Use Oracle Content Curation Service

You can automatically get recall notices ingested into your pod that have been published by the U.S. Food and Drug Administration (FDA) by subscribing to the Oracle content curation service.

Note: To use this service, you must enable and configure it in the application. For more information, see the Enable the Oracle Content Curation Service topic 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 Recall Content from the Curation Service
• Identifies if the Recalled Part is Relevant During Ingestion
• Automatically Assigns Business Units

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 (or "pod"). The application scans incoming emails, parses their contents, and imports them as recall notices within the recall management application. This automated process runs on a scheduled job, ensuring that recall notices are consistently updated and accurately captured in your system.

Identifying if the Recalled Part is Relevant During Ingestion

In the recall notice ingestion process, the application validates recalled parts to ensure correct identification by cross-referencing specific item identifiers, including the Oracle item number, supplier part number, manufacturer part number, UDI or GTIN. These identifiers are either configured in trading partner relationships within the Product Information Management (PIM) cloud application or have been utilized in transactions such as purchase orders and agreements within the Procurement Cloud Application.

Once the correct item identifier is derived, the application then checks whether these items were received during the designated recall tracking period. The recall notice is classified based on the following criteria:

• Relevant Recall Notice:
  • If at least one line in the recall notice includes an item identifier that has been previously received during the tracking period, the recall notice is deemed relevant.
  • This relevant recall notice is then assigned a status of Pending Acceptance to indicate that further action may be required.
• Irrelevant Recall Notice:
  • If none of the lines in the recall notice contain a valid item identifier or if the identified items were not received during the tracking period, the notice is marked as irrelevant.
  • The status for these notices is set to Pending Review, highlighting that no immediate action is necessary unless further review suggests otherwise.

This process helps streamline the recall notices management by ensuring only pertinent notices receive attention.

You can focus on the relevant recalls by reviewing recalls in the Pending Acceptance status and accept them so that they become eligible for tracing the material and managing the disposition of affected parts.

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

• verify if there is any misconfiguration in the product master, that is, product master does not have the required trading partner relationship, or the item does not have the required extensible flexfield attribute mapping. Therefore, a match is not being found.

• make the necessary changes and validate the item again or withdraw the recall if they are irrelevant.

  Recalls that are deemed irrelevant, that are not withdrawn, continue to be re-evaluated by a scheduled process to determine if over time the recall becomes relevant.

Automatic Assignment of Business Units

The business unit is automatically assigned based on the association of the item to the inventory organization.