Challenges for the Small and Large

Small and large manufacturers can face quite distinctive challenges that impact procedures and practices across operations, however there are also many areas in which the size of the manufacturer matters little. Additionally, there are positives and negatives to both.

One of the greatest challenges that Bruce Ferree, director of quality for California Natural Products (CNP), sees as facing smaller manufacturers is that of number of staff and the individual capacity of each worker. While it may seem natural that less production requires less staff, this often means that each person is responsible for a multitude of responsibilities. “At smaller plants, people are required to wear a number of hats,” Ferree said.

At a large company, for example, a quality assurance manager can focus purely on quality assurance. A person in the same position at a smaller facility often also is responsible for quality control, food safety and defense, supplier quality and documentation, regulatory compliance, and whatever else gets assigned to the position. At very small facilities, the owner may need to wear just about every management hat, and sometimes production as well.

With such a set-up, it can be difficult for one person to cover all areas for which he or she is responsible as well as could or should be done. For example, a quality assurance manager at a large, multi-facility organization generally will have a traditional quality assurance function, determining and writing guidance to assure quality, while another person is responsible for enforcement to control it. At a smaller facility, the two functions usually are combined so that the quality assurance manager not only sets and writes the policy, but also must be out on the floor to enforce and control it.

The same person often also will be responsible for regulatory compliance, which means staying updated on regulation, understanding its applicability, then ensuring and enforcing compliance. On the other hand, a larger manufacturer usually will have a regulatory person, or team of people, at the corporate level, then additional people in each plant for enforcement.

FSMA. Today, the prominent focus of regulatory compliance is on the gradually appearing FSMA rules. Cathy Crawford, vice president of HACCP Consulting Group, sees one of the greatest small-business impacts as being the written Food Safety Plan required by the proposed Preventive Controls rule. Often, between the smallest and the largest manufacturers, “the greatest difference is in how formal their systems are,” Crawford said.

“What I’ve found interesting is that what the law tends to do is force formalization of food safety plans,” Crawford said. For large companies, that is critical, but in small plants, the need for formalization is not as strong.

While both small and large focus heavily on food safety, the larger businesses are more likely to have it in writing, because it is necessary to do so to dispense the information to multiple facilities. At smaller, single-location businesses, policies can be effective when dissemination is more visual and verbal. However, because it is becoming law, and having a structured system does make sense, “smaller plants are going to have to learn to improve what they’re doing in this area,” she said.

“The most important thing that small plants need to do is to set down in writing what they are doing, and be ready to be more formal,” Crawford explained, adding that too many small plants will say that they are already doing it on a daily basis and the proof is the fact that it is written down on their calendar. But that’s not enough; the plan has to be in writing and the actions documented. “Most companies are already doing the right thing—but they need to start writing it down.”

The FSMA rules do take the challenges of small and very small businesses into consideration, with longer timelines provided for compliance. Although CNP fits into the FDA’s definition of a small business, Ferree does not expect his company to take advantage of the extended time. “We’ve had to have a HACCP plan and GFSI, and we already do risk analyses,” he said, and because the company is a co-packer for other brands, it is expected to be in compliance. “Even if we are in one of those [exempted] categories, we will do all this as soon as we can. And I think we already have.”

And it’s not just CNP with such a focus. “I think that the industry is that way. The food industry wants to produce safe food, and consistent quality food,” he said. “Everyone wants to do this to be in the forefront of food safety.”

Consumer Expectations. The extensions and exemptions can cause issues in and of themselves. “Exemptions, in some cases, make sense if it is an economic consideration, but not when it’s a food safety consideration,” Crawford said. If a food product is disseminated to a daycare or healthcare facility or other immuno-compromised group, the requirements should be the same regardless of the size of the provider. Thus, the risk-based exemptions do make sense, but not those that are finance based.

The issue actually brings up a conflict with the mindset of the American public as well, she said. Consumers have become more concerned about the safety of food and want producers to have more oversight. “At the same time,” she said, “there has been a push over the last five to ten years in that they don’t like factory foods and want artisan products.” However, these are the very producers who are being exempted from the food safety regulations and oversight.

Crawford sees much of the answer to the conflict—both within the industry and with the consumer—as being a matter of education and training. Consumer education is critical to their understanding of their role and responsibility in food safety. For example, she said, consumers should understand that they need to wash fresh produce regardless of where it was sourced. “They tend to forget that it came from a field.”

Internal training and education is just as important within the industry, she added. But it is another area that often challenges smaller plants because of a lack of resources. “What I would like to see happen is a system with more regional training facilities,” she said. Although there is a great deal of guidance online, there are very small plants—who most need the information—who don’t have Internet access in the plant, she said. Rather, Crawford would like to see FDA and USDA/FSIS regional offices offer outreach, to help make the message more consistent and less confusing, she said. Another option would be to train the inspection personnel on the available resources so that they can help reach out to the smaller businesses as well.

All that said, large companies are not immune to challenges. A small manufacturer may be able to gather the entire team for training at one shot, while a larger business may need multiple sessions in multiple locations and multiple languages for even simple updates and training. And the written word could be critical for every aspect of larger company policy, not just that which is mandated. Otherwise, as Crawford noted, a solely verbal communication could be like the game “telephone,” so that what starts as a concise policy at the corporate level could be virtually unintelligible at a remote plant.

Small plants also have the advantage of speed. When something happens or change is needed, a small plant can often react within hours. A large company, on the other hand, can be like a big ship that turns very slowly.

But whether your company is dealing with multiple hats or a slow-turning ship, the key to a successful food safety plan and general compliance can generally be reduced to training, education, and communication.

The author is Editor of QA magazine. She can be reached at llupo@gie.net.