Tim Lozier, EtQ, Inc.
FST Soapbox

How to Mitigate Risks and Issues in Your Supply Chain

By Timothy Lozier
No Comments
Tim Lozier, EtQ, Inc.

As business becomes more global, effective and efficient, supply chain management is more vital than ever. Even if you’ve optimized your supply chain, uncertainty can cause issues when sourcing raw materials, goods and services, which could ultimately impact on your business, customers, revenue and reputation.

Fortunately, forward-looking risk management can help you understand potential problems in the supply chain and allow you to create contingency plans or take mitigating actions. Supplier risk management will let you ensure quality at every stage, help you prepare for potential issues, and deliver goods and services to the quality and deadlines your customers expect.

An Overview of the Supply Chain

The supply chain is the process through which you source raw materials, goods, services and other key functions from your suppliers. It has multiple facets:

  • Identify the right suppliers and vendors.
  • Negotiate prices, terms and conditions.
  • Place orders with suppliers.
  • Arrange for transport of goods and services to your business or to other manufacturers.
  • Make payments to suppliers.
  • Receive products and services into your business for onward provision to end customers.

If you want to avoid problems and maximize quality throughout the supply chain, you will need to explore each of these areas.

Key Risks to Effective Supply Chain Management

Here are the main risks on the supplier side, and how to manage potential issues.

Poor Quality Supplier Challenges

Risks with poor quality suppliers include:

  • Goods, services and raw materials that do not meet your requirements.
  • Delays in sending out your orders.
  • Unreasonable demands made to your business.
  • Hidden, detrimental terms and conditions.
  • Damaged vendor relationships.

You can mitigate these risks through:

  • Getting recommendations from other organizations that are sourcing similar items or services.
  • Insisting on samples of the items you are planning to purchase.
  • Reading reviews of suppliers and feedback from other customers.
  • Ensuring you have robust contracts in place that clearly define the relationship.
  • Employing a vendor manager who can ensure that relationships and negotiations run smoothly.

Unexpected Prices or Supply Challenges

Risks with pricing and supply include:

• Volatile pricing and potential overcharging.
• Suppliers not being able to source and provide what you have ordered.

You can mitigate these risks through:

  • Locking in guaranteed pricing for specific areas and predefined lengths of time.
  • Auditing of invoicing and costs versus agreements and contracts.
  • Getting backup suppliers in place if your original supplier has a supply issue.
  • Guaranteeing with the supplier that they will hold a certain amount of inventory for your specific needs.
  • Insisting on regular reports of stock levels that you can draw down from.

Cultural, Environmental and Economic Challenges

Risks with culture, environment and the economy include:

  • Language and cultural barriers with suppliers leading to misunderstanding.
  • Local laws that impact on a supplier’s ability to meet your needs.
  • Environmental factors like natural disasters
  • Unstable political movements.
  • Societal unrest and conflict.

You can mitigate these risks through:

  • Getting backup suppliers in place if your original supplier has a supply issue.
  • Using local expertise to understand and deal with any potential legal or political issues.
  • Creating a contingency plan in the event of a natural disaster or economic issues.
  • Using a relationship manager who can understand and deal with differences in language and culture.

Transportation and Distribution Challenges

Risks with transportation and distribution include:

  • Inefficient logistics and distribution, leading to delays or loss.
  • Unexpected costs of transportation, import and export, including tariffs and customs.

You can mitigate these risks through:

  • Getting backup distributors in place if your original distributor has an issue.
  • Reading reviews of distributors and feedback from other customers.
  • Ensuring you have robust contracts in place that clearly define the relationship.
  • Understanding potential costs throughout the supply chain.
  • Creating a contingency plan in the event of supplier issues.

Examples of Supply Chain Risks and Issues in the Food Industry

Let’s dig into some potential risks to food supply chains, and how you might mitigate them.

Unusual Weather Patterns Lead to Smaller Harvests and Lower Yields
Food manufacturers rely on a steady supply of raw materials to make the products consumers eat every day. However, weather and climate can be anything other than predictable, and have several associated risks. Potential mitigation plans include:

  • Identifying early climate trends that could impact a region and seeking out alternative sources.
  • Having backup contracts with other suppliers if the crops from one region fail to meet appropriate yields.
  • Developing alternative products that use fewer of a particular type of raw material or ingredient.
  • Stockpiling vital ingredients in secure, long-term storage.

Tariffs Impact Import and Export Prices
Political uncertainty can result in increased customs tariffs to trade in certain goods. Potential mitigation plans include:

  • Importing or exporting a surplus of goods before the tariffs come into effect.
  • Seeking out alternative routes for food supply chains that do not go through impacted countries.
  • Diversifying into food production that’s not impacted by specific tariffs.
  • Moving part of manufacturing to regions not affected by tariffs.

Unexpected Production Issues Impact Food Safety
Food safety is critical to consumer confidence and a food manufacturer’s reputation. Despite stringent quality in the ingredient and manufacturing process, the global food supply chain can sometimes introduce contamination or other risks. Potential mitigation plans include:

  • Clear, objective, verified, regular testing of all raw ingredients, independent of origin, type or destination.
  • Labeling, batch numbers and other identifiers so all goods can be tracked through the supply chain to allow for easy identification of contaminant sources.
  • st recall process so any products that are in stores can be easily removed and returned for testing.
  • Exceeding FDA regulations and guidelines for safe food manufacturing.

When you’re managing risk in the supply chain, it is vital to capture all potential issues and prioritize them in terms of likelihood, impact and any other variables that are critical to your business. You can then get risk mitigation plans in place, and ensure your stakeholders and cross-functional teams have the resources they need to resolve your supply chain risks.

Stephanie Pollard, ClearLabs
In the Food Lab

The Power of Advanced NGS Technology in Routine Pathogen Testing

By Stephanie Pollard
No Comments
Stephanie Pollard, ClearLabs

The food industry is beginning to transition into an era of big data and analytics unlike anything the industry has ever experienced. However, while the evolution of big data brings excitement and the buzz of new possibilities, it also comes coupled with an element of confusion due to the lack of tools for interpretation and lack of practical applications of the newly available information.

As we step into this new era and begin to embrace these changes, we need to invest time to educate ourselves on the possibilities before us, then make informed and action-oriented decisions on how to best use big data to move food safety and quality into the next generation.

Stephanie Pollard will be presenting “The Power of Advanced NGS Technology in Routine Pathogen Testing” at the 2018 Food Safety Consortium | November 13–15One of the big questions for big data and analytics in the food safety industry is the exact origins of this new data. Next Generation Sequencing (NGS) is one new and disruptive technology that will contribute significantly to a data explosion in our industry.

NGS-based platforms offer the ability to see what was previously impossible with PCR and other technologies. These technologies generate millions of sequences simultaneously, enabling greater resolution into the microbial ecology of food and environmental surfaces.

This represents a seismic shift in the food safety world. It changes the age-old food microbiology question from: “Is this specific microbe in my sample?” to “what is the microbial makeup of my sample?”

Traditionally, microbiologists have relied on culture-based technologies to measure the microbial composition of foods and inform risk management decisions. While these techniques have been well studied and are standard practices in food safety and quality measures, they only address a small piece of a much bigger microbial puzzle. NGS-based systems allow more complete visibility into this puzzle, enabling more informed risk management decisions.

With these advances, one practical application of NGS in existing food safety management systems is in routine pathogen testing. Routine pathogen testing is a form of risk assessment that typically gives a binary presence/absence result for a target pathogen.

NGS-based platforms can enhance this output by generating more than the standard binary result through a tunable resolution approach. NGS-based platforms can be designed to be as broad, or as specific, as desired to best fit the needs of the end user.

Imagine using an NGS-based platform for your routine pathogen testing needs, but instead of limiting the information you gather to yes/no answers for a target pathogen, you also obtain additional pertinent information, including: Serotype and/or strain identification, resident/transient designation, predictive shelf-life analysis, microbiome analysis, or predictive risk assessment.

By integrating an NGS-based platform into routine pathogen testing, one can begin to build a microbial database of the production facility, which can be used to distinguish resident pathogens and/or spoilage microbes from transient ones. This information can be used to monitor and improve existing or new sanitation practices as well as provide valuable information on ingredient quality and safety.

This data can also feed directly into supplier quality assurance programs and enable more informed decisions regarding building partnerships with suppliers who offer superior products.

Similarly, by analyzing the microbiome of a food matrix, food producers can identify the presence of food spoilage microbes to inform more accurate shelf-life predictions as well as evaluate the efficacy of interventions designed to reduce those microbes from proliferating in your product (e.g. modified packaging strategies, storage conditions, or processing parameters).

Envision a technology that enables all of the aforementioned possibilities while requiring minimal disruption to integrate into existing food safety management systems. NGS-based platforms offer answers to traditional pathogen testing needs for presence/absence information, all the while providing a vast amount of additional information. Envision a future in which we step outside of our age-old approach of assessing the safety of the food that we eat via testing for the presence of a specific pathogen. Envision a future in which we raise our standards for safety and focus on finding whatever is there, without having to know in advance what to look for.

Every year we learn of new advancements that challenge the previously limited view on the different pathogens that survive and proliferate on certain food products and have been overlooked (e.g., Listeria in melons). Advanced NGS technologies allow us to break free of those associations and focus more on truly assessing the safety and quality of our products by providing a deeper understanding of the molecular makeup of our food.

Megan Nichols
FST Soapbox

Sustainability Strategies for the Food Industry

By Megan Ray Nichols
No Comments
Megan Nichols

Sustainability is a word that you’ll hear a lot these days, especially as industries try to become more eco-friendly. The food industry has been lagging behind in the world of sustainability, and in order to keep up with national and international food demands, it is difficult to implement the kind of change that is necessary to make the world a little greener. However, that doesn’t mean that food companies shouldn’t try. The following are some sustainability strategies that might be easier to implement in the food industry.

Water Conservation

field irrigation
Field irrigation (Wikipedia commons image)

While the majority of the Earth’s surface is covered in water, only about 3% of that water is drinkable—and 2 of that 3% is frozen in the planet’s glaciers and ice caps. This is why water conservation is so important. According to the United States Geological Survey (USGS), roughly 39% of fresh water used in the United States is used to irrigate crops.

Switching from flood irrigation with sprinklers to drip irrigation can reduce water usage.

Wastewater reuse is also a new technique that is gaining traction in the food industry. While it isn‘t practical in all situations due to the technology needed to remove chemicals and impurities from the wastewater, it can help reduce water waste and water use in the food industry. Simply reviewing water usage and switching to procedures that are less water-intensive can save a company money and reduce its overall water usage.

Natural Pest Control

Pesticides and fertilizers are among some of the most dangerous chemicals in the food industry. For largescale operations, however, they are necessary to ensure a large and healthy harvest. Some companies, such as Kemin Industries, are shunning these typical processes in favor of more sustainable options.

“Our mission at Kemin is to improve the quality of life for more than half the world’s population, and we believe sustainability plays an important role in our work,” said Dr. Chris Nelson, president and CEO of Kemin Industries. “Our FORTIUM line of rosemary-extract-based ingredients uses Kemin-grown rosemary for maximum effectiveness against color and flavor degradation. Kemin is the only rosemary supplier that is certified SCS Sustainably Grown, and we’re one of the world’s largest growers of vertically integrated rosemary.”

Vertical integration doesn’t have anything to do with how the rosemary is grown. In the agriculture industry, it means Kemin owns the entire supply chain for its rosemary, from field to processing to distribution.

“We use botanicals—spearmint, oregano, marigold and potato, in addition to rosemary—in our other products as well,” continued Nelson. “As an ingredient manufacturer, we understand the value of good suppliers. When the planet is supplying us with the ingredients we use in our products, it’s important to us that we are responsible in our growing practices.”

Sustainable Distribution

Distribution is one of the biggest problems when it comes to creating eco-friendly and sustainable supply chains. Upwards of 70% of the products in the United States are transported by truck, and each of those trucks generates CO2 and greenhouse gases.

There are two plans of attack for sustainability in food distribution: Reducing the distance food needs to travel, and upgrading trucks to use greener fuel options like biodiesel or electricity, such as the ones Tesla is offering.

Reducing the emissions created by tractor-trailers could help make the entire process a bit more sustainable, although it would require a large investment to upgrade the distribution process.

Back to Their Roots

It’s only in recent decades that agriculture has started being sustainable in an effort to keep up with the demands of the consumer. By going back to our roots and focusing on farming techniques that promote things like soil health—by rotating crops instead of using artificial fertilizers—and lowering water use and pollution, agriculture can become sustainable once again.

Farming, sustainability
Creative Commons image

Modern agricultural techniques are detrimental, both to the environment and to the people who work there. These methods ensure we have enough food to supply consumers, but they lead to soil depletion and groundwater contamination. In addition to this, it can also lead to the degradation of rural communities that would normally be centered on farm work. That’s because corporate farms focus on quotas and large harvests without the community angle.

These commercial farms also cost more to run, and many have poor conditions for farmworkers because of the harsh chemicals used to kill pests and fertilize depleted topsoil.

Farm numbers have dropped since the end of World War II, with corporate farms taking the place of smaller family farms. While the number of farms has dropped, the remaining farms have increased in size. The average farm in 1875 was roughly 150 acres, and there were more than 4 million of them. Today, less than half that number remains, but the average size of the farms has increased to more than 450 acres.

Sustainability is a popular buzzword right now, but it’s a lot more important than most people believe. Switching to sustainable practices, whether that means changing production, distribution or anything in between, will help ensure the food industry can keep fresh, healthy food on our table for decades to come without damaging the environment. Sustainability is something that should be adopted by every industry, especially agriculture.

Jessia Burke, Allergen Control Group
Allergen Alley

Allergen Detection & Control: Challenges & Strategies

By Jessica Burke
No Comments
Jessia Burke, Allergen Control Group

While global market demand for “free-from” food products is increasing, undeclared and mislabelled allergens, sulphites and gluten, throughout the supply chain, continue to be the number one cause of consumer product recalls. This is of major concern since the number of individuals affected by life-threatening allergies is on the rise, especially in children. Unfortunately, there is no cure for a food allergy; avoidance of allergenic food(s) is the only way to prevent an allergic reaction.

It is clear that allergen recalls negatively affect the consumer, however, they also result in huge financial implications and loss of brand credibility to all organizations involved. Businesses and brands may take a significant hit to their reputation since consumer perception plays a key role in the success of a business. With the increased use of the internet and social media, it is even more important to stay out of the spotlight and avoid recalls.

Among the reasons allergens hold the #1 position for product recalls may be lack of knowledge, insufficient supplier and raw material information, packaging errors, and accidental cross-contact. Cross-contact may be the result of poor cleaning practices, inadequate handling and storage procedures, employee traffic, and improper identification and assessments of risks. In addition, from a regulatory perspective, priority allergen lists and ingredient labeling laws vary from country to country, causing confusion for both manufacturers and consumers.

The good news is, implementing a strong allergen control plan can help to prevent recalls, protecting consumers and your business.

It starts with conducting a thorough risk assessment of each step in your process to determine where procedures and controls need to be implemented. A process flow diagram is very useful in understanding where allergenic ingredients and foods exist in the plant and where they are introduced into the process.

Control measures must be implemented even before raw materials enter the facility. The importance of understanding the incoming ingredients, inputs and suppliers cannot be overstated. The allergen status of every raw material handled or present in a food business needs to be identified and effective risk assessment tools applied. This involves identifying and documenting the food allergens present in each raw material, including non-food items like maintenance and cleaning chemicals. It’s imperative to recognize suppliers and backup suppliers’ vulnerabilities to ensure the success of the program. This should include identifying all allergens handled in the facility, as this might not be obvious based on ingredient declarations or product specification documents. Ensure supplier ingredient specification documents are current and routinely reviewed so accurate assessments can be made about the level of allergen risk.

Ensure there is segregation of allergenic foods or ingredients at every step of the process, from receiving raw materials through to shipping finished product. It is important to review labels at receiving to confirm the allergen status of raw materials. This serves as verification that ingredients have not been modified and the allergen status is still accurate. It also provides the basis upon which to determine storage and handling requirements. Visual tools are great for displaying the allergen status of each raw material. This can be done through applying color coded stickers or tape, unique tags or some other method, and should be done immediately at receiving. To avoid the potential for cross contamination from one ingredient to another, each allergen and/or group of allergens should have its own designated storage area or space. In addition, never store allergenic ingredients above ingredients that do not contain the same allergen.

Ensure there is segregation of allergenic foods or ingredients at every step of the process, from receiving raw materials through to shipping finished product. (Shutterstock image)

Controlling allergen risk throughout processing can be a major challenge since there are so many opportunities for cross contact. Ideally, physically segregate production of foods containing allergens from the production of non-allergenic foods. When physical segregation is not possible, dedicated production lines and equipment is best practice. Barring this, scheduling production runs appropriately can reduce the risk of cross contact and minimize sanitation and changeover activities. Where possible, schedule non-allergenic production before processing allergen-containing products. In addition, dedicate and identify tools and utensils for allergenic ingredients and products. Providing a visual aide can help ensure appropriate practices, and one way to do this is through color coding. Similarly, use dedicated employees on non-allergenic production lines and/or allergenic production lines. Make the employees easy to identify by implementing colored uniforms, hairnets or smocks. Identify allergenic materials by labelling or color coding throughout the manufacturing process. This should include rework, which should only be added to work in progress containing the same allergens.

Control of allergens does not stop at processing; the Maintenance department also plays a big role. Sanitary design needs to be considered when purchasing any piece of equipment. The equipment must be easily and fully washable to ensure proper sanitation. Positioning of equipment is also important in terms of cleanability and the potential of cross contact from an allergenic production line to a non-allergenic production line. Airflow and the potential for contamination of air borne allergenic dust to non-allergenic ingredients, products and equipment also should to be considered. Lastly, maintenance procedures must be put in place to prevent cross contact. This includes processes for repairing or maintaining equipment, cleaning tools and changing work apparel between repairs, as appropriate.

Consumers rely heavily on ingredient declarations and allergen statements on packaging to make purchasing decisions. “For those living with the medical condition of food allergy, the simple act of eating is complicated; avoiding their allergen is the only tool they have to manage the risk of a potential allergic reaction. These consumers require accurate labeling information to help them stay safe while still having sufficient food choices,” states Jennifer Gerdts, executive director at Food Allergy Canada. As such, it is imperative that the information on finished product labels and packaging is accurate. A solid allergen control program includes processes for reviewing labels for new and modified products to ensure they are reflective of the ingredients in the product. Labels and packaging should also be verified for accuracy prior to receipt, and at the beginning of a production run or at changeover. Outdated labels and packaging should be discarded immediately to prevent the chance of accidental usage. Inventory control procedures and label/packaging reconciliation is imperative to ensure the correct labels/packaging have been applied to the appropriate finished product.

It is crucial to develop and implement robust procedures for effectively cleaning equipment, utensils, food contact surfaces and non-food contact surfaces. This must include cleaning between batches of allergenic and non-allergenic production and responding to allergen spills. Carefully consider the tools and cleaning chemicals used for each the task, as this can make a significant difference in the success of the sanitation program. Verification and validation of cleaning practices must be undertaken to confirm that cleaning activities are effective in removing the allergens in the facility. This can be done through visual inspections, swabbing after sanitation and trending results.

One of the most important tools for ensuring the success of any allergen control program is educated employees. All foods handlers, regardless of their position, should undertake training in food allergens. Employees are the eyes and ears of the plant floor, the more knowledgeable they are, the more likely proper procedures will be followed, and potential risks identified.

Complete regular reviews of the allergen management program to ensure that it remains current, effective, and continues to assist in the production of a safe and legal food product. The program should be reviewed, at a minimum, whenever a customer complaint is received regarding allergic reactions, there is a change to raw materials or suppliers, there is a change in manufacturing processes, there has been an introduction of new machinery, or there is a change to cleaning practices and procedures.

An important aspect of an allergen control program is allergen testing. Testing can be used to confirm the allergen status of raw materials at receipt, to verify cleaning processes, and to evaluate finished products. An array of test methods exist for this purpose, including but not limited to, immunochemical methods such as ELISA or lateral flow devices, DNA-based methods, such as Polymerase Chain Reaction (PCR), Mass spectrometry (MS), and other non-specific methods such as Protein tests, ATP and visual inspection to verify cleaning. The choice of test method is very important and depends on the purpose of the test, the type of sample, food matrix, processing effects, desired turn-around time, availability of equipment, skill level of person doing the analysis and cost. ELISA and lateral flow devices are often used on-site at the production facility because results can be obtained quickly, costs are relatively low, and personnel can be easily trained to use these tests. In some circumstances of highly processed samples, PCR may be a better choice. However, PCR testing requires specialized equipment and skilled technicians so is usually performed in a third-party testing lab. Mass spectrometry is yet another option but can be costly and like PCR, this method requires specialized equipment and skilled personnel to perform the analysis.

As you can see, there are many factors to consider when developing an effective allergen control program. While it may seem daunting, it is critical understand how to identify and assess all allergen risks and develop a plan to control, verify and validate each one. The upfront work may be challenging, however once implemented, an effective allergen control program will protect allergenic consumers from the potentially life-threatening effects of inadvertently consuming and allergenic product, and will protect your business from financial loss and a tainted brand reputation.

Karen Everstine, Decernis
FST Soapbox

Food Fraud Quick Bites: A Look at Fraudulent Labeling Practices

By Karen Everstine, Ph.D.
No Comments
Karen Everstine, Decernis

Food fraud happens in many ways, and it can be challenging to categorize the various methods of fraud. Dilution and/or substitution involves the intentional addition of an alternate product with the intent to replace weight or volume (olive oil, juices and fish are prone to this type of fraud). Artificial enhancement is the addition of a substance that is not intended to replace weight or volume, but to have a functional effect (such as the use of industrial dyes in spices). Certain forms of food fraud, such as theft/resale, counterfeit packaging, or overruns may not involve the addition of alternate ingredients. However, as customers and consumers, we would be taking a risk to trust the safety of any foods that are intentionally misrepresented.

Food Fraud
Categories of methods by which food fraud happens (as defined in the Food Fraud Database1). Graphic courtesy of Decernis

While all forms of fraud can be considered “mislabeling” in one way or another, we consider fraudulent labeling claims to be defined as misrepresentation of a label attribute that implies a particular production technique. Examples include representing non-organic products as organically produced, the sale of foods as halal that do not meet the appropriate standards, changing poultry expiration dates, and labeling products such as eggs and Iberian ham as “free range.” In 2017, a company in Canada was fined for selling falsely labeled kosher cheese. More recently, in Malaysia, millions of products were seized based on the use of fraudulent halal labels.

We have compiled more than 300 records of food fraud involving the use of fraudulent labeling claims. The most common fraudulent claims identified in our records are shown in the chart below.

Fraudulent labeling claims
Fraudulent labeling claims based on records reported in the Food Fraud Database.1

Consumer interest in organic foods is increasing and NSF cites “added value claims” such as organic and free range as one of the important factors driving food fraud risk.2 There continues to be a need for robust analytical tools for the authentication of organic foods. However, recent research has indicated it may be unlikely that authentication of these food products can be can be achieved by a single analytical method or the measurement of a single marker.3,4 Given the technical complexity and cost of ensuring the authenticity of organic label claims through analytical testing, preventing this type of food fraud also requires strong supply chain management and trustworthy supplier relationships along with effective auditing programs.

References

  1. The Decernis Food Fraud Database is a continuously updated collection of food fraud records curated specifically to support vulnerability assessments. Information is gathered from the scientific literature, regulatory reports, media publications, judicial records, and trade associations from around the world and is searchable by ingredient, adulterant, country, and hazard classification.
  2. NSF, “Risk Modelling Of Food Fraud Motivation – ‘NSF Fraud Protection Model’ Intelligent Risk Model Scoping Project FS 246004.” (2014). Retrieved from https://www.food.gov.uk/sites/default/files/media/document/NSF%20Final%20report.pdf.
  3. Inacio, CT and Chalk, PM. (January 2017) Principles and limitations of stable isotopes in differentiating organic and conventional foodstuffs: 2. Animal products. Crit Rev Food Sci Nutr.. Retrieved from https://www.ncbi.nlm.nih.gov/pubmed/25849871
  4. Capuano, E., et al. (September 11, 2012). Analytical authentication of organic products: an overview of markers. Journal of the Science of Food and Agriculture. (Vol. 93) No. 1. https://doi.org/10.1002/jsfa.5914
Laura Bush, Mike Taylor
Food Safety Culture Club

Is FSMA Driving Food Safety Culture?

By Lauren Bush, Michael Taylor
No Comments
Laura Bush, Mike Taylor

We were asked if we think FSMA is driving strong food safety cultures. Our answer is: Yes, but there’s more to the story.

For the dozens of impacted families that advocated for years on behalf of the thousands of individuals who are sickened and die each year from foodborne illness, FSMA marked a sea change in accountability for preventing foodborne illness. And it demonstrated that the consumer voice can impact a Washington legislative process often perceived as impenetrable to the everyday citizen. It’s also true, however, that even before FSMA, leading companies had been implementing modern preventive measures in response to unacceptable illness outbreaks and consumer demands. And food safety thought leaders were writing about food safety culture and working to drive it. We thus see FSMA reinforcing the movement to strengthen food safety cultures rather than being the primary driver.

After all, a genuine food safety culture is as much about people and motivation as regulation. The people in food companies driving strong cultures are motivated at a personal level by knowing the severe harm deadly pathogens in food can inflict on illness victims and their families. And they are motivated at a business level by the realization that the success of a food company hinges on continuously meeting high consumer expectations for food safety. These personal and business motivations are the original and continuing drivers of strong food safety cultures.

The 2011 enactment of FSMA was made possible by the coming together of consumers, food safety experts, and industry leaders who agreed that application of the best available science to prevent problems is the responsibility of everyone. This agreement and the enactment of FSMA powerfully demonstrated how far our food safety culture had come since the uphill battles of 25 years ago over accountability for keeping E. coli O157H:7 out of ground beef and mandating HACCP for meat, poultry and seafood. There is now consensus that adoption of modern preventive controls is a basic responsibility of everyone producing food.

Food safety culture is about much more, however, than simply doing the basics of preventive controls. It’s about staying on top of change in the hazards that occur in our food system and in the means available to minimize them, and being committed to continuous improvement in response to these changes. FSMA took the breakthrough step of making continuous improvement a regulatory requirement by tying the definition of preventive controls to current expert knowledge about how to control hazards and requiring controls to be updated regularly as new knowledge emerges. In this way, FSMA reinforces the movement to strengthen food safety culture and makes it everyone’s responsibility.

But it all still comes back to motivation. Stop Foodborne Illness has long contributed to that motivation by sharing the stories of individuals and families who have experienced devastating loss and lasting harm from foodborne illness. Companies seeking to strengthen their cultures invite Stop constituents to tell their stories in employee training sessions and meetings with senior executives. In this new era of food safety, we see great opportunity to expand collaboration with food companies to help drive the widest possible implementation of best practices, continuous improvement and strong food safety cultures. In this effort, FSMA is our important ally.

Bush and Taylor co-chair the Board of Directors of Stop Foodborne Illness, a non-profit consumer organization that represents victim of foodborne illness and their families.

Leonard Steed, AIB International
FST Soapbox

Unannounced Audits: Are You Ready?

By Leonard Steed
No Comments
Leonard Steed, AIB International

Many industries are moving toward unannounced third-party certification audits and the food industry is no different. If regulatory audits are unannounced, why is the food industry reluctant to adopt unannounced third-party audits? There are a number of benefits to unannounced audits—most importantly is their positive impact on a company’s food safety culture and how they prepare facilities to face FDA inspections.

Unannounced audits for food are required for many third-party certification audits. Typically, regulatory audits are always unannounced. Unannounced audits help demonstrate compliance and provide confidence to all stakeholders that your manufacturing sites are operating on the same GMP level, day to day, shift to shift, for every day your organization is manufacturing and distributing food products. With announced audits, companies tend to prepare for them before they occur. However, if there is a significant amount of difference between your sanitary operations prior to and during an announced audit versus normal operating conditions, you are sending your employees the wrong message.

Although there are differences between certification schemes, the GFSI third-party unannounced audits usually have a 40- to 60-day window in which the audit must be completed to allow the certification body to complete technical reviews and review corrective actions so that the certificate does not lapse. If it is a surveillance audit, then the audit is more likely to be truly unannounced, but a company still has the option of using blackout dates and the auditor will verify that the request was necessary. The bottom line is most companies have a certain timeframe when they know unannounced audits will occur.

Leonard Steed will present “Unannounced Audits: Are You Ready?” on November 14 at the 2018 Food Safety ConsortiumThe biggest impact on third-party audits is when the audit score is directly related to financial incentives for employees. This situation motivates employees to pursue activities to achieve the maximum score, not directly related to food safety. Activities may include significant audit preparation to eliminate or reduce GMP deficiencies, reduce or control the auditor’s access to records or areas of known plant deficiencies, “auditor shopping”, and to appeal any audit finding that lowers the score. Switching auditors or appealing findings can be legitimate tools to correct a system when auditors make errors in judgement or behavior. The activities to achieve the highest score should be reasonably governed because they could take away from the primary goal to operate in a food safe mode.

The goal of an internal audit program is to be compliant with regulatory inspections and third-party certification requirements and should therefore be risk-based. Determine what factors present the most risk to an organization and then align internal audits with those risks. At this point in time, being able to perform well on a regulatory audit should be a primary concern. Since the FDA and state regulatory agencies usually perform unannounced inspections, it would seem necessary to have your food safety plan, prerequisite programs and operations in a constant state of readiness to mitigate the risk of potentially unsafe food in commerce resulting in a recall.

One way to evaluate your food safety culture is to anonymously survey employees at all levels of the organization to gather information on attitudes and opinions about food safety and institute changes to improve your position. Another way is to initiate change by instituting unannounced audits on all manufacturing shifts and require participation by all departments in the audit function to move away from “QA-centric” food safety verification systems. The significant change is that all departments would be involved as an auditor and responsible for maintaining regulatory compliance. For some companies, the inclusion of all plant departments in the audit function has moved the needle in the goal to improve their food safety culture. To further define food safety culture in other terms, it could mean adhering to GMPs all the time, the importance of accurately completing and verifying food safety records, and fostering consensus between departments on the severity of food safety nonconformances requiring prompt corrective action.

Maintaining GFSI certification is an excellent way to achieve food safety requirements for compliance with FDA inspections. Although not specifically required by GFSI, another application of your internal audit program is to review your regulatory policy by performing a mock FDA inspection to identify any gaps in hazard analysis, identify preventive controls including the supply chain controls, accurately complete food safety records, and provide examples of corrective actions when preventive controls were not completed properly, and environmental corrective actions. If you decide to perform a mock FDA inspection of your facility, do not forget to include the FDA Guidance document criteria, as it is important to understand what the FDA expects to see when they are evaluating your implementation. Your internal audit program is a proactive program to note nonconformances before they become full blown problems, so don’t be afraid to use it to its fullest extent.

Chelle Hartzer, Orkin
Bug Bytes

Don’t Let Pests Wreck Your Supply Chain

By Chelle Hartzer
No Comments
Chelle Hartzer, Orkin

In today’s global marketplace, it has become necessary for facility managers to implement more detailed inspection and documentation policies for incoming shipments as part of the larger food safety plan. But plan as you might, pests are adept at infiltrating food products and contaminating shipments. Their resilience and persistence will make you pay, literally, if you’re not paying close attention.

Pest management is a key component of any facility manager’s food safety plan, but understanding how best to prevent pests from compromising shipments—and by extension the supply chain—takes diligence.

Chelle Hartzer will be speaking during the complimentary webinar, Pest Management’s Role in Food Safety and FSMA Compliance, on September 26, 2018
An integrated pest management (IPM) program is the best way to ensure that insects and rodents are kept away from processing, packaging and storing food products. Again, this information shouldn’t be anything new if you’re a food processing facility manager, but it’s important to note that IPM focuses on proactive prevention of pests, to align with FSMA’s Hazard Analysis and Risk-Based Preventive Control (HARPC) regulations. These newer regulations shift the focus from reacting to potential contamination concerns to preventing as many issues as possible. Being proactive is a must.

Aside from the legal backlash a facility could face if found if violating these rules, pest issues can also have a major negative impact on a business’ bottom line. Imagine the cost of even one of your outgoing shipments being contaminated by cockroaches or stored product pests. Now, imagine the impact on your business from consumer backlash if the pest-ridden shipment travels further down the line. Simply put, it’s never good if the pest problems are traced back to your facility.

So, what’s the best way to protect your supply chain from potential pest issues and remain compliant under FSMA and HARPC?

All food safety plans should have considerations in place based on a review from a Preventive Controls Qualified Individual (PCQI). This individual is responsible for preparing the document, with the input of as many departments and people as possible, such as QA/QC, maintenance, production teams, and more. Since pests are a common potential hazard, a pest management program should be included in the plan.

That being said, it’s important to inspect all incoming shipments. Even if suppliers have implemented measures to help keep pests away from their sites and products, pests are tough to entirely prevent and it’s always a possibility some have slipped through the cracks (literally!). Pests are attracted by food, water and shelter, so a truck transporting products to your facility is going to be chock-full of attractants! Carefully inspecting incoming shipments will not only help ensure pests don’t enter your facility, but it will help you and your supply chain partners target exactly where problems may be occurring. Forming good relationships with your suppliers, and keeping communication open can help to manage any issues that may pop up.

The faster pest issues are detected, the better. It’s easier to address a pest problem and more accurately pinpoint where it originated if it can be caught early. Otherwise, pests can reproduce quickly and spread, making it harder to pin down the source of an infestation and to treat it. It’s tough to overstate the importance of open lines of communicated between supply chain partners!

To avoid allowing pests into your facility or sending them to a supply chain partner, implement the following processes:

  • Inspect shipments for pest activity, especially incoming shipments. Some common signs include live or dead insects, droppings and damage to the product and packaging.
  • Ensure packaged products are properly sealed and undamaged before transport, and then check the transportation vehicle before loading product for shipping.
  • If there is a pest sighting, remove any compromised product to avoid allowing pests to spread to other goods or find a way into the facility. If it can’t be removed from the facility, isolate it in a contained area and call your pest management provider immediately.
  • Empower employees to call out pest issues as well by implementing a “see something, say something” policy. Don’t forget to have a pest sighting log, and let the employees know where it is and what to record.
  • Use monitoring devices to detect pest activity levels. Devices like insect light traps, pheromone monitors, and glue boards can be easily placed in shipping and receiving areas as an early warning sign of pest activity.

With an untrained eye, pest issues can be difficult to notice. Ask your pest control professional about a free training session for employees. Most pest management companies offer this service free of charge, and it can be a big help. There’s no reason you shouldn’t take advantage.

The pest pressure a facility faces is dependent on a variety of factors including location, geography and the type of product being produced and stored. No two facilities are the same, which is why every pest management program should be customized to meet the needs of the business.

As a start, the following pests are the most common to find in the food processing industry.

  • Rodents: Rats and mice can carry disease-causing pathogens that can be deposited onto other surfaces by simply making contact with equipment or products. Both are capable of fitting through tiny gaps (mice can fit through a hole the size of a dime, while rats can fit through a hole the size of a quarter), meaning any openings on the exterior of a building serve as a welcome mat to a curious rodent. To spot the signs of rodent activity, look for droppings and yellowish-brown grease marks around corners and along baseboards, as these marks can be caused as a rodent rubs against these areas. In addition, look for gnaw marks around any gaps or openings in walls and on products.
  • Cockroaches: Able to squeeze their bodies through miniscule gaps, cockroaches will feed on just about anything. With a good food source, they can reproduce quickly. A couple cockroaches can become an infestation in a matter of months, especially with an abundant food supply. Cockroaches are most active at night, so if you see one during the day it’s a good sign that it’s time to act quickly!
  • Flies: While less likely to find their way into packaged products, flies can spread dangerous, potentially disease-spreading pathogens on everything they touch. They usually don’t travel too far from their larval food source, but their ability to reproduce quickly can make them a nightmare to get rid of if steps aren’t taken to remove them immediately.
  • Stored Product Pests: There are numerous kinds of stored product pests, but all are adept at thriving in and around products undetected. The Indian meal moth, for example, is a moth with small, cream colored larvae that will eat just about anything. Stored product pests are some of the most likely pests you’ll find on incoming shipments and in storage areas, as they’re right at home breaking into and surviving within product packaging.

Keep these pests on the radar, and make sure to take note of where pests are found and how many are spotted. The more information, the better, as it helps pest management professionals get to the root of pest problems.

Documentation is always a major key. It shows an auditor that careful planning and proactive prevention are points of emphasis, which will be important. Although there are numerous documents to keep on hand, add the following to your list in order to more easily demonstrate compliance with pest related FSMA regulations:

  1. Supply chain program, including suppliers and ingredients.
  2. Receiving procedures, including the pest management program that helps prevent pests from entering the facility on products or through loading areas.
  3. Receiving records, or, in other words, documentation of shipments received from suppliers.
  4. Monitoring records of any captured pests in or around the facility and any corrective actions.
  5. Application records for treatments used in and around the facility.

If suppliers are located in another country, note the requirements differ from facilities located in the United States. The FDA breaks this down on their website, but importing products from another country means a facility must follow the Foreign Supplier Verification Program. This comes with a different set of compliance documents and means the importing facility must monitor foreign suppliers’ food safety plans.

Remember: Preventing pests needs to be a proactive process included in the food safety plan. If you want your supply chain to remain pest free, partner with a pest management company and talk to your supply partners to establish standards for documentation and communication. All will benefit, as you’ll be able to catch problems early and have a better chance of keeping pests from wrecking your supply chain.

Read on for more articles by Chelle Hartzer.

How to Prepare for an Audit at Any Time

Minimize the Risk of Pests by Maximizing Your Staff

 

Richard Wilson, AuditComply
FST Soapbox

Why SaaS and Food Safety Are A Perfect Match

By Richard Wilson
No Comments
Richard Wilson, AuditComply

Food manufacturers, what’s keeping you up at night? What’s the one issue that could damage your reputation so badly that you lose customers? The answer: A food safety crisis that at best, requires your products to be recalled and at worst, puts valued consumers at risk.

Similarly, if you’re a global supply chain manager, what’s your number one worry? The answer: Maintaining continuous compliance with industry standards, meeting increased regulation requirements, or maybe it’s a key supplier failing their BRC audit?

Whatever it is, we all know food manufacturers are under increased pressure, facing multiple internal and external challenges in an ever-changing complex environment. Challenges such as price volatility, stronger competition, increasing customer demands, complex supply chains and globalization are all taking their toll.

Furthermore, to add to this increasing pressure, organizations are still relying on paper-based systems and manual processes to help manage their risk, quality and compliance, and even their environmental health and safety (EHS)! This approach is inefficient, makes the audit and compliance process costly and difficult to scale, while compromising quality and complicating traceability. It’s time to take advantage of the digital age and relieve the pain and pressure of traditional risk and compliance management with a SaaS (software as a service) solution.

What is SaaS (Software as a Service)?

SaaS providers use the internet to deliver their bespoke software offering, usually in the form of a subscription-based service with a monthly or annual fee. The main benefit of SaaS is the cloud, being cloud-based software, upgrades and fixes are managed by the software provider, reducing or eliminating the need for an IT infrastructure—all your data is readily available in real time, on one centralized platform. SaaS is delivering more visibility and mobility without hassling organizations with the details and streamlining software integration across the globe.

SaaS solutions have become a game changer in modern risk management, and the following points illustrate why.

Speed of Deployment

Food and beverage manufacturers require a SaaS solution for multi-site global deployment with complete local management. A SaaS solution will graft onto your business processes immediately. No additional IT hardware should be needed, which means you don’t waste your time procuring and installing an IT infrastructure for multiple sites to benefit. It’s important to remember that the food and beverage industry is moving fast, so if your chosen SaaS solution requires months or years to implement, you’re talking to the wrong people. There is a common saying at my company: “We don’t count in months or years, we count in hours and minutes”.

Providers that offer traditional, on-premise solutions, require extensive configuration and bespoke coding to map to the client’s needs. Long rollout and deployment cycles are inherently expensive to maintain and have poor user experience. This is the reason most consumers revert to Excel/Word and Sharepoint, ultimately losing the ability to manage consistently at scale across their real estate. With an RPM (risk and performance management) SaaS solution you can expect a fast deployment with a comprehensive and configurable enterprise workflow from day one.

Staying Up to Date Is Automatic

Your chosen SaaS provider manage your entire solution from their side, which means upgrades, fixes and customization requests are immediate and automatic. Again, reducing or eliminating, the resource needs of an IT infrastructure. Organizations will have the advantage of immediately being able to utilize the latest features the SaaS solution has to offer. These upgrades will often be driven by feedback from users as organizational and industry requirements change. On-going system development will be crucial to staying in, and assuring, compliance and risk mitigation.

As a food manufacturer, it is important that your SaaS solution comes with a comprehensive document control library—a feature that will always be automatically updated by your SaaS provider. When you are conducting assessments in the field, many users require the ability to refer back to specific document types such as manuals, procedures, work instructions and the latest standards or regulations. These documents should be all managed by your SaaS provider, with teams consistently reviewing and updating important industry documentation on the platform for any user out in the field.

Ease of Use

Proofs of concept are crucial. Living in a world where we have an abundant amount of choice, organizations need to know their chosen SaaS solution has the ability to meet requirements and demands of both the organization and industry. This is made easy with SaaS, allowing organizations to test the software functionality in advance of purchase. Even for large food manufacturers, SaaS offerings can be used to test the software before it is purchased, and there should be no limit to the amount of trial users. The right risk and performance platform will also allow your team to upload specific templates, allowing new users to be familiar with assessments provided on the platform, easing your transition to a digital format.

Mobility and 360o Visibility

For further flexibility, popular SaaS providers will offer their solution in mobile format. Assessments conducted on the platform should be seamlessly synchronized between smartphone, tablet and desktop, allowing you to start an assessment on one platform and then pick it up on another. Users are no longer restricted to one location and can access their robust platform from any device, online or offline. We know that many companies are operating in

harsh environments, whether it’s the scorching temperatures of the Sahara desert or the blistering wind chills of northern Canada—your SaaS solution needs to come equipped with the right tools. By utilizing SaaS mobile offerings, organizations gain full visibility of their risk profile, making room for a culture of continuous compliance whether they’re in the field or back at the office.

Scalability at a Lower Cost

Implementing a SaaS solution means all your data is securely stored in the cloud. This provides scalability to match organizational growth strategies. Food manufacturers can add more users as their business grows without ever thinking about changing the hardware or requiring a full IT department for assistance. However, although SaaS offerings are provided at a lower cost than traditional solutions, each platform has its own rates, so shop around for a solution that will best suit your budget and requirements.

Bottom Line

Cloud-based software models have made risk, quality and compliance more affordable and flexible, considerably improving and streamlining business processes worldwide. Next time you are evaluating a SaaS solution for your food and beverage organizations, remember, the providers are staking their own survival on the software platform working. Whether it’s the protection, security, availability or performance of your data. Providers want to make their platforms a hassle-free and secure option for any food manufacturer looking to thrive in this demanding industry.

Relieve the pain and pressure of traditional risk and compliance management: Realize your investment from day one.

Gabriela Lopez, 3M Food Safety
Allergen Alley

Establishing an Effective Food Allergen Control Plan

By Gabriela Lopez-Velasco, Ph.D.
No Comments
Gabriela Lopez, 3M Food Safety

It’s nearly 2019: Do you know where your allergen control plan is? The need for food manufacturers to have a clearly defined allergen control plan in place has never been more essential. Today, as food allergies are a growing health problem around the world to both children and adults, control measures to prevent food allergenic reactions simply must be established and enforced within the food manufacturing environment.

How did we arrive here? After all, it wasn’t that long ago that the approach to prevent an allergic reaction caused by a particular food relied on avoidance of the consumption of that food by reading product labels. Allergic individuals would merely rely on the information provided on the label to determine whether the ingredients include a food that may be a source of a potential allergen.

That approach started to become more stringent in January 2006 when the Food Allergen Labeling and Consumer Protection Act (FALCPA) took effect in the United States. The law requires that food labels specifically and clearly declare the presence of what is commonly referred to as the Big 8 Food Allergens: Milk, egg, fish, crustacean shellfish, tree nuts, peanuts, wheat and soy. (Outside the United States, the European Union, Canada, New Zealand, Japan and other countries have similar requirements for these and other known food allergens.) Despite U.S. law now requiring the declaration of allergens on food labels, estimates of food recalls due to mislabeling is at more than 40% in the United States—alarming evidence for the need for a strong and structured allergen control plan. According to the USDA, the number of recalls due to undeclared allergens and ingredients considered a public concern increased from 13% in 2008 to 35% in 2012. The most common causes of recalls stem from changes in product formulation, changes in supplier’s ingredient formulation, regulatory inspections or consumer complaints.

So, what should today’s food manufacturers do? They must declare any allergens in their food to consumers, and they should follow Good Manufacturing Practices (GMP) and keep ingredients segregated within the plant. However, with increased food demand, this is more challenging than ever. As more food and food varieties are produced, the practice of sharing lines for allergen-containing and allergen-free foods is now commonplace. If a company shares production lines within its plant, then it needs to take steps to minimize the risk of cross contact and the unintentional addition of allergens during food production.

The FSMA final rule for Preventive Controls for Human Foods requires facilities to have a food safety plan in place that should consider a risk-based analysis of hazards and preventive controls to minimize or eliminate chemical, physical and biological hazards in the food supply chain. Within these preventive controls, food allergen controls should be in place as written and implemented procedures to control cross contact and ensure proper labeling.

For food and beverage manufacturers looking to establish a food allergen control plan, there are three key steps:

  1. Risk Assessment: Is there a chance that unintentional allergens could be present in the food or manufacturing equipment in your plant? Risk assessment involves a hazard analysis by a multifunctional team that includes members from such departments as manufacturing, quality, food safety, sanitation, research and development, and regulatory compliance. Risk assessment helps identify potential sources of food allergens and maps their path through each step of the manufacturing process. Once the path is identified, controls can be put in place in target areas such as reception and storage, scheduling of production runs, variations in production, equipment design and supply and cleaning materials. It is important to periodically review and reassess your risk assessment as new products, formulation changes or vendor changes may change production conditions.
  2. Risk Management: Now that risks have been identified, they need to be managed. The key to successful risk management is developing work instructions and standard operating procedures that control the possibility of unintentional allergen contamination. These procedures and instructions include quality requirements for vendors’ ingredients, segregation, production controls, manufacturing scheduling, equipment and plant design, as well as cleaning and sanitation procedures. It is important to validate that these procedures and practices are effective using a science-based approach. In addition, these activities should be routinely reviewed and evaluated for effectiveness. A successful allergen control plan relies on continuous training, clear explanation of procedures and documentation of the existence and effectiveness of the plan.
  3. Risk Communication: The next step after assessment and management is communication. If you have an allergenic food in your plant that could be unintentionally found in the finished food product, it is essential that this information appears on the food label. Risk assessment can help define the nature of the potential allergen. Is the final product manufactured from ingredients that contain allergens or is it manufactured on equipment that is in direct contact with allergenic ingredients? This analysis can ensure proper labeling, either in the food ingredients or as a precautionary allergen label (PAL).Ultimately, it is important to remember that food allergen control plans require management commitment to succeed. Continual communication and training increase the safety of manufactured products. Allergen control is but one of the many efforts to prevent and minimize foodborne illness in humans, but the development of and adherence to an effective allergen control plan will go far in protecting allergic consumers and reducing the food manufacturer’s risk to reputational and recall costs.