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From: Food Quality & Safety magazine, August/September 2009

Trace to Keep Safe

Tracking ingredients can diminish the scope of a recall or prevent one altogether

by Gerald Kelly

With recent Salmonella outbreaks involving peanuts and pistachios dominating the headlines, an inordinate number of recalls have occurred across the food industry. The recall notices for these nut products, which are used as ingredients in many types of foods, include phrases such as “may have been contaminated” and “potentially may be contaminated with Salmonella because of the inclusion of the suspect peanuts/pistachios.” This language suggests a lack of traceability of ingredients going into many finished products.

So how can a company build traceability into its products? A verifiable system of tracking ingredients from supplier through distribution can mitigate the scope of a recall or even negate the necessity of a recall altogether. While this article will focus on the food manufacturer, the principles included are applicable to each point on the food chain from ingredient supplier through manufacturing to distribution through retail or food service outlet.

Food facilities generally have an operational flow of:

  • raw material receiving;
  • raw material storage;
  • production;
  • finished product storage; and
  • shipping.

A good traceability model is concentrated in the areas of raw material receipt, warehousing, production, and quality control (QC). This model should emphasize a system of documenting redundant references to product and material codes throughout the supply chain.

The Traceability Train

For all companies, traceability begins at the receiving dock. All suppliers should be required to go through a qualification process that includes a quality systems audit. Part of that audit should document that the materials supplied by the vendor are traceable to their source as well as through their unit operation. All material should be coded with appropriate lot numbers that appear on the product containers delivered to a company’s back door. At the time of delivery, receiving personnel should check that the lot numbers correspond to the product received. QC, as part of the raw material qualification process, should verify the shipment as well.

Proper warehouse practices are necessary to maintain the traceability of raw materials as well as finished product after manufacture. It is the responsibility of the warehouse to link the lot numbers of the raw materials to their receive dates and any in-house material codes. To ensure proper product flow, “First In First Out” inventory methods are required for the handling of both raw and finished goods. While this may be done manually, there are many forms of software available to assist with this function.

When shipping finished products to distribution, the warehouse should document on all bills of lading the production codes and amounts of good shipped. Records of all shipments must be kept on file in order to reconcile and recover product in the event of a recall. To facilitate this process, companies should keep a list of key contacts on file for quick access.

Production is primarily responsible for building traceability into its finished food products. At the time of batching, production personnel must ensure that the proper materials have been withdrawn from the warehouse. They must check to see that all materials have appropriate lot numbers and reject any that do not. During the batching process, production personnel must document on the batch record the lot numbers of the raw materials and the amount of each material used.

As manufacturing proceeds, other traceability concerns arise. One involves the issue of rework. One of the biggest causes for recall is the inclusion of undeclared allergens in a product, and one way undeclared allergens may enter into a food is through rework. If a manufacturer’s process involves rework, it is vitally important to understand what is going into the finished food. Batch documentation, including lot numbers and ingredients of any rework, must be attached to the batch record of the finished good. Think of the rework as another raw material check to make sure that the ingredients in the rework, including allergens, are included in the ingredient declaration on the finished product package. This point cannot be emphasized enough.

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.

It is critically important that an audit be performed at least once a year. Recall procedures are living documents, and personnel changes occur all too frequently. When crises occur, companies will often find that their recall manual lists people who have changed positions, and the personnel they need to find are not listed for prompt, easy access. Time is critical in a recall situation; ensuring response lists and procedures helps lessen the recall response time.

Developing traceability is extremely important in minimizing the risk of recall and its accompanying costs. If a company can document that suspect raw materials are limited to particular codes of product, limited to particular segments of a code of product, or not included in a code at all, the potential for a damaging recall is lessened. In the event that a recall is required, a company can recover and replace product in a more efficient manner, which may reduce the extent of the recall. The result: Companies can keep their consumers safer, reduce their recall costs, maintain their brand reputation, and protect themselves from costly, broad-based total recalls.

Kelly is a senior technical consultant at Specialized Technology Resources Inc. Reach him at gerald.kelly@strus.com.

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