Posts Tagged ‘Regulatory Compliance’

The program includes reporting key data during an initial disclosure and via follow-up reports including items such as the date the article of food was determined to be reportable, a description of the food including quantity and amount, the extent or nature of the adulteration, the result of investigation to determine the cause of the adulteration, disposition of the article of food, and product information typically found on packaging sufficient to identify the article of food.

Once the submission is completed, a confirmation page identified via an Individual Case Survey Report ID (ICSR), including all submitted information, is produced.  This report can be saved as a PDF file and associated with key data elements in the food and beverage processor’s Enterprise 21 ERP system, including customer incident reporting, lot traceability data, and associated customer shipments.

Food and beverage processors are strongly encouraged to review their Comprehensive Recall Management plans and make appropriate adjustments based on the FDA’s Reportable Food Registry mandate.  For an overview of the Reportable Food Registry, please review the FDA’s “Reportable Food Registry (RFR): At a Glance” document.

Many companies that believed they were immune to this process have recently had to initiate recalls.  Some of these companies were so ill-prepared they had to close their doors due to poor preparation for such a possibility.

So, what do companies in life sciences and food and beverage industries need to do to make certain they are well prepared for a potential recall initiation?  Companies need to have automated lot tracking software functionality and a comprehensive recall management system in place.  At the core of a comprehensive recall management system are well-defined policies and procedures to be followed in the event of a recall.

The Ohio State University Extension published an excellent article on this subject titled, “What Can You Do to Be Ready for a Recall?” which overviews what companies can do to avoid the potential need for a recall and a high-level summary of the procedures that should be followed in the event that it becomes necessary to initiate a recall respectively.

Key points made about how to avoid a recall include having a Hazard Analysis and Critical Control Point (HACCP) plan in place, complying with the FDA’s current Good Manufacturing Practices (cGMP) regulations, developing and maintaining quality management systems, developing a food security and tampering prevention program consistent with the FDA’s Bioterrorism/Food Safety Security Act of 2003, and ensuring quality of raw materials by working with credible suppliers.  When defining a recall plan, one must pay special attention to the key element of such a plan which is fact gathering about the defective product.  This includes both internal and external discovery.

In TGI’s Enterprise 21 ERP system, service and support functionality can be used as a coordination point for external discovery.  This includes logging of all support calls, routing to appropriate resources for investigation, and documenting and tracking the associated resolution.  A recall coordinator would be alerted should the problem be determined to be of sufficient nature and require immediate action.

Enterprise 21 manages internal discovery by supporting complete chain of custody tracking through lot traceability of inbound ingredients, their consumption in manufacturing processes which can yield intermediates, and ultimately to finished goods which are shipped to customers.  In addition, quality data is recorded for each lot during this process.  Enterprise 21 supports both forward and backward lot traceability.

Through a combination of policies and procedures, along with strong system functionality for quality management and lot traceability, TGI customers leverage the Enterprise 21 ERP system as a key element of their comprehensive recall management systems.