> 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/create-new-capa.md).
# Create New CAPA
Create and submit a new CAPA to initiate the CAPA Management workflow.
## Workflow Overview
:location-dot: **Current Task:** Create New CAPA
:user: **Performed By:** Report Creator (e.g., QA Specialist, Process Owner, Department Manager)
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## Completing the Form
Use the **Create New CAPA** form to document the issue, nonconformity, or improvement requiring corrective and/or preventive action.
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{% 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 %}
***
{% stepper %}
{% step %}
### Identify, Classify, & Assign Ownership
Provide the information needed to uniquely identify, classify, and assign ownership of the CAPA.
* **CAPA Name:\*** Enter a brief, descriptive title summarizing the issue or improvement.
* **Event Type:\*** Select the classification that best describes the nature of the event.
{% hint style="warning" %}
Additional fields may appear based on your selection.
* **Audit Finding (Internal)**
* [**Audit Plan ID (Internal):**](#user-content-fn-1)[^1]**\*** Select the identifier of the associated internal audit program.
When an audit is linked, the Audit Information accordion appears in the form, containing the relevant details.
When a quality event is linked, the Quality Event Information accordion appears in the form, containing the relevant details.
- If the selected quality event is itself linked to an audit plan, the Audit Information accordion will also appear.
━━━━━━━━━━━━━━━━━━━━━━━━━━━
**Read-Only Fields** (🔒)
* **CAPA ID:** A system-generated, unique identifier used for tracking and reference.
{% hint style="warning" %}
This ID is assigned upon submission and includes a classification code based on the selected event type.
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{% endhint %}
***
{% endstep %}
{% step %}
### Specify Organizational Context (Optional)
Document the organizational areas affected or involved.
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* [**Business Division:**](#user-content-fn-7)[^7] Select the primary functional unit (department) associated with the CAPA.
* Selecting a division filters the options shown in the **Business Line** field.
* [**Business Line:**](#user-content-fn-8)[^8] Select the specialized unit within the selected division.
* [**Category:**](#user-content-fn-9)[^9] Select the classification used to group similar CAPAs for reporting and analysis.
* [**Site:**](#user-content-fn-10)[^10] Select one or more physical or operational locations associated with the CAPA.
***
{% endstep %}
{% step %}
### Define Timeline
Provide dates for initiating, completing, and verifying the CAPA.
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* **Start Date:\*** Select the date the CAPA is initiated.
{% hint style="info" %}
This field defaults to the current date; modify it if the CAPA starts earlier or later.
{% endhint %}
* **Closure Date Est.:** Select the estimated closure date for the CAPA.
{% hint style="warning" %}
The assigned reviewer may provide a new closure date [later in the workflow](/interfacing-help-files/quality-managers/implementing-capas-apps/navigating-the-capa-management-workflow/check-effectiveness-and-approve.md) if the original estimate cannot be met.
{% endhint %}
* **Eff. Start Date:** Select the date the effectiveness check will begin.
* **Eff. End Date:** Select the date the effectiveness check will end.
***
{% endstep %}
{% step %}
### Describe the Issue
Provide a clear, factual description of the issue, nonconformity, or improvement opportunity. Include relevant background, potential impact, and supporting evidence.
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***
{% endstep %}
{% step %}
### Link Related Elements (Optional)
Associate the CAPA with relevant elements to indicate relationships, dependencies, or impacts.
IMAGE
* [**Related To:**](#user-content-fn-11)[^11] Select one or more associations relevant to the CAPA.
{% hint style="warning" %}
Additional fields may become available based on your selection.
* **Process**
* [**Process(es):**](#user-content-fn-12)[^12] Select one or more associated processes.
* **Service**
* [**Service(s):**](#user-content-fn-13)[^13] Select one or more associated services or capabilities.
* **Product**
* [**Product(s):**](#user-content-fn-14)[^14] Select one or more associated products.
{% endhint %}
* [**Supplier-Related:**](#user-content-fn-15)[^15] Select the supplier associated with the CAPA.
* [**Contractor-Related:**](#user-content-fn-16)[^16] Select the contractor associated with the CAPA.
* **Add Related Findings:** Select to link one or more findings to the CAPA.
* If selected, use the provided grid to manage findings.
Managing Related Findings
To link new or existing audit findings to the CAPA, follow these steps:
1. **Access Related Findings**
* In the **Related Findings** grid, click **Add**. This opens the **Select Finding** form.
* In the **Select Finding** dropdown, click the :angle-down: icon to open the **Audit Findings** form, which lists all available audit findings.
2. **Locate or Create Finding**
* Locate the finding you want to link in the list.
* **If the finding already exists:**
* Proceed to the next step.
* **If you need to create a new finding:**
* Click **Add**. This opens the **Enter New Finding** form.
* Complete the form:
* **Type:** Select the type of finding.
* **Notes:** Enter the details of the finding.
* Choose one of the following:
* **Save and New**: Click to save the finding and open a new form to create another.
* **Save and Close**: Click to save the finding and close the form.
{% hint style="success" %}
#### Filtering & Managing Findings
* Use the **Filter Panel** at the top of the form to filter findings by type or creation date.
* Use the following options to manage findings:
* **Edit** ( :pencil: ): Click to modify a finding.
* **View** (  ): Click to open a finding in read-only mode.
* **Delete** ( :trash-can: ): Click to remove a finding.
Confirm deletion by clicking Save Changes or clicking outside the grid. To cancel, click Discard Changes or Undo ( :rotate-left: ).
***
{% endstep %}
{% step %}
### Define Actions
Define actions required to correct, prevent, or improve the issue.
{% hint style="warning" %}
#### **Actions & Their Impact**
An **action item** represents a corrective, preventive, or improvement activity intended to achieve measurable outcomes in quality, compliance, or risk reduction.
* When defined, actions are formally tracked through the workflow. They are assigned to responsible owners and must be completed and approved before the report can be closed.
{% endhint %}
Click **Add** to create a new action item.
Add Action Item
The **Add Action Item** form allows you to create actions associated with the CAPA.
{% hint style="warning" %}
This form is a modal version of the standard **New Action** form found in the **Action Items** application. It retains nearly all the original fields and functionality, but is adapted to fit the context of the current application.
{% endhint %}
**Key Differences:**
* **Source of the Action:** This field is automatically populated based on the current application context and cannot be modified.
* For example, in this case, the source is set to **CAPA**.
* At the bottom of the form, you can choose from the following save options:
* **Save and New**: Click to save the action and open a new form to create another.
* **Save and Close**: Click to save the action and close the form.
{% hint style="success" %}
For guidance on shared fields and functionality, refer to the [documentation for the **New Action** form](/interfacing-help-files/quality-managers/action-item-application/creating-and-managing-action-items/create-new-action.md).
{% endhint %}
Added entries appear in the grid with the following options:
* **Edit** ( :pen: ): Click to modify an action.
* **View** (  ): Click to open an action in read-only mode.
* **Delete** ( :trash-can: ): Click to remove an action.
{% hint style="info" %}
Confirm deletion by clicking **Save Changes** or clicking outside the grid. To cancel, click **Discard Changes** or **Undo** ( :rotate-left: ).
{% endhint %}
{% hint style="info" %}
If any of the added actions have associated budget items, an additional grid will appear in the accordion, listing the budget items for each action.
{% endhint %}
***
{% endstep %}
{% step %}
### Add Comments (Optional)
Use the **Comments** field to add clarifications, observations, or additional information relevant to the CAPA.
IMAGE
{% hint style="info" %}
#### Commenting Guidelines
Comments remain visible throughout the workflow for transparency and communication.
* 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 %}
### Submit Report
Click **Submit** to enter the report into the **CAPA Management** workflow, routing it to the designated reviewer for [evaluation](/interfacing-help-files/quality-managers/implementing-capas-apps/navigating-the-capa-management-workflow/review-capa.md).
***
{% endstep %}
{% endstepper %}
***
## See Also
[^1]: 💡 **For Administrators:**
* The list of internal audits is sourced from the Completed Audits module of the **Audit** application.
[^2]: 💡 **For Administrators:**
* The list of complaints is sourced from the **Complaint List** module of the **Complaint** application.
[^3]: 💡 **For Administrators:**
* The list of quality events is sourced from the [**Quality Event List**](/interfacing-help-files/quality-managers/quality-event-application/tracking-and-monitoring-quality-events/quality-event-list.md) module of the **Quality Event** application.
[^4]: 💡 **For Administrators:**
* Manage the options that populate the **Reviewer** dropdown in:
* **Library** > [**Organization**](/interfacing-help-files/process-analysts/organization-management.md).
* Only **active** users, roles, and groups will appear in the dropdown.
[^5]: 💡 **For Administrators:**
* Manage the options that populate the **RCA Owner** dropdown in:
* **Library** > [**Organization**](/interfacing-help-files/process-analysts/organization-management.md).
* Only **active** users will appear in the dropdown.
[^6]: 💡 **For Administrators:**
* Manage the options that populate the **Eff. Check Responsible** dropdown in:
* **Library** > [**Organization**](/interfacing-help-files/process-analysts/organization-management.md).
* Only **active** users will appear in the dropdown.
[^7]: 💡 **For Administrators:**
* Manage the options that populate the **Business Division** dropdown in:
* **Library** > [**Organization**](/interfacing-help-files/process-analysts/organization-management.md).
* Only **active** departments will appear in the dropdown.
[^8]: 💡 **For Administrators:**
* Manage the options that populate the **Business Line** dropdown in:
* **Library** > [**Organization**](/interfacing-help-files/process-analysts/organization-management.md).
* Only **active** departments linked to the selected parent department will appear in the dropdown.
[^9]: 💡 **For Administrators:**
* Manage the options that populate the **Category** dropdown in:
* **QMS Admin Settings** > **General Settings** > [**Category**](/interfacing-help-files/administration-and-configuration/configuring-application-settings/general-application-settings/category.md).
* Only **active** options will appear in the dropdown.
[^10]: 💡 **For Administrators:**
* Manage the options that populate the **Site(s)** dropdown in:
* **QMS Admin Settings** > **General Settings** > [**Location**](/interfacing-help-files/administration-and-configuration/configuring-application-settings/general-application-settings/location.md).
* Only **active** options will appear in the dropdown.
[^11]: 💡 **For Administrators:**
* Manage the options that populate the **Related To** dropdown in:
* **QMS Admin Settings** > **CAPA Settings** > [**Related To**](/interfacing-help-files/administration-and-configuration/configuring-application-settings/capa-application-settings/related-to.md).
* Only **active** options will appear in the dropdown.
[^12]: 💡 **For Administrators:**
* Manage the options that populate the **Process(es)** dropdown in:
* **Library** > **Process**.
[^13]: 💡 **For Administrators:**
* Manage the options that populate the **Service(s)** dropdown in:
* **Library** > **Capabilities**.
[^14]: 💡 **For Administrators:**
* Manage the options that populate the **Product(s)** dropdown in the [**Product(s) / Equipment**](/interfacing-help-files/supplier-and-product-management/products-equipment-application.md) application.
[^15]: 💡 **For Administrators:**
* Manage the options that populate the **Supplier-Related** dropdown in the [**Supplier**](/interfacing-help-files/supplier-and-product-management/supplier-application.md) application.
[^16]: 💡 **For Administrators:**
* Manage the options that populate the **Contractor-Related** dropdown in the [**Contractor**](/interfacing-help-files/supplier-and-product-management/contractor-application.md) application.
---
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