Ready For Tougher FSMA Regulations? How an Automated Process Can Help

October 22, 2014

By Sparta Editorial


When the Food Safety Modernization Act (FSMA) was signed into law in January 2011, it raised the standards for food safety. As a result, the food and beverage manufacturing industry saw a 41% increase in the instance of warning letters issued by the FDA. FSMA regulations only stand to get tougher, as indicated by the FDA’s new set of proposed amendments to the law that will focus on produce safety, preventive controls for human food and pet food, and changes to the foreign supplier verification program.

In the wake of FSMA and its new set of proposed amendments, it calls for manufacturers to take a more proactive approach to conducting thorough safety checks. Manufacturers should be prepared to manage potential food safety hazards by providing supporting records to ensure a risk-managed environment and quality finished product.

When a HAACP Plan Isn’t Enough

Leveraging a HAACP plan, or in the case of FSMA requirements a Hazard Analysis and Risk Based Preventative Controls (HARPC) plan, reviewing each product’s past reproduction, and monitoring how food products come and go through the production line, can help manufacturers identify a critical control point and flag it during a crucial stage of the process. Although most manufacturers currently do that today, in accordance with current Good Manufacturing Practices (GMPs) for food facilities, taking a more proactive stance and developing a strong Hazard plans that the manufacturer and suppliers stick to is important as new amendments loom.

Devising these Hazard plans isn’t enough. Implementing corrective and preventive actions (CAPA) and monitoring when those hazards occur should also be another best practice for manufacturers. Because food companies are responsible for putting plans in place, they need to be able to accurately measure those results and then determine the work flow process from that point.

Having both documented HACCP and HARPC processes and a CAPA process in place helps ensure your facility is staying on top of any hazards or issues that could relate to the quality of the final product. Leveraging technology, such as an Enterprise Quality Management System (EQMS), can help you to enforce this plan and demonstrate accountability.

Technology and Accountability: Working Hand-in-Hand

At the end of the day, it’s not just a company that’s accountable, but all of the people who are a part of that company. Technology can be leveraged to help manufacturers automate HAACP and HARPC processes and stay proactive and efficient.

Companies can easily make use of technology and an EQMS in a way that defines the company culture of quality. It shouldn’t be an added step, but a necessary part of the quality workflow processes supporting that company culture. Manufacturers can use an EQMS to identify team members and departments that play an integral role in each phase of the risk management process. Once these individuals are trained, these will be the people responsible for recording problems and expediting resolutions in an EQMS.

Using technology, manufacturers can gain greater insight into the supply chain – in real time – recording hazards, scheduling audits, and enforcing workflow processes to minimize errors and prevent other tiers in the supply chain from taking any shortcuts that may compromise quality and compliance.

In the event of facility inspections, consistent recordkeeping and standardization of processes can help reinforce standardized operating procedures. EQMS provides that central repository of data for easy access and review of incidents and corresponding corrective actions that provide assurance that a closed-loop quality process in in place.

EQMS & Technology: A Team Member That’s Always There

As we become more mobile, auditors, Directors of Quality and other managerial personnel may often out of the office on business travel; a point of contact may decide to take a vacation, or a person may leave a company.  By leveraging technology to automate checkpoints throughout the process, your team is prepared and knows what to do in the event of a quality issue without relying upon one person as the lynchpin that holds the process together.

When a red flag is raised, it’s critical to tackle the issue at hand. Time is of the essence and leveraging a system that walks everyone through the process in a logical, sequential manner ensures that no corners are cut and that no one on your team throws their hands up, wondering “What do I do now?”

Using technology to automate the process helps keep people in the loop and accountable. Rather than wonder when an issue needs to be escalated if approval or sign off has not been given for several days, it can be escalated automatically.

EQMS & the Benefits of a Transparent Process

This transparency of process is not just helpful to colleagues within your organization’s four walls, but to suppliers outside those walls. An automated, technological process can extend your organization’s culture of quality to your suppliers, holding them accountable to the same standards as your parent company. Additionally, this transparency of process is useful when dealing with larger regulatory bodies in case of an audit. In light of FSMA amendments on the horizon, leveraging technology that allows for a more robust system of supplier quality management can be impactful from a regulatory standpoint, as well.

By leveraging a web-based extension of your EQMS that can be used by second and third tier suppliers, quality events can trigger corrective action flow within the system. If an incorrect ingredient is used or packaging mislabeled, a supplier quality management system can allow your organization to incorporate the supplier and document their participation in the corrective process.

Conversely, the use of technology can give your suppliers the opportunity to alert you that a change or substitution had been made and their timely communication can trigger a quality event. Transparent communications with suppliers help to extend the culture of your organization’s internal quality and provide the collaboration that many companies are looking for to be more competitive in the marketplace.

As FDA laws are likely to get even tougher, it’s even more important for organizations to maintain visibility into the supply chain for accountability and traceability purposes. It will be critical for manufacturers and their suppliers to demonstrate their plans to regulatory bodies, along with how they are enforcing those plans.

Learn more about how your organization can more efficiently prepare for more stringent FDA and FSMA regulations. Download our whitepaper, Simplifying FSMA Compliance through Technology.

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