> 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/execute-root-cause-analysis.md).

# Execute Root Cause Analysis

Investigate the root cause and define actions to address it.

## Workflow Overview

<i class="fa-location-dot">:location-dot:</i> **Current Task:** Execute the Root Cause Analysis

<i class="fa-user">:user:</i> **Performed By:** Assigned RCA Owner (e.g., QA Specialist, Process Owner, Subject Matter Expert)

<p align="center"><kbd><strong>IMAGE</strong></kbd></p>

***

## Accessing the Task <a href="#accessing-the-task" id="accessing-the-task"></a>

The **Execute the Root Cause Analysis** task can be accessed through any of the following:

* The **To Do** module.
* The **Notification Panel** (via the **Notification Bell**).
* The **direct link** provided in the email notification.

***

## Completing the Task

After the CAPA is reviewed and approved, perform a thorough examination to determine the root cause of the issue or situation. Review any associated actions and create or update actions as needed to ensure proper follow-up.

<p align="center"><kbd><strong>IMAGE</strong></kbd></p>

{% 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 %}

{% hint style="info" %}

#### Saving Your Work

To save progress without submitting, click **Save** in the top-right corner of the panel.

* The task remains in the **To Do** module for you to revisit and complete later.
  {% endhint %}

***

{% stepper %}
{% step %}

### Conduct Root Cause Analysis (RCA)

Perform a thorough investigation to identify the root cause.

<p align="center"><kbd><strong>IMAGE</strong></kbd></p>

* **RCA Method:** Enter the method used to perform the RCA.
* [**RCA Reason:**](#user-content-fn-1)[^1] Select the main reason or trigger for performing the RCA.
  * Selecting a reason filters the options shown in the **Description** field.
* [**RCA Description:**](#user-content-fn-2)[^2] Select the option that best describes the issue related to the selected reason.
* **Type of Analysis:** Select the checkbox(es) for the type(s) of analysis you want to perform.
  * Selecting a checkbox makes the corresponding section appear.

<details>

<summary><mark style="color:blue;"><strong>5W</strong></mark></summary>

The **5W** section enables systematic analysis by addressing the following questions: **What, Where, When, Who, Why,** and **How**.

{% hint style="info" %}
This structured approach breaks the problem into key elements for comprehensive understanding.
{% endhint %}

<p align="center"><kbd><strong>IMAGE</strong></kbd></p>

* **What:** Identify the core issue or situation requiring analysis.
* **Where:** Determine the location or context of the issue.
* **When:** Establish the timeline or occurrence of events related to the issue.
* **Who:** Identify the individuals or parties involved in or affected by the issue.
* **Why:** Investigate the underlying reasons or causes contributing to the issue.
* **How:** Explore the mechanisms or processes involved in the issue.
* **Related Documents:** Upload any relevant files.

</details>

<details>

<summary><mark style="color:blue;"><strong>Comparative Analysis</strong></mark></summary>

The **Comparative Analysis** section helps identify root causes by comparing affected and unaffected scenarios.

{% hint style="info" %}
By examining differences in objects, processes, locations, and timings, this analysis helps pinpoint the true source of the issue.
{% endhint %}

* **Finding (Is)**

Use this tab to document what is observed in the affected object or process.

<p align="center"><kbd><strong>IMAGE</strong></kbd></p>

* **Comparison (Is Not)**

Use this tab to document objects or processes that were not affected.

<p align="center"><kbd><strong>IMAGE</strong></kbd></p>

</details>

<details>

<summary><mark style="color:blue;"><strong>3 x 5 Why Analysis</strong></mark></summary>

The **3 × 5 Why Analysis** applies the 5Ws (**What**, **Where**, **When**, **Who**, **Why**) across three types of causes:

* **Direct Cause**
* **Detection Cause**
* **Systemic Cause**

***

* **Direct Cause**

Use this tab to examine and identify the immediate or specific cause of the problem. This is often the initial factor that directly led to the issue.

<p align="center"><kbd><strong>IMAGE</strong></kbd></p>

* **Detection Cause**

Use this tab to examine the factors that allowed the issue to pass through without detection. This involves understanding how the problem reached the customer or end-user without being intercepted.

<p align="center"><kbd><strong>IMAGE</strong></kbd></p>

* **Systemic Cause**

Use this tab to explore how the broader system, including business processes, contributed to the problem. This involves identifying any systemic failures or weaknesses that may have played a role in the emergence of the issue.

<p align="center"><kbd><strong>IMAGE</strong></kbd></p>

</details>

* **Unable to Determine Root Cause:** Select if a root cause could not be determined despite investigation efforts.
* **Relevant Document(s):** Upload supporting files or documentation.
* **RCA File(s):** Upload any root cause analysis files or supporting evidence.
* **Describe Root Cause:** Provide a description of the identified root cause.
* **RCA Result:** Summarize the findings of the analysis.

***

{% endstep %}

{% step %}

### Define Actions

Define actions required to address, mitigate, or prevent recurrence of 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 to create a new action item.

<details>

<summary><mark style="color:blue;"><strong>Add Action Item</strong></mark></summary>

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 %}

</details>

Added entries appear in the grid with the following options:

* **Edit** ( <i class="fa-pencil">:pencil:</i> ): Click to modify an action.
* **View** ( <i class="fa-eye">:eye:</i> ): Click to open an action in read-only mode.
* **Delete** ( <i class="fa-trash-can">:trash-can:</i> ): 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** ( <i class="fa-rotate-left">:rotate-left:</i> ).
{% endhint %}

***

{% endstep %}

{% step %}

### Provide Feedback

Use the **Comments** field to share feedback, ask questions, or provide clarification.

<p align="center"><kbd><strong>IMAGE</strong></kbd></p>

{% hint style="info" %}

#### Commenting Guidelines

* You can **edit**, **delete**, or **reply** to your own comments.
* You may **reply** to others' comments but cannot edit or delete them.
  {% endhint %}

***

{% endstep %}

{% step %}

### Finalize Investigation

From the **Task Resolution** dropdown, select **Send for Verification**, then click **Submit**.

→ Next Step: [Verify CAPA](/interfacing-help-files/quality-managers/implementing-capas-apps/navigating-the-capa-management-workflow/verify-capa.md)

***

{% endstep %}
{% endstepper %}

***

## See Also

<table data-view="cards"><thead><tr><th></th><th></th><th data-hidden data-card-cover data-type="image">Cover image</th><th data-hidden data-card-target data-type="content-ref"></th></tr></thead><tbody><tr><td><strong>CAPA List</strong></td><td>Browse and filter all submitted CAPA reports across the organization.</td><td><a href="https://1488562728-files.gitbook.io/~/files/v0/b/gitbook-x-prod.appspot.com/o/spaces%2FTx7AmE0d2Q4ja20EYjF5%2Fuploads%2FNZOvD3ldHJ3i1zsvDksS%2FCR-V16-Icons-1.png?alt=media&amp;token=7c420cc4-9abf-4601-8fc3-8e9769771b27">App-V16-Icons-1.png</a></td><td><a href="/interfacing-help-files/quality-managers/implementing-capas-apps/tracking-and-monitoring-capas/capa-list.md">CAPA List</a></td></tr></tbody></table>

[^1]: 💡 **For Administrators:**

    * Manage the options that populate the **RCA Reason** dropdown in:
      * **QMS Admin Settings** > **General Settings** > [**RCA Reason & Description**](/interfacing-help-files/administration-and-configuration/configuring-application-settings/general-application-settings/rca-reason-and-description.md).

[^2]: 💡 **For Administrators:**

    * Manage the options that populate the **RCA Description** dropdown in:
      * **QMS Admin Settings** > **General Settings** > [**RCA Reason & Description**](/interfacing-help-files/administration-and-configuration/configuring-application-settings/general-application-settings/rca-reason-and-description.md).


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