With the majority of recalls caused by undeclared allergens, the FDA focuses efforts of preventing cross-contact with new provisions in the Food Safety and Modernization Act (FSMA). Special thanks to Len Steed, Global Innovation Manager at AIB for contributing to this article.
The importance of food safety has a face, and a name. Debra Miller-Tossey, a grandmother of 8 and avid outdoorswoman living in Cadillac, Michigan, was diagnosed with Celiac disease in 2013. Celiac is an autoimmune response to the protein (gluten) found in grains like wheat, barley and rye, which causes the body to attack and damage the small intestine. “It was such a relief, I had been feeling sick for so long, and so worried it was cancer. It was just a relief to know it had a cause and could be managed.” Standard management of allergies and intolerances from foods such as milk, eggs, peanuts, tree nuts, soy, wheat, fish and shellfish, is often strict avoidance, as even trace amounts can cause severe and even life threatening reactions called anaphylaxis. With an estimated 15 million Americans living with food allergies, the FDA, via the FSMA, is requiring documented controls to prevent undeclared allergens. Companies that produce and distribute food and beverage products will need to review the proposed 21 CFR 117 Good Manufacturing Practices (GMP) to ensure that existing prerequisite programs and Hazard Analysis Critical Control Points (HACCP) plans are effectively implemented to prevent recalls due to GMP deficiencies allowing for operational cross-contact and mislabeling.
Preventable Recalls: Undeclared and Allergen Cross Contact
The FDA Reportable Food Registry (RFR) collects data on Class 1 Recalls which is defined as ”…a reasonable probability that an article of food will cause a Serious Adverse Health Consequences or Death in Humans and Animals termed a (SAHCODHA) event. This data was used to track preventable recalls and incident patterns to help the FDA identify risk in the food chain which includes foods imported to the USA. Each year the RFR publishes a report titled “Targeting Inspection Resources and Identifying Patterns of Adulteration”. The fourth annual 2012-2013 report cites undeclared allergens as the largest reason for recalls accounting for 44% of all recalls. Food manufacturers and distributors will need to implement preventive controls as required by Section 103 Hazard Analysis and Risk Based Preventive Controls (HARPC) and the proposed GMPs.
HARPC Preventative Controls
The current GMP’s describe the methods, equipment and control procedures required for specific food sectors to prevent unsanitary conditions. The proposed change to the GMPs in 21 CFR 117 will require that companies re-examine their existing GMPs and decide if a process step, operational program or prerequisite program must be monitored similar to a HACCP Critical Control Point due to its importance to prevent a Class 1 SACODHA event. For those companies shipping product to the USA, the HARPC and proposed GMP requirement will be applicable under an additional FSMA rule called the Foreign Supplier Verification Program (FSVP). The final rule for HARPC and FSVP will be issued in August 30 2015 and October 31, 2015 respectively so the time to act is now.
For more information on how the FDA FSMA rules will affect your organization, the AIB has published an excellent resource, available here: http://www.columbianlogistics.com/AIB-FSMA-Ready
For a truly effective HACCP plan, companies must formalize vendor policies and communication with vital service partners.
Janitors, electricians, plumbers, landscaping crews are all hard working professionals who carry out their jobs to little acclaim or fanfare, but whose respective functions are vital to operational success. Often times these duties are entrusted to outside vendors, and when they are performing excellently, they fade into the background of the day to day cycle of commerce. Companies must not overlook these diligent service providers as components under the umbrella of analysis and controls that Hazard Analysis Critical Control Points (HACCP) places on all facets of operations. A HACCP based vendor certification program helps ensure safety and compliance through standard vendor communication, management, and traceability.
Where to Start: Know Your Processes & Communicate!
A vendor certification program will only be successful if a company has well documented
processes. A vendor policy should serve as an overview of expectations and roadmap to the more detailed and specific processes contained within Pre-Requisite Programs (PRP). These PRP’s are individual components that make up the greater HACCP plan.
By providing access to these processes, companies can educate their vendors and avoid costly non-compliance issues, as well as avoid damaging important working partnerships. The vendor policy needs to be a part of a contract, signed or recognized as an agreed upon set of criteria for operation between the two parties.
Management: Compliance Audits & Tracking
Once vendors have been brought onboard with a compliance program, a system of audits should be in place to monitor compliance. Monthly and yearly reviews to verify that any process changes have been communicated, as well as reviews of vendor practices, should be documented. For large companies that employ an equally large number of vendors, digital vendor management systems, also known as asset management software, can serve as a central and easily maintained repository for maintaining a program that may be spread across geographies and diverse locations. Smaller companies can achieve proper management with a simple spreadsheet matrix, as long as processes are in place to ensure diligence in maintaining updated information. No matter what tool is used, the basics of creating a central repository for tracking vendor communication & compliance must be functional and easily accessible to parties that interact with outside vendors.
Your Employees: The Best Defense
Your employees will always be the best safeguard and control to help maintain vendor compliance. “When employees are thoroughly trained and aware of the process and procedures that make up a HACCP plan, they will always be vigilant to any issue that might arise.” said Jim Gadziemski, General Manager of Warehousing at Columbian Logistics Network. In essence, everyone becomes part of the HACCP team. Training and frequency will differ for each PRP. Posting an approved vendors list for facility managers to review prior to vendor selection can help speed the selection process and remove potential hazards that may arise from contracting with un-vetted suppliers.
A HACCP plan is only effective if every part of your organization participates, and that includes the important support provided by outside vendors. Clearly communicating your processes, and creating an audit system to track compliance issues will insure that there are no weak links in your vendor network.
Questions? Contact Mandy VanHaitsma at 616-460-5489 or firstname.lastname@example.org