Authored by: Jon Wheeler, Microbac Laboratories, Inc., South Carolina Division, and Tom Zierenberg, Microbac Laboratories, Inc., Pittsburgh Division

The regulatory introduction of the HACCP (Hazard Analysis Critical Control Points) food safety model, which began in 1995, has led to considerable progress in reducing food safety incidents coming from those sectors of the food manufacturing industry targeted for mandatory HACCP compliance (seafood, meat and poultry, and juice processing).  As a result, many other food manufacturing industries have adopted the HACCP model.  They seek to improve their process management to assure the production of safe, high quality foods. Yet, we continue to experience recalls and food-borne illness outbreaks, including many resulting from pathogen contamination in foods outside the mandate of HACCP, namely E. coli in lettuce and spinach, and Salmonella in tomatoes, peanut butter, and jalapeno peppers.

The U.S. Department of Agriculture and the U.S. Food and Drug Administration are primarily responsible to ensure food safety in the United States.  However, the ultimate burden of responsibility for the safety of any food product rests with the product’s manufacturer. The FDA or any other regulatory agency simply cannot completely protect consumers from the occurrence of food-borne illness outbreaks. With the demand for a wide variety of food products, and with today’s global food supply, there are increasing possibilities for outbreaks of food-borne illness.

When implemented as a science-based program, HACCP has proven to be an effective means to ensure food safety. The recent case involving Salmonella-tainted peanut butter and peanut products illustrates what can happen when Good Manufacturing Practices (GMP) are not used by producers. Such failures may contribute to outbreaks of illness that could be prevented by proper implementation of fully-validated HACCP and prerequisite (supporting) programs such as facility maintenance, integrated pest management, and sanitation standard operating procedures by plant personnel and management.

As a network of independent food testing laboratories and consultants to the food industry, we sometimes review HACCP programs that are missing critical details or are inadequately implemented. Though there are seven necessary principles to implement and maintain a hazard plan, in this article we are focusing on the two which we cite most often in our facility audits: Principle 1 (Hazard Analysis) and Principle 6 (Verification). When these two components of HACCP are not properly addressed, supporting programs also fail because they have not been designed to address all hazards or because their performance is inadequately monitored.

- Principle 1: The hazard analysis must address every reasonable possible source of contamination or adulteration, including biological, physical and chemical agents. Potential hazards related to ingredients, process water, processing equipment and facilities, warehousing, packaging, and shipping must all be addressed.  These hazards are then controlled through well-defined prerequisite programs such as Good Agricultural Practices (in the case of fruit and vegetable growers), strict adherence to written purchasing specifications, facility maintenance, SSOP’s, and integrated pest management. Biological hazards are addressed through combinations of prerequisite programs and in-process interventions, process controls, proper product formulation (in many foods this may involve using preservative systems and/or hurdle strategies), and lethality or “kill steps". Such measures should be evaluated to achieve the greatest effectiveness.

In addition to producing safe food and protecting a manufacturer’s brand, making the extra effort to improve these measures is often rewarded with extended product shelf- life.  This results in improved yields which may significantly reduce the net cost to implement a HACCP-based approach to food safety.

- Principle 6: Verification means demonstrating on a regular and ongoing basis that a system, process, or procedure performs as expected. A related term, validation, means demonstrating that a system, process, or procedure is capable of achieving a desired effect. Validation is a robust means of challenging a process to determine whether the performance target can be achieved under the most adverse set of conditions likely to be encountered.

Typically, validations are performed annually or when a significant change is made in a process (such as use of a different antimicrobial or contact time in a wash step, or increasing the amount of product in a sealed pouch). Verifications take many forms, but all consist of measurements that demonstrate on an ongoing basis that the process is operating within predetermined safe tolerances.

A shelf-life study is a good example of a validation study. Microbial challenge studies  performed on certain foods are also an effective way to demonstrate that the process or product formulation is effective in preventing food-borne illness.  Examples of  verification operations include temperature measurements, daily thermometer calibration, ATP (bioluminescence) swabbing, microbiological swabbing of food contact surfaces,  hourly concentration checks on automated antimicrobial mixing systems, quarterly verification of Certificates of Analysis for high-risk ingredients, and finished product testing to verify that product specifications are being met.

Verification and validation are powerful tools for ensuring that a HACCP program performs to its potential and that product safety and quality are not being compromised by the ineffective use of procedures. The failure to use these tools effectively limits the potential benefit of the HACCP program.

Recent food safety incidents highlight the responsibility that food producers bear in maintaining their systems and processes to assure safe products. Professional food safety consultants and accredited food safety audit organizations, while working alongside accredited third party food laboratories, can assist food manufacturers in developing key components of an effective food quality system.

Microbac Laboratories has the expertise to provide GMP and science-based audits, troubleshooting, and consulting to improve manufacturing processes and product performance. As the requirements for food safety expand, Microbac Laboratories’ network of laboratories is well positioned to serve as your technical partner to assist your company in meeting and exceeding these requirements.

For more information, please contact: microbac_info@microbac.com.