Three-Stage Regulatory Compliance in Food Manufacturing

Introduction

To safeguard quality and standards, food manufacturing and distribution is highly regulated. To be fully compliant, companies need insight into their complete supply chain — end-to-end from base ingredients to finished product —  and they must be prepared to act in the event of a contaminated or compromised product that jeopardizes customer health. This demands detailed and precise planning, execution, monitoring and assessment. Disconnected, manual governance, risk and compliance (GRC) tools and processes can be inefficient for the job.

The regulatory landscape in the food industry is increasingly complex, particularly for global manufacturers and distributors. Companies have to comply with all local, national and regional regulatory agencies relevant to their business. This means keeping up with evolving regulations and ever-changing circumstances. Guidelines and mandates must be interpreted, acted upon and compliance tracked. The impact on businesses is far-reaching across manufacturing, handling and food distribution.

Three-Stage Compliance

GRC is central to business operations in all industries; in food manufacturing and distribution it must be integral to the way companies work. Robust management, quality inspection and corrective action is of paramount importance. Companies that automate and streamline activities through supply chain traceability and GRC systems will be quicker to react and take control in the event of a food quality or standard issue.

The stakes are high when it comes to public health and safety. Preserving company and brand reputation depends on successful GRC and this means excellence across three stages of compliance:

1. Policy and Procedures
Regulatory compliance requires tight control over policy and procedures. Organizations need first to be fully aware of the regulations appropriate to their business, to understand what it takes to be compliant and to ensure that all staff and suppliers have up-to-date training.

In the U.S., this largely means being up-to-speed on regulations from the USDA Food Safety and Inspection Service (FSIS) and the Food and Drug Administration (FDA), which together are responsible for ensuring food safety.

2. Execution and Controls Monitoring
Organizations must take a proactive approach to food safety and compliance to mitigate against incidents and to protect their business, onward supply chain and customers.

The first step is to identify hazards, in order to stop them from causing a problem. Again, this involves being up to date on the latest information as the FDA identifies specific hazards, for example, related to agricultural products and pesticides. To help exercise effective controls, companies must choose suppliers wisely and impose rigorous prerequisites around aspects such as sanitation and pest control.

Each hazard has its own characteristics and, therefore, control measures. In the case of the pathogens Salmonella and Clostridium botulinum for example, each requires its own particular control measures.

3. Access to Data and Incident Management
A host of issues can cause a food safety standard problem. These include allergens, viral and parasitic outbreaks and bacterial contamination. One such issue occurred last year when nearly 30,000 cases of hummus had to be recalled due to a possible listeria contamination.

To maximize information capture, companies should tap into all data sources that can provide feedback on product quality. These days, this can include social media as news spreads quickly when a food standard issue occurs. Once an organization is aware of an issue, it must be able to rapidly track and trace the impact on its own production and be ready to instigate robust incident management. Preparation is key.

Earlier this year, Mars had to recall millions of confectionery bars in response to pieces of plastic found in some items. As a global brand, the task of tracking down impacted batches and isolating the production problem is significant. Thanks to the efficiency of its supply chain management systems and GRC controls, Mars was able to quickly identify the root cause, trace the contaminant back to a specific factory and track affected batches.

Many Links, One Chain

Supply chain management is all-important in regulatory compliance. No company can rapidly and successfully track forward and back the impact of an issue without knowing its supply chain. Traceability back to source and forward to consignees is essential. For example, the conditions on the farms that breed the cows for the beef that makes the hamburgers are important. Not just to the farmers (or the cows) but to all the companies that do business with those farms.

In the event that something does go wrong, the impacted organization needs to put its action plan into operation quickly. Then, root cause analysis can begin and be swiftly followed by corrective and preventive action planning.

Effective GRC for Product Recalls

Product recalls must be effectively managed for regulatory compliance and for the protection and preservation of the company’s brand reputation. The complex multi-stage process will include:

1. Making the Decision
Generally, the decision to initiate a food recall is taken voluntarily by the food manufacturer.  This could be as a result of the organization’s own issue identification — from its own tests,  industry watching or customer feedback monitoring — or from a supplier notification. Regulatory agencies may detect a problem from sample testing or field inspections.

Both FSIS and the FDA have the power to instigate a recall themselves. Such action is rare, but can occur if a company refuses to act and there is a threat to human health.

2. Communication and Investigation
The investigation must identify impacted items so that action can be taken to remove them from the food supply and to prevent any more from entering it. Communication is critical here — within the organization, with suppliers, with partners, with distributors, with governing bodies and with customers.

The recalling firm should discuss the nature of its communications with the FDA District Office Recall Coordinator, including any requirement for translation into other languages. Press releases are also used for wider notification.

The manufacturer is responsible for notifying all its recipients of the compromised food product and they, in turn, must contact all of the companies they passed it on to, in whichever form. For example, tomato purée may be used in a range of products such as sauces and pizza, as well as being sold as a product in its own right. The complexity of the food distribution and supply chain highlights the importance of swift and clear recall communication.

The timeline for the recall will vary according to the level of urgency and nature of the product. Where there is a risk to human health, action must be immediate and regular progress reports should be provided to the regulator.

The regulator will oversee the recall process and carry out audit checks to determine that diligent action was taken and that the recall was successful. FSIS or the FDA may choose to contact the likes of distributing agencies and school food authorities to confirm that they received information about the recall and acted accordingly.

Once the issue has been contained, root cause analysis can begin. Unfortunately, an all too common obstacle to this is access to required data. Electronic records and a connected, digital system of supply chain management can help here, greatly easing the task of traceability and communication.

3. Prevention and Control
Learning from a product recall must feed back into the organization to support continuous improvement and, if required, change. Regular inspections and risk assessments — across the entire supply chain — must be integral to processes and procedures as well as control measures and a comprehensive understanding of compliance. The final status report on a product recall must be shared with the relevant regulatory agency, detailing actions taken and the preventive action program implemented.

Through effective GRC, food manufacturers and distributors can help meet the requirements of regulatory compliance, manage issues when they arise and mitigate against repeat problems. By streamlining processes and procedures that expedite these activities, companies will work more effectively with supply chain partners, better serve clients and customers and ultimately drive improved business performance.