Having a strong prerequisite program is a key part of maintaining compliance with FSMA and food safety management systems standards. In a recent discussion with Food Safety Tech, Debby Newslow, president of DL Newslow & Associates gave a preview of some of the expertise that she will be sharing during her session at next week’s Food Safety Consortium, “Food Safety/HACCP Prerequisite Programs” (session takes place Thursday, November 19).
Food Safety Tech: What are some of the challenges that companies face in establishing prerequisite programs for HACCP?
Debby Newslow: Understanding the significance of the prerequisite program—a lot of times, employees are [going through the motions] of things like wearing hairnets or not wearing jewelry—but [they need to] understand why it’s important. There’s a weakness in the education of employees. We need to redefine the word “training”, because training should mean education, too and understanding the importance of it. Companies take it for granted—they have defined procedures that they may or may not follow. And the other challenge is commitment and an understanding from management as to why it’s important.
On Wednesday, November 18, Debby Newslow will participate in the Ask the Experts session, “Food Safety Training Challenges”. LEARN MOREFST: What are best practices that companies can implement in this area?
Newslow: They need a program established, along with commitment to and support from a food safety team that has a responsibility to the team to evaluate the effectiveness. They also need support from top management. Every group and department needs to understand their requirements and why they’re important. They need to have the tools and the knowledge to understand what’s needed. Through the food safety team or internal audit team they can have the independence to monitor and look at its effectiveness. A lot of companies hold strong that the auditors need to find everything that’s wrong, and that’s an old school way of thinking.
Educate everyone and encourage them to take ownership for compliance, and use the internal programs and teams to evaluate the effectiveness.
On Thursday, November 19, Debby Newslow will present, Food Safety Management Systems—Understanding the Three Legged Stool” LEARN MOREFST: What do you hope attendees gain from your session on food safety & HACCP PRPs at the Food Safety Consortium?
Newslow: My session is going to be focused on prerequisite programs and how they fit with FSMA and the preventive controls (they really go side-by-side)
I want folks not to be so nervous about FSMA. If they have a strong program now for food safety and HACCP, and have the prerequisite programs identified and managed, they’ll be 95% there for FSMA [compliance]. Companies really need to focus on their internal programs and have a food safety program that is compliant with FSMA, and expand and confirm the effectiveness of these internal programs. Take pest control, for example. Some companies will hire the outside company and will monitor and know the effectiveness on a regular basis. Other companies will hire an outside firm and let them do whatever they want, and not have a clue what’s going on. Then there are smaller companies that have someone come in, spray, and send them a bill, and they won’t even know what the [outside] company is using as an insecticide. So you have different levels, and that’s why we have to understand each program and what is required for effectiveness and compliance.
The role of the prerequisite program and preventive controls is that if you look at recalls in today’s world, 90% of recalls are caused from ineffective or nonexistent prerequisite programs [Newslow estimate]. Very seldom do we see a recall because a CCP fails. We get so hung up on other things and forget why do we take off our jewelry, for example. The odds of something going wrong are thin but when you look at it from the big picture, it can happen and it does happen. I’ll have some significant recent examples in my session.
SafetyChain Software recently announced the successful wrap-up of its online series, “FSQA Enabling Technologies – the Food Safety & Quality Assurance Game Changer.” Kicked off in January of 2015 and ending this past October, the series attracted more than 2,000 participants.
Known for offering a wide variety of complimentary online FSQA thought leadership events to the food industry – including its FSMA Fridays and GFSI in the Age of FSMA series – SafetyChain introduced the Enabling Technologies series to begin an important dialogue on the role of emerging technologies in managing key challenges faced by today’s food and beverage companies.
The complimentary series, which featured Leadership Forums, Tech Talks and eBriefs – many featuring recognized industry thought leaders as well as SafetyChain experts – is now available on-demand.
Series topics included:
Leveraging Technology for Best-in-Class Food Safety & Quality Operations
Tackling FSMA Compliance
Understanding and Managing Cost of Quality
Unleashing the Power of the Cloud on Food Safety & Quality
Conquering HACCP, HARPC and Food Safety Program Management
Tackling Food Safety Audits
The Critical Role of Technology on Today’s Food Safety and Quality Operations
FSQA on the Go – the Power of Food Safety & Quality Automation Mobile Applications
Dr. David Acheson, president of The Acheson Group and former Chief Medical Officer for USDA and Associate Commissioner for Foods at FDA – who kicked off the series with a leadership forum on Food Safety Risk Management and Supply Chain Controls, which also featured Nancy Wilson, Director of Quality Assurance, Risk and Safety for Wawa – commented, “With today’s global, complex food supply chain – and increasing regulatory requirements such as FDA’s FSMA – it is becoming increasingly difficult to manage risk while meeting operational KPIs using manual FSQA management systems.” Acheson continued, “There’s an important role for enabling technologies to increase operational efficiencies while sending safer food into commerce, and this was an important series to bring the food safety community into the discussion.”
Added Jill Bender, Vice President of Marketing Communications for SafetyChain, “SafetyChain is a recognized leader in offering online forums that provide insights, and facilitate discussions, on how the industry addresses challenges in sending safe, quality food into commerce – with more than 20,000 registrants for our events. Deploying enabling automation technologies has become a vital strategy for improving FSQA, creating ROI and protecting brand from risk – and we wanted to promote meaningful dialogue on the impact of technology on key food safety and quality issues. We’re delighted that more than 2,000 safety, quality and operations professionals joined the conversation.”
Accreditation, certification, certificates…the structure that supports the third-party audit system can be very confusing! Further, an audit company offers a menu of audits: An audit to their own private standard, audits to several GFSI benchmarked schemes, and perhaps in the future, an “FDA accredited” audit. How do you know which one you need? How do you know which best prepares you for FSMA?
Jennifer McEntire spoke during the session, “Staying Ahead of New USDA and FDA Mandates for Controlling Pathogens in Food Processing” at the Food Safety Consortium conference. LEARN MOREUntil the compliance dates for the Preventive Controls rules pass, food manufacturers really only need to be compliant with good manufacturing practices (GMPs), from a regulatory standpoint. There are some specific audits that evaluate adherence to GMPs, but many companies wanted to take their food safety programs to the next level by demonstrating that they were implementing effective food safety management systems. Certification to a GFSI-benchmarked audit scheme (BRC, SQF, FSSC22000, IFS, etc.) was a primary means to show a commitment to food safety and the demonstration of exemplary programs. With the finalization of the Preventive Controls Rules, FDA is catching up. So how do the FDA requirements compare with the main elements of the GFSI Guidance Document?
Let’s evaluate the extent to which the scope of GFSI aligns with FSMA. In September, the Preventive Controls for Human Food rule was finalized, and the areas addressed within that rule constitute the bulk (although not all) of the topics covered by GFSI (GFSI covers additional areas for which FDA has not yet finalized rules, such as food defense and traceability). The question on everyone’s mind is, “If I’m certified to a GFSI-benchmarked audit scheme, am I compliant with the rule?” The answer is, “You’re probably in way better shape than someone who is not certified.” The reason is, regardless of which GFSI benchmarked audit scheme you choose, your facility will need to demonstrate, through fairly exhaustive documentation, the nature and validity of the programs that are in place, and the proof that those programs are followed day in and day out. FDA is looking for the same thing.
The Preventive Controls rules go beyond strict HACCP in that they require facilities to consider what has historically been termed the HACCP system. This includes programs that may not be critical control points (CCP) per se, but are critical to the safety of the food product. FDA identifies elements of sanitation and allergen control, as well as a supplier program, in this category. If you’re familiar with FSSC 22000, you might call these “operational prerequisite programs”. FDA will want to see how each and every hazard is evaluated to determine if it needs a preventive control, whether that is a traditional CCP or another control. For the most part, this is aligned with the GFSI benchmarked schemes, although some of the language may differ.
When it comes to the implementation of a supplier program, facilities should be aware that FDA’s requirements of such a program are much more explicit than most of the GFSI-benchmarked schemes. Even if the result is the same at the end of the day, FDA inspectors may be looking for companies to follow a fairly structured approach compared to a GFSI auditor.
To further complicate matters, FDA will be finalizing a program for the accreditation of third-party auditors. If an effective private third-party audit system exists, why is FDA adding another layer with its own form of audits (separate from inspections)? The answer lies with Congress, not FDA, as it identified two specific circumstances in which a special regulatory audit would be necessary. One situation is when a facility (or their customer) wishes to participate in the forthcoming Voluntary Qualified Importer Program. The second is if FDA has determined that the food poses food safety risks such that a facility wishing to export that food needs a certification issued by an auditor under this program. In neither case will domestic facilities be audited under this program; this program only applies to foreign facilities and only in very limited instances.
Since the rule and accompanying guidance documents related to accreditation of third-party auditors hasn’t been issued by FDA, it is premature to comment on how these audits will compare to those in use by private industry today.
So with the implementation of new rules from FDA, is there still a market for audits? Absolutely. From a very practical standpoint, FDA won’t be inspecting most facilities on an annual basis, and many private audits are conducted on an annual schedule. Plus, industry typically pushes itself further than regulations, which lag behind. Regulations can be viewed as the floor for expectations, but not the ceiling. Moving forward, we expect audit standards and private audits to become even more stringent and aggressive in terms of promoting the very best food safety practices. But beware, as history has shown us, a certificate is not a guarantee or indication of the ongoing quality of a plant’s food safety system. This is why FDA will not blindly accept that a facility has a favorable audit; regardless of the audit certifications you hold, FDA will still inspect you. That said, depending on the audit, it can serve as a credible certification of a food safety system in a plant and demonstrate to your customers your level of food safety commitment. And poor performance during an audit can find its way to FDA too, since in some instances the agency will have access to the conclusions of the audit and corrective actions taken in response to significant deficiencies identified during the audit. FDA initially proposed that serious issues uncovered during consultative audits conducted as part of the third-party accreditation of auditor program would be shared with FDA, and when audits are used as part of supplier programs, FDA will see how serious deficiencies in audits have been addressed. Be clear on why you are pursuing a particular audit, and take the program seriously. Audits should reflect your food safety culture, not serve as your motivation.
If you watch the evening news or read the local newspaper, the chances are pretty good that you will read or see something about a food safety concern or incident.
An estimated 1 in 6 Americans fall victim to a foodborne illness annually.
While the American food supply is among the safest in the world, the Federal government estimates that there are about 48 million cases of foodborne illness annually—the equivalent of sickening 1 in 6 Americans each year, according to Foodsafety.gov. And each year these illnesses result in an estimated 128,000 hospitalizations and 3,000 deaths. Five types of organisms—Salmonella, Toxoplasma, Listeria, norovirus, and Campylobacter—account for 88% of the deaths for which the cause is known.
We watched from the sidelines when major retailers faced public scrutiny over their practices on safeguarding consumer credit card information when their websites were hacked. Today, consumer and regulatory interest in food safety are the new focus areas for the news media, especially in light of the Blue Bell Creameries Listeria and the Peanut Corporation of America (PCA) Salmonella outbreaks. Unlike consumer credit information, serious missteps in our industry can kill people, and in the case of PCA, can put you permanently out of business.
In 2008, peanut butter paste manufactured by PCA killed nine people and sickened 714 others, some critically, across 46 states and was one of the largest food recalls in American history, according to the CDC. Although still under appeal, PCA CEO Stewart Parnell was convicted and sentenced to a 28-year prison term for his role in knowingly shipping out salmonella-contaminated peanut butter. Parnell received one of the toughest punishments in U.S. history in a foodborne illness case.
In the Blue Bell case, a total of 10 people with Listeriosis related to this outbreak were reported from four states, with three deaths reported from Kansas, according to the CDC. Blue Bell pulled their products from store shelves on April 20, 2015. On May 7, the FDA released findings from inspections at the Blue Bell production facilities in Brenham, Texas, Broken Arrow, Oklahoma and Sylacauga, Alabama. The FDA reports highlighted serious problems across multiple sites.
Both cases shine a spotlight on what can happen if you don’t have an effective food safety management system (FSMS). So what makes up a good FSMS, and is it enough to keep you out of trouble? An effective FSMS is built on three elements: Good Manufacturing Practices (GMPs), Hazard Analysis Critical Control Points (HACCP) and a management system. Food safety issues are avoidable, and good processes and a strong culture within an organization make them more unlikely to occur.
Does your leadership recognize the importance of your FSMS? An effective FSMS should be established before a product incident or recall occurs.
Implementing a FSMS does not happen in a few months; it may take up to two years to establish one. No doubt, foundational activities need to be in place for factory operations. In addition to focusing on foundational elements such as making sure equipment is cleaned properly and procedures for allergens are implemented, the leadership team needs to make it clear that it is never acceptable under any circumstances to take shortcuts that could jeopardize food safety. This policy needs to be indoctrinated throughout the organization and thus does not happen overnight.
Underlying an effective FSMS are strong HACCP and GMPs, but food safety should always be the top priority for management and its employees, not share price, earnings or profit margin. Although financial performance is important, food safety must take precedence in the organization, and leadership at all levels needs to send that message loud and clear to all employees. In today’s environment, HACCP is pretty much mandatory from a regulatory standpoint and is an essential part of a FSMS. But the missing piece in many organizations is the support from the top—this is where culture becomes embedded in the organization.
The FSMS culture is the collective behavior from the organization around shared values and beliefs. The organization will follow the actions of leaders, not necessarily what they say—we all know actions speak louder than words. A good food safety culture is one where best practices are openly discussed, defined and rewarded. Food safety culture has become a buzz word and there needs to be a focus on making it come to life through a structured FSMS.
At this year’s Food Safety Consortium conference, Tim Ahn will discuss advancing food safety training and harmonization (November 19). LEARN MOREFood safety training is important not only for first line supervisors and operators, but also for senior managers and leadership, because they define the objectives and policies of the FSMS. What does it mean to conduct an effective management review? What does it mean to do an internal audit? What’s a good corrective action process? Training often misses the mark, because organizations fail to embed it correctly.
For FSMS to thrive, management must commit to the FSMS being a required way of doing things throughout the entire organization. A FSMS is most effective when it benchmarked against a proven standard and verified by an independent third party. Certification against a proven standard will reduce risk within your business.
Select your independent third-party verifier carefully. Do they have the resources and time, and do they know what they are doing? Do they add value to your organization? This is important since once you get certified, your journey starts and it doesn’t end. The value comes in two areas: Identifying risks and developing the appropriate control measures, and ensuring that the process drive continuous improvement in your organization. FSMS is focused on how continuous improvement applies to the management of risk and business operations.
The most effective way to establish an FSMS is to have leadership that recognizes its importance. The worst way is to have a recall or an incident, which draws attention to the fact that there is a problem and something needs to happen. In the case of Blue Bell, they probably understood the importance of food safety and thought they were taking the right actions. However, their management system led them to problems. FSMS must be independently verified against world-class standards to ensure effective performance.
A thorough auditor won’t look the other way and will find the problems. Call it as you see it–don’t be too soft when getting an assessment.
Companies can develop blind spots where they cannot see their own bad practices, and they become institutionalized over time. Fortunately, experienced independent third-party assessors can shine a spotlight on those bad practices. That is the true value in bringing in outsiders to look at your operations and culture to uncover those blind spots.
At PCA, their poor culture and actions to the problem sealed their fate. In some ways, this criminal case presented a wake-up call to boardrooms across America and highlights how badly leadership mismanaged matters. This case came to light in the context of the public complaining to the regulators that they were not doing enough following several highly visible food poisoning cases. A FSMS would have prevented these problems because the structure would not allow such bad decisions to be made and would have been verified by an independent third party that would test and check everything. A reputable third-party verifier would not miss poor GMP/ HACCP processes.
A good assessor can help a company understand what is really important and what is not so important when it comes to findings (i.e., context). We don’t waste a client’s time with insignificant issues and that is where the experience and judgment of the auditor becomes critical. Last year I met with a client and said, “you need to be checking for Salmonella in your environment—how do you know it is not there?” I pushed them into checking because I understood the changing regulatory environment. I came back a year later, and they had confirmed that regulators were interested in their Salmonella monitoring program during a recent inspection. As an auditor, you have to be confident enough to provide advice and context to the client in a way that is understood and accepted, and that helps to build trust.
With FSMA, the government can now take specific actions against companies. If I am plant manager or CEO, how do I know for sure that I am in compliance with the requirements? How do I know that I don’t have any of these potential issues? The only way to know for sure is to have the FSMS assessed. Just like a bank or publicly traded company hires financial auditors to assure everything is done correctly, companies need to audit their FSMS to ensure compliance. Get a process audit and ensure they drill down deep into the organization—that is where we find issues and gaps. A thorough auditor will find your problems instead of looking the other way. It is important to call it the way you see it and not be too “soft” when getting an assessment.
If I am the CEO, I want to know where those problems exist. Independent third party assurance is the best way to find out how compliant you are with regulations. No CEO wants to deal with the inevitable lawsuits and lost business impacts. At least with an effective FSMS, you can show a level of due diligence when the regulators show up at your doorstep and the culture is such that you want to address any problems.
We have entered an important time for the food industry with FSMA implementation and other food safety regulatory requirements in the United States. These new rules place an emphasis on management accountability, risk assessment and control of supply chains. The bar for due diligence has been raised and it up to all us to show that we have done everything possible, and the best way is with an effective FSMS.
As the popular phrase goes, if you’re going to talk the talk, then you need to walk the walk. This expression really does ring true when discussing an effective food safety culture within an organization. Timothy Ahn, senior technical manager of food safety at LRQA sheds some light on the importance of management commitment as a foundation for success in implementing a food safety culture and how employee training fits into the picture.
Food Safety Tech: In your column on Food Safety Tech, “Tackling the ‘Why’ of Food Safety”, you touch on the point that food safety culture needs to start at the top. What are the issues in management today that prevents a food safety culture from flourishing within organizations?
Timothy Ahn: First, it’s important to define food safety culture. It can mean a lot of different things to people. The culture is the collective behavior from the organization around shared values and beliefs. From that perspective, it’s extremely important the leadership understands its beliefs and values. The collective behaviors of the leaders become really important, because we’re also talking about how the leadership sets management commitment and drives what’s important in the organization. The organization will follow whatever the leaders do and not necessarily what they say. That’s the issue—having the ability to get commitment from leadership that is demonstrated through their actions, which then transfers into rewards, objectives and consequences. What are the issues that are preventing the culture from embedding itself? Actions aren’t aligned with their words. You have a senior leadership group that will say one thing, but then their actions are different.
In addition, when cascading priorities are very different, food safety doesn’t get the right messages. It’s about growth, market share, profits—all of those financial measures are extremely important, because they have consequences and are also rewarded. Meanwhile, depending on the organization, the objectives around food safety culture may or may not be talked about, defined, or even rewarded. It’s really about making sure that the organization has cascading priorities.
FST: When taking a holistic approach to employee training, what are some of the challenges that companies can expect to encounter?
Ahn: I put food safety into three different buckets that build on top of each other.
At the bottom is the foundation. It’s around good manufacturing practices and all the foundational activities that need to be in place for factory operations. How often you clean your equipment? What do you do around allergens? Can you trace your materials from one end to the other? Do you have a pest control program?
Our food safety system: This includes things around HACCP: Do you have a HACCP plan in place? Do you understand what your hazards are? Have you defined your control measures?
The last bucket is around the management system that drives food safety. Have you defined your objectives? Do you have a policy? Do you conduct a management review? Do you have an internal audit?
The issue with training is many operations only focus on the foundation. You need to have people who know how to clean equipment; you have to make sure that the pest control is done; you need to have good allergen management. Those are all pretty well done. Now you’re starting to get more traction in the second bucket, which is around HACCP, because with FSMA, HACCP is no longer an option; you need to be able to do it.
But the missing piece in many organizations is at the top—the management systems. This is important, because when you talk about culture, that’s where it gets embedded within an organization—through implementation of the management system.
If you look at this holistically, you need to train across all of those areas, not just in the foundation. You can differentiate yourself from organizations that have effective food safety management systems (not just food safety systems) because they’re training across all those buckets.
The other part of training is management systems. Who do you train? Besides targeting first line employees and operators, you also need to train senior managers because these managers, along with leadership, need to better define the objectives and policies. What does it mean to conduct an effective management review? What does it mean to do an internal audit? What’s a good corrective action process? The training often falls apart because organizations haven’t embedded that very well.
FST: Do you see differences between implementing these practices in small versus large organizations?
Ahn: There are differences, but it’s not necessarily a function of the size of the company. It’s more around how they’ve approached developing and organizing their management system and in particular, their food safety management system.
FST: In reality, how long does it take a typical company to create an effective food safety culture?
Ahn: There are two parts to that question.
My belief is that if you want to implement a food safety culture, you need to create a food safety management system, otherwise it is just all words and talk. It’s what you do, not what you say. The way to do that is to embed a food safety management system within your organization.
The two questions are: How do you get to initiate it? And, how long does it take to execute once you decide to initiate?
To address the first question: How do you initiate it?
There are a couple of ways that it can happen. There’s nothing like a crisis to get the fire under somebody’s feet, whether it’s a recall or an incident, it will draw attention to the fact that there’s a problem and something needs to happen. But, that’s reactive and detrimental.
The other way to initiate is that if you have enlightened leadership—an owner or group of owners who understand where they want to go, where they need to go, what needs to be avoided and understands the importance of the organization’s culture in getting to the right place, etc.
Secondly, once you start this process, how long does it take to get this type of system running?
Based on my experience in implementing food safety management systems like FSSC 22000, it takes anywhere from 18 months to 2 years to get it established, and then probably another 18 months or so to actually fully implement. So it’s not something that happens in a couple of months. It takes some time to really get it implemented and embedded, because these are foundational elements you must put into place. There’s a lot of momentum involved, and it has to move throughout the organization.
The term food safety culture has gotten a lot of attention—it’s a buzzword. But what does it really mean and how do you make it come to life? That’s really where people need to start looking. You make it come to life through implementation of structured food safety management systems—ones that are verified, and independently verified. Put substance and real work around your food safety culture instead of using a lot of fluffy words to describe it.
Research and development (R&D) is an essential starting point toward the creation or modification of new and exciting food products, processes and packaging. To ensure that a product is safe for consumption, food safety should be considered during the initial stages of a product’s lifecycle. Incorporating food safety into R&D can be tricky, as safety considerations may change the initial idea or concept of a new food product. For example, the idea of a freshly squeezed orange juice in every supermarket shelf is appealing; however, without pasteurization, that juice will not be safe for consumption, nor will it have the desired shelf life. Adding raw chopped garlic to a hummus product makes it taste great, but will it be safe for consumption after being on the shelf for a month?
To better understand how safety of new products is assured from concept to launch, I spoke with two R&D scientists about food safety considerations during new product development. The interviewees, Maria and Laura, work for the same large food manufacturer, which is located in the Midwest, in the snack foods and breakfast cereals categories, respectively. They both confirm that the R&D team follows a specific procedure during the product concept phase—one that places food safety at the forefront. The team starts by determining how the new product compares to food safety regimens already in place with other products that the company manufactures. If the product is a line extension with only a few changes to an existing formulation, the food safety concerns are likely to be low, and the food safety program already in place is adapted to meet the safety needs of the new product. However, if the product being developed is highly differentiated from other products manufactured by the company, food safety moves into a more central role throughout the development cycle.
According to Maria and Laura, the first step in ensuring food safety for a new product is for the development scientists to have in-depth discussions about the product’s formulation, ingredients and supply sources. These three aspects, along with the planned manufacturing process, are then evaluated through a hazard assessment. The hazard assessment is comprised of microbiological, quality, regulatory, stability and physical hazard assessments. Ingredients that pose food safety concerns without prior controls and process conditions are identified. The quality team determines controls for these ingredients and subsequently involves process engineers to verify that process conditions are attainable and will provide proper control for the hazards identified. A complete HAACP plan is put in place for the new product production, taking into consideration equipment cleanability and location, traffic control for ingredients and operators, and air handling systems. The hazard assessment is documented in detail and must be approved by the quality manager before production runs can begin and development can resume. Although the entire process is led by R&D, multiple other functions are involved and consulted throughout the process.
Manufacturing processes, formulation and market availability of ingredients drive the food safety of a new product, with manufacturing processes and formulation usually being the key drivers. “However, in cases like the recent shortage of eggs due to the avian flu crisis, finding substitutions for ingredients in shortage becomes an important driver for food safety,” says Maria. Laura says that at times, product formulations can change due the integrity of the ingredient or its source. In such cases, a similar ingredient from a credible source is chosen and the safety of the product is re-assessed. There are critical quality and food safety elements that must be considered in the product design phase to prevent issues later in development. When R&D professionals keep these elements top-of-mind when considering formulation and ingredient sourcing, everyone benefits—from the company to consumers.
Although consumer confidence in the safety of the U.S. food supply is slipping (11% said they were “very confident” in the safety of the food supply, down from 15% in 2013; 50% said they were “somewhat confident”, down from 55% in 2013, according to the International Food Information Council’s 2015 Food and Health Survey), the interview with Maria and Laura shows that manufacturers are putting significant effort into developing safe food products. It is equally as important for suppliers and vendors to have robust food safety programs to build strong relationships with manufacturers. Food companies have a lot to lose if a product they develop is, or becomes, unsafe for consumption. Not only can the average cost of a recall add up to $10 million in direct costs to a food company, lost sales and the impact to the company’s market value, brand reputation, and business relationships is major. Some companies never recover from the punch. Through taking the time to audit suppliers, screen new ingredients, and make robust prototypes, food companies can be more confident in the safety of their innovative new products as they go through the development process.
In June FDA officially deemed the use of partially hydrogenated oils (PHOs) as unsafe, or technically, not generally recognized as safe (GRAS). The use of PHOs has been debated for more than a decade, and as a result of FDA’s latest ruling on PHOs, food processors must remove these ingredients from their products within three years.
From preservatives to artificial sweeteners to natural flavors, the list of ingredients that go into processed foods can be quite extensive. Consumers are becoming more vigilant about what they put into their bodies, and FSMA will give FDA the authority to act immediately in instances related to safety. Does this mean that some ingredients could be in danger? The answer is yes, according to Jim Lassiter, president and COO of Ingredient Identity. “[Ingredients] are products that you literally take inside your body, and there is nothing more personal than that,” says Lassiter. Combine this simple yet fundamental fact with consumer awareness and the entrance of FSMA, and food and beverage manufacturers may be entering a new era of scrutiny.
Food Safety Tech: From an ingredients perspective, what challenges are the industry facing?
Jim Lassiter: Implementation of FSMA. Although it’s being implemented at a slower pace than Congress desired, and I believe slower than [FDA’s] original intent, that pace is accelerating. And while the increase in challenges related to the composition and manufacturing of products will be significant, FSMA will be an overall benefit to consumer confidence.
Consumer confidence. Whether the issue is bioengineered foods or disclosure of bioengineered foods through the business of trans fats, or just the general composition and healthful nature of foods. Slowly but surely, increasing consumer awareness of food choices and diet will have a significant impact. Regardless of the type of product, this is going to be universal and will increasingly play a role in decisions that food companies make during product development.
The unknowns. We don’t know what is coming around the corner, whether it’s positive or negative. A lot of effort is being extended within the food sector to discover the next big thing—whether it’s probiotics or prebiotics; addressing product reformulation in light of the elimination of trans fat [requirement]; or something that strikes out of the blue. That is always the most challenging aspect of the ingredients industry. Foods themselves, regardless of what country you are in, are cultural in nature; they are the most personal consumer good that you can obtain. As a result, our awareness as an industry of what we do to products must bear both of those pieces in mind. We have to recognize the cultural nature of food and simultaneously recognize the personal nature of products. As a result, we won’t necessarily have insights into the great unknown or the next big thing, but at least we will have the perspective necessary to deal with any unknowns as we move forward.
FST: In the coming year, what overall effect will FSMA have on food and beverage manufacturers related to ingredients themselves?
Lassiter: From an ingredients perspective, what’s going to happen is simple and straightforward. FSMA grants FDA the broad authority to assist and act in instances where there are issues with safety. That is, however, still nebulously defined and interpreted. So, there’s potential for FDA to suddenly make a determination that an ingredient is not safe or [that it] poses some degree of safety risk. FSMA authorizes FDA to take immediate action rather than [submit] a new process notification, etc. They will also have the authority to take immediate action in the case of violations of good manufacturing practices if the perception can be tied to any aspect of safety. FSMA stands for safety; that is the hinge point on which all of this occurs.
For example, with the revised good manufacturing practice for the manufacturing of food products coming out and the full implementation of HACCP across all food categories, it’s conceivable that FDA will take immediate action on inspection deficiencies in the food manufacturing realm. I think that’s one of the big issues. I don’t want to make it sound like the boogey man is out there, but it is a very real possibility. Ingredients themselves can suddenly be identified as unsafe. I don’t see that necessarily being a very radical reaction. The potential impact is more likely to be broad, but I suspect that at some point in time, there will be an ingredient that pops up out of a FSMA ruling that will suddenly be declared to be unsafe and [consequently] removed from market.
Second, I think the implementation of HACCP across all food categories will have notable impact, initially through common regulatory action (i.e., via inspection deficiencies reports, which are very common in terms of dietary supplement manufacturer inspections). I think you’ll see those becoming increasingly common in food manufacturing operations, because of the implementation of HACCP more broadly. The first round will be more likely for increased regulatory activity in food manufacturing inspections. If that message is not received and implemented rapidly, then the extension of FSMA is that [FDA] can shut down the plant without any due process whatsoever. That looms as part of the implementation. In terms of ingredients, you’re likely to see [some] that folks may not have previously thought about [as unsafe] identified as potentially hazardous. I’m not sure in what area it will occur, but I’m fairly confident that it will happen at some point in time.
Part II of Food Safety Tech’s conversation with Jim Lassiter takes a closer look at GRAS self declarations and the areas of confusion among companies.
With publication of the first set of final rules for FDA’s Food Safety Modernization Act (FSMA) expected any day now, food safety teams are busy strategizing as to how they are going to prepare for compliance and be “FSMA-ready” on Day 1.
Across industry, it is generally agreed that being certified to a GFSI scheme is a solid foundation for FSMA compliance. In a new three-part online series, “GFSI in the Age of FSMA: How GFSI Schemes Align With and Prepare You for FSMA”, the North American leaders of the three major GFSI schemes – SQF, BRC and FSSC 22000 – will discuss the following topics:
How certification to their scheme prepares a company for FSMA compliance in terms of alignment with:
Supplier Controls
Building a food safety plan
Migrating from HACCP to HARPC
Being audit ready all the time
Environmental monitoring … human & animal food rules … and much more
What changes to the scheme have been made (or are planned) to better align with FSMA
Gaps the leaders see in FSMA that are filled by their scheme
What companies who are, or plan to be, GFSI certified should be doing now for Day 1 FSMA compliance
(left to right) John Kukoly of BRC, Jacqueline Southee of FSSC 22000, and Robert Garfield of SQFI are the featured speakers of the GFSI series.
Food company teams working in Regulatory, Food Safety & Quality Assurance, Operations, C-Suite, Legal and other related positions in companies who are – or are planning to become – certified in a GFSI scheme are encouraged to attend one, two or all three sessions.
The series is being sponsored by SafetyChain Software with media partner Food Safety Tech.
In America’s food supply chain, food is sourced globally. Since ingredients often come from multiple countries, inspection and quality control is challenging, as regulations, policies and processes differ in each country. Product management begins with the suppliers, from the fields where the foods are grown, to the pesticides and fertilizers used, to harvesting, washing, shipping, storing, and processing (manufacturers), and finally, to packaging and delivery to consumers.
Figure 1. LIMS will facilitate FSMA by providing complete traceability from farm to table, in addition to accelerating collaboration, communication and providing operational insight. (Click to enlarge)
Figure 1 shows each step of the product management process can introduce contamination due to unsafe practices or other risks. As such, test data and traceability must begin in the field and end when the final product is delivered to the consumer. The Laboratory Information Management System (LIMS) captures all information to ensure that quality data is effectively managed, communicated, and easily and quickly accessible in the event of a contamination issue. The LIMS allows producers to provide authorities with the required sampling and testing documentation to prove compliance.
U.S. consumers expect their food products to be affordable, consistent, safe and unadulterated. Consumers have seen numerous food recalls in the news, and it has shaken their confidence. The CDC estimates that about one in six Americans (or 48 million people) get sick, 128,000 are hospitalized, and approximately 3,000 die of foodborne diseases each year. Global food directives for international food initiatives include CODEX, ISO (International Standards Organization), and the Global Food Safety Initiative (GFSI).
The U.S. Government has implemented various food safety programs, from Hazard Analysis & Critical Control Points (HACCP) to FSMA in order to identify and correct potential contamination in the food supply. In fact, one of the primary focuses of FSMA is preventive action based on risk assessment.
The food landscape has changed significantly, especially over the past decade, as consumers demand year-round fresh fruits, vegetables and juices, along with more exotic foods. The fact that U.S. food is globally sourced has resulted in numerous challenges in quality assurance, shipping, traceability, labeling, storage, blending, testing, and reporting.
Use LIMS to track and manage information in a relational SQL Server LIMS database. (Click to enlarge)
For example, upon reading the labeling on an apple juice can, it is not uncommon to learn the juice has been possibly sourced from numerous countries including the United States, China, Brazil, Argentina, Chile and many other countries from the European Union. Oftentimes, labels state that ingredients may come from some of the countries listed, but it does not specify what percentage comes from each country or exactly from which country the product was sourced. Figure 2 shows how LIMS can track and manage this information in a relational SQL Server LIMS database.
A similar scenario is true for tracking hamburger meat: The meat that was used to make burgers can come from multiple ranches and hundreds of cows. Many consumers don’t understand why their food/beverage is blended in large ton batches, and producers want to reach the required final product specifications, while offering a consistent product and experience to the consumer. Blending has become commonplace in the food industry, and it makes traceability much more challenging. The same is true in blending different meats, for example regulators have found pork in products marked 100% beef, this has led to the use of molecular tests to determine if meat has been adulterated.
FSMA and Traceability
FSMA focuses on a preventive approach rather than reaction and response to foodborne outbreaks. A central focus is on traceability, involving a complete understanding of the complex food chain and conducting testing at the key control points that can introduce contamination. It is important to understand the source of all the raw ingredients that make up a final product as well as the details of where they are sourced, the CoA (Certificate of Analysis) report, other test results, and all associated documentation. These elements are especially important, because each region of the world has different approved testing methods and is challenged with different potential contaminants and processes. As a result, food manufacturers must manage a significant amount of information on all raw materials that they receive, along with the associated paperwork, which includes the CoA, confirmatory test data, and all plant, production and final product test data.
Case example. As operations scale, so does the testing. In order to manage all the testing, most laboratories turn to LIMS and laboratory automation to manage high throughput screening. A client that was performing nearly 1,000 Listeria tests per day was using an automated microbiological screening platform to complete this testing. They were struggling to hire more resources to manage and run the instrument, as the time was short and the increased sample volume was imminent. The goal was to automate testing from the nine plants that were submitting samples to the main laboratory, such that the entire process could be automated from the laboratory knowing how many samples were coming from each plant and from deploying pre-configured worklists to upload to the instruments. The instruments would then run the samples and send the result back into the LIMS. This integration alone saved more than six hours per day. In addition, the electronic data transfer was fast and error-free, and since the data was imported into the LIMS, any positives were automatically flagged in real time. This approach allows immediate action.
In addition, all data from shelf life studies and additional testing on the food product (i.e., pesticide testing, environmental testing for Listeria sp., mold, yeast, etc., formulations, and blending) can be managed in the LIMS, one centralized database.
How LIMS Supports FSMA
Over the years some manufacturers have relied on less-robust tools to manage and maintain testing data, from multiple Excel spreadsheets to paper log books. Challenges with using these tools include data corruptions, data loss, typographical errors, and accidental or malicious data changes. These systems are often costly, especially from a resource standpoint (i.e., data errors, hours spent interacting with the data for calculations, tracking samples, and manual report creation alone). In addition, creating reports for regulating authorities can be time-consuming and because there is no control over changes to the Excel sheets or logbooks, there is typically no audit trail, and because the data is not in the database, querying the data can be very difficult.
A quality LIMS will ensure that the organization is bullet-proof when it comes time for regulatory audits. It also provides a complete and secure solution to manage, track and monitor batches of product from farm to table. LIMS not only helps clients manage their regulatory compliance goals, but it also facilitates communication across the organization and provides laboratory intelligence that gives buyers insight into the best suppliers to purchase from, based on final product specification, consistency and pricing. Managers can also better understand when it is time to outsource testing based on workload data, allowing them to maximize their resources and profitably through more efficient operations. The system also accelerates communication: As soon as testing is completed, reports can be automatically emailed and alerts sent to cell phones, if any issues arise.
When dealing with perishable products, time is of the essence, LIMS save time. Table 1 lists just a few of major benefits of the LIMS in FSMA regulatory compliance.
Process/Requirement
Advantage
Sample tracking and management
Integrated barcode support (both 1D and 2D), manage all batch data, tests, from raw materials, in process testing to final packaged product testing
21 CFR Part 11
Compliance with electronic signature requirements
CoA
Easily, automatically generate the CoA report once testing is completed, validated and approved
Specification Management
Manage final product, supplier and customer specifications and pricing
Document Management
Link all paperwork to Work Order for ready access and retrieval
Full Chain of Custody
Automatically generated and linked to the order
Records data and all paperwork associated with product
All paperwork that arrived with the raw ingredients, CoA, and shipping documentation or additional test data
Records all test results
Automatic data import from instruments as well as hand entered data
Shelf-life Studies
Setup, manage and track all aspects of shelf life studies
Formulations and Blending
Manage and track as components and specifications for final product blends, and leverage predictive tools for optimal purchase options from suppliers
Audit Trail
Track actions in the system and generate a report of all audits made to any result data
CAPAs (Corrective and Preventative Actions)
Track and manage open CAPAs in the LIMS, and tie to testing results for easy management to increase customer satisfaction
Traceability back to the source (farm, country) and forward to the store that it was shipped to, with key data (lot number, ship date, etc.)
Users can view all components and associated test results, along with any notes on the final product, back to the supplier and forward to locations that offer the product to the consumer
Employee Training
Manage employee training records and view Standard Operating Procedures online to ensure access to work instruction and provide evidence for audits
Instrument Management
Manage all quality control data on the instruments used in the testing, as well as documented calibration data, maintenance, any repairs, or any issues. Users can link the PDF manual in the LIMS
Enterprise integration (ERP, SAP, SCADA, MES, SAS JMP)
Data sharing allows users with permissions access to data when they need it, so that they can quickly view and monitor information they need to perform their job. Users can also view data with integrated statistical tools to view trends that may not be readily evident
Table I
A LIMS is a critical tool to the success of food companies. It organizes and securely manages all aspects of food testing, facilitates regulatory compliance, enhances communication within the organization, and maximizes productivity. Many food producers are concerned about protecting their brand and providing a high quality, consistent, and safe product to consumers while operating efficiently and at a profit. An LIMS allows them to meet these goals.
With nearly one in every six Americans falling prey to foodborne illnesses each year, food safety is a major public health issue. For several decades, current Good Manufacturing Practices (cGMPs) provided the basic food safety framework for manufacturers. However, these guidelines were not sufficient to cover all potential food safety hazards. In the 1960s, NASA asked Pillsbury to manufacture the first foods for space flights, and so the Hazard Analysis & Critical Control Point (HACCP) system was born. HACCP was later endorsed by the Codex Alimentarius Commission, which was formed by the Food and Agriculture Organization of the United Nations and the World Health Organization in 1963.
HACCP is a global standard and its principles are the defining elements of ISO 22000, BRC and SQF, all premiere global food safety standards. In 1996, an E. coli outbreak in Scotland claimed 10 lives. The Pennington report in the aftermath of this tragedy recommended use of HACCP by all food manufacturers to ensure food safety. While HACCP is mandatorily used for seafood, juice and USDA-regulated meat processing, it could not win universal acceptance across the food industry; most of the food industry sectors rely on cGMP for providing a food safety framework.
The number of people affected by foodborne illnesses can be attributed to a flawed food safety system. Thinking caps were put on and President Obama’s administration rigorously pursued what it hoped would be an effective food safety paradigm. On July 4, 2012 Hazard Analysis and Risk Based Prevention Control (HARPC) was introduced under FSMA section 103. Although the system is still a work in progress and FDA has yet not disclosed the regulations that will determine the functionality of HARPC, the agency is bound to issue the regulations by August 30, 2015. HARPC will become effective 60 days following this date, and companies will be required to enforce HARPC within a period of 12 to 36 months, depending on the size of a facility.
HARPC is designed along the lines of HACCP but is meant to be more comprehensive. For a “Simple Simon” it would be tough to differentiate between the two, but HARPC provides an all-encompassing food safety structure by focusing on preventive controls to make food safety more iron clad. With the exception of exempted facilities, HARPC will apply to all facilities subjected to FDA’s Bioterrorism Facility Establishment registration. All such facilities will be expected to enforce a functioning and adequate HARPC plan. Failure to do so and FDA would be authorized to take legal actions such as issuing a public warning letter or an import alert (in case of a foreign supplier), initiating criminal proceedings against a non-compliant facility, or suspending food facility registration of a facility until requirements are met. By doing so, FDA has put the onus squarely on the shoulders of respective facilities. Companies will be required to do a lot more and should expect deeper FDA involvement. Expert help to enforce a rather complex HARPC protocol seems unavoidable; there is a fair chance that users could find themselves lost in the translation and may end up facing FDA’s wrath if their plan is inadequate. Let me break it down a bit more and distinguish the main differences between HARPC and HACCP.
Qualified Food Safety Experience. HARPC requires one member of a company to be the qualified individual to complete an entire food safety plan. This means that said individual has undertaken education from a credible institution and gained experience by completing it. HACCP requires at least one person to be HACCP certified, but the plan must be constructed by a team of people.
Process Flow Diagram. Under the HACCP standard, food safety plans must include a clear flow diagram outlining the process, from start to finish, that the ingredients will take throughout your facility. HARPC has no regulations regarding this.
Hazard Variables. Traditionally, hazards were limited to biological, chemical and physical hazards under the HACCP paradigm. Yet, under HARPC, you must also outline Radiological and Terrorism hazards.
Controlling Hazards. Here is largely where the main difference lies: How to control a hazard. HACCP requires companies to mention their critical control points as well as outline a prerequisite program (PRP), although this has no set requirements. HARPC requires you to apply a sanitation preventive control to the hazards, which looks at monitoring, confirmation, corrective action, reviewing records and re-analyzing.
Reviewing the Plan. HACCP requires the individual in charge to review all HACCP documentation every year. This is in comparison to HARPC, which requires a facility to reanalyze its plan every three years.
Recall Plans. Recalls, as required under HARPC, are a special type of incident, with all of the attributes necessary to create and manage a recall plan. HACCP does not have such a requirement.
Use Software to Implement HARPC Plan
Using software can make life easier when it becomes time to implement a HARPC plan. Documentation is an important part of the HARPC system, and software can help generate most of the documents used to establish the plan. Such a system can link regulatory requirements with procedures and customize several aspects of the system during run time.
A risk analysis component of software helps a user identify the likelihood and severity of a particular hazard (a HARPC requirement). HARPC also requires sanitation control procedures at food surface contact points; software features can support cross contamination points to which hazards are assigned and controlled. Software also allows users to define equipment, with a facility to schedule and record calibration, maintenance, and verification activities, including management task assignment to satisfy HARPCs provisions regarding sanitation of utensils and equipment. In addition, it has the provision to document procedures as required by HARPC and can also flag employees for refresher training if they are involved in a violation.
Software also enables users to electronically record inspections, which satisfies the obligation under HARPC to carry out an environmental monitoring program (for pathogen controls). Interestingly, sensors could also be integrated with logging facilities to automatically collect sensor data, which could then be used to send out alerts if there is an abnormality. Software systems can also accommodate coverage of allergen hazards and run a food allergen control plan, including documentation of the process.
An incident management plan can assign and track corrective actions, root causes, employee retraining tasks, and preventive measures to individuals, and recall plans can be created and managed using the system. As many inspectors prefer remote review of documentation, software can provide such remote access, allowing inspectors to conduct off-site document reviews. This process can reduce on-site inspection times from five to three days. A list of approved suppliers can be maintained as well, and these suppliers can be linked to receiving functions, enabling users to receive and maintain a detailed and comprehensive record of ingredients.
HARPC is a reality that will have to be embraced very soon. Using software is a simple solution for the tough times that lay ahead for the food industry. It can serve as an all-encompassing and one-stop-shop for businesses that need help enforcing HARPC plans.
This website uses cookies so that we can provide you with the best user experience possible. Cookie information is stored in your browser and performs functions such as recognising you when you return to our website and helping our team to understand which sections of the website you find most interesting and useful.
Strictly Necessary Cookies
Strictly Necessary Cookies should be enabled at all times so that we can save your preferences for these cookie settings.
We use tracking pixels that set your arrival time at our website, this is used as part of our anti-spam and security measures. Disabling this tracking pixel would disable some of our security measures, and is therefore considered necessary for the safe operation of the website. This tracking pixel is cleared from your system when you delete files in your history.
We also use cookies to store your preferences regarding the setting of 3rd Party Cookies.
If you visit and/or use the FST Training Calendar, cookies are used to store your search terms, and keep track of which records you have seen already. Without these cookies, the Training Calendar would not work.
If you disable this cookie, we will not be able to save your preferences. This means that every time you visit this website you will need to enable or disable cookies again.
Cookie Policy
A browser cookie is a small piece of data that is stored on your device to help websites and mobile apps remember things about you. Other technologies, including Web storage and identifiers associated with your device, may be used for similar purposes. In this policy, we say “cookies” to discuss all of these technologies.
Our Privacy Policy explains how we collect and use information from and about you when you use This website and certain other Innovative Publishing Co LLC services. This policy explains more about how we use cookies and your related choices.
How We Use Cookies
Data generated from cookies and other behavioral tracking technology is not made available to any outside parties, and is only used in the aggregate to make editorial decisions for the websites. Most browsers are initially set up to accept cookies, but you can reset your browser to refuse all cookies or to indicate when a cookie is being sent by visiting this Cookies Policy page. If your cookies are disabled in the browser, neither the tracking cookie nor the preference cookie is set, and you are in effect opted-out.
In other cases, our advertisers request to use third-party tracking to verify our ad delivery, or to remarket their products and/or services to you on other websites. You may opt-out of these tracking pixels by adjusting the Do Not Track settings in your browser, or by visiting the Network Advertising Initiative Opt Out page.
You have control over whether, how, and when cookies and other tracking technologies are installed on your devices. Although each browser is different, most browsers enable their users to access and edit their cookie preferences in their browser settings. The rejection or disabling of some cookies may impact certain features of the site or to cause some of the website’s services not to function properly.
Individuals may opt-out of 3rd Party Cookies used on IPC websites by adjusting your cookie preferences through this Cookie Preferences tool, or by setting web browser settings to refuse cookies and similar tracking mechanisms. Please note that web browsers operate using different identifiers. As such, you must adjust your settings in each web browser and for each computer or device on which you would like to opt-out on. Further, if you simply delete your cookies, you will need to remove cookies from your device after every visit to the websites. You may download a browser plugin that will help you maintain your opt-out choices by visiting www.aboutads.info/pmc. You may block cookies entirely by disabling cookie use in your browser or by setting your browser to ask for your permission before setting a cookie. Blocking cookies entirely may cause some websites to work incorrectly or less effectively.
The use of online tracking mechanisms by third parties is subject to those third parties’ own privacy policies, and not this Policy. If you prefer to prevent third parties from setting and accessing cookies on your computer, you may set your browser to block all cookies. Additionally, you may remove yourself from the targeted advertising of companies within the Network Advertising Initiative by opting out here, or of companies participating in the Digital Advertising Alliance program by opting out here.
