Fine Tune Your Compliance with Validation

HACCP systems have been required in a number of food manufacturing categories for many years and continue to expand as the standard model for all categories in the food industry and supply chain. Validation, an important component of HACCP Principle 6 verification, is not a new concept to the food industry. However, the subject of validation is not always well understood by those individuals who perform food safety and quality audits to determine compliance with current regulatory and industry standards.

Validation is the act of proving, in accordance with the principles of good manufacturing practices (GMP), that any procedure, process, equipment, material activity, or system consistently leads to the expected results. Documented evidence provides a high degree of assurance that a specific system, equipment, or process will consistently produce a product that meets its pre-determined specifications and quality attributes. Simply put, validation is nothing more than proving that a process works.

Validation is often confused with verification and monitoring. While the definitions of these three terms vary depending on the exact standards being used, the following plain English descriptions provide clarity:

• Validation: Scientific and technical proof that a plan works
• Monitoring: Taking measurements and actions following the plan
• Verification: Independent confirmation that all monitoring was done according to plan

Validation and HACCP

HACCP is a food safety management system that is increasingly utilized in all aspects of the food industry and is the cornerstone of many food safety management system compliance

standards. HACCP, a preventive food safety system rather than a traditional quality control inspection system, relies on process controls to minimize food safety risks in the food processing industry. It is not zero risk and does not eliminate the possibility of a hazard getting into the food product. Instead, HACCP attempts to decrease that possibility to an acceptable level.

HACCP has been widely used by the food industry since the late 1970s and is internationally recognized as the best system for ensuring food safety. It is endorsed internationally by the Food and Agriculture Organization and the World Health Organization and in the U.S. by the National Advisory Committee on Microbiological Criteria for Foods.

The FDA used HACCP-based principles when setting up its low-acid food canning regulations in the 1970s. In 1995, the FDA issued regulations that made HACCP mandatory for fish and seafood products and, in 2001, the agency issued regulations for mandatory HACCP in juice processing and packaging plants. In addition, a voluntary HACCP program was implemented in 2001 for Grade A fluid milk and milk products under the cooperative federal/state National Conference on Interstate Milk Shipments (NCIMS) program.

The FDA has also implemented pilot HACCP programs for a variety of other food processing segments as well as for retail foods. In Section 103 of the Food Safety Modernization Act (FSMA)—Hazard Analysis and Risk-Based Preventive Control—all FDA-registered facilities subject to the requirements of the section must identify known or reasonably foreseeable hazards and implement preventive controls in a written plan to significantly minimize or prevent those identified hazards.

Facilities already in compliance with existing seafood, juice, and low-acid canned food regulations are considered exempt from this section of the act, because they are already required to have such plans in place. HACCP has also been implemented by the USDA. In 1998, the USDA’s Food Safety and Inspection Service (FSIS) mandated HACCP for the nation’s meat and poultry processing plants.

Validation is an important concept in HACCP systems, yet there are often situations in which it is inadequately implemented, overlooked, or omitted. In the FSMA’s Section 103, the word validation is not even mentioned.

On March 19, 2010, the FSIS issued a response letter with an attached guidance document to the meat and poultry industries outlining what it considers proper validation of HACCP systems, including clarification of the meaning of validation as required in 9 CFR 417.4. The regulation states that each establishment is required to validate the effectiveness of its HACCP plans in controlling those food safety hazards identified during the hazard analysis. The regulation also states that each establishment must conduct these validation activities during its initial experience with a new HACCP plan and that this must encompass additional activities that make up the entire HACCP system. In the guidance document, the FSIS indicated that validation should be a two-step process.