Working with Field Corrective Actions

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 rapidly identify, effectively communicate, and efficiently execute FCAs to minimize any disruption to patient care and business operations.

This article covers key roles within the field corrective action process and how to process them in your Vault. The field corrective action feature is not available by default and Admins must configure this feature before use.

Important Roles

The following personas may be responsible for participating in the FCA process. These personas may be mapped to application roles in your Vault to assist with your organization’s needs. Consult your Admin to confirm the actual application roles for your Vault’s implementation.

Field Action Requester: Responsible for identifying the need for an FCA, gathering information about the issue, and submitting a request for a recall.
Field Action Owner: Responsible for overseeing the FCA from initiation to completion, developing and managing an action plan, coordinating with all involved parties, and ensuring compliance with regulatory requirements and organizational policies.
Field Action Coordinator: Provides administrative support for the FCA, manages communication with affected parties, tracks the FCA’s progress, and may assist with issuing notifications, managing returns, and coordinating field activities.
Field Action Approver: Responsible for reviewing and approving the FCA prior to implementation, ensuring the plan aligns with organizational policies and regulations, and providing final authorization for the action to proceed.
Field Action Team Member: Responsible for completing tasks for the FCA assigned by the Owner.

Key Objects

The following key objects exist in your Vault to assist with the FCA process:

Field Corrective Action (FCA): An action taken to reduce the risk of harm to patients from a device. This object tracks information associated with the action and relates to objects such as Product Variants, Batches (quality_batch__v), and Organizations.
Health Hazard Evaluation (HHE): A form that documents the justification for the Field Corrective Action. The details in this form align closely with the one provided by the FDA. Organizations may choose to add additional fields to this object depending on their own process.
Batch: This object represents a batch of products. In this article, this object is referred to as a lot.
Product Action: An object that tracks various consignees that need to be contacted about the FCA.
Product / Material Tracking: This object is used to track the lot-level details for each consignee.
Product / Material Tracking Outreach: This object tracks various communications with the impacted consignees such as emails, phone, mail, fax, or other means.
Lot - Consignee: A new join object that connects the Batch and Person objects to track who has the Impacted Lots and corresponding quantities of devices.
Implementation Action: A new object to track non-product-specific actions, such as training and Public Relations material updates.

Field Corrective Action Process

The following process exemplifies how Vault helps streamline the FCA process:

A person identifies the need for a field corrective action by monitoring Complaint, Nonconformance, and CAPA records. Vault’s existing reporting and dashboard capabilities can assist in identifying trends.
If a trend analysis indicates a potential safety risk, the organization may conduct a Health Hazard Evaluation (HHE). The HHE assesses the severity of the risk and the likelihood of patient consequences due to device use. Using the External Collaboration feature, you can invite external SMEs to participate in a workflow to review and approve the Health Hazard Evaluation record in Vault. There may be instances where your organization skips the HHE process when there is obvious harm identified. Your Vault’s configuration determines whether HHE’s are required.
Your organization may decide whether a Field Corrective Action is necessary based on the HHE’s findings, then relate any Impacted Products and Impacted Lots to the Field Corrective Action record.
If Impacted Lots are identified, their Consignees need to be contacted. Vault stores their information in a Lot - Consignee record. An entry action creates Product Action records, grouping Impacted Lots by Consignee. These Product Action records identify who needs to be contacted, log communication efforts, and track the state of the returned device. Vault automatically generates Recall Notices using formatted outputs or document templates and utilizes External Notifications to send emails to the affected Consignees.
The Product / Material Tracking object captures the disposition action once affected devices are retrieved.
Manufacturers can utilize Vault reporting and dashboard to conduct ongoing effectiveness checks to verify that Consignees have received notification and taken appropriate action.

Creating Field Corrective Actions

To create a Field Corrective Action record:

Navigate to Business Admin > Field Corrective Actions or to a custom object tab.
Click Create.
Provide a Title and populate any remaining fields.
In the Event Description section, define an Issue Source, Issue Description, and Reason for Field Request.
Click Save.

Upon the creation of a Field Corrective Action record in its initial lifecycle state, a workflow begins automatically and a Field Action Triage team may be assigned a task to define a Quality Team to participate in the workflow.

Creating & Conducting Health Hazard Evaluations

The Health Hazard Evaluation (HHE) assesses the severity of the risk and the likelihood of patient consequences due to device use. There may be instances where a Requester decides to conduct an HHE prior to proceeding with an action. From an existing Field Corrective Action record, you can click Add from the corresponding related object section to create a Health Hazard Evaluation record or create it directly from a custom object tab.

Using the External Collaboration feature, you can invite external SMEs to participate in a workflow to review and approve the Health Hazard Evaluation record in Vault. If configured by an Admin, you can initiate the workflow through a user action.

Adding Impacted Products & Lots

After you have created a Field Corrective Action, you can navigate to the corresponding related object sections on the record and click Add to create Impacted Products and Impacted Lots. From the search dialog, you have the option to filter by fields on Batch records in addition to Product Variants that include specific Impacted Products.

Defining Consignees

From a related Impacted Lot record, you can add Consignees by clicking Add from the Lot - Consignees related object section. Each Lot - Consignee has a Consignee Type of External or Internal and maps to a corresponding Person record. Vault uses the person’s email to send notifications.

Product Tracking Automation

Admins can configure Vault to automatically create Product Action 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.

When the operation completes successfully, Vault sends a notification to the Owner that includes the number of lots that were processed successfully, the number of lots that failed to process, and the number of lots skipped. If the operation fails, Vault sends a notification to the Owner informing them of the reason for the failure.

The related records are accessible from the Product Return related object section on the parent Field Corrective Action record. Vault groups the Product Return records by Consignee.

Email Notification Automation

Admins can configure Vault to send External Notifications to all the affected consignees. When the Field Corrective Action record reaches a particular lifecycle state indicating the outreach stage, Vault sends emails to each of the contact persons with a Product Return and saves a Notification Letter within the record. The Notification Letter is a templated document stored within your Vault, customized with the information pertinent to the contact person and impacted lots. Users with the appropriate permissions can view this letter. External recipients do not need access to Vault to access this document from the sent email.

On the Product Return record, the related Product / Material Tracking Outreach section contains information about the attempt method used to reach the Contact Person. The Sent Notifications section captures which notifications were sent, their recipient, when it was sent, and its status. The status of the notification changes once the recipient has opened the email.

Limitations

Vault can asynchronously create up to 10,000 related Product Return records.

Your security profile requires the following minimum permissions to work with Field Corrective Actions:

Type	Permission Label	Controls
Security Profile	Object: Field Corrective Action	Ability to view, create, edit, and delete Field Corrective Actions.
Security Profile	Object: Health Hazard Evaluation	Ability to view, create, edit, and delete Health Hazard Evaluations.
Security Profile	Object: Product Actions	Ability to view, create, edit, and delete Product Actions.
Security Profile	Object: Implementation Actions	Ability to view, create, edit, and delete Implementation Actions.
Security Profile	Object: Product / Material Tracking	Ability to view, create, edit, and delete Product / Material Tracking records.
Security Profile	Object: Product / Material Tracking Outreach	Ability to view, create, edit, and delete Product / Material Tracking Outreach records.
Security Profile	Object: Product Return	Ability to view and edit Product Returns.