> 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/execute-root-cause-investigation-and-create-actions.md).

# Execute Root Cause Investigation & Create Actions

Investigate the incident’s root cause and define follow-up actions.

## Workflow Overview

<i class="fa-location-dot">:location-dot:</i> **Current Task:** Execute RCA Investigation and Create Action(s)

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

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

***

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

The **Execute RCA** 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 <a href="#completing-the-task" id="completing-the-task"></a>

If the incident is submitted for further investigation, complete the root cause analysis, document findings, and define appropriate actions to address identified causes.

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

{% hint style="warning" %}
To download a PDF copy of the incident report, click **Download PDF** at the bottom of the form.
{% endhint %}

{% 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 %}

### Review Incident

Review the incident report to ensure a clear understanding of the event, context, and any prior findings before beginning root cause analysis.

{% hint style="info" %}
Most fields in this section are **read-only**. Editable fields function the same as in the [**New Incident**](/interfacing-help-files/quality-managers/incident-application/creating-and-managing-incidents/create-new-incident.md) form.
{% endhint %}

***

{% endstep %}

{% step %}

### Manage Root Cause Analysis (RCA)

Perform and coordinate the root cause analysis.

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

#### 2.1 Conduct RCA

Perform a structured investigation to identify the underlying cause(s) of the incident.

* **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>

* **RCA Result:** Document the investigation outcome, including identified root cause(s), contributing factors, and supporting evidence.
* **RCA File(s):** Upload any supporting documentation or evidence.

#### 2.2 Delegate Investigation Tasks

To assign investigative work to other subject matter experts or relevant stakeholders:

* Click **Assign Root Cause Investigation Sub-Tasks***.*
* In the section that appears, select an investigator and provide the requested investigation details.

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

* Click **Send Request** to submit.

{% hint style="info" %}
If you change your mind before submitting, click **Cancel** to withdraw the request.
{% endhint %}

{% hint style="info" %}
Investigation requests are recorded in the **Requested Investigation** grid. When the assigned investigator sends their report, the grid updates to reflect the response message provided.

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

Note that the **Requested Investigation** grid and any updates to it are visible only after closing and reopening the form.
{% endhint %}

***

{% endstep %}

{% step %}

### Define or Update Actions

Review existing action items (if any) to ensure they align with the latest RCA findings. Add new actions as needed to address the incident, prevent recurrence, or improve processes.

{% hint style="info" %}
If no actions exist, select **Add Action Items** to reveal the section.
{% endhint %}

{% 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 %}

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

Click **Add** 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 incident.

{% 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 **Incident**.
* 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, where they can be modified by clicking **Edit** ( <i class="fa-pen">:pen:</i> ).

***

{% endstep %}

{% step %}

### Review Recommendations & Comments

Review any recommendations and comments left by previous stakeholders in the workflow. Add additional recommendations for consideration and contribute to ongoing discussions by adding new comments or replying to existing ones.

<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 can **reply** to others' comments but cannot edit or delete them.
  {% endhint %}

***

{% endstep %}

{% step %}

### Escalate to QE or CAPA (Optional)

If the incident requires further review and processing beyond standard incident handling, escalate the issue to a quality event (QE) or CAPA.

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

* **Escalate the Issue to QE or CAPA?:** Select the appropriate escalation path.
  * In the field that appears, select the user, role, or group responsible for reviewing the report.

***

{% endstep %}

{% step %}

### Finalize Investigation

From the **Task Resolution** dropdown, select one of the following actions:

* **RCA Completed (Trigger Actions)**

  Complete the investigation and initiate any defined follow-up actions.

  → Next Step: [Execute Action(s)](/interfacing-help-files/quality-managers/incident-application/creating-and-managing-incidents/execute-action-s.md)

{% hint style="warning" %}

#### How Resolution Proceeds

Depending on the incident report, one of the following will occur:

* If **actions** are defined, they will be assigned to their respective owners for [execution](/interfacing-help-files/quality-managers/incident-application/creating-and-managing-incidents/execute-action-s.md).
  * Once all items are completed and approved, the reviewer will [verify the resolution](/interfacing-help-files/quality-managers/incident-application/creating-and-managing-incidents/check-effectiveness-and-approve-report.md).

* If **no actions** are defined, resolution is assumed to proceed without individual task tracking.
  * In this case, the reviewer will proceed directly to [validating that the resolution meets requirements](/interfacing-help-files/quality-managers/incident-application/creating-and-managing-incidents/check-effectiveness-and-approve-report.md).
    {% endhint %}

* **No Action Needed, Close Incident**

  Close the incident if the investigation determines no further action is required.

* **Escalate the Issue**

  Escalate the incident to a quality event or CAPA for further processing.

{% hint style="warning" %}

#### How Escalation Works

Based on the selected escalation path, the issue is automatically routed to the appropriate workflow:

* **Quality Event**

  → Workflow: [**Quality Event Management**](/interfacing-help-files/quality-managers/quality-event-application/creating-and-managing-quality-events.md)

  → Task: [**Review Issue**](/interfacing-help-files/quality-managers/quality-event-application/creating-and-managing-quality-events/review-issue.md)
* **CAPA**

  → Workflow: [**CAPA Management**](/interfacing-help-files/quality-managers/implementing-capas-apps/navigating-the-capa-management-workflow.md)

  → Task: [**Review CAPA**](/interfacing-help-files/quality-managers/implementing-capas-apps/navigating-the-capa-management-workflow/review-capa.md)
  {% endhint %}

After selecting the appropriate resolution, click **Submit** to finalize your investigation and advance the workflow.

***

{% 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>Tracking &#x26; Monitoring Incidents</strong></td><td>Monitor the status and progress of incidents using lists and dashboards.</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/incident-application/tracking-and-monitoring-incidents.md">Tracking &amp; Monitoring Incidents</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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