Closing the Loop on Common Internal Audit Gaps

Non-compliance with FDA regulations can lead to significant financial and legal ramifications for your business — as well as pose a risk to public health. And with recent FDA workforce reductions limiting oversight resources, manufacturers are facing increased pressure to meet food safety compliance standards. That’s where food safety internal audits come in; while not always mandated by the FDA, they are widely recognized as an essential measure to protect consumers, increase internal food safety accountability, and ensure operations remain compliant.

However, internal audits are only as effective as they are thorough. Blind spots could put your food safety efforts at risk, so keeping an eye out for commonly neglected areas during your internal audit (and knowing how to fix them) is key to maintaining compliance and optimizing your internal audit process. 

The Importance of an Effective Food Safety Self Audit

A well-maintained internal audit process is more than just checking off items on a list; it must account for all production areas and processes, define roles, document processes thoroughly, and allow for adjustments to address problem areas. Effective internal audits allow operations to:

• Proactively identify food safety issues: Performing effective self audits allows you to keep tabs on every step of your food manufacturing process — and where they could go wrong. A thorough internal assessment can help identify otherwise hidden food safety hazards and address them before they become an issue, delay production, or cause a recall.
• Help ensure compliance: When performed to their full potential, food safety internal audits can help you maintain compliance with national standards, like FDA regulations, as well as international standards. Performing internal audits regularly allows your team to identify and fix issues before an external auditor deems you noncompliant.
• Strengthen food safety culture: Reinforcing the importance of food safety internal audits to your employees is essential to fostering a successful overall food safety culture. Periodic, randomized internal audits encourage employees to stay prepared at all times, avoid complacency, remain vigilant for common hazards, and prioritize food safety.

Tapping into these key advantages may require your team to reevaluate its current food safety self-audit process. But to improve your audit skills, you must first understand common roadblocks and implement solutions that will drive success. 

Common Food Safety Internal Audit Gaps and How to Solve Them

Internal food safety audits are complex, and with so many elements and processes to consider, sometimes hazards can slip through the cracks. Contamination can lead to food safety incidents, recalls, and legal action or fines. Identifying food safety hazards in your production processes enables you to address them before they become problems for your business, so it’s crucial to perform thorough internal audits that go beyond surface-level checks, include verification of preventive controls, and cover the entire operational area. Here’s a look at common areas where internal audits often fall short (and how you can alter your audit processes to address them). 

Incomplete Documentation

During a regulatory food safety audit, your evaluator won't just take your word on your food safety practices. They'll require documentation — the more thorough, the better. This recordkeeping must cover food safety processes such as:

• Training records
• Sanitation logs
• Food safety plan
• Standard operating procedures
• Corrective actions records
• Product traceability records
• Supplier verification records (when applicable)

Sub-par documentation can put your operation at risk of noncompliance. This is especially true thanks to the latest updates to the Requirements for Additional Traceability Records for Certain Foods outlined in FSMA 204 — which impose stricter traceability recordkeeping guidelines for foods on the Food Traceability List.

How to Avoid It: Ensure that your documentation system meets regulatory requirements during food safety internal audits — and that your employees follow recordkeeping protocols. Your team should maintain detailed records of logs, checklists, corrective actions, and more to demonstrate traceability, compliance, and verification during a third-party audit. 

Overlooking Cross-Contact Risks

Allergen cross-contact is a serious threat to food safety compliance, and it can happen at any time during product manufacturing, including during processes like:

• Product line changeovers
• Rework
• Ingredient receiving and warehousing
• Improper packaging control or labeling

But even though cross-contact is a major food safety threat, some operations don’t prioritize reviewing allergen management practices during their food safety internal audits, and could leave themselves exposed to a potential recall as a result.

How to Avoid It: To prevent allergen cross-contact issues in your operation, review cross-contact controls during every internal review, including sanitation processes, potential exposure areas, and production scheduling practices. Checking these processes regularly can protect both you and your customers from the ramifications of undeclared allergens and a potential recall. 

Lack of Mock Recall Testing

Despite best efforts, recalls are an inevitable part of the food manufacturing industry. In the event of a recall, your team must be prepared to handle:

• Product traceability
• Crisis communication
• Internal investigations
• Rapid response
• Recall documentation

A speedy, thorough response is crucial to mitigating damage — to your business and consumers alike. But the worst time for you to find out you're not prepared is during a food safety incident. Without mock recall testing, your team will be vulnerable to mistakes and inefficiencies during the real thing.

How to Avoid It: Make mock recall testing part of your food safety plan. Schedule regular, randomized testing and time your response to ensure your team can act quickly under pressure — reacting, communicating, and documenting in accordance with regulations. Discuss results with employees to identify potential bottlenecks and address them proactively. 

Infrequent Self Audits

It’s unwise to wait until just before a regulatory audit to review your operation’s compliance, as any issues you find in last-minute internal audits likely won't be fixable in time for an auditor visit. Likewise, waiting too long in between self audits could allow ineffective processes to slip by unnoticed over time.

Delaying internal audits can lead to noncompliance. Allowing sufficient time to identify, respond to, and correct potential food safety issues before a third-party audit (or a food safety incident) is essential to building out a food safety self-audit plan.

How to Avoid It: Schedule regular internal audits to allow time to address incorrect processes or potential hazards before you're assessed for compliance. Randomizing your audit schedule will also encourage your team to follow food safety best practices all the time (not just in anticipation of an external audit). This preparedness can foster more consistent performance, streamline regulatory audits, and provide a better snapshot of what your operations look like on a given day. 

Ignoring Floor-Level Feedback

Your floor operators are the first line of defense when it comes to identifying food safety issues. But many businesses don't consider their perspective — or even ask for it at all. Avoid this mistake; your frontline employees have the most hands-on experience with your production and know where your operation might be falling short of food safety standards. Ignoring their insight can leave you vulnerable to potential food safety incidents. 

How to Avoid It: Establish feedback loops and foster a food safety culture that encourages speaking up about potential issues. Your team should feel comfortable sharing their perspective on food safety, good or bad. Using methods like feedback forms, suggestion boxes, town halls, and more can help you gather this vital information and make adjustments based on your team’s experience.

Avoid these common pitfalls and maximize compliance by optimizing your operation’s approach to food safety internal audits. Treat every audit as an opportunity not only to pass, but to improve your system and company culture to meet future regulatory and customer demands. And when in doubt, don’t be afraid to lean on expert help. 

Strengthening Your Internal Audit Process With AIB International

Internal audits are the backbone of your food safety compliance efforts. Even with robust food safety practices in place, you must ensure that employees are following proper protocol and your processes aren’t falling short; waiting until an external regulatory audit is a recipe for noncompliance.

Unsure where to begin strengthening your internal food safety audit process? AIB International's Internal Auditing Techniques course can help your team identify gaps, adjust processes accordingly, and prepare for regulatory scrutiny.