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Food Risk Reduction: How to Prevent Your Next Food Recall

Whenever a food recall occurs, it has the potential to unravel major implications with regard to costs, reputational damage, compliance penalties, supply chain interruption, and sales declines. Worse yet, these impacts can linger for years afterward. It’s a risk no plant can afford to take, albeit one that manufacturers everywhere are struggling to prevent.

So, what’s the secret to food risk reduction? Where is your facility failing, and what specific steps should you be taking to minimize the threat of a recall?

This online resource will provide you with valuable insights on the most important aspects of food recall prevention, walking you through your biggest threats, essential compliance obligations, expert tips for mitigating and preventing your next food recall and highly effective solutions for reducing risk.

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Table of Contents

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What current threats exist in the area of food safety?

Before you can articulate a strategy to reduce the risk of experiencing a costly, brand-damaging food recall, it’s necessary to consider the reasons why recalls happen in the first place. Here are some of the most notorious contributing factors:

Bacterial Contamination

There are over 200 known species of bacteria related to foodborne illnesses. Some of the most prominent ones include Salmonella, E. coli and Listeria, though there are plenty more with names you’ve probably never heard. If an outbreak of any type of pathogen occurs under the watch of your company (from supplier to production and through transport), you could be facing a recall with profound ramifications.

Contamination from Other Residues (Antibiotics, Chemicals, Toxins)

When animals are treated with antibiotics or other chemicals, or produce is treated with pesticides or other toxins, residues from these treatments can linger through the manufacturing process. Sometimes even residues from cleaning solvents can contaminate a product. If proper testing and remediation actions are not implemented on a regular basis, contamination from these residues can lead to a recall. 

Sanitation/Hygiene Failures

Sanitation of the manufacturing plant is a pivotal contributor to contamination prevention, overall food safety and risk management. Your crew must be equipped to ensure sanitary conditions throughout the manufacturing process and adhere to strict procedures for hygiene and cleaning. When failures in these areas occur, the company is vulnerable to devastating outcomes.

Inadequate Supplier Verification

Food safety in your operations is impacted by any hazards your suppliers may be introducing as a result of improper handling and sanitation procedures. If you’re not taking the necessary actions to ensure that your suppliers are preventing these hazards, you can’t be sure that your own product won’t be affected. A lack of attention to your food supplier verification program can incur a host of recall costs to handle investigation, remediation, customer management, logistics and brand perception.

Allergen Contamination (Cross-Production)

Undeclared allergens continue to be the leading form of contamination. The biggest offenders include milk, eggs, peanuts and wheat. If there are multiple items being manufactured in one of your production facilities, there’s a real risk of cross-production contamination. As the number of people with a food allergy continues to grow, it’s critical for manufacturers to ensure that their products are not being cross-contaminated by known allergens or mislabeled. Whether the allergen contamination is a result of improper cleaning of machinery or insufficient labeling of ingredients, the recall effects are bound to be costly. 

Presence of Foreign Materials

Material contaminants are a risk to the safety and quality of your food products. Small material particles (glass, metal, plastic, rubber, wood, sand or soil) may be introduced throughout processing or during transportation. Whether resulting from supplier handling, machinery failure or simply employee error, the presence of these particles is a huge health risk and puts your brand in a very precarious situation.

Poor Internal Processes

The complexity of your organization and its food safety needs makes it essential to foster powerful communication, data tracking, visibility, training and process improvement throughout the company, at all levels and in each department. If you’re relying on poor, outdated or manual processes to keep food safety efforts on track, you’ll find that there’s a limit to how much and how well your team can prevent recalls.


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What regulatory realities are affecting your risk levels?

Food companies large and small are being challenged to implement the requisite plans and procedures to meet the evolving demands of proactive food safety. Transformation in this arena, led by government regulation, has shined a spotlight on the responsibility of suppliers and manufacturers to protect consumers.

Regardless of which specific food industry your company operates in, or which governing body it reports to, it’s essential to stay informed on the full span of food regulations in order to reduce the risk of experiencing a recall. Here are some of the most recent and noteworthy happenings in food safety regulation.

U.S. Food & Drug Administration

FDA regulations have undergone a tectonic shift over the past few years, largely due to new mandates introduced by the Food Safety Modernization Act (FSMA). These laws turn the focus from reactive food safety measures to proactive and preventive approaches. Compliance requires much more than simply testing your finished products. That may have been sufficient in the past, but now your manufacturing plant is tasked with identifying areas of weakness in the production process that may lead to contamination or other safety issues, and then enforcing controls to minimize or eliminate those risks.

In September of 2015, the FDA published its final rules for preventive controls in both human and animal foods, and the majority of implementation deadlines have already passed. These rules require FDA-registered facilities that handle human and animal foods to monitor for hazards and implement preventive controls to mitigate pathogens. The FDA has been on a mission to make food production safer for some time now, and the organization hopes that these new standards will help minimize the occurrence of foodborne illness and associated complications.

As mandated by the Food Safety Modernization Act, food production facilities registered with the FDA are required to include a plan for Hazard Analysis and Risk-Based Preventive Controls (HARPC). Companies must test these programs regularly and adjust them as needed to keep them in good working order. Manufacturing plants are also obligated to develop and run risk-based programs for raw material supply, as well as ensure that all of their employees are trained in current good manufacturing practices.

For a more detailed breakdown of FSMA requirements, refer to the FDA’s extensive collection of information on the matter. Understanding your compliance accountabilities under FSMA is integral to your ability to enact business and operational processes that reduce the company’s recall risk.

Produce Safety Rule

One of the newest additions to FSMA is the Produce Safety rule, which outlines minimum standards for safe growing, harvesting, packing and holding of produce. These new regulations are all science-based and very detailed. The term “produce” in this context refers to fruits and vegetables that have been grown for human consumption.

There are some exceptions to these new standards, including: 

  • Produce that is not usually consumed raw
  • On-farm consumption of grown produce
  • Produce that is not a raw agricultural commodity
  • Some products that already undergo extensive commercial processing to limit the presence of microorganisms

The new standards instituted under the Produce Safety rule specifically refer to:

  • Worker training, health and hygiene
  • Agricultural water sources and water cleanliness
  • Biological soil amendments (use of natural fertilizer)
  • Provisions on domestic and wild animals
  • Equipment and physical spaces
  • Sprout and seed processing

You can view the FDA’s fact sheet on the final Produce Safety rule here. You should also consult the Produce Safety Network, which was developed by the FDA (in coordination with the USDA) to support state regulators in implementing the Produce Safety rule, as well as farmers and other key stakeholders in complying with it. The network comprises produce safety experts from the Center for Food Safety and Applied Nutrition (CFSAN) and specialized investigators from the Office of Regulatory Affairs (ORA).  


The new rule for foreign supplier verification programs is directed at food importers, and it includes both food for humans and food for animals. According to FSVP, foreign food processing and packaging facilities are required to complete certain risk-based activities that verify the imported food meets U.S. safety standards.

Under the FSVP rule, importers are responsible for:

  • Determining known or reasonably foreseeable hazards with each food
  • Evaluating the risk posed by a food, based on the hazard analysis and the foreign supplier’s performance
  • Using that evaluation of the risk posed by an imported food and the supplier’s performance to approve suppliers and determine appropriate supplier verification activities
  • Conducting supplier verification activities
  • Conducting corrective actions

A compliant hazard analysis must consider factors that include:

  • Formulation of the food
  • Condition, function and design of the establishment and equipment of a typical entity that produces the food
  • Raw materials and other ingredients
  • Transportation practices
  • Harvesting, raising, manufacturing, processing and packing procedures
  • Packaging and labeling activities
  • Storage and distribution
  • Intended or reasonably foreseeable use
  • Sanitation, including employee hygiene

Any failure to uphold stringent protocol in this area not only affects your noncompliance liability, but also puts your facility at greater risk of experiencing a recall. For more information, view the FDA’s fact sheet on the final FSVP rule here. 

United States Department of Agriculture

The USDA is a cabinet-level Department overseeing the U.S. farming industry. It ensures the safety of the American public’s food supply and places “grades” based on measurable attributes that describe the utility of the product. With regard to food safety, all meat, poultry and certain egg products are regulated by the USDA’s Food Safety Inspection Service (FSIS).

The FSIS established requirements designed to reduce the occurrence and numbers of pathogenic microorganisms on meat and poultry products and reduce the incidence of foodborne illness associated with the consumption of those products. These regulations require that:

  • All meat and poultry establishments develop and implement written sanitation standard operating procedures
  • Slaughter establishments perform regular microbial testing to verify the adequacy of their process controls for the prevention and removal of fecal contamination and associated bacteria
  • Slaughter establishments and those producing raw ground products implement reduction performance standards for Salmonella
  • All meat and poultry establishments develop and implement a system of preventive controls designed to improve the safety of their products (otherwise known as HACCP)

HACCP is a systematic approach to the identification, evaluation and control of food safety hazards based on seven principles:

  • Principle 1: Conduct a hazard analysis.
  • Principle 2: Determine the critical control points (CCPs).
  • Principle 3: Establish critical limits.
  • Principle 4: Establish monitoring procedures.
  • Principle 5: Establish corrective actions.
  • Principle 6: Establish verification procedures.
  • Principle 7: Establish record-keeping and documentation procedures.

The FSIS maintains comprehensive audits of foreign country inspection systems, a complete listing of foreign establishments certified to export meat, poultry or egg products to the United States and the roster of eligible countries (as well as product types) eligible to export meat, poultry or egg products to the U.S. from each country. This agency is commissioned to enforce actions that ensure consumer products are safe, wholesome and properly labeled.

If the FSIS becomes aware of misbranded or adulterated product in commerce, they will conduct an investigation to determine whether a recall is warranted. Investigation-prompting sources may include:

  • The company that manufactures, distributes or receives the product
  • Test results from FSIS sampling programs
  • Observations or information gathered by FSIS inspection program personnel (IPP) in the course of their routine duties or investigations
  • Consumer complaints reported through the FSIS Consumer Complaint Monitoring System (CCMS)
  • Epidemiological or laboratory data submitted by State or local public health departments, other USDA agencies and other Federal agencies, such as the FDA, the Centers for Disease Control and Prevention (CDC) or the Department of Defense
  • Information from other agencies such as the Department of Homeland Security, Customs and Border Protection, the Animal and Plant Health Inspection Service or foreign inspection officials

Compliance with USDA guidelines and requirements is a major risk mitigator for manufacturing companies. For more information, view the USDA FSIS website’s regulatory compliance section.


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What should your action plan for recall prevention look like?

Now that you have a clearer understanding of the factors that impact your company’s food recall risk, it’s important to construct an action plan that minimizes this wide-spanning risk to the fullest. When it comes to maintaining the livelihood of your brand, there’s simply no substitute for a proactive approach. Leverage the following fundamentals of a solid prevention plan at your company.


Implement a USDA- and FDA-Compliant Food Safety Plan

Developing and executing an effective and compliant food safety plan involves some of the following components:

  • Initiating comprehensive, prevention-based controls across the food supply to prevent or significantly minimize the likelihood of problems occurring
  • Instituting a verification process to ensure that foreign and domestic suppliers have adequate preventive controls in place
  • Designing a well-communicated voluntary recall response plan for your organization
  • Maintaining organized, accessible and up-to-date documentation on everything from FSMA and HACCP/HARPC to SOPs, testing results and corrective actions
  • Adopting visibility and communication tools to meet unfolding regulations and enable a strong food safety culture


Update Your HARPC

An up-to-date Hazard Analysis and Risk-based Preventive Controls (HARPC) is an essential component of preventing recalls. If your facility is following an inadequate one, you’re not in a good position to proactively address the food safety hazards that could lead to a devastating recall. Make sure that your plan is updated to accommodate issues such as:

  • Emergent employee and equipment sanitation hazards
  • New ingredients that may pose allergen risks
  • Ineffective control measures and preventive controls
  • Actual versus documented production flow processes
  • Changes to compliance requirements or industry standards

It’s wise to have a HARPC and food safety team that meets on a regular basis to assess problems, implement updates and protect your brand from future recalls.


Require Proper Training of All Employees

Preparing your facility to prevent food safety issues that lead to recalls requires a strong plan for education and training. Designate a team or individual to oversee this function. Food safety and compliance doesn’t happen in a silo. Every member of your organization -- from the top down and across every department -- has a role in keeping food safe.

Depending on their position and function, each should be trained on their part of an effective implementation. With the proper education and training, proactively preventing the threat of a recall is a shared responsibility with more successful outcomes.

To support a strong culture of food safety and minimize recall effects, make ongoing awareness and education a significant aspect of your efforts. Preparing your entire team to take on the major shift in mindset that’s required to meet evolving food safety risks hinges on having a strong plan for education and training across the entire company.


Utilize Food Safety Software

The complexity of your organization and its food safety needs makes it essential to foster powerful communication throughout the company, as well as robust visibility for all members of the team. True, widespread transparency requires a software solution that facilitates a high level of visibility, communication and data tracking. Leveraging food safety software will increase your team’s capability by enabling them to:

  • Visualize your critical control points and any other preventive control points on an intuitive floor plan
  • Quickly identify locations and patterns within your food safety plan
  • Communicate quickly and effectively
  • Leverage automated notifications and alerts
  • Systematize the scheduling of preventative controls and testing
  • Easily access all sampling data, testing results and corrective action records
  • Verify performance


Document Your Efforts

When it comes to contamination prevention and recall risk protection, documentation is everything. From the history and results of test points to the corrective actions applied to remediate problems, it is mandatory to have a dynamic documentation process in place.

Food safety cannot truly be achieved without standardized, documented, shareable and automated processes to safeguard against contamination and the onset of foodborne illness. Within your operations, there should be a formal process for collecting and utilizing detailed, efficient, accessible documentation.


Automate Reporting

In reams of testing data are hidden insights waiting to be found to help you identify trends and improve your plants. A software solution that keeps all of your records digitally stored and available in one centralized database can be easily accessed to compile automated reports that provide valuable insight to various teams. Manual reporting systems are labor-intensive webs of manual spreadsheets and paper trails which inevitably lead to gaps in communication. They bring major challenges and increase risks to your operation.

In order to implement the appropriate and necessary steps for continuous improvement through monitoring, corrective action and verification, you must be able to access and evaluate collected data. Leverage automated reporting to stay on the pulse of your operation, enabling early detection and action based on tracking and trending of some of the following data components:

  • Quantitative and qualitative testing data
  • Pathogenic and hygienic testing data
  • Indicator organisms, allergens, toxins, residue, etc.

Fully harnessing this data means making reporting and assessment a routine practice. This is the best way to improve your processes, rectify inefficiencies and minimize the risks and costs associated with blind, outdated methods. It’s the right way to make informed decisions, take required actions and be truly proactive rather than reactive. It gives you the control and insight needed to protect your brand and your bottom line.


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What role does technology play in risk reduction?

Advancing technology has had a profound effect on just about every area of life and business, transforming operations, strategies and outcomes, as well as creating innovative efficiencies and elevating outdated processes to faster, more streamlined ones. In terms of food safety and recall prevention, it has turned the tables on traditional approaches. Here’s what you need to know about the role of technology as a catalyst for food risk reduction.

Tightened Documentation

Today’s manufacturers face a time of heightened regulation, and with stricter enforcement comes greater requirements for documentation. From facility registrations and foreign supplier verifications to food safety plans and sanitary transportation data, everything must be recorded, updated and secured in a highly structured way. As a result, technology has become more integral to the management of food safety and compliance.

Unfortunately, organization and attention to detail are often sacrificed when managers fail to implement the proper technological solutions. Fulfilling fundamental documentation requirements involves a smart, automated approach. This is the best way to optimize recall prevention.

As consumers become more committed to buying from companies that are sustainably responsible and supportive of local producers, manufacturers are pressed to implement high-quality verification and traceability programs. All through the stages of growing, harvesting, processing and distributing, it is paramount to maintain thorough recordkeeping and documentation. A lack thereof is apt to cause compliance and recall problems that can jeopardize your plant, your job and consumer trust.

Forward-thinking companies and facility managers are leveraging valuable software solutions to improve processes, protect their reputations, minimize inefficiencies and simplify multifaceted compliance and audit tasks. Documentation in food safety has never been more essential than it is now, and with the benefit of technology, it has also never been more streamlined.

Widespread Transparency

Technology has made it possible to gather information from as far back in the food chain as the farming fields. Though there are still many growers and harvesters that prefer a more traditional approach, adapting to technological evolution has enabled others to gain a competitive advantage with faster, smarter quality management systems.

From sensors for air, soil, equipment, livestock and crops, to the monitoring of crop gases throughout the ripening process, spectral imaging for plant health and even pathology detection, these innovations in agriculture significantly impact manufacturers’ efforts to maintain a commitment to food safety. Traceability is key to minimizing the production and distribution of unsafe or low-quality foods, so it’s incredibly important for plants to record and track every step of the product’s journey from farm to fork.

Big Data Discoveries

As the technology in nutrition research advances, researchers are equipped with big data to make connections between certain foods and human health. These discoveries impact how government regulators manage the farming, production, handling and distribution of various types of food. These tech-driven progressions in nutritional knowledge affect manufacturers in every category of food production, which transfers to plant and quality managers who are responsible for food safety and recall prevention. 

But compliance can be an overwhelming feat for any production team. One of the many difficulties is maintaining complete, accurate and up-to-date records -- often using limited resources and simultaneously focusing on daily production goals. Paper-based and other manual forms of meeting compliance mandates render this objective highly challenging, if not impossible.

With the technology of cloud-based software as a service (SaaS), however, managing the necessary records and documentation doesn’t have to be a highly complex undertaking. A cloud-based software solution that manages all data and workflows via a centralized database allows you to unlock food safety and compliance insights, maintain document control and security, avoid the costs of extra manpower and IT resources, facilitate company-wide compliance contributions and eliminate points of risk, error, inefficiency and miscommunication.

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How does an investment in food safety reap financial returns?

Food safety is not just a compliance issue, a siloed compartment of your company or a list of boxes to check. It is a critical risk reduction and brand protection function, which makes it a driver of business profitability. The more powerful your solutions to ensure food safety, the more your company stands to gain in terms of financial return. By employing food safety software that lessens the risk and occurrence of food recalls, you make an investment in your brand, in consumer trust and in the longevity of your profitability.

Direct Costs of a Recall

The recall process in the food manufacturing industry is a highly expensive one, averaging more than $10 million in costs, which doesn’t even include the possibility of litigation, decreased sales, reputational damage or brand crisis management, which can add up to millions -- even billions -- more. Even though the vast majority of recalls are voluntary and a reflection of conscientious behavior by the retailers, wholesalers and producers, 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

The sooner and more proactively your organization can identify food safety non-compliances, the more effectively you can prevent full-blown recalls. With industry-leading food safety software that reduces recall risk, you make an investment in your brand, in consumer trust and in the longevity of your profitability. You protect millions of dollars at your bottom line and nurture the kind of relationship with your consumers that keeps them buying your products.

Compliance Penalties

For manufacturers, the evolving food safety landscape means adjusting processes and procedures to comply with legal requirements for monitoring, testing, documentation, risk assessment and more. 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, these agencies may consider regulatory actions like:

  • 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 adulterated food
  • Suspending a facility’s food registration to prevent the shipment of food

With the right software, you can manage your entire food safety and compliance program, track all new and historical data, create audit trails and reports, make informed decisions about corrective and preventive actions and document every effort. This gives you the advantage of reduced recall risk, which can save you monumentally in noncompliance expenses.

Operational Tools

A reliance on outdated, manual methods holds your company way back and makes it extremely difficult to achieve your business goals. To attain the highest levels of profitability, it is essential to have a strategy for streamlining operations and creating efficiencies. Food safety software fuels this kind of operational improvement through automation and advancement, with features that enable:

  • Automatic scheduling of preventative controls and testing to keep compliance and contamination prevention activities on track
  • Accelerated collection of data, plus automated assessment and reporting of trends, challenges and results
  • Quicker identification of and response to issues that necessitate corrective actions
  • Strengthened communication between departments to speed up the relay of information and reduce duplicate or unnecessary effort
  • Ability to verify food safety performance and effectiveness so that operational improvements can be made as required

From cleaning and testing procedures to documentation and audit preparation, there’s a magnitude of financial gain to be gleaned from streamlined food safety processes. Software helps to minimize the wasted time and resources that result from sluggish, manual efforts and human error.

Why Take the Risk?

A food recall is often an intense and stressful event. Again and again, we’ve seen it fatally impair brands and bring immense financial burden to even the most well known of companies. It can be a nightmare of legal and compliance headaches, consumer complaints, PR woes, logistical impediments, productivity inhibitors and lost sales. And with stricter regulations in place, the occurrence of recalls will continue to spike, which means the risks are imminent for all food manufacturers and brands.

Don’t put your reputation on the line by taking risks with food safety. Opt for a smart solution, as detailed herein, that empowers you to proactively manage your food safety risk, prevent recalls and protect your brand.

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