9.1.1. CAPA Details

In this section of the New CAPA form, users can define the details of the CAPA.

*For more details on the single-select and multi-select dropdown fields populating this form, click here. For more details on field behavior, click here.

1. CAPA ID: This field is automatically populated when a CAPA is initiated. It displays the CAPA ID. Users cannot modify the field.
   • When an event type is selected, the CAPA ID will automatically be altered to include the appropriate infix.
     • For example, if Incident is selected as an event type, the CAPA ID will be altered in the following manner:
       
2. CAPA Name: This is a text field that allows users to input the name of the CAPA. It is a mandatory field.
3. CAPA Start Date: This is a date picker that allows users to input/select the start date for the CAPA. It is a mandatory field.
   • This field will automatically be populated with today’s date; however, users can still modify the entry.
4. CAPA Initial Closure Date: This is a date picker that allows users to input/select the initial closure date for the CAPA.
5. Event Type: This is a single-select dropdown field that displays the list of event types. It is a mandatory field.
   • Event Types: Audit Finding (External/Internal), Complaint, Deviation, Incident, Inspection Finding, Non-Conformity, Out-of-Spec, Serious Breach, Variance.
     • If Audit Finding (External) is selected from the list, it will display the following field:
       
       • Audit Plan ID (External): This is a text field that allows users to input the ID of the external audit plan. It is a mandatory field.
     • If Audit Finding (Internal) is selected from the list, it will display the following field:
       
       • Audit Plan ID (Internal): This is a single-select dropdown field that retrieves the list of internal audit plans. It is a mandatory field.
         • Internal audit plans are retrieved from the List of Audit Plans section of the Audit application.
         • This field essentially allows users to manually create a CAPA for an audit plan—as opposed to triggering the CAPA directly from the Audit application.
           • A CAPA, however, can only be linked to an audit plan that has major observations.
         • When an audit plan is linked to the CAPA, its details will be included in the form.
           • These details appear in the following stages of the CAPA workflow. Users can also access these details if they save the form.
     • If Inspection Finding is selected from the list, it will display the following field:
       
       • Inspection ID: This is a text field that allows users to input the ID of the inspection.
         • This field essentially allows users to manually create a CAPA for an inspection—as opposed to triggering the CAPA directly from the Inspection application.

*For more information on triggering a CAPA directly from the Audit application, click here.

6. Business Division: This is a single-select dropdown field that retrieves the list of business divisions or departments.
   • Once a parent department has been selected from this field, it will filter the items in the Business Line dropdown.
7. Business Line: This is a single-select dropdown field that retrieves the list of business lines associated with the selected business division.
   • All child departments of the selected parent department will be displayed in this list.
8. Category: This is a single-select dropdown field that retrieves the list of predefined categories.
   • Categories are created in the Category section of General Settings.
9. 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. The user selected will be tasked with executing the root cause analysis.
   • RCA = Root Cause Analysis
   • For more details on this task, click here.

*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.

10. CAPA Reviewer: This is a single-select dropdown field that retrieves the list of users. It is a mandatory field. The user selected will be tasked with reviewing the CAPA.
    • For more details on this task, click here.
11. Eff. Check Responsible: This is a single-select dropdown field that retrieves the list of users. The user selected will be tasked with checking the effectiveness of and approving the CAPA.
    • For more details on this task, click here.
12. Site: This is a multi-select dropdown field that retrieves the list of predefined location sites.
    • Sites 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 CAPA, users will first need to set up 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.
13. CAPA Related To: This is a multi-select dropdown field that retrieves the list of predefined CAPA relations. It allows users to define their CAPA as specific to certain processes, products, services, etc.
    • CAPA Relations (Standard): Process, Service, Product.
      • If Process is selected, it will enable the EPC Process(es) dropdown.
        
        • EPC Process(es): This is a multi-select dropdown field that retrieves the list of processes from EPC.
      • If Service is selected, it will enable the EPC Service(s) dropdown.
        
        • EPC Service(s): This is a multi-select dropdown field that retrieves the list of capabilities from EPC.
      • If Product is selected, it will enable the Product(s) dropdown.
        • Product(s): This is a multi-select dropdown field that displays the list of products.
          
    • CAPA relations are created in the Related To section of CAPA Settings.
14. Related to Quality Event?: This is a checkbox which, if enabled, allows users to mark out that the CAPA is related to a quality event.
    • If selected, it will display the following field:
      
      • Quality Event: This is a single-select dropdown field that retrieves the list of quality events.
        • Quality events are retrieved from the Quality Event List section of the Quality Event application.
    • When a quality event is linked to the CAPA, its details will be included in the form.
      • These details appear in the following stages of the CAPA workflow. Users can also access these details if they save the form.
15. Submit Form: This button allows users to submit the form.
    • For more details on this function, click here.
16. Save Form: This button allows users to save the form.
    • For more details on this function, click here.