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. 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.
The actions for Product Return, Service Requests, and Safety Notification also support automation around identifying FCA-Lot records that are not in a completed lifecycle state. If the Consignee Type field is External, Vault creates or updates Product / Material Tracking records for FCA-Lots with the Product Return, Service Requests, or Safety Notification actions indicated. If the Consignee Type field is Internal, Vault creates Containment records for the indicated actions. This process skips any FCA-Lot records that have no indicated action. To utilize this functionality, add the Field Action Type picklist to the FCA-Lot object.
If your organization detects an issue with a device that may be fatal for patients, Vault can create Safety Notice records and send the notice immediately to all affected Consignees. These notices are tracked in a similar manner to External Notifications and support the Email From functionality.
To turn on this functionality, add the Email From field to the page layout of the Product Action object. This allows users to send acknowledgement of a notice to your organization and allows your organization to track send and delivery failures.
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.