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.
Foodborne pathogens, such as bacteria and parasites in consumable goods, can result in illnesses and deaths, wreaking havoc on residents of states and countries. The companies at fault often face severe damage to their reputation as people fear that continuing to do business with a brand is not safe. Moreover, if the affected enterprises do not take decisive steps to prevent the problem from happening again, they may receive substantial fines or closure orders.
Statistics from the U.S. federal government indicate that there are approximately 48 million cases of foodborne illnesses in the American food supply each year. Fortunately, there are proven steps that production plant managers can take to minimize the risk of foodborne pathogens. Being familiar with the preventative measures, and taking steps to implement them prevents catastrophes.
Engage with Suppliers about Their Efforts to Kill or Reduce Foodborne Pathogens
Foodborne pathogens can enter a production plant on items like fresh produce received from farm suppliers. Agricultural professionals commonly use chlorine to decontaminate goods before shipping them. However, researchers used a chlorine solution on spinach leaves to assess its effectiveness in killing common types of bacteria. The team discovered that, even after chlorine exposure, some bacteria remained viable but undetectable by industrial methods.
Foodborne pathogens can originate at farms for other reasons, too. Failing to take the proper precautions during animal slaughter can introduce contaminants into meats that end up in food production facilities. Water impurities can also pose dangers.
All production plants should regularly communicate with suppliers about the actions they take against foodborne pathogens. Food safety is a collective effort. Practicing it means following all current guidance, plus updating methods if new research justifies doing so. If suppliers resist doing what’s in their power to stop foodborne pathogens, they must realize they’re at risk for severing profitable relationships with production plants that need raw goods.
Consider Using Sensors to Maintain Safe Conditions
The Internet of Things (IoT) encompasses a massive assortment of connected products that benefit industries and consumers alike. One practical solution to enhance food safety in a production plant involves installing smart sensors that detect characteristics that humans may miss.
For example, the USDA published a temperature safety chart that explains what to do with food after a power outage. Most items that people typically keep in refrigerators become dangerous to eat if kept above 40o F for more than two hours.
Food production plants typically have resources like backup power to assist if outages occur. But, imagine a cooler that appears to work as expected but has an internal malfunction that keeps the contents at incorrect temperatures. IoT sensors can help production plant staff members become immediately aware of such issues. Without that kind of information, they risk sending spoiled food into the marketplace and getting people sick.
Researchers also developed a sensor-equipped device that detects the effectiveness of hand washing efforts. In a pilot program involving 20 locations, contamination rates decreased by 60% over a month. Most restrooms at food preparation facilities remind people to wash their hands before returning to work. What if a person takes that action, but not thoroughly enough? Specialty sensors could reduce that chance.
Install Germicidal Ultraviolet Lights
With much of the world on lockdown due to the COVID-19 pandemic, many people want to know if germicidal ultraviolet lights could kill the novel coronavirus. Researchers lack enough information to answer that question definitively. They do know, however, that germicidal ultraviolet lights kill up to 99.99% of bacteria and pathogens.
Plus, these lights are particularly useful in food production because they get the job done without harsh chemicals that could make products unsafe. Ultraviolet lights can damage the skin and eyes, so you must only run them when there are no humans in the room. However, it’s immediately safe to enter the environment after switching the lights off.
These specialized light sources do not eliminate the need for other food safety measures. Think about implementing them as another safeguard against adverse consequences.
Teach Workers about Safe Practices
Food contamination risks exist at numerous points along the supply chain. Mishandling is a major culprit that could make several parties partially responsible for a foodborne pathogen problem. For example, if a person does not wear the proper gear when handling food or stores items intended for raw consumption in places where meat juices touch them, either of those things and many others could cause issues with foodborne pathogens.
As you inform employees about which procedures to take to manage the risks, emphasize that everyone has an essential role to play in keeping products free from contaminants. If workers make ready-to-eat foods, such as packaged sandwiches, ensure they understand how to avoid the cross-contamination that happens when reusing cutting boards or utensils without washing them first.
The FDA requires domestic and foreign food facilities to analyze and mitigate risks. Employee training is not the sole aspect of staying in compliance, but it’s a major component. If a person makes a mistake due to improper or nonexistent training, that blunder could have significant financial ramifications for a food production facility.
Widely cited statistics indicate that food recall costs average more than $10 million, which is a staggering figure in itself. It doesn’t include litigation costs incurred when affected individuals and their loved ones sue companies, or the expenses associated with efforts to rejuvenate a brand and restore consumer confidence after people decide to take their business elsewhere.
Ensuring that workers receive the necessary training may be especially tricky if a human resources professional hires a large batch of temporary employees to assist with rising seasonal demands. If a higher-up tells them that time is of the essence and the new workers must be ready to assume their roles on the factory floor as soon as possible, training may get overlooked. When that happens, the outcomes could be devastating. Efficiency should never get prioritized over safety.
Stay Abreast of Emerging Risks
Besides doing your part to curb well-known threats that could introduce foodborne pathogens, spend time learning about new problems that you may not have dealt with before.
For example, scientists have not confirmed the origin of COVID-19. However, since early evidence suggested live animal sales and consumption may have played key roles, Chinese officials cracked down on the wildlife trade and imposed new restrictions on what was largely an unregulated sector cloaked in secrecy.
Much remains unknown about COVID-19, and it’s but one virus for food producers to stay aware of and track as developments occur. The ongoing pandemic is a sobering reminder not to blame specific groups or ethnicities, and to avoid jumping to hasty conclusions. It’s good practice to dedicate yourself to learning about any production risks that could introduce foodborne pathogens. Read reputable sources, and don’t make unfounded assumptions.
A Collective and Constant Effort
There is no single way to combat all sources of foodborne pathogens. Instead, anyone involved in food production or supply must work diligently together and know that their obligation to prevent issues never ceases.
Safety is defined as controlling exposure for self and others. Going into 2020, the food industry battled safety concerns such as slips and falls, knife cuts, soft-tissue injuries, etc. As an “essential industry”, food-related organizations now face a unique challenge in controlling exposure to COVID-19. Not only must they keep their facilities clean and employees safe, they must also ensure they do not create additional exposures for their suppliers or customers.
These challenges increase at a time when employees may be distracted by stress, financial uncertainties, job insecurity, and worry for themselves and their families. Additionally, facilities may be understaffed, employees may be doing tasks they do not normally do, and we have swelling populations working from home.
While there is much we cannot control with COVID-19, there are specific behaviors that will reduce the risk of viral exposure for ourselves, our co-workers, and our communities. Decades of research show the power of behavioral science in increasing the consistency of safe behaviors. The spread of COVID-19 serves as an important reminder of what food-related organizations can gain by incorporating a behavioral component into a comprehensive exposure-reduction process.
Whether you have an existing behavior based safety process or not, follow these four steps.
It is critical to clearly pinpoint the behaviors you want to see occurring at a high rate. In the food industry, an organization must control exposure both within their facilities as well as during interactions with suppliers and customers. Controlling exposure within facilities will typically include those behaviors recommended by the CDC such as:
Maintain six feet of separation at all times possible.
Avoid touching your eyes, nose and mouth with unwashed hands.
Minimize personal interactions to reduce exposure to transmit or receive pathogens.
Frequent 20-second hand washing with soap and warm water.
Make hand disinfectant available.
Use alternatives to shaking hands.
Frequently clean and disinfect common areas, such as meeting rooms, bathrooms, doorknobs, countertops, railings, and light switches.
Sneeze and/or cough into elbow or use a tissue and immediately discard.
Conduct meetings via conferencing rather than in person.
If you are sick, stay home.
If exposed to COVID-19, self-quarantine for precaution and protection of others.
Supplier/Customer exposure-reduction behaviors will vary depending upon your specific industry and may include pinpointing the critical behaviors for food preparation, loading dock delivery, customer home delivery, and customer pick up. When creating checklists to meet your unique exposures, be sure the behaviors you pinpoint are:
Measurable: The behavior can be counted or quantified.
Observable: The behavior can be seen or heard by an observer.
Reliable: Two or more people agree that they observed the same thing.
Active: If a dead man can do it, it is not behavior.
Influenceable: Under the control of the performer.
Once you have drafted your checklists, ask yourself, “If everyone in my facility did all of these behaviors all the time, would we be certain that we were controlling exposure for each other, our suppliers, and our customers?” If yes, test your checklists for ease of use and clarity.
Step 2: Develop Your Observation Process
To do this, you will want to ask yourself:
Who? Who will do observations? Can we leverage observer expertise from an existing process and have them focus on COVID-19 exposure reduction behaviors or should we create a new observer team?
Where? Which specific locations, job types, and/or tasks should be monitored?
When? When will observers conduct observations?
Data: How will you manage the data obtained during the observations so that it can be used to identify obstacles to safe performance? Can the checklist items be entered into an existing database or will we need to create something new?
Communication: What information needs to be communicated before we begin our COVID-19 Exposure Reduction process and over time? How will we communicate it?
Step 3: Conduct Your Observations and Provide Feedback
Starting the Observation
Your observers should explain that they are there to help reduce exposure to COVID-19 by providing feedback on performance.
Recording the Observation
Observers should note on the checklist which behaviors are occurring in a safe manner (protected) and which are increasing exposure to COVID-19 (exposed).
Feedback is given in the spirit of reducing exposure. It should be given as soon as possible after the observation to reinforce protected behaviors and give the person to opportunity to modify exposed behaviors.
Success feedback helps reinforce the behaviors you want occurring consistently. Effective success feedback includes:
Context: The situation in which the behavior occurred.
Action: The specific behaviors observed which reduce exposure to COVID-19.
Result: The impact of those behaviors on themselves or others—in this case, reduced COVID-19 exposure for themselves, their families and community.
“I care about your safety and do not want to see you exposed to COVID-19. I saw you use hand sanitizer prior to putting on eye protection. By doing that, you reduced the likelihood of transferring anything that might have been on your hands to your face which keeps you safe from contracting COVID-19.”
Guidance feedback is given for exposed behaviors to transform that behavior into a protected one. Effective guidance feedback includes Context, Action, Result, but also:
Alternative Action: The behavior that would have reduced their exposure to COVID-19.
Alternative Result: The impact of that alternative behavior, such as reduced COVID-19 exposure for themselves, their families, and community.
“I care about your safety and do not want to see you exposed to COVID-19. I saw that you touched your face while putting on eye protection. By doing that, you increased the likelihood of transferring anything on your hand to your face which increases your risk of exposure to COVID-19. What could you have done to reduce that exposure?”
When giving guidance feedback, it is important to have a meaningful conversation about what prevented them from doing the safe alternative. Note these obstacles on the checklist.
Step 4: Use Your Data to Remove Obstacles to Safe Practices.
Create a COVID-19 exposure reduction team to analyze observation data. This team will identify systemic or organizational obstacles to safe behavior and develop plans to remove those obstacles. This is critical! When an organization knows that many people are doing the same exposed behavior, it is imperative that they not blame the employees but instead analyze what is going on in the organization that may inadvertently be encouraging these at-risk behaviors.
For example, we know handwashing and/or sanitizing is an important COVID-19 exposure reduction behavior. However, if your employees do not have access to sinks or hand sanitizer, it is not possible for them to reduce their exposure.
Similarly, the CDC recommends that people who are sick not come to work. However, if your organization does not have an adequate sick leave policy, people will come to work sick and expose their co-workers, customers and suppliers to their illness.
Your COVID-19 exposure reduction team should develop plans to remove obstacles to safe behavior using the hierarchy of controls.
Consistently executing critical behaviors is key to reducing exposure to COVID-19 as flattening the curve is imperative in the worldwide fight against this pandemic. Regardless of the type of behavior or the outcome that the behavior impacts, Behavior based safety systems work by providing feedback during the observations and then using the information obtained during the feedback conversation to remove obstacles to safe practices.
By using these tips, you can add a proven and powerful tool to your arsenal in the fight against COVID-19 and help keep your employees, their families, and your community safe.
Today the FDA announced that it will begin requesting electronic records related to import records required under FSVP for Importers of Food for Humans and Animals. The agency is moving to remote inspections as a result of the COVID-19 pandemic. FDA stated that in “rare” instances it will onsite FSVP inspections—these situations include outbreaks.
“The FDA will immediately begin conducting a limited number of remote inspections, prioritizing the inspections of FSVP importers of food from foreign suppliers whose onsite food facility or farm inspections have been postponed due to COVID-19. The Agency is also planning to continue to conduct previously assigned routine and follow-up inspections remotely during this time. Importers subject to the remote inspections will be contacted by an FDA investigator who will explain the process for the remote inspection and make written requests for records.” – CFSAN Constituent Update
Well-known food and beverage brands will often turn to contract manufacturers to produce the quality products that their customers expect and enjoy. With their brand names on the line, these brand owners need assurance that their suppliers can deliver safe and high-quality goods and mitigate the looming threat of recalls.
How do they know if they’re working with a reliable contract manufacturer? Well, many will look to see if they hold certifications from a reputable third-party organization, such as the Safe Quality Food Institute (SQFI). In fact, one in four companies today require that their suppliers have SQF certification, making it one of the most important certifications in contract manufacturing.
SQF certification demonstrates that a supplier has met benchmarked standards—set by the Global Food Safety Initiative (GFSI)—for upholding quality and controlling food safety risks. It’s a form of validation of an organization’s ability to consistently produce safe and high-quality products. Contract manufacturers that have SQF certification are more likely to win contracts and can bid for business on a national or global scale. Thus, it presents a clear competitive advantage to those certified in the various levels of SQF certification.
Level 1: The SQF Safety Fundamentals Program is an introduction to food safety standards for small- to medium-sized food suppliers. Ideal for those with low-risk food products, the program doesn’t meet GFSI standards but establishes a foundation for doing so. Suppliers certified at this level typically sell their services to smaller, local purveyors.
Level 2: The SQF Food Safety Program follows GFSI-benchmarked food safety standards. It helps sites implement preventive food safety measures according to Hazard Analysis and Critical Control Points (HACCP) regulations, which ensure scientific analysis of microbiological, physical and chemical hazards are applied at each step of the supply chain. This level is ideal for businesses that would like to work with purveyors that require adherence to GFSI benchmarked standards.
Level 3: The SQF Food Safety and Quality Program shows an ability to not only contain safety risks through the HACCP system, but also monitor and control threats related to food quality. This highest level of certification is ideal for large-scale producers, manufacturers, food packaging facilities and distributors that have successfully deployed an SQF Food Safety Program and want to go above and beyond in their quality efforts.
While it’s the most demanding of the three, Level 3 certification is what most contract manufacturers should aspire to because it’s required by many of the world’s largest food and beverage brands. In order to attain this level of distinction, contract manufacturers need an effective way to demonstrably meet all GFSI benchmarked standards and readily access their quality data during an audit. This is where statistical process control (SPC) comes in.
The SPC Gamechanger
SPC is a proven methodology for monitoring and controlling quality during the manufacturing process. SPC enables manufacturers to chart real-time quality data against predefined control limits to identify unwanted trends and product or process variations. If there is an issue, timely alerts will notify responsible parties to take remedial action early on, preventing unsafe or poor-quality goods from entering the supply chain and triggering a recall. This establishes strong controls for food quality and safety in accordance with a Level 3 SQF Program. Audits also become a breeze, as all historical data are stored digitally in a centralized repository. Suppliers can thereby quickly and easily produce auditor-requested reports showing compliance with SQF requirements and GFSI standards.
But beyond quality monitoring and facilitating audits, SPC can deliver greater impact by providing suppliers with analytical tools useful for mining historical data for actionable insights. They can run comparative analyses of the performance of different lines, products, processes, or even sites, revealing where and how to further reduce risk, improve consistency, streamline operations, and lower production costs. In this way, SPC lends itself to a profit-positive business model—driving additional savings through process improvement while increasing new business opportunities through contracts won via SQF certification.
A Snacking Success
One contract manufacturer of savory and healthy snacks previously struggled with large variations in product quality. These inconsistencies often resulted in quality holds or process aborts that generated high waste and costs. By implementing SPC, the snack supplier was able to take advantage of a wide range of data—including incoming receiving tracking and quality inspection tracking—to finetune its production processes with effective controls for food quality and safety. In addition to a 30% reduction in customer complaints, SPC has helped the supplier realize a $1 million reduction in product waste and attain Level 3 SQF certification, the latter of which has generated continued new business from several well-known snack food brands.
This snack supplier is a clear example of SQF certification as a competitive differentiator. Working with such SQF-certified and SPC-powered contractors is important to food and beverage brands because they can protect their reputations and ensure continued customer retention by way of safe, consistent, high-quality products. Ultimately, it builds greater trust and integrity in the supply chain among companies and consumers alike.
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