Documentation is key to proving hazard control

June 19, 2019

Published in Food Engineering, June 19, 2019 By Rose Shilling

The methods for documenting control of hazards have increased due to more complex regulations and technology advances. All the additional bacterial tests, external audits and sensor measurements come with a load of new data.

Those facts and figures can make the difference between a recall and persuading an inspector that a product is safe. If a question about a positive swab arises, think how much weight that favorable finished-product test results would carry or how helpful an aggressive record of clean environmental sampling would be.

Many processors have grown more sophisticated at compiling the information and presenting it when inspectors ask for proof that a facility’s food safety management system is working. They use software tools that can pull up any record they need for an inspector or auditor with a few taps on a tablet or computer. Sadly, other plants still pull out paper files for inspections.

But no matter the companies’ size or record management methods, they likely experience some of the common deficiencies that experts see.

Shawn Stevens, founder of Food Industry Counsel, says he’s learned in his legal work and safety consulting that companies’ food safety management systems vary wildly across businesses of all sizes.

Before FSMA, “companies were pretty much left to their own devices” to develop what they believed to be good safety systems, he notes. Some companies followed just GMPs, and others would combine GMPs with other prerequisite programs, but the guidelines for a safe operation covered only the basics, such as employee hygiene and sanitary equipment.

The law at the time did not require comprehensive, written plans for food safety, recalls and food defense, for example. “To the extent that companies did have these programs, there wasn’t any standard bar for everybody to follow. The rules of the road, so to speak, were just the Wild West,” he says. “Now that’s beginning to crystallize in that the FDA has spelled out exactly what it wants to see when it shows up in these facilities.”

Software to manage safety records, abundant in choices today, mostly didn’t exist before regulations became more complex. The mindset of filling more file folders and bankers’ boxes with paper records persists, Stevens says, though he thinks most companies are doing OK at documenting food safety with the record-keeping systems that they’re used to, which could include internal software that individual processors created.

Electronic tools for proof

SafetyChain cloud-based software company works with many large processors that made their own data management tools internally 10 to 15 years ago, and now, they’re struggling to maintain the functionality and want to shed the cost of maintenance. “Their line to us is usually: ‘We want to get out of the software business; we’re in the food business,’” SafetyChain President Brian Sharp says.

The vast majority of smaller processors that SafetyChain works with are converting from records tracked on clipboards and kept in filing cabinets, he says. “For a lot of them, it’s really just about getting off of paper because they’re trying to keep up with this fast-changing, complex environment that’s not getting any easier, and they’re not getting any more help.”

Oscar Garrison, senior vice president of food safety regulatory affairs for United Egg Producers, says the shell egg industry has similar variation of paper record keeping versus more advanced software solutions. He likes to learn about the different data management products at the annual Food Safety Summit in Chicago and notes that the amount of resources that small operations have for data collection are significantly different from those for large businesses.

“Somehow, we’ve got to encourage some of these companies to maintain a platform that is easy for the user to utilize, gives them the data they need and still be not too much of a financial burden, so it can be an affordable process,” he says.

Roger Woehl, chief technical officer of SafetyChain, says the market has reached that point. SafetyChain offers a solution that 10 to 20 years ago would have cost millions of dollars, but now, the software is practical for small and medium-sized companies, he says.

“Quite frankly, the functionality has got to the point where the small guys [and] the medium guys have more functionality than the big guys have with their own [software] that they built from scratch years ago,” he says.

When he started working in the food industry, he thought processors must be “old school” and simply lagged behind other fields in adopting cloud-based software to manage data, but he came to realize that food production is technically demanding, with thin margins and challenging work environments, and it needs mobile capabilities for tracking and monitoring.

Solutions used 20 years ago in the pharmaceutical industry, for example, didn’t make economic sense in the food business, but now, the technology has caught up to the industry’s need for a cloud-based system to manage the emerging trends of big data, IIoT and mobile use.

And the industry clearly needs technology badly to manage complex operations with growing safety requirements. “It’s so gratifying when you go into a company, and you deliver it, and you see that you just made everybody’s life easier or more efficient,” Woehl says.

Change motivators

Companies often are driven initially to seek help with safety data management because they want to improve their environmental testing program or because they have “the fear of FSMA,” as Sharp puts it, worrying about keeping up with complicated requirements.

“If you’ve seen the code, it’s a handful,” Sharp says. However, SafetyChain tied that code to the digital forms in the software, connecting the data directly to the regulation.

“So if an auditor were to come in, it’s not just finding the paper you did; it’s being able to show what it [the record] satisfies, who satisfied it, when they satisfied it. Was there an issue? Here’s a picture of the issue. Here’s what we did to correct the issue—all in one digital record, which is really, you could say, helping them sleep at night,” Sharp says.

And while FSMA remains important, some processors must prove themselves in so many audits—weekly in some cases for GFSI, organic, SQF, customers, etc.—that SafetyChain’s conversations with clients are often about going “beyond compliance,” Woehl says.

How it’s done with eggs

Egg producers have been doing environmental sampling longer than most food processors, Garrison says. That’s because the FDA’s Egg Safety Rule has required monitoring and documentation since 2010. Its extensive safety requirements include procuring chicks from flocks that test negative for Salmonella enteritidis, establishing an environmental monitoring program and meeting controls for biosecurity and vectors.

“That was very cutting edge,” Garrison says of the environmental monitoring mandate. And because of the rule, the FDA and the industry have seen declines in the amount of Salmonella enteritidis they’re isolating from the environment, he says.

Poultry houses are swabbed for Salmonella enteritidis at established intervals in the litter on the floor or on the belts in belted houses. “That’s kind of been our preventive controls, particularly on the live processing side, for years,” Garrison says.

Plus, shell eggs are packed under inspection by the USDA’s Agricultural Marketing Service and with strict sanitation requirements.

Even though the industry’s rules differ somewhat from those for packaged food, the safety concepts are the same. “There’s a very rigid food safety program around the production of the eggs in this country,” Garrison says.

One safety concern in the industry is the appearance in recent years of two emerging strains of Salmonella in outbreaks, detected with whole genome sequencing traceback, Garrison says. “Any time we see an emerging pathogen like that show its face where it really hasn’t been shown before, that’s when we start engaging our partners,” he says.

Working with the USDA Agricultural Research Service and academic experts, the industry is trying to determine whether the strains made simple “one-off” appearances or there’s wider concern.

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