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FSMA: Responding To A New Era Of Regulations

With world-leading technology and transportation supported by regulations and laws, the food supply in the United States is considered relatively safe and secure. Yet each year about 48 million Americans get sick from foodborne diseases, according to Home Food Safety. Of those, 128,000 are hospitalized and 3,000 die every year.

With world-leading technology and transportation supported by regulations and laws, the food supply in the United States is considered relatively safe and secure. Yet each year about 48 million Americans get sick from foodborne diseases, according to Home Food Safety. Of those, 128,000 are hospitalized and 3,000 die every year.

The 2011 Food Safety Modernization Act (FSMA), which puts greater emphasis on preventing foodborne illness, was enacted to enhance accountability in today’s globally intertwined food supply chain. The law gives the Food & Drug Administration (FDA) broader authority to inspect records related to food. Under the provisions of the FSMA, companies will be required to develop and implement written food safety plans.

In addition, the FDA will also have the authority to better respond to and require recalls when food safety problems occur as well as the ability to better ensure that imported foods are as safe for consumers as foods produced in the United States. Proponents say the law makes everyone responsible and accountable at each step in the food supply chain, whether producing, processing, transporting or preparing foods.

Regardless of how the food industry reacts to the law, companies must adapt to these new regulatory realities and renewed scrutiny or face a stark reality: without making changes, they may very well be left behind.

Documentation: Keep critical records in compliance

To ensure compliance, all registered facilities must conduct a hazard analysis and develop and implement a written preventive controls plan that evaluates hazards; identifies and implements preventive controls; monitors the performance of those controls; and maintains records of such monitoring and preventive controls for two years.

In essence, it means companies need to have in place a current, validated and verified food safety program subject to annual review.

The key to responding to these new regulatory teeth is to organize and clean up existing documentation, establish a system to control documents going forward and implement adequate policies to ensure ongoing compliance.

Just as the new law is intended to modernize regulations, this is an opportunity for the industry to adapt to new technology that manages documents and information, including tools that can digitally and centrally store inspection records.

Companies seeking a solution should look for a system that provides electronic approval and access; efficient storage; document identification numbers that can easily be searched; a full audit trail of previous revisions; and a fully reportable indexed document system. When new documents come in, they should be entered into the system and immediately tracked, stored and instantly available for managers, employees—and auditors.

Audits: Access data timely and orderly

Stepped-up and more complex audits will be more prevalent under the new law, and the industry needs to be prepared with quick access to systems that provide a robust and accurate history of records.

Preparing for audits, administering inspections, recording observations and scoring and trending results is a necessary activity for any successful food company. Today, a successful audit means keeping all the information you need accessible, electronic and actionable.

An electronic solution ensures only the most current documentation is available, that gaps in compliance can easily be found and that all company processes are electronically routed. All the information you need for a successful audit is right at your (and your auditor’s) fingertips. With the right system, audit readiness is a matter of clicks, not hours.

Traceability: Managing data for maximum recall

When it comes to food recalls, everyone involved has to own the process and isolate the potential for danger. You need to be able to have the ability to provide records quickly. You need to track every retail establishment selling your product.

The FSMA requires traceability one step up and one step back from your contribution to the production process. This includes packaging, processing, work in progress, rework and potentially even your waste materials. Among other components, the law provides for whistleblower protection, increased inspections, increased record-keeping requirements and more authority to review records.

You’ll need to be ready—whether HACCP records, inspection data, supplier history, customer complaints, corrective actions or others.

Digitization: Get wired or get fired

Despite its restrictions and short-term pain, the new law is an opportunity to enhance quality in the food industry. Rather than spend countless hours compiling paper and verifying data to meet the new requirements, the industry will need to fully embrace an electronic solution that ensures documents are up to date and performing under the rigors of the production environment.

Having the right compliance software helps you do what you say and say what you do with a controlled electronic environment that prevents issues and accidents associated with manual record-keeping.

One significant benefit of the new law is its emphasis on food safety plans and recall scenarios. An electronic system can reduce the time to plan and execute scenarios from weeks to days.

Implementation of the law is also a good time to contemplate the future of your business—what automation will be needed to maximize your efficiency and profitability? What other regulations are around the corner that will impact your business? What can you afford to spend on the next audit or recall?

Managing regulations won’t be getting any easier. In fact, with more frequent audits and other mandates, it will indeed become more challenging. More tools and technology will be needed for better record keeping and growing demands.

The industry—finally—is embracing automation as a way to combat the growing complexity of regulations and bigger magnifying glass of compliance.

The author wishes to thank Christine M Humphrey, Esq. and Cathy Crawford for their assistance in preparing this article.

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