> 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/quality-event-application/creating-and-managing-quality-events/gather-details.md).

# Gather Details

Investigate the quality event by analyzing root causes, assessing associated risks, and defining actions to address or prevent recurrence.

## Workflow Overview

<i class="fa-location-dot">:location-dot:</i> **Current Task:** Gather Details

<i class="fa-user">:user:</i> **Performed By:** Report Creator (e.g., Operator, QA Representative, Department Manager)

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

***

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

The **Gather Details** 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 quality event is submitted for further investigation, review the situation to identify the root cause, assess associated risks, and define the actions needed to resolve the issue or prevent recurrence.

<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)

Collect data and analyze it to determine the root cause of the quality event.

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

* **RCA Method:** Enter the method used to perform the RCA.
* **RCA Reason:** Select the main reason or trigger for performing the RCA.
  * Selecting a reason filters the options shown in the **Description** field.
* **RCA Description:** 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>

* **Investigation Type:** Select the type of investigation being conducted.

{% hint style="warning" %}
An additional field may appear based on your selection.

* **Simple** or **Advanced**
  * **Investigation Technique:** Specify the method or technique used in the investigation.
    {% endhint %}

* **Provide Additional Details on Issue:** Document key information about the event, including its nature and contributing factors.

* **RCA Result:** Summarize the findings of the analysis.

* **Relevant Document(s):** Upload supporting files or documentation.

* **RCA File(s):** Upload any root cause analysis files or supporting evidence.

***

{% endstep %}

{% step %}

### Associate Risks

Identify and document associated risks by linking existing or newly created risks to the quality event.

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

To associate existing risks, select **Yes** in the **Do You Want to Associate Existing Risks** field.

<details>

<summary><mark style="color:blue;"><strong>Associating Existing Risks</strong></mark></summary>

To associate existing risks to the quality event, follow these steps:

1. **Select Folder**
   * In the **Select Folder** field, click the <i class="fa-angle-down">:angle-down:</i> icon to open a form displaying a tree structure of risk folders.&#x20;
   * Double-click the desired folder to select it.
2. **Select Risks**

   * Once a folder is selected, its child items populate the **Selected** **Documentation** grid.
   * Mark the items you want to assign by checking the corresponding **Selected** checkbox.

   <div data-gb-custom-block data-tag="hint" data-style="success" data-icon="lightbulb" class="hint hint-success"><p><strong>Tip:</strong> You can also use <strong>Select All</strong> to select all items in the grid, or <strong>Deselect All</strong> to clear all selections.</p></div>

   * Click **Save Changes**, or click outside the grid to automatically save your selections.
     * To cancel, click **Discard Changes**.
3. **Assign Risks**
   * Click **Assign Selected** to finalize the assignment.
4. **Review Assigned & Impacted Documentation**
   * Assigned items appear in the **Assigned Risks** grid.
   * If any objects are impacted by the assigned ones, they will appear in the **Impacted Documentation** grid. Otherwise, this grid will be hidden.

{% hint style="success" %}
To assign risks from multiple folders, repeat this process as needed.
{% endhint %}

</details>

To create a new risk, click **Add**.

<details>

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

The **Add Risk** form allows you to create risks associated with the quality event.

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

1. **Define Details**

Complete the relevant fields to configure the risk.

* **Name:** Enter a descriptive name for the risk.
* [**Related To Control(s):**](#user-content-fn-1)[^1] Select one or more controls associated with this risk.
* **Description:** Provide a detailed description of the risk.
* [**Impact:**](#user-content-fn-2)[^2] Select the level of potential impact.
* [**Probability:**](#user-content-fn-2)[^2] Select the likelihood of occurrence.
* [**Detectability:**](#user-content-fn-2)[^2] Select the ability to detect the risk before it impacts the process.

{% hint style="warning" %}
Based on the selected impact, probability, and detectability, the **Score** is automatically calculated.
{% endhint %}

* **Add to EPC:** Select the folder in EPC where the identified risk will be added or stored.

  * Instead of a dropdown menu, this field opens a pop-up window.

  <div data-gb-custom-block data-tag="hint" data-style="info" class="hint hint-info"><p>In this window, navigate through the tree structure displaying object sets and nested folders. To select a folder, simply double-click it.</p></div>

  * The selected folder name will populate the **Selected EPC Folder** field.
* **EPC Identifier:** Enter a unique identifier for the risk in EPC.

***

2. **Save Changes**

When ready to save, choose one of the following options:

* **Save and New:** Click to save the risk and open a new form to create another.
* **Save and Close:** Click to save the risk and close the form.

</details>

Added entries appear in the grid with the following options:

* **Edit** ( <i class="fa-pencil">:pencil:</i> ): Click to modify a risk.
* **View** ( ![](https://1488562728-files.gitbook.io/~/files/v0/b/gitbook-x-prod.appspot.com/o/spaces%2FTx7AmE0d2Q4ja20EYjF5%2Fuploads%2FIAlpvjgSBR3lKZjwsXm7%2FIMS-KI-L-9.svg?alt=media\&token=262f3701-b544-43fe-b1bc-d17a29a18e55) ): Click to open a risk in read-only mode.
* **Delete** ( <i class="fa-trash-can">:trash-can:</i> ): Click to remove a risk.

{% 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 %}

### Define Actions

Define actions required to address, mitigate, or prevent recurrence of the event.

{% 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 quality event.

{% 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 **Quality Event**.
* 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 **Review Notes** or **Comments** fields 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 one of the following actions:

* **Send for CAPA Assessment**

  Submit the quality event for formal CAPA evaluation.

  → Next Step: [Review Issue - Escalate to CAPA?](/interfacing-help-files/quality-managers/quality-event-application/creating-and-managing-quality-events/review-issue-escalate-to-capa.md)
* **Close QE**

  Close the quality event, bringing the workflow to an end.

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>Quality Event List</strong></td><td>Browse and filter all submitted quality event 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/quality-event-application/tracking-and-monitoring-quality-events/quality-event-list.md">Quality Event List</a></td></tr></tbody></table>

[^1]: 💡 **For Administrators:**

    * Manage the options that populate the **Related to Control(s)** dropdown in:
      * **Library** > **Control**.

[^2]: 💡 **For Administrators:**

    * Manage the options that populate the **Impact** dropdown in:
      * **System Admin** > **Risk**.


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