# 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. 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:
1. Navigate to **Business Admin > Field Corrective Actions** or to a custom object tab.
2. Click **Create**.
3. Provide a **Title** and populate any remaining fields.
4. In the _Event Description_ section, define an **Issue Source**, **Issue Description**, and **Reason for Field Request**.
5. 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_.
The actions for _Product Return_, _Service Request_, 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 Request_, 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.
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_ and _Reply To_ functionality.
## 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.
## Product Action Email Ingestion
If a Consignee acknowledges or replies to a notification from your organization, Vault uses an email processor for the _Product Action_ object to process the incoming email and attach the email reply and any email attachments, such as completed acknowledgement forms, to the appropriate _Product Action_ record. Processing these emails is particularly important during field corrective actions and recalls when a confirmation of receipt for the notification and an agreement to take appropriate action for the affected product may be required.
When the _Product Action_ email processor executes, it creates _Email_ and _Product Action Email_ records and associates them with the _Product Action_ record. The email processor determines if a _Product Action_ record already exists for the incoming email; if the processor does not find a matching record, Vault moves the _Email_ record to a _Failure_ lifecycle state and notifies the _Email Processor User_ of the failure using the _Email Processing: Failed_ (`qms_product_action_email_processing_failed__v`) object message template. If the processor locates a _Product Action_ record, Vault sends the Owner a notification each time a new email reply is received using the _Reply Received_ (`qms_product_action_email_received__v`) notification template.
## Limitations
Vault can asynchronously create up to 10,000 related _Product Return_ records.
## Related Permissions
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_. |