FDA has given an update on its resources to provide the industry with continued assistance as it struggles through the challenges presented by the ongoing pandemic.
The Food and Agriculture Sector Coordinating Council is a collaboration between FDA, USDA, the U.S. Department of Homeland Security and the Food and Agriculture Government Coordinating Council to discuss critical infrastructure security and resilience activities. Companies that want to get involved with the council or discuss the supply chain disruptions that they have been experiencing, they can contact Clay Detlefsen, Chairman of the council and Senior Vice President, Environmental and Regulatory Affairs & Staff Counsel; National Milk Producers Federation.
The FDA has also issued several temporary policies (guidance documents) to help companies, including:
A very volatile sector, there are always new trends, opportunities and challenges in the food space, as a multitude of factors—including global climate and geopolitical challenges—can cause supply chain disruptions. Sustainable audits are heightening in demand, in order to validate company claims and provide consumers with peace of mind, as the industry continues to evolve with new ingredients, processes and technologies in play.
Consumers Today Demand Sustainable Practices and Transparency
The shift towards sustainability has further been accelerated by COVID-19, as the pandemic has made for more ethical and conscious consumers. According to research from Forrester, 68% of highly empowered consumers plan to ramp up their efforts to identify brands that reduce environmental impact. While there are numerous audits to measure sustainability and social responsibility, trending focus areas in the food space today are around sustainable packaging, water usage and food waste.
Three Ways Food Processors and Manufacturers Can Reduce Their Footprint
Key players across the food industry are stepping up to the challenge and finding innovative ways to minimize their environmental impact. The following are three ways food processors and manufacturers can reduce their footprint.
Use Environmentally Friendly Packaging: Food packaging is a major source of waste and pollution. In fact, containers and packaging make up a major portion of municipal solid waste (MSW), amounting to 82.2 million tons of generation in 2018, according to the EPA. Unfortunately, most packaging is designed as single-use, and is typically thrown away rather than reused or recycled. Given the impacts of packaging on the environment, more manufacturers are looking into packaging options that reduce waste and boost sustainability, including wood- and paper-based alternatives. Other manufacturers are developing innovative alternative packaging from biodegradable materials. The same rings true for takeout and grocery delivery, as the demand for home consumption grows, retail and foodservice companies are considering utilizing more sustainable packaging or reduce the use of virgin plastics to offset their impact.
Increase Energy and Water Efficiency: Food processing and manufacturing are energy- and water-intensive. In fact, according to the World Resources Institute, the 1.3 billion tons of wasted food annually also includes 45 trillion gallons of water. Water conservation methods can be implemented throughout the entire food chain—from selecting more efficient crops, to using less water within processing facilities and ultimately reducing food waste on the backend of the chain.
Reduce Food Waste: According to the Food and Agriculture Organization of the United Nations (FAO), nearly one-third of food produced for human consumption gets wasted each year. In fact, the carbon footprint of food waste is greater than that of the airline industry. This also includes the waste of resources used to produce the food including water, soil, transportation and labor. By improving processing and manufacturing efficiencies, we can reduce waste and better manage resources. Implementing systems to categorize and assess food waste can help identify areas for improvement and enable your team to develop a plan to correct.
Value-Add of Sustainability
Sustainability provides benefits to the consumer, the manufacturer and society-at-large. The consumer feels better about making a purchase that is not only better for the planet, but that may also provide health benefits to themselves and their families. The Organic Trade Association’s 2021 U.S. Organic Industry Survey highlights this trend, as organic food has the reputation of being better for your health and more sustainable for the planet. Organic food sales were up 12% in 2020, the highest growth rate in this category in over a decade.
Intrinsically, manufacturers with sustainable programs in place feel better about the work they are doing, knowing that they are supporting a better world. Companies that publicize their green programs and back them up with the applicable certifications can also attract top employees, despite today’s talent wars. Employees are zeroed in on corporate social responsibility and desire to work for a company that aligns with their purpose.
As it relates to the bottom line, the common misconception is that the sustainable choice will cost more. However, as sustainable supply increases due to consumer demand, companies are able to source sustainable inputs more affordably. Furthermore, they can communicate their commitments via certification bodies, through public forums and by labeling products based on their certifications. These approaches help reach and educate consumers at different levels—from their initial research of products to purchases from the store shelves.
Key Certifications and Auditing Technology
To reduce their environmental footprint throughout the value chain and implement more sustainable business practices, food companies can move toward a circular economy business model. By renewing, reusing and recycling materials at every stage of the food supply chain, companies can preserve the critical resources that allow their business to flourish.
There are a wide range of services help food producers make the transition to a more sustainable business model. This includes the GHG emissions verification, and management system auditing and certification or training to standards like ISO 14001 (Environmental Management System), ISO 24526 (Water Efficiency Management System), AWS (Alliance for Water Stewardship), ISO 50001 (Energy Management System) and SA8000 (Social Accountability standard), as well as SMETA (Sedex Members Ethical Trade Audit) audits. There are also a range of food sustainability-related product certifications including Organic, MSC, ASC and RSPO.
Auditing technology supports a range of requirements and helps teams set achievable targets. It can be used to analyze packaging materials, categorize and assess food waste, and monitor water usage. Newer auditing technology is now blockchain enabled to assess raw materials and packaging, and to ensure third party partners are also socially responsible. This information is packaged into a blockchain solution so that food companies can be confident that the auditing information is correct and secure. Furthermore, this technology provides the added visibility into their network should they have a recall.
How To Initiate or Ramp Up Your Sustainable Programs
For companies interested in kicking off a sustainability program, or branching into new levels of sustainability, a great place to start is training, in order to understand the audit standard. Early on in this process, ensure all parties are onboard and aware of the certification process and related costs—from managers who will be implementing the program daily to board level executives providing the final sign off. Doing this helps allocate sufficient time and resources and avoids surprises down the road.
It’s helpful to work with a third-party consultant through this process, as they are able take a birds-eye-view look to identify gaps in the program and help you achieve specific certification requirements that meet your unique food product needs. If your team works with a consultant to put together a plan that includes auditing, testing, inspection and certification, the right partner can verify that the program meets all the requirements necessary for the certification.
To keep your program running efficiently, arrange regular trainings for employees to stay up to date on the latest requirements and fill any gaps. For more specialized programs, it’s also a good idea to set aside standalone training sessions to avoid information overload.
As the industry continues to innovate, there will be more ways to reduce waste throughout the entire supply chain and build more efficient business models that are better for the company, consumers and the planet. Looking ahead to next year and beyond, the trend towards sustainability and transparency will press on. Ultimately, companies that take the extra steps to be more sustainable are setting a higher standard for industry and supply chain partners and building a pathway for long-term success.
This week the final episode of the 2021 Food Safety Consortium Virtual Conference Series takes place, and appropriately closes out with an afternoon of insights about navigating a career in food safety. The following is the agenda for Thursday’s episode, which begins at 12 pm ET.
A Modern, Multi-Layered Approach to Professional Development in Food Safety, with Darin Detwiler, Northeastern University
What I Wish I Had Known Early in My FSQ Career, with Jill Stuber, The Food Safety Coach and Tia Glave, Tia Glave Consulting
Mentorship Minute and Career Development Journey: From QA Technician to SVP, a conversation between Deborah Coviello, Illumination Partners and Brian Perry, TreeHouse Foods
This week’s episode of the 2021 Food Safety Consortium Virtual Conference Series will discuss the challenges that the industry faces in managing the supply chain, including in the realm of audits. The following is the agenda for this Thursday’s session:
Food Safety as a Supply Chain Management Problem, with John Spink, Ph.D., Michigan State University
Supplier Certification in Today’s Supplier Quality Management Programs: A Discussion with Gary van Breda, McDonald’s; Jorge Hernandez, Wendy’s; and moderated by Kari Hensien, RizePoint; Sponsored by RizePoint
What Needs to Change in Food Safety Certification: A GFSI Panel Discussion moderated by Erica Sheward, GFSI
Auditing Update in the Age of COVID: FDA Standards and Regulations Alignment Pilot, with Trish Wester, AFSAP
This year’s event occurs as a Spring program and a Fall program. Haven’t registered? Follow this link to the 2021 Food Safety Consortium Virtual Conference Series, which provides access to all the episodes featuring critical industry insights from leading subject matter experts! Registration includes access to both the Spring and the Fall events. We look forward to your joining us virtually.
Managing the complexities of a management system is challenging for any food and beverage company, particularly for the team tasked with implementing the system throughout the organization. That is because every regulatory agency (e.g., FDA, USDA, OSHA, EPA) and voluntary certification (e.g., GFSI-benchmarked standards, gluten-free, organic, ISO) calls for companies to fulfill compliance requirements—many of which overlap. Supply chain and internal requirements can create further complications and confusion.
In today’s “New Era of Smarter Food Safety,” having a common system to organize, manage and track compliance offers an ideal solution. Dynamic tools are becoming available—systems that can manage employee training, pest control, laboratory testing, supply chain management tools, regulatory compliance and certification requirements, etc.
Unfortunately, these systems are often not set up to “talk” to each other, leaving company representatives to navigate many systems, databases, folders, and documents housed in many different locations.
The Solution: Compliance Management Systems
An integrated compliance management system (CMS) is intended to bring all these tools together to create one system that effectively manages compliance requirements, enables staff to carry out daily tasks and manage operations, and supports operational decision making by tracking and trending data that is collected daily by the team charged with implementation.
A CMS is used to coordinate, organize, control, analyze and visualize information to help organizations remain in compliance and operate efficiently. A successful CMS thinks beyond just access to documents; it manages the processes, knowledge and work that is critical to helping identify and control business risks. That may include the following:
Ensuring only authorized employees can access the right information.
Consolidating documents and records in a centralized location to provide easy access
Setting up formal business practices, processes and procedures
Implementing compliance and certification programs
Monitoring and measuring performance
Supporting continuous improvements
Documenting decisions and how they are made
Capturing institutional knowledge and transferring that into a sustainable system
Using task management and tracking tools to understand how people are doing their work
Enabling data trending and predictive analytics
CMS Case Study: Boston Sword and Tuna
In early 2019, Boston Sword and Tuna (BST) began the process of achieving SQF food safety certification. We initially started working with BST on the development, training and implementation of the program requirements to the SQF code for certification—including developing guidance documents for a new site under construction.
The process of attaining SQF certification included the development of a register of SQF requirements in Microsoft SharePoint, which has since evolved into a more comprehensive approach to overall data and compliance management. “We didn’t plan to build a paperless food safety management system,” explains BST President Larry Dore, “until we implemented our SQF food safety management program and realized that we needed a better way to manage data.”
We worked with BST to structure the company’s SharePoint CMS according to existing BST food safety management processes to support its certification requirements and overall food safety management program. This has included developing a number of modules/tools to support ongoing compliance efforts and providing online/remote training in the management of the site and a paperless data collection module.
The BST CMS has been designed to support daily task activities with reminders and specific workflows that ensure proper records verifications are carried out as required. The system houses tools and forms, standards/regulatory registers, and calendars for tracking action items, including the following:
Ambient Temperature
Corrective and Preventive Action (CAPA)
Chemical Inventory/Safety Data Sheets (SDS)
Compliance Management
Customer Complaints
Document Control
Employee Health Check
Food Safety Meetings Management Program
Forklift Inspections
Good Manufacturing Practices (GMP) Audit
SQF Register
Maintenance (requests/work orders/assets/repairs)
Nightly Cleaning Inspections
Operational/Pre-Operational Inspections
Sanitation Pre-Op Inspections
Scale Calibration
Sharp/Knife Inspections
Shipping/Receiving Logs
Thawing Temperature Log
Thermometer Calibration
Key Considerations for Designing a Successful CMS
An effective CMS requires an understanding of technology, operational needs, regulatory compliance obligations and certification requirements, as well as the bigger picture of the company’s overall strategy. There are several key considerations that can help ensure companies end up with the right CMS and efficiency tools to provide an integrated system that supports the organization for the long term.
Before design can even begin, it is important to first determine where you are starting by conducting an inventory of existing systems. This includes not only identifying how you are currently managing your compliance and certification requirements, but also assessing how well those current systems (or parts of them) are working for the organization.
As with many projects, design should begin with the end in mind. What are the business drivers that are guiding your system? What are the outcomes you want to achieve through your system (e.g., create efficiencies, provide remote access, reduce duplication of effort, produce real-time reports, respond to regulatory requirements, foster teamwork and communication)? Assuming that managing compliance and certification requirements is a fundamental objective of the CMS, having a solid understanding of those requirements is key to building the system. These requirements should be documented so they can be built into the CMS for efficient tracking and management.
While you may not build everything from the start, defining the ultimate desired end state will allow for development to proceed so every module is aligned under the CMS. Understand that building a CMS is a process, and different organizations will be comfortable with different paces and budgets. Establish priorities (i.e., the most important items on your list), schedule and budget. Doing so will allow you to determine whether to tackle the full system at once or develop one module at a time. For many, it makes sense to start with existing processes that work well and transition those first. Priorities should be set based on ease of implementation, compliance risk, business improvement and value to the company.
Finally, the CMS will not work well without getting the right people involved—and that can include many different people at various points in the process (e.g., end user entering data in the plant, management reviewing reports and metrics, system administrator, office staff). The system should be designed to reflect the daily routines of those employees who will be using it. Modules should build off existing routines, tasks, and activities to create familiarity and encourage adoption. A truly user-friendly system will be something that meets the needs of all parties.
Driving Value and Compliance Efficiency
When thoughtfully designed, a CMS can provide significant value by creating compliance efficiencies that improve the company’s ability to create consistent and reliable compliance performance. “Our system is allowing us to actually use data analytics for decision making and continuous opportunity,” said Dore. “Plus, it is making remote activities much more practical and efficient”.
For BST, the CMS also:
Provides central management of inspection schedules, forms, and other requirements.
Increases productivity through reductions in prep time and redundant/manual data entry.
Improves data access/availability for reporting and planning purposes.
Effectively monitors operational activities to ensure compliance and certifications standards are met.
Allows data to be submitted directly and immediately into SharePoint so it can be reviewed, analyzed, etc. in real time.
Creates workflow and process automation, including automated notifications to allow for real-time improvements.
Allows follow-up actions to be assigned and sent to those who need them.
All these things work together to help the company reduce compliance risk, create efficiencies, provide operational flexibility, and generate business improvement and value.
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.
3M Food Safety has received the AOAC Research Institute’s Performance Tested Method Certification for its Petrifilm Rapid E.coli/Coliform Count Plate. Introduced in February, the rapid microbial test helps food and beverage processors detect the presence of E.coli and other coliform bacteria. The test can recover E.coli and distinguish it from other coliforms within 18–24 hours.
The AOAC PTM designation validated the count plate as an equivalent alternative to FDA and ISO standard references to enumerate these bacteria. The evaluation was performed by an independent lab on food and environmental surfaces that include raw and pasteurized dairy products; raw and prepared meat; poultry and seafood; fresh fruit and product; and baby food, pet food and flour.
3M Food Safety is also pursuing MicroVal validation in accordance with ISO 16140-2.
Eurofins Food Safety Systems and Orion Assessment Services have announced a partnership that will expand their auditing and certification services on a global scale.
“The partnership will allow Eurofins to broaden their BRC Global Standards and GFSI scheme auditing resource base and provide them additional expertise in BRC to utilize. It will also allow Orion Assessment Services to operate under the Eurofins accreditation for BRC, SQF and FSSC 22000 schemes,” according to a Eurofins news release. “As a certification body, this collaboration will enhance the standards currently offered through Orion Assessment Services’ accreditation for ISO 17065 and ISO 17021, as well as offering brand new opportunities in the various GFSI schemes, for both existing and new clients internationally.”
This year is being described as “the year of FSMA compliance,” as many compliance dates for the various FSMA rules fall in 2017. As one might expect, the FSMA law and rules include many aspects of the established Global Food Safety Initiative (GFSI) standard; however, there are also differences in how they are applied to create better food safety enforcement.
At the most basic level, GFSI is an industry conformance standard for certification, while FSMA is a compliance regulation that must be met. However, both work together to ensure companies are effectively managing food safety.
GFSI Conformance
The GFSI is facilitated by the industry network of The Consumer Goods Forum. It provides a very solid foundation and supporting objective of “safe food for consumers everywhere”.
GFSI was originally established based on a growing pattern of food safety outbreaks throughout the international marketplace. This led to the proactive development of GFSI standards as an alternative to the more limited and less effective customer audits in place at the time. An important part of this outcome was that CEOs in the food industry—not a regulatory body—determined the need to address food safety through the GFSI food safety standard.
With its beginning as a benchmarking organization, GFSI has since evolved throughout the food supply chain as a strong means for achieving global food safety. It is now established, growing, and improving across the primary supply chains within the global food market.
As such, much work to address food safety has been accomplished by GFSI over the past sixteen years. In fact, the industry-driven aspect of GFSI along the food supply chain has led many companies to achieve levels of food safety comparable to those required to achieve FSMA compliance. Based on its collaboration of food safety experts, GFSI provides for a significant evolution of food safety programs and supports those requiring FSMA compliance.
FSMA Compliance
During a similar timeframe, the United States identified food safety as a major concern for the public. In the 1990s, a growing number of food outbreaks from biological contamination continued to spread, prompting the addition of controls within both the USDA and FDA. These brought the mandated requirement for Hazards and Critical Control Points (HACCP) and supporting Good Manufacturing Practices (GMPs) to specific industry sectors. However, these efforts were measured to have limited effect, as the outbreaks continued.
By the early 2000s, the public concern for food safety continued, and the FDA was determined to make changes. Along with Congress, the FDA commissioned research into the underlying issues that were resulting in the growing number and severity of food outbreaks. This research was being conducted and analyzed just as GFSI was determining its final group of benchmarked standards. At the same time, GFSI was positioned to be advanced into the U.S. market by food industry leaders, including Cargill, McDonalds, Walmart, Kroger, Coca Cola and Wegmans.
The outcomes from the FDA studies determined that the GMPs (in existence for the past 40 years) were not effectively implemented across the U.S. food industry. Further, the studies indicated that the ability to prevent food safety issues through specific controls would provide a means for reducing the number of foodborne illness.
This effort led to the development of FSMA, which passed in January 2011. Additional FSMA rules have since been published, starting in September 2016. The FSMA rules represent a rewrite of the existing FDA food safety regulations. However, with the FSMA law taking several years to roll out, the existing FDA laws remain in effect until they are replaced. These actions expand the FDA’s jurisdiction now and until full compliance of FSMA.
Bringing GFSI and FSMA Together
The presence of GFSI in the United States, as well as the GFSI certification of many suppliers to U.S. food importers, provides for a synergy between the GFSI standard and the FSMA law being enforced throughout the United States and its foreign suppliers. GFSI’s global focus provides the structure to adapt and meet many of the FSMA requirements, with the ability to expand to all FSMA requirements.
As one would expect, the FSMA law and rules include several aspects of the GFSI standard; however, there are many differences in how each is applied to encourage better food safety enforcement that must be considered. For instance, GFSI has the advantage of providing the time to develop programs, and thousands of companies are certified to the various programs under the standard. Conversely, FDA is implementing FSMA compliance over several years, with 2017 being a big year for compliance (based on the rules’ published dates, company size and industry segment).
In this new order of food safety in the United States, those companies that have achieved GFSI certification should have an advantage over those who do not, provided they can align their GFSI programs with the FSMA law requirements. There is also a benefit to starting with FSMA and moving to a GFSI certification.
Existing GFSI certifications provide an established framework, with many of the program requirements similar to those required by FSMA. For example, personnel are required by both to establish HACCP and Food Safety Plans, as well prerequisite procedures (PRPs) and current-Good Manufacturing Practices (cGMPs). The challenges are ensuring the complete development of these food safety procedures to guarantee they meet both GFSI and FSMA requirements.
As another example, personnel requirements are similar but different under FSMA and GFSI, which calls for training, updating and qualifying resources. Ultimately, advanced HACCP training under GFSI provides the means for establishing a Qualified Individual under FSMA, but it requires expanding the training to include FSMA Preventive Controls and procedures. The resulting plan is the food safety plan that can be based on HACCP but with the proper additions to meet FSMA requirements.
Global Food Safety Conference
The upcoming Global Food Safety Conference (February 27 – March 3 in Houston, Texas) provides an opportunity for those seeking compliance to FSMA or certification to a scheme within the GFSI Standard to get a deeper understanding of food safety. With 2017 being the year of FSMA compliance, it is very appropriate that the Global Food Safety Conference be held in the United States this year. The conference will provide U.S. companies attending, as well as foreign supplier of products to the U.S. market, an educational opportunity and forum to reach out to experts from industry, government, and academia to better understand these two key areas for food safety program development. Some of the topics to be addressed at the conference include the following:
Food safety management commitment and corporate governance
Required training of food safety roles, including management, staff and operations
Specific requirements of the documented food safety program or written programs under FSMA
FDA requirements of the past and existing requirements prior to FSMA and the relationship of these as comparable to GFSI
Implications for FDA enforcement under FSMA of these previous requirements and program requirements that may need to be formalized under FSMA
The proof of evidence with supporting records required by FSMA that may be addressed in part by existing or GFSI-level food safety programs
How to adapt a FSMA-level food safety plan and preventive controls cGMPs from existing programs, including GFSI, or develop these to function with existing programs
Levels and numbers of qualified individuals, qualified auditors and competent sanitation for oversight and management of FSMA food safety plans
Management reanalysis and update of the written FSMA programs to ensure compliance and readiness for inspection by FDA FSMA investigators
Process used to ensure compliance with FSMA Preventive Controls and the other FSMA rules being issued in 2017 and 2018, including Foreign Suppler Verification, Sanitary Transportation and Intentional Adulteration
Kestrel has been a long-time advocate of GFSI, performing site certification program development support for hundreds of companies. We have served as a GFSI Stakeholder, Technical Working Group participation, and panelist at previous GFSI Global Food Safety Conferences. We look forward to seeing you at the 2017 GFSI Global Food Safety Conference and to helping you navigate GFSI conformance and FSMA compliance requirements.
Now that the first of the FSMA compliance dates have passed, let’s look back at the past year of training new PCQIs, their questions and concerns from classes as well as the perspective from our FDA friends (yes, really!) who attended our workshops. We have learned so much, it is hard to narrow it down to only five things—but if we look at the issues that arose, the following five proved to be recurring themes throughout 2016.
5. Don’t Scrap Your Current Plan
Many clients have approached us and said they were planning to throw their current food safety and/or HACCP plan in the trash and start from scratch. Please don’t do this! Companies that care about quality and food safety already have effective quality management systems in place. It would be a disservice to the company and the general public for all these time-tested plans to go straight into the bin. It is more realistic to take a look at the current system in light of the new regulation and ask yourself if there are any gaps that can be addressed. This brings us to the next point.
4. Education Is Key
A compliant system cannot be developed without an understanding of the requirements. Although FSMA is derived from the basic principles of HACCP, there are key differences, and not all of them in the direction of less regulation. It is important to understand not only the updated Good Manufacturing Practices and Preventive Controls for both Human and Animal food, but also the Foreign Supplier Verification Program, Sanitary Transportation and the Produce Rule (if they apply). Although the FDA-recognized curriculum for some of these companion regulations have not yet been released, some independent training providers are offering workshops to help fill the gap while the FDA and FSPCA are working on the official curriculum. (Comment on this article for more information via email).
3. “You Must Evaluate If You Need It” Is Not the Same as “You Don’t Need It”
Some training providers have told their attendees that they can scrap many of their current systems because FSMA is less stringent than GFSI-approved schemes. Your certification body for FSSC 22000, SQF or BRC does not care one whit how stringent FSMA is (as long as you are compliant with its requirements, as local regulatory compliance is a key factor in GFSI approval). FSMA will not change expectations related to the GFSI-approved food safety schemes. It is also misleading to think that because FSMA is flexible, FDA regulators will not have expectations of excellence when they arrive at food processing facilities. This law gives regulators the power to take legal actions to address many infractions they have seen over the years but have been powerless to stop; the flexibility may well be a double-edged sword in that regard. Ensure that all decisions are based on data and records exist to validate any claims.
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