Audit Coming? Mind the Gap.

Read more at PetFoodProcessing.com The US Food and Drug Administration’s (FDA) sweeping Food Safety Modernization Act continues to reverberate through the pet food industry with a stern audit forecast: not if, but when. The law’s mandate boosting preventive controls is firmly in place, as is the Foreign Supplier Verification Program (FSVP) – meaning the FDA has graduated “from an educational mindset to that of enforcement,” said Rick Barham, manager of the Food Facility Inspection Team, Registrar Corp., Hampton, Va., that offers compliance services across a spectrum of FDA-regulated corporations. “Failure to develop an FSVP was the most frequently cited violation during FDA inspections in both 2019 and 2020,” he added. “Food safety plan and hazard analysis violations have steadily increased as well. Now, even if you are following good manufacturing practices, you are still likely to be cited if you have not properly documented those practices as required under FSMA.” Bulletproof documentation is crucial, then. But Barham and other industry veterans said that achieving broader audit readiness yields more benefit than burden. Where to start A nontechnical first principle for turning “when” into “anytime” is reliable year-round communication, advised Douglas Marshall, PhD, certified food scientist and chief scientific officer for Eurofins Microbiology Laboratories, Fort Collins, Colo. “The food safety team should have representatives from all functional departments,” he said, “and such team members should communicate preaudit expectations and use audit findings to support continual improvement projects.” Inside communication also means knowing how your own systems and procedures work – and where they demand improvement. “Being prepared by understanding the audit’s criteria versus the implemented system in place is a good place to begin,” said Wendy Yap, consulting partner with food-integrity organization AIB International, Manhattan, Kan. “Knowing specifically how your system meets the audit criteria can show knowledge and confidence in the audit, while also reducing stress in the audit,” Yap added. “Sometimes it is as simple as having the audit criteria with your personal notes of which documents and departments have that information. In a remote auditing world, which is happening more frequently now, this is even more important because you will need to have the documents easily accessible electronically.” Marshall agreed and recommended a decidedly analog but effective tool. “A well-organized document binder — whether hard-copy or electronic — is essential,” he said. “Too many keep multiple folders hidden in file folders so finding information leads to an unnecessary hunting project. Scattered monitoring records also is an annoying reality at many operations.” “You want to make sure the documentation is organized, reviewed, and kept up to date,” Barham said. “Proper safeguards should be in place to ensure that the records are accurate and protected from unauthorized changes.” Yap added, “Good recordkeeping starts by documenting what you do and doing what you document. Keep it simple. The document should be easy to read and understand and be user-friendly. A good structure of documentation and recordkeeping will support the organization during any audit.” Once an audit is on the calendar, Yap said, that communication and emphasis on organization should flow in both directions, from management to line and back again. “It is important that everyone is involved throughout the process,” she advised. “You can prepare your staff through the internal audit process and then build awareness and understanding toward the audit criteria and implemented standard by participating in the actual audit. Results of the audit should then be communicated promptly, so everyone in the organization will do their best to evaluate the root cause of any nonconformities and rectify those issues.” Next steps “An FDA inspection can be stressful,” Barham said, perhaps understating things a bit. But the anxiety bound to ripple through any organization notified of a pending audit can be planned for, allowing you to avoid its undesirable byproducts. That includes procrastination, which Marshall called “a common issue” and which, he said, can cause friction when it comes into contact with the flip side of auditing’s human element: an inspector trained to see what you’ve missed. “The auditor is expecting the worst and looking for high-risk situations that are poorly managed,” Marshall said. “Don’t challenge a finding without facts supporting your claim. A minor citation can generate a rebuttal that makes things worse. Having situations well-controlled ahead of time will save the auditor time and will likely influence whether the outcome is a nitpick affair or one of thoughtful collaboration.” Barham echoed this concern, noting that this is where the recordkeeping comes in. “Respond to the FDA with evidential solutions and not vague answers,” he suggested. “Be ready to provide supporting documentation — records of repairs, pictures, revised HACCP plans — to verify that corrective action has been completed.” When Pet Food Processing spoke to Marshall on this subject in 2019, he identified, among preauditing’s key challenges, the failure to implement good manufacturing practices, along with a handful of predictable bugs (poor machinery, inadequate facility sanitation, poor line-worker hygiene). What are his red flags in 2021? Here’s what he says rates an F – for “failure” – more recently.

• Failure to keep accurate monitoring records
• Failure to identify all food safety hazards that are reasonably foreseeable in the product and process
• Failure to conduct a well-thought-out root-cause analysis
• Failure to implement an effective corrective action
• Failure to consider opportunities to implement preventive actions
• Failure to document out of compliant situations
• Failure to understand why repeat occurrences are happening
• Failure to use preventive controls for hazards reasonably foreseeable to occur in the product or process (or using inadequately designed preventive controls)
• Failure to properly validate process preventive controls
• Failure to properly conduct verification monitoring

In the live-audit setting as well as ahead of it, Barham emphasized that a company’s communication culture is again paramount. “Expect the FDA to interview some of your employees,” he said. “They should be trained to never be argumentative with an FDA investigator or speak on areas outside of their general duties or knowledge. They should be able to implement a company’s operating procedures and they should show a commitment to comply fully with the laws and regulations.” To reach that high ground, Barham advised conducting regular internal audits, calling it the surest way to monitor “the effectiveness of your food safety system, whether it’s effectively implemented and updated, and whether it meets regulatory requirements.” Whether performed entirely in-house or via an outside consultant, gap assessments — scrutiny of any process component that may have fallen out of regulatory compliance — also can tamp down apprehension. “Companies that invest in a gap assessment, and well in advance of an audit, can identify oversights and weaknesses in their programs and documents,” Marshall said. “Plugging major deficiency holes before an audit helps team confidence and allows for additional time to button up minor oversights.” Regardless of approach, such rehearsals also provide opportunities to make FSMA second nature. “The best way to ensure a successful FDA inspection is to become exceptionally familiar with the FDA’s rules and regulations governing the food products you manufacture,” Barham said. “Like human food, pet food is required by the FDA to be safe to eat, produced under sanitary conditions, and properly labeled. Inspections therefore focus on the preventive controls requirement found in 21 CFR 507 – Subpart C.” If that’s alphabet soup to some team members, the internal process is your chance to bring them up to speed. “It is important that pet food manufacturers ensure they have knowledge of regulatory compliance in the countries they manufacture in and are exporting to,” Yap said. “A lack of controls may mean that the products will be noncompliant, which is a common weakness in the industry. It’s important to understand the clause or section requirement where this noncompliance was cited. Then you can assess the gap between your currently implemented procedure compared to the requirement, and the root cause that prompted the issue. “Issues can also arise whenever there is a version change in any of the regulatory standards,” Yap added. “The manufacturer being audited will depend on the training provided by approved service providers or auditors’ findings to re-direct themselves.” That was then, this is now Now that FSMA compliance rules are well established, audit pros said a picture has emerged of what’s been improved, as well as what challenges have stiffened. Yap said she sees the leveled playing field for manufacturing standards governing US-marketed products as a net gain. FSMA, she said, has built trust between industry suppliers and customers against the backdrop of improved compliance. “It’s also made it more difficult for economically motivated fraud to occur,” she added. Following 2020s’ pandemic disruptions and economic struggles, Yap said she anticipates something else for auditors to look for: spikes in feed fraud. “The industry needs to have a plan to ensure there are no fraudulent ingredients entering their supply chain prior to processing so the final product is in compliance with current regulations,” she cautioned. For his part, Marshall said manufacturers now face “more emphasis on proving that your preventive controls are working and verifying that outcomes are achieved every time.” Compounding this shift is that the industry suffers from a “major shortage of well-qualified individuals responsible for food safety.” On the other hand, he added, “many processes that were previously assumed to work now have scientific evidence of efficacy.” And for smart firms, a welcome byproduct of the paperwork increase will be better organized documents. If the pressure is elevated, so are the tools designed to streamline certain processes: The preaudit market doesn’t lack off-the-rack systems and automation marketed to those daunted by the process. But Yap did not necessarily counsel a “set it and forget it” approach. “So far, the turnkey systems are mainly focused on improving the tracking and tracing of the ingredients as well as compliance to HACCP and FSMA, efficiency, and cost-effectiveness in production,” she said. “A challenge with each of these turnkey systems is validation against their system, which is part of the requirements.” By and large, best practices start from within, Marshall said.