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. Created By: This field is automatically populated with the full name of the user currently creating the CAPA. Users cannot modify the field.
3. Creation Date: This field is automatically populated with the creation date of the CAPA. Users cannot modify the field.
4. CAPA ID: This field is automatically populated with a unique identifier when a CAPA is created. Users cannot modify the field.
   • 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:
       
5. 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, 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.

6. CAPA Reviewer: This is a single-select dropdown field that retrieves the list of users, roles, and groups in the system. It is a mandatory field. It allows for the selection of the user, role, or group responsible for reviewing the CAPA.
7. 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.

8. Effectiveness Check Responsible: This is a single-select dropdown field that retrieves the list of users in the system. It allows for the selection of the user responsible for checking the effectiveness and approving the CAPA.
9. Accordions: The form includes several collapsible sections, known as accordions, which each serve a specific purpose.
   • Additional Details
   • Actions
10. Comment: This field allows users to add comments related to the CAPA.
11. 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 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.
      
    • Once the New CAPA form has been submitted, the assigned reviewer will be tasked with reviewing the CAPA.
12. Save Form: This button allows users to save the form.
    • If saved, this form can be found in the Drafts folder (shown in the image below).
      • A saved form can be found in the Drafts folder if it is the first step in a given workflow. If it is a task assigned in the middle of a workflow, the saved form will remain in the Pending Tasks folder.
        

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