiated.
This workflow is organized into **two key stages**:
{% stepper %}
{% step %}
### Request Additional Investigation
> **Performed By:** Assigned Investigator (e.g., Subject Matter Expert, QA Specialist, Process Owner)
**Responsibilities**:
* Initiate the investigation request.
* Select an investigator and provide the requested investigation details.
* Submit the request to initiate the workflow.
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{% endstep %}
{% endstepper %}
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{% 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 incident. 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 Effectiveness & Approve Report
> **Performed By:** Assigned Reviewer (e.g., Incident Manager, Department Manager, Compliance Officer)
**Responsibilities**:
* Evaluate whether implemented measures effectively resolved the incident.
* Provide feedback and recommendations.
* Optionally define recipients for incident report distribution.
* Take appropriate action:
* Request additional review and approval.
* Approve closure of the incident.
* Escalate the incident to a quality event (QE) or CAPA.
{% hint style="warning" %}
This stage is triggered only if the incident report is submitted for additional review and approval.
{% endhint %}
***
{% endstep %}
{% endstepper %}
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---
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