The FDA Center for Food Safety and Applied Nutrition (CFSAN) and Office of Food Policy and Response (OFPR) has released a list of draft and final guidance topics that are a priority for the FDA Foods Program to complete during the next 12 months.
The guidance documents do not impose legally enforceable requirements, but they can help stakeholders plan for potential changes that may impact their businesses and organizations. The agency anticipates it will publish many of the listed documents by January 2024.
The priority list of draft and final guidance topics include (by category):
Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling and Consumer Protection Act of 2004 (Edition 5); Guidance for Industry
Compliance Policy Guide Sec. 555.250 Major Food Allergen Labeling and Cross-contact; Draft Guidance for FDA Staff
Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Listed in the Federal Food, Drug, and Cosmetic Act; Guidance for FDA Staff and Stakeholders
Preparation of Premarket Submission for Food Contact Substances (Chemistry Recommendations): Draft Guidance for Industry
Premarket Consultation on Cultured Animal Cell Foods: Draft Guidance for Industry
Foods Derived from Plants Produced Using Genome Editing; Draft Guidance for Industry
Inorganic Arsenic in Apple Juice: Action Level; Draft Guidance for Industry
Detention Without Physical Examination (DWPE) of Fish and Fishery Products Due to the Appearance of Adulteration by Bacterial Pathogens, Unlawful Animal Drugs, Scombrotoxin (Histamine), or Decomposition – Evidence Recommended for Release of Goods Subject to DWPE and Removal of a Foreign Manufacturer’s Goods from DWPE; Draft Guidance for Industry
Compliance Policy Guide Sec. 555.320 Listeria monocytogenes in Human Food; Draft Guidance for FDA Staff
Hazard Analysis and Risk-Based Preventive Controls for Human Food; Appendix 1: Potential Hazards for Foods and Processes; Draft Guidance for Industry
Hazard Analysis and Risk-Based Preventive Controls for Human Food; Chapter 11: Food Allergen Controls; Draft Guidance for Industry
Hazard Analysis and Risk-Based Preventive Controls for Human Food; Chapter 16: Validation of Process Controls; Draft Guidance for Industry
Hazard Analysis and Risk-Based Preventive Controls for Human Food; Chapter 17: Classifying Food as Ready-To-Eat or Not Ready- to-Eat; Draft Guidance for Industry
Hazard Analysis and Risk-Based Preventive Controls for Human Food; Chapter 18: Acidified Foods; Draft Guidance for Industry
Compliance with and Recommendations for Implementation of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption for Sprout Operations: Guidance for Industry
Labeling of Plant-Based Alternatives to Animal-Derived Foods; Draft Guidance for Industry
Questions and Answers About Dietary Guidance Statements in Food Labeling; Draft Guidance for Industry
Use of Nutrient Content Claims for Added Sugars in the Labeling of Human Food Products: Draft Guidance for Industry
Public comments on the list of guidance topics, including suggestions for alternatives or recommendations on the topics the FDA is considering, can be submitted to www.regulations.gov, using Docket ID: FDA-2021-N-0553.
Implementing an integrated management system that encompasses food safety and quality standards is a complex process that requires careful planning, team buy-in and good communication. If an organization fails to plan properly, these large-scale projects can fall by the wayside.
The planning process will help to identify risks and potential roadblocks. Keep expectations realistic by considering the stakeholders’ needs and expectations. Reach out to those impacted for feedback before the project launches. The information gathered can be helpful in identifying stakeholders’ concerns, unforeseen issues, and resource constraints that may impact the project.
It’s also important to understand the certification process when working through the planning phase, as processes may vary slightly between certification bodies. Factors such as the need for single site vs. multi-site certification, number of standards included, the organization size, geographic location, and auditor availability can all impact the timeline. Meeting with your certification body to walk through these details will aid in setting a realistic project timeline.
Develop a Communication Plan
Communicating project details is critical to project success. This can be done in a variety of ways; often the development of a communication plan will help to set things into motion. These plans describe the who, what, when, and how of the project. Larger companies may need a more in-depth plan while smaller companies can take a more informal approach.
Work with your management team to develop messaging for the larger organization around the project that fits into the overall strategic vision of the organization. The message should communicate the plan for fulfilling the goals and objectives of the project as well as the strategic connection to the overall vision or mission of the company. Remember, there is no one size fits all for communication plans. Feel free to get creative and do what works best for your organization.
Once the plan has been outlined, engage top management to build a strong foundation for success. Get their buy in on the timeline and agenda. Look to them to provide overall support of the project and act as advocates for implementing the change. Seek out their advice when issues arise or when delays are encountered. They are often the key to helping move the project forward.
Planning an official project kickoff as well as milestone events is a great way to give the project momentum. Encourage top management to attend the kickoff, and keep everyone engaged by providing frequent status updates. Highlight success stories and small wins throughout the life of the project.
Encourage implementation team members to communicate regularly with their internal groups. Utilizing communication boards and site wide meetings to keep everyone apprised of progress is helpful. Implementation projects often take several months, so it’s wise to continuously share information to keep motivation up.
Intentionally Select Team Members
Identifying the right people for the implementation team is a critical step in the project development process. Integrated systems often require collaboration between a variety of groups. When building your implementation team consider current activities and identify processes that are within the scope of the standards being implemented. The individuals who manage these processes are the ideal candidates for the implementation team. Pulling from a pool of subject matter experts will help to streamline the process, as the team will be able to spend their time aligning current business practices rather than mastering the subject. Utilize your team’s expertise and influence to drive change. An understanding of the standards requirements will help identify the specific expertise needed.
Review the standards within the scope of the project and identify differences and commonalities. This should be relatively simple due to fact that ISO standards are all based upon a High-Level Structure (HLS) format, which harmonizes the standard format and requirements. The standard creators adopted this approach with the understanding that many organizations intend to integrate management systems. Similarities often lie within management system activities such as context, leadership, document control, management review, internal audit, and corrective action.
In each of the standards there are sections that will be unique depending on the specific focus. For example, ISO 9001 has extensive requirements around customer focus and operations, while ISO 22000 is tailored towards food safety with specific requirements around HACCP and PRPs. Identify who within the organization has the skillsets needed for the project and create an outline for the roles and responsibilities of each team member.
When establishing roles and responsibilities seek input from the team members and take into consideration their workloads outside of the project. Implementation projects require an extensive amount of time, so you want to ensure you don’t overload them.
Consider allowing team members to establish their own deadlines to provide them with a sense of ownership of their identified areas. Use small, focused teams to help break the project down into segments to make it easier to manage. Team members will be able to focus on their individual tasks and not be overwhelmed with the overall scope. If workload is a concern, consider splitting responsibilities between team members or reaching out to those in your organization who maybe underutilized.
Building the project around current processes and process owners will save time and reduce the need to sell the idea of implementing an integrated system. Many times, organizations are unknowingly meeting partial requirements and only minor modifications will be needed to close the gap. By utilizing internal subject matter experts, gaps can be identified and corrective actions established with minimal effort.
Utilize Auditing Throughout Implementation
Gap assessments and internal audits are an excellent way to ensure the implementation efforts are going as intended. Conducting a gap assessment of the management system provides an overview of the full system and highlights where gaps may lie. This is a great tool to use for project planning and timeline development. The quantity and complexity of the gaps will help guide the team to the areas that need heightened focus.
Develop a team action log to track status of specific actions and identify responsible parties. Keep it simple with clearly identified project milestones. Consider incorporating these milestones into communication plans for awareness across the organization.
Once the team has begun to close the gaps identified, the next step is to verify that the changes are effective. Internal audits can be used to confirm that changes are being rolled out as intended.
Establish an audit program early in the implementation process to help clarify the requirements across the organization. The format of the audit schedule will be unique to each company. Consider aligning with the current processes or departments for a streamlined approach.
As integration activities are rolled out, conduct focused audits a few weeks after launch to verify proper adoption. Work with the team to build a checklist tailored to the process or department being audited. This customized approach will provide a detailed look at current activities.
Take time to accurately document the requirements and any nonconformities. Document the findings in a formal report and set aside time to discuss the results with the auditee. Be sure to include any positive findings that are encountered. Lastly, come to an agreement on the timeline for corrective actions and set a date for any follow-up audits.
When working through corrective actions be sure to work with your stakeholders to help them understand the ISO requirements and how the organization can adapt to meet them. Encourage them to ask for operator input on corrections. Their firsthand knowledge of day-to-day operations provides great insight on current processes.
Utilize team huddles or site wide meetings to spread awareness of the audit results and status of the implementation project. Be sure to allow time for questions and provide follow up as needed. With proper planning, leadership buy-in and consistent communication throughout the process, implementing an integrated management system can become a more manageable and positive process for the entire team.
The Acheson Group (TAG), a global food safety and public health consulting team led by David Acheson, MD, former FDA Associate Commissioner for Foods, has expanded its operations to India.
As part of the expansion, TAG brought on two new team members. Food Safety Specialist Koshal Ram has nearly three decades of experience working in low-acid agri-food manufacturing and has held technical and global leadership roles managing supply chain food safety and product quality with multiple companies. Ram has a diploma in Quality Assurance and ISO from the University of Chennai, India. He speaks four languages (English, Hindi, Tamil and Kannada) and is a Preventive Controls Qualified Individual (PCQI) and an FSVP Qualified Individual. He is trained in Food Safety and Standards Act 2006, ISO 2000 requirements, QAS validation and verification of HACCP Plans and QAS development and implementation of HACCP Plans, Acidified Food Manufacturing School (21CFR section 108.25(f) and 114.10) and FDA Acidified Foods.
Ranjeet Klair will work in conjunction with Ram at TAG India as Director of Food Safety. She brings more than two decades of industry experience working with Canadian, U.S. and global food retailers, production plants and certification bodies in food safety, quality assurance and regulatory compliance. Klair holds a Master of Science degree in Food Sciences, Master of Global Food Law (Jurisprudence) degree and a Bachelor of Applied Science and certification in International Food Laws and Regulations. Along with completing a certification program for International Food Laws and Regulations, she is a BRC, FSSC22000, HACCP, PCQI, FSVP trainer and BRC, SQF, FSSC, ISO 22000, Gluten-free, GMP and Canada GAP lead auditor.
As a key component of service to India, TAG will provide expertise and resources to assist exporters in food safety efforts and domestic and foreign standards and regulatory compliance.
“With TAG’s 10-year anniversary quickly approaching, we are excited to bring on valuable new TAG Team members who can help further expand our business to different areas of the world,” said Dr. Acheson, TAG CEO and President. “Ranjeet’s and Koshal’s expertise and ability to work onsite with clientele throughout India enables us to bring TAG support to India.”
The traditional process for ensuring food safety in storage and transportation focuses on maintaining temperatures that are safe for the types of food or beverage the organization sells. Doing this without data logging technology means that the organization needs to appoint an individual to check refrigeration temperatures on a regular cadence and record that data by hand in case of an audit by the FDA.
Unfortunately, this method lacks 24/7 accountability of temperatures and allows for human error/neglect. If a refrigeration unit goes down outside of the regularly scheduled temperature monitoring cadence, the product can quickly fall outside of the designated safe temperatures. If the food is outside of the safe temperature range for an extended period, that food must be disposed of and will cost the organization a tremendous amount of time and money.
This problem is equally apparent in transportation. Companies often utilize third-party transportation companies, which means they are relying on someone outside of the organization to responsibly manage and record temperatures and report back to the necessary parties. But the risk of human error and equipment failure can come into play. Temperature issues can even stem from drivers shutting off refrigeration while they sleep to save diesel fuel.
The most effective way to maintain quality control within storage and transport is by utilizing real-time data monitoring with a connected high-precision data logger. Multiple types of data loggers can be used to monitor temperatures in different scenarios. These includes traditional data loggers connected by Ethernet and wireless data loggers with Bluetooth or cellular connectivity. Each version has its role in food and beverage safety.
Connected vs. Manual Loggers
In fixed cold storage, such as within a restaurant or storage facility, an Ethernet or Wi-Fi-connected data logger is a great choice due to its affordability and reliability. For users who’d like to check temperatures on their mobile device while moving around the facility, a Bluetooth logger with mobile application support can be a strong option as well.
These loggers allow the user to get a 24/7 view of their refrigeration unit and correct issues before they lead to food disposal. For instance, if a food storage unit goes down over the weekend when no one is staffing the facility, or a restaurant is closed for a holiday, and temperatures within a refrigerator fall outside of the norm, these connected loggers will alert the user via email or text to correct the issue so they can save the product from spoiling.
One tip for using a connected logger is to set the alert feature to notify the user when temperatures reach the high and low end within the safe temperature spectrum for the food or beverage being stored. This provides an alert before the unit temperature falls outside the safe range, allowing the user to take corrective action before the product falls into unsafe temperatures.
In food and beverage delivery, transport companies are liable for temperature issues, especially if corrective action is not taken. This is where a cellular-connected data logger becomes critical. With a traditional data logger, there is no way for a consignor to know whether a temperature issue has occurred, unless it is checked manually by the driver. At that point, it may be too late to save the consignment. However, cellular-based technology allows consignors to do real-time monitoring without any interaction with the transport company.
Because many shipments are made using third-party transporters, cellular-based data loggers are becoming increasingly popular for maintaining trust between the transporter and all other segments of the supply chain. These wireless loggers also allow a trusted driver to monitor conditions while in route, allowing the driver to take corrective action before temperatures reach critical ranges.
Connected Data Loggers and FSMA
Transporters must also be fully aware of the Food Safety and Modernization Act (FSMA). These regulations make quality data loggers even more important as transporters may have to verify at any given moment that food was handled properly while in their possession. FSMA also emphasizes the importance of data logging technology. The act requires food handlers to develop a plan that meets the guidelines for Hazard Analysis and Critical Control Points (HACCP), which should involve an advanced data logger. Issues with data entry, misreading and misinformation are the responsibility of the transporter, and failure to comply with these guidelines can result in seizure, injunction and recalls, all of which can damage the reputation of the entire supply chain.
With all things considered, connected data loggers are extremely cost-effective technology options that can save thousands of dollars and hours of hassle. Because they can be monitored by multiple parties, the transporter or manager of a storage unit/restaurant can become aware of issues regarding temperature before the only safe course of action becomes product disposal.
Loggers help save money in the form of legal fees, compensation and premiums, while also drastically reducing the risks of consumer illness and public relations disasters. Some data logger companies also offer free cloud storage, allowing monitoring and analytics tracking in all locations, at any time of day.
With the high costs of noncompliance in the food industry, it is important for storage managers and transporters to understand that implementing high-precision, connected data monitoring tools can help put these issues to rest.
Over the last 20 years, I have helped thousands of companies prepare for food safety audits. You can only imagine the plethora of questions that my team and I are asked by the food companies as they build their food safety programs. Many revolve around the basics of building an initial food safety plan. Here are the top five food safety plan questions I am asked regularly that I will address within this article:
What are the foundations of a good food safety plan?
Who should be involved in the process of building the food safety plan?
Can I convert my HACCP Plan into a food safety plan?
Are there resources and tools available to help build my food safety plan?
Should I add food safety culture to my food safety plan?
What Are the Foundations of a Good Food Safety Plan?
FDA dictates that a food safety plan is a set of written documents that are based on food safety principles and incorporates:
Written procedures to be followed for:
Verification and validation
A food safety plan is developed for every individual facility based on the unique issues at each facility. For example, if a company has multiple processing plants processing the exact same product in multiple areas throughout the country, each facility will need their own unique plan. The reason for that is each facility may have different risks based on process flow layout, equipment used, suppliers and even employee and management cultures.
Each facility will have a separate HACCP plan detailing each chemical, biological and physical risk for the layout of the operation and equipment used. Recall plans will need to be created for each facility’s unique customers. Supplier monitoring will need to be developed for each facility’s unique suppliers.
Who Should be Involved in the Process of Building the Food Safety Plan?
Creating the team to build your food safety plan is one of the most important steps in the process and probably the most overlooked. Most teams I have seen include the QA and/or food safety person, the operations manager and the maintenance manager. This is too limited and often leads to risks being missed and processes that are either too simple or over complicated. A food safety team should have a member from each of the following departments:
Crew or shift lead
Executive management (preferably the CEO)
A line worker or two
Why the CEO, a shift supervisor and line worker(s)? The CEO creates the company culture and should be funneling information down from the top. If the CEO is part of the team, the whole organization will see the importance of the food safety plan.
Line workers and crew leads are on the floor working the processes day in and out. They will be key to implementation of the plan. As processes are created, the line workers and crew chiefs can provide amazing insight on the processes and reporting tools that will be most effective on the floor. Having this information before implementation will save hours of time and minimize the risk of having to alter processes that don’t work in reality.
Can I Convert my HACCP Plan into a Food Safety Plan?
Many companies have a basic HACCP plan for their facilities. Often the question is, “Isn’t my HACCP plan a food safety plan?” The answer is yes and no. Basically, you can have an HACCP plan and not have a food safety plan, but you cannot have a food safety plan without an HACCP plan.
A food safety plan is more encompassing than an HACCP Plan. Looking at your facility floor plan and analyzing chemical, biological and physical risks is a key part of a food safety plan. The food safety plan adds another layer of monitoring for all risks and provides added processes for preventative controls, recalls and supplier monitoring.
Also, companies that have only an HACCP plan often have not been keeping that plan up to date with an all encompassing team described above. Once the new, more robust teams are created and they start building the food safety plan, many find they need to significantly alter their HACCP plans.
Are There Resources and Tools Available To Help Build My Food Safety Plan?
Luckily, we live in a technical world full of inexpensive or free tools. There are many very smart people that have services available to assist in creating a food safety plan as well. Here is a list of some free and low cost solutions:
The FDA created a free solution, the “FDA Food Safety Plan Builder.” This solution walks you through the process of creating a food safety plan step-by-step.
If you need a food safety plan for a specific GFSI Standard, walking through the individual check lists provided by the standards you choose will lead you to the creation of a food safety plan, albeit a very robust one.
If you do not need full certification, building a food safety plan based on GFSI Global Markets is a great stepping stone and they have a free toolkit.
There are many software tools that you can purchase. The pricing and features will vary based on the company. Google “Food Safety Plan Software” and you will see the many options available.
Working with a consultant is a great option if you don’t have the time to learn the process of creating, building and implementing a food safety plan. There are many great and not so great consultants in the industry. If you decide to go this route make sure you interview at least three consultants and ask the following questions:
“Are you going to coach us on how to own and maintain our food safety program or do you do everything on your own?” Many consultants think they “own” the programs they develop, as if they are proprietary systems. Some will charge you year after year to use their program. Avoid these consultants.
“How long have you been consulting?”
“May I talk with a couple of your past clients?” If they are unwilling to provide testimonials that may be a red flag.
Should I Add Food Safety Culture to My Food Safety Plan?
Recently, I wrote an article for FoodSafetyTech.com titled “The Costs Of Food Safety: Correction vs. Prevention,” and the opening sentence is “Every company that grows, produces, packs, processes, distributes and serves food has a food safety culture. In the food industry, when looking at food safety culture there are essentially two groups: The correction and the prevention groups.”
By starting the process of creating a food safety plan, you are already crossing the chasm into the “prevention group.” Adding elements of food safety employee training, recognition and food safety behavior management into your food safety plan and implementing those elements will alter your organization in some of the most positive ways.
Every food company has a food safety culture, some are toxic and others are refreshingly positive. If you have read this article to the end I assume you either have a positive food safety culture or would like to create one. Incorporating key teams members in your planning and taking advantage of the resources available will place you on the path to developing an effective food safety plan and a company culture that embraces food safety.
The digital transformation of food safety management programs is a common topic of discussion today, across the full range of media including print, blogs, websites and conferences. It has also been generally acknowledged that the COVID-19 pandemic has significantly accelerated the adoption of various digital technologies. However, let’s be clear, COVID-19 may have accelerated the process, but the process was under way as the only way for food companies to efficiently cope with the increase of required compliance documentation for regulatory bodies, such as FDA, USDA, etc., non-regulatory organizations such as GFSI, and customer specific requirements. COVID-19 has added a sense of urgency, as the fragility of both domestic and international supply chains has been exposed with long-term sources of ingredients or equipment being cut off overnight. We must also overlay the need to manage food safety risk and food fraud vulnerability in real time (or even predict the future, which will be discussed further in a future article). The food industry has also had to adjust to dealing with many aspects of work and production without typical face-to-face interaction—a norm of operating within the environment of a global pandemic over the past two years.
What is not clear, however, is the meaning of “digital transformation” or the “digitization” of a food safety management program. What is not clear is what these terms mean to individual organizations. The frenzy of buzzwords, “urgent” presentations, blogs and webinars help to create an improved level of awareness but rarely result in concrete actions that lead to improved results. I admit to being guilty of this very hyperbole—in a previous article discussing “Chocolate and Big Data”, I said, “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.” Sounds great, but it presupposes a high level of awareness of those “digital tools”. What is not clear to many organizations is how to get started and how to create a road map that leads to improved results, more efficient operations and importantly, to ongoing improvement in the production of safe food.
Addressing a new concept can be intimidating and paralyzing. Think back to the beginning days of HACCP, then TACCP, then VACCP, and post FSMA, preventive controls! So, where do we start?
Nikos Manouselis, CEO of Agroknow, a food safety data and intelligence company with a cloud-based risk intelligence platform, Foodakai, believes the place to start is for food companies to perform an honest, self-assessment of their digital risk maturity. Think of it as a digital risk maturity gap analysis. While there are certainly different approaches to performing this self-assessment, Agroknow has developed a simple, straightforward series of questions that focus on three critical areas: Risk monitoring practices and tools; risk assessment practices and tools; and risk prevention practices and tools. The questions within each of these areas lead to a ranking of 1–5 with 1 being a low level of maturity and 5 being a high level of maturity. One of the goals of the self-assessment is to determine where your company stands, right now, compared to where you want to be or should be.
While this is not a complete nor exhaustive process, it helps to break the inertia that could be holding a company back from starting the process of digitizing their food protection and quality systems, which will allow them to take advantage of the benefits available from continuous monitoring of food safety risks and food fraud vulnerabilities, artificial intelligence and predictive analytics.
Packaging is an essential component of our modern, global food supply. While it helps us preserve and protect food and creates instant brand recognition for consumers, packaging also inserts an additional level of necessary risk mitigation into the manufacturing process. Liability stemming from packaging is a serious concern for food manufacturers of all sizes, with millions of dollars and brand-damaging lawsuits on the line. Processed foods need packaging to arrive in the hands of consumers, and processed foods are necessary to feed the world’s population. According to a survey conducted by the United States National Library of Medicine, “60% of calories consumed were from ultra-processed foods.”1 This shows the prevalence of processed foods and the significant impact packaging, a ubiquitous component of processed foods, plays in the food industry.1 However, if not handled properly, food packaging can be a significant liability.
Liability from packaging commonly presents in two ways: First, as foreign material contamination. Broken, damaged or defective packaging material can end up in food products, which increases the risk of a consumer attempting to consume contaminated goods. Second, packaging can be a hurdle to effective remediation of foreign material contamination, as goods can often not be efficiently or effectively inspected back through in-plant critical control points. The resulting disposal of product can contribute to food and environmental waste, as well as lost profits.
The harsh truth is that if manufacturers lack processes to identify, prevent or mitigate foreign material contamination when it occurs in packaged food, packaging can be a significant liability at every stage from the manufacturing facility to the store shelf. Following strict food safety plans can save countless hours, resources and dollars in the long run.2
Foreign Material Contamination: Where It Comes From
Foreign material contamination comes from multiple sources in the production cycle. It can come from raw materials, like animal bones ending up in boneless meat products. It can happen during the production process when a screw or seal detaches from a machine and gets mixed into a pie. It can be biological, like an insect ending up in a bag of chips. Or it can come from packaging: A shard of glass winding up in a jar of salsa or a plastic wrapper finding itself in a muffin. All of these foreign material contaminants are risks and dangers for which manufacturers can be held liable.
Packaging-related contamination is a high priority for manufacturers. Foreign material contamination due to packaging occurs when contaminants like metal, plastic, styrofoam and other objects end up where they do not belong, disrupting the integrity and quality of the product. Packaging materials can break down into tiny pieces that inline inspection machines may not be able to identify. Inline machines are calibrated for a certain size and certain types of foreign material contamination, which may not include packaging materials. Additionally, inline machines are often used at critical points during the manufacturing process but are not commonly used to inspect completed packaged products.
Break It Down: Liabilities Within Food Packaging
The party most affected by missed foreign material contamination is the consumer. Current consumer trends point to greater ingredient awareness, education and research into the companies from which consumers purchase products. The consumer mindset of environmentally friendly products and socially responsible purchases are impacting the food industry directly. Consumers seek transparency from brands about the products they’re ingesting. When a consumer discovers foreign material contamination inside a product, it creates frustration and eliminates trust. In addition to negatively impacted brand reputation, a foreign object from packaging can be incredibly costly. Recalls, especially those that require a local or national public warning, are detrimental to a brand’s reputation.3 Consumer trust in a brand is priceless and can take years to repair when broken.
In the age of social media, consumer reports of foreign material contamination can spread like wildfire across multiple platforms, reaching countless consumers across the world. One tweet about a contaminated product can go viral, costing corporations their reputations or worse–– lawsuits. An accidental miss somewhere along the production line can result in public outrage and cost the manufacturer millions of dollars in wasted product and crisis management. Suppose a consumer accidentally consumes a foreign contaminant from product packaging which results in injury. In that case, the manufacturer could be held liable for the medical bills and even long-term care if the injury is debilitating. These court cases can be highly costly monetarily and in terms of public perception.
In addition to legal liability from consumers, the loss of product for foreign material contamination is typically very costly when labor, storage, time, materials and lost revenue are taken into account. A producer who makes the moral and ethical decision to dispose of product that may be contaminated loses money doing so. They also risk harming their reputation with consumers by contributing to the problem of food waste.
In the 21st century, shoppers are increasingly looking “beyond the label,” and are concerned with the impact their purchase behaviors have on the environment.4 Consumers in younger demographics are significantly more likely to have a purchase decision influenced by a company’s impact on and concern for the environment. Packaging is a major concern for food manufacturers as they seek to lessen their environmental impact to meet market demands. This impacts foreign material contamination in two important ways. First, as packaging materials move towards the use of biodegradable materials, the capability of technology to detect the difference between packaging and food material must increase. Second, environmentally-friendly packaging is still relatively new compared to traditional materials, and the risks of foreign material contamination associated with these materials are still relatively unknown.
Manufacturers are in a difficult position when dealing with the liabilities stemming from packaging as a foreign material contaminant. Compounding this issue is the role packaging plays in preventing manufacturers from using in-house processes or inline equipment to inspect product back through Critical Control Points. Inline mechanisms for identifying foreign material contamination are not designed to inspect completed, packaged product. If producers dispose of and rework product, they risk harm to sustainability-focused brands, production quotas and bottom lines. If they attempt to identify the contamination themselves, they lose valuable production time and potentially lose perishable product to spoilage. With nearly every solution, another liability arises.
Packaging Contaminants: Prevention, Response and Liability
The FDA-required Hazard Analysis and Critical Control Points (HACCP) plan has seven principles to ensure manufacturers meet food safety goals from production to consumption. Physical, chemical and visual tests are involved to ensure foreign contaminants do not exist in products produced in the manufacturing facilities.5 The more detailed processes are in place, the more protected companies are from recalls and reducing the chance of a lawsuit where the manufacturer is liable. Implementing different programs and processes to prevent and diminish food waste ultimately positively impacts the manufacturer’s bottom line. The Business Case conducted a study called “Reducing Food Loss, and Waste” that found “99% of companies earned a positive investment when they implemented programs to reduce food waste”.6
Many companies engage third-party food inspection partners as an extra measure to ensure that their product is free from foreign material contamination. By electing to utilize third-party inspection services, manufacturers hit a trifecta: They can typically salvage the majority of on-hold product, reduce food waste, and with the right partner, get the data they need to have traceability of foreign material contamination issues at their plant.
Manufacturers should pursue third-party inspection partners that meet a high standard of excellence. The best third-party inspection partners use cutting-edge technology to inspect products in higher detail than inline machines. Their machines should be capable of identifying foreign material contaminants of all types and have a high capacity to turn around large volumes of product efficiently. Their machines should be capable of overcoming the obstacle of packaging as an impediment to inspection using machines with a larger aperture than typical inline tools. Lastly, third-party inspection adds significant value if it has the ability to find and retrieve foreign material contamination so manufacturers can effectively use the resulting data to identify and remediate problems within the plant. An inspection service that does not meet these criteria is not an inspection service, but merely a method for outsourcing the same practices that a manufacturer would conduct in-house.
Liability Questions Answered
So, when are companies liable for packaging issues? Unfortunately, the answer isn’t always black and white. FSMA is in place to help prevent foodborne illness, requiring Food Safety Plans. In addition, the FDA recognizes “that ensuring the safety of the food supply is a shared responsibility among many different points in the global supply chain for both human and animal food,” so manufacturers may not be the only ones liable in many cases.7 The problem arises when manufacturers miss foreign contaminants or if foreign biological contaminants affect the integrity of the packaging.
Even if companies take the necessary steps, incorporate a HACCP plan and are vigilant, contamination can, unfortunately, happen at any time to any manufacturer. Using a third-party partner as an outside resource for foreign material inspection is important. Choosing a third-party partner with the experience, certifications, technology, processes and reputation to protect your brand is critical. Manufacturers can validate their internal processes and data using reports from their third-party inspection partner more quickly than they could internally.
Food packaging and the potential liability involved can be daunting. Still, with proper processes and procedures in place, manufacturers can have confidence that their products are hitting the shelves with a low probability of recall or lawsuit due to a packaging issue. While there is always a chance of foreign material contamination, quality packaging materials, quality assurance processes and quality third-party inspection partners can significantly reduce a company’s potential liability.
“Food safety plan” is a term often used in the food industry to define an operation’s plan to prevent or reduce potential food safety issues that can lead to a serious adverse health consequence or death to humans and animals to an acceptable level. However, depending on the facility, their customers, and or regulatory requirements, the definition and specific requirements for food safety plans can be very different. To ensure food safety, it’s important that the industry finds consensus in a plan that is vetted and has worked for decades.
One of the first true food safety plans was HACCP. Developed in 1959 for NASA with the assistance of the food industry, its goal was to ensure food produced for astronauts was safe and would not create illness or injury while they were in space. This type of food safety plan requires twelve steps, the first five of which are considered the preliminary tasks.
Assemble a HACCP team
Describe the finished product
Define intended use and consumer
Create process and flow diagram
Verify process and flow diagrams
This is followed by the seven principles of HACCP.
Conduct the hazard analysis
Identify critical control points
Establish critical limits
Establish monitoring requirements
Establish corrective actions for deviations
Procedures for verification of the HACCP plan
Record keeping documenting the HACCP system
HACCP is accompanied by several prerequisites that support the food safety plan, which can include a chemical control program, glass and brittle plastics program, Good Manufacturing Practices (GMPs), allergen control program, and many others. With these requirements and support, HACCP is the most utilized form of a food safety plan in the world.
When conducting the hazard analysis (the first principle of HACCP), facilities are required to assess all products and processing steps to identify known or potential biological, chemical and physical hazards. Once identified, if it is determined that the hazard has a likelihood of occurring and the severity of the hazard would be great, then facilities are required to implement Critical Control Points (CCP) to eliminate or significantly reduce that identified hazard. Once a CCP is implemented, it must be monitored, corrective actions developed if a deviation in the CCP is identified and each of these are required to be verified. Records then also need to be maintained to demonstrate the plan is being followed and that food safety issues are minimized and controlled.
HACCP is, for the most part, the standard food safety plan used to meet the Global Food Safety Initiative (GFSI) standards. This is utilized in various third-party audit and customer requirements such as FSSC 22000, SQF, BRC, IFS and others. These audit standards that many facilities use and comply with also require the development of a food safety management system, which includes a food safety plan.
Further, HACCP is often used to demonstrate that potential food safety issues are identified and addressed. FDA has adopted and requires a regulated HACCP plan for both 100% juice and seafood processing facilities. USDA also requires the regulated development of HACCP for meat processing and other types of facilities to minimize potential food safety issues.
For facilities required to register with the FDA—unless that facility is exempt or required to comply with regulated HACCP—there is a new type of food safety plan that is required. This type of plan builds upon HACCP principles and its steps but goes beyond what HACCP requires. Under 21 CFR 117, specific additions assist in identifying and controlling additional food safety hazards that are on the rise. This includes undeclared allergen recalls, which constituted 47% of recalls in the last reportable food registry report published by FDA.
Prior to developing this plan, FDA provided recommendations for preliminary steps that can be completed and are essential in development of a robust food safety plan but are not a regulatory requirement. The steps are very similar to the preliminary tasks required by HACCP, including the following:
Assemble a food safety team
Describe the product and its distribution
Describe the intended use and consumers of the food
Develop a flow diagram and describe the process
Verify the flow diagram on-site
Their recommended plan also requires a number of additional steps, including:
A written hazard analysis. Conducted by or overseen by a Preventive Controls Qualified Individual (PCQI). However, this hazard analysis requires assessing for any known or reasonably foreseeable biological, chemical, physical, radiological, or economically motivated adulteration (food fraud that historically leads to a food safety issue only). You may note that two additional hazards—radiological and EMA—have been added to what HACCP calls for in the assessment.
Written preventive controls if significant hazards are identified. However, similar preventive controls are different than a CCP. There are potentially four types of preventive controls that may be utilized for potential hazards, including Process Preventive Controls (the same as CCP), Allergen Preventive Controls, Sanitation Preventive Controls, Supply Chain Preventive Controls and Others if identified.
A written supply chain program if a Supply Chain Preventive Control is identified. This includes having an approved supplier program and verification process for that program.
A written recall plan if a facility identified a Preventive Control.
Written monitoring procedures for any identified Preventive Control that includes the frequency of the monitoring what is required to do and documenting that monitoring event.
Written corrective actions for identified Preventive Controls in case of deviations during monitoring. Corrective actions must be documented if they occur.
Written verification procedures as required. This could include how monitoring and corrective actions are verified, procedures themselves are verified, and calibration of equipment as required. Also required is training, including a Preventive Control Qualified Individual. Additional training is required for those individuals responsible for performing monitoring, implementing corrective actions, and verification of Preventive Controls. Further, all personnel need to have basic food safety training and all training needs to be documented.
While the term “food safety plan” is used widely, it’s important that operations don’t just use the term, but enact a plan that is vetted, proven to work, and encompasses the principles of HACCP. Doing so will help ensure that their facility is producing foods that customers and consumers will know is safe.
During the production process, physical hazards can contaminate food products, making them unfit for human consumption. According to the USDA’s Food Safety and Inspection Service (FSIS), the leading cause of food recalls is foreign material contamination. This includes 20 of the top 50, and three of the top five, largest food recalls issued in 2019.
As methods for detecting foreign materials in food have improved over time, you might think that associated recalls should be declining. To the contrary, USDA FSIS and FDA recalls due to foreign material seem to be increasing. During the entire calendar year of 2018, 28 of the 382 food recalls (7.3%) in the USDA’s recall case archive were for foreign material contamination. Through 2019, this figure increased to approximately 50 of the 337 food recalls (14.8%). Each of these recalls may have had a significant negative impact on those brands and their customers, which makes foreign material detection a crucial component of any food safety system.
The FDA notes, “hard or sharp foreign materials found in food may cause traumatic injury, including laceration and perforation of tissues of the mouth, tongue, throat, stomach and intestine, as well as damage to the teeth and gums”. Metal, plastic and glass are by far the most common types of foreign materials. There are many ways foreign materials can be introduced into a product, including raw materials, employee error, maintenance and cleaning procedures, and equipment malfunction or breakage during the manufacturing and packaging processes.
The increasing use of automation and machinery to perform tasks that were once done by hand are likely driving increases in foreign matter contamination. In addition, improved manufacturer capabilities to detect particles in food could be triggering these recalls, as most of the recalls have been voluntary by the manufacturer.
To prevent foreign material recalls, it is key to first prevent foreign materials in food production facilities. A proper food safety/ HACCP plan should be introduced to prevent these contaminants from ending up in the finished food product through prevention, detection and investigation.
Food manufacturers also have a variety of options when it comes to the detection of foreign objects from entering food on production lines. In addition to metal detectors, x-ray systems, optical sorting and camera-based systems, novel methods such as infrared multi-wavelength imaging and nuclear magnetic resonance are in development to resolve the problem of detection of similar foreign materials in a complex background. Such systems are commonly identified as CCPs (Critical Control Points)/preventive controls within our food safety plans.
But what factors should you focus on when deciding between different inspection systems? Product type, flow characteristics, particle size, density and blended components are important factors in foreign material detection. Typically, food manufacturers use metal and/or x-ray inspection for foreign material detection in food production as their CCP/preventive control. While both technologies are commonly used, there are reasons why x-ray inspection is becoming more popular. Foreign objects can vary in size and material, so a detection method like an x-ray that is based on density often provides the best performance.
Regardless of which detection system you choose, keep in mind that FSMA gives FDA the power to scientifically evaluate food safety programs and preventive controls implemented in a food production facility, so validation and verification are crucial elements of any detection system.
It is also important to remember that a key element of any validation system is the equipment validation process. This process ensures that your equipment operates properly and is appropriate for its intended use. This process consists of three steps: Installation qualification, operational qualification and performance qualification.
Installation qualification is the first step of the equipment validation process, designed to ensure that the instrument is properly installed, in a suitable environment free from interference. This process takes into consideration the necessary electrical requirements such as voltage and frequency ratings, as well as other factors related with the environment, such as temperature and humidity. These requirements are generally established by the manufacturer and can be found within the installation manual.
The second step is operational qualification. This ensures that the equipment will operate according to its technical specification. In order to achieve this, the general functions of the equipment must be tested within the specified range limits. Therefore, this step focuses on the overall functionality of the instrument.
The third and last step is the performance qualification, which is focused on providing documented evidence through specific tests that the instrument will performs according to the routine specifications. These requirements could be established by internal and industry standards.
Following these three steps will allow you to provide documented evidence that the equipment will perform adequately within the work environment and for the intended process. After completion of the equipment validation process, monitoring and verification procedures must be established to guarantee the correct operation of the instrument, as well procedures to address deviations and recordkeeping. This will help you effectively control the hazards identified within our operation.
There can be massive consequences if products contaminated with foreign material are purchased and consumed by the public. That’s why the development and implementation of a strong food safety/ HACCP plan, coupled with the selection and validation of your detection equipment, are so important. These steps are each key elements in protecting your customers and your brand.
Recent food scandals around the world have generated strong public concerns about the safety of the foods being consumed. Severe threats to food safety exist at all stages of the supply chain in the form of physical, chemical and biological contaminants. The current pandemic has escalated the public’s concern about cross contamination between people and food products and packaging. To eliminate food risks, manufacturers need robust technologies that allow for reliable monitoring of key contaminants, while also facilitating compliance with the ISO 17025 standard to prove the technical competence of food testing laboratories.
Without effective data and process management, manufacturers risk erroneous information, compromised product quality and regulatory noncompliance. In this article, we discuss how implementing a LIMS platform enables food manufacturers to meet regulatory requirements and ensure consumer confidence in their products.
Safeguarding Food Quality to Meet Industry Standards
Food testing laboratories are continually updated about foodborne illnesses making headlines. In addition to bacterial contamination in perishable foods and ingredient adulteration for economic gains, chemical contamination is also on the rise due to increased pesticide use. Whether it is Salmonella-contaminated peanut butter or undeclared horsemeat inside beef, each food-related scandal is a strong reminder of the importance of safeguarding food quality.
Food safety requires both preventive activities as well as food quality testing against set quality standards. Establishing standardized systems that address both food safety and quality makes it easier for manufacturers to comply with regulatory requirements, ultimately ensuring the food is safe for public consumption.
In response to food safety concerns, governing bodies have strengthened regulations. Food manufacturers are now required to ensure bacteria, drug residues and contaminant levels fall within published acceptable limits. In 2017, the ISO 17025 standard was updated to provide a risk-based approach, with an increased focus on information technology, such as the use of software systems and maintaining electronic records.
The FDA issued a notice that by February 2022, food testing, in certain circumstances, must be conducted in compliance with the ISO 17025 standard. This means that laboratories performing food safety testing will need to implement processes and systems to achieve and maintain compliance with the standard, confirming the competence, impartiality and consistent operation of the laboratory.
To meet the ISO 17025 standard, food testing laboratories will need a powerful LIMS platform that integrates into existing workflows and is built to drive and demonstrate compliance.
From Hazard Analysis to Record-Keeping: A Data-Led Approach
Incorporating LIMS into the entire workflow at a food manufacturing facility enables the standardization of processes across its laboratories. Laboratories can seamlessly integrate analytical and quality control workflows. Modern LIMS platforms provide out-of-the-box compliance options to set up food safety and quality control requirements as a preconfigured workflow.
The requirements set by the ISO 17025 standard build upon the critical points for food safety outlined in the Hazard Analysis and Critical Control Points (HACCP) methodology. HACCP, a risk-based safety management procedure, requires food manufacturers to identify, evaluate and address all risks associated with food safety.
The systematic HACCP approach involves seven core principles to control food safety hazards. Each of the following seven principles can be directly addressed using LIMS:
Principle 1. Conduct a hazard analysis: Using current and previous data, food safety risks are thoroughly assessed.
Principle 2. Determine the critical control points (CCPs): Each CCP can be entered into LIMS with contamination grades assigned.
Principle 3. Establish critical limits: Based on each CCP specification, analytical critical limits can be set in LIMS.
Principle 4. Establish monitoring procedures: By defining sampling schedules in LIMS and setting other parameters, such as frequency and data visualization, procedures can be closely monitored.
Principle 5. Establish corrective actions: LIMS identifies and reports incidents to drive corrective action. It also enables traceability of contamination and maintains audit trails to review the process.
Principle 6. Establish verification procedures: LIMS verifies procedures and preventive measures at the defined CCPs.
Principle 7. Establish record-keeping and documentation procedures: All data, processes, instrument reports and user details remain secured in LIMS. This information can never be lost or misplaced.
As food manufacturers enforce the safety standards set by HACCP, the process can generate thousands of data points per day. The collected data is only as useful as the system that manages it. Having LIMS manage the laboratory data automates the flow of quality data and simplifies product release.
How LIMS Enable Clear Compliance and Optimal Control
Modern LIMS platforms are built to comply with ISO 17025. Preconfigured processes include instrument and equipment calibration and maintenance management, traceability, record-keeping, validation and reporting, and enable laboratories to achieve compliance, standardize workflows and streamline data management.
The workflow-based functionality in LIMS allows researchers to map laboratory processes, automate decisions and actions based on set criteria, and reduce user intervention. LIMS validate protocols and maintain traceable data records with a clear audit history to remain compliant. Data workflows in LIMS preserve data integrity and provide records, according to the ALCOA+ principles. This framework ensures the data is Attributable, Legible, Contemporaneous, Original and Accurate (ALCOA) as well as complete, consistent and enduring. While the FDA created ALCOA+ for pharmaceutical drug manufacturers, these same principles can be applied to food manufacturers.
Environmental monitoring and quality control (QC) samples can be managed using LIMS and associated with the final product. To plan environmental monitoring, CCPs can be set up in the LIMS for specific locations, such as plants, rooms and laboratories, and the related samples can then be added to the test schedule. Each sample entering the LIMS is associated with the CCP test limits defined in the specification.
Near real-time data visualization and reporting tools can simplify hazard analysis. Managers can display information in different formats to monitor critical points in a process, flag unexpected or out-of-trend numbers, and immediately take corrective action to mitigate the error, meeting the requirements of Principles 4 and 5 of HACCP. LIMS dashboards can be optimized by product and facility to provide visibility into the complete process.
Rules that control sampling procedures are preconfigured in the LIMS along with specific testing rules based on the supplier. If a process is trending out of control, the system will notify laboratory personnel before the product fails specification. If required, incidents can be raised in the LIMS software to track the investigation of the issue while key performance indicators are used to track the overall laboratory performance.
Tasks that were once performed manually, such as maintaining staff training records or equipment calibration schedules, can now be managed directly in LIMS. Using LIMS, analysts can manage instrument maintenance down to its individual component parts. System alerts also ensure timely recalibration and regular servicing to maintain compliance without system downtime or unplanned interruptions. The system can prevent users from executing tests without the proper training records or if the instrument is due for calibration or maintenance work. Operators can approve and sign documents electronically, maintaining a permanent record, according to Principle 7 of HACCP.
LIMS allow seamless collaboration between teams spread across different locations. For instance, users from any facility or even internationally can securely use system dashboards and generate reports. When final testing is complete, Certificates of Analysis (CoAs) can be autogenerated with final results and showing that the product met specifications. All activities in the system are tracked and stored in the audit trail.
With features designed to address the HACCP principles and meet the ISO 17025 compliance requirements, modern LIMS enable manufacturers to optimize workflows and maintain traceability from individual batches of raw materials all the way through to the finished product.
To maintain the highest food quality and safeguard consumer health, laboratories need reliable data management systems. By complying with the ISO 17025 standard before the upcoming mandate by the FDA, food testing laboratories can ensure data integrity and effective process management. LIMS platforms provide laboratories with integrated workflows, automated procedures and electronic record-keeping, making the whole process more efficient and productive.
With even the slightest oversight, food manufacturers not only risk product recalls and lost revenue, but also losing the consumers’ trust. By upholding data integrity, LIMS play an important role in ensuring food safety and quality.
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