Organizations often need to initiate field corrective actions (FCAs) or recalls when a potential safety issue arises with a medical device, in accordance with 21 CFR 7 and 21 CFR 806 regulations. The FCA process involves notifying healthcare providers and patients of the problem, outlining steps to mitigate risk, and potentially retrieving devices for repair or replacement. Vault QMS includes automation and workflows to identify, capture, communicate, and execute FCAs through the use of the Field Corrective Action object.
Enabling Field Corrective Actions
Admins must enable this feature in Vault by navigating to Admin > Settings > Application Settings and selecting Enable Field Corrective Action.
Configuration Overview
Complete the following steps to support the automation of Field Corrective Actions:
- Configure actions on the Field Corrective Action object lifecycle to automate the creation of Product Tracking records.
- Add the
email__vpicklist value to the Attempt Method (attempt_method__v) picklist. - Configure user actions to activate and inactive External Collaborators on the Health Hazard Evaluation object lifecycle. Configure the appropriate message templates to send to third-party contacts.
- Configure external notifications for the Product Action object.
Product Tracking Automation
Admins can configure Vault to automatically create Product Return records when a Field Corrective Action enters a particular lifecycle state, based on the Impacted Lots, their Consignees, and their Location. If the Consignee Type field of a Lot - Consignee record is External, Vault creates a Product Return record for each Consignee and assigns the Owner of the Field Corrective Action as the Owner of the Product Return record. If the Consignee Type field is Internal, Vault creates Containment records that relate back to the parent Field Corrective Action.
To set up product tracking automation, add the Create Product Tracking Records action as a user or entry action to the desired lifecycle state of the Field Corrective Action object lifecycle.
Configuring External Notifications for Product Actions
Admins can utilize External Notifications to enable Vault to send emails to external recipients and automatically create a Product Return Outreach record upon the creation of a Sent Notification, linking the records to each other.
To configure this for the FCA process:
- Add the Create Distribution Group Membership and Send External Notification actions to the Product Action object lifecycle.
- Configure fields and page layouts for the Product Action object.
- Create any necessary object message templates for external notifications.
- Create a Quality External Notification configuration for the Product Action object, then create Distribution Groups and Notification Templates.