The past year has tested and stressed the food system, putting tremendous pressure on worker safety and supply chain resilience. Despite the challenges, the industry continued to work day in and day out to meet the needs of Americans. “Consumers could still go then and now to their favorite supermarket or online platform and have access to thousands of food SKUs that are available,” said Frank Yiannas, FDA deputy commissioner for food policy and response. “We have the people in the food and agriculture sector to thank, and that’s you.”
Last week Yiannas gave his third Food Safety Consortium keynote address as deputy commissioner, reflecting on the past year and recognizing the progress and the work ahead. “I appreciate the larger conversation that the Consortium facilitates on food safety.” The Spring program of the Food Safety Consortium Virtual Conference Series takes place every Thursday in May.
Since the Fall of 2020, FDA has made advances in several areas, all of which take steps to advance the agency’s New Era of Smarter Food Safety initiative. The goals set as part of the New Era aim to help the agency more efficiently and efficiently respond to outbreaks and contamination, and other food safety challenges. The intent is to go beyond creating food safety programs into fostering a culture of food safety and truly bending the curve of foodborne illness, said Yiannas. In September the FDA issued the proposed FSMA rule on food traceability with the intent on laying the groundwork for meaningful harmonization. Nearly 6200 comments were submitted to the docket on the Federal Register, and the agency held three public meetings about the proposed rule in the fall, hosting more than 1800 people virtually. Yiannas anticipates the final rule will be published in early 2022.
The pandemic has shown how enhanced traceability might have helped prevent supply chain disruptions during a public health emergency, and the FDA continues its efforts to establish greater transparency and traceability. It is supporting the development of low-cost traceability technology solutions that are accessible to companies of all sizes. The agency also continues to explore the role of predictive analytics via the use of artificial intelligence. It has moved its AI program involving imported seafood from proof of concept into the field. Based on the results, it is expected that AI will help the FDA better manage the ever-increasing amount of imported foods by targeting inspectional resources in a more informed manner.
Efforts to strengthen food safety culture within organizations include collaborating with partners, industry, academia and consumers to define food safety culture in a transparent way. The agency will also be developing and launching internal training modules for FDA inspectional staff to introduce them to important concepts such as behavioral sciences. “We want to make food safety culture part of the dialogue and part of the social norm,” said Yiannas.
The agency will also be proposing new agricultural water requirements, a move as a result of feedback that FDA received in response to the Produce Rule. “Produce safety is one of the last frontiers because of product being grown outside,” said Yiannas.
In addition, FDA continues to review and evaluate feedback from proposed lab accreditation rule. It is expected that the FDA will issue the final rule early next year.
“We just lived through a historic year and historic challenges. These have been the most difficult of times in my profession. We have been able to move forward nonetheless,” said Yiannas. “We’re going to get through this stronger and more resilient than ever.”
Disruptions in the Supply Chain and the Government Response, with Brian Ravitch and Benjamin England, FDA Imports
Food Safety Risks and the Cold Supply Chain, with Jeremy Schneider, Controlant
A panel discussion on the Third-Party Certification Program, moderated by Trish Wester, AFSAP and featuring Doriliz De Leon and Clinton Priestly of FDA
TechTalk on How Restaurant Brands International has Digital Transformed Its Supply Chain to Ensure Food Safety, Quality & Consistency, with Jim Hardeman, CMX
The event begins at 12 pm ET on Thursday, November 19. Haven’t registered? Follow this link to the 2020 Food Safety Consortium Virtual Conference Series, which provides access to all the episodes featuring critical industry insights from leading subject matter experts! We look forward to your joining us virtually.
Food Fraud Vulnerability Assessment and Mitigation Plan, with Steve Sklare, Food Safety Academy; Karen Everstine, Ph.D., Decernis; and Peter Begg, Glanbia Nutritionals
Food Fraud Case History: Glanbia Nutritionals, with Peter Begg, Glanbia Nutritionals
Public Standards—Protecting the Integrity of the Food Supply Chain, with Steven Gendel, Ph.D., Food Chemicals Codex
Monitoring and Predicting Food Safety and Fraud Risks in Challenging Times, with Giannis Stoitsis, Agroknow
The event begins at 12 pm ET. Haven’t registered? Follow this link to the 2020 Food Safety Consortium Virtual Conference Series, which provides access to 14 episodes of critical industry insights from leading subject matter experts! We look forward to your joining us virtually.
Almost everybody loves chocolate, an ancient, basic, almost universal and primal source of pleasure. “The story of chocolate beings with cocoa trees that grew wild in the tropical rainforests of the Amazon basin and other areas in Central and South America for thousands of years… Christopher Columbus is said to have brought the first cocoa beans back to Europe from his fourth visit to the New World” between 1502 and 1504.1
Unfortunately, the production of chocolate and chocolate products today is as complex as any other global food product with supply chains that reach from one end of the world to the other. The complexity of the supply chain and production, along with the universal demand for the finished product, exposes chocolate to increasing pressure from numerous hazards, both unintentional and intentional. For example, we know that more than 70% of cocoa production takes place in West African countries, particularly the Ivory Coast and Ghana. These regions are politically unstable, and production is frequently disrupted by fighting. While production has started to expand into more stable regions, it has not yet become diversified enough to normalize the supply. About 17% of production takes place in the Americas (primarily South America) and 9% from Asia and Oceania.2
In today’s world of global commerce these pressures are not unique to chocolate. Food quality and safety experts should be armed with tools and innovations that can help them examine specific hazards and fraud pertaining to chocolate and chocolate products. In fact, the global nature of the chocolate market, requires fast reflexes that protect brand integrity and dynamic quality processes supported by informed decisions. Digital tools have become a necessity when a fast interpretation of dynamic data is needed. If a food organization is going to effectively protect the public’s health, protect their brand and comply with various governmental regulations and non-governmental standards such as GFSI, horizon scanning, along with the use of food safety intelligent digital tools, needs to be incorporated into food company’s core FSQA program.
This article pulls information from a recent industry report about chocolate products that presents an examination of the specific hazards and fraud pertaining to chocolate and chocolate products along with ways to utilize this information.
Cocoa and chocolate products rely on high quality ingredients and raw materials, strict supplier partnership schemes and conformity to clearly defined quality and safety standards. During the past 10 years there have been a significant number of food safety incidents associated with chocolate products. The presence of Salmonella enterica, Listeria monocytogenes, allergens and foreign materials in cocoa/chocolate products have been reported on a global scale. Today, information on food safety incidents and potential risks is quickly and widely available by way of the internet. However, because the pertinent data is frequently siloed, food safety professionals are unable to take full advantage of it.
Top Emerging Hazards: Chocolate Products (2013-2018)
Publicly available data, from sources such as European Union RASFF, Australian Competition and Consumer Commission, UK Food Standards Agency, FDA, Food Standards Australia New Zealand (FSANZ), shows a significant increase in identified food safety incidents for cocoa/chocolate products from 2013 to 2018. For this same time period, the top emerging hazards that were identified for chocolate products were the following:
Foreign bodies: 13.83%
Food additives & flavorings: 4.26%
Other hazards: 2.66%
By using such information to identify critical food safety protection trends, which we define to include food safety (unintentional adulteration) and food fraud (intentional adulteration, inclusive of authenticity/intentional misrepresentation) we can better construct our food protection systems to focus on the areas that present the greatest threats to public health, brand protection and compliance.
A Data Driven Approach
Monitoring Incoming Raw Materials
Assessment and identification of potential food protection issues, including food safety and fraud, at the stage of incoming raw materials is of vital importance for food manufacturers. Knowledge of the associated risks and vulnerabilities allows for timely actions and appropriate measures that may ultimately prevent an incident from occurring.
Specifically, the efficient utilization of global food safety and fraud information should allow for:
Identification of prevalent, increasing and/or emerging risks and vulnerabilities associated with raw materials
Comparative evaluation of the risk profile for different raw materials’ origins
Critical evaluation and risk-based selection of raw materials’ suppliers
A comprehensive risk assessment must start with the consideration of the identified food safety incidents of the raw material, which include the inherent characteristics of the raw material. Next, the origin-related risks must be taken into account and then the supplier-related risks must be examined. The full risk assessment is driven by the appropriate food safety data, its analysis and application of risk assessment scientific models on top of the data.
Using food safety intelligent digital tools to analyze almost 400 unique, chocolate product related food safety incidents around the globe provides us with important, useful insights about cocoa as a raw material, as a raw material from a specific origin and as a raw material being provided by specific suppliers. The graph below represents the results of the analysis illustrating the trend of incidents reported between 2002 and 2018. It can be observed that after a significant rise between 2009 and 2010, the number of incidents approximately doubled and remained at that level for the rest of the evaluated period (i.e., from 2010 to 2018), compared to the period from 2002 to 2005.
By further analyzing the data stemming from the 400 food safety incidents and breaking them down into more defined hazards, for incoming raw materials, we can clearly see that chemical hazards represent the major hazard category for cocoa.
Organoleptic aspects: 5.93%
Other Hazards: 4.38%
Foreign bodies: 2.06%
Food additives and flavorings: .77%
Food contact materials: .52%
Using the appropriate analytical tools, someone can drill down into the data and identify the specific incidents within the different hazard categories. For example, within the “chemical hazard” category specific hazards such as organophosphates, neonicotinoids, pyrethroids and organochlorines were identified.
Comparative Evaluation of Risk Profiles for Different Origins of Raw Materials
The main regions of origin for cocoa globally are Africa, Asia and South America. After collecting and analyzing all relevant data from recalls and border rejections and the frequency of pertinent incidents, we can accurately identify the top hazards for cocoa by region.
The top five specific hazards for the regions under discussion are listed in Table I.
Poor or insufficient controls
Table I. Top Five Hazards By Region
After the first level of analysis, a further interpretation of the data using the appropriate data intelligence tools can help to reach to very specific information on the nature of the incidents. This provides additional detail that is helpful in understanding how the regional risk profiles compare. For example, the prevalence of chemical contamination, as either industrial contaminants or pesticides, has been a commonly observed pattern for all three of the regions in Table I. However, beyond the general hazard category level, there are also different trends with regard to specific hazards for the three different regions. One such example is the increased presence of mold in cocoa beans coming from Africa.
The primary hazard categories for cocoa, as a raw ingredient were identified and a comparison among the primary hazards for cocoa by region (origin-specific) should take place. The next step in a data-powered supplier assessment workflow would be to incorporate our use of global food safety data in evaluating the suppliers of the raw materials.
The Role of Global Food Safety Data
This article has been focused on chocolate products but has only touched the surface in terms of the information available in the complete report, which also includes specific information about key raw materials. Let’s also be clear, that the techniques and tools used to generate this information are applicable to all food products and ingredients. As we strive to produce food safely in the 21st Century and beyond, we must adapt our methods or be left behind.
The regulatory environment the food industry must operate in has never been more intense. The threats to an organization’s brand have never been greater. This is not going to change. What must change is the way in which food companies confront these challenges.
Global food safety data can contribute to the establishment of an adaptive food safety/QA process that will provide time savings and improve a quality team’s efficiency and performance.
Based on the continuous analysis of food recalls and rejections by key national and international food authorities, a food safety / quality assurance manager could establish an adaptive supplier verification process and risk assessment process by utilizing the knowledge provided by such data. In that way, QA, procurement, food safety and quality departments can be empowered with critical supplier data that will inform the internal procedures for incoming materials and ingredients (e.g., raw materials, packaging materials) and allow for adaptive laboratory testing routines and compliance protocols. Moreover, food safety systems can become adaptive, enabling quality assurance and safety professionals to quickly update points of critical control when needed, and intervene in important stages of the chocolate manufacturing process.
Well-known food and beverage brands will often turn to contract manufacturers to produce the quality products that their customers expect and enjoy. With their brand names on the line, these brand owners need assurance that their suppliers can deliver safe and high-quality goods and mitigate the looming threat of recalls.
How do they know if they’re working with a reliable contract manufacturer? Well, many will look to see if they hold certifications from a reputable third-party organization, such as the Safe Quality Food Institute (SQFI). In fact, one in four companies today require that their suppliers have SQF certification, making it one of the most important certifications in contract manufacturing.
SQF certification demonstrates that a supplier has met benchmarked standards—set by the Global Food Safety Initiative (GFSI)—for upholding quality and controlling food safety risks. It’s a form of validation of an organization’s ability to consistently produce safe and high-quality products. Contract manufacturers that have SQF certification are more likely to win contracts and can bid for business on a national or global scale. Thus, it presents a clear competitive advantage to those certified in the various levels of SQF certification.
Level 1: The SQF Safety Fundamentals Program is an introduction to food safety standards for small- to medium-sized food suppliers. Ideal for those with low-risk food products, the program doesn’t meet GFSI standards but establishes a foundation for doing so. Suppliers certified at this level typically sell their services to smaller, local purveyors.
Level 2: The SQF Food Safety Program follows GFSI-benchmarked food safety standards. It helps sites implement preventive food safety measures according to Hazard Analysis and Critical Control Points (HACCP) regulations, which ensure scientific analysis of microbiological, physical and chemical hazards are applied at each step of the supply chain. This level is ideal for businesses that would like to work with purveyors that require adherence to GFSI benchmarked standards.
Level 3: The SQF Food Safety and Quality Program shows an ability to not only contain safety risks through the HACCP system, but also monitor and control threats related to food quality. This highest level of certification is ideal for large-scale producers, manufacturers, food packaging facilities and distributors that have successfully deployed an SQF Food Safety Program and want to go above and beyond in their quality efforts.
While it’s the most demanding of the three, Level 3 certification is what most contract manufacturers should aspire to because it’s required by many of the world’s largest food and beverage brands. In order to attain this level of distinction, contract manufacturers need an effective way to demonstrably meet all GFSI benchmarked standards and readily access their quality data during an audit. This is where statistical process control (SPC) comes in.
The SPC Gamechanger
SPC is a proven methodology for monitoring and controlling quality during the manufacturing process. SPC enables manufacturers to chart real-time quality data against predefined control limits to identify unwanted trends and product or process variations. If there is an issue, timely alerts will notify responsible parties to take remedial action early on, preventing unsafe or poor-quality goods from entering the supply chain and triggering a recall. This establishes strong controls for food quality and safety in accordance with a Level 3 SQF Program. Audits also become a breeze, as all historical data are stored digitally in a centralized repository. Suppliers can thereby quickly and easily produce auditor-requested reports showing compliance with SQF requirements and GFSI standards.
But beyond quality monitoring and facilitating audits, SPC can deliver greater impact by providing suppliers with analytical tools useful for mining historical data for actionable insights. They can run comparative analyses of the performance of different lines, products, processes, or even sites, revealing where and how to further reduce risk, improve consistency, streamline operations, and lower production costs. In this way, SPC lends itself to a profit-positive business model—driving additional savings through process improvement while increasing new business opportunities through contracts won via SQF certification.
A Snacking Success
One contract manufacturer of savory and healthy snacks previously struggled with large variations in product quality. These inconsistencies often resulted in quality holds or process aborts that generated high waste and costs. By implementing SPC, the snack supplier was able to take advantage of a wide range of data—including incoming receiving tracking and quality inspection tracking—to finetune its production processes with effective controls for food quality and safety. In addition to a 30% reduction in customer complaints, SPC has helped the supplier realize a $1 million reduction in product waste and attain Level 3 SQF certification, the latter of which has generated continued new business from several well-known snack food brands.
This snack supplier is a clear example of SQF certification as a competitive differentiator. Working with such SQF-certified and SPC-powered contractors is important to food and beverage brands because they can protect their reputations and ensure continued customer retention by way of safe, consistent, high-quality products. Ultimately, it builds greater trust and integrity in the supply chain among companies and consumers alike.
Visibility, accountability and traceability are paramount in the agriculture industry, says Allison Kopf, founder and CEO of Artemis. In a Q&A with Food Safety Tech, Kopf explains how growers can take advantage of cultivation management platforms to better arm them with the tools they need to help prevent food safety issues within their operations and maintain compliance.
Food Safety Tech: What are the key challenges and risks that growers face in managing their operations?
Allison Kopf: One of the easiest challenges for growers to overcome is how they collect and utilize data. I’ve spent my entire career in agriculture, and it’s been painful to watch operations track all of their farm data on clipboards and spreadsheets. By not digitizing processes, growers become bogged down by the process of logging information and sifting through old notebooks for usable insights—if they even choose to do that.
I was visiting a farm the other day and the grower pulled out a big binder. The binder contained all of his standard operating procedures and growing specifications for the varieties he’s grown over the past 20 years. Then he pulled out a pile of black notebooks. If you’ve ever worked on a farm, you’d recognize grower notebooks anywhere. They’re used to log data points such as yield, quality and notes on production. These notebooks sit in filing cabinets with the hopeful promise of becoming useful at some point in the future—to stop production from falling into the same pitfalls or to mirror successful outcomes. However, in reality, the notebooks never see the light of day again. The grower talked about the pain of this process—when he goes on vacation, no one can fill his shoes; when he retires, so does the information in his head; when auditors come in, they’ll have to duplicate work to create proper documentation; and worse, it’s impossible to determine what resources are needed proactively based on anything other than gut. Here’s the bigger issue: All of the solutions are there; they’re just filed away in notebooks sitting in the filing cabinet.
Labor is the number one expense for commercial growing operations. Unless you’re a data analyst and don’t have the full-time responsibilities of managing a complex growing operation, spreadsheets and notebooks won’t give you the details needed to figure out when and where you’re over- or under-staffing. Guessing labor needs day-to-day is horribly inefficient and expensive.
Another challenge is managing food safety and compliance. Food contamination remains a huge issue within the agriculture industry. E. coli, Listeria and other outbreaks (usually linked to leafy greens, berries and other specialty crops) happen regularly. If crops are not tracked, it can take months to follow the contamination up the chain to its source. Once identified, growers might have to destroy entire batches of crops rather than the specific culprit if they don’t have appropriate tracking methods in place. This is a time-consuming and expensive waste.
Existing solutions that growers use like ERPs are great for tracking payroll, billing, inventory, logistics, etc., but the downside is that they’re expensive, difficult to implement, and most importantly aren’t specific to the agriculture industry. The result is that growers can manage some data digitally, but not everything, and certainly not in one place. This is where a cultivation management platform (CMP) comes into play.
FST:How are technologies helping address these issues?
Kopf: More and more solutions are coming online to enable commercial growers to detect, prevent and trace food safety issues, and stay compliant with regulations. The key is making sure growers are not just tracking data but also ensuring the data becomes accessible and functional. A CMP can offer growers what ERPs and other farm management software can’t: Detailed and complete visibility of operations, labor accountability and crop traceability.
A CMP enables better product safety by keeping crop data easily traceable across the supply chain. Rather than having to destroy entire batches in the event of contamination, growers can simply trace it to the source and pinpoint the problem. A CMP greatly decreases the time it takes to log food safety data, which also helps growers’ bottom line.
CMPs also help growers manage regulatory compliance. This is true within the food industry as well as the cannabis industry. Regulations surrounding legal pesticides are changing all the time. It’s difficult keeping up with constantly shifting regulatory environment. In cannabis this is especially true. By keeping crops easily traceable, growers can seamlessly manage standard operating procedures across the operation (GAP, HACCP, SQF, FSMA, etc.) and streamline audits of all their permits, licenses, records and logs, which can be digitized and organized in one place.
FST: Where is the future headed regarding the use of technology that generates actionable data for growers? How is this changing the game in sustainability?
Kopf: Technology such as artificial intelligence and the internet of things are changing just about every industry. This is true of agriculture as well. Some of these changes are already happening: Farmers use autonomous tractors, drones to monitor crops, and AI to optimize water usage.
As the agriculture industry becomes more connected, the more growers will be able to access meaningful and actionable information. Plugging into this data will be the key for growers who want to stay profitable. These technologies will give them up-to-the-second information about the health of their crops, but will also drive their pest, labor, and risk & compliance management strategies, all of which affect food safety.
When growers optimize their operations and production for profitability, naturally they are able to optimize for sustainability as well. More gain from fewer resources. It costs its customers less money, time and hassle to run their farms and it costs the planet less of its resources.
Technology innovation, including CMPs, enable cultivation that will provide food for a growing population despite decreasing resources. Technology that works both with outdoor and greenhouse growing operations will help fight food scarcity by keeping crops growing in areas where they might not be able to grow naturally. It also keeps production efficient, driving productivity as higher yields will be necessary.
Beyond scarcity, traceability capabilities enforce food security which is arguable the largest public health concern across the agricultural supply chain. More than 3,000 people die every year due to foodborne illness. By making a safer, traceable supply chain, new technology that enables growers to leverage their data will protect human life.
Food defense is the effort to protect food from intentional acts of adulteration where there is an intent to cause harm. Like counterterrorism laws for many industries, the IA rule, which established a compliance framework for regulated facilities, requires that these facilities prepare a security plan—in this case, a food defense plan—and conduct a vulnerability assessment (VA) to identify significant vulnerabilities that, if exploited, might cause widescale harm to public health, as defined by the FDA. Lessons learned during the conduct of food defense vulnerability and risk assessments and the preparation of the required food defense plan are detailed throughout this three-part series of articles. Part I of this series is intended to assist facilities that have not yet conducted vulnerability assessments or wish to review those already conducted, by leveraging lessons learned from assessments conducted for the largest and most complex global food and beverage facilities.
Lesson 1: VA outcomes are greatly enhanced if a physical security professional is consulted. In support of this contention, there are several physical security mitigation strategies, which can be employed to support a food defense program, that are frequently under-utilized and are not optimally managed by non-security staff. Also, the FDA seems to promote the use of cameras even though this equipment is unlikely to prevent an incident of intentional adulteration. For organizations that choose to use video surveillance, a competent security professional can help organizations engineer and operate video surveillance for maximum benefits and to meet challenging record-keeping requirements when this mitigation strategy is included in a food defense plan.
Lesson 2: Given the focus by the FDA on the insider, a formal insider threat detection program is highly recommended. Trying to promote the common, “See Something, Say Something” strategy may not be enough. For example, if employees are not clearly told what to look for in terms of uniform requirements, how to identify persons who do not belong or changes to a coworker’s baseline behavior, which may indicate moving toward a path to violence or sabotage, then “See Something, Say Something” may end up being no more than a catchy slogan.
A key element of an insider threat detection program is the completion of effective background checks for all persons who will be allowed in the facility unescorted. This includes temporary employees and contractors. A common theme in many of the recent, serious intentional adulteration incidents was that the person responsible was involved in some sort of grievance observable to coworkers and supervisors. In all insider threat detection programs, the grievance becomes an important trip wire. The Carnegie Mellon University Software Engineering Institute has published a document titled, “Common Sense Guide to Mitigating Insider Threats, Sixth Edition”. In this document is some particularly helpful guidance that can be used to stand up an insider threat detection program, but this is an effort that can take some time to fully implement.
Lesson 3: The FDA has made it abundantly clear that they believe the focus for the food and beverage industry should be the radicalized insider. A closer look at all the recently publicized contamination events suggests that there are other profiles that need to be considered. A good foundational model for building profiles of potential offenders can be found in the OSHA definitions for workplace violence offenders, which has been expanded to address ideologically based attacks. Table I applies those descriptions to the food and beverage industry, with an asterisk placed by those offender profiles that exist in recent incidents and discussed later in the text.
OSHA Workplace Violence Offender Description
Motivation Translated to the Food and Beverage Industry
The offender has no legitimate relationship to the business or its employee(s). Rather, the violence is incidental to another crime, such as robbery, shoplifting, trespassing or seeking social media fame.
Behavioral Health Patient *
Social Media Fame Seeker *
Economic motivation *
The violent person has a legitimate relationship with the business—for example, the person is a customer, client, patient, student, or inmate—and becomes violent while being served by the business, violence falls into this category.
My load isn’t ready, you are costing me money
The offender of this type of violence could be a current employee or past employee of the organization who attacks or threatens other employee(s) in the workplace.
I am upset with a coworker and adulterate to create problems for that person *
I am upset with the company and adulterate as retribution and to harm the brand *
I am not paid enough *
The offender may or may not have a relationship with the business but has a personal (or perceived personal) relationship with the victim.
I am upset with an intimate partner/ coworker and adulterate to create problems for that person
Ideological workplace violence is directed at an organization, its people, and/or property for ideological, religious or political reasons. The violence is perpetrated by extremists and value-driven groups justified by their beliefs.
Table I. A description of OSHA workplace violence offenders and how it can be applied to the F&B industry.
A supermarket in Michigan recalled 1,700 lbs. of ground beef after 111 people fell ill with nicotine poisoning. The offender, an employee, mixed insecticide into the meat to get his supervisor in trouble. In Australia, the entire strawberry industry was brought to its knees after a disgruntled supervisor “spiked” strawberries with needles. There were more than 230 copycat incidents impacting many companies. A contract employee in Japan, apparently disgruntled over his low pay, sprayed pesticide on a frozen food processing line resulting in illnesses to more than 2,000 people. A contract worker upset with a union dispute with the company at a food manufacturing plant videoed himself urinating on the production line, then uploaded the video to the Internet. Be cognizant of any grievances in the workplace and increase monitoring or take other proactive steps to reduce the risk of intentional adulteration.
Lesson 4: The IA Rule requires that every point, step and procedure be analyzed to determine if it is an actionable process step (APS). The Hazard Analysis Critical Control Point flow charts are a good starting point to comply with this element of the law but cannot be counted on completely to achieve the standard of analyzing every point, step or procedure. Critical thinking and persons familiar with the production process need to be involved to ensure that no steps are missed. Oftentimes companies modify the HACCP flow diagrams after a VA.
Lesson 5: The FDA states in the second installment of guidance (here’s the full copy) to the industry that, “There are many possible approaches to conducting a VA. You may choose an approach based on considerations such as the time and resources available and the level of specificity desired. You have the flexibility to choose any VA approach, as long as your VA contains each required component (21 CFR 121.130).”
The FDA further states that the Key Activity Type, or KAT method, is an appropriate method for conducting a VA because it reflects consideration of the three required elements and the inside attacker. Using this methodology alone, however, can result in substantially more APS’s, which might otherwise be ruled out for practical purposes such as a lack of accessibility or a lack of feasibility to contaminate the product at a point, step or procedure. We have experienced up to a 90% decline in APS’s by utilizing another FDA recommended assessment approach, the hybrid approach, which assesses each point, step or procedure as first whether it is a KAT. Then to qualify as an APS, it must also trigger positively for public health impact, accessibility and feasibility to contaminate the product.
Organizations who have yet to execute vulnerability assessments (due July 26, 2020) or who may wish to reflect back on their existing VA’s in an effort to eliminate unnecessary APS’s should find these strategies helpful to focus limited resources to the areas where they can have the greatest effect. The next two articles in this series will cover more information on electronic access, the value of site tours, comparisons to drinking water security strategies, dealing with multi-site assessments and more. Read Part II of this series on intentional adulteration.
The supply chain is a potentially weak and vulnerable part of a company’s food safety plan. The annual Food Safety Supply Chain Conference is months away and we are accepting abstracts for presentations. The conference takes place May 29–30, 2019 in Rockville, MD.
If you have expertise in the following areas, we invite you to submit an abstract to present at the conference:
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.
Sanitation in a food processing plant is a large-scale effort that many organizations see as an added cost of doing business. Yet, it’s essential and can have costly consequences if done improperly.
Because time is money and facilities want to avoid any necessary downtime, the window for completing proper sanitation procedures is small. Many food processors simply put more people on the job while requiring them to work third shift, hoping to get things done faster.
Automating certain sanitation procedures in your plant can provide real benefits, many of which will help reduce the costs associated with food safety and keeping your facility clean. Here’s a look at the three main ways food plants can save by implementing automated sanitation solutions.
1. Resource Management
When you invest in sanitation automation, one of the biggest advantages is the increased understanding of how resources are being used. This knowledge and improved visibility gives you control of how resources such as water and chemicals are used during sanitation.
Perhaps the most significant area in which facilities experience savings is through reduction of water usage. Automated solutions improve the efficiency of rinse cycles while ensuring appropriate water pressure is being used. Every plant has unique water needs, but you should expect water savings between 30% and 50%, depending on the solutions that are applied.
Sanitation automation will also lead to a reduction in energy costs. Using less water means less energy is required to heat that water. Advancements in sanitation technology have made certain solutions more energy efficient. Features such as multi-stage pumps for full alternation, motors that allow pumps to ramp up and down as needed, and flow switches that send pumps into “hibernate” mode help reduce electricity usage.
Waste water from food processing also needs to be treated before it goes down the drain. Less water treatment means fewer chemicals are needed.
Food processors that introduce automated sanitation solutions will use cleaning chemicals more efficiently. Automation ensures chemicals are dispensed precisely where they are needed at the correct concentration, without any over spray. Again, while every situation is unique, most facilities can expect a 20–30% reduction in chemistry costs.
In the end, you will have a very clear picture of the amount of water and chemistry needed to complete sanitation, and you’ll know the amount of time it should take. That means you can plan for more uptime.
Overall, not only can automation help food processors make efficient use of resources, it also makes them more sustainable.
2. Labor Costs
Labor is yet another resource that can be more effectively managed when there’s an investment in sanitation automation. The labor market is tight, and it is becoming increasingly difficult to hire the people needed to carry out sanitation work.
Sanitation often involves menial and tedious tasks that also require attention to detail. It usually entails working overnight when production stops, and certain responsibilities can be dangerous. At the same time, minimum wage is rising, and many organizations are looking to reduce labor costs.
Introducing sanitation automation can certainly cut labor expenses and remove the need to hire more people, but more importantly, it can make the workers you do have more productive. Automation should be used to eliminate menial tasks from sanitation workers. For example, instead of a person standing in front of a conveyor belt and spraying it down with a hose for hours on end, the job could be easily automated.
We worked with a brewer who was having two employees take as long as three hours to clean a filler. By automating that task, they turned it into a 45-minute job and allowed those employees to refocus their efforts. Plus, the before and after pictures of the equipment show a visible difference in cleanliness.
You can trust an automation solution to do a consistent job, and it will never call in sick.
Still, you’ll always need to have “boots on the ground” and human eyes evaluating sanitation. Automating certain sanitation practices will free up employees to work on more important duties that add value and keep them engaged in their work.
3. Mitigating Safety Risks
The most important thing sanitation automation provides is more peace of mind. No one wants to lose sleep worrying about a failed inspection or the potential for a worker injury. Automation reduces the risk of product contamination and lessens potentially dangerous situations for employees.
For instance, spiral freezers are particularly precarious areas to clean. Automating its cleaning process eliminates the need for a worker to maneuver through an unsafe space, reducing the likelihood of a workplace injury.
Human labor can also lead to human error. But, when sanitation tasks are automated, they become more consistent and easily repeatable. This is especially important for cleaning hard-to-reach problem spots that become harborage areas for bacteria. There may be a tendency among human workers to skip areas they can’t reach, or fail to clean them properly, but a machine cleans everything the same every time.
The monetary risk of contamination inside your facility is significant. For example, if Listeria were to take up residence in a plant, it could cost your business millions of dollars.
According to a study from the Food Marketing Institute and Grocery Manufacturers Association, the average food product recall will have direct costs of $10 million while indirect costs could reach into the hundreds of millions. That’s because you also need to consider the ongoing cost of a damaged brand reputation, not to mention lost productivity from business interruptions and lost profits from disposing of potentially contaminated product.
Sanitation Automation: The Future is Now
There are many reasons to start implementing automation into your food and beverage plant’s sanitation practices. Food processors in Europe have been quicker to adopt these solutions because many of the same issues U.S. manufacturers face, such as wages and resource scarcity, can be even more pronounced overseas.
As the labor market in the United States presents challenges for hiring managers, and drought conditions in some regions make water a scarce commodity, automation presents an opportunity to bring your facility into the future. Add to those concerns the increased regulations from FSMA, and there is even more reason to invest in dependable sanitation solutions.
Food processors need to find trusted advisors who can evaluate operations inside the plant and look for ways to implement automation in ways that make the largest impact.
While there is certainly an upfront cost in automating sanitation, the potential savings and added visibility these solutions provide won’t take long to pay for themselves. In most cases, facilities that invest in sanitation automation will see a return within a year to 18 months. If done properly, you can achieve impressive cost-saving results through automation.
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