For the last two years, we consumers have experienced the global supply chain challenges associated with a variety of items such as lack of home appliances, favorite packaged foods or paper towels. And now the Ukraine war has sparked a new supply chain crisis with projected shortages of chemicals, oilseeds, iron, steel, fertilizers, wood, palladium and nickel. It’s clear that disruptions will continue as the world endures a crippled supply chain.
Most consumers don’t consider how supply chain interruptions affect the production and safety of so many of the foods we eat. Delays in any food ingredient or packaging can disrupt production schedules, delay shipments, and lead to empty retail shelves for thousands of food processors, manufacturers and retailers across the globe.
As manufacturers cope with these challenges, they frequently have to identify new suppliers or change processes and formulas on the fly. These unanticipated changes may often lead to shortcuts that can pose significant risks to consumers and cause food recalls.
It’s often hard to imagine all the interdependencies within the global supply chain, but one missed shipment or unavailable product can produce ripple effects throughout the globe. To reduce the risks associated with supply chain delays, food processors should implement resiliency measures such as effective change management and food safety vendor audit programs, detailed product specification and vendor expectation requirements, and multi-sourced vendor strategies.
To address these issues, this article reviews three ways food manufacturers can continue to minimize delays and reduce food safety risks when the supply chain interrupts production.
It’s always important to remember that employees can be the best defense against food safety threats. They’re the ones who interact with the products day-to-day and have the most familiarity with the ingredients. Their expertise is especially important now that supply chain disruptions are introducing new issues and anomalies.
Food manufacturers should train employees to understand which ingredients and products are acceptable and encourage them to speak up when they notice any anomalies. It’s also critical that training instills in workers the idea that they share the responsibility to ensure the safety and quality of the products they produce.
When frontline employees have the authority and the autonomy to alert their supervisors when they see something unusual or unexpected, they can become a powerful weapon in the food safety risk prevention arsenal. Harnessing the eyes of all your employees as your ultimate quality control team will help prevent costly recalls, product rework and further production delays.
2. Review Supplier Specs
When food manufacturers start working with a new supplier, they should take the necessary time to review their detailed product specifications to understand the technical and functional aspects of their product. From nutritional values and potential allergens to ingredients and chemical properties, it’s critical to have a full picture of what goes into the product before incorporating it into your manufacturing process.
As a best practice, manufacturers should also ask for a copy of the supplier’s recent GFSI food safety audits or equivalent and proof of liability insurance.
It’s also critical to thoroughly review vendor product specifications to confirm that a newly sourced ingredient meets your purchase expectations, label requirements, and food safety and quality risk profile. Considering how quickly an interruption can occur, it’s important to establish new vendor expectations and develop a supplier questionnaire. In addition, always plan ahead by sourcing multiple backup suppliers prior to ingredient and packaging disruptions.
3. Examine Supplier Labels
Understanding the product specifications is a critical first step, but it’s equally important to compare the label to the specs to ensure it is compliant and expected.
When a package arrives on the dock, receivers need to know if the contracted product has arrived as specified. Is the product packaged correctly, within expected shelf life, in a sanitary condition? Receivers should answer these and other questions by looking for inconsistencies per pallet like mixed lot codes and product shelf-life variances. Employees should also check the condition of incoming products including noting unusual odors or colors that might not seem right or for packaging that looks different from prior shipments.
The ongoing supply chain disruptions are predicted to continue this year, which means they can potentially cause food safety challenges based on inconsistencies in raw materials and undocumented process changes in production. Food safety leaders must hone their change management skills to successfully lead their organizations through these challenging times.
Adhering to the strict practices detailed in this article might seem like a lot of extra work and attention, but it’s actually something food manufacturers should be doing all the time as part of a mature food safety culture.
The food and beverage industry has seen a big push for digital transformation over the past several years. Consumers and regulators alike are demanding increasingly high levels of safety and traceability across the global supply chain—driving food manufacturers to modernize their approach to quality control.
Now, many are looking to retire outdated software or inefficient paper-based systems that limit visibility across their production lines, plants and supply chains. They are exploring modern tools that enable proactive quality and safety monitoring. And fortunately, cloud technology is making this shift easier than ever.
Cloud-based quality management solutions offer simple deployment, rapid scalability and low up-front costs—breaking down many of the barriers to digital transformation. Food manufacturers gain anytime, anywhere access to critical resources needed to maintain product quality, ensure compliance and drive continuous improvement across their organizations.
To make it all possible, food manufacturers should select a cloud-based solution that offers the following features and tools.
1. A centralized data repository for improved visibility, compliance and collaboration
In a traditional manufacturing environment, quality and process data are locked away in paper files, Excel spreadsheets, or on-premises software. These data silos prevent manufacturers from monitoring enterprise-wide quality performance, and inhibit data sharing with external parties across the supply chain.
But the cloud can break down those silos. Cloud solutions provide a single, unified data repository where food manufacturers can standardize and centralize quality data—from all processes, production lines, and sites in their enterprise, as well as from suppliers, co-packers and third-party producers.
The resulting “big picture” view of quality enables food companies to:
Perform enterprise-wide analyses to pinpoint problem areas, identify best practices, and prioritize resources—ultimately improving quality and compliance across the entire organization.
Verify ongoing regulatory compliance and enforce accountability for all required checks and tests.
View supplier data in real time to prevent food safety issues and ensure incoming ingredients meet quality standards before they are ever shipped. Only the highest-quality ingredients get accepted and incorporated into products.
Monitor supplier performance to better manage suppliers and prevent supply chain disruptions.
Collaborate with contract manufacturers and packers to make sure they uphold quality standards and protect the brand.
2. Real-time SPC for proactive response on the plant floor
A preventative approach to quality and safety just isn’t possible when using manual methods for data collection and analysis. Operators spend valuable time recording data with a pencil and paper, then sift through page after page of control charts—on top of all their other daily responsibilities. It’s easy to see how mistakes could be made and production issues could be missed.
Quality teams are also at a disadvantage, reviewing old data about products that have already come off the production line. Overall, everyone operates in “firefighting” mode. They try to fix one issue after another, but it’s often already too late. Some problems may not be spotted until final inspection, if even caught at all. Manufacturers end up dealing with defective products, wasted resources, and damaging recalls.
The cloud transforms how food manufacturers collect and analyze quality data. Cloud-based statistical process control (SPC) software can automatically collect measurement values from a variety of data sources, then monitor processes in real time. When the software detects specification or statistical violations, automated alarms instantly alert key personnel. The appropriate teams can take immediate action to correct any issue before it gets out of hand.
In addition, food manufacturers can put up further safeguards on the plant floor with “workflows.” Essentially, these are prescriptive guides for responding to quality issues, predefined in the cloud-based quality solution. They help all employees respond consistently and effectively to specific problems, and then document the corrective actions taken. These responses can then be analyzed across an entire company, allowing manufacturers to spot trends and prevent reoccurring issues.
Ultimately, operators and quality personnel can stay on top of potential problems and prevent unsafe or defective goods from reaching customers—without having to manually monitor every line, in every plant, around the clock.
3. Timed data collections to keep everyone on the same page
Routine sampling and quality checks are critical for food safety and compliance with regulatory and industry-specific standards. But how can manufacturers ensure required checks are completed according to schedule? After all, the plant floor is a busy place and where it’s easy for operators to get sidetracked tackling other issues.
Here, cloud-based quality systems can help. These solutions enable manufacturers to set up timed data collections, which send automated notifications to remind operators when it’s time to perform HACCP, CCP, and other critical quality and safety checks. Operators can stay focused on production, without having to watch the clock or worry about missing a check. Plant supervisors also get alerts if a data collection is missed—no matter where they are working—so they can keep everyone on top of compliance.
4. Digital reporting to make audits a breeze
Every manufacturer dreads the auditing process. It is time consuming and resource intensive, adding another layer of stress and complexity to the already complex nature of food production. Those that rely on paper records and spreadsheets usually struggle to piece together and produce auditor-requested information. And failed audits can have major consequences.
Instead, quality records and other compliance documentation can be digitized, stored and made quickly accessible via the cloud. This makes it easy for food companies to pull historical data for specific timeframes. Reports can be produced in just minutes to complete regulatory, third-party certification, or internal audits—rather than the days or weeks it would typically take to put together a report from a complicated trail of paper.
5. Lot genealogy for improved traceability and recall response
Recalls are another big source of stress for food manufacturers. After all, food quality or safety incidents that result in a recall not only hurt profits and brand reputation, but also put the health and lives of consumers at risk. Fortunately, recalls can be mitigated or avoided through better traceability.
Cloud-based quality solutions can help food companies trace raw ingredient lot codes through the manufacturing process and supply chain. With all quality data stored in that centralized cloud repository mentioned earlier, manufacturers can generate genealogical “trees” showing the relationship between incoming ingredients and outgoing products.
This information in critical for preventing and responding to product recalls. If a safety issue is found within a specific ingredient lot, for example, manufacturers can quickly identify output lots where those ingredients were used. They can prevent those finished lots from being released, or in the worst-case scenario, remove those lots from store shelves in a swift, targeted recall.
A Tactical Approach to Digital Transformation
Looking at the FDA’s New Era of Smarter Food Safety blueprint, it’s clear to see that the industry at large is heading towards a new digital age. Food manufacturers shouldn’t wait to take the first steps, and cloud-based quality can get them on the right path.
While any big change comes with hesitancy, a tactical approach can help ease any fears. Some food manufacturers have started with small-scale projects, deploying cloud-based quality solution to monitor a single process or production line. Leadership teams and employees alike can see how quality in the cloud benefits everyone at all levels of their organization—and then deploy the solution on a wider scale. It is a great way to successfully introduce new digital technology and lay the foundation for future transformation.
Vanilla is one of the most popular and expensive flavoring ingredients, used in ice cream, dairy, beverages, baked goods and more. Its smooth, warm taste and ability to enhance other flavors make it a sought-after element in cooking and baking worldwide. Insufficient natural sources, impacted by adversary weather events, are unable to keep up with an increasing demand. As a result, what is labeled as “pure vanilla” is occasionally adulterated with ingredients that are not derived from vanilla beans, but either synthetic or made from other plant or even animal sources. In the case of on Australian retail company, the vanilla extract was mislabeled as “pure” with a picture of vanilla plant parts shown on the label, misleading consumers. The Australian Competition and Consumer Commission issued a hefty fine after two infringement notices.
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. Basically, the prevention group is constantly improving their food safety practices to minimize foodborne illness while the correction group waits until there is an outbreak to make changes.
The correction group isn’t proactive and has a number of excuses that keep them from implementing a food safety program. Oftentimes owners or managers think, “The chances of my company being involved in a food safety outbreak are so rare, I just won’t worry about it.” Or they think, “The cost of having a food safety program is so prohibitive that I’d rather handle the consequences of an outbreak if it were to arise.” Also, sometimes there’s a lack of knowledge and some producers don’t even know about food safety programs and don’t have or want to take the time to learn about them.
If your food company is in the corrective group, you are not alone. Three years ago a private study was done to see how many food facilities could pass a basic Good Agriculture Practice (GAP) and/or Good Manufacturing Practice (GMP) audit. It was discovered that less than 20% of these companies would be able to pass the most basic food safety audit. This number is staggering and unfortunately the correction group is much larger than anyone thinks—it equals a majority of the facilities at around 80% of the food industry. This statistic is frightening and needs to be addressed to help reduce outbreaks.
What does the preventative group look like? Well it is more of an investment up front, but in the end helps reduce risk and costs. Companies that take on this responsibility go through an audit and implement procedures that prevent outbreaks. That is level one. The next level of protection involves applying and gaining a certification. All of these procedures help to give your organization a barrier against costs such as crisis management with a PR firm, a recall that leads to lost product and sales, and a thorough clean-up process.
Food safety prevention is an ongoing journey of understanding your many risks and implementing procedures and processes to minimize these risks. Prevention is not a one person job, but rather the whole company needs to join the common cause of protecting the brand and more importantly customers lives.
The cost though is always a huge consideration and can become a deterrent to implementation. Oftentimes owners or managers of facilities will say, “The cost of food safety prevention is so prohibitive that we can’t implement a program.” Yes, there is a cost to building, implementing, and maintaining a preventative food safety program. However, this cost pales in comparison to a corrective program.
Overall Cost of Correction: FDA – Lives – Individual Companies (Restaurants and Farms)
Just recently CDC posted that the economic impact of pathogenic food safety outbreaks is $17.6 billion which is $2 billion higher than 2013. The CDC calculates this based on medical expenses, productive decreases in wages, and ultimately loss of American lives. This large number and massive increase in economic cost has made headlines recently as a huge problem, but few in the media understand this number is small compared to the true cost of foodborne illness.
So what is the true cost annually of the collective in the corrective group to the food industry and America as a whole? To come up with that number we need to look at all the costs of an outbreak: Legal costs, fines, bankruptcies, decrease of overall commodity market share, decrease in public trust, and jail time. And let’s not forget, the real cost is that lives were lost due to lack of prevention.
To understand the cost, let’s look at a few examples, starting with Chipotle. Last year the company agreed to pay the largest fine in history of $25 million for its part in multiple outbreaks from 2015–1018 sickening more than 1,000 people. This fine is tiny in comparison to the stock market loss. In 2015 the stock went from $740 a share to a low of $250, and in fact Chipotle’s stock did not get back to $740 until July of 2019. That is billions of market opportunities lost.
Johns Hopkins Bloomberg School of Public Health did a study and concluded that foodborne illness costs the American food service industry $55.5 billion annually. On average each food safety outbreak costs the establishment between $6,330 to $2.1 million, depending on size of the operation and how widespread the outbreak is. Chipotle has a lot of resources to manage and recover from a crisis; many small and/or over-extended companies go bankrupt and are forced to close down.
There are plenty of examples on the supply chain side. The first example is the Salmonella outbreak of Peanut Corporation of America. The largest part of this tragedy is that 714 people got sick, about half of whom were kids, and nine people lost their lives. Due to this, three executives went to jail, not for a few months for decades. The economic cost is astounding; Peanut Corp of America had an annual revenue of around $25 million, but the cost of the outbreak was over $1 billion. This may seem like a very large number, but don’t forget peanuts are an ingredient in many other products. Kellogg’s estimates they lost $65–70 million in products they needed to recall from this one outbreak, and Kellogg’s is just one of many Peanut Corp of America customers.
Another example is the Jensen Farms Listeria outbreak that sickened 147 people and of those 33 died. The brothers, of this multiple generation farm, Eric and Ryan Jenson, went bankrupt and were sentenced to five years probation and six months of home detention; each had to pay a $150,000 fine. Again, this small family’s operations outbreak had massive ramifications for the cantaloupe industry, which suffered significant damage as a result. Walmart reached a settlement for an undisclosed amount in 23 lawsuits involving the Listeria outbreak linked to the cantaloupes
Overall Cost of Prevention: Internal Programs, Supplier Programs, Testing and Audits
The FDA has conducted a few studies on the industry cost of the many leafy greens outbreaks. One study showed the spinach industry alone lost more than $200 million just in retail sales and many more millions in opportunity sales from the 2006 E. coli outbreak. And a recent leafy green outbreak in 2018 cost the industry an estimated $350 million. With staggering numbers like these, the LGMA was created in 2007 to help raise the bar for food safety prevention in this high-risk product. The LGMA study found that their members, which are large leafy green marketers, including Dole, Taylor Farms and Ready Pack, increased their spending three times for true prevention measures.
What does it look like to go from the corrective group to the preventative group? First you have to make the decision of implementation and get buy-in from your entire team. If you are starting from zero, asking your clients and competitors what standards they are utilizing and being audited to, or should be audited to, is a good starting point. This will help in developing a plan of action.
Once you have the checklist, audit human resources. Do you have a Food Safety and/or QA person or team? Are they capable of guiding the executives on this journey? If not, hire a consultant to help you get started.
Once they are on the journey of prevention, people see their entire operation in a different way. They see risks where they never previously saw them—risks with people, equipment, products, building, and the surrounding area. This can get super overwhelming, but if they don’t panic they will be excited about the future. The paradigm will change and they can build, implement and maintain practices to minimize risks one by one, starting with the biggest risks.
In accounting for the physical costs of prevention, the largest will come from the human resources component. Hiring people to build, implement and manage your food safety program will be your largest expense. Another human resources cost is the continued training for the entire staff on food safety expectations. After that cost drops significantly, annual audits and microbiological testing come into play, and the cost will vary on the size of your operation and the risk of your products. For instance the LGMA study showed on average the cost of their members went from $200,000 to about $600,000 annually for prevention, but these are very large multiregional organizations with a very high risk product.
The most important things in life come with hard work and at a price. Every person who has climbed Mount Everest did so one step at a time. Food safety prevention is no different. Is there a cost in money, time, and stress? Yes. Is that cost less than sitting on the beach with your head in the sand of the correction camp? No doubt. But the choice of leaving the majority that are wrong to the minority that are right is yours. Hopefully, you make the right decision.
Known officially as The California Safe Drinking Water and Toxic Enforcement Act of 1986, California Proposition 65 reaches far beyond state boundaries and has potential regulatory implications for almost any company that manufactures, imports, and / or sells products containing listed chemicals in the state. California Prop 65 prohibits the sale of a product in California that knowingly and intentionally exposes an individual to a California Office of Environmental Health Hazard Assessment (OEHHA) listed chemical without a specific stated warning. For many food and supplement companies, the risk of opportunistic litigation based on California Prop 65 drives the need to monitor updates, new amendments and enforcement of the law.
Prop 65 Background
California Proposition 65, also known by the shortened name Prop 65, is not a ban on products or ingredients. The law is intended to inform consumers in California about exposure to a list of chemicals exceeding a defined level in products for sale, including product packaging. The regulation mandates a warning label for exposure to chemicals at a level that could cause cancer, birth defects or other reproductive harm. Guidance for upper limits (“Safe Harbor Level”) on chemicals is based on expected daily exposure. If no Safe Harbor Level exists for a chemical, the product containing a listed chemical must include a warning, unless the exposure level can be proven to not pose a significant risk of causing harm.
With the size of the California economy and the interconnected U.S. supply chain, the state law effectively reaches other states and U.S. importers. More recently, the Prop 65 requirements impact online and catalog sales, which have increased significantly during the global pandemic.
Know Your Suppliers
All companies need to proactively evaluate and document Prop 65 risks. Enforcement occurs primarily through civil litigation, resulting in specialized legal firms profiting from a company’s ignorance of the law’s extent. Even the threat of publicity from a lawsuit can cause targeted companies to settle a case.
At each point of manufacturing and distribution—supplier, manufacturer, packager, importer or distributor—regulatory teams should ask about Prop 65 compliance. The main point of responsibility is at the manufacturer, but a retailer can also be obligated for introducing a chemical at point-of-sale.
What’s New with Prop 65
The OEHHA issues notices regarding amendments to the California Code of Regulations Title 27, Article 6, covering “Clear and Reasonable Warnings”. Recently the OEHHA requested public comments on proposed amendments that would modify the content and methods for providing “short-form” warnings. The short form was originally intended for products with restricted label space.
The proposed rule would modify the existing short-form warning provisions to:
Only allow use of the short-form warning on products with five square inches or less of label space.
Eliminate use of short-form warnings for products sold via the Internet and catalogs.
Clarify how short-form warnings can be used for food products.
Require the name of at least one chemical be included in the short-form warning.
Bottomline: Know Your Business and Risk
As an advisor with more than 20 years of regulatory compliance experience in food and food ingredients, my guidance for business best practice on Prop 65 is to be proactive, maintain supply chain knowledge, and understand risk. Regulatory or legal staff, or consultant teams specializing in Prop 65, should regularly monitor for additions to the chemical list and rulemaking changes to the far-reaching law.
2020 has taken a lot away from us, but it has also taught us the importance of being able to quickly adapt (can you say…“pivot”?) to rapidly changing, dire circumstances. For Food Safety Tech, that meant shifting our in-person annual Food Safety Consortium to a virtual event. I really look forward to the Consortium each year, because we are a virtual company, and this is the one time of year that most of the Food Safety Tech and Innovative Publishing Company team are together. When we made the decision to move the event online, we really wanted to be considerate of our attendees, who more than likely were quickly developing webinar and Zoom fatigue. So we created a series of 14 Episodes that spanned from September until last week. I am not going to single out one episode or speaker/session in particular, because I think that all of our speakers and sponsors brought a tremendous amount of education to the food safety community. Thank you.
COVID-19 has served as the springboard for digital transformation, more of which we have seen in the past nine months than in the last several years or even decade. Tech advances are increasing efficiencies, adding the ability to be more predictive, giving more visibility and traceability in the supply chain and offering increased accessibility. These include: IoT; Advanced analytics; Artificial intelligence (FDA has been piloting AI technology); Graph technology used in supply chain visibility; blockchain; mixed reality; and remote monitoring.
There are new responsibilities that come with being a part of America’s critical infrastructure and protecting essential frontline workers.
Companies must have a strong relationship (or work to build one) with local health departments and authorities
Name a COVID Czarat your company: This is a designated person, located both within a production facility as well as at the corporate location, who manages the bulk of the requirements and precautions that companies should be undertaking to address the pandemic.
Every company should have an emergency risk management plan that centers around good communication.
The COVID-19 pandemic is a reminder to us that the threat for viruses is always lurking beneath the surface. There is still work to be done on the food labs side regarding more rapid assays, leveling the playing field regarding conducting viral testing, and technology that enables labs to get safe, effective and consistent results.
Lessons in sanitation: Investment in sanitation is critical, there are no shortcuts, and empower your sanitation employees, give them the tools they need to effectively do their jobs.
Know your suppliers, know your suppliers, know your suppliers!
Biofilms are ubiquitous, and the process of detecting and eliminating Listeria in your facility is a marathon with no finish line.
Food Safety Culture is a profit center, not an overhead department.
“If I’m not well, I can’t do well.” Making sure your needs are met personally and professionally plays an important role in being a better contributor to your company’s success.
As part of a special offering, we are making four episodes of the 2020 Food Safety Consortium Virtual Conference Series available on demand for free. Head to our Events & Webinars page to register to view the sessions on or after January 2021.
For a long time, companies could effectively run food safety programs using only manual methods of quality management, such as pen, paper, spreadsheets and emails. Those practices have served the food industry well, but it was only a matter of time before food safety and quality management systems became mostly an exercise of technology.
Even before COVID-19, industry trends and government requirements (e.g., FSMA, the FDA’s New Era of Smarter Food Safety) were setting roadmaps for modernizing food safety and quality management with technology. Additionally, the food industry is thirsty for better performance, more insights and data-based decisions—all things that need more sophistication than manual systems.
As we continue through the throes of the pandemic, it’s abundantly clear that the tech-based future we were planning for five to ten years in the future is happening now. It’s both unavoidable and imperative for the food industry to quickly adapt to the new landscape in front of us. It’s as the CEO of Airbnb, Brain Chesky, recently said: Because of the pandemic, he had to make “10 years’ worth of decisions in 10 weeks.”
From my viewpoint, I see at least seven additional trends that are also expediting modernization in our industry.
1. A shift toward proactive mindset versus reactive habits. Always reacting to what’s happening around you is precarious and makes it difficult to mitigate risks, for you as well as your location employees. The benefits of being more strategic and prepared for different scenarios can shore up your foundation, making you more ready for crises at the corporate and location level. Gathering, combining and analyzing data with technology gives you more insights, so you can make data-based decisions quickly and with more confidence.
2. Empowerment of employees to act as chief quality officers. This comes down to the difference between training employees versus coaching them. Giving employees rules (training) is one thing but showing them the reason why a rule exists (coaching) is another. In other words, when you add more coaching, you’re empowering employees to identify and act on the right thing to do for themselves—which is chief quality officer behavior.
It is important to reassure employees during coaching that honest assessments will result in managers’ support rather than punishment when things go wrong. When all employees proactively watch for quality and compliance issues and get the right support when bringing up these issues, you’re more likely to catch (and fix) small issues before they become huge liabilities.
3. An increase in virtual audits and self-assessments. I don’t believe the corporate audit will ever go away, but our customer data is showing a marked increase in location self-assessments and virtual audits before the pandemic, and even more since March.
Right now, these audit types are a necessary stopgap while the health and safety of auditors is in question. However, I’m also confident that virtual audits and self-assessments will continue to rise. The reason? These audits can start giving you a continuous view of food safety initiatives instead of a single point-in-time view.
Even though corporate audits are still part of best practices, shorter self-assessments and other evaluations can help you glean more data and gain more visibility on a continual basis, especially if you use technology to store and analyze your data in one place.
4. Continuous quality monitoring is overtaking point-in-time audits. Let’s expand on this trend. Manual processes may provide some valuable data, but it’s impossible to build real-time, integrated views into your business with only a yearly audit. It merely shows you a single (but important) point in time rather than what’s going on at each location right now. Additionally, since everyone is watching every employee at all store locations due to COVID-19, it is critical to have a checks and balances system to continually correct small issues and to find coaching opportunities.
Again, it’s virtually impossible to do this with paper checklists and email blasts because the daily-gathered data can easily be misfiled, deleted or otherwise lost. Many quality management software systems are built to integrate, store and analyze your data in a continuous manner.
5. Consolidation of multiple programs into single software solutions. As you think about updating your programs and systems from manual processes, it is important to remember that you don’t need a different solution for every activity. For example, you don’t necessarily have to invest in an auditing app, an analytics platform, and a document storage solution (and still probably manage many spreadsheets). There are many quality management software companies that have solutions built to combine and streamline all the activities you need to manage food safety or other quality management programs.
6. Innovations to share costs with suppliers. Budgets have not likely increased due to COVID-19, so investing in modernization may seem like a pipe dream. But many companies are offsetting their costs in a new way. They are requiring suppliers to use a specific software system to submit their qualifying documents, and then these companies are charging reasonable fees for suppliers’ use of the software.
Additionally, there more benefits to managing suppliers within your quality management system. First, it can streamline document collection and storage, and second, it gives you an opportunity to communicate and collaborate with your suppliers on a deeper level.
7. Standards bodies are accelerating plans to update requirements. As seen with GLOBAL.G.A.P. this year, some standards bodies are updating their digital submission requirements to streamline certification submissions as well as start building up sharable industry data so certification bodies can do their jobs better. Additionally, GLOBALG.A.P has already partnered with existing quality management software companies to make the integration and submission process even easier, and other standards bodies are sure to follow.
It’s clear to me that these trends are of a long-term nature, and each one requires updating manual food safety and quality programs to quality management system software solutions. Acting on these trends in any number will require modernization and digital transformation to have a lasting impact on your programs and your business. The mode of “just keeping the doors open” is not sustainable and will not last forever, so now is the time to start building a better food safety future.
On Friday FDA announced a voluntary pilot program to help the agency and industry better understand whether private third-party food safety audit standards align with the requirements in FSMA’s Preventive Controls for Human Food and Produce Safety Rules. The program, which will be conducted over one year, is part of the goals established under the New Era of Smarter Food Safety Blueprint, which states that FDA is exploring the reliability of third-party audits in ensuring food safety.
“The FDA understands that determinations that third-party audit standards align with the FSMA regulations could provide importers and receiving facilities with confidence that the standards used to audit their suppliers adequately consider FDA’s food safety requirements,” the agency stated in a constituent email update. “In addition, alignment determinations could help the FDA’s investigators more efficiently determine whether importers and receiving facilities are in compliance with the FSMA supplier verification requirements.”
During the pilot, FDA will assess up to five third-party food safety standards for alignment with the above-mentioned FSMA rules—including what resources are needed to review and assess those standards, and whether the pilot participants can provide adequate information allow FDA to determine alignment. “Alignment determinations would give those relying on audits conducted to those standards confidence that they are meeting certain FDA requirements for supplier verification audits,” FDA stated. “In addition, the pilot will enable FDA to gain information and experience that will allow the Agency to evaluate the resources and tools required to conduct alignment reviews.”
FDA is requesting those who want to participate in the program, both the public as well as owners of third-party food safety standards, submit requests in the Federal Register within 30 days.
SQF Q&A with Shawna Wagner, CP-FS, Food Sector Technical Manager, North America
SQF Auditor of the Year 2019
FSSC 22000 Q&A with Isabella D’Adda, DNV GL Global Food & Beverage Manager
BRCGS Q&A with Veronica Ramos, DNV GL Lead Auditor, BRCGS Auditor of the Year 2020 award winner
Can we have 100% remote audits?
Shawna Wagner (on SQF): SQF does permit conducting an audit at 100% using ICT. Audits using ICT are not mandatory. This option must be a last resort option, as full onsite and the 50/50 blended option (50% onsite and 50% remote) shall be the first options. A feasibility assessment with a certified organization is needed to verify that a full remote audit is an effective and practical option. An SQF Fully Remote Audit only applies to announced re-certification and/or surveillance audits of the SQF Food Safety and/or Quality Codes. It does not apply to initial certification audits or unannounced re-certification audits.
SQF Fully Remote Audit certification can be applied to the following SQF Codes:
SQF Food Safety Code for Food Manufacturing
SQF Food Safety Code for Storage and Distribution
SQF Food Safety Code for Manufacture of Food Packaging
SQF Food Safety Code for Primary Production
SQF Quality Code
Isabella D’Adda (on FSSC 22000): Yes, 100% remote audits are now allowed also for FSSC 22000. On the 5th of October, 2020 FSSC published a new document called “Full Remote Audit Addendum” that explains the conditions and the rules for conducting FSSC 22000 audits fully remotely. This document is valid and applicable only, when a certified organization cannot be accessed due to a serious event – as in the case of a pandemic.
The FSSC 22000 full remote audits are completed using Information and Communication Technology (ICT); these will be accredited audits, which will not be recognized by GFSI – the transparency of the certification process is always granted, that’s why the certificate that will be issued after these kind of audits will have a specific reference that a Full Remote Audit was conducted.
Before conducting a 100% remote audit, a certification body must evaluate an impact of the serious event on the current certificate and certification status, and conduct a feasibility assessment with the certified organization in order to verify that a full remote audit is an effective and practical option.
The FSSC 22000 full remote audits can be done when annual announced surveillance/periodical or recertification audits cannot take place on-site. But not for Stage 2 Initial audits. Note: even during the 100% Remote audits, auditors need to spend about 50% of the time on documents and records evaluation, and the rest of the audit time on performing video plant tours and interviews.
The addendum to the standard called “FSSC 22000 Annex 9” is still valid in cases where a certification body and an organization agree that it is more appropriate and effective to conduct an audit in two steps: document review and interviews with key personnel remotely, using information and communication technology (ICT), then audit implementation and perform verification of the food management system on-site, with a time-lapse between the two steps.
In the case of the first certification, the FSSC 22000 Annex 9 can be applied and the whole stage 1 audit can be conducted remotely, while the subsequent stage 2 audit will be conducted on-site at least within 6 months after stage 1. For all other audits, according to Annex 9, part of an audit can be conducted remotely, and the rest of the activity completed onsite, considering that the onsite audit cannot have a duration less than 1 day and shall be at least 50% of the total audit duration.
Veronica Ramos (on BRCGS): The rules have been changing recently for the BRCGS standards. These rules are published in the Position Statement BRCGS 078, 080 and 086 (www.brcgs.com) – and these are applicable only for already certified sites. Currently, all certified sites, whose certificates can be affected due to COVID-19 in respect to travel restrictions and internal rules of receiving external visitors to the sites, can opt to any of the following three options:
Request a certificate extension for six months with a COVID-19 risk assessment (see Position Statement BRCGS 072);
Request their re-certification audit with the “blended audit” modality (see Position Statement BRCGS 080) – where a remote audit (using ICT electronic systems) is combined with an on-site audit for re-certifications;
Request the new temporary modality to conduct 100% of an audit remotely (according to the Position Statement BRCGS 086).
This is only applicable for announced audits. It is considered that the best option is to conduct a regular on-site audit or to go with the blended audit option, because an auditor can have a better opportunity to confirm the level of compliance on-site. The on-site audit part should be of at least 1.0 day duration, while the remote part shall not exceed 50% of the total audit duration. Note: full (100%) remote re-certification audits must replicate the exact methodology of a regular audit, including plant tours and interviews, however, it must be first verified that electronic devices and communication means can be used successfully. Also, one should be aware that 100% remote audits are not GFSI benchmarked, but are accredited. Please contact your lead auditor or certification body for more information.
What can be audited during the remote portion?
Wagner (on SQF): For SQF we would focus mainly on Module 2 items, such as Food safety policy, Management Reviews, Approved Supplier Program, Specifications, Validations, Verifications, and Training for the 50/50 blended audit. The 100% remote audit shall include all steps associated with an SQF Systems audit including the opening and closing meetings and discussion and agreement on non-conformities.
D’Adda (on FSSC 22000): When an audit is 100% remote, the whole activity will be done using an appropriate ICT. The audit will follow the same format and organization as an on-site one and, in any case, an auditor must be able to complete the full audit against all FSSC 22000 requirements: also during these audits a possibility to do interviews with personnel must be granted, an appropriate site inspection of all production areas, facilities, storage and external areas must be completed, implementation of PRPs must be verified, documentation must be evaluated with involvement of all management and staff, who manages the food safety system.
A fully remote audit can be conducted only, when a site is operational, and production is taking place.
For FSSC 22000 fully remote audits, it is advisable to provide supporting information to an auditor before an audit takes place. Documentation, such as site maps, updated flow diagrams, a list and overview of OPRPs/CCPs, any changes, caused by a serious event, and any other supporting information regarding the production process will be useful during an audit.
For audits done 50% remotely and 50% on-site there is the following process: during the remote part, focus will be on the ISO 22000 components of the FSSC 22000 scheme and interviews with management and key personnel. An auditor will review documents and procedures, check management review with specific focus on FSMS objectives and key process performance indicators, HACCP plan, internal audits, complaints and recalls, and how these were managed, focusing on key changes since the previous audit (applicable in the case of periodic audits and re-certification).
Ramos (on BRCGS): During the remote part of a blended audit focus should be on the information included in the documents and records: an auditor would need information on implementation and maintenance of the requirements since the last audit (meaning that samples of records, which could be requested, could be for the last twelve months). Most of the BRCGS standards are color coded, clearly indicating, which are the expected requirements to be audited against on-site, and which can be audited against remotely (e.g. management review, internal audits, complaints, recalls, etc.). But as mentioned before, everything will need to be audited, if the option selected is 100% remotely.
Who should attend the remote portion?
Wagner (on SQF): We would look at this audit no differently than as if we were onsite. It would be recommended that whichever employee is responsible for the section being audited that they attend. Employees could also be interviewed during a remote audit. This should be discussed with key personnel at the opening meeting.
D’Adda (on FSSC 22000): During remote audit both management and involved key personnel shall be available to support the auditor in his/her activity. Companies should cooperate and provide adequate resources to ensure the audit is conducted successfully.
Ramos (on BRCGS): During a remote audit both management and involved key staff shall be available to support the auditor in his activity.
What documents should we have ready for the remote portion?
Wagner (on SQF): Documents would be the same as if it were an onsite audit. All documentation should be made readily available to the auditor during the time of the remote portion and/or onsite portion of the audit.
D’Adda (on FSSC 22000): The documents that should be available for the remote audit are the same, as the ones requested for ISO 22000 implementation, like context analysis, food safety management system with its defined scopes, products and processes that are included and the objectives of the FSMS, food safety policy, HACCP Plan, management review, updated internal audits and all procedures that a company has documented, which are necessary for the effectiveness of their food safety management system.
Ramos (on BRCGS): All types of documents in their latest updated version shall be readily accessible. It is up to an auditor to request documentation, which is required to fulfil the objectives of an audit within its scope. Documents could be manuals, procedures, work instructions, templates of records, and actual records.
Can we send documents ahead of time?
Wagner (on SQF): It is not required that documents be sent ahead of time, although in some cases this could be helpful for the site and the auditor. Information that is sent ahead of time would be confidential and not audited until the actual audit.
D’Adda (on FSSC 22000): It is not required to send documents ahead of time, however all documents must be prepared and available for the planned audit dates, remote or onsite. There are some organizations, which want to share information in advance and show potentially useful examples, such as master list of documents, flow diagrams, maps, or a summary of preliminary answers to key requirements/topics. This information will not be audited until the actual audit (remote or on-site) starts. Thus, this information will be handled as confidential. As a representative of a certified organization, one should know that during an audit, it is up to auditors to request certain information, which may help to get proper evidence, needed to fulfill objectives of the audit.
Ramos (on BRCGS): It is not required to send documents in advance, however there are some organizations, who want to share information beforehand to demonstrate examples, which might be useful during an audit, such as master list of documents, flow diagrams, maps, or a summary of preliminary answers to the key requirements/topics. This information will not be audited until the actual audit (remote or on-site) starts. Such information will be handled as confidential. As a certified organization, one should know that it is up to auditors to request certain information, which may help to get proper evidence, needed to fulfil the audit objectives, during an audit.
Is my information confidential?
Wagner (on SQF): All information that is sent shall be confidential and follows DNV GLs Information Security Policy.
D’Adda (on FSSC 22000): All DNV GL auditors received specific training on how to manage remote audits and treat confidential information in accordance with the DNV GL’s Information Security Policy.
Ramos (on BRCGS): All DNV GL auditors received specific training on how to manage remote audits and treat confidential information, in accordance with the DNV GL’s Information Security Policy and confidentiality agreements signed with customers.
When does the onsite portion need to happen?
Wagner (on SQF): The onsite needs to happen within 30 days of the remote portion. Both audits must occur within the 60-day audit window for SQF.
D’Adda (on FSSC 22000): In the case of fully remote audits, there won’t be an onsite auditing activity, and it will be completed using ICT equipment. In the case of an audit done partially remotely and partially on-site: FSSC has defined that the maximum timeline between a remote audit and the on-site portion shall be 30 calendar days. In the case of a serious event, this timeline can be extended to 90 calendar days, but only after a documented concession process and risk assessment have been completed by a certification body. Serious events that could lead to a postponement of the onsite portion of an audit are pandemic emergencies like Covid-19, legal proceedings, prosecutions, affecting food safety or legality, public food safety events (e.g. public recalls, calamities etc.), natural disasters (e.g. floods, fire, earthquake), war or political instability and other serious situations, like malicious hacking.
Ramos (on BRCGS): It is expected that in a blended audit the remote part is conducted first and then the on-site part, however, if logistics require that the audit is conducted in the reverse order, this is acceptable as well. The second part of a blended audit needs to happen within the following 28 calendar days, allowing enough time for a site to do a non-conformity closure (when applicable), and a re-certification decision can be issued before the expiration date of the current certificate. In exceptional justifiable circumstances, a certification body may request a concession from BRCGS for a maximum of 90 days. In the case of a 100% remote audit, the full audit shall be conducted as scheduled on consecutive full days.
The COVID-19 crisis has led to supply chain management challenges for food manufacturers and processors, ingredient suppliers and vendors, and regulators. In its Q1 2020 Recall Index, experts from Stericycle advise that companies use this time to take a closer look at their supply chain processes and reevaluate their recall plan.
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