> 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/implementing-capas-apps/navigating-the-capa-management-workflow.md).
# Creating & Managing CAPAs
Perform tasks assigned to your role to advance reports through the CAPA Management workflow.
## Workflow Overview
The **CAPA** application operates through a single, standardized workflow: the **CAPA Management** workflow. This workflow governs the full lifecycle of a CAPA report, from creation through final evaluation and closure.
***
## Interactive Tour
Explore the **CAPA Management** workflow and learn how each stage works, with key guidance and best practices along the way.
{% @howdygo/embed url="" %}
***
## Workflow Initiation
A CAPA can be initiated through any of the following triggers.
{% tabs %}
{% tab title="Triggered by User" %}
A user may manually initiate a CAPA when a recurring issue, systemic problem, or significant risk is identified that requires corrective and/or preventive action.
{% endtab %}
{% tab title="Triggered by Audit" %}
At the final stage of the **Audit Planning & Execution** workflow, the audit team leader may initiate a CAPA for one or more observations associated with the audit plan.
{% hint style="info" %}
Before initiating the CAPA, the team leader must assign a party (user, role, or group) to act as the reviewer. This party is responsible for completing the [**Review CAPA**](/interfacing-help-files/quality-managers/implementing-capas-apps/navigating-the-capa-management-workflow/review-capa.md) task. This task includes details of the audit plan and the selected audit observations.
{% endhint %}
{% endtab %}
{% tab title="Triggered by QE" %}
At the [**Review the Issue - Escalate to CAPA?**](/interfacing-help-files/quality-managers/quality-event-application/creating-and-managing-quality-events/review-issue-escalate-to-capa.md) stage of the **QE Management** workflow, users may escalate the quality event to a CAPA.
{% hint style="info" %}
Before initiating the CAPA, the user must assign a party (user, role, or group) to act as the reviewer. This party is responsible for completing the [**Review CAPA**](/interfacing-help-files/quality-managers/implementing-capas-apps/navigating-the-capa-management-workflow/review-capa.md) task, which includes details of the quality event.
{% endhint %}
{% endtab %}
{% tab title="Triggered by Incident" %}
At various stages of the **Incident Management** workflow, users may escalate an incident to a CAPA.
{% hint style="info" %}
Before initiating the CAPA, the user must assign a party (user, role, or group) to act as the reviewer. This party is responsible for completing the [**Review CAPA**](/interfacing-help-files/quality-managers/implementing-capas-apps/navigating-the-capa-management-workflow/review-capa.md) task, which includes details of the incident.
{% endhint %}
{% endtab %}
{% endtabs %}
***
## Workflow Stages
The workflow is organized into **nine 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 CAPA
> **Performed By:** Report Creator (e.g., QA Specialist, Process Owner, Department Manager)
**Responsibilities:**
* Identify an issue, nonconformity, or improvement requiring corrective or preventive action.
* Provide the necessary details (e.g., classification, ownership, timeline, description).
* Define actions to address the issue.
* Submit the report to initiate the workflow.
***
{% endstep %}
{% step %}
### Review CAPA
> **Performed By:** Assigned Reviewer (e.g., QA Manager, Department Manager, Compliance Officer)
**Responsibilities:**
* Review the CAPA for completeness, clarity, and significance.
* Assess classification, context, timeline, and proposed actions.
* Provide feedback if revisions are needed.
* Approve the CAPA for further investigation or return it for modification.
{% 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 Analysis
> **Performed By:** Assigned RCA Owner (e.g., QA Specialist, Process Owner, Subject Matter Expert)
**Responsibilities:**
* Conduct a root cause analysis to determine the underlying issue.
* Define actions to address, mitigate, or prevent recurrence.
* Submit the analysis for verification.
***
{% endstep %}
{% step %}
### Verify CAPA
> **Performed By:** Assigned Reviewer (e.g., QA Manager, Department Manager, Compliance Officer)
**Responsibilities:**
* Review the root cause analysis and associated actions for completeness and adequacy.
* Define or confirm required actions to address the issue.
* Specify closure and effectiveness dates as needed.
* Provide feedback if revisions are needed.
* Approve the CAPA for implementation or return it for modification.
{% hint style="warning" %}
This stage is triggered only if the report is returned for modification after verification.
{% 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 correct, prevent, or improve the identified issue. 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
> **Performed By:** Assigned Eff. Check Responsible (e.g., QA Analyst, Department Manager, Compliance Officer)
**Responsibilities:**
* Assess the effectiveness of implemented actions to ensure the CAPA achieved its intended outcomes.
* Mark actions for re-execution if necessary and adjust related dates.
* Provide feedback or clarification as needed.
* Approve completed actions or reject them for re-execution.
***
{% endstep %}
{% step %}
### Sign Off on CAPA
> **Performed By:** Assigned Reviewer (e.g., QA Manager, Department Manager, Compliance Officer)
**Responsibilities:**
* Review the CAPA to confirm completeness, effectiveness, and proper implementation.
* Adjust the effective closure date if necessary.
* Approve the CAPA for closure or return it for revision if additional work is required.
***
{% endstep %}
{% endstepper %}
***
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