CAPA Plan Initiation

To create a CAPA Plan, navigate to the "Create Request" section located within the CAPA Plan Initiation side menu bar.

1 Initiating a New CAPA Plan

Click “Create Request” and select the category that requires corrective action. “Incoming," "In-Process," "External Audit," "Customer Compliant,".

Once you select category. Fill in all the CAPA details by using the dropdown menu and enter the summary and Description of the Non-Conformance observed. If you choose to initiate the CAPA Instantly click "initiate".

The CAPA Plan will be listed under " CAPA Plan Initiation Pending Work List ".

You can edit the CAPA Plan by clicking the CAPA or forward it to a reviewer, or assign it to others by clicking Assign icon.

When you click the CAPA Plan, a new window with the details added during initiation and you can add the additional details. Click "+ Add Product Details" to enter specifics about the affected product.

Select the product category from "Product Type", enter the specific "Product Name" affected, then choose the appropriate "Compliant Type Subcategory". Fill out the remaining details, including Packaging/Manufacturing Date, Quantity, Lot No/Batch No, SKU/Variant, Start Time, End Time, Quality In-Charge, Vendor Company Name, Vendor Location, and any Comments in the provided fields.

To add more product, click “+” icon, to remove a product click “-“ icon.

Click "+ Add Link References" to include relevant reference materials.

Click "Click to Upload" to upload supporting documents.

Click the dropdown menu under "Select Assignee" to choose a reviewer for the CAPA plan. If you do not wish to add an assignee, select "No Assignee" from the dropdown. The created request will be available in the next activity.

If you want to submit the CAPA Plan click “Submit”. If you want to save the changes made click “Save”

2 Saving CAPA Plan as Draft

Click “Create Request” and select the category that requires corrective action. “Incoming," "In-Process," "External Audit," "Customer Compliant,".

Once you select category. Fill in all the CAPA details by using the dropdown menu and enter the summary and Description of the Non-Conformance observed. If you choose to save the CAPA as draft click “Save as draft”.

3 Initiating a CAPA Plan from a Draft

When you save a CAPA Plan as a draft, it appears in the list of drafts within the CAPA Plan initiation section. You can delete a draft by clicking the delete button.

To initiate a CAPA Plan from a draft, Click the desired draft. Choose "Initiate" to proceed with the CAPA plan, or Click "Save as Draft" to keep it for later editing.

4 CAPA Plan Initiation Pending worklist and Draft List

CAPA Plan Initiation Pending worklist list shows all CAPA plans created but not yet sent for verification. The Draft list has all the CAPA plans that have been saved but not initiated.

4.1 CAPA PLAN FILTERS AND SEARCH

Within the CAPA Plan Initiation Pending Work List, you can filter the list to view:

• Your Requests Only: Click "My Requests" to see CAPA plans you initiated.

• All Requests: Select "All Requests" to view all pending CAPA plans, regardless of initiator.

If you want to search for any specific CAPA Plan in initiation stage, enter the CAPA number in the "Search Control No" look up box.

4.2 Sort and filter

You can opt to sort the CAPA Plans based on the CAPA Plan number. You can filter the 'CAPA Plan Initiation Pending Work List' by clicking the filter icon next to various fields like “Classification,” “Type,” “Source,” “Assigned By,” and “Assigned To.” Choosing a filter will refine the list based on your selection.

4.3 Manage CAPA Plan List Outputs

The "CAPA Plan initiation work list" and "Draft list" can be exported, printed, or downloaded by clicking the corresponding icons within the vertical ellipsis menu.

4.4 Direct Forwarding CAPA Plan

You can either Submit the CAPA Plan to the reviewer as described in section 5.2. or Forward it directly from the "CAPA Plan initiation work list" by clicking the forward icon corresponding to the CAPA Plan and providing your electronic signing credentials.

5 Change Assignee

To assign a CAPA Plan to a different person, Click the "Assign" icon next to the desired CAPA Plan in the list.

Select the new assignee from the dropdown menu. Click "Assign" to confirm the change.