Tag Archives: compliance

Mitzi Baum, Stop Foodborne Illness
Food Safety Culture Club

Our Petition to USDA: The Time for Change Is Now

By Mitzi Baum
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Mitzi Baum, Stop Foodborne Illness

On January 25, 2021 Stop Foodborne Illness (STOP), in collaboration with Center for Science in the Public Interest, Consumer Reports, Consumer Federation of America and five STOP constituent advocates filed a petition with USDA Food Safety Inspection Service (FSIS) to reform and modernize poultry inspections. The goal of these reforms is to reduce the incidence of Salmonella and Campylobacter contamination in raw poultry thus drastically decreasing foodborne illnesses due to these pathogens.

According to the CDC, in 2019, these two pathogens combined were responsible for more than 70% of foodborne illnesses in the United States. As Mike Taylor, former FDA Deputy Commissioner for Foods and Veterinary Medicine, shares in his
Op-Ed, the time for change is now as the current regulatory framework is inadequate and has not delivered the desired results of reducing Salmonella and Campylobacter outbreaks.

Today, the USDA’s mark of inspection is stamped on poultry, although birds may exceed the performance standards; there are no clear consequences for establishments that do not meet the current guidelines. Without science-based standards or penalties for non-compliance, the burden of this problem falls upon consumers.

At STOP, we share the voices of consumers whose lives have been altered due to preventable problems such as this. Our constituent advocates share their journeys through severe foodborne illness to share the WHY of food safety. Real people, real lives are impacted when we do not demand action. STOP board member, Amanda Craten, shares her son Noah’s story:

“My toddler suddenly came down with a fever and diarrhea, but it wasn’t until weeks later that I learned that his symptoms, which nearly killed him, were caused by a multi-drug resistant strain of Salmonella.

After being admitted to the hospital, his doctors found abscesses in the front of his brain caused by infection and they were creating pressure on his brain. He underwent surgery and weeks of antibiotic treatments.

My 18-month son was seriously injured and permanently disabled as a result of Salmonella-contaminated chicken.” – Amanda Craten.

Unfortunately, Noah’s story is not rare, which is why Amanda supports this petition for change and has provided a powerful video about Noah’s foodborne disease journey and his life now.

Because there are too many stories like Noah’s, STOP and its partner consumer advocacy organizations want to work with FSIS and industry to:

  1. Develop real benchmarks that focus on reduction of known, harmful pathogens in poultry
  2. Modernize standards to reflect current science
  3. Implement on-farm control measures
  4. Re-envision the standards to focus on the risk to public health

As a new administration begins, capitalizing on this opportunity to modernize poultry inspection that can benefit consumers and the food industry makes sense. STOP and its partners are hopeful that leadership at USDA/FSIS will take this opportunity to create consequential and relevant change. Ultimately, this transformation will reduce the incidence of foodborne illness due to contamination of poultry and increase consumer confidence in the USDA’s mark of inspection. Please comment on this petition.

Have you been impacted by foodborne illness? Tell STOP Foodborne Illness about it.

Earl Arnold, AIB International
FST Soapbox

HACCP is the Past, Present and a Building Block for the Future

By Earl Arnold
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Earl Arnold, AIB International

“Food safety plan” is a term often used in the food industry to define an operation’s plan to prevent or reduce potential food safety issues that can lead to a serious adverse health consequence or death to humans and animals to an acceptable level. However, depending on the facility, their customers, and or regulatory requirements, the definition and specific requirements for food safety plans can be very different. To ensure food safety, it’s important that the industry finds consensus in a plan that is vetted and has worked for decades.

One of the first true food safety plans was HACCP. Developed in 1959 for NASA with the assistance of the food industry, its goal was to ensure food produced for astronauts was safe and would not create illness or injury while they were in space. This type of food safety plan requires twelve steps, the first five of which are considered the preliminary tasks.

  1. Assemble a HACCP team
  2. Describe the finished product
  3. Define intended use and consumer
  4. Create process and flow diagram
  5. Verify process and flow diagrams

This is followed by the seven principles of HACCP.

  1. Conduct the hazard analysis
  2. Identify critical control points
  3. Establish critical limits
  4. Establish monitoring requirements
  5. Establish corrective actions for deviations
  6. Procedures for verification of the HACCP plan
  7. Record keeping documenting the HACCP system

HACCP is accompanied by several prerequisites that support the food safety plan, which can include a chemical control program, glass and brittle plastics program, Good Manufacturing Practices (GMPs), allergen control program, and many others. With these requirements and support, HACCP is the most utilized form of a food safety plan in the world.

When conducting the hazard analysis (the first principle of HACCP), facilities are required to assess all products and processing steps to identify known or potential biological, chemical and physical hazards. Once identified, if it is determined that the hazard has a likelihood of occurring and the severity of the hazard would be great, then facilities are required to implement Critical Control Points (CCP) to eliminate or significantly reduce that identified hazard. Once a CCP is implemented, it must be monitored, corrective actions developed if a deviation in the CCP is identified and each of these are required to be verified. Records then also need to be maintained to demonstrate the plan is being followed and that food safety issues are minimized and controlled.

HACCP is, for the most part, the standard food safety plan used to meet the Global Food Safety Initiative (GFSI) standards. This is utilized in various third-party audit and customer requirements such as FSSC 22000, SQF, BRC, IFS and others. These audit standards that many facilities use and comply with also require the development of a food safety management system, which includes a food safety plan.

Further, HACCP is often used to demonstrate that potential food safety issues are identified and addressed. FDA has adopted and requires a regulated HACCP plan for both 100% juice and seafood processing facilities. USDA also requires the regulated development of HACCP for meat processing and other types of facilities to minimize potential food safety issues.

For facilities required to register with the FDA—unless that facility is exempt or required to comply with regulated HACCP—there is a new type of food safety plan that is required. This type of plan builds upon HACCP principles and its steps but goes beyond what HACCP requires. Under 21 CFR 117, specific additions assist in identifying and controlling additional food safety hazards that are on the rise. This includes undeclared allergen recalls, which constituted 47% of recalls in the last reportable food registry report published by FDA.

Prior to developing this plan, FDA provided recommendations for preliminary steps that can be completed and are essential in development of a robust food safety plan but are not a regulatory requirement. The steps are very similar to the preliminary tasks required by HACCP, including the following:

  1. Assemble a food safety team
  2. Describe the product and its distribution
  3. Describe the intended use and consumers of the food
  4. Develop a flow diagram and describe the process
  5. Verify the flow diagram on-site

Their recommended plan also requires a number of additional steps, including:

  1. A written hazard analysis. Conducted by or overseen by a Preventive Controls Qualified Individual (PCQI). However, this hazard analysis requires assessing for any known or reasonably foreseeable biological, chemical, physical, radiological, or economically motivated adulteration (food fraud that historically leads to a food safety issue only). You may note that two additional hazards—radiological and EMA—have been added to what HACCP calls for in the assessment.
  2. Written preventive controls if significant hazards are identified. However, similar preventive controls are different than a CCP. There are potentially four types of preventive controls that may be utilized for potential hazards, including Process Preventive Controls (the same as CCP), Allergen Preventive Controls, Sanitation Preventive Controls, Supply Chain Preventive Controls and Others if identified.
  3. A written supply chain program if a Supply Chain Preventive Control is identified. This includes having an approved supplier program and verification process for that program.
  4. A written recall plan if a facility identified a Preventive Control.
  5. Written monitoring procedures for any identified Preventive Control that includes the frequency of the monitoring what is required to do and documenting that monitoring event.
  6. Written corrective actions for identified Preventive Controls in case of deviations during monitoring. Corrective actions must be documented if they occur.
  7. Written verification procedures as required. This could include how monitoring and corrective actions are verified, procedures themselves are verified, and calibration of equipment as required. Also required is training, including a Preventive Control Qualified Individual. Additional training is required for those individuals responsible for performing monitoring, implementing corrective actions, and verification of Preventive Controls. Further, all personnel need to have basic food safety training and all training needs to be documented.

While the term “food safety plan” is used widely, it’s important that operations don’t just use the term, but enact a plan that is vetted, proven to work, and encompasses the principles of HACCP. Doing so will help ensure that their facility is producing foods that customers and consumers will know is safe.

Adam Serfas, R.S. Quality
FST Soapbox

Tips for Creating an Inclusive Color-Coding Plan for Food Manufacturing Facilities

By Adam Serfas
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Adam Serfas, R.S. Quality

Color-coding as a quality assurance and safety measure has been on the rise since the passage of FSMA in 2011. Now, 10 years later, color-coding is being used in a wide range of industries from food manufacturers and processors to pharmaceutical developers and even brewers. As the popularity of the practice of color-coding has increased, so too has the market for color-coded tools. Nowadays, those in the industry can find virtually every high-quality cleaning tool under the sun, and a hygienic tools storage option for that tool in the color needed. The improved quality and availability of these products is wonderful, but nice tools alone cannot ensure a successful color-coding plan. Color-coding compliance is only possible when there is team-wide buy-in. That means meeting the team where they are—making the plan important to every single employee who steps onto a production floor. To do that, it needs to be introduced in an inclusive manner. The following are some tips for creating and implementing an inclusive color-coding plan.

Draw Up the Plan With Folks Beyond Management

Before you ever lock in a color-coding plan—whether you plan to color-code by zone, by allergen or by shifts—you first need to consult a wide range of team members. One common mistake is developing a color-coding plan with only quality assurance experts and those in management. This presents a problem for a couple of reasons.

One, you’re missing out on the perspective of those who will most often be asked to execute the plan. Say you choose the color purple as one of the colors in your color-coding plan, and you purchase all of the tools you think you will need in that color. You roll out the plan only to find out there’s an essential tool you need, and it doesn’t come in that color. You now have a problem on your hands, and a costly one at that, as you’re going to need to start over with a new color and new tools.

Beyond needing that on-the-ground perspective, you miss out on a key opportunity to gain buy-in early on from those who will be directly involved in carrying out the plan. Do yourself a favor and invite shift leaders to the table. Explain to them what you would like to do with a color-coding plan and listen to any advice they might have on executing a plan everyone is going to want to see succeed. Generally speaking, it pays to go with a big-tent approach to planning, so spend some time thinking about which parties should be represented in the planning process to capture all of the varying viewpoints of those at your facility.

Ensure the Plan Is Color-Blind Friendly

As selecting colors is one of the most important things you do in drafting a color-coding plan,pay special attention to the colors themselves. Color-blindness affects 1 in 12 men and 1 in 200 women—certainly not a negligible amount, and something you want to take into consideration.

Once you figure out all of the tools you need, determine which colors can accommodate those needs. From that list, try to avoid the most commonly confused color pairings in your plan. Red and green, green and brown, green and blue, blue and gray, blue and purple, green and grey, and green and black are the most commonly confused. If possible, avoid using those color combinations. Instead, opt for high-contrast options such as orange and purple, purple and yellow, or blue and yellow to name a few.

Some people will also look to shades to help achieve a higher contrast. For example, lime green and a maroon red is much better for a color-blind person than your standard royal red and shamrock green. These days more tools are available in varied shades but, again, you need to ensure that you’re able to get every tool you need now—and in the foreseeable future—in the color you pick.

Should you need to use colors that are not high-contrast, do your best to keep those tools separate. If you are color-coding by zone, use the most commonly confused color combinations on the opposite ends of the facility, where they are less likely to swap places. You can also help by using tool storage boards such as shadow boards or wall racks that are color-coded to match the tools. That way, tools always go back to the same place after each use.

Employ Multilingual Trainings and Signage

Generally speaking, the food industry is particularly diverse, and many facilities employ staff whose first language is not English. Work with your HR team and managers to identify which languages are primarily spoken among your staff and ensure you can offer trainings on the color-coding plan in all of those languages. Frequently, facilities have employees who are multilingual and can therefore translate during a training session. If not, it may be wise to hire a translator. This presents a nominal fee, whereas an employee failing to follow a color-coding plan could have disastrous consequences.

It is also important to ensure that any signage you have explaining the color-coding plan is available in the primary languages of the employees.

Make Use of Different Teaching Methods

Just as in the classroom, employees come to work with different learning styles. It’s up to the employer to meet those different needs with varying teaching styles and materials that speak to the importance of the color-coding plan. For the auditory learners, an all-hands meeting where a leader explains the importance of color-coding is going to be great. For the visual learners, handouts and permanent signage throughout your facility will be appreciated.

Meanwhile, tactile learners might want to run through a practice of grabbing tools, seeing where they will be used and returning them to their designated storage spot to see the plan in action. While asking employees to go through these different teachings might draw some eye-rolls for those who feel they grasped the concept the first time, the exercise might help make the color-coding plan click for someone who struggled to understand what they were being asked to do. Additionally, repetition helps all learners, so revisit these trainings to refresh veteran staff and bring newer folks up to speed.

Invite Feedback

Finally, invite employees to share feedback with you along the way. An inclusive culture is one that allows everyone to have a voice. Make it clear that team members are welcome to share any feedback they have on the color-coding plan, the trainings and tools along the way. Once again, in the interest of accommodating everyone, it’s a good idea to offer multiple avenues for feedback reporting. You might like to invite employees to share feedback directly with managers and also offer an anonymous suggestion box that gets checked regularly. Every facility and every staff has unique needs, so listening to the suggestions that come your way can help shed light on important considerations.

FDA

FDA Releases More Resources for Food Traceability Proposed Rule, Risk-Ranking Model for Food Tracing

By Food Safety Tech Staff
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FDA

Yesterday FDA released more resources to help stakeholders in understanding the FSMA Food Traceability proposed rule. The Risk-Ranking Model for Food Tracing is designed to help users learn more about the methods and criteria for scoring commodity-hazard pairs, along with the results of the scoring that are used to determine the foods included on the Food Traceability List [https://www.fda.gov/food/food-safety-modernization-act-fsma/food-traceability-list].

The agency also published a pre-recorded webinar about the proposed rule, featuring Frank Yiannas, deputy commissioner for food policy and response, and Angela Fields, a traceability expert with FDA’s Coordinated Outbreak Response and Evaluation Network.

Other resources include a flowchart to assist with determining who is subject to the rule and a glossary of key terms.

Food Safety Consortium

2020 FSC Episode 6 Preview: Sanitation Issues

By Food Safety Tech Staff
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Food Safety Consortium

The integration of sanitation is a critical part of the food manufacturing process. This week’s episode of the 2020 Food Safety Consortium Virtual Conference Series will focus on effective approaches, best practices and lessons learned. The following are some highlights:

  • Sanitation Methods, Day-to-Day Operations and Applying It to a Pandemic (Now and Future Outbreaks), with Elise Forward, Forward Food Solutions; David Shelep, Paramount Sciences; and Bill Leverich, Microbiologics, Inc.
  • The Critical Nature of a Good Environmental Program: The Story Behind Sabra’s Recall, Experience with the FDA, and Environmental Monitoring Journey, with Rob Mommsen, Sabra Dipping Company
  • Surrogates & Emerging Applications: Their Role in Validation, Verification and Compliance, with Laure Pujol, Ph.D. and Vidya Ananth, Novolyze
  • Tech Talks from Sterilex and Romer Labs

The event begins at 12 pm ET. Haven’t registered? Follow this link to the 2020 Food Safety Consortium Virtual Conference Series, which provides access to 14 episodes of critical industry insights from leading subject matter experts! We look forward to your joining us virtually.

Mikael Bengtsson, Infor

As COVID-19 Stresses Food Suppliers, Technology Steps In

By Maria Fontanazza
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Mikael Bengtsson, Infor

The theme of better traceability and more transparency is a theme that will only grow stronger in the food industry. Just last week we heard FDA Deputy Commissioner for Food Policy and Response Frank Yiannas talk about the agency’s recently proposed FSMA rule on food traceability during the 2020 Food Safety Consortium Virtual Conference Series. In a recent Q&A with Food Safety Tech, Mikael Bengtsson, industry & solution strategy director for food & beverage at Infor, explains yet another role that technology can play in helping companies maintain agility during changes that affect the supply chain such as the coronavirus pandemic.

Food Safety Tech: How can food suppliers mitigate the risks of foodborne illness outbreaks under the stress of the COVID-19 pandemic and with limited resources?

Mikael Bengtsson: Food safety must always be a top priority for any food and beverage company. The risks associated with contamination can have a severe impact for public health, brand and company reputation. Safety routines are therefore always of the highest priority. In today’s situation with COVID-19, the stress on safety is further increased. Now, it’s not only about keeping products safe but also keeping employees healthy. One progression and resource that all food suppliers must follow is the FDA [FSMA rules], which require suppliers to be diligent and document their compliance. Especially now, while suppliers are faced with limited resources and additional stress during the pandemic, they must rely on the basics—ensuring masks are worn in and out of the workplace, washing hands for at least 20 seconds prior to touching any food, and remaining six feet apart from co-workers. When it comes to a crisis like COVID, take solace in knowing suppliers can rely on the basics—even when conditions are strained.

This year we have seen many companies having to adapt and change quickly. Demand has shifted between products, ingredients have been in shortage and many employees have had to work from home. Some were better prepared than others in adapting to the new situation. Technology plays a big role when it comes to agility. Regarding food safety, there are many proactive measures to be taken. The industry leaders establish transparency in their supply chain both upstream and downstream, use big data analysis to identify inefficiencies, as well as couple IoT with asset management systems to foresee issues before they happen.

FST: How can technology help suppliers meet the growing consumer demand for transparency in an end-to-end supply chain and improve consumer trust?

Mikael Bengtsson, Infor
Mikael Bengtsson, industry & solution strategy director for food & beverage at Infor

Bengtsson: Communication with consumers is changing. It is not only about marketing products, but also to educate and interact with consumers. This requires a different approach. Of course, consumers are loyal to brands, but are also tempted to try something new when grocery shopping. After a new study is published or a new story is written, consumers are likely to shift their shopping preferences.

It is therefore important to build a closer connection with consumers. Companies who have full supply chain visibility, transparency and traceability have detailed stories to tell their consumers. One way they can build these stories is by including QR codes on their packages. The consumer can then easily scan the code and be brought to a website that shows more product details—e.g. who was the farmer, how were the animals cared for and what sustainability efforts were involved. These are all important aspects to build consumer trust. According to researchers at MIT Sloan School of Management, investing in supply chain visibility is the optimal way to gain consumer trust, and can lead to increased sales.

FST: What technologies should suppliers leverage to better collaborate with trading partners and ensure consistent food safety procedures?

Bengtsson: When a food safety problem arises, batches, lots, and shipments need to be identified within minutes. Manufacturers must be able to trace all aspects of products throughout the entire supply chain—with complete visibility at the ingredient level—from farm to table, and everything in-between. An efficient and transparent food supply chain requires extensive collaboration and coordination between stakeholders. New technologies can extend both amount of collaboration possibilities and the impact of those collaborations. In order to maintain a transparent, efficient food supply chain, companies need to invest in modern cloud-based ERP and supply chain systems that incorporate the increased visibility of the Internet of Things (IoT) with data sharing, supplier and customer portals, and direct links between systems—all aimed at facilitating joint awareness and coordinated decision-making. Modern technologies that enable transparency will also have the added benefits of meeting consumer demand for product information, identifying and responding to food safety issues, reducing food waste, and supporting sustainability claims.

Jill Henry, Essity
FST Soapbox

The New Hygiene Standard: Building Trust Through Employee Safety

By Jill Henry
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Jill Henry, Essity

The pandemic has heightened the need for a new hygiene standard at food manufacturing sites. On August 19, OSHA and FDA released a health and hygiene checklist for food manufacturers to increase employee safety and help mitigate the spread of COVID-19 at sites. This checklist reinforces the importance of elevating hygiene standards, but it can be difficult to know where to start—especially for food manufacturers aiming to maintain productivity while maximizing hygiene compliance and safety.

For food manufacturers seeking to navigate OSHA and FDA’s new guide, it’s important to remember that no matter the environment, the basics of hygiene remain true. You can kick-start your updated hygiene plan by implementing simple hygiene best practices and establishing comprehensive and clear protocols to achieve compliance on the road ahead. Remember, employee health and productivity begins with a safety-first mindset. Start by establishing a strong foundation with these tips that will help you maintain your food manufacturing site’s hygiene checklist amid COVID-19 and beyond.

Achieve Hand Hygiene Compliance

Hands are the most exposed part of the body to pathogens. Therefore, hand hygiene is considered one of the most important and effective measures to avoid the transmission of harmful pathogens, viruses and diseases. Given this, consistent and proper handwashing is a fundamental aspect of any hygiene plan, especially in food manufacturing sites where employees frequently touch common surfaces (e.g., door handles, technical equipment, etc.) . People often (and unknowingly) touch their eyes, nose and mouth after touching contaminated surfaces, which contributes to potential transmission.

Hand hygiene is proven to be a primary line of defense in stopping the spread of COVID-19 and other pathogens, but only when conducted properly. To maintain hand hygiene compliance, the CDC advises that employees thoroughly wash their hands with soap and water, under warm or cold water for at least 20 seconds, before properly drying their hands with a paper towel. All too often, people forget the importance of hand drying in the handwashing process, but it’s very significant as hand drying can help remove any remaining germs from the skin. In addition, germs can be transferred more easily to and from wet hands, which makes hand drying critical after a thorough handwashing.

Utilize Signage as Visual Cues

While many are familiar with the importance of hand hygiene, it can be difficult to put into practice when employees are busy on the job and forging ahead on production lines. Keep hand hygiene top of mind by utilizing visual cues, such as signage, to remind employees about when, where and how to wash their hands properly. Signage serves as visual reminders to achieve proper hand hygiene compliance and is an important part of establishing a site’s hygiene standard and foundation.

Opt for signage that includes a direct call to action for employees. Using the word “you” can also increase efficacy by calling directly upon the person reading the sign to participate in hand hygiene compliance. Additionally, signage should be updated frequently to keep employees engaged and hand hygiene top of mind. New and fresh reminders on the importance of handwashing will help keep employees attentive, but if you don’t have the time or resources to continually update on-site signage, leverage free tools available online to help you get started.

Establish Surface Cleaning Protocols without Sacrificing Productivity

COVID-19 can spread from surface-to-person contact. This can happen when an employee carrying the virus touches technical equipment on a production line that is not properly wiped down before the next employee’s shift. With this in mind, it’s critical to establish effective surface cleaning protocols that mitigate instances of cross-contamination and don’t create downtime in production or processing.

To create an efficient surface hygiene plan, assess high-touch areas, and develop a list based on where you observe high-touch surfaces to ensure these areas are properly sanitized ahead of shift changes. Provide employees with the surface cleaning checklist that enables them to effectively sanitize surfaces prior to departing their shift. The checklist should include key areas that must be disinfected, as well as tips to properly disinfect surfaces.

When disinfecting surfaces, use an approved disinfectant and a disposable cloth, which ensures the surface is being wiped down with a non-contaminated wiper each time. If using an alcohol-based product, use one with a minimum of 70% alcohol (i.e., Ethanol or Isopropyl alcohol), and always follow the manufacturer’s application guidelines.

Optimize Sanitization Stations and Dispenser Placement
Think strategically and practically about dispenser placement in food manufacturing sites because where sanitizer dispensers are placed makes a difference in whether they are used by employees. Similar to establishing surface cleaning protocols, start by observing where high-traffic areas are on site, and consider critical entry and exit points that would benefit from a dispenser. Dispensers should also be placed in clear view, so they are easily accessible for employees. Consider pairing signage with dispensers as a helpful reminder to utilize these stations and provide instruction on best practices to sanitize effectively.

Optimizing dispenser placement doesn’t stop with implementation. Once dispensers are in place, continue to monitor where dispensers are most frequently used, and assess other areas prime for dispensers. Remember: Employee hygiene and safety is a priority, and optimally placing dispensers and hygiene solutions where they are needed to encourage use is key to creating a safer environment. Place dispensers in areas such as common spaces, near production lines, in locker rooms, and at entrances and exits in order to encourage regular surface cleaning and hand washing. Flexible mounting solutions and portable solutions can facilitate access in harsher environments. The availability of hygiene products encourages their use, so be sure to keep dispensers fully stocked.

Promote Awareness among Employees and Instill Confidence

It’s more important than ever to build employee trust and confidence. As the saying goes, knowledge is power. Communicate frequently with employees and distribute guidelines around COVID-19 so that they understand the measures being introduced and how you will continually monitor your environment. Consider implementing COVID-19-specific training and education sessions that empower employees to ask questions about hygiene and safety measures on site, and provide essential instruction on COVID-19 and what to do if a case is confirmed among employees. These sessions can also be used to provide further education and emphasis on how individuals can maintain hygiene compliance for the greater good of the manufacturing site and their colleagues.

In the current environment, it’s clear that food manufacturers must secure a new hygiene standard to maintain employee health and safety and continue to deliver essential products. But with ongoing shifts, changes and uncertainty, it can be challenging to juggle operations and hygiene compliance—while instilling trust and confidence among employees. Whether a site is continuing, resuming or re-evaluating operations amid the current pandemic, it is critical to maintain a strong foundation for hygiene, so that employees are safe and essential production moves ahead.

Tom Gosselin, DNV GL
FST Soapbox

Time to Get More Value From Social Audits

By Tom Gosselin
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Tom Gosselin, DNV GL

If global supply chains were considered complex before COVID-19, it’s hard to imagine what we’d call them now. Is there a single business operating exactly as it did before the pandemic?

All the more surprising, when survival would seem to be the top priority, pre-pandemic risk factors are not only alive and well, but they also actually outweigh coronavirus as strategic business concerns. In fact, COVID-19 didn’t even make the top five risk factors in the World Economic Forum’s 2020 Risk Report.

In its analysis of the WEF report, consulting firm Ernst and Young stated the following:

“While the risk of a pandemic was noted as important in the report, and something for which we are unprepared globally, it was not identified as one of the top five risks in terms of likelihood or impact in the 2020 survey. High-impact and highly probable risks, such as climate change, biodiversity loss and water crises, are just as present now as they were before the pandemic started . . .”

In our experience, some pre-pandemic business trends have actually gone from “warm and fuzzy” to red hot in spite of, or perhaps even due to, the COVID chaos. One prime example is in the case of social audits.

Social audits have been increasingly used over the past decade to evaluate corporate social responsibility and, indeed, the ethical conduct of entire supply chains. We’ve worked extensively with some of the biggest names in consumer electronics to conduct hundreds of social audits among component suppliers of all sizes. These assessments are mandatory, not by law, but by business policy. The vast scope reflects the importance—and business value—of operational factors that go beyond pure economics, whether it’s related to labor practices, health and safety, or environment.

A growing number of organizations strongly believe that social responsibility and profits are not mutually exclusive; they are in fact enablers of one another—but only if you commit to mining the full value of these programs. Think of it like data mining. Within any large body of information, you can almost always find hidden value. If you know how to look and have the proper tools. In the case of social auditing, the tools are the insights and methods employed by the auditing teams.

This is such a vital concept that we have designed its social auditing process to exceed even what the Responsible Business Alliance requires in its code of conduct. As a baseline, like every other auditor, we first look for nonconformities, which are the most serious issues requiring immediate attention. We also report “observations”, a second level of findings that speaks to things that are suboptimal but are not out of compliance, per se. That’s where it usually stops. This is the mentality of fault finding. And it has defined social auditing for a long time.

We can, and do, break that mold. Taking another critical step to ask, “what’s going right?”, provides an extra level of inquiry that probes for opportunities embedded in the fabric of the way things work. It could be an unrecognized best practice, something that people have been doing but nobody took the time, or had the awareness, to document and share. Often times, it’s something frontline workers have done as a response to an unexpected development, like a pandemic that makes you work from home.

In one service-based organization, we found that the sudden shift to working from home led to an unwelcomed rise in cases of domestic violence. We discovered this during audits of pay rates and working hours. The company was able to develop an innovative response, establishing a framework of verbal signals that workers now use to communicate stress or threat. In another instance, while auditing a large industrial company for workplace safety, we found that employees were using a shortcut to avoid a required safety measure. By probing and asking questions in a non-accusatory way, those same workers recommended a very simple workaround to the workaround—thereby restoring the safety measure without adding complexity to the task.

The key to all of this is mindset. Not just ours (the auditors), but the client organization’s as well. You must be willing to broaden the very idea of “compliance.” Sometimes, things that are out of spec are that way for a reason. Rather than lump every outlier as a flaw, you should look beneath the surface and see if there’s a good reason for it. That doesn’t automatically mean nonconformities are suddenly something else. But if you are only looking for problems, that’s all you’re going to find.

Kari Hensien, RizePoint
FST Soapbox

How to Enhance Your Food Safety Culture, Now More Important than Ever

By Kari Hensien
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Kari Hensien, RizePoint

I don’t have to tell you that COVID-19 is a crisis, and the consequences have been immediate and difficult. But as I speak to clients and look beyond the immediacy of the problems the food industry is facing, I am seeing positive insights that can help us now and in the future.

Food safety culture hasn’t always been clearly defined, nor has it been a “must” in many food safety systems. But the reality is that food safety culture—and the buy-in that needs to happen in your entire organization—is a direct and important element for staying up to date with new rules and being consistent and compliant at every location.

Join Kari Hensien for a complementary webinar, “4 Solvable Challenges for Enhancing Your Food Safety Culture 2020” | October 28 | Register NowWhat Does Food Safety Culture Mean Now?

The definition I have liked most is “food safety culture is what you’re doing when no one is watching.” But with the coronavirus pandemic, everyone is always watching, so the definition must expand.
Customers are carefully watching every employee at every location to gain a feeling of safety and trust at restaurants and eateries. And if employees aren’t up to speed or don’t have buy-in to your food safety culture, or even food safety in general, a single incident can turn away customers for good.

As an example, I recently visited a favorite taco joint. After the cashier rang me up, he put hand sanitizer on his gloves and proceeded to put handfuls of chips into my takeaway bag with those same “sanitized” gloves. I will not be going back.

So, food safety culture is still about what you do when no one is watching and when everyone is watching, making participation from every member of your organization critical.

What Can You Do Now to Enhance Food Safety Culture?

Practices that enhance food safety culture should initiate a shift in perspective before you implement more tangible activities. These shifts will be more challenging because they require your entire organization to be on board.

Perspective Shifts for Food Safety Culture

One or more paradigm shifts may be necessary to make enhancing your food safety culture successful. Sometimes initiatives like food safety culture can feel more like another addition to your to-do list rather than an asset that ultimately makes the job of a quality manager easier. So, consider these suggested shifts as you move forward.

  1. Food safety culture is part of your food safety system and your corporate social responsibility plans. With any crisis, not just the current pandemic, the values and expectations you instill in your employees can give you an immovable base, even if the surface is in constant fluctuation. And whether you’re dealing with an outbreak or a pandemic, showing you put customers and location employees first demonstrates good corporate citizenship.
  2. Location employees can be your biggest asset or your biggest liability. Employees perform better when they know the purpose behind what they’re doing rather than following rules that may seem arbitrary if they don’t have a clear understanding of why.
  3.  Punitive systems encourage hiding problems; supportive systems encourage collaboration and trust. If employees feel safe reporting issues or problems at their location, the more likely they’ll catch small issues before they become huge liabilities.
  4. Food safety culture can be a huge asset. In other words, instead of looking at food safety culture as another chore in your already crowded list, see it as an asset that improves food safety and creates better work environments, which inherently decreases risk and protects your brand.

In-Practice Shifts for Food Safety Culture

The paradigm shifts suggested above help build a support perspective for a strong food safety culture. The following shifts I suggest can help you implement tangible actions that benefit every level of your organization.

  1. Take great care of location employees. These employees are in direct contact with customers the most, and they are truly your first line of defense. Which means they can be an incredible asset or the weakest link.
  2. Consider audit and checklist software over laminated or paper checklists. The right software or app can instantly push new policies or standards to every location and employee at the same time, so everyone is always on the same page. Choose software or other tools that 1) makes it easy for all employees to get the information they need; 2) helps them quickly build behaviors that serve your quality and safety programs; and 3) empowers them to confidently share issues that need to be corrected so you get a true view of the health of any location.
  3. Consider quality management system software. With a platform (there are many that include audit and checklist tools), you can collect data points more quickly and from more sources to create a single source of truth and deepen insights. Software can directly support food safety culture, helping you:
    • Find new insights and continually improve your processes
    • Systematically rollout new policies and procedures
    • Drive adoption of new policies and “build muscle memory” so employees build good habits
    • Validate that your policies and practices are followed in every location
    • Identify locations or policies that need increased focus while you reward areas of successful performance.
  4. Look at your organization from a 30,000-foot perspective. This is not so easy to do if you are using manual processes such as paper, file cabinets or even spreadsheets. With those tools, you can see data points, but it takes a lot of work to build a big-picture view. Again, this is where software is invaluable. Many quality management system software options include built-in analytics and reporting, which means much of the work is done for you, saving you valuable time.

I hope your main takeaway from this article is that surviving a crisis requires a strong food safety culture. It helps unify employees across your organization, so everyone knows what’s expected of them and how their work affects the big picture. I see strong evidence that enhancing your food safety culture is more than the “next thing on your to-do list.” It’s a tool that you can put to work to decrease risk, increase compliance, and find small issues before they become huge problems.

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.

Conclusion

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.