FSMA’s Record-Keeping Challenge

 

Of the many new requirements in the Food Safety Modernization Act, one of the most challenging is maintaining detailed records of compliance with the new law.

It’s a requirement that going to be especially difficult for small food manufacturers, those that typically do not operate with large administrative staffs. Even though small businesses (defined as those with less than 500 FTE employees) have until August 30, 2017 to achieve compliance, they still face a challenge: who are they going to tap to manage the array of records FSMA requires?

In fact, industry experts point out, FSMA requires that companies assign a management-level person to handle the record keeping, as well as an internal auditor to insure that the records are accurate and honest.

This will be no small assignment. FSMA’s record keeping regulations will require constant attention, for one thing, because the law says FDA inspectors can ask to review the records on just 24-hour notice. For another, once the August grace period ends and enforcement begins, operators who don’t meet the record keeping requirements could face costly fines.

The Food and Drug Administration (FDA) justifies the records maintenance requirement as being cost-effective in the long run. “We estimate that processed foods covered by this rulemaking are responsible for approximately 903,000 foodborne illnesses each year, at a total cost to the American public of approximately $2.2 billion,” FDA’s economic analysis of the rule explains.

Another wrinkle in FSMA is that the company’s records must be available whenever the FDA comes calling.  “Currently, the FDA only has broad records access in emergency situations when it uses authority granted by the Bioterrorism Act,” explained Maile Gradison Hermida, an Associate with the global law firm Hogan Lovells, in a 2015 Food Online blog post. “However, FSMA gives the FDA this broad records access every day, for routine inspections and without cause. The FDA will review records to assess whether you have the systems in place to make safe food and whether you are always following these programs.”

Through contractors, the FDA is offering training sessions to help companies understand the breadth of what they’ll need to keep track of: from hazard analyses to safety plans to documentation of suppliers and transporters. Still, there are common sense procedures that small and medium-sized manufacturers can implement early in 2017 (if they haven’t already been put in place):

  • Undertake a company-wide audit of existing record-keeping procedures, including how they are stored, who does the compilation, and what data might be located on cloud-based servers;
  • Assemble a FSMA compliance team that includes representatives of senior management (or ownership), operations, IT, accounting, legal and marketing. Its role would be to oversee all aspects of food safety implementation, including record-keeping and tracking. To assure efficiency, someone with the requisite experience in records handling should be designated as the team leader.
  • Invest in new technologies that will ease the record-keeping burden. Manufacturing software that monitors products throughout the manufacturing process should be a top priority. Cloud-based technology will not only provide a cost-effective way to store digital documents, but also offer an array of predictive analytics that can unearth potential production issues and also preempt alarm and failure events.

The enthusiastic buy-in of senior management to place food safety at the pinnacle of production is essential. In a very real sense, FSMA is a risk management tool intended to help companies in food production to protect their brands while maintaining product quality and safety.

Managing risk, after all, is a fundamental necessity for any business. Now, under FSMA, it can be the spur to efficient, profitable – and safe – performance.

 

 

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The Challenge of FSMA Transparency

UPDATE

The critical importance of food transparency was underscored by the results of a recent global survey on consumer attitudes about overall food safety. Bottom line, confidence in food safety has declined, and consumers look to manufacturers and retailers to be proactive in preventing food contaminations and recalls. Read about the survey results here:

 

The new Food Safety Modernization Act (FSMA) presents food manufacturers and their suppliers with a significant challenge: how to efficiently filter FSMA preventative controls down the food supply chain to encompass the thousands of suppliers and vendors that will have to create and manage their own food safety plans?

The answer lies in a key section of FSMA, which codifies in its regulations the concept of “supply chain transparency.” Under the new regulations drawn up by the Food and Drug Administration (FDA), a manufacturing/processing facility must have a risk-based supply chain program for those raw material and other ingredients for which it has identified a hazard requiring a supply-chain applied control. In other words, at every step along the food chain from farm to table, manufacturers and producers must be fully cognizant of the safety controls of their suppliers – and have the records to prove it.

Actually, transparency has been around for several years in business-to-business circles. A series of disastrous food recalls traced to suppliers who either didn’t know what they were doing, or intentionally sold adulterated, unsafe product, prompted businesses here and abroad to begin putting their suppliers on notice: unsafe practices will not be tolerated. Under FSMA, manufacturers are obliged to hold their suppliers to the same food safety standards they must follow.

(Transparency and another descriptor, traceability, are often used interchangeably, but have slightly different meanings. Traceability usually describes the technical ability to verify the identity, history, location or application of an item, while transparency is used when talking about broader collaborations among trading partners in the food chain).

For the FDA, supply chain transparency is part of the agency’s new operating model that emphasizes strengthened collaboration and improved information sharing and gathering among trading partners, data-driven risk analytics, and the smart allocation of resources for food safety management.

food mfg close upThere are many places along the manufacturing production line where unintentional food adulteration may accidentally occur. Water used to hose down equipment may contain harmful bacteria. The lubricants used to keep the machines running at peak efficiency might touch the product as it whizzes by. And so on.

Suppliers of material used in manufacturing, such as lubricants, are required under FSMA to demonstrate that their products are properly formulated, labeled, stored and used to prevent compromising food safety, and that only “food grade” lubricants are allowed in those parts of the manufacturing facility where the food is produced. Lubricant manufacturers also must document their processes so that if a food safety problem arises, preventative control records and product formulations are readily accessible should a problem arise.

Over time, transparency will become second nature for manufacturers and their many supply chain partners. For the time being, however, companies all along the food chain are quickly realizing that the new way of doing business to prevent food contaminations will require time, attention and management focus not just inside their own operations, but also up and down the supply chain.

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