Tag Archives: compliance

Megan Nichols
FST Soapbox

Tips to Train Employees and Maintain FSMA Compliance

By Megan Ray Nichols
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Megan Nichols

Eight years ago, the government passed FSMA. As a manufacturer, training new and existing employees to remain compliant with legislation is paramount. The goal isn’t to make life harder for business owners—it’s to protect American consumers from unsafe food handling and transportation practices.

The following are five tips to help warehouse managers train employees while maintaining FSMA compliance.

Understand FSMA Final Rules

It’s essential for everyone in the facility, from the CEO to the newest hire, to understand the FSMA rules. According to current Good Manufacturing Practices (cGMP), everyone who works in manufacturing, processing or packaging of food is required to train in food hygiene and safety. Managers can offer training in one of two ways—through on the job experience or via an FSMA-accredited classroom curriculum.

For individuals with specialized jobs, such as quality auditors or preventative controls qualified individuals (PCQI), the training option that allows compliance with FSMA rules is an accredited curriculum.

Utilize Warehouse Management Systems

FSMA gives the FDA authority to issue mandatory recalls for any food products if deemed necessary. To meet FSMA standards, record keeping and lot tracking is a necessity. If a product type is linked to a disease outbreak, the FDA wants to know where each product in that lot is within 24 hours. Having the ability to track and trace 100% of the products ensures that the company is FSMA compliant.

A warehouse management system (WMS) can track products, but only if you train employees in its use. While the average employee won’t be responsible for tracing a production lot in the event of a recall, each worker needs to know how to enter data into the system correctly, and how to retrieve the information if necessary. Include training in your WMS to ensure compliance.

Warehouse management systems, when paired with IoT sensors, can prevent recalls and ensure compliance by monitoring temperature fluctuations in climate-controlled areas. According to the Department of Agriculture, frozen food stored at temperatures at or below -0.4° F is always safe. A comprehensive WMS can monitor the temperature inside a facility’s freezers and alert workers or management if there are dramatic fluctuations that may result in a recall.

Seek Out Alliances

Warehouse managers are not alone when it comes to creating a compliant workplace. The FDA has established and funded three alliances—Produce Safety, Food Safety Preventative Controls, and Sprout Safety—each with their own standardized curriculum designed to help those who fall under FSMA rules.These alliances work for the majority of those in the food production industry, though they may not work for everyone.

Seek out the applicable food safety alliance and see if their training curriculums apply to your facility. Even if they don’t fit directly, these alliances can give managers an excellent place to start creating their training curriculum.

Create a Culture of Compliance

FSMA isn’t designed to make life harder for warehouse managers. Its goal is to keep people safe when buying their weekly groceries. Don’t just focus on training to meet FSMA standards. Instead, create a culture of compliance throughout the facility. Make FSMA everyone’s responsibility, and make it easier for employees to communicate with management if they notice a problem that normal channels don’t address.

As part of this culture of compliance, create incentives that reward employees for reporting problems, maintaining compliance levels and completing accredited training. Sometimes incentives can be the best way to motivate employees, whether you’re offering money, paid vacation or other benefits. Walk employees through the process of how to spot a problem and report it to management.

Continue Education Throughout Employment

FSMA compliance training isn’t something you should restrict to an employee’s onboarding. It’s something you should continue throughout their time at your facility. Make FSMA education a priority for every worker in your facility. While you want to start their training with onboarding, it shouldn’t stop there. Offer new training courses once a month or every three months—as often as you’d like without compromising productivity.

As the day-to-day grind continues, most workers forget about rules and regulations. Continuing education ensures FSMA compliance is at the forefront of everyone’s mind throughout their careers. Continuing your employee’s education is also shown to increase loyalty and reduce turnover, keeping things running smoothly and preventing warehouse managers from training new workers every quarter.

Looking Forward

The FDA oversees food safety and can issue a recall when a problem occurs. Yes, as a whole, it’s the responsibility of every single person working in the food production industry—from the highest-paid CEO to the newest employee on the production floor—to maintain compliance. It’s not enough to review guidelines with new employees during onboarding.

Training is essential to ensure everyone in a facility maintains the rules laid down by FSMA. Seek out assistance in the form of the FDA-funded alliances, continue employee education and make it a point to create a culture of compliance from the moment employees walk through the door. Offer continuous training opportunities and you’ll never have to worry about breaking FSMA rules.

2019 Food Safety Consortium, Glenn Black, CFSAN, FDA

Say What? Perspectives We Heard at the 2019 Food Safety Consortium

By Maria Fontanazza
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2019 Food Safety Consortium, Glenn Black, CFSAN, FDA

Last week’s seventh annual Food Safety Consortium brought together a variety of industry experts to discuss key topics around regulation, compliance, leadership, testing, foodborne illness, food defense and more. The following are just a few sound bytes from what we heard at the event. (Click on any photo to enlarge)

Food Safety Consortium, Frank Yiannas, FDA “The food system today, while it’s still impressive, it still has one Achilles heel—lack of traceability and transparency.” – Frank Yiannas, deputy commissioner for food policy & response, FDA. Read the full article on Yiannas’ keynote session

“A typical food company only has about 5% visibility into known supply chain threats.” – Ron Stakland, senior business development, FoodChain ID, Inc.

“For most of us, our supply chain is a big black hole. Why are we so fearful of technology? Is it the implementation itself? What if technology could help us solve some of those perennial problems? There are resources available to help us get there.” – ¬ Jeremy Schneider, business development director, food safety and quality assurance, Controlant

“The records tell the story of how well the facility is being managed. It’s the first thing the regulators are going to look at.” – Glenn Black, Ph.D., associate director for research, CFSAN, FDA, on validation considerations and regulations for processing technologies in the food industry 2019 Food Safety Consortium, Glenn Black, CFSAN, FDA

“We’ll see more robotics enter the food space.” – Gina Nicholson Kramer, executive director, Savour Food Safety International

Melody Ge, Corvium, 2019 Food Safety Consortium “Changes are happening; you can choose to face it or ignore it. We’re at least 10 years behind on technology. Automation/technology is not a new term in aerospace, etc., but to us [the food industry], it is. We will get there.” – Melody Ge, head of compliance, Corvium, Inc., on how industry should prepare for the data-driven transformation occurring in the smarter era of food safety

It’s okay to risk and fail, but how are going to remediate that with your employee? The more learners practice in different scenarios, the less they rely on specific examples. [They] become more adept with dealing with decision making.” – Kathryn Birmingham, Ph.D., VP for research and development, ImEpik, on employee training

“As a contract lab with the vision of testing for foodborne viruses for about 10 years—it wasn’t until about three or four years ago that we had the test kits to turn that into a reality. We also didn’t have a reference method.” – Erin Crowley, chief scientific officer, Q Laboratories, on the viral landscape of testing in the food industry

“You have to be strong and you have to believe in yourself before you get into any situation—especially as a food safety professional.” – Al Baroudi, Ph.D., vice president of quality assurance and food safety at The Cheesecake Factory, on what it takes to earn respect as a food safety professional Jorge Hernandez, Al Baroudi, Ph.D., 2019 Food Safety Consortium

“’See something, say something’ is likely not enough. We recommend that companies develop a formal detection program that includes management buy-in, HR and governance, and policy documents, formal training and an awareness program…While FDA focuses on the insider threat, we feel that using a broader mitigation approach works best.” – R. Spencer Lane, senior security advisor, Business Protection Specialists, Inc. on lessons learned from food defense intentional adulteration vulnerability assessments

“Food safety is a profession, a vocation, [and] a way of life.” – Bob Pudlock, president of Gulf Stream Search

FDA

FDA Updates Food Defense Plan Builder to Support Compliance with Intentional Adulteration FSMA Rule

By Food Safety Tech Staff
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FDA

Attend the Food Defense Plenary Panel Discussion at the 2019 Food Safety Consortium | Tuesday, October 1, 2019Today FDA released an updated version of its Food Defense Plan Builder in efforts to help companies comply with the International Adulteration FSMA rule. Version 2.0 of the tool includes the following sections to help food facility owners and operators in developing a facility-specific food defense plan:

  • Facility Information
  • Process/Product Description
  • Vulnerability Assessment
  • Mitigation Strategies
  • Food Defense Monitoring Procedures
  • Food Defense Corrective Action Procedures
  • Food Defense Verification Procedures
  • Supporting Documents
  • Signature

The tool is for use on a computer, and FDA states that it does not have access to any content or documents used with the tool, nor does it track or monitor how the tool is being used. The agency also emphasizes that use of this tool is not required by law and its use does not mean that a company’s food defense plan is FDA approved or compliant with the IA rule requirements.

The original version of this tool was released in 2013. FDA will be conducting a demonstration of the Food Defense Plan Builder v. 2.0 during a webinar on October 10.

Melody Ge, Corvium

Corvium’s Melody Ge Joins Food Safety Tech Advisory Board

By Food Safety Tech Staff
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Melody Ge, Corvium
Melody Ge, Corvium
During the 2019 Food Safety Consortium, Melody Ge will present, “What shall we prepare in this data-driven transitioning time?” on Wednesday, October 2 | View the agenda

Melody Ge, head of compliance at Corvium, Inc. has been appointed to the Food Safety Tech/Food Safety Consortium Advisory Board. Ge joins an esteemed group of food safety professionals who care deeply about helping the industry understand and navigate the various challenges companies face on a daily basis.

“As someone who has contributed insightful knowledge to our publication, we chose to extend an invitation to Melody to join our Board because we think she will be an asset for the industry to learn from when it comes to better compliance and leveraging technology in food safety programs,” said Maria Fontanazza, editor-in-chief of Food Safety Tech, in a Corvium press release.

“All of us in the food industry understand the importance of embracing the best practices to ensure the safest products to protect the public,” said Ge. “I look forward to bringing my experience which complements so many other industry leaders already part of this organization.”

Some of Ge’s recent contributions to Food Safety Tech include:

FDA

FDA Says Routine Intentional Adulteration Inspections Will Start March 2020

By Food Safety Tech Staff
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FDA

Learn more about how to mitigate the risks of food fraud and intentional adulteration at the Food Safety Supply Chain Conference | May 29–30, 2019 | Rockville, MD or attend virtuallyThis week FDA made an announcement during a public meeting that the agency’s routine inspection to verify compliance with the FSMA Intentional Adulteration rule will start next March.

The first compliance date for the rule is this July. It is a requirement for food facilities covered under this rule to develop and implement a food defense plan that identifies vulnerabilities and the consequent mitigation plan.

FDA stated that it has received feedback on the “novel nature” of the rule’s requirements and that stakeholders want more time to develop their food defense plans. “ To allow industry time with the forthcoming materials, tools, and trainings, and because the IA rule represents new regulatory territory for all of us, we will be starting routine IA rule inspections in March 2020,” FDA stated and added that it is working on developing more resources as well as the final part of draft guidance to continue to assist industry.

2019 Food Safety Supply Chain Conference

FDA to Provide FSMA Update at 2019 Food Safety Supply Chain Conference

By Food Safety Tech Staff
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2019 Food Safety Supply Chain Conference

EDGARTOWN, MA, April 8, 2019 – Innovative Publishing Co., publisher of Food Safety Tech, has announced three speakers from FDA will kick off the 5th Annual Food Safety Supply Chain Conference on May 29–30. Priya Rathnam, Supervisory Consumer Safety Officer, CFSAN; Andrew J. Seaborn, Supervisory Consumer Safety Officer, Division of Import Operations, ORA; and Lisa L. Ross, Consumer Safety Officer, CFSAN (Office of Food Safety, Multi-Commodity Foods, Refrigerated and Frozen Foods Team) will provide the opening presentations on Wednesday, May 29. An interactive Town Hall with attendees will follow.

Lisa Ross, CFSAN, FDA
Lisa L. Ross, Consumer Safety Officer, CFSAN

Seaborn, Rathnam and Ross will provide FDA perspective on FSVP inspection updates, including outcomes and compliance, the voluntary qualified importer program (VQIP) and where the agency is headed with enforcement activities. They will also take a deeper dive into supply chain requirements as per subpart G of part 117.

“As FDA continues its ‘educate while regulate’ strategy, having FDA officials present to inform attendees of the agency’s latest activities, available resources for industry, and how industry can work together with FDA in achieving compliance provides a crucial benefit,” said Rick Biros, president of Innovative Publishing Co., Inc. and director of the Food Safety Supply Chain Conference. “Andrew and Priya added tremendous insights to the conference last year, and I am thrilled to welcome them back, along with the addition of Lisa this year.”

The Food Safety Supply Chain conference takes place May 29–30 in Rockville, MD. Registration is open with a virtual attendee option as well.

Rick Biros, Priya Rathnam, and Andrew Seaborn, 2018 Food Safety Supply Chain Conference
Priya Rathnam (middle) pictured with Rick Biros, president of Innovative Publishing (left) and Andrew J. Seaborn,Supervisory Consumer Safety Officer, Division of Import Operations, ORA, FDA at the 2018 Food Safety Supply Chain Conference

About Food Safety Tech

Food Safety Tech publishes news, technology, trends, regulations, and expert opinions on food safety, food quality, food business and food sustainability. We also offer educational, career advancement and networking opportunities to the global food industry. This information exchange is facilitated through ePublishing, digital and live events.

About the Food Safety Supply Chain Conference

A food company’s supply chain can be the weakest link in their food safety program. Food ingredient adulteration, fraud, and counterfeiting negatively impacts everyone in the food supply chain. FDA has recognized the risk in the food supply chain. Sanitary transportation and the Foreign Supplier Verification Program (FSVP) are major components of FSMA. The Food Safety Supply Chain Conference addresses best practices, and new tools and technologies that can help food companies, including manufacturers, retailers and food service companies protect their brands and customers from food safety threats in their supply chain while being compliant with regulators.

FDA

Routine Produce Inspections to Start in Spring, FDA Offering Compliance Support

By Food Safety Tech Staff
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FDA

After FDA delayed product inspections under FSMA to further prepare industry and ensure there was enough training and education, the agency is reminding farmers and other stakeholders in the produce industry that there are resources available to help them in preparing for the routine inspections—for large farms, these will start in the spring. The inspections will be conducted to verify compliance with the Produce Safety rule.

Resources include the FDA’s produce safety inspections page on its website to serve as a central resource for industry and state partners during the inspection preparation process and the draft guidance, “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption”.

An FDA Voices blog by FDA Commissioner Scott Gottlieb, M.D., Deputy Commissioner for Food Policy and Response Frank Yiannas and Associate Commissioner of Regulatory Affairs Melinda Plaisier also discussed how the agency has been supporting industry work to comply with the rule, including:

  • Granting 46 states and one territory with more than $85 million through the State Produce Implementation Cooperative Agreement Program to aid in the development of state produce safety systems that offer education, outreach and technical assistance
  • With partners, supporting the training of more than 31,000 produce farmers globally on the Produce Safety rule requirements
  • The sharing of expertise via the FDA’s Produce Safety Network
  • With partners, the creation of a new inspection form that gives farms feedback and observations that occurred during the inspection, regardless of whether non-compliance issues were found, in an effort to help explain what they’re looking at and how observations apply to the produce rule
Food Safety Tech

Call for Abstracts: Be a Part of the 2019 Food Safety Supply Chain Conference

By Food Safety Tech Staff
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Food Safety Tech

The supply chain is a potentially weak and vulnerable part of a company’s food safety plan. The annual Food Safety Supply Chain Conference is months away and we are accepting abstracts for presentations. The conference takes place May 29–30, 2019 in Rockville, MD.

If you have expertise in the following areas, we invite you to submit an abstract to present at the conference:

  • Food Safety Supply Chain Vulnerabilities & Solutions
  • Audits & Inspections
  • How to Write Supplier Specifications
  • Blockchain Technology
  • FSMA’s Sanitary Transportation Compliance Tools & Techniques
  • Supply Chain Traceability
  • FSMA’s FSVP Compliance Tools & Best Practices
  • Data, Predictive Analysis
  • Recalls: barcode labeling, case histories and lessons learned
  • Testing Strategies of the Supply Chain
  • Supplier Verification Best Practices
  • Supply Chain Risk Management
  • Food Safety Transportation, Distribution and Logistics
  • Food Authenticity
  • Food Safety/Quality Culture measurement in supplier management
  • Supplier Management Case Histories

Each abstract will be judged based on educational merit. The submission deadline is February 8, 2019.

Rizepoint Exhibiting at #2018FSC: A Better Supplier Quality Management Solution

RizePoint, a leading provider of brand, quality, and safety management software (QMS), will be exhibiting at Food Safety Consortium (FSC) in Chicago from November 13–15, 2018.

FSC is the first event where the company is demonstrating the new functionality for frictionless supplier onboarding and upgraded supplier quality management (SQM). This product enhancement helps managers in any industry onboard, track, and communicate with suppliers and vendors to help ensure regulatory and company standards compliance. Demonstrations will take place in booth 121 during exhibition hours.

“This expanded supplier quality solution further demonstrates RizePoint’s commitment to foster brand protection. We have enhanced the supplier onboarding experience, improved communication with suppliers, and made tracking compliance documents simple and easy.” – Frank Maylett, RizePoint

The update to the RizePoint enterprise compliance SaaS solution also includes:

  • Creating clear and simple onboarding workflows
  • Configuring forms and surveys based on your specific business needs
  • Building reports and dashboards that help you see into the health of supplier compliance
  • Setting due dates with automated alerts for expiring qualifying documents
  • Automating CAPA with triggered alerts and communications

About RizePoint

RizePoint offers a robust software solution that helps companies keep brand promises through their quality and compliance efforts. Our customers gather better data, see necessary actions earlier, and act faster to correct issues before they become costly liabilities. Considered the industry standard for food service, hospitality, and retail, RizePoint mobile and cloud-based solutions serve millions of audits every year. RizePoint is headquartered in Salt Lake City, Utah. For more information, visit RizePoint.com.

About Food Safety Consortium

The Food Safety Consortium is a premier educational and networking event for food safety solutions. Attracting the most influential minds in Food Safety, the Consortium enables attendees to engage conversations that are critical for advancing careers and organizations alike. Visit with exhibitors to learn about cutting edge solutions, explore five diverse educational tracks for learning valuable industry trends, and network with industry executives to find solutions to improve quality, efficiency and cost effectiveness in an ever-changing, global food safety market. Learn more about FSC at http://foodsafetyconsortium.net/.

Michael Koeris, Ph.D. and vice president of operations, Sample6, pathogen detection
FST Soapbox

The True Costs You Endure During a Food Recall

By Michael Koeris, Ph.D.
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Michael Koeris, Ph.D. and vice president of operations, Sample6, pathogen detection

When you think about the expense of a recall, you probably automatically focus on the costs to pull the affected product from shelves and reimburse customers. Yes, this can be an expensive undertaking. But the true, comprehensive cost of a recall involves immensely more than these obvious financial tolls. Do you fully understand the price to be paid when your organization is up against a food recall?

The recall process in the food manufacturing industry is a highly expensive one, averaging more than $10 million in costs to cover activities such as communicating the recall across the supply chain, retrieving and handling the recalled product, investigating the event and implementing corrective actions to prevent reoccurrence.

Of course, this average doesn’t address the possibility of litigation costs, decreased sales, reputational damage or brand crisis management, which can add up to millions—even billions— of dollars more. The public has become much more informed and aware of food safety events, and a single breach of trust could result in resounding losses to your brand. This makes it critical to understand the true costs you endure when faced with a food recall.

Immediate, Direct Costs

A recall can be a company-defining event. The vast majority of recalls are voluntary and a reflection of conscientious behavior by the retailers, wholesalers and producers, but that doesn’t mean you won’t incur serious expenses. The most obvious, immediate and direct ones include:

  • Pausing production to carry out recall response initiatives
  • Alerting necessary parties within and outside the organization, including regulatory agencies and relevant retailers
  • Managing the logistics of removing affected or mislabeled products
  • Examining the source of the recall, including issues with suppliers, equipment, processes or contamination prevention plans
  • Remediating the identified problems to prevent similar occurrences
  • Planning for expanded human resources to handle recall tasks in addition to routine operations

Again, these expenses could equate to millions of dollars from your bottom line, but the truth is they may be the most minor of your concerns in the face of a food recall.

Compliance Penalties

As you likely know by now, there’s a monumental shift happening in the regulatory arena. FSMA has enacted strict laws that place a greater emphasis on proactive and preventive approaches to food safety. In addition, the USDA has been focusing on strong enforcement of its guidelines for years.

For manufacturers, this means adjusting processes and procedures to comply with legal requirements for monitoring, testing, documentation, risk assessment and more. It is not enough for companies to have a plan for taking corrective action on contaminated products; they must also have a strong preventive plan in place to identify pathogens in the production environment before they affect the product and/or leave the facility. If your company undergoes an FDA or USDA audit or investigation that reveals noncompliance with government-mandated prevention efforts, you could be looking at significant consequences like criminal fines and forfeitures to the U.S. government.

FSMA laws and USDA regulations stipulate that depending on the nature of the violation, and whether the food is adulterated or misbranded, the FDA or USDA may consider regulatory actions, including:

  • Issuing advisory letters
  • Initiating court actions, such as seizure or injunction
  • Implementing administrative detention to gain control of adulterated or misbranded products
  • Mandating a recall of violative food
  • Suspending a facility’s food registration to prevent the shipment of food

Lawsuits and Litigation

According to the CDC, 48 million people get sick from foodborne illness each year, 128,000 are hospitalized and 3,000 die. If your organization is sued on the basis of a contaminated or unsafe product, you can expect to deal with attorney fees, court costs and settlements. In the worst cases, you may even need to pay damages to harmed consumers.

Yes, prosecutions are rare. But they are a reflection of a failure to protect consumers, as well as potential negligence or (in the rarest of cases) malicious intent. The financial effects of these reputational scars go well beyond obvious litigation expenses.

Lost Sales

Once a recall is ordered, a series of actions unfold that drastically impact your income. Manufacturers halt production, and retailers pull products from their shelves. Worse, a loss in consumer trust can initiate a long-lasting sales depression. Your customers want to know that the products they’re buying are safe. In response to a recall, they may change their purchasing, food preparation and consumption practices, or they may avoid the product for months or years after the recall has ended.

Insurance Impacts

Most food companies have recall insurance to protect their assets if a recall occurs. But, are you fully informed on what it means to work through a recall with your underwriter or how a recall affects your premiums? Is there a possibility of losing your insurance? It’s crucial to understand how your insurance is affected by a recall and what is contractually covered under your plan.

Brand Deterioration

Recalls are happening more frequently today than ever before, for reasons including stricter compliance regulations and supercharged government testing regimes using novel technologies like next-generation sequencing. This increased focus on testing by the government has led to a greater discovery rate of contamination, which is a good thing for the public. It means that improvements will be made to yield an even safer food production environment.

Nonetheless, recalls are alarming to your customers, and the last thing you want to risk is their trust in your brand. At the end of the day, your brand is your primary asset. It is a representation of who you are and how you do business. When recalls happen, customers lose faith in your brand, which comes with a hefty price tag for your company. If your brand deteriorates due to consumer mistrust, you’re risking business failure.

Unfortunately for the food industry, stories exposing scandals are a proven way to catch the public’s eye. Therefore, any news of a recall receives immediate and aggressive media coverage from both traditional and social media platforms. In the event of a recall, publicity is inevitable, and it’s an expense that spans every aspect from public relations management to eroded sales.