Tag Archives: consumer trust

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.

Food Safety Consortium

Making Your Supply Chain Smarter, Safer and More Sustainable

By Maria Fontanazza
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Food Safety Consortium

How to build a smarter, safer and more sustainable food supply chain: This was a big topic at the 2018 Food Safety Consortium last month. David McCarthy of IBM Food Trust led a panel of experts from the retail side of the industry in a Q&A session about their biggest challenges in the supply chain, the role of digital and how to achieve a higher level of transparency.

What are the main areas in the supply chain where there’s a major need for improvement?

Sean Leighton, vice president of food safety and quality, Cargill: One of the biggest challenges that I see from a supplier perspective is people’s assumptions around what is the supply chain—our mindsets, our ability to talk with each other on “what do you mean by ‘supply chain’”?

Cindy Jiang and Scott Horsfall at the 2018 Food Safety Consortium
Cindy Jiang and Scott Horsfall (all images credit: amybcreative)

What is food safety’s role in the supply chain?

Cindy Jiang, senior director of worldwide food safety, quality and nutrition, McDonald’s Corp.: The supply chain is a supply network; it’s not linear. The most fundamental thing is to ensure there’s no disruption—that the supply chain can provide goods and food product to your customers. When you’re looking at the supply chain, [there’s a] change between the traditional thinking and the digital demand. How do you provide information in an effective way to your customers?

Howard Popoola, vice president, corporate food technology and regulatory compliance, The Kroger Company: Our supply chain means nothing if we aren’t able to deliver safe foods to those consumers in the last mile. Consumers are thinking about the experience that they’re going to have with this product. They’re not thinking about whether it’s safe or not. They’re thinking about the meal they’re going to make at home with the ingredients that they purchased.

The biggest pain point from the retailer’s perspective, when you look at us as being the last in the chain, is in transparency [and] knowing where the products are coming from. Transparency is very big for us. And it takes more than the retailer to open that door of transparency to the consumer.

What are the challenges you’re seeing in providing transparency?

Scott Horsfall, CEO, California Leafy Greens Marketing Agreement: I think a big challenge right now and in the future is communication.

Leighton: I think the winners….are going to be the ones that try to achieve consumer trust. The future is no place for the three ring binders…it’s digital. Where does the data sit? How can you provide access to them through customers?

Howard Popoola, Sean Leighton, Food Safety Consortium
Howard Popoola and Sean Leighton

How does the digital transformation play into providing transparency?

Popoola: The consumers have already trusted the food industry. There are millions of people walking into retail stores buying product. If the trust isn’t there, they wouldn’t be doing that. We erode that trust when [a consumer] has a terrible experience with that product.

How are you seeing digital transformation across the supply chain?

Jiang: Digital is one of the top three initiatives of McDonalds; how do we connect with consumers? When serving 70 million customers each day, how can we get to the transparency to understand the supply—digital is one of the answers. From the supply chain standpoint, we’re looking at the analytics. We cannot think about only one solution. We have to have different solutions to get the end results.

Popoola: I think the food industry has to see itself as a big ecosystem. If we don’t see ourselves as an ecosystem that strives for the one thing,… digital is always going to be a mirage. We have to look at what is digital and understand the fact that [we have large and small companies]. It’s not going to be one size fits all.

How long will it take the food industry to get to a completely digital operation?

Jiang: Looking at the total industry digitized—the majority of the work can be done within the next five years, [by] looking at leading companies. But in terms of total digitalization of the ood network in the U.S., I think that will take another 10 to 20 years.

Food Safety Consortium
(left to right) Howard Poopola, Sean Leighton, Cindy Jiang, Scott Horsfall and David McCarthy discuss supply chain challenges during the 2018 Food Safety Consortium

Horsfall: I think there’s a challenge with much of the farm community to get to this point. There’s also this issue with how you transmit the information. [Horsfall predicts] 10-15 years for the industry.

Leighton: Even a 100% digitized food industry has limited value if the players in the industry can’t pull together to deliver meaningful insights from it all.

What are the most promising innovations solving transparency?

Jiang: When looking at innovation, not just technology (technology is an enabler)— the most impactful innovation is human innovation: How can we work together? The GFSI platform started 20 years ago, and now it’s so impactful around the globe. [Now we’re] looking at how to harmonize food safety standards.

How can we standardize and harmonize… for ingredient suppliers?
How [can we] use the GS1 platform, numbering system to track on where the ingredient is coming from and how that product is made for us—what’s in my product?

Think about the human collaboration and how to improve where we’re at.

Poopola: I would like to tackle this from a different perspective: When we built technologies (whether off-the-shelf or customized) 20 years ago, we thought [it would be around for] the next 100 years. It’s clear today that the technology you have in place might be obsolete in five years. We have to look at the technology we’re building and acquiring today: Will it be relevant in five years?

Leighton: It’s hard to wrap my head around…deep learning and AI [artificial intelligence]. The insights we can gain from machine learning and predictive analytics. Could AI be human’s last invention?

Horsfall: In produce industry, which hasn’t always been in the front, I think that’s changing. [We’re] trying to bring AI and new technology to bear.

Food Fraud

PwC Partnership Fights Food Fraudsters

By Food Safety Tech Staff
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Food Fraud

Each year, food fraud costs the industry $30–$40 million worldwide, according to Michigan State University. In an effort to help food companies combat vulnerabilities in their supply chain, PricewaterhouseCoopers (PwC) and non-profit organization SSAFE have created a free tool to help detect food fraud. Developed in partnership with Wageningen University (The Netherlands), VU University Amsterdam and other industry experts, the tool consists of 50 questions and is available via a downloadable app or Excel spreadsheet. Upon completion, the tool provides a profile of the company’s potential for food fraud vulnerability in the form of a report that can be added to food safety documentation.  According to PwC, the assessment is confidential, and while the profile doesn’t offer any mitigation techniques, it provides links on where and how a company can find solutions to the issues mentioned.  

“Beyond the economic cost, food fraud can harm public health and damage consumer trust,” said Craig Armitage, PwC’s Global Leader of Food Supply and Integrity Services in a press release. “Food frauds, such as horse meat being passed off as minced beef or the addition of melamine in dairy, have increased the urgency with which the food industry is taking action.”

Companies can begin using the Excel spreadsheet, which is available on PwC’s website. The app will be available in February.

Maria Fontanazza, Editor-in-Chief, Innovative Publishing Co. LLC
From the Editor’s Desk

Feeding the Fear and The Battle to Regain Consumer Trust

By Maria Fontanazza
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Maria Fontanazza, Editor-in-Chief, Innovative Publishing Co. LLC

When it comes to educating consumers, the process of building trust goes beyond providing research and scientific information. Consumers respond to having connections and shared values related to food safety, the treatment of animals, and nutrition. However, today’s crowd-sourcing environment has served to both enlighten and distribute information that isn’t always fully understood by consumers.

As food companies are facing increasing pressure for transparency, they’re grappling with more effective ways to communicate what’s in their products. “That’s a healthy part of the marketplace, and there’s nothing wrong with food companies responding to consumer demands,” says Jayson Lusk, Regents Professor and Willard Sparks Endowed Chair in the Department of Agricultural Economics at Oklahoma State University. In many cases, when companies provide more information about certain ingredients, it puts them in a difficult position. “Often, many consumers are not in a position to evaluate or understand why an ingredient is used or evaluate the safety risks, so there are all kinds of biases that consumers have; [for example,] if it sounds like a chemical name, it must be deadly. There are all kinds of misinformation on the Internet about various food ingredients that consumers have easy access to.”

Just giving stats and scientific information isn’t always the most effective route. “People don’t tend to respond to just scientific information. That’s unfortunate,” says Lusk. “The research shows people are more persuaded by stories, by a better understanding of why farmers or food processors might be interested in using a particular ingredient.”

Issues surrounding artificial additives, antibiotics and GMOs are particularly contentious, and marketing and advertising play a big role in shaping public perception. Take, for example, gluten-free orange juice. Most natural juices (not juice drinks) are free of gluten, but labeling them as such opens the door to new markets (or maybe it just confuses people more). “One of the big challenges for a lot of food companies, especially big companies that have multiple brands appealing to different segments, is that on the one hand, they defend the use of certain ingredients [for example, genetically modified organisms],” says Lusk. “At the same time, they offer brands that make claims that say they don’t have those ingredients and make all efforts to make sure we aren’t selling you these things.”

This dichotomy can be perceived as a lack of integrity, because it undermines the message of trust that food companies want to convey to the market. Companies need to explain why they’re using certain ingredients in a product and the impact it has on safety and nutrition. And consumers need to understand that either the addition of or absence of certain ingredients can lead to higher prices. Many consumers are willing to pay a premium for products that are labeled as organic or non-GMO, but many consumers still want food to be affordable.

This year companies are being particularly aggressive in announcing their moves to remove additives or antibiotics, or provide GMO-free menus, but the question remains as to whether this will have a positive impact on the bottom line, as well as whether consumers really understand the implications. In April, Chipotle publicized that it was the first U.S. restaurant chain to use only non-GMO ingredients. However, if you read the fine print, you’ll learn that its tortillas still use additives, and the soft drinks that the chain sells may contain sweeteners from GMO corn. Panera stated its plans for removing artificial additives from its menus by the end of 2016. Kraft’s famous Macaroni & Cheese will no longer have that eerie glow, as the company is nixing artificial flavors and dyes, including Yellow No. 5 and 6. Walmart just voiced its new position on responsible use of antibiotics in farm animals, and so did President Obama—at least in Federal cafeterias.

And in an effort to put the kibosh on the “big is bad” mentality, Hormel has put down $775 million to pick up Applegate Farms, a producer of organic meats. Rest assured, as Applegate tells its irate consumers on its Facebook page, its products will “continue to work toward transparency in labeling” and its “standards and products won’t be changed”. Applegate is doing the right thing. It is engaging with consumers, whether or not it likes what they have to say, and it’s doing so in a non-defensive way.

Beyond this, companies need to really study their consumers, understand their patterns, and learn how to educate them in a meaningful way—beyond a simple label.

I try to avoid food with a lot of extra…crap. But sometimes I’m just too tired (or hungry) to pay attention to every detail on the label. And sometimes I eat that red velvet cupcake at a party and, after examining my florescent tongue in the bathroom mirror, I think, shoot—how much dye was in that??? And maybe I like the idea of slicing an apple that doesn’t turn brown. Then again…maybe I don’t.

Truth is, I’m just not sure yet.

Maria Fontanazza
Editor-in-Chief