Those involved in complex manufacturing are well aware that product recalls have been increasing over time. Much of this is due to increasingly stringent regulation.
One of the principal industries affected is the medical device manufacturing industry, where FDA enforcement of 21 CFR.820 points to the critical importance of product genealogy.
FDA 21 CFR.820 Compliance
“Each manufacturer shall establish and maintain procedures to ensure that device history records (DHRs) for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the device medical record (DMR) and the requirements of this part. The DHR shall include, or refer to the location of, the following information:
- Dates of manufacture
- Quantity manufactured & Quantity released for distribution
- Acceptance records demonstrating DMR compliance
- Primary identification label and labeling used for each production unit
- Any unique device identifier (UDI) or universal product code (UPC), and any other device identification(s) and control number(s) used.
Using MES to Support Effective Product Genealogy
Some companies do a good job of maintaining the DHR on the manufacturing floor. Once they start producing a product, they can normally track most of the related activities in their Manufacturing Execution System (MES), but it stops within the walls of the factory.
After the product is out the door, the genealogy goes dark. That can be problematic because medical device manufacturers are increasingly held responsible for their products across the entire product lifecycle. Consequently, MES systems must capture detailed product information both pre- and post-production.
There are two areas that are traditionally under-tracked in Medical Device Manufacturing.
- Tracking During Pre-Production
Medical device manufacturers need to know the genealogy of every part put into their devices, whether made in-house, or purchased. Lack of proper tracking can lead to difficulties. A very common source of problems has proven to be defective solvent, glue, or chemicals used in the manufacture of a part purchased for use in an end product. An effective MES needs to provide granularity, not only capturing the lot and serial numbers of the purchased components, but also the “lot numbers within lot numbers” as well as the “serial numbers within serial numbers” to enable true comprehensive tracking to problems like a bad glue can be solved efficiently. - Tracking During Post-Production
If a manufacturer builds a medical device such as an MRI machine, it needs to be able to track the history of that product even as it extends to repair and service. If one component is replaced for another, it needs to be traceable in case of a failure and need to recall. An effective MES captures this information so manufacturers can avoid long and costly “detective work” should a recall situation arise.
MES Mitigates Risk in Medical Device Manufacturing
In today’s global manufacturing environment, supply and manufacture is more dispersed and nuanced than it ever has been. This means an increased risk associated with sourcing and servicing products. Combine this trend with greater enforcement of regulatory standards and you have a situation where clear understanding of product genealogy is essential to protecting a company’s brand, product perception, and ultimately its customers.
Is your MES providing the critical clarity you need in this area?
Are you currently tracking:
- The complete manufacturing build record of every device you manufacture?
- Every part that was used with full revision control?
- The vendors that supplied the parts and the vendors that supplied them their parts along with all the associated lot and serial numbers?
- The manufacturing technicians who built every component?
- The quality personnel who conducted the inspections?
- Electronically signed quality records, time stamped per 21 CFR Part 11 regulations?
- The tools and equipment used to manufacture the parts?
- All the measurement and test data that was acquired?
- Any deviations, rework, and corrective actions that took place, along with all associated documents?
