From: Food Quality & Safety magazine, August/September 2012

Training is Key to FSMA Compliance

by Laura Dunn Nelson

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.

Pritzker said he has repeatedly urged companies to create a culture of safety that includes education, safety, and monitoring. “Frankly, I don’t think employees understand the implication of their mistakes,” said Pritzker, attributing that failure to inadequacies in training and proof of comprehension.

“Every one of the cases (I’ve litigated) involves a breakdown of systems, which is a function of training. Most employee contaminations are the fault of the supervisors.”

–Fred Pritzker, Attorney

Upgrade Training

It seems clear that the best strategy for food processors and manufacturers is to be proactive rather than wait for the issuance of new FSMA preventive control guidelines. That was the advice given by Donna Garren, PhD, vice president of regulation and technical affairs for the American Frozen Food Institute.

During a January 2012 presentation at the Northwest Manufacturing and Packaging Expo and Conference, Dr. Garren emphasized the importance of training records maintenance and access, and advised companies to plan for the additional responsibilities that are bound to result from the issuance of the new preventive controls. One proactive step the industry is taking is to create the Food Safety Preventive Controls Alliance—an organization made up of representatives from government, the food industry, trade associations, and academia—to help develop training materials that will allow the food industry to be compliant with FSMA. “We must adapt and be more proactive in addressing both regulatory and industry end user requirements,” Dr. Garren told the conference.

Her advice relates to training as well. New rules will affect a large number of companies that are not necessarily prepared to either implement them or apply them to their training modules. That problem has been borne out by far too many non-conformance audit citations for inadequate record keeping of training, testing, and worker comprehension. One proactive option, illustrated by the Cott and Ralcorp experiences, is the use of advanced automated interactive technology designed to effectively train, remediate where necessary, and thoroughly document training and comprehension. Automation enables instant access to all training and worker performance records—a particularly valuable benefit during an audit or supervisory review of worker performance.

These platforms can be effective tools for compliance with FSMA’s preventive controls and added requirements for proof of employee learning and understanding. Detailed proof of employee knowledge, however, is not what Pritzker said he uncovers in the cases he litigates. “Documentation usually amounts to a sentence or two that an employee has been trained or retrained on the use of a (particular) system, and there’s no proficiency testing for the most part.” Pritzker added that he often sees no proof of real comprehension.

Should the FDA include training in its preventive control guidelines, and there is a very good possibility that it will, training programs will face more scrutiny than in years past. The FSMA has given FDA inspectors unprecedented authority and responsibility, going well beyond a perfunctory check of training records. “Training is not just a box to check,” said Dr. Acheson. “The FDA has made clear that documentation of your safety plan will determine whether you are a pass or fail organization.” That explains the rise in acceptance of interactive technologies to assure comprehensive and thorough training and documentation as proof of a process in control and an aware workforce.

At the same time, positive behavior changes on the part of employees and supervisors through the use of automated programming can produce results that may even exceed company compliance with the FSMA and FDA’s preventive controls. Validating positive employee behaviors will provide greater employee awareness of potential hazards even while they concentrate on repetitive line tasks.

Such attitudinal changes, however, are not going to happen without two critical components: a thorough training program and competent instructors using available technology to uncover risky lapses in comprehension, along with immediate retraining to correct the deficiencies. These tools may well be a company’s greatest ally in complying with FSMA and implementing science-based preventive controls.

Laura Dunn Nelson is director of industry relations for Alchemy Systems, LP, an Austin, Texas-based company that creates and globally markets highly interactive training products that use technology and media to educate individuals and groups. Call (254) 965-8563 or e-mail Visit Alchemy’s website at



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