> 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/complaint-application/creating-and-managing-complaints.md).
# Creating & Managing Complaints
Perform tasks assigned to your role to advance reports through the Complaint Management workflow.
## Workflow Overview
The **Complaint** application operates through a single, standardized workflow: the **Complaint Management** workflow. This workflow governs the full lifecycle of a complaint, from creation through final evaluation and closure.
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## Interactive Tour
Explore the **Complaint Management** workflow and learn how each stage works, with key guidance and best practices along the way.
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## Workflow Stages
The workflow is organized into **five 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 Complaint
> **Performed By:** Report Creator (e.g., Customer Service Representative, Frontline Worker, Administrative Assistant)
**Responsibilities**:
* Identify the occurrence of a complaint.
* Provide the necessary details to accurately describe, classify, and contextualize the complaint.
* Document any immediate response measures taken to contain, mitigate, or address the situation.
* Define actions to address, correct, prevent, or mitigate the issue(s) and potential impact(s) associated with the complaint.
* Submit the report to initiate the workflow.
Create New Complaint
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{% endstep %}
{% step %}
### Review Complaint Report
> **Performed By:** Assigned Reviewer (e.g., Supervisor, Department Manager, QA Analyst)
**Responsibilities**:
* Evaluate the submitted complaint for clarity, completeness, and accuracy.
* Take appropriate action:
* Return the report to the creator for modification.
* Escalate the incident to a quality event (QE) or CAPA.
* Close the incident if no issue is identified.
* Initiate execution of defined actions to address the complaint.
Review Complaint Report
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{% endstep %}
{% step %}
### Modify Complaint Report
> **Performed By:** Report Creator (e.g., Customer Service Representative, Frontline Worker, Administrative Assistant)
**Responsibilities**:
* Review feedback from the assigned reviewer.
* Make necessary revisions (e.g., clarify complaint description, correct classification, add supporting evidence).
* Resubmit the report for further review.
Modify Complaint Report
{% hint style="warning" %}
This stage is triggered only if the report is returned for modification after the initial review.
{% endhint %}
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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.
Execute Action(s)
{% hint style="warning" %}
This stage is triggered only if specific actions were defined during the workflow.
{% endhint %}
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{% endstep %}
{% step %}
### Check Effectiveness of Actions
> **Performed By:** Assigned Reviewer (e.g., Supervisor, Department Manager, QA Analyst)
**Responsibilities**:
* Evaluate whether implemented measures effectively resolved the complaint.
* Document the complaint resolution.
* Take appropriate action:
* Close the complaint.
* Escalate the incident to a quality event (QE) or CAPA.
Check Effectiveness of Actions
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{% endstep %}
{% endstepper %}
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---
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