Tag Archives: standards

Sayed M Naim Khalid

The Imperative for an Integrated Food Safety Management System

By Sayed M Naim Khalid
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Sayed M Naim Khalid

As the global food industry continues to evolve, the importance of ensuring food safety has never been more critical. Various standards and certifications, such as GFSI, Organic, Global GAP, HACCP, and ISO standards, have been established to address different aspects of food safety. However, the proliferation of these diverse standards pose a significant challenge — especially for small businesses — in terms of cost, complexity, and overall compliance. In this article, we will explore the need for an integrated food safety management system (FSMS) that consolidates these standards into a comprehensive and unified framework.

Current Challenges in Food Safety Standards

The food industry is subject to a multitude of regulations and standards, each designed to address specific concerns related to food safety. The Global Food Safety Initiative (GFSI) aims to harmonize and strengthen food safety standards across the supply chain. Similarly, standards like Organic, Global GAP, HACCP, and ISO provide guidelines for organic production, agricultural practices, hazard analysis, and quality management systems, respectively.

While these standards individually contribute to enhancing food safety, their coexistence often imposes a heavy burden on businesses, particularly smaller ones. Each standard necessitates a separate certification process, involving costs related to preparation, audits, and ongoing maintenance. This fragmented approach can be overwhelming for businesses, leading to inefficiencies and potential gaps in compliance.

Cost Implications for Small Businesses

Small and medium-sized enterprises (SMEs) in the food industry face a unique set of challenges when it comes to adhering to multiple food safety standards. The financial implications of obtaining certifications for each standard can be prohibitive. For instance, a small-scale food producer dealing with organic products may also need to comply with GFSI standards for global market access.

Certification costs — including consulting fees, documentation, and audit expenses —  quickly accumulate. Moreover, the need for ongoing compliance monitoring and updates can strain the already limited resources of smaller businesses. This situation raises concerns about the equitable access to global markets for businesses of all sizes.

The Role of an Integrated Food Safety Management System

The call for an integrated FSMS is rooted in the idea of streamlining and unifying the various standards to create a more accessible and efficient framework. By integrating these standards, businesses could achieve a single certification that covers multiple aspects of food safety, reducing the financial and administrative burden.

Integration can lead to a more cohesive approach to food safety, eliminating redundancies and ensuring a holistic understanding of potential risks throughout the supply chain. This not only simplifies the certification process but also facilitates better communication and collaboration among stakeholders, including producers, processors, distributors, and regulators. Benefits of an integrated FSMS include:

  • Cost Efficiency. An integrated FSMS would significantly reduce the costs associated with multiple certifications. Businesses can allocate resources more efficiently, making certification attainable for a broader range of enterprises.
  • Simplified Compliance. Streamlining standards into a unified system simplifies compliance efforts. Businesses can focus on meeting a comprehensive set of requirements rather than navigating the intricacies of various individual standards.
  • Enhanced Food Safety. Integration ensures a more comprehensive and interconnected understanding of food safety risks. This can result in a more effective preventive approach, addressing potential hazards at various stages of the production and distribution process.
  • Global Market Access. A single, globally recognized certification can facilitate market access for businesses, especially SMEs. This reduces barriers to entry and fosters fair competition in the global marketplace.
  • Improved Collaboration. Stakeholders across the supply chain can better collaborate when operating under a common framework. Enhanced communication and information sharing contribute to a more resilient and responsive food safety ecosystem.
  • Adaptability to Emerging Challenges. An integrated FSMS can be designed to incorporate emerging challenges and adapt to evolving risks in the food industry. This flexibility ensures that the system remains relevant and effective over time.

Challenges in Implementing an Integrated FSMS

While the benefits of an integrated FSMS are evident, the transition from the current fragmented system to a unified framework is not without challenges. Some potential hurdles include:

  • Resistance to Change. Stakeholders accustomed to existing standards may resist the shift towards integration. Overcoming resistance through education and awareness campaigns is crucial for successful implementation.
  • Technical Harmonization. Ensuring technical harmonization across different standards requires meticulous planning and collaboration. Consensus on common terminology, risk assessment methodologies, and other technical aspects is essential.
  • Regulatory Alignment. Coordinating with regulatory bodies to align an integrated FSMS with existing regulations is necessary. This involves addressing legal and regulatory challenges to ensure widespread acceptance.
  • Resource Allocation. Developing and implementing an integrated FSMS requires significant resources. Small businesses, in particular, may need support and incentives to make the transition feasible.
  • Global Acceptance. Achieving global acceptance of an integrated FSMS may take time. International cooperation and agreement on common standards are vital to ensure recognition across borders.

The need for an integrated food safety management system is evident in the face of an ever-evolving food industry. As standards such as GFSI, Organic, Global GAP, HACCP, and ISO play crucial roles in ensuring food safety, their integration into a comprehensive framework is imperative. The benefits, including cost efficiency, simplified compliance, enhanced food safety, global market access, improved collaboration, and adaptability to emerging challenges, make a compelling case for the adoption of an integrated FSMS.

While challenges in implementation exist, the long-term advantages for businesses, consumers, and the industry as a whole outweigh the difficulties. Governments, regulatory bodies, industry associations, and businesses should collaboratively work towards the development and adoption of an integrated FSMS that strengthens food safety practices, fosters innovation, and promotes equitable access to global markets. In doing so, the global food industry can move towards a more unified and resilient future, ensuring the safety and quality of food products for generations to come.

Olvia Pitts

Tips for Building a Robust Internal Audit Program

By Olivia Pitts
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Olvia Pitts

Developing an internal audit program does not have to be a dauting task. With a small amount of work upfront a program can be developed and implemented in a matter of weeks. In this article we discuss the key elements of a successful program and provide guidance to ensure that audits add value to the daily operations across the facility.

Have a Plan in Mind

The first step in any successful audit program is to identify the overall structure and format. Audit programs can be set up in a variety of ways ranging from an annual full system audit to monthly departmental audits. The format and structure should be unique to each individual organization. Determine what works best for the organization and stick with it.

Developing a concise schedule will help to ensure expectations are clear. This schedule should be communicated with team members via appropriate channels. Identifying a point person to routinely follow up on the progress of the audits will ensure the program is being managed as expected. Considerations should be made for potential scheduling challenges. Build in additional time for those areas that are known to encounter delays.

Staying consistent with the maintenance and review of the program will ensure all audit activities are conducted within the expected timeframe. This can be accomplished by establishing a routine review of the program. Monthly review meetings can be established to review the audit schedule, results of audits and pending action items. During this time necessary adjustments can be made as needed and communication plans can be established. This helps to drive engagement across the organization around the entire audit program.

Accurate maintenance of audit records is a crucial step in maintaining a successful program. Ensure all records are properly filed and protected by establishing a designated filing system. Developing an organized file structure aids in keeping files in one place and reduces frustrations around locating documentation in the future. Be sure to include records for both internal and external audits as they are a required input to management review and may be needed for future assessments.

Build a Strong Audit Team  

Having a good pool of auditors to pull from is critical. The number of auditors needed will vary based upon the size of the business and complexity of the processes. When considering the format of your team consider the backgrounds of the team members selected. There should be a good mix of experienced and new auditors to provide balance among the group. When assigning auditors to specific areas consider technical knowledge for those complex processes that may require a deeper understanding. Pairing auditors together is a great way for auditors to learn from each other as they work through the review of the data.

Auditing is often a required responsibility for QA/RA. Recruiting internal auditors from departments outside of QA/RA is beneficial, as they bring a different perspective and may ask questions that seem obvious to QA/RA professionals. All of the standards require auditors to be trained and/or competent in the auditing process. Training can be done externally or internally, and companies must show proof of training.

Selecting auditors from varying backgrounds is a great way to incorporate diversity within the team. Each auditor brings their unique experience to the group which builds a richer audit. Varying viewpoints helps to push the team to dig deeper to identify issues that may otherwise go unnoticed. Encourage the audit team to work together to build audit checklists that are specific to the area being audited. Conducting a review of the process and supporting documentation prior to the audit will enable the team to gain an understanding of the area under review. Encourage auditors to not become locked into the checklist but rather think of it as a guide. If audit trails within the scope of the audit arise during the audit be all means explore if time allows. This approach helps to empower the audit team by providing a sense of autonomy over their work.

When building the audit team, management should be mindful of the workload. For the program to be successful you want to ensure that audit team members are not overloaded. Often audits will be delayed due to competing responsibilities of auditors. To mitigate this issue, develop the audit schedule so there is a balance across the assigned audits. Ensuring that the auditor has plenty of time to conduct the audits within the specified timeframe. Overall, the audit team should feel supported and appreciated for their efforts and not be overwhelmed and burdened with the task. A poorly balanced workload only leads to a lack of interest and a disengagement among the audit team.

Provide Opportunities for Education

Providing an understanding of quality management systems and the standard being audited is imperative to the success of any audit program. There are two groups that require education. Education for the auditors and those that are participating in the audits. The auditors need an in-depth understanding of the standard and the requirements which they are auditing against. While the employees need awareness of how the management system is structured and their role in supporting it.

These educational goals can be accomplished both formally and informally across the organization. Auditors will need a more formalized structured training program that focuses on the details of the standard and auditing principles. While employee training can be incorporated into departmental meetings or shared through one-point lessons. Building education programs into existing activities is a great way of incorporating the audit program into the organizational culture. This helps to educate as well as share information with those in the organization who may otherwise not have awareness. This could be conducted via training sessions around processes and their linkage to the standard in which the organization is certified. Providing an understanding of the connections between the departments helps build collaboration between working groups. Employees gain exposure to what others in adjacent departments are doing and obtain a sense of understanding of challenges that may be faced by those groups. This in turn results in a collaborative team approach to the management of the overall system.

Involving employees from all parts of the business helps to drive the message that the system cannot operate in one department alone. Through education, employees will be able to understand their role in the system. This will lead to more engagement in the internal audit program. Employees will become excited to aid in audit activities and improvement initiatives because they will see positive results. They will gain understanding of the impact of their actions and how it impacts the overall system. This value-added approach will result in a favorable outcome for both the organization and the individual employees.

Promote Continuous Improvement

The support of top management is a very important element in the success of any audit program. Establishing a culture of continuous improvement will motivate the team and build engagement across the organization. This can be accomplished by frequently sharing status updates around the management system activities. A simple 15-minute update during sitewide meetings goes a long way. It demonstrates a commitment to the program and growth of the organization and its people.

Develop a format of communicating the details around the management system and any upcoming activities. This can be done by having a specific time each month when updates are provided. Putting this on the calendar will ensure that information is effectively communicated. Details should include both the negative and positive outcomes of internal and external audits. Include specifics around the audit findings and actions taken to address concerns. This will communicate to employees that the organization is serious about growing and is focused on improvement.

Sharing information helps to engage employees by bringing them into the improvement efforts rather than just being bystanders. These seemingly small actions can help drive excitement for the overall program and build a culture of quality. Lastly, be sure to celebrate the wins and ensure that team members are appreciated for their efforts. Building a successful internal audit program is a lot of work. Celebrating and acknowledging the efforts of the team is imperative.

Accomplish the Mission  

There are many ways to build a successful internal audit program. Taking the time and effort to think through the process of identifying the format, structure and team members is critical. By reviewing these items upfront roadblocks can be identified early on. There will always be unforeseen challenges yet having a plan is key to developing a successful program. With a strong commitment from top management and a mindset of continuous improvement an organization can establish a robust internal audit program that exceeds expectations.

lightbulb, innovation

Upcoming Webinar Highlights How Standards Support the Food Supply Chain

By Food Safety Tech Staff
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lightbulb, innovation

Join Food Safety Tech and food safety leaders from BSI for a 60-minute webinar on “Food Safety & Quality: How Standards Support the Food Supply Chain” on Monday, December 13. Sponsored by Intelex, the complimentary event will educate attendees about key standards in ensuring food safety and quality in the supply chain—including ISO 22000, ISO 9001 and the new cold chain logistics standard, ISO 23412:2020, which addresses indirect, temperature-controlled refrigerated delivery services. Featured speakers are Sara Walton, sector lead (food) – standards at BSI, and Amanda McCarthy, chair of AW/90, quality systems for food industry at BSI. The event begins at 12 pm ET. Register now!

Jeff Witte, DNV

Does Your Organization Need a Tool to Assess Risks to the Psychological Well-being of Its Employees?

By Jeff Witte
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Jeff Witte, DNV

The current pandemic has faced us with unexpected feelings of uncertainty, loneliness and loss. For many people the hustling and bustling environment of productive interaction and communication was the world, within which they gladly spent most of their lives. Recognition, encouragement, appreciative looks, words of respect, collaboration, competition, and workplace friendships have been abruptly taken away. This has left us face to face with computer screens and outdated icons of co-worker’s faces.

As a result, the psychological well-being of employees has become a key factor in performance and productivity at work. To assist organizations with best practices in addressing employee well-being, the International Organization for Standardization has developed ISO 45003 standard.

ISO 45003 – Occupational health and safety management – Psychological health and safety at work – Guidelines for managing psychosocial risks, is an occupational health and safety management standard, which now covers “many areas that can impact a worker’s psychological health, including ineffective communication, excessive pressure, poor leadership and organizational culture”, as stated in the description on ISO.org. It will also help to meet the requirements of ISO 45001 (previously known as OHSAS), the world’s standard for a physical occupational health and safety management system.

Today, organizations can take preventative measures for securing their staff’s mental and physical well-being by implementing ISO 45003. This best practice guidance document covers elements such as:

  • How to identify, recognize and assess risk factors that may psychologically impair the workforce
  • How to determine necessary changes for improvement
  • How to control potential hazards and manage them effectively

Norma McCormick, Project Leader of the ISO technical committee that developed the standard, said on ISO.com, “While many have felt powerless about the impact of recent events, there are many things that can be done to build the resilience of staff and promote a strong organizational culture. This standard brings together international best practice in this area and is relevant to companies of all types and sizes.”

This global standard provides simple and practical ways for organizations to prioritize protection of employees, and others, who are associated with the organization’s activities.

This compilation of best practices will assist organizations with the recognition of psychosocial hazards and risks such as stress, bullying, harassment, violence in the workplace and the like.
These risks, if ignored or unchecked, can cause negative effects on the health, safety and well-being of employees, thus affecting total organizational performance. More importantly, these risks and hazards can lead to health conditions such as diabetes, cardio-vascular disorders and insomnia which, oftentimes, leads to behavior changes like overeating and alcohol and drug abuse.

The potential detrimental impact on employees’ commitment, productivity, and job satisfaction are clear. Organizations that do not recognize the risks and hazards, or choose to ignore them, will see increased absence from work due to sick leave, high turnover, declining quality of products and/or services, which in turn can cause additional expenses or layoffs, litigation and incident investigations resulting in low morale and damage to the brand.

If you’ve been looking for guidance and best practice in dealing with workforce health and safety in these trying times, take a look at 45003 and its potential benefits:

  1. High levels of discretionary effort
  2. Improved recruitment, retention and diversity
  3. Enhanced worker engagement
  4. Increased innovation
  5. Legal compliance
  6. Reduced absence from workplace due to stress, burnout, anxiety, and depression.1

As a guideline, ISO 45003 is a non-certifiable standard that can be assessed for compliance by an independent third party, like DNV. It can be conducted as a stand-alone assessment or in combination with an ISO 45001 (Occupational Health and Safety) management system certification audit.

Having achieved compliance to ISO 45003, you will demonstrate that you care and have the right measures in place for improvement of your workers’ health and well-being.

1Source: https://www.dnv.us/services/iso-45003-psychological-health-and-safety-at-work-204506

Food Safety Consortium Virtual Conference Series

2021 FSC Episode 4 Preview: Food Safety Supply Chain Management

By Food Safety Tech Staff
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Food Safety Consortium Virtual Conference Series

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.

CEA Food Safety Certification

CEA Food Safety Coalition Establishes First Food Safety Certification for Leafy Greens Grown Indoors

By Food Safety Tech Staff
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CEA Food Safety Certification

Last week the CEA Food Safety Coalition announced the first food safety certification program for leafy greens grown indoors. The food safety addendum intends to address the distinct attributes of controlled environment agriculture (CEA) as it relates to leafy greens and is a certification in addition to demonstrating GFSI compliance.

“Current food safety standards were written for the field, and many do not address the unique attributes of controlled, indoor environments,” said Marni Karlin, executive director of the Coalition in a press release. “This new certification process and the accompanying on-pack seal helps to unify CEA growers while also differentiating them from traditional field agriculture. It also better informs consumers and provides a quick-glance image to know when produce has been grown safely indoors, with a high standard of quality and without some of the hazards of the field, such as potential contamination from animal byproducts.”

CEA Food Safety Certification
CEA Food Safety Certification

CEA is a technology-forward method that establishes optimal growing conditions in controlled environments such as greenhouses and indoor vertical farms. The certification program is for CEA FSC members (at a cost) and is completed annually. It assesses CEA grower sites in the four main areas:

  • Hazard analysis.: Including use of water, nutrients, growing media, seeds, inputs and site control.
  • Water use. Any contact with the plant and food contact surfaces, along with the use of recirculating water.
  • Site control, infrastructure and system design. Including direct and adjacent food contact surfaces, and physical hazards such as lighting, robotics, sensors, and equipment.
  • Pesticide and herbicide use and testing during the plant lifecycle.
Food Safety Consortium

2020 FSC Episode 13 Preview: Traceability in Supply Chain Management

By Food Safety Tech Staff
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Food Safety Consortium

This week’s episode of the 2020 Food Safety Consortium Virtual Conference Series will explore traceability as it pertains to supply chain management. The following are highlights for Thursday’s session:

  • Food Safety Recalls – Digging Deeper into FDA, CDC, USDA & Food Industry Data, with Allen Sayler, EAS Consulting
  • Preparing for Blockchain in “A New Era of Smarter Food Safety”, with Kathy Barbeire, CAT Squared
  • The Road to Traceability is Paved with Standards, with Lucelena Angarita, IPC/Subway and Liz Serti, GS1 US
  • TechTalk from Controlant

The event begins at 12 pm ET on Thursday, December 10. Haven’t registered? Follow this link to the 2020 Food Safety Consortium Virtual Conference Series, which provides access to all the episodes featuring critical industry insights from leading subject matter experts! We look forward to your joining us virtually.

Kari Hensien, RizePoint
FST Soapbox

7 Trends Expediting Modernization in Food Industry

By Kari Hensien
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Kari Hensien, RizePoint

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.

Kari Hensien, RizePoint Kari Hensien and Matt Regusci of Rizepoint will be participating in a Q&A with Dr. Darin Detwiler, Assistant Dean, Northeastern University College of Professional Studies, during the final episode of the 2020 Food Safety Consortium Virtual Conference Series on December 17. 

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.

Karil Kochenderfer, LINKAGES
FST Soapbox

GFSI at 20 YEARS: Time for a Reboot?

By Karil Kochenderfer
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Karil Kochenderfer, LINKAGES

The marketplace has experienced dramatic changes that were barely on the horizon 20 years ago—by that, I mean mobile phones, Instagram, Facebook, climate change, consumer transparency, globalization, novel new products delivered to your doorstep and now COVID-19, too.

I write from a perspective of both pride and concern. I had the privilege of representing GFSI in North America and helping the organization expand beyond Europe as new food safety laws were implemented in both the United States and Canada.

Questionable Utility of Multiple, Redundant and Costly Certifications

However, I also sympathized with small and medium food companies that struggled with minimal resources and food safety expertise to understand GFSI and then to become certified not once, but multiple times for multiple customers. GFSI’s mantra, “Once Certified, Accepted Everywhere,” was far from their GFSI reality…or, frankly, the reality of many food companies. My concern was not insignificant. The food industry is populated by a majority of small businesses, each seeking that one big break that could possibly, maybe open up access to retail shelves. Their confusion about being audited and certified to one standard was significant. Certification to multiple and redundant standards presented a daunting and costly endeavor for these start-ups. I heard their anxiety in their voices as I served as GFSI’s 1.800 “customer service rep” in North America for years.

Karil Kochenderfer will present “GFSI at 20 Years: Time for a Reboot?” during the 2020 Food Safety Consortium Virtual Conference Series | Her session takes place on December 17Transparency

In the 20 years since GFSI was established, the world has become much more transparent. Today, entire industries operate on open, international, consensus-based ISO management standards in far bigger and more complex sectors than the food sector (e.g., the automotive, airline and medical device sectors). And, in the 20 years since GFSI was established, an ISO food safety management system standard has been developed that is now used widely throughout the world with more than 36,000 certifications (i.e., ISO 22000).

Auditing and certifying a facility to a single, international, public standard would enhance GFSI transparency. It also would help to hurdle government concerns related to the lack of public input into the development of private standards, enabling private certifications like GFSI to be used efficiently as a compliance tool—a benefit to both government and food interests and to consumer health, safety and trade.

New Technologies

Many new technologies, such blockchain, artificial intelligence, sensors and the Internet of Things are being heralded widely now as well, particularly for businesses with complex supply-chains like those in like the fast-moving food and retail sectors. The benefits of these technologies are predicated on the use of a common digital language…or standard. Multiple and diverse standards, like GFSI, complicate the use of these new technologies, which is why FDA is examining the harmonizing role of standards and data management in its proposed New Era of Smarter Food Safety.

Sustainable Development

Today, food safety often is managed in tandem with other corporate environment, health and safety programs. The Consumer Goods Forum, which oversees GFSI, should take a similar approach and merge GFSI with its sustainability, and health and wellness programs to help CGF members meet their existing commitments to the United Nations’ Sustainable Development Goals (SDGs) and to encourage others to do the same. Here, once again, adoption of a single, transparent ISO standard can help. Adoption of ISO 22000 as the single and foundational standard for GFSI makes it easy to layer on and comply with other ISO standards—for example, for the environment (ISO 14000), worker protection (ISO 45001), energy efficiency (ISO 50001) and information/data security (ISO 27001)— and to simultaneously meet multiple SDGs.


As I write, the COVID pandemic rages. It may re-align global supply chains and set back global trade temporarily, but the unprecedented rise in consumer incomes and corresponding decrease in poverty around the world attests to the importance of the global trade rules established by the World Trade Organization (WTO). Among these rules is a directive to governments (and businesses) to use common standards to facilitate trade, which uniquely recognizes ISO standards as well as those of Codex and OIE. When trade disputes arise, food interests that use ISO 22000 are hands-down winners, no questions asked. So, why use many and conflicting private standards?

Supply Chain Efficiency

Finally, ISO 22005, part of the ISO 22000 family of food management standards, also is aligned with GS1 Standards for supply-chain management, used throughout the food and retail sectors in North America and globally to share information between customers and suppliers. GS1 is most well known for being the administrators of the familiar U.P.C. barcode. The barcode and other “data carriers” provide visibility into the movement of products as well as information about select attributes about those products—including whether they have been certified under GFSI. Both GS1 and ISO GS1 standards are foundational to the new technologies that are being adopted in the fast-moving food, consumer products, healthcare and retail sectors both in the United States and globally. That alignment puts a spotlight on safety, sustainability, mobility, efficiency and so much more.

Focus Less on the Change, More on the Outcome

My proposal will surely set tongues in motion. Proposals to switch things up generally do. Disruption has become the norm, however, and food businesses are prized for their agility and responsiveness to the endless changes in today’s fast-moving marketplace. Still, ISO and Codex standards already are embedded in the GFSI benchmark so what I’m proposing should not be so disruptive and no one scheme or CPO should benefit disproportionately. And, less differentiation in the standard of industry performance will compel scheme or certification owners to shift their focus away from compliance with their standards and audit checklists to working with customers to truly enhance and establish “food safety-oriented cultures.” If they do, all of us emerge as winners.

The New Normal?

Around us new food businesses are emerging just as old businesses reinvent theirs. Trucks now operate as restaurants and athletes deliver dinner on bicycles. For a long time, we’ve operated businesses based on 20th century models that don’t resonate in the 21st century world. Are we at an inflection point, with both small and large businesses paying for costly and inefficient practices that no longer apply, and is it time for GFSI to change?

I welcome your thoughts. I truly do. Better, let’s discuss on a webinar or video call of your choosing. I look forward to connecting.

Submit questions you want Karil to answer during her session at the 2020 Food Safety Consortium Virtual Conference Series in the Comments section below.

LIMS, Laboratory information management system, food safety

How Advanced LIMS Brings Control, Consistency and Compliance to Food Safety

By Ed Ingalls
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LIMS, Laboratory information management system, food safety

Recent food scandals around the world have generated strong public concerns about the safety of the foods being consumed. Severe threats to food safety exist at all stages of the supply chain in the form of physical, chemical and biological contaminants. The current pandemic has escalated the public’s concern about cross contamination between people and food products and packaging. To eliminate food risks, manufacturers need robust technologies that allow for reliable monitoring of key contaminants, while also facilitating compliance with the ISO 17025 standard to prove the technical competence of food testing laboratories.

Without effective data and process management, manufacturers risk erroneous information, compromised product quality and regulatory noncompliance. In this article, we discuss how implementing a LIMS platform enables food manufacturers to meet regulatory requirements and ensure consumer confidence in their products.

Safeguarding Food Quality to Meet Industry Standards

Food testing laboratories are continually updated about foodborne illnesses making headlines. In addition to bacterial contamination in perishable foods and ingredient adulteration for economic gains, chemical contamination is also on the rise due to increased pesticide use. Whether it is Salmonella-contaminated peanut butter or undeclared horsemeat inside beef, each food-related scandal is a strong reminder of the importance of safeguarding food quality.

Food safety requires both preventive activities as well as food quality testing against set quality standards. Establishing standardized systems that address both food safety and quality makes it easier for manufacturers to comply with regulatory requirements, ultimately ensuring the food is safe for public consumption.

In response to food safety concerns, governing bodies have strengthened regulations. Food manufacturers are now required to ensure bacteria, drug residues and contaminant levels fall within published acceptable limits. In 2017, the ISO 17025 standard was updated to provide a risk-based approach, with an increased focus on information technology, such as the use of software systems and maintaining electronic records.

The FDA issued a notice that by February 2022, food testing, in certain circumstances, must be conducted in compliance with the ISO 17025 standard. This means that laboratories performing food safety testing will need to implement processes and systems to achieve and maintain compliance with the standard, confirming the competence, impartiality and consistent operation of the laboratory.

To meet the ISO 17025 standard, food testing laboratories will need a powerful LIMS platform that integrates into existing workflows and is built to drive and demonstrate compliance.

From Hazard Analysis to Record-Keeping: A Data-Led Approach

Incorporating LIMS into the entire workflow at a food manufacturing facility enables the standardization of processes across its laboratories. Laboratories can seamlessly integrate analytical and quality control workflows. Modern LIMS platforms provide out-of-the-box compliance options to set up food safety and quality control requirements as a preconfigured workflow.

The requirements set by the ISO 17025 standard build upon the critical points for food safety outlined in the Hazard Analysis and Critical Control Points (HACCP) methodology. HACCP, a risk-based safety management procedure, requires food manufacturers to identify, evaluate and address all risks associated with food safety.

LIMS, laboratory information management system
LIMS can be used to visualize control points for HACCP analysis according to set limits. Graphic courtesy of Thermo Fisher Scientific.

The systematic HACCP approach involves seven core principles to control food safety hazards. Each of the following seven principles can be directly addressed using LIMS:

  • Principle 1. Conduct a hazard analysis: Using current and previous data, food safety risks are thoroughly assessed.
  • Principle 2. Determine the critical control points (CCPs): Each CCP can be entered into LIMS with contamination grades assigned.
  • Principle 3. Establish critical limits: Based on each CCP specification, analytical critical limits can be set in LIMS.
  • Principle 4. Establish monitoring procedures: By defining sampling schedules in LIMS and setting other parameters, such as frequency and data visualization, procedures can be closely monitored.
  • Principle 5. Establish corrective actions: LIMS identifies and reports incidents to drive corrective action. It also enables traceability of contamination and maintains audit trails to review the process.
  • Principle 6. Establish verification procedures: LIMS verifies procedures and preventive measures at the defined CCPs.
  • Principle 7. Establish record-keeping and documentation procedures: All data, processes, instrument reports and user details remain secured in LIMS. This information can never be lost or misplaced.

As food manufacturers enforce the safety standards set by HACCP, the process can generate thousands of data points per day. The collected data is only as useful as the system that manages it. Having LIMS manage the laboratory data automates the flow of quality data and simplifies product release.

How LIMS Enable Clear Compliance and Optimal Control

Modern LIMS platforms are built to comply with ISO 17025. Preconfigured processes include instrument and equipment calibration and maintenance management, traceability, record-keeping, validation and reporting, and enable laboratories to achieve compliance, standardize workflows and streamline data management.

The workflow-based functionality in LIMS allows researchers to map laboratory processes, automate decisions and actions based on set criteria, and reduce user intervention. LIMS validate protocols and maintain traceable data records with a clear audit history to remain compliant. Data workflows in LIMS preserve data integrity and provide records, according to the ALCOA+ principles. This framework ensures the data is Attributable, Legible, Contemporaneous, Original and Accurate (ALCOA) as well as complete, consistent and enduring. While the FDA created ALCOA+ for pharmaceutical drug manufacturers, these same principles can be applied to food manufacturers.

Environmental monitoring and quality control (QC) samples can be managed using LIMS and associated with the final product. To plan environmental monitoring, CCPs can be set up in the LIMS for specific locations, such as plants, rooms and laboratories, and the related samples can then be added to the test schedule. Each sample entering the LIMS is associated with the CCP test limits defined in the specification.

Near real-time data visualization and reporting tools can simplify hazard analysis. Managers can display information in different formats to monitor critical points in a process, flag unexpected or out-of-trend numbers, and immediately take corrective action to mitigate the error, meeting the requirements of Principles 4 and 5 of HACCP. LIMS dashboards can be optimized by product and facility to provide visibility into the complete process.

Rules that control sampling procedures are preconfigured in the LIMS along with specific testing rules based on the supplier. If a process is trending out of control, the system will notify laboratory personnel before the product fails specification. If required, incidents can be raised in the LIMS software to track the investigation of the issue while key performance indicators are used to track the overall laboratory performance.

Tasks that were once performed manually, such as maintaining staff training records or equipment calibration schedules, can now be managed directly in LIMS. Using LIMS, analysts can manage instrument maintenance down to its individual component parts. System alerts also ensure timely recalibration and regular servicing to maintain compliance without system downtime or unplanned interruptions. The system can prevent users from executing tests without the proper training records or if the instrument is due for calibration or maintenance work. Operators can approve and sign documents electronically, maintaining a permanent record, according to Principle 7 of HACCP.

LIMS allow seamless collaboration between teams spread across different locations. For instance, users from any facility or even internationally can securely use system dashboards and generate reports. When final testing is complete, Certificates of Analysis (CoAs) can be autogenerated with final results and showing that the product met specifications. All activities in the system are tracked and stored in the audit trail.

With features designed to address the HACCP principles and meet the ISO 17025 compliance requirements, modern LIMS enable manufacturers to optimize workflows and maintain traceability from individual batches of raw materials all the way through to the finished product.


To maintain the highest food quality and safeguard consumer health, laboratories need reliable data management systems. By complying with the ISO 17025 standard before the upcoming mandate by the FDA, food testing laboratories can ensure data integrity and effective process management. LIMS platforms provide laboratories with integrated workflows, automated procedures and electronic record-keeping, making the whole process more efficient and productive.

With even the slightest oversight, food manufacturers not only risk product recalls and lost revenue, but also losing the consumers’ trust. By upholding data integrity, LIMS play an important role in ensuring food safety and quality.