Tag Archives: risk

Third party certification program, FDA, audits, Food Safety Supply Chain Conference

Your Supply Chain in 2019: Top Considerations

By Maria Fontanazza
No Comments
Third party certification program, FDA, audits, Food Safety Supply Chain Conference

Last week industry gathered for the Food Safety Supply Chain conference at USP in Rockville, MD. The following are some quick highlights of insights they shared.

Most Common Form 483 Observations

Following FSVP inspections, the most common Form 483 observation was a company’s failure to develop an FSVP. From FY 2017 to present, the observation was cited 552 times, outweighing any other observation and underscoring the need for an educational component. – AJ Seaborn, supervisory consumer safety officer, division of import operations, ORA, FDA

FDA, Food Safety Supply Chain Conference
(left to right) AJ Seaborn, Lisa Ross and Priya Rathnam of FDA share an update on FSMA implementation at the 2019 Food Safety Supply Chain Conference

Top Citations for FY 2018

  • Hazard analysis (when a facility is not identifying a hazard that requires a preventive control)
  • Lack of a food safety plan. “There’s still work to be done on the education and outreach on this one.”
  • Equipment and utensils (GMP deficiency)
  • Allergen controls monitoring
  • Sanitation control verification procedures
  • Personnel (usually, this is related to a repeated issue)
    Priya Rathnam, supervisory consumer safety officer, CFSAN, FDA

Critical Supplier Questions Must Be Asked

  • How do you choose and approve your suppliers?
  • What must be done to ensure that we aren’t receiving hazards from suppliers?
  • What requirements must be defined?
  • Does every supplier need to be audited?
  • Should we treat all suppliers equally? (No, it depends on their risk profile)
  • How do we ensure that our program is effective?
  • When working with suppliers, it’s important that your decisions are reproducible and that you apply the same risk methodology across the board. – Erika Miller, food safety specialist, D.L. Newslow & Associates, Inc.

“Before you can do anything to transform your business, you have to have visibility in your supply chain.” – George Dyche, senior director, innovations & solutions, Avery Dennison

“’Compliance’ should be replaced in industry with ‘commitment’…when you’re committed, compliance will follow.” – Felix Amiri, food sector chair, Global Coalition for Sustained Excellence in Food & Health Protection (GCSE-FHP)

Putting the “P” in CAPA = Getting out in front of issues before they happen. “Don’t wait for the consumer to get sick… if you have a recall, it means you haven’t done your work on the CAPA side.” – Andrew Kennedy, director, Global Traceability Center, IFT

Food Safety Supply Chain Conference
(left to right) Felix Amiri, Lucy Angarita and Andy Kennedy discusss supply chain vulnerabilities and solutions.

On critical success factors to establish a traceability program: Technology will never fix a company’s data quality or process issues. If you don’t already have it defined, you won’t get there. And after you understand the KPIs and goals, don’t give up. This doesn’t happen overnight. Engage your leadership, because the vision has to be from the top for others to also allocate the time and effort. “It’s a journey, not a destination. If you take your eyes off data quality, data quality goes down.” – Lucy Angarita, director, supply chain traceability, IPC/Subway

In 2018, 47% of recalls were allergen related, and this rate has increased. “People still don’t get [allergen labeling]”.  – Barry Parsons, senior consultant, PTI Consulting Group (Division of Paster Training)

On the significance of teaching truck drivers the importance of food safety risks: “They are part of our supply chain, and we need to incorporate them. It shouldn’t be out of sight, out of mind.” – Holly Mockus, senior industry analyst, Alchemy

Third party certification program, FDA, audits, Food Safety Supply Chain Conference
Trish Wester, chair of The Association of Food Safety Auditing Professionals, leads an FDA panel discussion about the Third-Party Certification Program. (left to right) Doriliz De Leon, program coordinator, accredited third-party certification program, FDA; Marla Keller, biologist, FDA; Marianne Fatica, policy analyst, Office of Compliance, FDA; Clinton Priestley, consumer safety officer, audit staff, human and animal food operations, ORA, FDA

Technology Helps Your Food Safety Employees Work Smarter, Not Harder

By Maria Fontanazza
No Comments

As the use of technology in manufacturing and quality continues to expand, there are many opportunities to help food companies streamline operations and enhance efficiencies. During a brief chat with Food Safety Tech, Melody Ge, head of compliance at Corvium, Inc. talks about the benefits of using technology in manufacturing and why some companies may be hesitant to take the leap.

Food Safety Tech: Your recent Food Safety Tech article, “Changes in the Food Safety Industry: Face Them or Ignore Them”, highlighted the role of technology in improving efficiency. What are the top areas in which companies are challenged to streamline processes?

Melody Ge, Corvium
Melody Ge, head of compliance at Corvium, Inc.

Melody Ge: When talking about a company’s production process, the challenge usually comes from where to start. A company may have difficulty figuring out which areas in the processing line can either be automated or how they can use technology as an advantage.

The challenge could also come from the fact that only parts of the process can be automated with the current technology. For example, with hazard analysis or risk assessment—those processes still need the human brain. So within a process, part of it can be automated, and part of it can’t—that could be another challenge.

FST: What technologies can food companies use to better help them manage risk in manufacturing?

Ge: It depends on what’s out there and what products a company is producing. From a manufacturing perspective, they can use supply chain management software or document management software to help them manage their approved supplier program. Using technology can make it easier and more efficient for companies to manage the risks from incoming goods and suppliers as it centralizes their documentation to make it easy to access.

Technology also helps companies use online software to centralize training documents on one corporate site and deploy it to all employees at different levels.

And from a HACCP and Preventive Controls perspective, companies can use digital technology to document temperature, pH Value, humidity, pathogen testing results, etc.—all the types of data that help execute a HACCP plan can be automated and help manage risk. After all the information is centralized and digitalized, you can see the data and easily translate that to help manage risk.

FST: What are the current technology adoption hurdles, and how are you helping companies understand the value of technology versus a paper-based system?

Ge: I think some hurdles come from fear: What’s going to happen as a result of technology is unknown, and especially at this stage, how FDA will respond is unknown. FDA already announced that this smarter food safety era is coming, but no one knows whether there will be new requirements as a result. Will requirements change because manufacturers are using new technology? Those unknowns make manufacturers fearful about what’s going to happen.

Another fear factor is job loss. For example, if processes are automated, or AI is used to capture data, or record keeping is automated, then what am I going to do? Does the company still need me as a QA professional or supervisor? I think those can stand in the way of making changes. However, [companies or employees] shouldn’t think that way. Technology is not replacing QA professionals, but [rather it] helps them do higher-level jobs. For example, in the time saved by technology, QA professionals can read and digest the data results, and study the trends and recommend best practices to continuously improve their food safety management system. It makes their time more valuable to the company.

Another hurdle is understanding which steps in processes can be automated. There are so many technologies out there that have pros and cons, and whether it will fit with the manufacturer or the facility—there’s an overwhelming amount of information, and the QA technician needs time to digest and understand the process at the facility as well as the technology out there to then select the most suitable technology for a process.

As far as helping companies understand the ROI of technology, there are four areas where I think technology can add value:

  1. It provides increased efficiencies and accuracy of daily operations and data collection. It reduces human error. Let the technology help the food safety professionals document daily operational data.
  2. It streamlines the food safety management system for continuous improvement. Because technology helps the food safety professional do the job of daily data collection, the time saved can be used wisely to study the data and outcomes, and truly understand how they can bring their food safety management system to another level.
  3. It centralizes all the documents and records for management. Using technology, the food safety professional can see their SOPs, records and any related documents in one place. They don’t have to physically go to several places to see what’s happening operationally. This can also help increase efficiency during the audit process.
  4. Centralized data helps the food safety professional more easily see where the deficiencies are located.

Ultimately, the ROI is that advanced technology can help the food safety professional increase operational efficiency, reduce product waste and production downtime.

FST: Any additional comments about the role of technology in food manufacturing?

Ge: In echoing on FDA’s announcement, although the smarter food safety era comes with using advanced technology, the mentality has not changed as all—it’s always FSMA based and people led. We need people to use the technology, and that foundation isn’t changing. We are protecting our consumers from any potential food safety risk. We’re just using a more efficient way to help all of us achieve this goal. I believe in the future, all food facilities will use at least one technology out there to help them automate one or more processing steps. And if you start with one step at a time, it will generally take over the entire production process.

Visit Corvium at next week’s Food Safety Supply Chain Conference at USP in Rockville, MD. Unable to travel? Attend the program virtually!

Steve Ardagh, Eagle Protect
FST Soapbox

Glove Polymers: The Unregulated Food Safety Threat

By Steve Ardagh
No Comments
Steve Ardagh, Eagle Protect

Various polymers are used in food contact applications that include food packaging and disposable gloves. More than 30 different types are used in packaging and up to six in disposables gloves. In terms of safeguards for the U.S. food supply as well as user safety, it is worth noting that 87% of the production of packaging polymers is based in the United States and subject to FDA regulation and monitoring. On the other hand, all (100%) of the 100 or more glove factories supplying the United States are based in Southeast Asia, according to a report by the British Medical Association and are not subjected to the same FDA monitoring or scrutiny.1

Packaging production is carefully overseen by the FDA, is included in FSMA, and covered in the HACCP process. Toxicology of food packaging is carefully prescribed and subject to strict enforcement action from production to storage.

Glove factories, however, are generally self-regulated, with FDA compliance required for a rough outline of the ingredients of the gloves rather than the final product. Few controls are required for glove manufacturing relating to the reliability of raw materials, manufacturing processes and factory compliance. A clear opportunity exists for accidental contamination within the glove-making process. More significantly, because of the geographic and economic implications in workforce and workplace conditions, intentional contamination potential is greatly increased. Polymer gloves utilized in food processing and service have been implicated in 15–18% of foodborne illness outbreaks in the United States.2

There is a striking difference in the requirements for these two different types of food contact polymers. Food packaging is extensively regulated, gets tested within the context of completed food product and has production primarily in the United States under close supervision. Disposable gloves, on the other hand, rely on self certification, often with testing results only on glove constituents, and little or no oversight of factory process and conditions. It seems as though this is a glaringly obvious but little accounted for risk to the U.S. food sector.

As a result, based on the root cause analysis of food cross contamination, a selection of tests and certifications, some of which are unique to the glove industry, are being implemented by one particular glove supplier. These tests ensure that their gloves coming into the United States are made in clean, well-run factories, free of any type of contamination and are consistent in material makeup to original food safe specifications. This glove fingerprint testing program consists of a number of proprietary risk reduction steps and targeted third-party testing methods, includes gas chromatography combined with mass spectroscopy (GC/MS, surface free energy determination, in vitro cytotoxicity analysis, and microbial viability-linked metagenomic analysis.

With a great deal of faith placed on a glove supplier’s ability to deliver disposable gloves sight unseen, I believe these tests are essential to further reduce the food safety risks associated with them. Objective…Zero surprises!

References

  1. Bhutta, M. and Santhakumar, A. (March 2016). In Good Hands. Tackling labor rights concerns in the manufacture of medical gloves. British Medical Association. Retrieved from https://www.bma.org.uk/collective-voice/influence/international/global-justice/fair-medical-trade/medical-gloves-report.
  2. Michaels, B. (2018). Determination of the % of Foodborne Illness Outbreaks Attributed to Glove-Related Cross-Contamination. Unpublished report

The author would like to acknowledge Barry Michaels, an international scientific consultant on food safety, infectious disease transmission and glove use, who has assisted in the fingerprint testing program discussed in this column.

Gisli Herjolfsson, Controlant
FST Soapbox

How Supply Chain Digitalization and Data Helps Prevent Costly Recalls

By Gisli Herjolfsson
No Comments
Gisli Herjolfsson, Controlant

Recalls are something that food brands plan for but hope to never experience. They are an important public safety issue, but they also have a significant economic impact as well. At best, a product recall is a benign mistake that causes little more than aggravation and inconvenience for a few angry customers. At worst, the consequences can be tragic, both in terms of human and financial impact.

Industry research conducted by the Food Marketing Institute and Grocery Manufacturers Association places the average cost of a single recall at $10 million. That calculation includes only the direct costs of a recall. For the full, long-term costs, including direct and indirect liabilities, you’d need to further account for the immediate loss in sales, litigation costs, as well as any long-term damage caused from a loss in consumer confidence in your brand.

Consumers’ relationship with food is ever changing. They demand transparency about its contents, origin and safety, and for good reason. The World Health Organization estimates that nearly 1 in 10 people are sickened yearly from eating contaminated food, leading to 420,000 deaths. Consumers have long memories for businesses that poison them. The larger the size of your company and the more attention it receives, the potentially greater impact on your long-term business prospects. With the recent E. coli outbreaks tied to romaine lettuce, food safety is top of mind for consumers, and it is impacting entire market segments.

One of the easiest ways to prevent recalls associated with perishable foods is to ensure that food and beverage products are safely produced and continually kept at the right temperatures. Sounds easy, right? In reality, it is far from it.
Gaining end-to-end supply chain visibility can help you prevent costly recalls altogether. Data that today’s technology provides will be important for mitigating risk and protecting a brand’s reputation.

Get Proactive

The idea of prevention is paramount to FSMA. It’s clear that the FDA expects that once a producer or supplier discovers that something has gone wrong, they go back and figure out exactly what happened so that they can put measures in place to prevent it from happening again.

While current FDA guidelines and various EU safety regulations generally require that food can be tracked one step up and one step down the supply chain, this remains a very siloed approach to traceability and is open to risks—risks that producers, food retailers and restaurant brands cannot afford to take.

For USDA-regulated products, HACCP employs a similar process. Prevention is key, and if your monitoring measures miss an issue that could compromise food safety, you’ll need to go back and determine the root cause of the problem.
A cold food manufacturer can do a lot to control risks under its own roof, but how do you avoid costly recalls with ingredients or with temperature abuse after a product leaves the facility? Regulations or not, knowing where your ingredients and food products come from and being assured of their safety is critical in protecting your brand and company from the financial and reputational damage caused by a food recall.

Looking forward in the supply chain, maintaining the cold chain is necessary for many products, including fresh produce, frozen and deep frozen foods, and also those that must be kept at room temperature but still require temperature control. Even if you and your suppliers are incredibly careful and practice prudent safety measures, you may not have full visibility over who else is handling your products. If temperature mishandling by someone else necessitates a food recall or results in a food safety incident, it is still associated with your brand, even if you weren’t the direct culprit.

For many food retailer and restaurant chains, it is common practice for them to share their internal food safety guidelines with their suppliers and partners, and require that they prove a product’s source of origin, lifespan, how those products are stored and transported from point A to point B, as well as the environmental conditions in which foods are kept. Allowing suppliers and logistics partners to self-manage their supply chain does nothing to proactively ensure that they and a food brand aren’t in the headlines due to a food safety incident.

Digitally Connect the Supply Chain

This is where technology and data can play a critical role in managing your temperature-controlled food and beverage products. More and more food enterprises are utilizing Internet of Things (IoT) technologies that talk to the internet so they can collect supply chain data into dashboards and access it on demand.

IoT can be considered as a central nervous system for the supply chain. Through IoT, you can track shipments or trace temperature, moisture or other factors that can have an impact on food quality. Not only can you discover problems more rapidly with this technology, you can narrow the scope of recall. For businesses transporting temperature-sensitive products, this means they can manage product movement data in real-time and respond to issues before they lead to a food safety incident or product waste.

From a food production standpoint, IoT solutions can substantially reduce recalls from issues like labeling, processing and contamination. One of the primary causes of a food recall is microbiological in nature, with the majority of cases involving fruits and produce. IoT data can help detect issues further upstream in the supply chain and, since products will change hands several times before they reach a consumer, it can give you a complete picture of the product’s lifecycle—something that cannot be done with clipboards and ad hoc or periodic inspections.

Through cloud technology, food businesses can connect their end-to-end supply chain, analyze data, discover trends, illuminate weak points and directly respond to them to improve their overall processes.

Track and Trace Everything

Continuous and consistent tracking and tracing through technology not only simplifies recalls, it helps prevent them altogether. The only thing worse than being faced with a food recall is not knowing which products are affected or where exactly they are located.

Real-time temperature monitoring and product movement traceability technology can give you the confidence that foods are continuously kept at their required temperatures and remain safe for consumption. When you need to track and trace an ingredient or product, time is often of the essence. Delays may mean more resources and efforts are spent in producing something that may be rejected, or worse, recalled, or that the potentially impacted product isn’t isolated in time.

The digital integration of suppliers and other partners is vital if a food enterprise wants to have more control over its cold chain. Consumer demand for social responsibility and ethical business operations means that businesses need to provide greater visibility and transparency into the origins of their products. With today’s supply chains, having data—essentially, a horizontal IT layer that lets people share and access data—removes the barriers of communication among stakeholders.
IoT serves as a tool to remove the barriers to collaboration between food manufacturers, food logistics businesses, restaurant and food retail chains, regulatory agencies, and the end consumer. It increases the transparency of information and helps to deliver better products throughout the food supply chain.

Get Started

Acknowledging that most food companies have limited resources, food brands can still face their efforts only on the suppliers and customers that are of the greatest concern. Often this means looking at the combination of “high-risk product” with “high-risk supplier/partner” and prioritizing that part of the supply chain. This prioritization will help food brands allocate their resources and focus their time and money on the highest risks to their customers and brand. Once they’re able to reap the benefits of a preventive food safety program, they’re better able to justify allocating additional resources to other parts of the cold chain.

While IoT, cloud monitoring and traceability technology has been around for some time, real-time data is now becoming standard. Traditionally, the cost of IoT technology and data infrastructure could be quite expensive. However, different business models like subscription are on the rise, which lower the cost of entry for new prospects and can connect a broader range of products, not only high-value goods.

Although many food brands already have some proactive food safety programs in place, it only takes one incident to lead to a major food recall—even if it isn’t your company’s product—and it can negatively impact your business.
As an industry, food brands need to continue raising the bar in terms of what is considered standard and “best practice” when building an effective, proactive food safety strategy. Utilizing best-in-class technology can ensure the delivery of safe foods to the market, prevent recalls, protect business interests, and most importantly, protect consumers.

Bryan Cohn, Foodlogiq

Managing Risk and Traceability in the Supply Chain

By Food Safety Tech Staff
No Comments
Bryan Cohn, Foodlogiq

Traceability and risk management go hand-in-hand. In a Q&A with Food Safety Tech, Bryan Cohn, food safety solution engineer at FoodLogiQ, shares his thoughts on risk and the critical role of communication.

Food Safety Tech: What does risk analysis mean in a complex supply chain?

Bryan Cohn: Risk analysis means the same thing it has always meant. The concept of risk is elemental; it transcends all of humanity and is rooted deep within our very DNA. Sure, we’ve added tools and technology to help us, but we still can not see into the future; thus, there will always be a risk. The best way to perceive, evaluate and comprehend risk in a complex world is faster and more accurate communications.

FST: Why is communication critical to avoid or mitigate risks within the supply chain?

Cohn: Let’s use an analogy here. Nobody likes traffic, right? In the morning when you’re getting ready for work, you might turn on the local news or check your favorite navigation app to find out the traffic conditions along your commute. You know your commute like the back of your hand, and you’re aware of every potential trouble spot along the way. But like most of us, you probably rely on fast and accurate communication from either traffic cameras, local news reports, or navigation information on your phone to give you a real-time analysis of what is happening. So aside from the usual trouble spots, you are made aware of any unexpected traffic accidents, road construction, or weather delays, which allows you to make real-time, actionable decisions about your commute.

If we think ahead – the same way we do about our work commute – and re-evaluate our communication strategy around our supply chains, we can begin to take a much stronger proactive approach to risk analysis and mitigation. If we spot a trend within our supply chain that may increase risk, we can take action before a threat materializes or intensifies.

FST: Can your risk management plan create value in the company?

Cohn: Any time a good communications strategy is integrated into your risk management program, you create value. By soliciting, evaluating and responding to feedback, you will inherently mitigate risk by addressing potential problems before they become problems and identifying new threats in a fast moving complex supply chain.

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.

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.

Food Fraud

Food Fraud: How Chemical Fingerprinting Adds Science to the Supply Chain

By Sam Lind, Ph.D.
No Comments
Food Fraud

You would be forgiven for thinking that food fraud is a sporadic issue but, with an estimated annual industry cost of $50 billion dollars, it is one currently plaguing the food and drink sector. In the UK alone, the food and drink industry could be losing up to £12 billion annually to fraud.

As the scale of food fraud becomes more and more apparent, a heightened sensitivity and awareness of the problem is leading to an increasing number of cases being uncovered.

Recently: Nine people contracted dangerous Vibrio infections in Maryland due to mislabeled crabmeat from Venezuela; food fraud raids have been conducted in Spain over fears of expired jamon re-entering the market; and authorities seize 1 ton of adulterated tea dust in India.

Spurred by the complexity of today’s global supply chains, food fraud continues to flourish; attractive commercial incentives, ineffective regulation and comparatively small penal repercussions all positively skew the risk-reward ratio in favor of those looking to make an extra dollar or two.

The 2013 horsemeat scandal in Europe was one such example, garnering significant media attention and public scrutiny. And, with consumers growing more astute, there is now more onus on brands to verify the origin of their products and ensure the integrity of their supply chains.

Forensic science is a key tool in this quest for certainty, with tests on the product itself proving the only truly reliable way of confirming its origin and rooting out malpractice.

Current traceability measures—additives, packaging, certification, user input—can fall short of this: Trace elements and isotopes are naturally occurring within the product and offer a reliable alternative.

Chemical Fingerprinting for Food Provenance

Like measuring the attributes of ridgelines on the skin of our fingertips as a unique personal identifier, chemical fingerprinting relies on differences in the geochemistry of the environment to determine the geographic origin of a product—most commonly measured in light-stable isotopes (carbon, nitrogen, sulphur, oxygen, hydrogen) and trace elements.

Which parameters to use (either isotopes, TEs or both) depends very much on the product and the resolution of provenance required (i.e. country, farm, factory): Isotope values vary more so across larger geographies (i.e., between continents), compared to smaller scales with TEs, and are less susceptible to change from processing further down the supply chain (i.e., minced beef).

The degree of uptake of both TEs and light isotopes in a particular produce depends on the environment, but to differing extents:

TEs are related to the underlying geochemistry of the local soil and water sources. The exact biological update of particular elements differs between agricultural commodities; some are present with a lot of elements that are quantifiable (“data rich” products) while others do not. We measure the presence and ratio of these elements with Inductively Coupled Plasma—Mass Spectrometry (ICP-MS) instrumentation.

Light Isotopes are measured as an abundance ratio between two different isotopes of the same element—again, impacted by environmental conditions.

Carbon (C) and nitrogen (N) elements are generally related to the inputs to a given product. For example, grass-fed versus grain-fed beef will have a differing C ratio based on the sugar input from either grass or grain, whereas conventionally farmed horticulture products will have an N ratio related to the synthetic fertilisers used compared to organically grown produce.

Oxygen (O) and hydrogen (H) are strongly tied to climatic conditions and follow patterns relating to prevailing weather systems and latitude. For ocean evaporation to form clouds, the O/H isotopes in water are partitioned so that droplets are “lighter” than the parent water source (the ocean). As this partitioning occurs, some droplets are invariably “lighter” than others. Then, when rainfall occurs, the “heavier” water will condense and fall to the ground first and so, as a weather front moves across a landmass, the rainfall coming from it will be progressively “lighter”. The O/H ratio is then reflected in rainfall-grown horticultural products and tap water, etc. Irrigated crops (particularly those fed from irrigation storage ponds) display different results due to the evaporation, which may occur over a water storage period.

Sulphur (S) has several sources (including anthropogenic) but is often related to distance from the sea (“the sea spray effect”).

Analysis of light isotopes is undertaken with specialist equipment (Isotope Ratio Mass Spectrometry, IRMS), with a variety of methods, depending on product and fraction of complex mixtures.

Regardless of the chemical parameter used, a fingerprinting test-and-audit approach requires a suitable reference database and a set of decision limits in order to determine the provenance of a product. The generation of sample libraries large enough to reference against is generally considered too cost prohibitive and so climatic models have been developed to establish a correlation between observed weather and predicted O/H values. However, this approach has two major limitations:

  1. The chemical parameters related to climate are restricted (to O and H) limiting resolving power
  2. Any model correlation brings error into further testing, as there is almost never 100% correlation between measured and observed values.
    As such, there is often still a heavy reliance on building suitable physical libraries to create a database that is statistically robust and comprehensive in available data.

To be able to read this data and establish decision limits that relate to origin (i.e., is this sample a pass or fail?), the parameters that are most heavily linked to origin need to be interpreted, using the statistics that provide the highest level of certainty.

One set of QC/diagnostic algorithms that use a number of statistical models have been developed to check and evaluate data. A tested sample will have its chemical fingerprint checked against the specific origin it is claimed to be (e.g, a country, region or farm), with a result provided as either “consistent” or “inconsistent” with this claim.

Auditing with Chemical Fingerprints

Chemical fingerprinting methods do not replace traditional traceability systems, which track a product’s journey throughout the supply chain: They are used alongside them to confirm the authenticity of products and ensure the product has not been adulterated, substituted or blended during that journey.

A product can be taken at any point in the supply chain or in-market and compared, using chemical fingerprinting, to the reference database. This enables brands to check the integrity of their supply chain, reducing the risk of counterfeit and fraud, and, in turn, reducing the chance of brand damage and forced product recalls.

Click on page 2 below Related Content to continue reading this article

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.
Megan Nichols
FST Soapbox

5 Ways to Manage Risk in the Global Food Supply Chain

By Megan Ray Nichols
No Comments
Megan Nichols

In 2017, the cost to import food, which has long been fairly predictable, rose by 6% over the previous year—and the number of possible risk factors has risen right alongside the higher price tag. There are several steps you can take to position yourself as an industry leader and manage risk simultaneously. First, though, it makes sense to better understand what’s at stake.

Why Take Steps to Reduce Risk?

Food has never been a more global market than it is today, and those who operate in the food supply chain are bound by the public’s trust in spoken and unspoken ways. Customers are used to taking for granted that they can walk into a supermarket and walk out with ethically sourced fish and eggs free from E. coli worries.

Not every food product is, or can be, a global one. However, some of these domestic risk factors scale up, just as our businesses do. When the food supply chain crosses borders of any kind, the familiar health and food safety risks are joined by several others:

  • Product mislabeling
  • Unplanned-for natural disasters
  • Spoilage due to any number of unforeseen circumstances
  • Damage while in transit
  • Unpredictable politics and shifts in regulations

A food company’s supply chain can be the weakest link in their food safety program. Learn more at the Food Safety Supply Chain Conference | June 12–13 | Rockville, MDIn all honesty, no list will ever encompass the scope of the risk you take on as part of the global food supply chain. That’s not to say you can’t take steps to reduce your risk—sometimes several types of risk at once—as your operation grows. The following is a look at several practical suggestions, some of them more time-intensive and perhaps cost-prohibitive than others, but all worth a look as the world grapples with globalization in the food industry.

1. Don’t Take Company Culture or Employee Training for Granted

Working safely and conscientiously in a particular trade is not knowledge we’re born with. When you consider the fact that at some level every food product we bring into our homes was handled at one point by another human being, you get a sense of the role proper training and a healthy culture can play in the safety we expect of our food.

Among recently surveyed manufacturers in the global food space, 77% of them said globalization itself was a source of risk. It’s easy to see why. In 2015, a relatively small—though still deadly—Listeria outbreak was traced to just a few Blue Bell Ice Cream factories. The company was almost ruined by the three deaths, the illnesses and the nearly crushing reputational damage.

Some momentary lapse of judgment at one or perhaps two factories almost killed this company. Now scale this type of risk up to the global level and think about the possible worst-case scenarios.

We’ll talk more in a moment about ways to introduce transparency and traceability to the food supply chain, but this is a reminder of the stakes. Mindfulness and conscientiousness in the work we do— not to mention well-rested and satisfied workers—are just as vitally important to look after as profitability.

2. Use Predictive Sales Forecasts and Intelligent Logistics to Avoid Spoilage

Unnecessary food waste and spoilage emerged as a mainstream issue in recent years all across the globe. For example, citizens in the EU are forced to discard some 89 million tons of food each year due to overstocking, poor quality control and a lack of attention paid to consumer trends. The United States throws out 35 million tons of food for the same reasons—a problem that, billed collectively, carries a price tag of $165 billion each year in the United States alone.

The solution has arrived in the form of predictive analytics and more intelligent warehouse and inventory management systems. Domestic and global supply chain partners alike now have access to, in some cases, highly customizable software systems that can provide vital data, such as:

  • Ideal stock levels for perishable items
  • Constant checks on incoming versus outgoing products
  • Intelligent insights into customer behavior patterns and near-future buying patterns

These types of data are highly actionable. They don’t just shield you from monetary risks by cutting down on waste— they can also protect you from public health risks by ensuring spoiled products never make it as far as store shelves.

3. Take Your Packaging More Seriously

Many of us don’t give packaging a second thought. So long as it’s easy to get into, eye-catching and protects the product long enough for the consumer to get their hands on it, it’s good enough — right? Not quite. When manufacturers think about packaging as merely a branding matter rather than as a safety check, the price is sometimes human health and lives.

One obvious solution to make sure your products can travel as far as they need to is to invest in vacuum packaging, even for small-scale operations. Compressed air equipment is a highly affordable way to accomplish this. The USDA and CDC provide guidelines on modified atmosphere packaging (MAP) and controlled atmosphere packaging (CAP).

Packaging material requirements are a global concern as well as a domestic one. The EU provides guidelines for packaging materials that are detailed down to the type of ink used. Knowing about the laws in your sales territories and staying aware of new breakthroughs in material sciences can help you remain in compliance and ahead of the game.

In a global supply chain, high-quality packaging serves not just as a risk mitigator, but also as a possible value proposition for your customers. Having your brand stand out as an example of high-quality products in thoughtful, health-conscious packaging could put you in a unique position.

4. Stay Abreast of Changing Regulations

American politics might be volatile, but one thing that isn’t likely to change is that consumers tend to look toward institutions like the FDA to provide updated guidelines and to pursue strong, consumer-friendly legislation. That means compliance isn’t always a choice, but it also means you have the opportunity to anticipate change and mitigate risks faster than your peers.

A recent example is FSMA. It’s had a long rollout, with plenty of advance warning for the industries it touches, but now most of its rules have reached the implementation stage. This lead time has been advantageous given the scope of the anticipated laws because it’s given food processing companies time to prepare for compliance. In fact, globalization lies at the very heart of it.

FSMA will be challenging at times to enforce, but its ultimate goal is to hold domestic and foreign companies in the global food supply chain responsible for a common set of guidelines and best practices.

What does this mean? It means you have yet another opportunity to establish yourself as an industry leader. The intentions of FSMA are to make every part of the supply chain more agile and better able to respond to emerging health concerns and other sources of risk as they unfold.

5. Use Data to Build Greater Transparency

There has perhaps never been a more important time to take transparency seriously in the global food supply chain. As of this writing, a historically significant outbreak of E. coli among romaine lettuce products is closing in on an “all clear” from the CDC after two difficult months. By the time you read this article it’s entirely possible another outbreak of a different kind might be underway or that some product or another has found itself under a recall. The possibility of reputational damage is greater than ever.

The good news is, even when the unfortunate happens, it’s possible to greatly reduce risk to your brand and your customers’ health. However, you need the tools to help you move quickly in tracing the problem.

Some digital technologies of a more physical nature, such as QR codes or RFID chips, can elevate your supply chain transparency and tamp down risk even further by allowing far more granular traceability for your products as they move about. In some high-profile examples, we’re seeing this concept taken to a logical, if slightly extreme, endpoint: Edible QR codes on restaurant food that contain a full history of the meal’s constituent ingredients.

Even if you don’t take your own efforts this far, this level of traceability can help you react far more quickly to emerging situations such as recalls. You’ll be able to isolate shipments with greater ease and trace contaminated products back to their sources. Also, as The Guardian points out, this technology delivers ethical and perhaps legal peace of mind by assuring you that your partners are trading in ethically sourced goods.

Vigilance and Technology in the Food Industry

The stakes in the food industry are high, as we’ve seen. However, with the right combination of a cultural approach to safety, a mindfulness of changing regulations and the sensible application of technology so you can act on the data you’re gathering, you’ll be in a prime position for global success in this quickly changing field.