Tag Archives: HACCP

LIMS, Laboratory information management system, food safety

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

By Ed Ingalls
No Comments
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.

Alex Kinne, Thermo Fisher Scientific
In the Food Lab

Ensuring Food Safety in Meat Processing Through Foreign Object Detection

By Alex Kinne
No Comments
Alex Kinne, Thermo Fisher Scientific

The USDA estimates that foodborne illnesses cost more than $15.6 billion each year. However, biological contamination isn’t the only risk to the safety and quality of food. Food safety can also be compromised by foreign objects at virtually any stage in the production process, from contaminants in raw materials to metal shavings from the wear of equipment on the line, and even from human error. While the risk of foreign object contamination may seem easy to avoid, in 2019 alone the USDA reported 34 food recalls, impacting 17 million pounds of food due to ‘extraneous material’ which can include metal, plastic and even glass.

When FSMA went into effect, the focus shifted to preventing food safety problems, necessitating that food processors implement preventive controls to shift the focus from recovery and quarantine to proactive risk mitigation. Food producers developed Hazard Analysis and Critical Control Point (HACCP) plans focused on identifying potential areas of risk and placement of appropriate inspection equipment at these key locations within the processing line.

Metal detection is the most common detection technology used to find ferrous, non-ferrous, and stainless steel foreign objects in food. In order to increase levels of food safety and better protect brand reputation, food processors need detection technologies that can find increasingly smaller metal foreign objects. Leading retailers are echoing that need and more often stipulate specific detection performance in their codes of practice, which processors must meet in order to sell them product.

As food processors face increased consumer demand and continued price-per-unit pressures, they must meet the challenges of greater throughput demands while concurrently driving out waste to ensure maximum operational efficiencies.

Challenges Inherent in Meat Metal Detection

While some food products are easier to inspect, such as dry, inert products like pasta or grains, metal foreign object detection in meat is particularly challenging. This is due to the high moisture and salt content common in ready-to-eat, frozen and processed, often spicy, meat products that have high “product effect.” Bloody whole muscle cuts can also create high product effect.

The conductive properties of meat can mimic a foreign object and cause metal detectors to incorrectly signal the presence of a physical contaminant even when it is nonexistent. Food metal detectors must be intelligent enough to ignore these signals and recognize them as product effect to avoid false rejection. Otherwise, they can signal metal when it is not present, thus rejecting good product and thereby increasing costs through scrap or re-work.

Equipping for Success

When evaluating metal detection technologies, food processors should request a product test, which allows the processor to see how various options perform for their application. The gold standard is for the food processor to send in samples of their product and provide information about the processing environment so that the companies under consideration can as closely as possible simulate the manufacturing environment. These tests are typically provided at no charge, but care should be taken upfront to fully understand the comprehensiveness of the testing methodologies and reporting.

Among the options to explore are new technologies such as multiscan metal detection, which enables meat processors to achieve a new level of food safety and quality. This technology utilizes five user-adjustable frequencies at once, essentially doing the work of five metal detectors back-to-back in the production line and yielding the highest probability of detecting metal foreign objects in food. When running, multiscan technology allows inspectors to view all the selected frequencies in real time and pull up a report of the last 20 rejects to see what caused them, allowing them to quickly make appropriate adjustments to the production line.

Such innovations are designed for ease of use and to meet even the most rigorous retailer codes of practice. Brands, their retail and wholesale customers, and consumers all benefit from carefully considered, application-specific, food safety inspection.

Ensuring Safety

The food processing industry is necessarily highly regulated. Implementing the right food safety program needs to be a top priority to ensure consumer safety and brand protection. Innovative new approaches address these safety concerns for regulatory requirements and at the same time are designed to support increased productivity and operational efficiency.

Megan Nichols
FST Soapbox

Four Ways To Improve Your Food Safety Management System

By Megan Ray Nichols
No Comments
Megan Nichols

Foodborne illnesses cost billions of dollars each year in the United States. A lack of standards can lead to severe consequences, including loss of customers, negative impact on brand reputation and employees missing work due to illness. As a result, safety is vital for any brand that is committed to high-quality food and maintaining a positive brand image.

Food safety management systems—the processes and procedures that companies set up to prevent contamination—are essential in reducing the risk of foodborne illness and ensuring the safest products possible.

By FDA regulation, most food processors must have HACCP as well as corrective actions/preventive action (CAPAs) plans in place. Even with the right safety guidelines, however, contamination or exposure to food hazards can still occur. The following are four ways to improve the quality of your food safety management system.

1. Conduct Regular Audits

Even if your business’s HACCP is highly effective in theory, it won’t prevent contamination unless actual practice lines up with documentation. Regular audits can ensure employee practice complies.

HACCPs are structured around identifying both potential food hazards and critical control points (CCPs) where your system has the opportunity to prevent, mitigate or eliminate a potential issue. Usually, this means storing food items or performing some biological, physical or chemical action to a target limit— like a specific temperature—to prevent or mitigate contamination.

For example, in the manufacturing of chicken products, cooking and hot-holding are critical control points at which the product needs to be heated to a certain temperature to eliminate or prevent potential hazards. Here, an audit would be a chance to ensure employees cooked and hot-held foods at the proper temperatures. If they aren’t, the food safety management team can make policy changes that ensure practice lines up with planning.

The audit process should be consistent and occur regularly. It should also cover every aspect of your HACCP strategy and place a particular focus on potential hazards and CCPs. These audits can be a way to uncover the strengths and weaknesses of your current HACCP strategy. Companies can use this information to build upon existing practices or demonstrate how procedures could be more effective.

Stainless steel
Stainless steel is popular in food handling due to impermeable surface and resistance to corrosion, two characteristics that help reduce the risk of food contamination. (free image from Splash)

2. Consider a CCP Monitoring System

You can use automated or digital systems to ensure that CCPs aren’t deviating from control limits. With the right sensors, it’s possible to ensure that food remains between target limits at each CCP. For example, automated sensors can quickly alert plant staff if the temperature of food in cold storage rises above a certain threshold, or if there is a deviation from a given CCP.

These alerts can help staff quickly respond to deviations, ensuring compliance, and reducing the risk of contamination by food hazards.

3. Review and Maintain Equipment

An thorough equipment program can be highly effective in reducing the risk of food contamination. To minimize risk, your plan should look at the equipment needed in your plant, as well as how it’s constructed and maintained. For example, choosing industry-standard or food-safe materials can help prevent contamination. Investing in the right kind of stainless steel can both improve operating costs and help reduce the risk of food exposed to hazards.

Preventive maintenance plans for food safety equipment can also reduce the risk of contamination by ensuring the proper functioning of site equipment.

4. Provide Employee Support and Encourage Buy-In

Training programs are an essential component of any HACCP. If your employees don’t know how to handle food properly or aren’t aware of HACCP documentation or the CCPs in the food processing pipeline, they won’t be able to execute the plan and prevent contamination.

While training programs are crucial, they don’t necessarily guarantee compliance. Common pitfalls exist that can discourage employees from following the plan. To encourage employee buy-in, training should begin by discussing the importance of food safety and the potential risks of contamination.

The training should also be robust enough that employees feel confident when executing the HACCP. Training staff should be sure to provide visual demonstrations and opportunities for employees to practice before they become responsible for food safety. Tests or evaluations both during and after training can be useful tools in determining how well your employees understand your business’s HACCP strategy. Regular follow-ups on training can also ensure compliance and reduce the risk of contamination.

Improving Food Safety Management Systems

For any business that works with food, safety programs are essential in ensuring the safest and highest quality product possible. Existing food safety management systems can often improve with the right methods. For example, automated monitoring systems can reduce the risk of deviating from CCP limits. Employee training and regular audits can also ensure that a plant’s food safety practices line up with the documented plan.

Michele Pfannenstiel, Dirigo Food Safety
FST Soapbox

Quality Assurance and Food Safety in Cannabis-Infused Products

By Michele Pfannenstiel, DVM
No Comments
Michele Pfannenstiel, Dirigo Food Safety

The legal cannabis-infused products industry is growing with impressive and predictable rapidity. But because the rollout of new regulations occurs in an awkward and piecemeal fashion, with stark differences from one state to another, and sometimes even one county to another, uncertainty reigns.1 Many entrepreneurs are diving headlong into the nascent industry, hoping to take advantage of an uncertain regulatory environment where government audits and inspections are rare. These business owners will see quality assurance and product safety as burdens—costs to be avoided to the greatest extent possible.

I have seen this time and time again, even in the comparatively well-regulated food industry, and it is always a mistake.

If you find yourself thinking about quality assurance or food safety as a prohibitive cost, annoyance or distraction, I encourage you to change your thinking on this issue. The most successful businesses realize that product safety and quality assurance are inextricably linked with profitability. They are best thought of not as distractions, but as critical elements of an efficient and optimized process. Proper QA and safety are not costs, they are value.

Food safety and quality assurance should be seen as important elements of the process that you undertake to enforce the high standards and consistency that will win you repeat customers. The fact that they guard against costly recalls or satisfy meddlesome auditors is only a bonus. Realizing this will make your business smarter, faster and more profitable.

Learn more about the science, technology, regulatory compliance and quality management issues surrounding cannabis at the Food Labs / Cannabis Labs Conference | June 2–4, 2020If today you cannot clearly communicate your product standards to your employees and to your customers, then you have some work to do. That’s because quality assurance always begins with precise product specifications. (A good definition of “quality” is “conformance to specifications.”) How can you assess quality if you don’t have a definitive standard with which to evaluate it? My consulting firm works with food businesses both small and large, and this is where we begin every relationship. You might be surprised how often even a well-established business has a difficult time naming and describing every one of its products, let alone articulating objective standards for them.

This may be doubly difficult for fledgling businesses in the cannabis world. Because the market is so new, there are fewer agreed-upon standards to fall back on.

When we help businesses create specifications, we always look at the relevant regulations while keeping in mind customer expectations. In cannabis, the regulations just aren’t as comprehensive as they are for conventional food and agriculture. Laws and guidelines are still in flux, and different third-party standards are still competing for market dominance. Different states have entirely different standards, and don’t even agree, for example, whether cannabis edibles should be considered pharmaceuticals or food. To some extent, it’s the wild west of regulation, and as long as the federal government remains reluctant to impose national guidelines, it’s likely to remain so.

The wild west may be a good place for the unscrupulous, but it’s not good for business owners that care about the health of their customers and the long-term health of their brand. Don’t take advantage of confusing quality and safety standards by doing the least possible to get by. At some point there will be a scandal in this country when a novel cannabis product makes dozens of customers sick, or worse. You don’t want it to be yours.

With cannabis-infused products, there is a unique additional factor at play: The strength of THC and other psychoactive compounds. Again, there are few agreed-upon standards for potency testing, and relatively little oversight of the laboratories themselves. This allows labs to get sloppy, and even creates an incentive for them to return inflated THC counts; at the very least, results may hugely differ from one lab to another even for identical products.2 Some labs are ISO 17025 accredited, and some are not. Using an unaccredited laboratory may prevent your efforts to create consistent and homogeneous products.

Even in comparatively well-regulated states, such as Colorado, it is ultimately your responsibility to create products that are safe and consistent. And in the states where the politicians haven’t even figured out which department is regulating cannabis products, your standards should be tougher than whatever is officially required.

And so we look to the more established world of conventional food and agriculture as a guide for the best practices in the cannabis industry.

Hazards

The most constructive way to look at food safety, and the way your (eventual) auditors and regulators will view it, is to look at your product and process from the perspective of the potential hazards.

Some day, when regulation finally gets sorted out, you are likely to be asked to implement a Hazard Analysis and Critical Control Points (HACCP) safety system. HACCP framework recognizes three broad categories of hazards:

  • Physical hazards: Foreign material that is large enough to cause harm, such as glass or metal fragments.
  • Chemical hazards: Pesticides and herbicides, heavy metals, solvents and cleaning solutions.
  • Biological hazards: The pathogens that cause foodborne illness in your customers, such as E. coli, and other biological hazards, such as mycotoxins from molds.

All of these hazards are highly relevant to cannabis-infused product businesses.

The HACCP framework asks us to consider what steps in our process offer us the chance to definitively and objectively eliminate the risk of relevant hazards. In a cannabis cookie, for example, this might be a cooking step, a baking process that kills the Salmonella that could be lurking in your flour, eggs, chocolate or (just as likely!) the cannabis extracts themselves.

A good HACCP system is merely the capstone resting atop a larger foundational system of safety programs, including standard operating procedures, good manufacturing practices, and good agricultural practices. It’s important to use these agreed-upon practices and procedures in your own facility and to ensure that your suppliers and shippers are doing the same. Does your cultivator have a culture of safety and professionalism? Do they understand their own risks of hazards?

HACCP offers a rigorous perspective with which to look at a process, and to examine all of the places where it can go wrong. The safety system ultimately holds everything together because of its emphasis on scrupulous documentation. Every important step is written down, every time, and is always double-checked by a supervisor. It sounds like a lot of paperwork, but it is better viewed as an opportunity to enforce consistency and precision.

When you thoroughly document your process you’ll create a safer product, run a more efficient business, and make more money.

References

  1. Rough, L. (2016, March 4). Leafly’s State-by-State Guide to Cannabis Regulations. Retrieved from https://www.leafly.com/news/industry/leaflys-state-by-state-guide-to-cannabis-testing-regulations
  2. Jikomes, N. & Zoorob, M. (2018, March 14). The Cannabinoid Content of Legal Cannabis in Washington State Varies Systematically Across Testing Facilities and Popular Consumer Products. Retrieved from https://www.nature.com/articles/s41598-018-22755-2
FST Soapbox

How SQF Certification Can Be a Contract Manufacturer’s Greatest Advantage

By Steve Wise
No Comments

SQF certification validates a contract manufacturer’s ability to produce safe, consistent, and high-quality products. It’s a mark of distinction, which can lead to more business. But to obtain SQF certification, a manufacturer must have effective quality and safety controls.

Well-known food and beverage brands will often turn to contract manufacturers to produce the quality products that their customers expect and enjoy. With their brand names on the line, these brand owners need assurance that their suppliers can deliver safe and high-quality goods and mitigate the looming threat of recalls.

How do they know if they’re working with a reliable contract manufacturer? Well, many will look to see if they hold certifications from a reputable third-party organization, such as the Safe Quality Food Institute (SQFI). In fact, one in four companies today require that their suppliers have SQF certification, making it one of the most important certifications in contract manufacturing.

SQF certification demonstrates that a supplier has met benchmarked standards—set by the Global Food Safety Initiative (GFSI)—for upholding quality and controlling food safety risks. It’s a form of validation of an organization’s ability to consistently produce safe and high-quality products. Contract manufacturers that have SQF certification are more likely to win contracts and can bid for business on a national or global scale. Thus, it presents a clear competitive advantage to those certified in the various levels of SQF certification.

Certification Tiers
SQF is a three-level certification program, with each tier progressively more rigorous than the last.

  • Level 1: The SQF Safety Fundamentals Program is an introduction to food safety standards for small- to medium-sized food suppliers. Ideal for those with low-risk food products, the program doesn’t meet GFSI standards but establishes a foundation for doing so. Suppliers certified at this level typically sell their services to smaller, local purveyors.
  • Level 2: The SQF Food Safety Program follows GFSI-benchmarked food safety standards. It helps sites implement preventive food safety measures according to Hazard Analysis and Critical Control Points (HACCP) regulations, which ensure scientific analysis of microbiological, physical and chemical hazards are applied at each step of the supply chain. This level is ideal for businesses that would like to work with purveyors that require adherence to GFSI benchmarked standards.
  • Level 3: The SQF Food Safety and Quality Program shows an ability to not only contain safety risks through the HACCP system, but also monitor and control threats related to food quality. This highest level of certification is ideal for large-scale producers, manufacturers, food packaging facilities and distributors that have successfully deployed an SQF Food Safety Program and want to go above and beyond in their quality efforts.

While it’s the most demanding of the three, Level 3 certification is what most contract manufacturers should aspire to because it’s required by many of the world’s largest food and beverage brands. In order to attain this level of distinction, contract manufacturers need an effective way to demonstrably meet all GFSI benchmarked standards and readily access their quality data during an audit. This is where statistical process control (SPC) comes in.

The SPC Gamechanger

SPC is a proven methodology for monitoring and controlling quality during the manufacturing process. SPC enables manufacturers to chart real-time quality data against predefined control limits to identify unwanted trends and product or process variations. If there is an issue, timely alerts will notify responsible parties to take remedial action early on, preventing unsafe or poor-quality goods from entering the supply chain and triggering a recall. This establishes strong controls for food quality and safety in accordance with a Level 3 SQF Program. Audits also become a breeze, as all historical data are stored digitally in a centralized repository. Suppliers can thereby quickly and easily produce auditor-requested reports showing compliance with SQF requirements and GFSI standards.

Statistical process control, InfinityQS
Statistical process control (SPC) is a method for monitoring and controlling quality during the manufacturing process. Image courtesy of InfinityQS

But beyond quality monitoring and facilitating audits, SPC can deliver greater impact by providing suppliers with analytical tools useful for mining historical data for actionable insights. They can run comparative analyses of the performance of different lines, products, processes, or even sites, revealing where and how to further reduce risk, improve consistency, streamline operations, and lower production costs. In this way, SPC lends itself to a profit-positive business model—driving additional savings through process improvement while increasing new business opportunities through contracts won via SQF certification.

A Snacking Success

One contract manufacturer of savory and healthy snacks previously struggled with large variations in product quality. These inconsistencies often resulted in quality holds or process aborts that generated high waste and costs. By implementing SPC, the snack supplier was able to take advantage of a wide range of data—including incoming receiving tracking and quality inspection tracking—to finetune its production processes with effective controls for food quality and safety. In addition to a 30% reduction in customer complaints, SPC has helped the supplier realize a $1 million reduction in product waste and attain Level 3 SQF certification, the latter of which has generated continued new business from several well-known snack food brands.

This snack supplier is a clear example of SQF certification as a competitive differentiator. Working with such SQF-certified and SPC-powered contractors is important to food and beverage brands because they can protect their reputations and ensure continued customer retention by way of safe, consistent, high-quality products. Ultimately, it builds greater trust and integrity in the supply chain among companies and consumers alike.

Lessons Learned from Intentional Adulteration Vulnerability Assessments (Part II)

By Frank Pisciotta, Spence Lane
No Comments

Food defense is the effort to protect food from intentional acts of adulteration where there is an intent to cause harm. Like counterterrorism laws for many industries, the IA rule, which established a compliance framework for regulated facilities, requires that these facilities prepare a security plan—in this case, a food defense plan—and conduct a vulnerability assessment (VA) to identify significant vulnerabilities that, if exploited, might cause widescale harm to public health, as defined by the FDA. Lessons learned during the conduct of food defense vulnerability and risk assessments and the preparation of the required food defense plan are detailed throughout this three-part series of articles. Part I of this series addressed the importance of a physical security expert, insider threat detection programs, actionable process steps (APS) and varying approaches to a VA. To further assist facilities with reviewing old or conducting new VAs, Part II will touch on access, subject matter experts, mitigation strategies and community drinking water through more lessons learned from assessments conducted for the largest and most complex global food and beverage facilities.

Lesson 6: Utilization of Card Access. The FDA costs of implementing electronic access control, as reported in the Regulatory Impact Analysis document (page 25) are shown in Table 1.

Average Cost Per Covered Facility Initial Recurring Total Annualized
Prohibit after hours key drop deliveries of raw materials $ $1070 $1070
Electronic access controls for employees $1122 $82 $242
Secured storage of finished products $1999 $– $285
Secured storage of raw materials $3571 $– $508
Cameras with video recording in storage rooms $3144 $– $448
Peer monitoring of access to exposed product (not used) $47 $1122 $1129
Physical inspection of cleaned equipment $– $303 $22
Prohibit staff from bringing personal equipment $157 $– $22
Total $9993 $1455 $2878
Table I. Costs of Mitigation

In our opinion, these costs may be underreported by a factor of five or more. A more realistic number for implementing access control at an opening is $5,000 or more depending on whether the wire needs to be run in conduit, which it typically would. While there are wireless devices available, food and beverage organizations should be mindful that the use of wireless devices may in some cases result in the loss of up to 50% of electronic access control benefits. This happens because doors using this approach may not result in monitored-for-alarm conditions, such as when doors are held open too long or are forced open. Some wireless devices may be able to report these conditions, but not always as reliable as hardwired solutions. Using electronic access control without the door position monitoring capability is a mistake. From a cost standpoint, even a wireless access control device would likely be upwards of $2,000 per opening.

Lesson 7: In the interest of time, and in facilities with more complex processes (which increases the work associated with the VA), plan to have quality, food safety and physical security personnel present for the duration of the VA. But also bring in operational specialists to assess each point, step or procedure for the respective operational areas. You may wish to have a quick high-level briefing for each operational group when it’s their turn to deliberate on their portion of the manufacturing operation. Proper planning can get a hybrid style VA done in one-and-a-half to three days maximum for the most complex of operations.

Lesson 8: Conduct a thorough site tour during the assessment process; do not limit your vulnerability activity to a conference room. Both internal and external tours are important in the assessment process by all members of the team. The external tour is needed to evaluate existing measures and identify vulnerabilities by answering questions such as:

  • Is the perimeter maintained?
  • Are cameras pointed correctly?
  • Are doors secure?
  • Are vehicles screened?
  • Are guards and guard tours effective?
  • Internal tours are important to validate documented HACCP points, steps or procedures.A tour also helps to validate process steps that are in multiple parts and may need to be further assessed as a KAT, for public health impact, accessibility and feasibility or to identify issues that have become “invisible” to site employees which might serve a security purpose.
  • Properly conducted tours measure the effectiveness of a variety of potential internal controls such as:
    • Access control
    • Visitor controls
    • Use of identification measures
    • Use of GMP as a security measure (different colors, access to GMP equipment and clean rooms)
    • Effectiveness of buddy systems
    • Employee presence

Lesson 9: Do not forget the use of community drinking water in your processes. This is an easy way to introduce a variety of contaminants either in areas where water is being treated on site (even boiler rooms) or where water may sit in a bulk liquid tank with accessibility through ladders and ports. In our experience, water is listed on about half of the HACCP flow charts we assessed in the VA process.

Lesson 10: Some mitigation strategies may exist but may not be worth taking credit for in your food defense plan. Due to the record keeping requirements being modeled after HACCP, monitoring, corrective action and verification records are required for each mitigation strategy associated with an APS. This can often create more work than it is worth or result in a requirement to create a new form or record. Appropriate mitigation strategies should always be included in your food defense plan, but sometimes it produces diminishing returns if VA facilitators try to get too creative with mitigation strategies. Also, it is usually better to be able to modify an existing process or form than having to create a new one.

Lesson 11: In cases of multi-site assessments, teams at one plant may reach a different conclusion than another plant on whether an identical point, set or procedure is an APS. This is not necessarily a problem, as there may be different inherent conditions from one site to the next. However, we strongly suggest that there be a final overall review from a quality control standpoint to analyze such inconsistencies adjudicate accordingly where there is no basis for varying conclusions.

Lesson 12: If there is no person formally responsible for physical security at your site, you may have a potential gap in a critical subject matter area. Physical security measures will make at least a partial contribution to food defense. Over 30 years, we have seen many organizations deploy electronic access control, video surveillance and lock and key control systems ineffectively, which provides a false sense of security and results in unidentified vulnerability. It is as important to select the right physical security measures to deploy, but also critical to administer them in a manner that meets the intended outcome. Most companies do not have the luxury of a full-time security professional, but someone at the plant needs to be provided with a basic level of competency in physical security to optimize your food defense posture. We have developed several online training modules that can help someone who is new to security on key food defense processes and security system administration.

Lesson 13: As companies move into ongoing implementation and execution of the mitigation strategies, it is important to check that your mitigation strategies are working correctly. You will be required to have a monitoring component, correction action and verification intended for compliance assurance. However, one of the most effective programs we recommend for our clients’ food defense and physical security programs is the penetration test. The penetration test is intended to achieve continuous improvement when the program is regularly challenged. The Safe Quality Food (SQF) Institute may agree with this and now requires facilities that are SQF certified to challenge their food defense plan at least once annually. We believe that frequency should be higher. Simple challenge tests can be conducted in 10 minutes or less and provide substantial insight into whether your mitigation strategies are properly working or whether they represent food defense theater. For instance, if a stranger were sent through the plant, how long would it take for employees to recognize and either challenge or report the condition? Another test might include placing a sanitation chemical in the production area at the wrong time. Would employees recognize, remove and investigate that situation? Challenge tests are easy high impact activities; and regardless of the outcome, can be used to raise awareness and reinforce positive behaviors.

Whether training a new security officer, reviewing existing security plans or preparing for an upcoming vulnerability assessment (due July 26, 2020), these lessons learned from experienced security consultants should help to focus efforts and eliminate unnecessary steps at your facility. The final installment in this series will address broad mitigation strategies, the “Three Element” approach and food defense plan unification. Read the final installment of this series on Lessons Learned from Intentional Adulteration Vulnerability Assessments, Part III.

Lessons Learned from Intentional Adulteration Vulnerability Assessments (Part I)

By Frank Pisciotta, Spence Lane
No Comments

Food defense is the effort to protect food from intentional acts of adulteration where there is an intent to cause harm. Like counterterrorism laws for many industries, the IA rule, which established a compliance framework for regulated facilities, requires that these facilities prepare a security plan—in this case, a food defense plan—and conduct a vulnerability assessment (VA) to identify significant vulnerabilities that, if exploited, might cause widescale harm to public health, as defined by the FDA. Lessons learned during the conduct of food defense vulnerability and risk assessments and the preparation of the required food defense plan are detailed throughout this three-part series of articles. Part I of this series is intended to assist facilities that have not yet conducted vulnerability assessments or wish to review those already conducted, by leveraging lessons learned from assessments conducted for the largest and most complex global food and beverage facilities.

Lesson 1: VA outcomes are greatly enhanced if a physical security professional is consulted. In support of this contention, there are several physical security mitigation strategies, which can be employed to support a food defense program, that are frequently under-utilized and are not optimally managed by non-security staff. Also, the FDA seems to promote the use of cameras even though this equipment is unlikely to prevent an incident of intentional adulteration. For organizations that choose to use video surveillance, a competent security professional can help organizations engineer and operate video surveillance for maximum benefits and to meet challenging record-keeping requirements when this mitigation strategy is included in a food defense plan.

Lesson 2: Given the focus by the FDA on the insider, a formal insider threat detection program is highly recommended. Trying to promote the common, “See Something, Say Something” strategy may not be enough. For example, if employees are not clearly told what to look for in terms of uniform requirements, how to identify persons who do not belong or changes to a coworker’s baseline behavior, which may indicate moving toward a path to violence or sabotage, then “See Something, Say Something” may end up being no more than a catchy slogan.

A key element of an insider threat detection program is the completion of effective background checks for all persons who will be allowed in the facility unescorted. This includes temporary employees and contractors. A common theme in many of the recent, serious intentional adulteration incidents was that the person responsible was involved in some sort of grievance observable to coworkers and supervisors. In all insider threat detection programs, the grievance becomes an important trip wire. The Carnegie Mellon University Software Engineering Institute has published a document titled, “Common Sense Guide to Mitigating Insider Threats, Sixth Edition”. In this document is some particularly helpful guidance that can be used to stand up an insider threat detection program, but this is an effort that can take some time to fully implement.

Lesson 3: The FDA has made it abundantly clear that they believe the focus for the food and beverage industry should be the radicalized insider. A closer look at all the recently publicized contamination events suggests that there are other profiles that need to be considered. A good foundational model for building profiles of potential offenders can be found in the OSHA definitions for workplace violence offenders, which has been expanded to address ideologically based attacks. Table I applies those descriptions to the food and beverage industry, with an asterisk placed by those offender profiles that exist in recent incidents and discussed later in the text.

Class OSHA Workplace Violence Offender Description Motivation Translated to the Food and Beverage Industry
1 The offender has no legitimate relationship to the business or its employee(s). Rather, the violence is incidental to another crime, such as robbery, shoplifting, trespassing or seeking social media fame. Behavioral Health Patient *
Social Media Fame Seeker *
Copycat *
Extortion *
Economic motivation *
2 The violent person has a legitimate relationship with the business—for example, the person is a customer, client, patient, student, or inmate—and becomes violent while being served by the business, violence falls into this category. My load isn’t ready, you are costing me money
3 The offender of this type of violence could be a current employee or past employee of the organization who attacks or threatens other employee(s) in the workplace. I am upset with a coworker and adulterate to create problems for that person *
I am upset with the company and adulterate as retribution and to harm the brand *
Youthful stupidity
I am not paid enough *
4 The offender may or may not have a relationship with the business but has a personal (or perceived personal) relationship with the victim. I am upset with an intimate partner/ coworker and adulterate to create problems for that person
5 Ideological workplace violence is directed at an organization, its people, and/or property for ideological, religious or political reasons. The violence is perpetrated by extremists and value-driven groups justified by their beliefs. Radicalized Insider
Table I. A description of OSHA workplace violence offenders and how it can be applied to the F&B industry.

A supermarket in Michigan recalled 1,700 lbs. of ground beef after 111 people fell ill with nicotine poisoning. The offender, an employee, mixed insecticide into the meat to get his supervisor in trouble. In Australia, the entire strawberry industry was brought to its knees after a disgruntled supervisor “spiked” strawberries with needles. There were more than 230 copycat incidents impacting many companies. A contract employee in Japan, apparently disgruntled over his low pay, sprayed pesticide on a frozen food processing line resulting in illnesses to more than 2,000 people. A contract worker upset with a union dispute with the company at a food manufacturing plant videoed himself urinating on the production line, then uploaded the video to the Internet. Be cognizant of any grievances in the workplace and increase monitoring or take other proactive steps to reduce the risk of intentional adulteration.

Lesson 4: The IA Rule requires that every point, step and procedure be analyzed to determine if it is an actionable process step (APS). The Hazard Analysis Critical Control Point flow charts are a good starting point to comply with this element of the law but cannot be counted on completely to achieve the standard of analyzing every point, step or procedure. Critical thinking and persons familiar with the production process need to be involved to ensure that no steps are missed. Oftentimes companies modify the HACCP flow diagrams after a VA.

Lesson 5: The FDA states in the second installment of guidance (here’s the full copy) to the industry that, “There are many possible approaches to conducting a VA. You may choose an approach based on considerations such as the time and resources available and the level of specificity desired. You have the flexibility to choose any VA approach, as long as your VA contains each required component (21 CFR 121.130).”

The FDA further states that the Key Activity Type, or KAT method, is an appropriate method for conducting a VA because it reflects consideration of the three required elements and the inside attacker. Using this methodology alone, however, can result in substantially more APS’s, which might otherwise be ruled out for practical purposes such as a lack of accessibility or a lack of feasibility to contaminate the product at a point, step or procedure. We have experienced up to a 90% decline in APS’s by utilizing another FDA recommended assessment approach, the hybrid approach, which assesses each point, step or procedure as first whether it is a KAT. Then to qualify as an APS, it must also trigger positively for public health impact, accessibility and feasibility to contaminate the product.

Organizations who have yet to execute vulnerability assessments (due July 26, 2020) or who may wish to reflect back on their existing VA’s in an effort to eliminate unnecessary APS’s should find these strategies helpful to focus limited resources to the areas where they can have the greatest effect. The next two articles in this series will cover more information on electronic access, the value of site tours, comparisons to drinking water security strategies, dealing with multi-site assessments and more. Read Part II of this series on intentional adulteration.

Jill Ellsworth, Willow Industries
FST Soapbox

Modeling Cannabis Safety from Food and Beverage Quality Regulations

By Jill Ellsworth
1 Comment
Jill Ellsworth, Willow Industries

There’s a reason you can eat or drink pretty much anything you want from American grocery stores and not get sick. Food manufacturing is highly regulated and subject to rigorous quality control.

Before food and beverages hit store shelves, the manufacturer must have a Hazard Analysis Critical Control Point (HACCP) system in place. The HACCP system requires that potential hazards—biological, chemical and physical— be identified and controlled at specific points in the manufacturing process. In addition, fresh foods undergo a kill-step. This is the point in the manufacturing or packaging process where food is treated to minimize and remove deadly pathogens like bacteria, mold, fungus and E. coli.

Generally speaking, when cannabis hits dispensary shelves, a less stringent set of rules apply, despite the fact that cannabis is ingested, inhaled and used as medicine. Cultivators are required to test every batch, but each state differs in what is required for mandated testing. Compared to the way food is regulated, the cannabis industry still has a long way to go when it comes to consumer safety—and that poses a considerable public health risk. In the early stages of legalization, the handful of legal states did not have rigid cannabis testing measures in place, which led to inconsistent safety standards across the country. State governments have had a reactionary approach to updating testing guidelines, by and large implementing stricter standards in response to product recalls and customer safety complaints. While local regulators have had the best intentions in prioritizing consumer safety, it is still difficult to align uniform cannabis testing standards with existing food safety standards while cannabis is a Schedule I substance.

The stark differences in safety measures and quality controls were first obvious to me when I moved from the food and beverage industry into the cannabis industry. For five years, I operated an organic, cold-pressed juice company and a natural beverage distribution company and had to adhere to very strict HACCP guidelines. When a friend asked me for advice on how to get rid of mold on cannabis flower, a light bulb went off: Why was there no kill step in cannabis? And what other food safety procedures were not being followed?

What to know more about all things quality, regulatory and compliance in the cannabis industry? Check out Cannabis Industry Journal and sign up for the weekly newsletterThe current patchwork of regulations and lack of food safety standards could have dire effects. It not only puts consumer health in jeopardy, but without healthy crops, growers, dispensaries and the entire cannabis supply chain can suffer. When a batch of cannabis fails microbial testing, it cannot be sold as raw flower unless it goes through an approved process to eliminate the contamination. This has severe impacts on everyone, starting with the cultivator. There are delays in harvesting and delivery, and sometimes producers are forced to extract their flower into concentrates, which really cuts into profits. And in the worst cases, entire crop harvests may have to be destroyed.

So, what do cannabis cultivators and manufacturers have to fear the most? Mold. Out of all the pathogens, mold is the most problematic for cannabis crops, perhaps because it is so resilient. Mold can withstand extreme heat, leaving many decontamination treatments ineffective. And most importantly, mold can proliferate and continue to grow. This is commonplace when the cannabis is stored for any length of time. Inhaling mold spores can have serious adverse health effects, including respiratory illness, and can even be deadly for immunocompromised consumers using it for medical reasons.

What the industry needs is a true kill step. It’s the only way to kill mold spores and other pathogens to ensure that they will not continue to grow while being stored. States that mandate microbial testing will benefit from the kill step because more cultivators will be in compliance earlier in the process. In states that don’t require comprehensive microbial testing, like Washington and Oregon, the kill step is a critical way to provide consumers with a preemptive layer of protection. Microbial testing and preventative decontamination measures encourage customer brand loyalty and prevents negative press coverage.

Adopting a HACCP system would also build additional safeguards into the system. These procedures provide businesses with a step-by-step system that controls food safety, from ingredients right through to production, storage and distribution, to sale of the product and service for the final consumer. The process of creating HACCP-based procedures provides a roadmap for food safety management that ultimately aligns your staff around the goal of keeping consumers safe.

It’s high time for the cannabis industry to adopt FDA-like standards and proactively promote safety measures. Cannabis growers must implement these quality controls to ensure that their products are as safe to consume as any other food or drink on the market. Let’s be proactive and show our consumers that we are serious about their safety.

LIMS, laboratory information management system

Integrated Informatics: Optimizing Food Quality and Safety by Building Regulatory Compliance into the Supply Chain

By Kevin Smith
No Comments
LIMS, laboratory information management system

Global food supply chains offer consumers more choice than ever before. Thanks to international networks of producers, wholesalers, manufacturers and suppliers, many ingredients can be sourced all year round, meaning diets are no longer limited by what’s in season. However, the increasing complexity of these supply chains means many food and beverage products are potentially more exposed to biological and chemical contamination as well as food fraud issues, putting brand reputation and human health at risk.

With consumer trust and public safety of paramount importance, global food regulators have introduced strict rules to protect the quality and authenticity of products. Regulations such as the FDA’s Food Protection Plan, for example, seek to incorporate safety measures throughout food supply chains in order to better prevent and respond to potential issues.1 These regulations are complemented by standards such as the ISO’s recently updated ISO 22000:2018 guidelines that recommend the implementation of hazard analysis and critical control points (HACCP) to achieve the highest levels of quality control (QC).2 For businesses working within this regulatory framework, it is essential to take a coordinated approach to deliver the standards of food quality and safety that customers and regulators expect.

Every food supply chain will have its own set of product specifications and QC parameters. However, all these requirements demand that decisions on the release of goods are made using accurate and timely information. Given the growing attention from regulators on the safety and provenance of food, as well as the need for operations to run as efficiently as possible, supply chain stakeholders are reevaluating the digital platforms they use to manage, store and recall their data. Here, we consider how laboratory information management systems (LIMS) can help businesses integrate efficient data collection workflows across multiple locations to support robust QC testing and build regulatory compliance into their operations.

Meeting the Challenges Facing Modern Food Supply Chains

Assuring consistent product quality and safety is a constant challenge for food supply chain businesses, given the broad range of issues that can compromise these standards. Although most businesses adopt strict storage and handling protocols to minimize the risk of foodborne illnesses caused by bacterial contamination, high-profile public health stories regularly hit the headlines. The widespread use of pesticides and veterinary drugs in farming also means that ingredients are potentially exposed to a wide range of known and unknown chemical contaminants. Contamination can also occur during the handling, processing and packaging stages. Robust QC measures are therefore essential to identify issues as early as possible.

Equally, food adulteration and counterfeiting continue to be key challenges, with high-value products regularly targeted by food fraudsters. The Grocery Manufacturers Association estimates that up to 10% of all commercially sold food products are affected by these practices, costing the industry between $10 and $15 billion each year and putting public health at risk.3 Comprehensive QC testing, supported by robust chain of custody data, is required to demonstrate quality and authenticity of goods, protect brands and safeguard consumers.

However, the extended nature of modern food supply chains can make delivering against these goals more difficult, especially if poorly integrated information management approaches are employed. As food supply chains have gone global, it has become increasingly common for businesses to operate storage, production and processing facilities across sites in multiple regions, countries and even continents. To deliver goods that meet well-defined safety and quality specifications, QC workflows must be built upon standardized protocols that are implemented correctly across the supply chain, regardless of the individual following them or the location in which they operate. These workflows must be supported by robust information exchange mechanisms that make sure the right decisions around product manufacturing and batch release can be made using accurate, complete and up-to-date information.

Improving QC Data Quality Using Integrated Data Management Solutions

With fragmented information management approaches often getting in the way of this ideal, many food businesses are looking to transform their poorly connected systems into informatics platforms that streamline operations, improve visibility and reduce errors. The latest LIMS allow businesses to bring all their QC data into a single integrated system, helping to harmonize processes and make information sharing more efficient to enhance product quality and safety.

Take the execution of standard operating procedures (SOPs) for pesticide residue testing, for example. By centrally connecting instruments and storing SOPs digitally on a LIMS, processes and parameters can be downloaded directly, eliminating the need for human error-prone manual set-up and supporting the consistent collection of data. Furthermore, because these SOPs are located in a centralized system, securely accessible to authorized users across all sites and facilities, the risk of SOPs becoming out of date or out of sync is greatly reduced. With guidance on residue levels regularly updated to reflect the evolving knowledge of these threats, ensuring the latest testing protocols are applied is particularly important.

Additionally, because LIMS capture and store QC measurements directly, as it is generated, they eliminate the need for labor-intensive transcription and data transfer processes. Not only does this improve measurement accuracy by taking human error out of the equation, it also boosts efficiency and reduces the administrative burden on those responsible for collecting QC data. As a result, experienced staff can spend less time on paperwork and data entry, and more time actively optimizing processes and finding solutions to other key challenges. With access to the most accurate and up-to-date information, businesses are better placed to maintain the integrity of the food supply chain and can act to resolve potential issues before they turn into more significant problems.

Supporting Well-Defined QC Processes and Regulatory Compliance

With international food regulators turning their attention to the methods used to assure the quality and authenticity of foodstuffs, supply chain stakeholders are now expected to have well-defined QC workflows that not only provide complete traceability of products from farm to fork, but also transparency around processes such as instrument calibration and data handling.

LIMS, laboratory information management system
Modern LIMS allow food businesses to visualize their workflow data using dashboards, process diagrams or facility maps. Image courtesy of Thermo Fisher Scientific.

LIMS allow food businesses to build regulatory compliance into their processes by providing a comprehensive overview of all supply chain data, including information associated with QC steps. As all data required to support proof of compliance is organized in a single system, it can be quickly and conveniently recalled for sharing or review purposes. Some of the latest systems allow users to visualize this data holistically on process diagrams or dashboards, helping to fulfill HACCP requirements and make keeping track of active workflows as easy as possible.

Furthermore, because LIMS can be used to capture and store data automatically, they also facilitate the real-time monitoring of supply chain processes, meaning out-of-specification QC parameters can be flagged and reported earlier. The sophisticated algorithms present in some of the latest LIMS can even be used to warn businesses of small but significant trends such as the decline in performance of an aging instrument, which could cause unexpected downtime or cause product quality standards to fall over time. These alerting capabilities mean potential issues can be remedied faster, helping stakeholders more proactively protect consumer safety.

Defensible data is central to protecting brand integrity, especially when it comes to issues around food adulteration and counterfeiting. As such, food businesses need robust data management tools that support complete traceability of actions. By automatically recording every interaction with the system to generate a comprehensive audit trail and facilitating the use of e-signatures to document review procedures, LIMS can safeguard the highest levels of accountability, from data collection all the way through to results reporting. Some of the most advanced LIMS also feature powerful audit trail search functionality, allowing authorized users to recall specific actions such as unusual QC activity or potentially non-compliant behavior. With a secure record of events and a single, integrated platform for supply chain data, food businesses can focus on what’s important—optimizing processes and delivering high-quality goods.

Optimizing and Safeguarding the Food Supply Chain Using LIMS

Modern LIMS allow food supply chain stakeholders to build regulatory compliance into their workflows by standardizing QC processes and giving authorized individuals full visibility over their data. By facilitating faster and more informed decision-making using accurate and up-to-the-minute data, LIMS are helping businesses meet current industry challenges head on to maintain the safety and integrity of the food supply chain.

References

  1. FDA. (November 2007). Food Protection Plan. Access April 7, 2019. Retrieved from , https://www.fda.gov/downloads/aboutfda/centeroffices/oc/officeofoperations/ucm121761.pdf .
  2.  International Organization for Standardization. (June 2018). ISO 22000:2018(en) Food safety management systems — Requirements for any organization in the food chain..
  3. The Grocery Manufacturers Association and A.T. Kearney. (2010). Consumer Product Fraud: Deterrence and Detection.
Question mark

The Results Are In: FSMA Supply Chain IQ Test (Part II)

By Food Safety Tech Staff
No Comments
Question mark

Thank you to everyone who participated in our latest FSMA IQ test, which focused on the supply chain. This series was developed by Kestrel Management. If you have any questions about the results, we encourage you to leave a comment.

We also invite you to learn more about important supply chain issues at our Food Safety Supply Chain Conference later this month, May 29–30. You can attend in person or virtually.

If you haven’t taken Part II yet, take the Supply Chain IQ Test now.

And now for the results!

  1. Control limits must be included within the hazard analysis and preventive controls for HACCP.
    • FALSE. More clarification is needed here, as 96% of respondents said this is true.
  2. CCPs previously established under HACCP or previous hazard analysis may be a preventive control under FSMA.
    • TRUE. 91% got this right.
  3. Product testing for pathogen or indicator organism is not addressed under FSMA verification and reevaluation.
    • FALSE. 87% answered correctly.
  4. You must document justification of records not required by a food safety plan in a food operation under FSMA.
    • TRUE. Just 44% responded “true”.
  5. You must implement corrective actions and corrections properly, including procedures to address the presence of organizations in ready-to-eat as a result of product testing.
    • TRUE. Congratulations, 100% got this one right!
  6. Under section 117.150, you must implement corrective actions based on your determined response for all affected food as evaluated.
    • FALSE. This seems to be another area that needs clarity: Just 13% answered “false”.
  7. Under FSMA supply chain requirements, you must document approved suppliers.
    • TRUE. Once again, great job—100% answered correctly!
  8. A foreign supplier of food to the U.S. must ensure that all the requirements of a FSMA Food Safety Plan under cGMP117.126 be met for the manufacture of the food being exported to the United States.
    • TRUE. 91% knew this one.
  9. A food broker of foreign-supplied product to the U.S. does not have any responsibility of meeting the FSMA requirements.
    • FALSE. 91% answered correctly.
  10. Data sets must be shared between shippers, carriers, loaders & receivers to ensure rules are properly implemented.
    • TRUE. 74% answered correctly.
  11. Only the personnel of the carriers transporting food product require training and training records.
    • FALSE. 96% got this one right.
  12. Shipper & carrier can agree to a condition & temperature monitoring mechanism for foods that requires temperature control for safety.
    • TRUE. 91% answered correctly.