Use Oracle Content Curation Service

You can automatically ingest recall notices published by the U.S. Food and Drug Administration (FDA) into your pod by subscribing to the Oracle Content Curation Service.

Note:

To use this service, you must first enable and configure it within the application. For setup instructions, see the Enable the Oracle Content Curation Service topic under the Product Recall Management section in the Implementation guide.

How does the Oracle Content Curation Service work?

The Oracle Content Curation Service team tracks and manages the FDA-published recalls for medical devices and other healthcare products. This team is dedicated to:

1. Continuous Recall Monitoring: Regularly tracking FDA recalls ensuring timely awareness of affected products.
2. Detailed Data Curation:
   • Reviewing each recall to capture all relevant data accurately.
   • Ensuring each data element, such as part numbers, lot numbers, and serial numbers is correctly mapped to the corresponding recall field.
   • Verifying data accuracy, identifying updates, and flagging duplicate entries to maintain data quality.
3. Multisource Validation: Utilizing multiple sources to confirm recall details, and, when necessary, directly communicating with the recall-initiating firm for clarification.
4. Approval and Communication:
   • Following a structured approval process for curated recalls.
   • Notifying customers via email, sent to a registered email associated with the customer’s account on their pod.

By streamlining recall data management and communication, the Oracle Content Curation Service team ensures that customers are informed of relevant recalls efficiently, with the highest standard of data accuracy and reliability.

Here is what the Oracle Content Curation Service does:

• Ingests FDA recall content curated by the Oracle Content Curation team
• Identifies whether the recalled part is relevant based on customer-specific item data during ingestion
• Automatically assigns the appropriate business units based on predefined configuration or item ownership

Ingesting Recall Content from the Curation Service

When a recall notification is sent to the designated recall email address, it is automatically received and processed by the Recall Management application within the customer's environment (also referred to as the "pod"). The application scans incoming emails, parses their content, and imports them as recall notices into the application.

This automated ingestion process is triggered by a scheduled job, ensuring that recall notifications are consistently captured, processed, and made available for action within the application

Identifying if the Recalled Part is Relevant During Ingestion

During the recall notice ingestion process, the application validates recalled part details—such as part number, model number, device identifier, GTIN, or product description—by cross-referencing them with item identifiers in your Oracle application.

These identifiers may include Oracle item numbers, supplier part numbers, or manufacturer part numbers. The validation checks are performed against data configured in trading partner relationships within the Product Information Management (PIM) Cloud application or derived from historical transactions, such as purchase orders and agreements, within the Procurement Cloud application.

Once the correct item identifiers are derived, the application checks whether any of the items were received during the designated recall tracking period. Based on this evaluation, the recall notice is classified into one of the following categories:

• Relevant Recall Notice:
  • If at least one line in the recall notice includes an item identifier that was received during the tracking period, the recall notice is considered relevant.
  • The system assigns it a status of Pending Acceptance, indicating that further action, such as tracing and containment may be required.
• Irrelevant Recall Notice:
  • If none of the lines in the recall notice include a valid item identifier, or if the identified items were not received during the tracking period, the recall notice is marked as irrelevant.
  • These notices are assigned a status of Pending Review, indicating that no immediate action is required unless a manual review suggests otherwise.

This classification process streamlines recall notice management by prioritizing only those notices that are relevant to your operations.

To take action on relevant notices:

1. Review recall notices with the Pending Acceptance status.
2. Once accepted, the status is updated to Open, making the notice eligible for material tracing and disposition actions.
3. After the status is set to Open, the recall notice will appear under the In Progress tab on the landing page.

For irrelevant recalls in the Pending Review status, you can:

• Verify if there is any incorrect configuration in the product master—for example, the product master may be missing the required trading partner relationship, or the item may lack the necessary extensible flexfield attribute mapping. These issues can prevent the system from finding a match.
• Make the necessary corrections and re-validate the item, or withdraw the recall notice if it is indeed irrelevant.

Recall notices in Pending Review status will automatically be withdrawn after a specified period, based on the time fence set in the Recall Parameters configuration. For more informatiom, see the Oracle Fusion Cloud SCM: Implementing Manufacturing and Supply Chain Materials Management guide.

Withdrawn recall notices will appear under the Completed tab on the landing page.

Recalls deemed irrelevant but not withdrawn will continue to be re-evaluated periodically by a scheduled process to determine if they become relevant over time.

Note: To validate the recalled part details and derive the right item identifier, you must complete all the prerequisite configurations. For more information, refer to the Oracle Fusion Cloud SCM: Implementing Manufacturing and Supply Chain Materials Management guide.

Automatic Assignment of Business Units

The business units are automatically assigned based on the association of the item to the inventory organizations.