It's almost an unwritten rule in food safety: Tomorrow is going to be more complicated than yesterday. Food safety audits are no exception to that rule. The Food Safety Modernization Act (FSMA) introduced new rules and requirements, as well as new compliance and enforcement actions. For facilities, these changes mean more processes and protocols that might be inspected by the FDA, and more internal audits to prepare for those potential inspections. 

Failing these inspections isn't an option: Not only does it risk expensive fines and corrective actions from the FDA, but it can also cause a public health crisis and lead to high costs for brand reputation and the bottom line. 

New requirements can be onerous if stacked on top of a shaky foundation, but are manageable if you build a sturdy framework to support them. This is that framework. 

What's adding to food safety audit complexity? 

There are three major drivers of additional complexity for food safety audits: 

1. New Auditing Requirements  

The FSMA was a much-needed update to food safety rules, but it has also added new auditing requirements for food manufacturers. These include: 

• Food defense as a result of the Intentional Adulteration (IA) Rule: Part of the FDA’s expansion of food safety initiatives included new food defense requirements. Due to agency differences, even companies with existing GFSI- or USDA-compliant food defense plans will need to develop a new plan to meet these updated requirements. 

• Foreign Supplier Verification Program: The FSVP requires food manufacturers to not only audit and verify their own food safety practices, but also those of each of their suppliers. This can add significant overhead and increase liability. 

• Food Traceability Rule: Food traceability will be a large FDA focus moving forward, and new rules require maintaining records on Key Data Elements (KDEs) and Critical Tracking Events (CTEs) in the food supply chain. These records must be audited regularly to ensure compliance and avoid penalties. 

2. More Complex Supply Chains 

While broader sourcing and distribution networks can make for more resilient supply chains in the face of challenges from market factors and climate change, they also create more complexity. This is especially true for companies that find themselves in the middle — forced to regularly audit their vendors for FSVP compliance, but also to be audited by downstream producers for their own FSVP requirements. 

3. Shorter Schedules 

Compliance timelines are shrinking, and many producers may find that they have less time than they used to between the announcement of new regulations and the date they go into effect. Likewise, they may experience shortened timelines between being notified of the need for a corrective action and their deadline for completing it. This time crunch complicates an already difficult task. 

How to Streamline Auditing Processes 

Modern auditing requirements are complex, but with the right framework in place facilities can manage them and avoid overwhelming internal resources or adding to liability. Below are key steps to building this framework: 

• Manage documents effectively: Most audit and inspection requirements state documents like food safety and food defense plans must be kept onsite, while others should be producible within 24 hours. Develop a clear system for managing your important documents, with a focus on access and redundancy, and then stick to it. 
• Invest in technology up front: There are software suites that exist specifically to assist with food safety requirements, and others like project management tools that can be easily adapted to the food safety environment. Take advantage of these tools and build workflows that can make an audit or inspection go smoother. 
• Don't skimp on training: More food safety training is always better, and keeping employees well-trained, especially in critical roles, can streamline the inspection process. 
• Recruit help internally: Food safety professionals don't have to handle audit readiness alone. Identify key allies and deputize them to help ensure your facility is always ready for a surprise audit or inspection. Go beyond just supervisors and other above-the-line employees: Line workers and the folks on the ground can be an invaluable asset. 
• Practice, practice, practice: Run regular mock audits, even if only partial ones, to ensure everyone knows what to do when the real thing happens. Drill any team members who may have to interact with inspectors on processes and procedures until they can perform them blindfolded. 
• Get outside validation: Sometimes, it takes an outside perspective to help you identify blind spots and improve. Use a third-party auditor to evaluate your food safety audit readiness or run a mock inspection and provide targeted and specific feedback to help you prepare. 
• Manage food safety proactively: Prioritize a proactive approach to food safety in your facilities. Doing things the right way in advance makes inspections easier, and will help reduce incidents that can hurt your reputation or bottom line, to boot. 

If you do things right, the words "food safety audit" don't have to keep you up at night, and an inspection day can be just another day at the office. Want help preparing for an upcoming inspection or leveling up your food safety audit readiness? Contact AIB International to learn about our Regulatory Readiness service.