Training is Key to FSMA Compliance

The FDA is expected to issue preventive control guidelines this year to address potential hazards in the food industry as required by FSMA. While there has been no confirmation related to the scope of the controls, one of them is likely to increase the scrutiny of training and its role in hazard avoidance.

If the findings in a 2011 survey of independent auditors for eight global firms are any indication, the FDA’s focus on training should come as no surprise. The responding auditors described the most common reasons for training non-conformance findings as inadequate training programs, little or no proof of comprehension, minimal follow-up or retesting, and insufficient documentation. “Plants put training on the back burner,” noted one of the auditors.

All of the reasons for non-conformances will be red flags for inspectors who, with the passage of FSMA, operate under a mandate for inspections “to be based on risk and the frequency of inspections to increase.” By design, effective training should closely support the implementation of science-based preventive controls—the often-quoted “Seven Principles of Hazard Analysis and Critical Control Points”—a written plan that contains a hazard analysis, identification and monitoring of critical control points, critical limits, and corrective action.

Yet, one can conclude from the auditors’ comments that there is often an apparent disconnect between the consistent execution of HACCP and the prerequisite programs and effective training of employees who are expected to follow the food safety plan. This is not how companies establish cultures of safety. Instead, they must implement and validate a successful training program for workers and—just as important—supervisors.

Shortcomings, Inconsistencies

If there is anyone who fully understands the relationship between safety culture and training, it is David Acheson, MD, former chief medical officer for the FDA Center for Food Safety and Applied Nutrition. “I think this boils down to the culture and the attitude of management in the particular establishment,” said Dr. Acheson, now the managing director of food and import safety for Leavitt Partners consultants. “Training is a more integral part of food safety and needs to be pushed in new directions.”

Dr. Acheson said management and employees have to completely understand the training process and “the importance of their job in protecting brand, bottom line, and the people who are going to consume the food.” The former FDA official expressed fears that management acceptance of inconsistent or even “haphazard” training could result in potential health problems in the workplace and beyond. “Training that doesn’t change behavior and maintain good behavior isn’t worth anything,” Dr. Acheson said.

Companies, especially those with multiple facilities, have found that comprehension and application of principles tend to vary when the training isn’t standardized. That was the case for Ralcorp Frozen Bakery Products and Ralcorp Snacks, Sauces and Spreads—two of six divisions of one parent company. Ralcorp conducted a gap assessment of its training programs in 2008 and found consistency in theme but not in message and content—a problem that it feared would negatively impact food safety.

A similar situation existed at Cott Beverages, a Tampa, Fla.-based large retailer brand beverage company. Validation of worker comprehension and specific understanding of training lessons varied in several company divisions. The two firms, recognizing the potential health and safety issues associated with training shortcomings, purchased and implemented a sophisticated interactive training system for verification of comprehension and thorough documentation to alleviate training shortcomings.

Attorney Fred Pritzker, founder and president of a national food safety law firm, has successfully represented plaintiffs who are survivors of foodborne illnesses. He points the finger at training issues and the failure of supervisors to recognize them. “Every one of the cases (I’ve litigated) involves a breakdown of systems, which is a function of training,” Pritzker said. “Most employee contaminations are the fault of supervisors.” The Minneapolis-based attorney said that proof of proficiency—the understanding of the training concepts—was minimal to nonexistent in many of those cases.

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