> 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/create-new-quality-event.md). # Create New Quality Event Create and submit a new quality event to initiate the QE Management workflow. ## Workflow Overview :location-dot: **Current Task:** Create New Quality Event :user: **Performed By:** Report Creator (e.g., Operator, QA Representative, Department Manager)

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*** ## Completing the Form Use the **Create New Quality Event** form to capture the initial details of a quality-related issue, observation, or concern.

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{% hint style="info" %} At this stage, document only observable facts—what occurred, where it occurred, and what may be affected. Do **not** perform root cause analysis or assign blame. {% 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 %} *** {% stepper %} {% step %} ### Identify, Classify, & Assign Ownership Provide the information needed to uniquely identify, classify, and assign ownership of the quality event.

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* **Quality Event Name:\*** Enter a brief, descriptive title summarizing the issue or observation. * [**Reported By:**](#user-content-fn-1)[^1]**\*** Verify the individual reporting the event. {% hint style="info" %} This field defaults to the logged-in user; modify it if reporting on behalf of someone else. {% endhint %} * **Reported Date:\*** Verify the date the event was identified. {% hint style="info" %} This field defaults to the current date; modify it if the event occurred earlier. {% endhint %} * **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-2)[^2]**\*** 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.

* **Audit Finding (External)** * **Audit Plan ID (External):\*** Enter the reference number or identifier of the associated external audit program. * **Complaint** * [**Complaint ID:**](#user-content-fn-3)[^3] Select the identifier of the associated complaint. * **Inspection Finding** * **Inspection ID (External):\*** Enter the reference number or identifier of the associated external inspection. {% endhint %} * **Severity:\*** Select the level that reflects the potential or actual impact of the event (e.g., Minor, Major, Critical). * [**Category:**](#user-content-fn-4)[^4] Select the classification used to group similar events for reporting and analysis. * [**Source:**](#user-content-fn-5)[^5] Select the origin of the event. * [**Reason:**](#user-content-fn-6)[^6] Select the primary reason or trigger for reporting the event. * [**QE Reviewer:**](#user-content-fn-7)[^7]**\*** Select the user, role, or group responsible for reviewing the report.

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**Read-Only Fields** (🔒) * **Quality Event 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) Identify where the event occurred and the areas affected.

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* [**Business Division:**](#user-content-fn-8)[^8] Select the primary functional unit (department) associated with the event. * Selecting a division filters the options shown in the **Business Line** field. * [**Business Line:**](#user-content-fn-9)[^9] Select the specialized unit within the selected division. * [**Site(s):**](#user-content-fn-10)[^10] Select one or more physical or operational locations associated with the event. *** {% endstep %} {% step %} ### Describe the Event Provide a clear and factual description of the issue, observation, or concern. Include: * Who was involved or affected * What happened and where * Any immediate containment actions taken

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*** {% endstep %} {% step %} ### Link Related Elements (Optional) Associate the quality event with relevant elements to indicate relationships, dependencies, or impacts. * [**Related To:**](#user-content-fn-11)[^11] Select one or more associations relevant to the event. {% 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. * **Associated Documentation:** Assign documentation related to the selected product(s).
Assigning Associated Documentation To assign documentation, follow these steps within the relevant tab: * **Select Folder** * In the **Select Folder** field, click the :angle-down: icon to open a form displaying a tree structure of documentation folders. * Double-click the desired folder to select it. * **Select Documentation** * 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.

Tip: You can also use Select All to select all items in the grid, or Deselect All to clear all selections.

* Click **Save Changes**, or click outside the grid to automatically save your selections. * To cancel, click **Discard Changes**. * **Assign Documentation** * Click **Assign Selected** to finalize the assignment. * **Review Assigned Documentation** * Assigned items appear in the **Assigned Documentation** grid. {% hint style="success" %} To assign documentation from multiple folders, repeat this process as needed. {% endhint %}
{% endhint %} * [**Supplier-Related:**](#user-content-fn-15)[^15] Select the supplier associated with the event. * [**Contractor-Related:**](#user-content-fn-16)[^16] Select the contractor associated with the event. *** {% endstep %} {% step %} ### Define Actions (Optional) 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 create a new action item.
Add Action Item 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 %}
Added entries appear in the grid with the following options: * **Edit** ( :pen: ): Click to modify an action. * **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 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 %} *** {% endstep %} {% step %} ### Add Supporting Information (Optional) To supplement the report, you may include:

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* **Relevant Documents:** Upload any files that provide evidence, context, or supporting documentation. * **Comments:** Add notes, clarifications, or other remarks related to the event. {% 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 **QE Management** workflow, routing it to the designated reviewer for [evaluation](/interfacing-help-files/quality-managers/quality-event-application/creating-and-managing-quality-events/review-issue.md). *** {% endstep %} {% endstepper %} *** ## See Also
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Quality Event ListBrowse and filter all submitted quality event reports across the organization.App-V16-Icons-1.pngQuality Event List
[^1]: :bulb: **For Administrators:** * Manage the options that populate the **Reported By** dropdown in: * **Library** > [**Organization**](/interfacing-help-files/process-analysts/organization-management.md). * Only **active** users, roles, and groups will appear in the dropdown. [^2]: 💡 **For Administrators:** * The list of internal audits is sourced from the Completed Audits module of the **Audit** application. [^3]: 💡 **For Administrators:** * The list of complaints is sourced from the **Complaint List** module of the **Complaint** application. [^4]: 💡 **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. [^5]: 💡 **For Administrators:** * Manage the options that populate the **Source** dropdown in: * **QMS Admin Settings** > **Quality Event Settings** > [**Source**](/interfacing-help-files/administration-and-configuration/configuring-application-settings/quality-event-application-settings/source.md). * Only **active** options will appear in the dropdown. [^6]: 💡 **For Administrators:** * Manage the options that populate the **Reason** dropdown in: * **QMS Admin Settings** > **Quality Event Settings** > [**Reason**](/interfacing-help-files/administration-and-configuration/configuring-application-settings/quality-event-application-settings/reason.md). * Only **active** options will appear in the dropdown. [^7]: 💡 **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. [^8]: 💡 **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. [^9]: 💡 **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. [^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** > **Quality Event Settings** > [**Related To**](/interfacing-help-files/administration-and-configuration/configuring-application-settings/quality-event-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. --- # Agent Instructions This documentation is published with GitBook. GitBook is the documentation platform designed so that both humans and AI agents can read, navigate, and reason over technical content effectively. Learn more at gitbook.com. ## Querying This Documentation If you need additional information that is not directly available in this page, you can query the documentation dynamically by asking a question. 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