How software helps manufacturers manage FSMA documentation

by Dan Malovany
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Relying on easy-to-use technology, production personnel monitor operations and gather vital data that can now reside securely on the cloud.

In a paperless world, people don’t have to worry about physically dotting an “i” or crossing a “t.” It’s pretty much done automatically in the digital age. And while bulky three-ring binders may phase out when it comes to food safety compliance, the paper trail has been transformed into an ever-expanding universe of data management under the Food Safety Modernization Act (FSMA).

In fact, FSMA — and the subsequent regulations that followed — require that everything in a bakery or snack operation be verified, validated and documented on an ongoing basis, according to Len Heflich, founder of Heflich Food Safety and contributing editor to Baking & Snack.

“You need to document your procedures, findings, failures, training programs, corrective actions … it all needs to be done,” he explained. “There is a lot of documentation required.”

Previously, food manufacturers needed to identify critical control points in their processes where a hazardous failure could occur and lead to a recall. 

“Under the new requirements, it’s about ‘all’ control points, not just critical ones,” Mr. Heflich said. “In a way, it’s a good thing because it sidesteps the whole discussion of defining what’s a critical control point and what’s a non-critical control point.”

Under FSMA, the bigger focus involves risk management, but don’t count on the Food and Drug Administration to explain how to do it. 

Consistent batching translates into better product quality by providing strict controls at the front end of the process.

“It’s up to the manufacturer to perform its own risk assessment and identify its own control points,” Mr. Heflich noted.

And yes, he added, that’s actually a good thing. 

“It’s great because that’s where the onus of responsibility belongs,” Mr. Heflich explained. “Those are the people who know the most about the process and products. In many ways, it’s a much more flexible and adaptive program than we had for food safety in the past.”

Simplified by software
Finding user-friendly software to manage food safety has become easier. For the most part, gone are the days when a program had to be customized to adapt to a specific operation. Most of the software today uses a standard platform for data storage, and compatibility issues have virtually disappeared, said Mr. Heflich, who has more than 20 years of experience in food safety — even writing programs years ago for some of the — nation’s largest bakeries.

“You have to ask, ‘Does the software have to be programmed or configured?’ There’s a big difference,” he said. “If it has to be customized and programmed, that’s expensive and time-consuming. If it has to be configured, that means the person who put together that program has already anticipated your needs. You’re not changing the program, just defining its elements.”

In most plants, the first line of protection starts with recipe management systems. Focus Works offers PRIMS, which stands for Product Recipe Ingredient Management System. The program ensures lot traceability control from when ingredients are received, maintaining a computerized record of each step in the process until the products are shipped. 

“It also provides management with the tools to prevent any inconsistencies within a batch,” said Bob White, the company’s president. “It can also track the process variables, piece weights and other data you wish to record that may affect the batch. Tracking a particular ingredient or batch lot is a simple process quickly accomplished with a few clicks on a screen.”

PRIMS also generates production schedules and monitors inventory purchasing, receiving and consumption in real time so issues with material shortages don’t occur. Mr. White noted that recipe compliance boils down to repeatability, adding that 98% of product failures come from the front end of the process — batching and makeup — from operator, equipment or other process issues.

“These errors range from an operator leaving out or putting in the wrong ingredient or incorrectly scaling an ingredient,” Mr. White said. “Problems with automated scaling and dosing equipment are also factors. These may include out-of-tolerance bulk ingredient draws and liquid metering failures due to inaccurate metering devices. Achieving a dough temperature within recipe tolerance is also very critical.”

MiT Systems offers its M-suite of cloud-computing software to manage raw materials and finished goods inventory, especially as more bakeries head toward making frozen products. 

“The manufacturing module is designed to streamline the production scheduling process while tracing raw materials and tracking lot by line items down to the invoice level,” said Mark Maraj, the company’s vice-president, sales and marketing. “The system also helps manage other aspects of the distribution supply chain in the event that tainted product has been shipped so it can be recalled by location or globally.”

Under FSMA, a fully implemented system should track formula changes as well as lot traceability from purchasing and analyzing raw materials to when consumers purchase the finished product. In many ways, it’s about connecting the dots to manage the process.

“A system should also include the proper record-keeping of the HACCP procedures for receiving, inventory management and handling of allergens through the entire manufacturing process,” Mr. White said.

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