Tag Archives: quality assurance

Arun Apte, CloudLIMS
In the Food Lab

Is Your Food Testing Lab Prepping for an ISO/IEC 17025 Audit?

By Arun Apte
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Arun Apte, CloudLIMS

With the increasing globalization of the food industry, ensuring that products reaching consumers are safe has never been more important. Local, state and federal regulatory agencies are increasing their emphasis on the need for food and beverage laboratories to be accredited to ISO/IEC 17025 compliance. This complicated process can be simplified and streamlined through the adoption of LIMS, making accreditation an achievable goal for all food and beverage laboratories.

With a global marketplace and complex supply chain, the food industry continues to face increasing risks for both unintentional and intentional food contamination or adulteration.1 To mitigate the risk of contaminated products reaching consumers, the International Organization for Standardization (ISO), using a consensus-based approval process, developed the first global laboratory standard in 1999 (ISO/IEC 17025:1999). Since publication, the standard has been updated twice, once in 2005 and most recently in 2017, and provides general requirements for the competence of testing and calibration laboratories.2

In the recent revision, four key updates were identified:

  1. A revision to the scope to include testing, calibration and sampling associated with subsequent calibration and testing performed by a laboratory.3
  2. An emphasis on the results of a process instead of focusing on prescriptive procedures and policies.4
  3. The introduction of the concept of a risk-based approach used in production quality management systems.2
  4. A stronger focus on information technologies/management systems, specifically Laboratory Information Management System (LIMS).4

As modern-day laboratories reduce their reliance on hard copy documents and transition to electronic records, additional emphasis and guidance for ISO 17025 accreditation in food testing labs using LIMS was greatly needed. Food testing laboratories have increased reliance on LIMS to successfully meet the requirements of accreditation. Food and beverage LIMS has evolved to increase a laboratory’s ability to meet all aspects of ISO 17025.

ISO 17025 requirements
Figure 1. A schematic representation of some of the requirements of ISO/IEC 17025:2017 compliance. (Figure courtesy CloudLIMS)

Traceability

Chain of Custody
A key element for ISO 17025 accredited laboratories is the traceability of samples from accession to disposal.5 Sometimes referred to as chain of custody, properly documented traceability allows a laboratory to tell the story of each sample from the time it arrives until the time it is disposed of.

LIMS software allows for seamless tracking of samples by employing unique sample accession numbers through barcoding processes. At each step of sample analysis, a laboratory technician updates data in a LIMS by scanning the sample barcode, establishing time and date signatures for the analysis. During an ISO 17025 audit, this information can be quickly obtained for review by the auditor.

Procurement and Laboratory Supplies
ISO 17025 requires the traceability of all supplies or inventory items from purchase to usage.6 This includes using approved vendors, documentation of receipt, traceability of supply usage to an associated sample, and for certain products, preparation of supply to working conditions within the laboratory. Supply traceability impacts multiple departments and coordinating this process can be overwhelming. A LIMS for food testing labs helps manage laboratory inventory, track usage of inventory items, and automatically alerts laboratory managers to restock inventory once the quantity falls below a threshold level.

A food LIMS can ensure that materials are ordered from approved vendors only, flagging items purchased outside this group. As supplies are inventoried into LIMS, the barcoding process can ensure accurate storage. A LIMS can track the supply through its usage and associate it with specific analytical tests for which inventory items are utilized. As products begin to expire, a LIMS can notify technicians to discard the obsolete products.

One unique advantage of a fully integrated LIMS software is the preparation and traceability of working laboratory standards. A software solution for food labs can assist a technician in preparing standards by determining the concentration of solvents needed based on the input weight from a balance. Once prepared, LIMS prints out a label with barcodes and begins the supply traceability process as previously discussed.

Quality Assurance of Test and Calibration Data

This section of ISO 17025 pertains to the validity of a laboratory’s quality system including demonstrating that appropriate tests were performed, testing was conducted on properly maintained and calibrated equipment by qualified personnel, and with appropriate quality control checks.

Laboratory Personnel Competency
Laboratory personnel are assigned to a specific scope of work based upon qualifications (education, training and experience) and with clearly defined duties.7 This process adds another layer to the validity of data generated during analysis by ensuring only appropriate personnel are performing the testing. However, training within a laboratory can be one of the most difficult components of the accreditation process to capture due to the rapid nature in which laboratories operate.

With a food LIMS, management can ensure employees meet requirements (qualifications, competency) as specified in job descriptions, have up-to-date training records (both onboarding and ongoing), and verify that only qualified, trained individuals are performing certain tests.

Calibration and Maintenance of Equipment
Within the scope of ISO 17025, food testing laboratories must ensure that data obtained from analytical instruments is reliable and valid.5 Facilities must maintain that instruments are in correct operating condition and that calibration data (whether performed daily, weekly, or monthly) is valid. As with laboratory personnel requirements, this element to the standard adds an additional layer of credibility that sample data is precise, accurate, and valid.

A fully integrated software solution for food labs sends a notification when instrument calibration is out of specification or expired and can keep track of both routine internal and external maintenance on instruments, ensuring that instruments are calibrated and maintained regularly. Auditors often ask for instrument maintenance and calibration records upon the initiation of an audit, and LIMS can swiftly provide this information with minimal effort.

Figure 2. A preconfigured food LIMS to manage instrument calibration and maintenance data. (Figure courtesy of CloudLIMS)

Measurement of Uncertainty (UM)
Accredited food testing laboratories must measure and report the uncertainty associated with each test result.8 This is accomplished by using certified reference materials (CRM), or known spiked blanks. UM data is trended using control charts, which can be prepared using labor-intensive manual input or performed automatically using LIMS software. A fully integrated food LIMS can populate control data from the instrument into the control chart and determine if sample data analyzed in that batch can be approved for release.

Valid Test Methods and Results
Accurate test and calibration results can only be obtained with methods that are validated for the intended use.5 Accredited food laboratories should use test methods that are current and contain embedded quality control standards.

A LIMS for food testing labs can ensure correct method selection by technicians by comparing data from the sample accession input with the test method selected for analysis. Specific product identifiers can indicate if methods have been validated. As testing is performed, a LIMS can track time signatures to ensure protocols are properly performed. At the end of the analysis, results of the quality control samples are linked to the test samples to ensure only valid results are available for clients. Instilling checks at each step of the process allows a LIMS to auto-generate Certificates of Analysis (CoA) knowing that the testing was performed accurately.

Data Integrity
The foundation of a laboratory’s reputation is based on its ability to provide reliable and accurate data. ISO 17025:2017 includes specific references to data protection and integrity.10 Laboratories often claim within their quality manuals that they ensure the integrity of their data but provide limited details on how it is accomplished making this a high priority review for auditors. Data integrity is easily captured in laboratories that have fully integrated their instrumentation into LIMS software. Through the integration process, data is automatically populated from analytical instruments into a LIMS. This eliminates unintentional transcription errors or potential intentional data manipulation. A LIMS for food testing labs restricts access to changing or modifying data, allowing only those with high-level access this ability. To control data manipulation even further, changes to data auto-populated in LIMS by integrated instrumentation are tracked with date, time, and user signatures. This allows an auditor to review any changes made to data within LIMS and determine if appropriate documentation was included on why the change was made.

Sampling
ISO 17025:2017 requires all food testing laboratories to have a documented sampling plan for the preparation of test portions prior to analysis. Within the plan, the laboratory must determine if factors are addressed that will ensure the validity of the testing, ensure that the sampling plan is available to the laboratory (or the site where sampling is performed), and identify any preparation or pre-treatment of samples prior to analysis. This can include storage, homogenization (grinding/blending) or chemical treatments.9

As sample information is entered into LIMS, the software can specify the correct sampling method to be performed, indicate appropriate sample storage conditions, restrict the testing to approved personnel and provide electronic signatures for each step.

Monitoring and Maintenance of the Quality System

Organization within a laboratory’s quality system is a key indicator to assessors during the audit process that the facility is prepared to handle the rigors that come with accreditation.10 Assessors are keenly aware of the benefits that a food LIMS provides to operators as a single, well-organized source for quality and technical documents.

Document Control
An ISO 17025 accredited laboratory must demonstrate document control throughout its facility.6 Only approved documents are available for use in the testing facility, and the access to these documents is restricted through quality control. This reduces the risk of document access or modification by unauthorized personnel.

LIMS software efficiently facilitates this process in several ways. A food LIMS can restrict access to controlled documents (both electronic and paper) and require electronic signatures each time approved personnel access, modify or print them. This digital signature provides a chain of custody to the document, ensuring that only approved controlled documents are used during analyses and that these documents are not modified.

Software, LIMS
Figure 3. A software solution for food labs helps manage documents, track their revision history, and ensure document control. (Figure courtesy of CloudLIMS)

Corrective Actions/Non-Conforming Work
A fundamental requirement for quality systems is the documentation of non-conforming work, and subsequent corrective action plans established to reduce their future occurrence.5

A software solution for food labs can automatically maintain electronic records of deviations in testing, flagging them for review by quality departments or management. After a corrective action plan has been established, LIMS software can monitor the effectiveness of the corrective action by identifying similar non-conforming work items.

Conclusion

Food and beverage testing laboratories are increasingly becoming accredited to ISO 17025. With recent changes to ISO 17025, the importance of LIMS for the food and beverage industry has only amplified. A software solution for food labs can integrate all parts of the accreditation process from personnel qualification, equipment calibration and maintenance, to testing and methodologies.11 Fully automated LIMS increases laboratory efficiency, productivity, and is an indispensable tool for achieving and maintaining ISO 17025 accreditation.

References

  1. Spink, J. (2014). Safety of Food and Beverages: Risks of Food Adulteration. Encyclopedia of Food Safety (413-416). Academic Press.
  2. International Organization for Standardization (October 2017). ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories. Retrieved from: https://www.iso.org/files/live/sites/isoorg/files/store/en/PUB100424.pdf
  3. 17025 Store (2018). Transitioning from ISO 17025:2005 to ISO/IEC 17024:2017. Standards Store.
  4. Perry Johnson Laboratory Accreditation (2019). An Overview of Changes Between 17025:2005 and 17025:2017. ISO/IEC 17025:2017 Transition. https://www.pjlabs.com/downloads/17025-Transition-Book.pdf
  5. Analytical Laboratory Accreditation Criteria Committee. (2018). AOAC INTERNATIONAL Guidelines for Laboratories Performing Microbiological and Chemical Analyses of Food, Dietary Supplements, and Pharmaceuticals, An Aid to Interpretation of ISO/IEC 17025. Oxford, England: Oxford University Press.
  6. Cokakli, M. (September 4, 2020). Transitioning to ISO/IEC 17025:2017. New Food Magazine.
  7. ISO/IEC 17025:2017. General requirements for the competence of testing and calibration laboratories.
  8. Bell, S. (1999). A Beginner’s Guide to Uncertainty of Measurement. Measurement Good Practice Guide. 11 (2).
  9. 17025Store (2018). Clause 7: Process requirements. Standards Store.
  10. Dell’Aringa, J. (March 27, 2017). Best Practices for ISO 17025 Accreditation: Preparing for a Food Laboratory Audit (Part I). Food Safety Tech.
  11. Apte, A. (2020). Preparing for an ISO 17025 Audit: What to Expect from a LIMS?
food safety tech

Next Week: Attend the ‘Drivers in Food Safety Testing’ Webinar

By Food Safety Tech Staff
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food safety tech
Angela Anandappa, Alliance for Advanced Sanitation
Angela Anandappa, Ph.D., founding director of the Alliance for Advanced Sanitation and member of the FST Advisory Board

Join Food Safety Tech next week for the first in a series of complimentary webinars, called Drivers in Food Safety Testing, about the important components and issues that encompass food safety testing. Angela Anandappa, Ph.D., founding director of the Alliance for Advanced Sanitation and member of the FST Advisory Board, will lead the discussion with a presentation about Technologies Leading the Way. The complimentary webinar is aimed at food safety professionals within quality assurance and control, compliance, food lab and contract lab management, and risk management. A technology spotlight given by Lyssa Sakaley, senior global product manager for molecular pathogen testing at MilliporeSigma will follow Anandappa’s presentation. The event will conclude with an interactive Q&A with attendees.

Drivers in Food Safety Testing: Technologies Leading the Way
Wednesday, March 18 at 1 pm ET
Register now!

Michael Bartholomeusz, TruTag
In the Food Lab

Intelligent Imaging and the Future of Food Safety

By Michael Bartholomeusz, Ph.D.
1 Comment
Michael Bartholomeusz, TruTag

Traditional approaches to food safety no longer make the grade. It seems that stories of contaminated produce or foodborne illnesses dominate the headlines increasingly often. Some of the current safeguards set in place to protect consumers and ensure that companies are providing the freshest, safest food possible continue to fail across the world. Poorly regulated supply chains and food quality assurance breakdowns often sicken customers and result in recalls or lawsuits that cost money and damage reputations. The question is: What can be done to prevent these types of problems from occurring?

While outdated machinery and human vigilance continue to be the go-to solutions for these problems, cutting-edge intelligent imaging technology promises to eliminate the issues caused by old-fashioned processes that jeopardize consumer safety. This next generation of imaging will increase safety and quality by quickly and accurately detecting problems with food throughout the supply chain.

How Intelligent Imaging Works

In broad terms, intelligent imaging is hyperspectral imaging that uses cutting-edge hardware and software to help users establish better quality assurance markers. The hardware captures the image, and the software processes it to provide actionable data for users by combining the power of conventional spectroscopy with digital imaging.

Conventional machine vision systems generally lack the ability to effectively capture and relay details and nuances to users. Conversely, intelligent imaging technology utilizes superior capabilities in two major areas: Spectral and spatial resolution. Essentially, intelligent imaging systems employ a level of detail far beyond current industry-standard machinery. For example, an RGB camera can see only three colors: Red, green and blue. Hyperspectral imaging can detect between 300 and 600 real colors—that’s 100–200 times more colors than detected by standard RGB cameras.

Intelligent imaging can also be extended into the ultraviolet or infrared spectrum, providing additional details of the chemical and structural composition of food not observable in the visible spectrum. Hyperspectral imaging cameras do this by generating “data cubes.” These are pixels collected within an image that show subtle reflected color differences not observable by humans or conventional cameras. Once generated, these data cubes are classified, labeled and optimized using machine learning to better process information in the future.

Beyond spectral and spatial data, other rudimentary quality assurance systems pose their own distinct limitations. X-rays can be prohibitively expensive and are only focused on catching foreign objects. They are also difficult to calibrate and maintain. Metal detectors are more affordable, but generally only catch metals with strong magnetic fields like iron. Metals including copper and aluminum can slip through, as well as non-metal objects like plastics, wood and feces.

Finally, current quality assurance systems have a weakness that can change day-to-day: Human subjectivity. The people put in charge of monitoring in-line quality and food safety are indeed doing their best. However, the naked eye and human brain can be notoriously inconsistent. Perhaps a tired person at the end of a long shift misses a contaminant, or those working two separate shifts judge quality in slightly different ways, leading to divergent standards unbeknownst to both the food processor and the public.

Hyperspectral imaging can immediately provide tangible benefits for users, especially within the following quality assurance categories in the food supply chain:

Pathogen Detection

Pathogen detection is perhaps the biggest concern for both consumers and the food industry overall. Identifying and eliminating Salmonella, Listeria, and E.coli throughout the supply chain is a necessity. Obviously, failure to detect pathogens seriously compromises consumer safety. It also gravely damages the reputations of food brands while leading to recalls and lawsuits.

Current pathogen detection processes, including polymerase chain reaction (PCR), immunoassays and plating, involve complicated and costly sample preparation techniques that can take days to complete and create bottlenecks in the supply chain. These delays adversely impact operating cycles and increase inventory management costs. This is particularly significant for products with a short shelf life. Intelligent imaging technology provides a quick and accurate alternative, saving time and money while keeping customers healthy.

Characterizing Food Freshness

Consumers expect freshness, quality and consistency in their foods. As supply chains lengthen and become more complicated around the world, food spoilage has more opportunity to occur at any point throughout the production process, manifesting in reduced nutrient content and an overall loss of food freshness. Tainted meat products may also sicken consumers. All of these factors significantly affect market prices.

Sensory evaluation, chromatography and spectroscopy have all been used to assess food freshness. However, many spatial and spectral anomalies are missed by conventional tristimulus filter-based systems and each of these approaches has severe limitations from a reliability, cost or speed perspective. Additionally, none is capable of providing an economical inline measurement of freshness, and financial pressure to reduce costs can result in cut corners when these systems are in place. By harnessing meticulous data and providing real-time analysis, hyperspectral imaging mitigates or erases the above limiting factors by simultaneously evaluating color, moisture (dehydration) levels, fat content and protein levels, providing a reliable standardization of these measures.

Foreign Object Detection

The presence of plastics, metals, stones, allergens, glass, rubber, fecal matter, rodents, insect infestation and other foreign objects is a big quality assurance challenge for food processors. Failure to identify foreign objects can lead to major added costs including recalls, litigation and brand damage. As detailed above, automated options like X-rays and metal detectors can only identify certain foreign objects, leaving the rest to pass through untouched. Using superior spectral and spatial recognition capabilities, intelligent imaging technology can catch these objects and alert the appropriate employees or kickstart automated processes to fix the issue.

Mechanical Damage

Though it may not be put on the same level as pathogen detection, food freshness and foreign object detection, consumers put a premium on food uniformity, demanding high levels of consistency in everything from their apples to their zucchini. This can be especially difficult to ensure with agricultural products, where 10–40% of produce undergoes mechanical damage during processing. Increasingly complicated supply chains and progressively more automated production environments make delivering consistent quality more complicated than ever before.

Historically, machine vision systems and spectroscopy have been implemented to assist with damage detection, including bruising and cuts, in sorting facilities. However, these systems lack the spectral differentiation to effectively evaluate food and agricultural products in the stringent manner customers expect. Methods like spot spectroscopy require over-sampling to ensure that any detected aberrations are representative of the whole item. It’s a time-consuming process.

Intelligent imaging uses superior technology and machine learning to identify mechanical damage that’s not visible to humans or conventional machinery. For example, a potato may appear fine on the outside, but have extensive bruising beneath its skin. Hyperspectral imaging can find this bruising and decide whether the potato is too compromised to sell or within the parameters of acceptability.

Intelligent imaging can “see” what humans and older technology simply cannot. With the ability to be deployed at a number of locations within the food supply chain, it’s an adaptable technology with far-reaching applications. From drones measuring crop health in the field to inline or end-of-line positioning in processing facilities, there is the potential to take this beyond factory floors.

In the world of quality assurance, where a misdiagnosis can literally result in death, the additional spectral and spatial information provided by hyperspectral imaging can be utilized by food processors to provide important details regarding chemical and structural composition previously not discernible with rudimentary systems. When companies begin using intelligent imaging, it will yield important insights and add value as the food industry searches for reliable solutions to its most serious challenges. Intelligent imaging removes the subjectivity from food quality assurance, turning it into an objective endeavor.

Ben Schreiber, ActiveSense
Bug Bytes

How ERM Can Simplify Pest Management

By Benjamin Schreiber
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Ben Schreiber, ActiveSense

Whether you work in food manufacturing, distribution or retail, pests are both a fact of life as well as a regulatory disruption. At the same time, pest management solutions aren’t always clear-cut: While there are a variety of effective strategies employed by pest management professionals (PMPs) servicing the food industry, industry challenges—shifting regulatory standards, a lack of proper documentation and more—can complicate the process. For these reasons, short-term rodent problems can become long-term logistical nightmares, leaving food manufacturers in an undesirable situation when a third-party food plant auditor arrives.

Fortunately, emerging technologies in pest management practices are helping facility managers streamline their food and beverage quality assurance processes, reducing the risk of product loss, regulatory action, improper brand management and more. Specifically, electronic remote monitoring (ERM) allows PMPs to detect and monitor rodents in real time, providing you with important information to help reduce risk and increase audit compliance. As such, the value of food safety pest management strategies that incorporate ERM systems is only growing. Seeking out PMPs who use ERM allows you to invest in technologies that protect your margins, ensure the quality of your product and, ultimately, safeguard your most important asset—your reputation.

Modernizing Pest Management With ERM

At first glance, it might seem like pest management practices haven’t drastically changed since they were first implemented in the food manufacturing industry. Many rodent trapping systems remain similar to their original design: Devices designed to trap or kill that must be individually inspected and serviced by professional technicians. Technicians must then relay any risks to facility managers, who have to determine if additional resources are needed to avoid product loss or audit-based infractions.

Upon closer examination, it’s clear that while pests themselves have not significantly changed, both the pest management industry and the modern food supply chain have become increasingly complex. Food facility managers must contend with increasingly stringent food safety standards, and PMPs must rise to meet these needs with evolving pest management strategies.

In many ways, ERM technologies are the structural pest control industry’s response to these challenges, providing technicians with real-time notifications about rodent behavior and allowing them to make risk-based assessments that identify and treat problems before infestations occur. Unlike pest control strategies that rely on periodic service visits from technicians, PMPs who utilize ERM technology can monitor pest activity around the clock, 24/7/365, in virtually any environment. Instead of monitoring individual traps, PMPs can use ERM technology to know exactly when and where pest activity occurs, including in hard-to-monitor areas such as drop ceilings, crawlspaces, shelving undersides and other traditionally overlooked spaces. Technicians then receive valuable analytics from each trap they install, as well as documentation and reporting, that help managers achieve audit and regulatory compliance.

FSMA and ERM

In 2015, the FDA issued the final component of preventative control for human food under FSMA, officially enacting legislation that requires food safety plants to focus on risk-based pest prevention instead of reactive pest control strategies. As a result, quality assurance professionals and facility managers are often tasked with reallocating personnel toward proactive pest control activities in addition to their day-to-day responsibilities.

In many ways, ERM systems go hand-in-hand with FSMA and GFSI regulations. While preparing for a situation that hasn’t yet occurred can be a costly and time-consuming process, ERM has helped PMPs develop custom pest management strategies that assess and control situations in accordance with FSMA and other auditing firm guidelines. In many ways, ERM can provide all parties—PMPs, in-house auditors and third-party regulators—with a track record of pest history that all parties can cross-reference when assessing a facility.

From Risk-Averse to Risk-Based

When it comes to food safety rules and regulations, the only constant is change. In the structural pest control industry, auditors have historically implemented strict guidelines about trap placement that are frequently changing: For instance, traps should be placed every 10, 15, or 20 feet, regardless of facility susceptibility to various pest conditions. Failure to comply with regulations can result in point deductions on audits, even if the conditions that might lead to an infestation are not present. As such, food processing plants often choose to abide by the most stringent audit guidelines imposed upon them by other parties, such as retailers. By utilizing ERM technologies, food safety and quality assurance professionals can use additional pest monitoring analytics to focus on specific compliance issues, rather than spending additional time and money on other strategies.

Additionally, ERM allows PMPs to focus their efforts not only on weekly service visits and station checks, but also on important tasks, including assessing facility vulnerabilities, tracking rodent access points, and providing consultation and additional management strategies to their client—you.

Approaching the Audit with ERM

Food plant managers and retailers alike know that auditor approval is everything. Because ERM is a fast-developing technology, many quality assurance managers and facility owners are curious to know if ERM is audit approved. In truth, there are many kinds of audits, each with different goals, assessment techniques and regulatory standards. When it comes to audits, the gold standard is not necessarily the assessment of the facility and production line itself, but rather how well the assessment matches records kept by the food production plant.

To this end, ERM might be the answer to a streamlined audit process. No matter what kind of audit a plant is currently undergoing, ERM allows PMPs to provide records auditors need to verify that all systems are working properly. ERM can mean the difference between a streamlined process and a laborious audit, acting as a documentation system that helps officials conduct a PMP-verified “second-check.” This kind of verification is invaluable in an industry where there are already more than enough regulatory categories to consider without having to further worry about potential pest infestations.

ERM-Oriented Solutions

Thanks to the many advantages they offer, ERM and other remote pest monitoring technologies are growing in popularity. Many facility managers appreciate that ERM allows them to assess pest activity, prevent infestations before they occur, gather data that helps them remain industry-compliant, and acquire and share information with additional parties. If you’re a facility manager, quality assurance professional or other food safety decision-maker interested in the opportunities ERM technologies provide, consider starting the conversation about your pest prevention system with your PMP and how ERM might help improve it.

Trust, But Verify

There is an overwhelming consensus in the pest control industry that technology should be developed to provide end-users with more information. ERM systems are a natural extension of this belief, providing each component of the food production and distribution supply chain—manufacturers, distributors, retailers, quality assurance officials, technicians and others—with more data about how pest control decisions are made. Without data, it can be difficult to ensure technician service visits end in greater transparency about the issues facility owners will face as they prepare for an audit.

Fortunately, ERM can help provide the level of trust and assurance plant managers need to feel confident in their day-to-day operations. ERM is an important step forward for manufacturer-regulator relations, which require a strong combination of data, trust and transparency to ensure that communication systems don’t break down. After all, there are many industries in which miscommunication can lead to catastrophic consequences, and food production is no exception.

While each manufacturing facility, processing plant, distribution center, storage warehouse and retail outlet is different, none are insusceptible to pest infestations, and none can avoid audits required to keep them compliant. Because rigorous oversight is crucial for food producers and consumers alike, working with your PMP to develop pest monitoring strategies that utilize ERM systems and other cutting-edge technologies should be part of your larger pest control consideration process.

In the end, the pest infestation that causes the least damage to your product, profit potential and industry reputation is the infestation that never occurs.

Michele Pfannenstiel, Dirigo Food Safety
FST Soapbox

Quality Assurance and Food Safety in Cannabis-Infused Products

By Michele Pfannenstiel, DVM
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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

Technical Writing Workshop Focuses on Key Skills Needed for Writing Up Non-Conformances and CAPAs

By Food Safety Tech Staff
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Technical writing is not as simple as it sounds—especially as it relates to writing non-conformances and CAPAs. Innovative Publishing is offering a Technical Writing Virtual Workshop that takes place over two two-hour sessions on March 3 and 10. The event is being hosted by Food Safety Tech’s sister publication, MedTech Intelligence, but the content is applicable to the food industry as well.

The course will be instructed by world-class, international quality and regulatory consultant Mark Proulx, president of MLB Consulting Services. Proulx has more than 25 years of direct manufacturing, auditing, and FDA experience and is a certified quality auditor and Six Sigma Black Belt.

The workshop was developed for the following industry professionals:

  • Engineers responsible for writing up investigations and reports
  • Tech writers who must communicate the results of testing in reports, write up papers, produce arguments for or against an issue
  • Middle-level managers who are attempting to make arguments or show results
  • Laboratory staff who document results and write reports
  • Technicians who must write up test protocols, non-conformance reports, corrective actions, reports to upper management, etc.
  • Quality Assurance/Quality Control and Regulatory Compliance people who must document clearly the purpose of investigations and produce final reports that clearly state actions to be performed or the results of testing

Learn more about this special Technical Writing Virtual Workshop now! Register by February 11 for a special discount.

Lin Mazurek, DNVGL
FST Soapbox

Where to Start on Your Company’s Food Safety Program

By Lin Mazurek
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Lin Mazurek, DNVGL

It’s 7 am and the canning plant is changing shifts. As the new quality assurance manager, you are looking at your to-do list and realize that the same topic has been at the top of the list all week: Food Safety Plan—a daunting topic but critical for the future success of the business and for the acknowledged safety of your company’s products being served in consumers homes.

Where to Begin?

For many companies, there are already procedures and common sense practices in place for sanitation, equipment cleaning and employee hygiene, to name a few. But that is not enough. As the quality assurance manager, you are looking to take food safety to the highest level, which includes selecting a food safety standard or scheme that will be audited by a certification body in order to claim that all-important food safety certification.

We talk to many start-ups, and emerging and expanding companies that are at the beginning of the certification process or are perhaps fine-tuning an existing plan. To assure success for a company at every step along the way, we have witnessed the most successful companies begin with a three-step process:

  • Assemble your food safety team, including top management
  • Research, implement and document a HACCP Plan
  • Select a food safety standard to guide the process along the way

Our customers use many resources to assist with a start-up food safety plan, to fine-tune an existing plan or to integrate new food products and processes into an existing plan. Here are their suggestions:

  1. Select a certification standard to follow: Companies are best served when they align their food safety program with a recognized standard. Each standard offers a structure to follow, documentation to track, and operational and functional guidelines to address to be “compliant” within the context of the segment of the industry they are tracking.
  2. Get organized: Every customer of ours talks about the challenge to get procedures, documentation and their HACCP plan organized. Checklists, provided on the website from standard holders, like BRC Global and SQF, offer details of processes and procedures to review in your own shop. Our technical staff recommends reviewing the published standard, line for line, to make sure your company has all of its bases covered prior to an audit. Many companies compile a digital record, or even a binder with paper printouts of validation and verification records, for documentation of critical control points. Both are acceptable to prove verification to a food safety auditor.
  3. Get industry and FDA/USDA advice: John Z, a food safety project manager at a food packaging company in Gurnee, IL started his company on the path to their food safety certificate with information from the FDA website and online conversations with industry colleagues. A large customer was mandating that John’s company acquire a food safety certification in order to continue to do business. That same customer was helpful in highlighting specific areas in a food safety plan that were critical to winning the business. John also reached out, via LinkedIn, to his industry community for advice and was both delighted and surprised at the wealth of information he was able to glean from asking general questions using the online format.
  4. Consultants: Consultants can be found by searching the Internet for the industry segment that your company operates in, whether it is food processing, storage and distribution or food packaging. When we asked Bill Bremer of Kestrel Management for the top three reasons to utilize a consultant, he commented:
    1. A good consultant can offer the “right-size compliance” for the food safety standard selected and the needs of the organization.
    2. The company’s people-resources can be reviewed for additional training, to assure that the organization has the talent in place to handle the verification and validation needed for a successful and comprehensive food safety management system.
    3. Consultants are an efficient resource to assist an organization to manage changes in products, processes and regulatory requirements and to update HACCP and FSMA plans. Bill commented that about 80% of HACCP plans he reviews are… like a lot of food, “overdone or underdone!”
      Consultants work on a contract basis that can be scaled to the needs of the organization. References are often offered or requested to get an independent voice on the credentials of the consultant.
  5. Industry Associations: Most industries have an industry association affiliated with their product or process. Typically a membership-based approach offers many benefits to the members for event participation, resources and shared information. Non-members often can sign up for newsletters or association announcements.
  6. State Extension Services: State governments have detailed information and free resources on their public health websites, pertaining to local food safety processing and handling regulations. As part of a company’s HACCP plan to comply with local regulations, these resources are specific to your site and must be followed according to local codes and business licenses.

A comprehensive and effective food safety program is not an option, it is a necessity. The liability your organization assumes for consumer complaints or health safety recalls would be financially devastating to most companies. Your time and effort in designing, implementing and maintaining such a program assures your organization that customers, consumers and your bottom line are protected.

Vicky Waskiewicz
FST Soapbox

Food Safety Issues Don’t Occur In The QA Manager’s Office

By Vicky Waskiewicz
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Vicky Waskiewicz

Just like many jobs, a quality assurance manager starts out with high hopes of creating a real difference in their day-to-day work. But that vision quickly gets blocked by stacks of paperwork and other to-dos taking top priority. Soon, QA managers find themselves far from the floor and far from where the real work is happening, usually stuck behind a desk in an office.

While this may have become standard practice, that doesn’t mean that there’s nothing you can do to change this reality. And, the sooner you are able to do so the better, because we all know that the job of a QA manager, especially when it comes to food safety, is important, both to the company and to the public.

Why Food Safety Should Be At The Top Of A QA Manager’s Priority List

The roles and responsibilities of a QA manager are vast, which is why it’s so easy to get caught-up in tasks that keep you holed up in your office. But of all the duties you have, the one that shouldn’t get overlooked is food safety. Because food is consumed, and has the potential to endanger consumers if it’s not produced properly, it is capable of destroying a company’s reputation and their margins, not to mention people’s lives.

As a QA manager, you know this, but you might not be doing everything in your power to make sure the food your company is producing is safe.

How To Improve Food Safety

While you can do a lot from your office, you can’t know what’s happening on the floor without actually spending time there. You have to work closely with your employees to make sure they understand the importance of food safety and therefore the importance of their job.

Here are five ways you can begin to improve the level of food safety in your company.

  1. Work directly with the production floor. Make it a priority to get out of your office regularly to observe the practices that are being used. The more you talk directly with employees about food safety, the more they will understand why it’s important and the safety precautions they can take to ensure they are creating food that is safe.
  2. Demonstrate the importance of food safety. Consider setting up a meeting or talk that gives real life examples of people who have gotten sick or hurt from food that is produced with improper practices. Demonstrating the importance of things, like proper sanitation, can make individuals on the floor aware of the repercussions if they don’t follow the safety guidelines.
  3. Get employees involved in food safety. Spend time educating your employees on measures they can take to assure that the food they are producing is safe. Letting them hold each other accountable is a powerful way to make sure there are eyes on the floor even when you’re not there.
  4. Lead by example. When management walks out onto the production floor, all eyes are on them. Be sure that senior management is aware of the rules, handwashing, hair restraints, etc. and that they follow them every time they enter the production area. Teach employees to kindly remind them if they see them bypass one of the good manufacturing practices.
  5. Regularly change signage throughout the facility. The same old signage over time becomes part of the landscape and eventually the worker is blind to it. Take the time to change the signs, using different sizes, bold colors and positive messaging.

Becoming A Food Safety Hero

QA managers play crucial roles in companies, but without putting food safety at the top of their list, they’re overlooking one of their most important jobs. By learning about steps you can take to improve food safety, like the five mentioned above, you can become a food safety hero, protecting your company and its consumers.

Supply Chain QA Management Goals

By Food Safety Tech Staff
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Need more help with setting strategic goals and tactics for success in supply chain quality assurance management? This month an upcoming webinar will help attendees do just that, along with delve into the perspectives of two project managers of Fortune 500 companies and how they used a supplier quality management software platform to manage quality assurance.

The complimentary webinar “Achieving Significant Goals in Supply Chain QA Management” (Register) will be held June 22, 2017 at 11 am ET. Speakers include Sandy DeGroot, formerly of Campbell’s Soup organic division, John McGlinn, vice president of sales at EMNS, Inc., and Justin Ramos, partner at Brand Solutions Group.

Bryan Armentrout, Food Leadership Group

What Do Food Facility Auditors Really Want?

By Bryan Armentrout
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Bryan Armentrout, Food Leadership Group

Third-party audits are critically important to food companies. They are the primary tool your customers use to determine if adequate food safety systems are in place. This article covers some of the strategies and tactics you should employ to maximize your chances of a successful audit.

Does This Scenario Sound Familiar?

A big audit is coming up. The plant has been preparing for months and this is the final team meeting before the auditor arrives. At some point during the meeting the plant manager turns to the QA manager and says, “Are you ready for the audit?” The QA manager swallows hard and responds, “As ready as we are going to be.”

So much stress and so much pressure just to get a “good score”. Corporate wants to know what happened before the auditor even leaves the plant. Performance evaluations, raises, year-end bonuses and sometimes even jobs are at risk. It’s no wonder people worry about audits so much.

What if I told you it doesn’t have to be that stressful? It doesn’t if you implement some of the things I have learned over the years.

What Is an Audit?

I informally define an audit as verification that things are being performed to established rules. Those rules can be a customer contract, an audit scheme such as SQF or government regulatory standards. For this article, we are going to talk specifically about independent third-party audits.

Who Is an Auditor?

An auditor is a person.

It’s easy to forget sometimes. They are people with their own story, training and experience. They may be a retired QA director from a major food company with decades of experience. They may be a former plant QA manager in the automotive industry with no food experience. This may be their first audit. They have a story and that will influence your audit.

Few people know that you can choose who audits you. Make sure the person who is coming in to evaluate your plant has the right experience and temperament to work with you. Ask the audit company to provide you with three to five resumes of auditors that they would like to send to your facility. Arrange for interviews with them and choose the one that fits best. You are looking for the right mix of experience and temperament. You don’t have to take who they want to send.

What Is an Audit About?

An audit is an answer to a series of specific questions and how you meet them. This is key to how you should approach an audit. The PDCA model is an ideal way to remember this point (see Figure 1).

PDCA Model
Figure 1. PDCA Model
  • Plan: What are the rules of the game?
  • Do: What is your procedure?
  • Check: What proof do you have that it was done?
  • Act: What happens if it is not correct?

Let’s address these one at a time.