9.1. New Quality Event Instance

In the New Quality Event form, users can create and customize the quality event to align with their specific needs and preferences.

*For guidance on common form functions, please refer to the dedicated section in the manual.

1. Quality Event Name: This is a text field that allows users to input a name for the quality event.
2. Quality Event ID: This field is automatically populated with a unique identifier for the quality event. It ensures that each event can be distinctly referenced and tracked within the system.
   • When an event type is selected, the quality event ID will dynamically update to incorporate the appropriate infix.
     • For example, if Variance is selected as an event type, the quality event ID undergoes the following modification:
       
3. Event Type: This is a single-select dropdown field that displays the list of event types. It is a mandatory field. It allows users to categorize the nature of the quality event.

   • Event Types

     Event Type	Definition	Updated Quality Event ID Format
     Audit Finding (Internal or External)	An observation or result from an audit (internal or external) indicating non-compliance with specified procedures, policies, or regulations, requiring corrective or preventive action.	QE-AF-XXXXX
     Complaint	A formal expression of dissatisfaction regarding a product, service, or process, requiring investigation and appropriate resolution to maintain customer satisfaction and compliance.	QE-COM-XXXXX
     Deviation	An intentional or unintentional departure from established procedures, processes, or specifications, potentially affecting quality or compliance, that must be documented and addressed.	QE-DEV-XXXXX
     Hazard (H&S)	A potential source of harm or adverse effects on people, property, or the environment, arising from conditions, activities, or materials. Hazards must be identified proactively to reduce risks and ensure compliance with safety standards.	QE-HS-XXXXX
     Incident	An unplanned event that caused or had the potential to cause harm, damage, or interruption to processes, requiring investigation and corrective action to prevent recurrence.	QE-INC-XXXXX
     Inspection Finding	An observation made during an inspection, indicating a deviation, non-compliance, or other issue that requires corrective or preventive measures to ensure quality and compliance.	QE-IF-XXXXX
     Issue	A problem or obstacle that has already occurred and is currently affecting the project, process, or operations. Issues require immediate attention and resolution to prevent further impact.	QE-ISS-XXXXX
     Management Review	A formal evaluation conducted by management to assess the performance and effectiveness of a system, process, or project, ensuring alignment with organizational goals and compliance requirements.	QE-MR-XXXXX
     Near-Miss	An event that could have resulted in an accident, injury, or damage but was narrowly avoided, either by chance or through timely intervention. Reporting near misses helps identify potential hazards and enhances safety measures to prevent future incidents.	QE-NM-XXXXX
     Non-Conformity	A failure to meet specified requirements, standards, or regulations, which must be addressed through corrective or preventive action to restore compliance.	QE-NC-XXXXX
     Out-of-Spec	An occurrence where a product, material, or process does not meet defined specifications, potentially affecting quality, safety, or compliance.	QE-OOS-XXXXX
     Serious Breach	A critical violation of regulatory, legal, or ethical standards with significant potential to harm individuals, processes, or the organization, requiring immediate investigation and escalation.	QE-SB-XXXXX
     Variance	A measurable difference between expected and actual outcomes in a process, which may require analysis and corrective actions to align with desired results.	QE-VAR-XXXXX

     **By choosing the most relevant event type, users contribute to faster resolutions and more effective prevention of future issues.

     • If Audit Finding (Internal) is selected, the following field becomes visible:
       
       • Audit Plan ID (Internal): This is a single-select dropdown field that retrieves the list of internal audit plan IDs. It is a mandatory field. It allows users to associate the quality event with a specific internal audit plan.
         • When an audit plan is linked to the quality event, a new accordion labeled Audit Information will appear in the form, containing the relevant details.
           
           *

           This field allows users to manually create a quality event for an internal audit plan, rather than triggering the quality event directly from the Audit application.

           • For details on triggering a quality event directly from the Audit application, click here

           **The list of internal audit plans is sourced from the Completed Audits module of the Audit application.

     • If Audit Finding (External) is selected, the following field becomes visible:
       
       • Audit Plan ID (External): This is a text field that allows users to input the unique identifier of the external audit plan. It is a mandatory field. It allows users to associate the quality event with a specific external audit plan.
     • If Inspection Finding is selected, the following field becomes visible:
       
     • Inspection ID (External): This is a text field that allows users to input the unique identifier of the inspection. It is a mandatory field. It allows users to associate the quality event with a specific external inspection.
4. Severity: This is a single-select dropdown field that displays the list of severity levels. It allows users to specify the severity of the quality event.
   • Severity Levels: Critical, Major, Minor.
5. Quality Event Reviewer: This is a single-select dropdown field that retrieves the list of active users, roles, and groups in the system. It is a mandatory field. It allows for the selection of the party responsible for reviewing the quality event.
6. Reported By: This is a single-select dropdown field that retrieves the list of active users in the system. It is a mandatory field. It allows for the selection of the user who reported the quality event.
   
   *

   By default, this field is populated with the name (full name and login name) of the user initiating the quality event.

   • User details, like name and login information, can be adjusted in the Users tab of the Organization Management (Admin) application.
7. Reported (Date & Time): This is a date-time picker that allows users to input/select the date and time when the quality event was reported.
   

   **By default, this field is populated with the current date.

8. Business Division: This is a single-select dropdown field that retrieves the list of active business divisions or departments in the system. It allows users to select the division relevant to the quality event.
   

   **Selecting a division from this field filters the available options in the Business Line field.

9. Business Line: This is a single-select dropdown field that retrieves the list of active business lines associated with the selected business division. It allows users to focus the quality event on a specific business line.
   

   **Only the child departments of the chosen division will be available for selection.

10. Category: This is a single-select dropdown field that retrieves the list of active categories in the system. It allows users to specify the category to which the quality event belongs.
    

    **Categories are created and managed in the Category section of General Settings.

11. Source: This is a single-select dropdown field that retrieves the list of active quality event sources in the system. It allows users to specify the source of the quality event.
    

    **Sources are created and managed in the Sources section of Quality Event Settings.

12. Reason: This is a single-select dropdown field that retrieves the list of active quality event reasons in the system. It allows users to specify the reason for the quality event.
    

    **Reasons are created and managed in the Reasons section of Quality Event Settings.

13. Site: This is a multi-select dropdown field that retrieves the list of active location sites in the system. It allows users to specify the site associated with the quality event.
    • Site options in this dropdown adhere to the following template: [Region] – [Country] – [Site].
      
      *

      Site options are created in the Site form. To properly set up a site, however, users will first need to set up the corresponding region in the Region form and the corresponding country in the Country form.

      • For example, to establish Montreal as the site for the event, users will first need to define North America as a region and Canada as a country in the associated forms.
        

      
      These forms are all found in the Location section of General Settings.
      
14. Provide a detailed statement of the issue: This is a rich text field that allows users to provide a comprehensive description of the issue, including relevant context, observations, actions taken, and individuals involved.
15. Accordions: The form includes several collapsible sections, known as accordions, which each serve a specific purpose.
    • Documents & Related Entities
    • Associated Action Item(s)
16. Comment: This field allows users to add comments or notes relevant to the quality event.
    

    **The Comment control functions similarly to a discussion board, enabling users to initiate and participate in collaborative discussions with stakeholders involved in the workflow.

17. Save Form: This button allows users to save the form.
    • If saved, the form can be found in the Drafts folder of the Task Navigation Pane.
      

      **A saved form can be found in the Drafts folder if it is the initial step of a workflow, also known as a starter form. If the form is a task assigned in the middle of a workflow, it will be located in the Pending Tasks folder.

18. Submit Form: This button allows users to submit the completed form.
    • Upon submission, this form will trigger the Quality Event Management workflow. The assigned reviewer will be tasked with reviewing the issue.

*To access additional options or perform actions related to the form, please utilize the kebab menu ( ) located in the upper rightmost corner.