Partners in Food Safety: Non-conformance on an Audit

Audits can be critical for food manufacturers and their ability to maintain production output while meeting regulatory compliance requirements. A non-conformance result from an audit can mean very different things depending on the type of audit being performed and the specific non-conformance detected. How an organization responds to a non-conformance can have a major impact on its ability to continue to operate.

Recently, we sat down with Food Safety industry professionals Dr. Andrew Wilson from Cultivate and Dr. Byron Chaves from the University of Nebraska - Lincoln. We discussed the possible impact of a non-conformance and what next steps should be taken when: "There is a non-conformance on the audit, now what?"

Initial Reaction to a Non-Conformance

"The first thing that we want to do is ensure the safety of the product," says Dr. Chaves. "One of the first pieces of advice that I would give people is don't make unilateral decisions. You really have to talk to your team." Dr. Chaves suggests taking a moment to evaluate the situation and discuss with colleagues before taking further action. "Assess the situation, put the product on hold, and call a meeting of the food safety team."

According to Dr. Chaves, determining the appropriate response depends on the nature of the non-conformance itself and its potential impact. "It all depends on the criticality of the non-conformity. If you determine that what failed is putting the product at risk of direct or indirect adulteration that can eventually translate into somebody getting sick, then of course that is a very critical non-conformity. So having risk assessment tools and understanding the actions or events that are really going to make a difference in terms of the safety of the product will be really critical."

Beyond the immediate steps taken when a non-conformance is identified, understanding the specific scope and objectives of the audit is essential for an appropriate response.

Understanding the Scope of the Audit

An appropriate response after a non-conformance requires an understanding of what you are being audited for, according to Dr. Wilson. "The first thing is to understand the scope of the audit; what's going to be audited. The next thing is to understand what information you should have prepared and then what people you need to have prepared. Look at behaviors on the floor and understand who is going to be working during that audit. Talk to the team and tell them that the auditor may want to come and talk with you." Team members may be nervous so be clear that they may be approached by the auditor to talk about their job. Give them an idea of what is being audited so that they can understand what the auditor is looking for and reiterate that the auditor is only going to ask them for a simple explanation of how they do their job.

Being prepared for audits can be time-consuming, especially if different auditors are looking for different things. "In the United States, we have federal, state, territorial, and municipal regulatory bodies. Each level of jurisdiction has different capabilities in terms of inspecting food facilities. Of course we comply with federal regulations, but there could also be, for example, licensing requirements that are additional to what the federal government is expecting," commented Dr. Chaves.

In addition to audits from government agencies and entities, such as the FDA, FSIS, CFIA, and more, audits may be mandated by other stakeholders. Customers, for example, may have a specific set of requirements that they want to explore. Your insurance company may be looking to assess your operational risk; your own risk management team may want to perform an internal audit. Regardless of where the audit is coming from, you will want to understand the scope of the audit and what areas of the business and what data will be reviewed. Once you have clarified the audit's scope, it is crucial to approach the findings constructively. How you respond to a non-conformance can significantly impact future compliance and overall food safety outcomes.

Non-Conformance Response

If an audit produces a non-conformance, understanding the auditor's perspective is very useful and it might be worth taking time to do so. "I think one of the best things that staff can do when they receive the results of an audit is to engage the auditor again; to ask them to respectfully explain why they've come to this result, particularly around what specific evidence they've gathered to draw them to that conclusion," discusses Dr. Wilson." At the end of the day, it's going to be upon you as the FSQA lead to understand the evidence so that you can effectively undertake a root cause analysis and implement appropriate corrective action to really get to the root cause and stop that issue from recurring again."

Sometimes the response to a non-conformance is obvious, but often, further investigation is required to get to the source. "If it's documentary, it's a little easier to fix," mentioned Wilson. "You can go and review a procedure, but also in reviewing that procedure, it's important to note that it is related to behaviors that may be exhibited on the floor. You need to talk to people about what they're doing and whether it's the document that needs to be fixed, or maybe it's the people themselves that need to consider why they're acting the way that they're acting. So, when we talk about behaviors and going to that root cause analysis, if you get that evidence, go and look at the people as well as the documents. If the documents are OK, then we can concentrate on the people and understanding why that behavior might have occurred."

Audits Help Improve Food Safety

Despite their negative connotation, audits can be very beneficial to a food manufacturer. An audit allows for your food safety program and manufacturing processes to be evaluated by someone not used to the day-to-day workflow within your facility. This can help ensure regulatory compliance and assist in the identification of potential hazards such as contamination or allergen cross-contamination. In addition, audits can build trust with regulatory agencies and customers alike and help identify areas for improvement and investment.

"The messaging needs to be that non-compliances are not a bad thing. Non-compliances are something that help to improve your system and that they should be viewed as an opportunity to strengthen food safety," noted Dr. Wilson.

"I think it's important to look at how you align your internal audit processes with your regulatory audit," continued Wilson. "Is it possible to talk to regulators about understanding their audit frameworks? Can you find some information that will help you to strengthen your internal audit so that your outcomes are more aligned between your internal processes and your regulatory processes? The closer you can get those processes together, the more prepared you can be to be audited."

With the various agencies and sources of audits, it will be critical to ensure that your team is prepared for audits rather than spending time preparing. An always-on audit engine, like Neogen Analytics, allows you to have data and reporting required for an audit ready in near real time. Reports can be customized to meet the specific requirements of an agency or valued customer. To see for yourself what an always-on audit engine looks like, sign up for a demo of Neogen Analytics today.

Audits can be very beneficial for a food manufacturer if teams are informed of what is being audited and understand the audit's scope. Being receptive to the audit findings allows your organization to change and adapt as new challenges arise. Wilson pointed out, "Food safety issues come from so many different areas in the facility that you may not know, especially if you're new to that facility. So, talk to maintenance, talk to pest control, talk to lab services, talk to marketing, and see where some of these potential issues might come from." With the right approach, a non-conformance from an audit becomes an opportunity to improve food safety.

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