# Configuring 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 <a class="external-link " href="https://www.fda.gov/medical-devices/postmarket-requirements-devices/recalls-corrections-and-removals-devices" target="_blank" rel="noopener">21 CFR 7 and 21 CFR 806<i class="fa fa-external-link" aria-hidden="true"></i></a> 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][1].
  * Add the `email__v` picklist value to the _Attempt Method_ (`attempt_method__v`) picklist.
  * Configure <a href="/en/gr/65819/#quality-event-lifecycle">user actions</a>
 to activate and inactive External Collaborators on the _Health Hazard Evaluation_ object lifecycle. Configure the appropriate <a href="/en/gr/65819/#object-message-template">message templates</a>
 to send to third-party contacts.
  * Configure [_External Notifications_][2] for the _Product Action_ object.
  * Configure [email ingestion][3] for the _Product Action_ object.

## Product Tracking Automation {#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 <a href="/en/gr/77669/">_External Notifications_</a>
 and support the _Email From_ and _Reply To_ functionality. 

To turn on this functionality, add the _Email From_ and _Reply To_ fields 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 {#external-notifications}

Admins can utilize <a href="/en/gr/77672/">_External Notifications_</a>
 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:

  1. Add the _Create Distribution Group Membership_ and _Send External Notification_ actions to the _Product Action_ object lifecycle.
  2. Configure fields and page layouts for the _Product Action_ object.
  3. Create any necessary object message templates for _External Notifications_.
  4. Create a <a href="/en/gr/77672/#quality-external-notifications">_Quality External Notification_</a>
 configuration for the _Product Action_ object, then create _Distribution Groups_ and _Notification Templates_.

## Configuring Email Ingestion for Product Actions {#email-ingestion}

Admins can configure Vault to process and attach incoming emails and email attachments to _Product Action_ records when a Consignee acknowledges or replies to a notification from your organization.

To configure email ingestion for the _Product Action_ object, create an <a href="/en/gr/74285/">_Inbound Email Address Configuration_</a>
 with an email inbox set up for the _Product Action_ and a System Admin set as the _Email Processor User_.

 [1]: #product-tracking-automation
 [2]: #external-notifications
 [3]: #email-ingestion