Tag Archives: documentation

Daniel Erickson, ProcessPro
FST Soapbox

Establishing Preparedness Initiatives to Mitigate the Effects of Recalls

By Daniel Erickson
No Comments
Daniel Erickson, ProcessPro

Despite manufacturers’ best intentions to provide safe products for consumers, notifications about recalled products appear in news headlines with increasing regularity. The CDC reports that each year, 48 million Americans experience foodborne illnesses, resulting in a reported 128,000 hospitalizations and 3,000 deaths. Behind these statistics are recall trends that can lead to operational and financial instability, and a loss of reputation for companies in the marketplace. Proactive measures and tools adopted by experienced food and beverage manufacturers can help mitigate the potentially harmful effects of these product recalls by establishing preparedness initiatives.

Recall Essential Facts

A recall is defined as a request for the return of a product from the market due to a defect or safety concern resulting from a variety of issues including improper labeling or contamination, which places the manufacturer at risk of legal action. Product recalls can be issued by either the manufacturer or a governmental agency, but it is the sole responsibility of the company to properly recall and notify consumers of unsafe products. Recalls are categorized as either voluntary or mandatory, with the majority falling under the voluntary classification. In the case of a voluntary recall, a manufacturer has greater control over the process with less stringent procedures, review and paperwork. While both have the same potential for negative effects and significant legal costs, a voluntary recall is preferred by manufacturers. Implementing an industry-specific ERP solution with a documented recall preparedness plan and mock recall capabilities provide the necessary tools for either scenario, as recalls are inevitable in today’s manufacturing environment.

Recall Trends

In the USDA- and FDA-regulated markets, comparatively, there have been a slightly higher number of recall incidents in the beginning months of 2019 versus 2018. Mispackaging is identified as one of the primary recall issues, involving packaging a finished good into the wrong container. Another trending recall cause involves not properly identifying an ingredient on the packaging label. Both of these manufacturing errors resulted in the labels not providing an accurate reflection of the product, which could be potentially harmful to consumers if the undeclared ingredient(s) include one of the common allergens. Well-documented and properly executed internal manufacturing processes, in addition to an automated ERP solution, create checks and balances and assist in generating accurate, compliant packaging and nutrition fact panels to meet the requirements of consumers and regulatory bodies.

A third recall trend of 2019 is being driven by consumer complaints in regards to foreign materials such as metal fragments, plastics or rubber pieces in finished goods. This is caused by incomplete testing, lack of or faulty material detection equipment, including metal detectors, x-rays and other devices used during manufacturing. Due to an increasing number of these types of incidents, the USDA has issued a guidance document requiring manufacturers to maintain updated documentation of their internal procedures in their hazard analysis and critical control point (HACCP) plan. This guidance necessitates follow up with federal inspectors regarding any adjustments made to the plan. HACCP information recorded within an ERP solution helps to identify and control potential hazards before food safety is compromised—providing quality, consistent and safe consumables for the public.

Progress towards fewer FDA food and beverage recalls continues due to an increase in FDA inspections as well as manufacturers’ success in proactive measures to stay abreast of FDA requirements. However, bacterial pathogenic concerns including Listeria, Salmonella and E. coli continue to be prevalent recall culprits. This has resulted in the FDA utilizing the Whole Genome Sequencing (WGS) Program in an attempt to protect consumers from foodborne illness. By swabbing manufacturing environments and sending samples to WGS, the DNA strains are documented in a centralized public database—holding manufacturer’s accountable for processing and sanitation control. When an outbreak occurs, the database is able to locate possible matches that help health officials identify the source of contamination, and stop outbreaks more quickly, thereby avoiding additional widespread illnesses. As the database grows in size, so will the speed of investigations to determine the root causes of illnesses. This program has the potential to not only stop outbreaks from spreading but also includes proactive applications for increasing the safety of the food and beverage industry as a whole.

ERP’s Role in Recall Preparedness

An industry-specific ERP’s real-time forward and backward lot traceability, detailed record keeping, allergen/attribute tracking and efficient, documented processes support end-to-end recall management functionality to maintain compliance. With preventative measures such as establishing supplier relationships, conducting quality control testing and documenting quarantine procedures, an ERP solution works to identify gaps and prevent future recalls. Accurate product labeling is one of the key factors of recall prevention and food and beverage ERP software handles the intricacies of packaging and label creation, such as ingredient and allergen statements, nutrient analysis, expiration dates and lot and batch numbers—creating an audit trail that allows items to be located promptly in the event of a recall. As part of a sound food safety plan, mock recalls conducted regularly encourages familiarity with internal recall processes, as well as allows for adjustments to be made as needed. With a comprehensive ERP to generate lot tracking reports, manufacturers are able to identify and locate contaminated products in order to notify clients, vendors, consumers and government agencies quickly in the event of a recall—helping to minimize harmful effects in the marketplace as well as legal action.

The trends identified in recent recalls issued by the FDA and the USDA, thus far in 2019, demonstrate that manufacturers need to be proactive in how they respond in order to mitigate the detrimental effects that recalls can have on companies and to public health. With the increasing scrutiny from the FDA and USDA, along with an aware consumer base, it’s important for forward-thinking businesses to address the eventuality of a product recall with sound food safety and HACCP plans and an industry-focused ERP software solution that promotes, supports and helps manage preparedness and responsive action, if needed.

Doug White, PSSI
FST Soapbox

The Real-Time Value of Technology in Food Safety

By Doug White
No Comments
Doug White, PSSI

We live in a world where information on any subject is at our fingertips and can be accessed instantly. These real-time notifications keep us up to date on whatever topics we choose. This information helps guide our daily decisions and communicate more effectively with each other.

The same is true in business. We can be more efficient and make more informed decisions based on the information we have at various points throughout our day. However, for many companies and industries, the key is figuring out what information is needed and how it can be transmitted in real-time to increase the efficiency or effectiveness of the work.

In an industry not known for being on the leading edge of new technology, it is still not uncommon to have data captured using the good old pad and pencil method. This, unfortunately, limits visibility and the timely application of that information. This is especially critical when it comes to sanitation and food safety data. It is a complex, high-risk industry with tight timelines and lots of moving parts (figuratively and literally), and various teams working together 24/7.

The 2019 Food Safety Consortium Conference & Expo features a dedicated track on Cleaning & Sanitation | Attend the event October 1–3 | Schaumburg, ILAdditionally, new rules and regulations around FSMA require processors to have more detailed documentation of a food safety plan and produce data proving adherence to that plan during plant inspections. Processors must show that best practices are being followed and address any instances where concerns may arise with immediate corrective actions, or face potential fines or temporary shutdown of production.

The bottom line is, technology is no longer a “nice to have”, it is a must have. Data is our friend and, if used appropriately, can significantly help mitigate risk and improve food safety.

Innovation in Sanitation

Specifically in the sanitization process, there is a distinct science-based, data-driven approach that can be used to document and report on the consistency and effectiveness of each cleaning process. However, without the right experience or specific microbiological training, it is hard for a processor to know what to document, how to document it and why it matters.

For instance, as part of standard operating procedures, our team always monitors and documents four key factors that can influence a successful cleaning process: Time, temperature, concentration of cleaning agents and mechanical force (i.e., water pressure). If any one variable as part of the sanitization process is off, it can impact the overall effectiveness of the cleaning.

This is the type of risk-based data that can be applied as part of FSMA reporting and compliance.

However, the real opportunity for improving food safety is about the visibility of that data and how it can be used to adjust the sanitization processes in real-time.

I was fortunate to be part of a team that developed and implemented a new real-time performance metrics platform over the last year. It is a digital system that helps sanitation teams proactively track and respond to critical data that can impact the effectiveness of the sanitation process.

Replacing the pen-and-paper method is a system in which data is logged digitally into an application on a tablet or mobile device in real-time during the sanitation process.

Site managers closely monitor data, which can be shared or accessed by other stakeholders to perform analytics and make real-time adjustments to the sanitation process. The system sends alerts and notifications regarding changes or updates that must be made as well.

From internal communications to coordination with USDA and FDA inspectors, it supports a much more seamless communication structure as well. Employees feel more confident and empowered to manage the sanitation process and partners feel armed with the right information and data to focus on managing the needs of their business.

As an industry, I believe we have a great opportunity ahead of us to continue advancing food safety. The technology and tools are there to support us. It is a matter of taking small steps to innovate and improve efficiencies in our own businesses every day that will have a drastic impact on the industry as a whole.

Question mark

FSMA Supply Chain IQ Test (Part I)

By Food Safety Tech Staff
No Comments
Question mark

Food Safety Tech’s FSMA IQ test series continues with a two-part series that addresses supply chain considerations under FSMA. Once again, the test was put together by the subject matter experts at Kestrel Management, LLC. We invite you to take the 12-question test and then learn more about important supply chain issues at our Food Safety Supply Chain Conference, May 29–30. You can attend in person or virtually.

Results of Part I will be posted next week, at which point Part II will be available.

Create your own user feedback survey

FoodLogiQ

Markon Selects FoodLogiQ Product for Global Supply Chain Visibility

FoodLogiQ

FoodLogiQ has announced that Markon has selected its FoodLogiQ Connect Manage + Monitor product for global supply chain visibility and streamlined supplier management. “We vetted several systems providers and felt that FoodLogiQ was best positioned to help us manage data and dramatically increase efficiencies. With hundreds of suppliers, and thousands of farms, a robust system is necessary for us to maintain our industry-leading food programs,” said Markon President Tim York in a press release.

According to, managing hundreds of growers and dozens of processing plants is a massive undertaking that requires more than just manual tracking methods like spreadsheets and paper documents. Markon needed a technology solution to provide a global view of their supplier quality management, and they needed greater transparency across the company’s supply chain..

Markon will use the FoodLogiQ Connect’s Manage + Monitor to:

  • Centralize supplier documentation to achieve corporate food safety standards, implement corrective actions, support supplier verification, and manage required recordkeeping
  • Track and report on food safety across their supply chain and address issues with suppliers directly to drive compliance
  • Leverage data-driven reporting to help leadership make informed decisions about supplier performance and expiring documents

Read the full press release about Markon’s adoption of the FoodLogiQ platform.

Data management, food manufacturing

FSMA and the Importance of Data Visibility and Management in Food Manufacturing

By Jeff Budge
No Comments
Data management, food manufacturing

Implementation of FSMA has prompted many organizations to take a closer look at sanitation practices, documentation of food safety plans and the traceability of materials and ingredients used to create food products.

Meanwhile, shifts in technology, such as cloud migration as well as the rise of big data and analytics platforms, present both opportunities and challenges in food manufacturing.

In many cases, digital transformation, including the adoption of a multi-cloud strategy, occurs as part of a roadmap set forth by a food company’s software vendors. Tech giants, including Microsoft, Oracle and SAP, are driving digital transformation through the modernization of ERP systems and dictating how food companies should utilize applications, data and software.

In those situations, digital transformation is not a choice, it’s a requirement. CIOs and IT professionals are seeking help. They are looking to understand the dynamics and characteristics of these new environments because they are compelled to change.

Yet, there are also organizations that would rather do more than simply follow the lead of their software vendors. Instead, they choose their own destiny in terms of IT modernization. They’re looking for opportunities by leveraging data to make better business decisions.

Before a food manufacturer can get to that point, however, there must be a strategy for gathering, storing, connecting and presenting different types of data across an organization as well as to external customers and business partners.

Managing the data required for FSMA compliance is an ideal example of the importance of pursuing digital transformation.

Food Safety Data and FSMA Compliance

A major component of FSMA involves having detailed documentation of a food safety plan and the ability to produce data proving adherence to that plan when the FDA shows up for a plant inspection. Food manufacturers need to show best practices are being followed, and that corrections are being made when concerns emerge. Otherwise, the FDA may impose fines or temporarily shut down production, which cuts into the bottom line.

Because of FSMA mandates such as the Sanitary Transportation Rule, your documented food safety plan needs to be communicated to key participants throughout the supply chain as responsibility for food safety problems typically falls back to the manufacturer.

For that reason, food processors need solutions allowing them to track and trace their product from the farm field to store shelves, or to any other final customer.

Imagine being a food manufacturer trying to document sanitation in a basic spreadsheet or even on paper. The extra work involved with specifying food safety tests, collecting and archiving results, and validating sanitation procedures would be overwhelming. Yet, just as perplexing of an issue is being a digitized food manufacturer with poor visibility and management of all the information that various IT systems and platforms provide.

Most companies acknowledge that the cloud is a necessity in today’s world. Organizations often need multiple cloud solutions to accomplish business objectives, from regulatory compliance to finances, inventory control and distribution.

CIOs, technology professionals and food safety/sanitation leaders should work with existing IT solutions partners or find consultants and experts who can ensure the following questions can be answered:

1. Is the location of your data known?

Data visibility in the cloud is the first step in the process, and it is a challenge for many organizations. You need to know where your data lives, that the right people have access to it and that it is secure. When you know where your data lives, you’ll better understand how to use and protect it.

2. Is your data in a location that allows for integration?

Can the different applications your company uses talk with each other, or is all the information siloed across different cloud providers and departments in the organization? Is it integrated? Can certain information, such as food safety plans, be communicated with partners including suppliers, distributors and your carrier network?

3. Can your data be put into a framework allowing it to be extracted, visualized and leveraged?

Data doesn’t help anyone if you’re unable to take that information and use it to make better business decisions. Whether it’s food safety, operational efficiency, forecasting needs or developing new ideas, the most successful food manufacturers will leverage integrated data to move the organization forward.

Data management, food manufacturing
Managing the data required for FSMA compliance is an ideal example of the importance of pursuing digital transformation in food manufacturing facilities. (Image courtesy of One Neck IT Solutions, LLC

The Advantages of Pursuing Digital Transformation

If you were to go back about a decade and observed a small- to mid-sized food manufacturer using Microsoft as its data platform, that manufacturer would likely have been running applications for the business that created data while receiving little guidance pertaining to how the information should be interpreted and used. Fortunately, that has changed.

Today, companies like Microsoft, Oracle and SAP actively focus on the use of data rather than only data collection. The right IT solution, coupled with expert partners, allows you to eliminate the guesswork and leverage data to your advantage.

FSMA mandates are complicated, and compliance is crucial, but the pursuit of digital transformation supports the efforts of food manufacturers who are prepared to improve transparency and responsibility surrounding food safety.

Digital transformation represents change, which is never easy, but it will be worth the effort. Start by evaluating your organization’s technology needs as they relate to FSMA compliance as well as additional business objectives. Then, identify areas of internal strength and areas where improvements are needed.

Some food manufacturers partner with an IT solutions provider for support developing a cloud migration plan and a subsequent strategy for operating in multi-cloud environments. Others need managed services, helping them handle day-to-day IT needs through outsourcing so in-house resources can develop high-value solutions. Still, others are looking for consultative guidance to help them understand what changes in technology truly mean to their organization.

You want your people to focus on what they do best. Many food manufacturers are in locations where there’s a lack of technical resources for hire. That’s why they turn to IT consultants and service providers who understand their business, can provide expertise that fills the talent gap and are able to interpret business needs into technology solutions.

Digital transformation isn’t one big project, it’s an ongoing journey, a series of waves of new technologies and new ways to use applications and data. Make sure you find trustworthy allies to give you the guidance and solutions you need, not only for regulatory compliance but for growth and continued success.

Melody Ge, Kestrel Management
FST Soapbox

8 Tips to Food Safety Program Development for Small and Entrepreneurial Businesses

By Melody Ge
No Comments
Melody Ge, Kestrel Management

The FSMA HARPC regulation has been in the implementation phase for approximately a year. Many small and entrepreneurial businesses are in the process of starting or finalizing the development of a food safety plan to comply with FSMA requirements. This includes program development, operational awareness and employee training. Often, small companies find this development more challenging compared to mature companies for several reasons, including a lack of resources or simply not knowing where to start.

The following eight tips can help small businesses that are developing a food safety plan to comply with FSMA.

1. Don’t be scared.

FSMA Preventive Controls is nothing scary. It is simply a series of food safety protocols and related documentation. It might seem overwhelming at the beginning with many documents and changes; however, it is actually a good method and tool to help strengthen operation lines and management.

FSMA helps businesses sustain and streamline processes. It is helpful to first map out the production process from the very beginning (when raw materials are received) through the end (when finished products leave the facility). The more details that are documented on the process, the easier and less time consuming it will be later to prevent potential risks.

2. Be familiar with the process and the FDA hazard types.

Once all processes are mapped, take time to study and get familiar with them. It will be helpful to have a team of individuals with different job functions review process maps together. The objectives are to identify the following:

  • Where is the weakness?
  • Where can weaknesses be controlled?
  • What should be monitored?
  • When is a good time to monitor each process step?

According to FDA, five hazard types need to be considered and prevented: Physical, chemical, biological, intentional adulteration and radiological. These five types should always be kept in mind when reviewing and analyzing the direct production and non-direct production processes.

3. Thoroughly understand the entire supply chain.

Supply chain management is one of the key preventive controls required by FSMA. Just like mapping out the process, FDA requires each business to have a thorough understanding and control of its supply chain to ensure the risks are minimized from raw materials to end consumers. Whether you have foreign suppliers, distribution centers or co-manufacturers, finished product safety must not be compromised by any party. If foreign suppliers are being used, FSVP (Foreign Supplier Verification Program) must be implemented and communicated to vendors.

4. Think in food safety mindset.

If your business has just been established, then congratulations! You have the opportunity to start everything right from the beginning. Take food safety into consideration throughout every step in the process and operation. Considering food safety aspects and preventing hazard types might help you make your next good business decision.

5. Get everyone involved!

Food safety is not only the food safety and quality departments’ responsibilities; it reflects the entire company’s operational structure—from building structure, security, production line, and supply chain to procurement, HR and finance. Get everyone involved, from top management to line workers. Their expertise, experiences and feedback will help the entire program’s implementation and execution. With the inputs from each department function, the food safety program will be more practical to the entire business operation and, therefore, will be more solid and sustained, especially when it comes to ongoing implementation.

6. Designate one project leader.

If FSMA program development is considered a project that the whole company engages in, a project leader is required to make the journey efficient and smooth. The leader needs to have both the company operational experience, as well as food safety knowledge. The leader plays an important role in leading the project, coordinating the timeline, prioritizing work across departments, and communicating with all levels of employees.

7. Keep everything documented and recorded.

Documentation and recordkeeping are core to the entire program. Say what you do by writing down all procedures, policies, programs and SOPs. Do what you say by demonstrating what is contained in all records kept onsite. This is not only for audit purposes, but also for your own business growth. Your own operation data is the best data to improve and modify your processes, if needed. Records can be used for trend study and analysis after years in business. Records can reveal whether methods or programs implemented are working effectively and helping the business. Records can also provide strong support/evidence when there is an unexpected event.

8. Utilize free third-party resources.

There are many technologies linking the entire world together—leverage them to learn from your peers. GFSI-recognized certification programs, such as SQF, FSSC22000 and IFS, are releasing a global market program to specifically help small business start their programs. Webinars and trainings are available on many program development and food safety hot topics to help address challenges, and there are many tools and templates available for download to assist with documentation and recordkeeping.

Although there are a lot of perspectives and aspects to be considered to comply with FSMA, compliance can be achieved one step at a time. Start by mapping out your own production process today.

Martin Flusberg, Powerhouse Dynamics
Retail Food Safety Forum

Automating Food Safety Processes in Restaurants: How 1+1 Can Equal 3

By Martin Flusberg
No Comments
Martin Flusberg, Powerhouse Dynamics

With the recent death of Anthony Bourdain, the topic of restaurant food safety is once again on the minds of many people. It has been 19 years since Bourdain’s exposé in The New Yorker (Don’t Eat Before Reading This) and 18 years since his memoir Kitchen Confidential, which became a TV series and has rocketed to the top of the Amazon best seller list since his death. Bourdain identified many issues that restaurants struggle with, including those that affect the safety of the food being served.

While many of the issues chronicled by Bourdain probably continue to this day, there has been a push by the restaurant industry to address food safety over the intervening years, and particularly in the last two or three.

Many restaurant chains have taken steps to automate the HACCP (Hazard Analysis Critical Control Points) food safety reporting process—or at least are exploring that option. The first and most common approach has been to replace time consuming, error prone, manual data collection processes with mobile apps that digitize tasks, may include digital probes to replace manual temperature data recording, and may even track corrective actions. These systems deliver more accurate data than fully manual processes and are faster. They also ensure that the data is easily retrievable, both for management review and for the times that inspectors visit the facility. And, they generally address a broader set of food safety processes than temperature monitoring.

Another approach that has begun to catch on is the installation of fixed temperature sensors—usually but not always wireless—into refrigeration and food warming equipment. These systems will capture and report on temperature at regular intervals—in some cases as frequently as every minute. This eliminates the need to manually check temperatures in monitored equipment as part of HACCP reporting. Moreover, these systems generally offer real-time alerts that can help avoid food safety problems. The more advanced systems track corrective actions and deliver escalating alerts to notify additional team members about issues that have not yet been addressed.

Automated temperature monitoring systems don’t fully take the place of the mobile systems described above since they cannot capture all temperatures and do not address aspects of the food safety process other than temperature monitoring.

Interestingly, the vast majority of restaurant brands that have automated food safety reporting—or are looking to do so—with whom we have spoken have implemented one but not both of these approaches. And yet, the approaches are inherently complementary.

As noted, automated temperature monitoring systems don’t address all aspects of the food safety process, while mobile technology cannot provide real-time warnings about food safety issues so that they can be addressed before they turn into major problems. Moreover, while mobile apps are faster than paper and pencil, they still require staff time. By contrast, automated temperature monitoring systems require no labor for monitored equipment—other than to address problems that are flagged in real-time.

To illustrate the potential of combining these two approaches, consider these results reported to us by one of our customers, a major restaurant chain. This brand started with fixed temperature sensors in refrigeration and other equipment, while continuing to perform manual data collection. They recently added a mobile digital task list app as a test in a group of restaurants. Their findings: What had been a 17-minute HACCP data capture process was now down to two minutes! Not needing to manually capture data now being automatically collected was part of this story, but savings also resulted from the shorter distances the staff now needed to cover to complete the process. Over the course of four checks a day, these savings were significant.

The market for automating food safety tasks and reporting is still in an early stage but appears to be accelerating. The technology is here today and constantly being improved. We would encourage all companies on the retail side of food services to explore technologies that cover the broadest range of capabilities for automating food safety processes.

What To Consider When Developing A Facility Food Safety Plan

By Adam Serfas
No Comments

No two facilities will have the same food safety plan, as each should address the specific needs of that facility. Before beginning your draft, there are several critical factors to consider. Use the guide below as a checklist to review before starting or revisiting your own food safety plan—the following tips can be applied to all food and beverage processors and manufacturers.

1. Review current legislation that applies to your industry

The food safety sector evolves rapidly. Keep your finger on the pulse of updates and changes, whether current or forthcoming, to ensure that your plan is current and up to code. You can quickly familiarize yourself with guidelines and regulatory bodies dealing with your industry with a handful of excellent resources. Generally, we recommend starting with the FDA website, and from there you can navigate to resources that are specific to your industry. We also recommend you make use of the FDA’s Food Safety Plan Builder to assist you in meeting requirements for Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventative Controls for Human Food regulation.

2. Identify current potential risks in your facility

Once familiar with your industry requirements and inspection standards, the next step is to identify any current potential food safety risks specific to your facility. Be sure to incorporate employees at all levels while detailing these potential hazards or concerns. Oftentimes, employees at the management level will make note of things different than employees working on the plant floor. And the delivery truck driver’s perspective will vary from those of your janitorial team. Aim to build a comprehensive list, noting everything from obvious high-risk areas, to what might be trivial or unlikely facility hazards. The more robust the list, the easier your food safety plan will be to form later on.

3. Consider your facility layout

Your facility’s physical layout often determines what type of food safety plan is necessary. Ask yourself:

  • Does your facility have natural zones?
  • Is it comprised of multiple buildings?
  • Are certain defined areas more high-risk than others?
    If you answered “yes” to any of these questions, you’ll most likely want to incorporate a zone-based color-coding plan as a part of your food safety plan to ensure that all of your tools remain in their proper location and are used correctly.

4. Review the quality of your current tools
Take stock of your current tools, that includes everything used to make or process your product and everything required to clean the facility itself. Consider the tool quality—are these presentable and acceptable for an inspector to see? Do your brushes have loose bristles? Has your mop seen better days? Tools that are made of low-quality materials or are not in top shape present potential risks for a food-safe environment. Note which tools need to be replaced and perhaps consider incorporating color-coded tools if you have not yet done so, as they are a great way to step up your food safety practices and safeguard against cross contamination.

5. Review and communicate the food safety plan and training procedures

Review your current employee training materials –in particular, your cleaning and sanitation measures and food handling procedures–and hold a meeting to go over current training protocols with your team. Consider the following questions:

  • Are the expectations made clear?
  • Are there references to procedures that are no longer up to date?
  • Is there appropriate signage that can be readily referenced?
  • Is information available for non-native speakers?
  • Are the appropriate channels in place for employees to voice concerns about these training procedures?

Be sure to take notes on each of these items that need to be addressed. One of the most important pieces of a food safety plan – and something inspectors pay close attention to – is that it is properly communicated to all employees. Taking detailed notes as you discuss these procedures will be helpful in documenting your training methodology for the food safety plan and, of course, will help you to ensure that the training procedures themselves are the best they can be.

6. Consider the documentation requirements for your industry.

Your industry might require certain specific documentation for your food safety plan, which can include facility policies, procedures, safety review records, maps and more. Additionally, some governing bodies require that the food safety plan is completed by a certified individual who doesn’t necessarily need to be an employee of the facility. Review all necessary requirements to ensure that you satisfy all of these standards for your next inspection.

Should you have any questions when getting ready to start on your plan, we suggest you reach out to a company that specializes in color-coding tools, as they have experience in creating plans to accommodate all kinds of identified risks and can be a great resource.

Blockchain, Food Safety Supply Chain Conference

Is the Food Industry Ready for Blockchain?

By Maria Fontanazza
No Comments
Blockchain, Food Safety Supply Chain Conference

Darin Detwiler will lead a plenary session titled, “Practical Use of Blockchain in Food Safety” at the 2018 Food Safety Consortium | Learn moreOn the heels of the deadly, widespread outbreak of E.coli O157:H7 illnesses linked to romaine lettuce—and 12 years after the infamous spinach outbreak of 2006—the food industry is struggling to find the solution to prevent these outbreaks. “I think it’s indicative that we need to do something different,” said Melanie Nuce, senior vice president, corporate development & innovation at GS1 US, during a panel discussion about blockchain at the 2018 Food Safety Supply Chain conference earlier this month. The panel, led by Darin Detwiler, assistant dean and director, regulatory affairs of food and food industry at Northeastern University, delved into the strengths and weaknesses of blockchain, along with industry readiness and acceptance.

In its most basic form, the technology would allow for the addition of information from every step of the supply chain, from manufacturing to packaging to distribution to retail, and would incorporate elements such as auditing, inspection, batch information, certification of auditors, preventive control plans, HACCP information, and allergen identification.

“Blockchain could be the death of the document.” Simon Batters, Lloyd’s Register

Strengths

The increased demand for transparency and traceability could be one of the biggest drivers for the adoption of blockchain. “[Blockchain] offers us the technology for traceability,” said Simon Batters, vice president of technology solutions at Lloyd’s Register. “It allows us to have an immutable record of a transaction; it won’t solve the food safety conundrum overnight—it’s part of the tool kit that we need.”

The fact that the food supply chain consists of millions of transactions, which could not be tampered with under blockchain, while the data could be used as reference points and for verification—those are strengths. However, Batters pointed out, there should be restrictions on who has permission to write the code and who has access to putting the information into a chain.

The technology would also enable smart contracts whereby shipments wouldn’t be finalized if they didn’t meet the conditions of a supplier, for example. “All parties to a transaction have a view to the entire chain at the same time,” said Nuce. “You have real time visibility. This democratizes that.”

Kathleen Wybourn, director, food safety solutions at DNV GL, calls blockchain “the birth certificate for food.” From a consumer standpoint, it would provide information on a product’s origin—and these days, consumers—especially millennials—are very interested in the story of food from farm to fork.

2018 Food Safety Supply Chain Conference, Blockchain
The blockchain panel, led by Darin Detwiler, Director: Regulatory Affairs of Food and Food Industry, Northeastern University featured (left to right) Kathy Wybourn, Director, Food Safety Solutions, DNV GL; Simon Batters,
Vice President of Technology Solutions, Lloyd’s Register and Melanie Nuce, Senior Vice President, Corporate Development & Innovation, GS1 US.

Weaknesses and Threats

The panel pointed out several areas of improvement (and unknowns that must be answered) before blockchain can be taken to the next level in the food industry.

  • Although the technology could aid in faster transaction times, as the size of the ledger gets larger, and it will become more difficult to manage.
  • Industry involvement: “If you don’t get 100% participation, it’s not going to be successful,” Nuce said. “To have true trace back, everyone has to participate.”
  • Blockchain platforms: Will they be able to interact and share data? What type of blockchain architecture is necessary for this?
  • Poor architecture
  • Need a better grasp on the type of data being used and how it delivers value
  • What impact will it have on the role of certification bodies?
  • Politics and the competitive element: Will certain parties seek to control this space?
  • Will the culture shift be a roadblock?
Melanie Nuce, GS1 US
Read Melanie Nuce’s column, Blockchain: Separating Fact from Fiction

Final Thoughts from the Panel

“Nobody can really tell where this is going to go in the future. I think it’s going to be part of food safety in their roles in one shape or form…I think we’ll see more of where this is headed within the next 12–18 months.” – Kathy Wybourn

“I think it’s going to be a fast-moving dynamic area.”– Simon Batters, who suggested that the organizations that embrace blockchain early may be the ones who show the way

“From an information/standards perspective, you have to have foundational business processes to support any type of technology. That’s what we’ve learned through the pilots.” – Melanie Nuce

“It’s not going to make a company any more ethical… a lot of what we need already exists out there; blockchain is just a tool out there. I keep warning people that this is not the only solution.” – Darin Detwiler

Compliance, food safety

Leveraging FSVP Compliance: Do Less, Get More

By Benjamin England, Nicole Trimmer
1 Comment
Compliance, food safety

With an ever-expanding international food trade and new government demands for food safety and supply chain transparency, the U.S. regulatory landscape is becoming increasingly more complex. FSMA (especially the Foreign Supplier Verification Program) aims to shift responsibilities for imported food safety from FDA to importers in an effort to reduce the regulatory burden on FDA. New regulations bring new burdens to food trade stakeholders, requiring significant investment. However, many of the data obligations of the FSVP rule dovetail with other agencies’ requirements.

Investments in one dataset can be leveraged to improve a company’s overall compliance related to international trade. The key is to integrate FSVP requirements into a strong regulatory compliance program without breaking the bank. This requires identifying data overlap, utilizing compliance integration to work smarter, not harder, leveraging the window of opportunity to collect more (and necessary) data from your foreign suppliers, and calling in the right help when needed.

TRUST…..BUT VERIFY: 2018 FSMA Focuses on Supplier Verification Activities | Learn more at the Food Safety Supply Chain Conference | June 12–13, 2018 | Rockville, MDToday’s International Supply Web

No longer can we reasonably talk about establishing, monitoring and maintaining a supply “chain” when importing anything. International trade in food and its ingredients is rarely bilateral—except for perhaps fresh produce, meat and seafood. Instead, food moves throughout a complex supply web of international transactions. Most processed food now contains ingredients from multiple countries, leading to food safety verification challenges and country of origin questions for finished goods.

The international supply web includes farms (land and aquaculture), agriculture cooperatives, food grade chemicals manufacturers, color and flavoring formulators and manufacturers, raw materials processors and fabricators, finished food processors & packers, warehouses, transportation companies, cooking, canning and irradiating facilities, shippers, exporters, product and commodities brokers, importers, wholesalers, retailers and e-tailers. Any (or all) of these players may be small operations located in different countries or multi-national conglomerates operating on several continents. There is very little food consumed in the United States that is not affected, in some way or another, by international commerce and trade.

Shift to a Preventive System

In 2011, Congress passed FSMA with the goal of moving U.S. food safety from a reactive to a preventive system, and integrating HACCP-like principles into the production of all food. Over the ensuing years, FDA issued seven major regulations that address various facets of food safety.

The Foreign Supplier Verification Program (FSVP) rule was included as a way to ensure that foods imported into the United States are produced in a manner that meets U.S. safety standards. FSVP requires that “importers,” which can be the distributors or retailers of products, verify and document the steps taken to ensure safe production of animal and human food. While the exact FSVP requirements vary depending on the commodity, the FSVP process often includes developing, maintaining and documenting a food safety plan and, as its name suggests, verifying that foreign suppliers are controlling for appropriate hazards. Developing and implementing these plans requires a wide variety of skills, including hazard analysis and risk assessment, establishing preventive controls, developing recall plans, and careful documentation of the process. FSVP also requires that verification activities be carried out by parties who have specific preventive control training, or “PCQIs” (Preventive Control Qualified Individuals).

Most importantly, FSMA and the FSVP rule shift the burden of safety from FDA to the importer. With increased interconnectedness, flaws in food safety documentation can become magnified throughout the system. Note that FSVP covers food safety only—not necessarily food traceability or food security defense—although there are opportunities for crossover ROIs. To achieve FSVP compliance, you need to know who is handling your food before it is imported, what they know about food safety, and how they apply food safety principles.

Cross-agency Data Usage

Approaching FSVP as a stand-alone regulatory compliance initiative is expensive and inefficient. Many activities and data elements that must be kept for other government agencies and their compliance programs should be linked together. The data your foreign suppliers must provide to international carriers for advanced notice to U.S. Customs and Border Protection (“CBP” or “Customs”) by importing carriers (airlines, trucking companies and vessel operators) is relevant to both Customs entry and FDA food safety compliance and documentation. This overlap presents an ideal opportunity to relieve the burden of the new FSVP requirements and kill two birds with one stone. And the overlap and leveraging opportunities are actually quite substantial—if one knows where and how to look for them.

For example, the USDA’s National Organic Program (NOP) regulations specify requirements for the processing, handling and labeling of raw materials and processed goods to meet organic standards. Organic labeling and marketing claims are affirmative assertions that the labeled food has not been exposed to processing steps, processing chemicals or particular substances (e.g., sewage sludge, ionizing radiation) that would cause it to fall out of the regulatory bounds of an organic food product. Where organic processing and handling crosses over to food safety, leveraging organic compliance documentation buttresses the safety of the resulting food—and the importer’s FSVP program.

Additionally, much of the information that the importer must know to properly classify their product under the Harmonized Tariff Schedule (HTS) is the same information that the importer needs for their FSVP plan; the importer must know the products, what they are made from, how they are processed, and how they are intended to be used to both properly classify and verify the safety of their product. Because FDA requires the importer to verify that its foreign supplier has a system that meets the domestic food safety standards, the foreign supplier must also be able to identify its own ingredient and raw material suppliers and their systems for food safety, as applicable. Therefore, the food importer’s FSVP process promotes documentation compliance with CBP’s and other government agencies’ requirements governing the country of origin of materials for applicability of preferential duty rates (e.g., under a free trade agreement) and country of origin labeling.

Another example of data overlap is the FSVP requirement for supplier verification and the responsibility to show correct valuation of your product for Customs. FSVP requires that you verify your suppliers and ensure your product is genuine, and Customs requires that you declare an appropriate valuation and identity for your shipment. If Customs investigates your shipment and determines your valuation is incorrect, it may trigger the Department of Commerce to investigate whether there are anti-dumping and countervailing issues going on with the product.

Issues with anti-dumping and countervailing duties are extremely time-consuming and expensive. In both 2008 and 2016, federal authorities investigated rumors of companies circumventing anti-dumping duties by transshipping food products through third countries (to conceal actual origin of the material). When Customs investigated a honey processing plant, they found evidence that the purported processor of Vietnamese honey was receiving finished product from China and relabeling it as originating from Vietnam. When importers declared imported Vietnamese honey, Customs determined from trace mineral testing that the honey was, as they suspected, Chinese. Customs seized the product. The lesson to learn from this is to know your suppliers and the actual supply web. In the case of country of origin violations, not verifying the country of origin can be costly. Where CBP finds negligence is involved, the agency can look back five years to recoup lost duty plus interest, and can even reopen old liquidated entries and assess monetary penalties. In completing your FSVP plan, requesting documentation demonstrating origin is a small additional step that furthers the strength of CBP-required documentation to support the origin declaration at entry. That’s leveraging.

Document, Document, Document

Under the Customs Modernization Act of 1993, the compliance watch-words for all importers (and customshouse brokers) are “record keeping,” “shared responsibility,” “reporting,” and “due diligence.” Anything that is required for a proper importation is subject to CBP review and audit—whether the requirement arises as supply chain and source data under the Seafood Import Monitoring Program (SIMP) under the National Marine Fisheries Service (NMFS), or organic labeling and compliance under USDA’s NOP regulations, or speciation documentation under the Lacey Act enforced by U.S. Fish and Wildlife (USFW), or FSVP implemented by FDA. Therefore, the engagement between food importer and foreign food supplier forced by FSVP opens the opportunity for the importer to clarify and shore up its documentation obligations for many other coexisting regulatory regimes.

A clear demonstration of this fact is borne out by the regular process that ensues when CBP issues to an importer of record a Customs Form 28 (or “CF28”). The CF28 is a CBP request for additional information relating to an imported shipment. The importer is usually required to respond within 30 days of its issuance. But ordinarily the CF28 is issued months (and sometimes years) after the importation occurred. Therefore, the CF28 process represents a significant challenge to the importer’s record keeping and compliance documentation systems, and legal liability to the importer’s bottom line.
Documents needed to respond adequately to a CF28 include contracts, purchase orders, packing lists, shipping documents, declarations to government authorities throughout the import process, powers of attorney, country of origin certifications, emails and other communications discussing any of these documents. CBP requests these documents to confirm the proper electronic data was submitted with the importation. And, of course, CBP is checking to see if the importer is attempting to circumvent U.S. import or export laws that may deprive the government of revenue.

The identity and location of an importer’s trading partners (including the foreign supplier and its suppliers), contracts between and among them (e.g., related to description, processing methods, equipment used, quality and condition of goods), origin documentation, proofs of packing and shipping, etc., are all subject to production via the CF28 process. Penalties for errors in the documentation that result in a regulatory or administrative action are imposed upon the importer (for failing to document or exercise due diligence in performing its function as an importer under U.S. law).

The FSVP regulation presents an ideal opportunity for the importer to establish and populate a compliance program that integrates its FDA import regulatory obligations with those of CBP and other regulatory agencies, as applicable. Failing to take this rare opportunity—at a time when foreign suppliers are expecting probing questions from their U.S. trading partners—is a mistake.

Because the government is more connected, it is essential to change how you prepare for and respond to issues that arise. Just as the FDA’s FSVP rule aims to move food safety from a reactionary to preventive system, coordinated proactive compliance with all government agency requirements will be necessary for the future. Further, with new regulations, your customs broker may not be equipped to deal with certain areas or when administrative matters escalate. But how do you prepare for any eventuality when the enforcement possibilities seem endless?

When preparing your FSVP plans, reviewing your Customs documentation, and reviewing other government agency requirements, it is critical that you think through all the potential issues that may arise with your product or its supply chain, and address them proactively in your documentation. What might an inspector or compliance officer think about the information provided? Is it thorough, clear, and logical? Does it tell a consistent narrative? What if another agency sees this information? Will they have further questions? The ultimate goal is accurate and thorough data for submissions to FDA, Customs and any other partner government agencies.

Key Steps to Prepare for the Worst-case Scenario

Lastly, let’s not forget that part of being prepared is preparing for the worst-case scenario. What happens when you are confronted by an issue? We recommend taking four key steps. First, marshal your resources (documents, documents). Second, ask, “Who are the key players in the story (e.g., which agencies are involved or could possibly be involved, and what are they requesting)?” The third question, a bit less straightforward, is, “How must I respond? (e.g., is the agency within its regulatory authority and required time constraints; are there conflicts of interest; what is the potential legal exposure to risk for different actions)?” Finally, do a gut check: Are the examinations subjective in nature or qualitative (rather than quantitative)? Is any required testing appropriate for the product? If you feel you cannot confidently answer these questions using current staff, we recommend you prepare for import issues by selecting professionals who have experience with integrated agency regulations and legal compliance requirements. The keys to expediting the process when working with multiple government regulatory agencies are integrating your compliance to ensure you have a true green-means-go light before you ship and being able to present a clear and consistent regulatory narrative to all agencies. This requires a clear understanding of how the government regulatory requirements actually intersect.