Tag Archives: food safety hazards

Workers production line

Beyond Detection: Building a Multi-Layered Food Safety Defense System

By Michael Ciepiela
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Workers production line

In today’s rapidly evolving food safety landscape, recalls continue to outpace many of the advancements made in manufacturing efficiency, automation, and operational performance. Early in my career, a member of the operations team once told me, “If those belts aren’t running, we aren’t making any money.” To a certain extent, that statement is true. The purpose of manufacturing is to efficiently produce a quality product that consumers enjoy. However, in the food and beverage industry, success is measured by more than throughput and production volume. Unlike the latest television or smartphone, where the Voice of the Customer (VoC) may focus on features and performance, food consumers have a much simpler expectation: confidence that the product they are consuming is safe. The challenge arises when operational excellence begins to outpace the food safety systems designed to protect both consumers and brands.

Growth, continuous improvement, and increased throughput should never come at the expense of robust food safety practices. Instead, food safety programs must evolve alongside manufacturing operations to ensure both objectives advance together. The industry frequently discusses food safety culture and what it truly means to establish and sustain one. A strong food safety culture is not achieved simply through policies, procedures, or certifications; it is demonstrated when organizations refuse to compromise established controls, even when production pressures mount. Finding new ways to “keep the belts moving” should never result in bypassing the safeguards designed to prevent food safety failures. Food safety is not the responsibility of a single department—it is a shared responsibility that extends across operations, quality, sanitation, maintenance, supply chain, and leadership teams alike.

During my 13 years in the food industry, I have witnessed a remarkable transformation in how food safety programs are managed. The industry has progressed from paper-based records and spreadsheets to sophisticated Electronic Quality Management Systems (EQMS) capable of real-time monitoring, automated workflows, and predictive analytics powered by artificial intelligence. At the same time, consumers, customers, and regulators are demanding greater transparency, stronger supply chain oversight, and higher standards of accountability than ever before. As a result, food safety and food defense can no longer rely solely on hazard detection. The future of food safety lies in prevention through a multi-layered defense system that integrates supplier controls, facility design, environmental monitoring, advanced detection technologies, employee engagement, and data-driven decision making. The most effective food safety systems are not those that detect hazards after they occur, but those designed to prevent hazards from occurring in the first place.

So, what is a hazard?

Under the Food Safety Modernization Act (FSMA), food manufacturers are required to identify and evaluate potential hazards that could be introduced, occur naturally, or be unintentionally introduced throughout their manufacturing processes. This evaluation extends beyond the product itself and includes every step of the process flow, from receiving raw materials to packaging and distribution. Manufacturers must also consider all process inputs, such as water, ice, compressed air, and employee handling practices, as well as outputs including waste streams, rework, and by-products that could impact food safety.

In addition to evaluating process-related hazards, manufacturers are required to conduct a hazard analysis for each ingredient used in their products. Whether the finished product consists of a single commodity, such as fresh produce, or a complex multi-ingredient formulation, every ingredient must be assessed for potential biological, chemical, and physical hazards. These hazards may originate from the raw material itself, the supplier’s manufacturing practices, transportation conditions, storage environments, or the processing activities conducted within the facility.

A hazard is generally defined as any biological, chemical, or physical agent that has the potential to cause illness, injury, or adverse health effects if not properly controlled. Examples include pathogenic microorganisms such as Salmonella or Listeria monocytogenes, undeclared allergens, cleaning chemical residues, metal fragments, glass, plastic, or other foreign materials. Understanding where hazards originate and how they can enter the food supply chain is the foundation of an effective food safety system and serves as the first step toward developing preventive controls designed to mitigate risk before contamination occurs.

Following the Process Flow

When people hear the phrase “hazard intrusion,” it is natural to immediately think of physical foreign materials such as plastic, metal, glass, wood, or other extraneous objects entering a product. While physical hazards are often the most visible and easiest for consumers to recognize, they represent only one category of food safety hazards. An effective food safety program must also account for chemical hazards, such as undeclared allergens, cleaning and sanitation chemicals, lubricants, and pesticide residues, as well as biological hazards, including pathogenic microorganisms such as Salmonella, Listeria monocytogenes, and pathogenic strains of E. coli.

One of the greatest challenges facing food manufacturers is that these hazards can be introduced at virtually any point throughout the supply chain and production process. Hazards may originate from raw materials and ingredients, supplier practices, employee handling, equipment design, utility systems such as water or compressed air, sanitation activities, environmental conditions, packaging materials, or transportation practices. Even after multiple preventive controls have been established, opportunities for contamination can still exist if systems are not properly maintained and verified.

This reality highlights why modern food safety programs can no longer focus solely on detecting hazards in finished products. Organizations must implement multiple layers of preventive controls designed to identify, mitigate, and control risks before they impact product safety. Understanding how physical, chemical, and biological hazards can enter the process is the first step toward building a comprehensive food safety defense system capable of protecting both consumers and brands.

Shifting to Prevention

While the detection of a food safety hazard before product release is certainly a success, it often still carries significant consequences for the manufacturer. Foreign material findings, allergen cross-contact events, or pathogen detections frequently result in product holds, rework, additional inspections, production downtime, investigations, and increased labor costs. Although these outcomes are far preferable to releasing contaminated product into commerce, they still represent failures somewhere within the process that require resources to correct and manage.

The consequences become substantially greater when a hazard is not detected and affected product reaches the consumer. Product recalls can cost organizations millions of dollars in direct and indirect expenses, including product retrieval, disposal, regulatory oversight, legal liability, lost sales, brand damage, and diminished consumer trust. In many cases, the long-term impact on a company’s reputation can far exceed the immediate financial costs associated with the recall itself. For this reason, food safety professionals often face the challenge of justifying investments in new technologies, equipment, and preventive control programs, particularly when capital expenditures are under scrutiny.

This is where the philosophy of modern food safety has fundamentally shifted. Rather than relying solely on detection systems to identify hazards after they have occurred, organizations are increasingly investing in preventive measures designed to stop hazards from entering the process altogether. Enhanced supplier verification programs, sanitary equipment design, environmental monitoring, allergen management systems, predictive analytics, employee training, and advanced inspection technologies all serve as layers of protection that reduce risk before contamination occurs. The most effective food safety programs recognize that while detection remains essential, prevention delivers the greatest return by protecting consumers, preserving brand integrity, and avoiding the substantial costs associated with food safety failures.

Controls That Matter

Mitigating food safety risks and potential points of hazard intrusion throughout the manufacturing process requires the implementation of control measures designed to either prevent, eliminate, or reduce hazards to acceptable levels. Depending on the nature and severity of the hazard, these controls may be managed as preventive controls within a food safety plan or identified as Critical Control Points (CCPs). Regardless of the designation, each control must be supported by appropriate monitoring, verification, and corrective action procedures to ensure effectiveness. While every food manufacturing operation is unique, biological, chemical, and physical hazards each have distinct monitoring and control strategies.

Biological hazard controls are often centered around an Environmental Monitoring Program (EMP), which serves as an early warning system for potential pathogen harborage within the facility. Areas identified as higher risk for pathogen growth, particularly those located near food contact surfaces, are routinely swabbed on a predetermined frequency to verify sanitary conditions. These locations may include floor drains, equipment framework, conveyor supports, wheels, and, in some cases, food contact surfaces themselves. Depending on the product and associated risk profile, finished product pathogen testing may also be performed to further validate that products are free from contamination. However, biological hazard prevention extends beyond testing programs. Effective sanitation procedures, hygienically designed equipment, validated cleaning methods, sanitizer concentration monitoring, and ATP verification programs all play a critical role in reducing risk. As I often say, production starts with sanitation; without effective cleaning and sanitation practices, even the most advanced food safety programs can quickly become ineffective.

Chemical hazard controls focus primarily on preventing contamination from allergens, cleaning compounds, lubricants, and other chemical agents used throughout the facility. Verification that food contact surfaces are free from detergent and sanitizer residues prior to production is a critical component of any sanitation program. Equally important is the management of allergen cross-contact through proper cleaning validation, product scheduling, segregation practices, employee training, and label verification programs. The consequences of allergen contamination can be severe, particularly for sensitive consumers, with reactions ranging from mild discomfort to life-threatening anaphylaxis. As a result, undeclared allergens continue to be one of the leading causes of food recalls across the industry.

Physical hazard controls are designed to prevent or detect foreign materials before they reach the consumer. Common preventive measures include equipment inspections, preventive maintenance programs, sanitary equipment design, and foreign material control programs. Detection technologies such as metal detectors and X-ray systems are frequently implemented as CCPs or preventive controls to identify and remove contaminated product from the production stream. Depending on the manufacturing process, additional controls such as magnets, screens, filters, and sieves may be utilized to capture foreign materials before they enter finished products. While these systems are highly effective at detecting hazards, they should be viewed as one layer within a broader prevention strategy rather than the sole means of protection.

The most successful food safety programs recognize that no single control can eliminate all risk. Instead, they rely on multiple layers of preventive and monitoring activities working together to identify hazards early, prevent contamination events, and protect both consumers and the organization.

Creating a Culture of Prevention

Even the most robust food safety systems, advanced detection technologies, and comprehensive preventive controls can fail if the organization does not foster a culture that supports them. Food safety culture is the collective mindset, behaviors, and values that influence how employees approach food safety on a daily basis, especially when no one is watching. Building a culture of prevention requires more than annual training sessions or compliance audits; it requires visible leadership commitment, employee engagement, accountability, and continuous communication across all levels of the organization. From sanitation personnel and machine operators to supervisors and executive leadership, every individual plays a role in identifying risks, reporting concerns, and protecting consumers. When food safety becomes embedded into everyday decision-making rather than treated as a regulatory requirement, organizations move beyond simply reacting to hazards and begin proactively preventing them. Ultimately, the strongest defense against biological, chemical, and physical hazards is not a piece of equipment or a written procedure, but a workforce that understands the importance of food safety and is empowered to uphold it every day.

What the Future Holds for Food Safety Hazard Prevention

The food industry has made tremendous advancements in technology, automation, and operational efficiency, yet the fundamental responsibility remains unchanged: producing safe food for consumers. While detection systems such as metal detectors, X-ray units, environmental monitoring programs, allergen testing, and pathogen analyses remain critical components of a food safety program, the future of food safety lies in prevention. The most successful organizations recognize that hazard control is not achieved through a single piece of equipment, a laboratory result, or a regulatory requirement, but through a comprehensive system of preventive controls working together to reduce risk before contamination occurs.

Building an effective food safety defense system requires a multi-layered approach that incorporates supplier oversight, hygienic design, sanitation, environmental monitoring, allergen management, foreign material controls, employee engagement, and emerging technologies. Equally important is fostering a culture where every employee understands their role in protecting the consumer and where food safety is viewed as a shared responsibility rather than the sole responsibility of the Quality department. When food safety programs evolve alongside operational growth, organizations can achieve both production excellence and consumer protection without sacrificing one for the other.

At the end of the day, keeping the belts running is important, but ensuring that every product leaving the facility is safe is what sustains consumer trust, protects brand integrity, and ultimately keeps those belts running for years to come. The strongest food safety programs are not those that simply detect hazards—they are the ones that prevent them.

Food Safety Hazards Conference

The Food Safety Hazards Conference will take place April 20-22 in St. Louis MO. The Program is two and a half days of high-level panel discussions and educational presentations focused on the detection, mitigation, control and regulations of food safety hazards through technology, best practices and data analytics. The Hazards addresses in the program include Listeria, e-Coli, Salmonella, Allergens, Chemicals and Foreign Matter.

Food Safety Consortium 2023
From the Editor’s Desk

Call For Abstracts: 2023 Food Safety Consortium

Food Safety Consortium 2023

Are you ready to share your knowledge, experience or research with fellow food safety and quality assurance professionals? Food Safety Tech is requesting abstracts for the 11th Annual Food Safety Consortium, which will take place October 16-18, 2023, at the Hilton in Parsippany, New Jersey.

We are accepting abstracts for educational presentations, panel discussions and Posters for a new Poster Session. All abstracts, which are due by March 31, will be judged based on the educational value.

Submit abstracts here.

Presented by Food Safety Tech, the Food Safety Consortium is a business-to-business conference that brings together food safety and quality assurance professionals for education, networking and discussion geared toward solving the key challenges facing the food safety industry today.

In addition to two full days of high-level panel discussions, this year’s program will include a second Food Safety Hazards track. These “Boots on the Ground” sessions build on the success of Food Safety Tech’s virtual Food Safety Hazards program by providing two days of education on the detection, mitigation, control and regulation of key pathogen, pest, chemical and physical food hazards.

Call for Abstracts Now Open

Also new this year is a strategic co-location with the Cannabis Quality Conference, as well as several pre-conference workshops to be held on October 16, including:

  • Advanced Listeria Workshop
  • Food Safety Recalls Workshop
  • Food Safety Auditor Re-certification Training
  • Infused Products Workshop

Registration Opening Soon!

“We are bringing two great conferences together under one roof,” says Rick Biros, president of Innovative Publishing and director of the Food Safety Consortium. “The Food Safety Consortium will continue its strategic meeting of the minds format, but we are complementing that with the practical, boots-on-the-ground Food Safety Hazards track. Co-location with the CQC allows attendees to take advantage of additional education on product testing and quality assurance in the burgeoning cannabis market, as well as preconference workshops delving into infused product safety and compliance that will appeal to both food safety and cannabis professionals.”

For sponsorship and exhibitor inquiries, contact RJ Palermo, Director of Sales. Stay tuned for registration and early bird specials.

 

 

OSU_CFI Logo
Food Safety Think Tank

It is Time for Industry to Embrace Whole Genome Sequencing

By Food Safety Tech Staff
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Whole genome sequencing (WGS) has become a powerful tool to track the origins of foodborne illness, but if industry views WGS simply as a tool for regulators, it is missing out on a valuable instrument to improve food safety within its facilities. Join Fabien Robert, head of zone AMS for Nestlé Quality Assurance centres, and Food Safety Tech on April 3-5 at Ohio State University, as we take a closer look at:

Fabien Robert
Fabien Robert
  • How WGS can help industry mitigate food safety risks and enhance root cause analysis
  • How to use WGS in your operations to improve food safety

The Food Safety Tech’s Hazards Conference + CFI Think Tank brings together leading minds in industry and academia for two days of practical education on the detection, mitigation, control and regulation of key food hazards, followed by discussion geared toward identifying gaps for research and innovation.

In person and virtual registration options available

Additional speakers include:

Biofilm Prevention and Control Practices

Charles Giambrone, Food Safety Manager, Rochester Midland

Giambrone received his M.S. degree in Microbiology from Rutgers University in 1978, where his research focus was applied and environmental microbiology. In his current and previous roles as VP & Sr. Technical Support Manager for Rochester Midland Corp, he provides applied research and technical support in the whole area of food safety and sanitation including processing and preparation, membrane cleaning, and water treatment systems plus supervision of R & D projects. Giambrone has a broad and in-depth expertise in the areas of hygiene, disinfection, and biocides. This includes working with systems to remove or prevent biofilm formation in food processing and water system lines as well as other applications.

The USDA’s Proposed Approach to Salmonella Control in Poultry Products

Sandra Eskin, Deputy Under Secretary for Food Safety, Food Safety and Inspection Service, USDA

Sandra Eskin leads the Office of Food Safety at the USDA, overseeing the Food Safety and Inspection Service (FSIS), which has regulatory oversight for ensuring that meat, poultry and egg products are safe, wholesome and accurately labeled. Prior to joining USDA, Eskin was the Project Director for Food Safety at The Pew Charitable Trusts in Washington, D.C. She also served as the Deputy Director of the Produce Safety Project (PSP), a Pew-funded initiative at Georgetown University from 2008-2009.

RTE Meats and Ice Cream – Mitigating Listeria Risks & Responding to Contamination

Stacy Vernon, Food Safety Specialist & Project Manager, CIFT

Stacy Vernon is the Food Safety and Operations Program Manager at CIFT, where she works alongside food manufactures of all sizes to help them achieve their food safety goals and objectives. She delivers business solutions and technical expertise to her clients as they work towards achieving, maintaining and improving their regulatory and third party food safety certification compliance. Stacy has over 15 years of experience in the food and beverages industry as prior to joining CIFT in 2016, she worked in food safety and quality assurance management roles for Smithfield Foods, Inc. and Rudolph Foods Company.

View the full agenda

Listeria in the Retail Food Environment

Janet Buffer, Center for Foodborne Illness & Prevention, OSU

Janet Buffer’s expertise spans across multidisciplinary medical and clinical research centers, higher education institutions, extension agencies, and regulatory departments. Throughout her 28-year professional career, Janet has served in various capacities; relentlessly utilizing her unique skill sets and ability to connect with students and consumers, to thoroughly educate and actively train those around her. She has spearheaded food safety information accuracy efforts and prioritized food production and food safety regulatory compliance in the healthcare and business spheres above all else. All the while, advising and aiding in corporate administration and the improvement of food technologies.

Application of Ozone for Decontamination of Fresh Produce

Al Baroudi, Ph.D., Vice President of Quality Assurance & Food Safety, The Cheesecake Factory

In addition to his current role, Dr. Baroudi has conducted workshops, published White Papers and introduced the HACCP program to developing countries on behalf of the U.S. government. He is the recipient of Borden’s “President Award”, the Sani “Food Safety Champion Award”, and the “Outstanding Food Safety Program Innovation Award,” and the Southern California IFT “Distinguished Achievement Award.” In 2022, NR News named, Dr. Baroudi as one of the top 50 most influential restaurant executives in the country, and The NRA presented him their inaugural Lifetime Achievement Award for “Outstanding Leader in Food Safety.” He was instrumental in passing the Food Facilities Sanitization Bill “AB 1427” in the California State Assembly that cleared the way for the ozone to be approved in California Cal Code (2012).

Ahmed Yousef, Ph.D., Department of Food Science & Technology, Ohio State University

Dr. Yousef earned his Ph.D. in Food Science from University of Wisconsin-Madison. He worked as a postdoctoral researcher at the University of Wisconsin-Madison before joining Ohio State as an Assistant Professor in 1991. Since the late 1990s, Dr. Yousef and his research team have worked to develop methods to pasteurize shell eggs and to decontaminate fresh produce while maintaining products’ fresh qualities. His ozone research led to developing methods to decontaminate spinach, apples, and other fresh produce. As a result of this research, Dr. Yousef established the largest ozone research laboratory in the U.S. at Ohio State.

View the full agenda and register here.

 

Food Safety Consortium 2023
From the Editor’s Desk

Save the Date: Food Safety Consortium 2023 October 16-18

Food Safety Consortium 2023

The Food Safety Consortium, now in its 11th year, will take place October 16-18, 2023, at the Hilton in Parsippany, New Jersey. Presented by Food Safety Tech, the Consortium is a business-to-business conference that brings together food safety and quality assurance professionals for education, networking and discussion geared toward solving the key challenges facing the food safety industry today.

In addition to the two full days of high-level panel discussions, this year’s program will include a second Food Safety Hazards track. These “Boots on the Ground” sessions build on the success of Food Safety Tech’s virtual Food Safety Hazards program by providing two days of education on the detection, mitigation, control and regulation of key pathogen, pest, chemical and physical food hazards.

Call for Abstracts Now Open

Also new this year is a strategic co-location with the Cannabis Quality Conference (CQC). Presented by Cannabis Industry Journal, CQC is a business-to-business conference and expo where cannabis industry leaders and stakeholders meet to build the future of the cannabis marketplace. Attendees will have the opportunity to take part in pre-conference workshops designed to address safety and compliance in cannabis edibles on October 16.

“We are bringing two great conferences together under one roof,” says Rick Biros, president of Innovative Publishing and director of the Food Safety Consortium. “The Food Safety Consortium will continue its strategic meeting of the minds format, but we are complementing that with the practical, boots-on-the-ground Food Safety Hazards track. Co-location with the CQC allows attendees to take advantage of additional education on product testing and quality assurance in the burgeoning cannabis market, as well as preconference workshops delving into infused product safety and compliance that will appeal to both food safety and cannabis professionals.”

All of these events will take place October 16-18, 2023, at the Hilton in Parsippany, New Jersey.

If you would like to present at the Food Safety Consortium, please submit abstracts here.

For sponsorship and exhibit inquiries, contact RJ Palermo, Director of Sales. Stay tuned for registration and early bird specials.

About The Food Safety Consortium
Organized by Food Safety Tech, the Food Safety Consortium Conference has been providing education and networking for Food Protection professionals since 2012. The conference focuses on food safety, food integrity and food defense as the foundation of the educational content of the program. With a unique focus on science, technology, best practices and compliance, the Consortium features critical thinking topics that have been developed for both industry veterans and knowledgeable newcomers.

About Food Safety Tech

Food Safety Tech is a digital media community for food industry professionals interested in food safety and quality. We inform, educate and connect food manufacturers and processors, retail & food service, food laboratories, growers, suppliers and vendors, and regulatory agencies with original, in-depth features and reports, curated industry news and user-contributed content, and live and virtual events that offer knowledge, perspectives, strategies and resources to facilitate an environment that fosters safer food for consumers.

Melody Ge, Kestrel Management
FST Soapbox

Supply Chain Management 101

By Melody Ge
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Melody Ge, Kestrel Management

Supply chain management is becoming more and more relevant to small and entrepreneurial food businesses, particularly related to FSMA requirements that are required to be fully implemented by this September. To meet these requirements, it is important for small businesses to understand:

  • Applicable FSMA requirements
  • How to develop a supplier approval program
  • What challenges companies may encounter and tips to overcome them
  • How to find an appropriate starting point to develop a supply chain management program

Supply Chain Management Program

1. Receiving facility: A facility that is subject to preventive controls and supply-chain program and that manufacturers/processes raw materials or ingredients that it receives from a supplier.
2. Supplier: The establishment that manufacturers/processes the food, raises the animal, or grows the food that is provided to a receiving facility without further manufacturing/processing by another establishment, except for further manufacturing/processing that consists solely of the addition of labeling or similar activity of a de minimis nature.
Food manufacturers need to develop and implement a supply chain management program, including supply chain preventive control, to control those potential hazards identified that shall be controlled by the suppliers when receiving all raw materials and ingredients. As defined in the actual FDA regulation, a supply management program will only be considered as a preventive control when it is linked to a potential food safety hazard in the raw materials and incoming ingredients. It is the supply-chain-applied control (21 CFR 117.3). As a receiving facility, you have the right to ask your suppliers for all related information associated with the food safety hazards that you identified from your own food safety plan.

What should be in your supply chain management program or supply-chain-applied control?

  1. There needs to be a series of credentials for approval. This can be determined by you, depending on the hazards and product risks. For example, a third-party audit result or a certification from a reliable audit can serve this purpose.A few questions can be considered, including whether suppliers have a recall plan, whether suppliers have an existing food safety plan to control hazards, or whether suppliers have a non-conforming products control plan. Often these can be checked and verified when a third-party audit or third-party accredited audit is conducted. Once a supply chain management program becomes a preventive control, the raw materials can only be supplied by an approved supplier.
  2. Monitoring activities and verifications should be applied to those approved suppliers in your supply chain. This can be done throughout the business history and supplier performance. You need to demonstrate how you continue monitoring the supplier approval status, and suppliers must demonstrate how their products remain guaranteed. Public records (e.g., warning letters), sample testing incoming goods, and customer audits are commonly utilized in the industry. However, in FSMA, when an approved supplier is supplying a high-risk raw material, such as one with SAHCODHA (Serious Adverse Health Consequences or Death to Humans or Animal) risks, an onsite (your own audit or third-party (accredited) audit) is required to be conducted as the verification activity. This must be completed annually unless you can provide a risk-based justification of other types validated verification activities.
  3. Afterwards, as a receiving facility, you need to consider and develop procedures for non-conforming suppliers:
  • How do you require your suppliers maintain their “approval” status in your supply chain management program throughout the business years?
  • When one approved supplier is unapproved or experiencing unexpected incidents, how do you manage back-up suppliers?
  • What criteria do back-up suppliers need to meet prior to supplying the product(s)/ingredient(s)?

Melody Ge will be presenting “What Have We Learned After FSMA Implementation?” at the 2018 Food Safety ConsortiumDifferent products will have different approaches based on facility business operations. However, one thing remains the same. The justification must ensure that potential hazards identified from the original approved supplier are controlled when a back up supplier is used.

4. Last but not least, just like all other programs and controls, records and documentation are important! Records must be kept for all parts of the supply chain management program, including plan, monitoring, verification and any corrective actions that have been conducted. These data are precious to your facility over time, as supplier performance and trending could be a strong reference to see whether adjustment or modifications should be applied to your supply chain management.

There may be challenges collecting information or approving suppliers, but never forget the intention of a supply chain management program—to control the food safety hazards of incoming goods. Your supply chain management program will allow you to demonstrate that you have made all efforts to control the hazards that could potentially arise from your supply chain.

Resource

  1. FDA FSMA Preventive Controls to Human Foods. Retrieved from https://www.fda.gov/food/guidanceregulation/fsma/ucm334115.htm