Developing Traceability to Prevent Recalls

The next important point along the traceability path is packaging. Production personnel must make sure that the product labels match the product being made. They also must check that the lot code of the finished product matches the batch record, which includes the raw materials used. This finished product code must then be placed not only on the product unit but also on the master shipping cases.

Who Is Responsible?

Monitoring these functions is the responsibility of the QC department, and this responsibility takes many forms. First, QC personnel must confirm that raw material receipt procedures have been followed before releasing the product for production. They confirm and sign off on batch records. They match the production labels and codes to the production records. Most importantly, QC keeps and maintains all of these records so that, in the event of a potential recall, they can quickly determine what product is affected and the extent of the impact of the affected product.

All of a company’s records—including purchasing, manufacturing, and shipping records—should be kept for one year beyond the shelf life of the product.

The purchasing records include the raw materials purchased and received. They also include the lot numbers of the materials received and the amount purchased. Current inventory records should also be maintained. The records should be housed in both the accounting and shipping/receiving departments.

Manufacturing records include all records related to production. Batch records contain the name of the product, date and time of production, raw materials used (including lot numbers), amount produced, amount packaged, finished product code, and a copy of the finished product label. These records may be maintained in manufacturing and/or QC.

Shipping records include the inventory of finished goods as well as orders filled. Included in these records should be amounts ordered, the codes of finished goods shipped, and the destination of the shipment. These should be kept in accounting and shipping/receiving.

Verify That the System Works

Once a company has a traceability system in place, it is essential to test and verify that the system is effective. This is done through auditing the processes and conducting mock recalls. QC, with the guidance of upper management, should develop a recall manual that details each individual’s responsibilities for conducting a recall, and personnel should keep the manual up to date to ensure rapid product recovery. Once the recall manual is in place, the traceability of products and ingredients can be tested.

Mock recalls are performed by tracking random codes of finished product that have been placed into distribution. The entire production of these codes of product must be reconciled with the amounts ordered, the destinations they have been shipped to, and the amount still left in the warehouse.

Another, more robust, way to check the traceability of raw materials is to conduct similar tests of the system using a sensitive raw material that is used in the production of the product. To test the system in this manner, select a raw material code for a product that is in distribution. Next, ascertain the lots of finished product in which this raw material was used in manufacture. Then, follow the raw materials throughout distribution as described above. End this mock recall by reconciling the amounts of the code of raw material utilized in production with the amounts ordered and the amounts left in the raw material warehouse.

The last part of the verification process involves auditing the mock recall procedures. This is done by examining the documented procedures in the manual to determine that they function properly during the recall process. The manual should also be scrutinized to make sure that the recall team is up to date and that the list of key contacts for both raw material supply and finished product distribution is active and current.