9.1. New CAPA Instance

In the New CAPA form, users can create and customize the CAPA to align with their specific needs and preferences.

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

1. CAPA Name: This is a text field that allows users to input a name for the CAPA. It is a mandatory field.
2. CAPA ID: This field is automatically populated with a unique identifier for the CAPA. It ensures that each CAPA can be distinctly referenced and tracked within the system.
   • When an event type is selected, the CAPA ID will dynamically update to incorporate the appropriate infix.
     • For example, if Variance is selected as an event type, the CAPA 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 CAPA.
   • Event Types: Audit Finding (External/Internal), Complaint, Deviation, Incident, Inspection Finding, Management Review, Non-Conformity, Out-of-Spec, Quality Event, Serious Breach, Variance.
     • 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 CAPA with a specific internal audit plan.
         • Internal audit plans are retrieved from the Completed Audit Plans module of the Audit application.
           

           **This field essentially allows users to manually create a CAPA for an internal audit plan, as opposed to triggering the CAPA directly from the Audit application. For more information on triggering a CAPA directly from the Audit application, click here.

         • When an audit plan is linked to the CAPA, a new accordion labeled Audit Information will appear in the form, containing the relevant details.
           
     • 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.
     • If Quality Event is selected, the following field becomes visible:
       
       • Quality Event: This is a single-select dropdown field that retrieves the list of quality event IDs. It is a mandatory field. It allows users to associate the CAPA with a specific quality event.
         • Quality events are retrieved from the Quality Event List module of the Quality Event application.
           

           **This field essentially allows users to manually create a CAPA for an internal quality event, as opposed to triggering the CAPA directly from the Quality Event application. For more information on triggering a CAPA directly from the Quality Event application, click here.

         • When a quality event is linked to the CAPA, a new accordion labeled Quality Event Information will appear in the form, containing the relevant details.
           

           **If the selected quality event is itself linked to an audit plan, the Audit Information accordion will also appear in the form, containing the relevant details.

4. CAPA 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 CAPA.
5. RCA Owner: This is a single-select dropdown field that retrieves the list of users assigned to the RCA Owner group. It is a mandatory field. It allows for the selection of the user responsible for executing the root cause analysis.
   • RCA = Root Cause Analysis
     

     !!The RCA Owner dropdown retrieves a filtered list of users, displaying only those that are part of the RCA Owner group. This list of users can be adjusted in the Groups tab of the Organization Management (Admin) application.

6. Start Date: This is a date picker that allows users to input/select the date when the CAPA process officially begins. It is a mandatory field.
   

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

7. Closure Date Est.: This is a date picker that allows users to input/select the estimated date by which the CAPA is expected to be completed.
   

   *Users will be able provide a new closure date at a later stage of the workflow if the original estimation cannot be met.

8. Eff. Check Responsible: This is a single-select dropdown field that retrieves the list of active users in the system. It allows for the selection of the user responsible for checking the effectiveness and approving the CAPA.
9. Eff. Start Date: This is a date picker that allows users to input/select the date when the effectiveness check period will begin.
10. Eff. End Date: This is a date picker that allows users to input/select the date when the effectiveness check period will end.
11. 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 CAPA.
    

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

12. 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 CAPA on a specific business line.
    

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

13. 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 CAPA belongs.
    

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

14. 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 CAPA.
    • 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 action, 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.
      
15. Provide a comprehensive description of the issue: This is a rich text field that allows users to provide a description of the issue at hand.
16. Accordions: The form includes two collapsible sections, known as accordions, which each serve a specific purpose.
    • CAPA Related To
    • Associated Action Item(s)
17. Comment: This field allows users to add comments or notes related to the CAPA.
    

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

18. 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.

19. Submit Form: This button allows users to submit the completed form.
    • To maintain the integrity of the CAPA ID system, we have implemented a validation mechanism. When users select this button and are ejected from the New CAPA module, a pop-up window may appear with the following message:
      
      *

      Background: This notification is triggered by the ID allocation system, which is designed to prevent duplicate CAPA IDs when multiple CAPAs are initiated simultaneously or in rapid succession.

      • Example Scenarios:
        • If two users simultaneously create and submit their CAPAs, the following change (or lack thereof) will be observed:
          • For one user, the CAPA ID in the following stages of the CAPA Management workflow will match the value displayed in this form.
          • For the other user, the CAPA ID will be one value greater than the value displayed in this form.
        • Similarly, if one user saves a CAPA as a draft while another user submits a CAPA, the CAPA ID for the submitted instance will be one value greater than the saved draft.

      
      

      Any necessary alterations to the CAPA ID will be communicated through this message. Users can dismiss the window by clicking either the Exit button (X) or the OK button.

    • Upon submission, this form will trigger the CAPA Management workflow. The assigned reviewer will be tasked with reviewing the CAPA.

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