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
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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.
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