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INSIGHT REPORT

INNOVATION
IN FOOD
SAFETY AND
QUALITY:
An Industry 4.0 Look
at Food Integrity

© INTELEX TECHNOLOGIES INC. | 1 877 932 3747 | INTELEX.COM


TABLE OF CONTENTS

INNOVATION IN FOOD SAFETY AND QUALITY:


AN INDUSTRY 4.0 LOOK AT FOOD INTEGRITY

Introduction..................................................................................................1

Industry 4.0 Technology Drives Food Integrity...............................................1

Innovations in Analytical Tools.......................................................................2


Hazard Analysis and Critical Control Points (HACCP)...............................2
Hazard Analysis and Risk-Based Preventative Controls (HARPC).............3
Hazard Analysis and Risk Mitigation with FMEA.......................................4
Other Methods........................................................................................4

Innovations in Scientific Approaches to Food Integrity...................................5


Food Authentication................................................................................5
Packaging Markers..................................................................................7
Genetic Markers and Isotope Analysis.....................................................7

Innovations in Data-Driven Technologies.......................................................8


Process Verification.................................................................................8
Traceability..............................................................................................8
Machine Learning for Food Integrity.........................................................9

Conclusions................................................................................................10

References.................................................................................................10

About the Authors / Disclaimer / About Intelex........................................14

Innovation in Food Safety and Quality:


An Industry 4.0 Look at Food Integrity

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INSIGHT REPORT | Innovation in Food Safety and Quality: An Industry 4.0 Look at Food Integrity
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INTRODUCTION
The global food supply chain continuously grows in complexity as more food producers enter the market to
satisfy the demands of international consumers and an expanding global population.
The complexity of this supply network means that safety, quality, defence, security, traceability, origin, and labeling
must all be managed to ensure the delivery of safe, unadulterated food to the consumer. (Davidson 2017) According
to Manning (2017), a food integrity system that addresses each of these areas should encompass the integrity
not only of the product, but also the processes, people, and data that support it along the entire supply chain.
In this Insight Report, we examine innovations in the food and beverage industry such as hazard analysis,
methods for determining whether a hazard has been realized, and technologies for data management and
analysis. Together, these new technologies define the potential for safer and more efficient food production for all.

INDUSTRY 4.0 TECHNOLOGY DRIVES FOOD INTEGRITY


Over the past century, the supply network for food production has transformed into a global machine. The fourth
industrial revolution will bring even more changes, as increased connectedness between people, machines,
and data makes actionable, real-time insights possible. Industry 4.0 technologies like sensors, the Internet of
Things (IoT), machine learning, and blockchain will leverage and extend the capabilities of the global information
and transportation networks. These will complement older methodologies—which are also technologies and
are also being improved—to meet the new challenges associated with achieving food safety and quality goals.
Technology enables capabilities and product offerings. Before industrialization, local production dominated
and fruits and vegetables that could be grown and harvested locally were only available “in season.” Modern
supermarket shelves, in contrast, provide the option to buy fresh strawberries in December as well as in July.
Consumers are also increasingly concerned with additional attributes like sustainability and genetically modified
production methods. The supply chain that supports those requirements is enormous. In the United States,
food travels on average 1300 miles from farm to fork in the custody of multiple agents along the path, with
33% of produce and 80% of seafood imported from other countries. Overall, food products regulated by
the U.S. Food and Drug Administration (FDA) are processed by more than 300,000 different facilities in 150
different countries. (Lu 2017).
In such a multifaceted supply chain, there are many opportunities for risks to be realized. Nellemann (2009),
for example, reports that the global food supply chain loses 1.3 billion tonnes of food annually without any
awareness of where it goes or the point along the chain at which it goes missing. This shows how difficult
traceability can be in such a complex system and suggests that potentially adulterated or contaminated food
can enter and exit the supply chain at various points without producers having any awareness of its origins.
(Fassam 2017) In addition, over-legislation in some parts of the food chain, as well as the inability of multiple
smaller organizations to meet legislative requirements, creates a black market with invisible and untraceable
supply chains that almost certainly intersect with the legitimate ones at multiple points. (Fassam 2017)
The following sections cover key innovations in analytical tools for risk reduction, including hazard analysis; scientific
approaches for determining whether food has been compromised; and data-driven technologies that enhance
visibility and transparency through data analysis and management, including process verification and traceability.

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INNOVATIONS IN ANALYTICAL TOOLS
Many global innovations are being driven (or at the least, motivated) by the U.S. Food Safety Modernization
Act (FSMA), which was signed into law by President Obama in 2011. Gradually implemented ever since,
FSMA establishes a broad vision for the food industry, driven by safety, quality, and sustainability. FSMA
encourages producers to think about the interrelationships between risk management, decision making, and
the environment—in addition to safety and quality—because everything is interconnected. Even for those
outside the US not governed by FSMA, these regulatory changes have been raising the bar globally for what
can and should be done in operations.
Producers and retailers began developing independent food standards in the 1990s to better meet the needs
of the global marketplace. Because they wanted to strengthen consumer confidence in the management
systems governing food safety, organizations like SQFI (Safe Quality Food Institute) and BRC (British Retail
Consortium) created additional voluntary standards. To standardize the requirements, an international consortium
of industry and academic experts created the Global Food Safety Initiative (GFSI) in 2000, which now serves
as an international benchmark for all regional and international standards.
All GFSI approved schemes are required to include HACCP (Hazard Analysis and Critical Control Points), a
hierarchical hazard analysis tool for identifying and addressing food safety hazards. It is also a foundational
element of FSMA (Weinroth 2018) but is being expanded to better support risk mitigation. This new technique
is called HARPC (Hazard Analysis and Risk-Based Preventative Controls).

Hazard Analysis and Critical Control Points (HACCP)


HACCP focuses entirely on the production process. It assumes that prerequisite programs and good manufacturing
practices (GMPs) are in place and stable. HARPC, on the other hand, does not make that assumption. It requires
that you take a holistic look at your sanitation controls, allergen controls (including labeling practices), supply
chain controls, and process controls. When these processes run for months or years without a change, it is
a risk to make the assumption that the production environment will stay the same. Mitigating this risk is the
basis for HARPC. Whereas HACCP assumes that GMPs and prerequisite programs are in place and performing
effectively, HARPC puts all elements under continuous review.
HACCP originated in the 1960s, when NASA worked with Pillsbury to find a way to ensure the safety of food
products in space. (Weinroth 2018) In 1985, the National Academy of Sciences determined that HACCP
should be the standard method for food safety rather than the traditional approach of testing for contaminants
randomly. HACCP was revised in 1992 and has seven fundamental principles:
1. Conduct a hazard analysis.
2. Determine Critical Control Points (CCP).
3. Establish critical limits for each CCP.
4. Establish a monitoring system for each CCP.
5. Establish corrective actions.
6. Establish verification procedures.
7. Establish documentation and recordkeeping.
The 1993 outbreak of E. coli 0157:H7 in the Jack in the Box food chain in the United States, which sickened 178
people and killed four children, as well as the peak of the BSE (Bovine Spongiform Encephalopathy) outbreak
in the United Kingdom, led to support of HACCP as an international practice through its inclusion in the Codex

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Alimentarius run by the Food and Agriculture Organization (FAO) and the World Health Organization (WHO)
of the United Nations. In the first seven years after its implementation, HACCP was credited with reducing
foodborne illness by 20%. (Weinroth 2018)
HACCP is not without weaknesses, and it cannot guarantee food safety. Recordkeeping, verification, and
corrective actions are areas of high risk in HACCP (Trafialek and Kolanowski 2014). In addition, HACCP does
not completely meet the requirements of some facilities, such as small food and grain processing facilities,
because it excludes non-critical control points that must be examined during risk assessments. (Grover 2016)

Hazard Analysis and Risk-Based Preventative Controls (HARPC)


Section 1 of FSMA prescribes HARPC as an extension of HACCP. This updated approach incorporates risk-
based thinking, corrective actions, and verification of preventative controls for minimizing hazards. HARPC
requires that a qualified employee use scientific principles to evaluate the controls, identify potential hazards,
and maintain documentation. (Grover 2016)
HARPC is built on a system of CCPs (Critical Control Points), PRPs (Prerequisite Programs), and OPRPs
(Operational Prerequisite Programs). CCPs are the points in a procedure at which controls that prevent, eliminate,
or reduce food safety hazards are applied. Traditional CCPs include cooking, dehydration, and pasteurization.
(Canadian Food Inspection Agency 2019)
Prerequisite programs govern the production environment itself. They are not specific to individual process
points or hazards and may not be documented or monitored to the same extent that CCPs are. PRPs typically
relate to practice-level elements such as GMPs, pest control, and sanitation. OPRPs are similar to CCPs in that
they require measurement and documentation but do not require establishment of critical limits. They control
significant hazards, but may not target specific sources of the hazard. Typical examples include temperature
control, hand washing, sanitation effectiveness for pathogens or allergens, and pest monitoring. (Slowinski
2015) HARPC unifies PRPs, CCPs, OPRPs, and risk-based thinking under the banner of Preventative Controls
(PC) (Slowinksi 2015), which require continuous monitoring, documentation, and improvement.
The HARPC process steps are as follows:
1. Identify hazards.
2. Implement preventive controls.
3. Monitor effectiveness of preventive controls.
4. Implement corrective actions for preventive controls.
5. Verify preventive controls.
6. Maintain recordkeeping.
7. Prepare written plans and documentation.
8. Reanalyze the plan every three years.
Current research suggests that small businesses, which have less experience with food safety management
systems (FSMS), face the most challenges implementing HARPC. These challenges include a lack of understanding
of the distinction between HACCP and HARPC, lack of expertise in interpreting the requirements, financial
limitations, inadequate equipment, and developing an organizational quality culture that is dedicated to
understanding HARPC requirements. (Grover et al 2016)

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Hazard Analysis and Risk Mitigation with FMEA
Although powerful, hazard analysis is not a complete method for risk assessment. Oyarzabal (2015) explains
that “hazards are concrete agents that have… a large variability in their ability to cause disease. Risk, on the
other hand, is the probability that a hazard will occur in a food commodity, and encompasses a lot of uncertainty,
mainly in relation to the prediction of the presence or distribution of the hazards in foods.” Thus, hazard analysis
should be performed in conjunction with one or more approaches to risk assessment and mitigation.
Trafialek and Kolanowski (2014) propose incorporating the well-known FMEA (Failure Mode and Effects
Analysis) tool into HACCP/HARPC to verify control points. Table 1 shows one example of how this integration
can be accomplished.

TABLE 1. HACCP/FMEA INTEGRATION. ADAPTED FROM SCIPIONI ET AL. (2002).


Phase Hazard FMEA preventive action HACCP control
Wafer cooling Anomalous aspect Operative instructions about cooling Visual inspection by
(colour, shape, etc.) parameters and controls group lead
Primary Incorrect propriety of Definition of stamp life and periodical Visual inspection by
packaging stamped data (shelf-life, substitution group lead
special information)
Primary Inadequate package shape Preventive control of integrity and Visual inspection by
packaging and integrity position of wrapping paper reel; operative group lead
instructions of wrapping paper calibration

Other Methods
The practice of integrating risk assessment has been reinforced by the introduction of standards and methods
such as PAS 96:2017 and CARVER+Shock, which seek to address the specific requirements for defending
against intentional and ideologically motivated attacks on the food supply chain. CARVER+Shock allows
organizations to think like an attacker to identify and protect the most vulnerable points of the system from
both economically motivated and ideologically motivated attacks.
The U.S. Department of Agriculture (USDA) adopted the CARVER method from the Department of Defence
for targeting prioritization. The CARVER+Shock approach was developed to assess the vulnerability of food
systems and infrastructure (USDA 2009) in terms of the following elements:
• Criticality: measure of public health and economic impacts of an attack.
• Accessibility: ability to physically access and egress from target.
• Recuperability: ability of the system to recover from an attack.
• Vulnerability: identify the potential for an attack.
• Effect: amount of direct loss from an attack as measured by loss in production.
• Recognizability: ease of identifying target.
• Shock: the combined health, economic, and psychological impacts of an attack.
In 2014, the UK government sponsored the Elliott review into the integrity and assurance of food supply
networks: final report—A national food crime prevention framework. This review assessed the weaknesses of
the UK food supply chain and its vulnerability to food crime. Its recommendations provide a useful framework
for cooperation between government and industry for securing food supply chains.

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INNOVATIONS IN SCIENTIFIC APPROACHES TO FOOD INTEGRITY
Food defence presents a unique challenge to securing the food supply chain and ensuring food integrity.
Concerns are broad, and many relate to technologies for authentication, labeling, and origin. A survey of EU
food experts (Davidson 2017) provides a summary of these concerns:
1. There is not enough equipment that is sensitive enough to detect contaminants while simultaneously
providing low false alarm rates.
2. Much of the equipment in use has not been tested on a sufficiently wide range of potential
contaminants.
3. Employees with access to sensitive areas of food production are not always properly vetted, and
insider threats are potentially serious.
4. There is not enough collaboration between the food industry and public health authorities, which
results in too much time between a contamination event and its detection and investigation.
5. Traceability solutions for authentication and item-level identification lack harmonization across
international suppliers meeting different regulatory requirements. Mapping the entire supply chain
would increase transparency to combat food fraud and contamination but could also reveal potential
vulnerabilities that attackers could exploit.
Fortunately, as time goes on, new technologies are more broadly adopted and companies become profitable,
while problems relating to sensitivity of new equipment and the scope of testing will be solved in a few years.
Insider threats can be addressed by harmonizing hazard analysis and risk assessment, potentially by introducing
methods like FMEA, CARVER+Shock, or TACCP (a HACCP-like process emphasizing the threats that provide
the first letter of the acronym). New methods for authentication, packaging, and determining origin can support
requirements for traceability and could possibly reduce the time to identify and resolve a contamination event.

Food Authentication
Food composition must be authenticated and matched to the descriptions on the label. Medina (2019) has
identified four primary analytical techniques for food authentication as follows.
• Chromatographic and Hyphenated Techniques: These methods separate components of a sample
and generate spectral signals that can be analyzed. Hyphenated techniques combine spectrometry
with separation techniques.
• Spectroscopy: This technique collects information about the food composition based on the
frequencies it emits during analysis. (Figure 1) This approach is relatively inexpensive, fast, and
capable of detecting multiple compounds simultaneously.
• Mass Spectrometry: Mass spectrometry, in which samples are ionized and sorted along a spectrum,
.is usually performed in conjunction with chromatographic techniques. It is used to analyze authenticity
of complex samples.
• Electronic Sensors: These sensors mimic the eyes, tongue, and nose to assess food quality using
computer vision and colorimetric techniques. They can only recognize a limited number of compounds.

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Examples of these techniques are listed in Table 2.

TABLE 2. TECHNIQUES FOR FOOD AUTHENTICATION. ADAPTED FROM MEDINA (2019).


Electronic Chromatographic and Spectroscopy Mass Spectrometry
Sensors Hyphenated
E-tongue Capillary electrophoresis (CE) Infrared (IR) Triple quadrupole mass
spectrometry (QqQ-MS)
E-nose Gas chromatography (GC) Fourier-transform infrared spectroscopy Quadrupole time-of-
(FTIR) flight mass spectrometry
(QTOF-MS)
E-eye Liquid chromatography (LC) Raman spectroscopy Matrix-assisted laser
desorption ionization
time-of-flight (MALDI-
TOF-MS)
High-performance liquid Near-infrared (NIR) Proton transfer reaction
chromatography (HPLC) mass spectrometry
(PTR-MS)
Ultra-high-performance Mid-infrared spectroscopy (MIR) Direct analysis in real
liquid chromatography time mass spectrometry
(UHPLC) (DART-MS)
Two-dimensional gas Surface-enhanced Raman spectroscopy Orbitrap
chromatography (GC x GC) (SERS)
Multidimensional liquid-liquid Nuclear magnetic resonance (NMR) Tandem mass
chromatography 2D spectrometry (MS/MS)
Two-dimensional nuclear magnetic
(LC x LC)
resonance (2D-NMR)

These methods of analysis produce large amounts of complex data that sometimes requires advanced statistical
analysis. This can make the implementation process more challenging.

FIGURE 1. ACIDULANTS IN WHITE WINE. ADAPTED FROM GRATZFELD-HÜSGEN & SCHUSTER (2001).
Organizations such as the
Food Safety Intervention
Technologies Research Unit
(FSIT), which is part of the
U.S. Department of Agriculture
(USDA) Agricultural Research
Service (ARS), are focused on
improving these techniques
and inventing new ones to
monitor for contaminants
more accurately and cost-
effectively.

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Packaging Markers
Technology also plays an important role in combating counterfeiting by protecting packaging and labeling.
The wine industry, for example, provides some excellent cases where innovative solutions are being used to
frustrate attempts to engage with food fraud using high-value products. (Lecat 2017) These solutions include:
• Bubble tags: 3D images based on random generation of bubbles.
• Radio frequency identification (RFID) tags: These ultra-high frequency tags transmit radio waves
to a reader to provide unique identification.
• Holograms: These unique and difficult-to-replicate 3D images are projected onto the surface of the
packaging.
• Secure Near Field Communication (NFC): This technique uses magnetic field induction to facilitate
communication between two devices in proximity.
In addition to combating counterfeiting, science can improve packaging in another important way: by improving
the expiration dates posted on it. Researchers have identified that date labels can lead to confusion about
food quality and safety in two ways: by encouraging people to throw out food that is still usable, and by not
preventing them from consuming the food when it is in fact unsafe. Psychological studies on the best phrasing
and placement of these dates may lead to improvements in both areas. (Wilson et al. 2017)

Genetic Markers and Isotope Analysis


To identify the origin of food products and raw ingredients, genetic markers and isotope analysis can also be
useful. This technology is based on the principle that the hydrogen and oxygen in every food product have a
ratio of light to heavy isotopes that are unique to the geographical location in which the raw ingredients were
cultivated. Beef from U.S. cattle, for example, is isotopically distinct from that derived from cattle raised in the
EU. This ratio can be matched to isotope maps to ensure that every raw ingredient in a food product originated
from the location identified on the label. (Spink and Moyer 2011) This method, while innovative, remains
expensive and beyond the reach of many food producers, which is a constraint on its wider implementation.

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INNOVATIONS IN DATA-DRIVEN TECHNOLOGIES
Food crime targets gaps and vulnerabilities in the supply chain. Gaps can occur when narrowing the focus of
inspections takes elements of the supply chain out of scope (Spink and Moyer 2011), where quality assurance
programs between practices and agents fail to intersect, or where technology solutions fail to integrate data.
Advances related to process verification, traceability, and data analysis with machine learning promise to
close these gaps.

Process Verification
Food integrity requires vigilance at both the product and process level. Food safety has a sophisticated
toolkit for identifying known contaminants, such as E. coli, in food products. Adulterants, however, are usually
undetectable, since the perpetrators aim to avoid being detected by traditional testing methods. Research on
existing testing methods (Pedersen et al 2016, Davidson et al 2017) has shown that they are frequently unable
to detect high levels of rat poison, norovirus, bacillus spores, mercury chloride, and bromadiolone when the
testing methods are not specifically calibrated to detect them.
The impossibility of testing for every known adulterant, and the specialized techniques required to perform the
testing, such as mass spectrometry, stable isotope analysis, genomics, and proteomics, can be a constraint
for many organizations. (Spink and Moyer 2011) The combination of the lack of availability of sophisticated
testing methods with the inaccuracy of traditional methods means that most current risk assessment tools
are effectively useless as deterrents against food crime. (Esteki 2019)
Process verification is therefore a pivotal part of the integrity of the food supply chain. This means documentation,
certifications, labeling, and traceability data will provide the means of tracing the movement of food items
and ensuring that process gaps at each level are filled. Machine readable devices such as bar codes and QR
codes will ensure that harmonized data can be shared across agents. (Spink and Moyer 2011) Audits and
inspections, particularly those that are unannounced, can also have a considerable impact on ensuring that
producers and handlers adhere to requirements. Regulators in Denmark, Germany, the UK, and the U.S. have
also had success with a name-and-shame approach to publishing information about a company’s compliance
behavior. (Bavarova et al 2017)

Traceability
There are many reasons why organizations want traceability. Some may be required to have it by law, or
potentially a producer needs it to support robust root cause analysis. For others it is the key to continuously
improving a global supply chain, which could generate massive financial savings. HACCP also requires mass
balance traceability, which is the ability to account for each raw ingredient in every food product. Every traceable
resource unit (TRU) must be accounted for in the final product. This relies entirely upon documentation, which
means that documentation processes are as vital a part of authenticating products as technological testing.
(Manning and Soon 2016)
The primary new technological solution that is being proposed for traceability is blockchain. Blockchain uses
a cryptographic, mathematical process called hashing. This turns a data structure (e.g. the contents of a
spreadsheet or an image) into a sequence of unique numbers and letters. Most of the systems you log into on

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a daily basis hash your password and store that sequence of letters and numbers—not your actual password.
When you log in, your input is hashed and compared to the hash of your real password on file. If the hashes
match, your login is authenticated. This is why so many systems require you to reset your password if you forget
it—they don’t actually know your password. They just know the hash, which cannot be reverse engineered.
A blockchain records a chain of transactions. For example, imagine collecting data from sensors or people as
a product is shipped for variables like temperature, humidity, location, or inspection results. At various times,
the data is pooled together and validated with a “smart contract” to create a block. The hash from the previous
block is added to the new block, and then the entire new block is hashed. Because it contains the hash from
the previous block, it’s part of a chain of related blocks: a blockchain.
If any of the elements in a block change, the new hash will not match the old hash, and an alarm is sounded.
Blockchain, then, is an immutable peer-to-peer transaction record that is tamper proof, since it immediately
complains if anyone tries to manipulate the data or the order of transactions. A blockchain is also instantly
auditable. In fact, since smart contracts evaluate the data before it can be committed to the blockchain, bad
data shouldn’t even be able to get in. Projects like IBM Food Trust, which uses Hyperledger for its blockchain
infrastructure, promise to demonstrate how monitoring supply chains can lead to breakthroughs in supply
chain efficiency and resilience. (Radziwill 2019)
Although blockchain prototypes are predominantly seen in supply chain applications now, the future promises
instantaneously auditable QMS and food safety management systems too.

Machine Learning for Food Integrity


Research into algorithms that distinguish between safe and unsafe foods is also advancing thanks to several
factors, including the low cost of storing data, the availability of robust and easy-to-use software libraries, and
the proliferation of cloud computing to operationalizing models. In many cases in food production, machine
learning is used for classifying complex observations in different ways: good vs. bad, safe vs. unsafe, and
multi-way classifications like relevant, unclear, or not relevant.
Machine learning algorithms are often used to extend the scientific approaches outlined earlier. For example,
Kamruzzaman et al. (2016) demonstrated that machine learning can be combined with hyperspectral imaging
to see if minced beef has been adulterated with chicken. Harris et al. (2017) used a supervised classification
approach to examine social media posts to identify food poisoning cases as early as possible. Bisgin et al.
(2018) used artificial neural networks (ANNs) and support vector machines (SVMs) to successfully detect trace
amounts of beetles, which are associated with both food contamination and public health risks, in multiple
products. Species identification is an active area of research.
Multidisciplinary examples are also starting to emerge. Njage et al. (2018) combined food safety assessment with
methods from epidemiology and used multiple machine learning approaches (ANNs, SVMs, gradient boosting,
and random forests) to predict the likelihood that someone who ingested a food product would be affected by
Listeria monocytogenes. In addition to just determining whether a food is safe or unsafe, these studies show
that exciting possibilities are ahead for changing the way we think about food safety and quality controls.

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CONCLUSIONS
Food integrity systems that successfully mitigate the risk of contamination, fraud, and crime in a complex
international supply chain cannot rely on a single approach. Food producers, government, and the academic
research community must work together to create a resilient supply chain that integrates tools, people, and
processes to reduce opportunities for food crime and fraud.
Even though there is no single methodology or technology solution to ensure food integrity, a combination of
multiple methods can strongly enhance an organization’s ability to make it happen. Pedersen et al. (2016), for
example, recommends a two-stage approach to address threats more effectively: untargeted detection tools in
Stage 1 that look for changes in product conformity and trigger alerts for deviations, and a targeted approach
in Stage 2 that uses detection tools to identify specific contaminants. Organizations must also design systems
that incorporate risk assessment, updated hazard analysis approaches like HARPC and CARVER+Shock,
and threat assessments like TACCP. They should also consider including up-to-date instrumentation and
software for chemical assessment, process verification, and traceability. Finally, the research literature can
help to identify machine learning methods for solving classification or prediction problems that align with an
organization’s needs.
The last decade has seen the proliferation of advanced technological tools. In the upcoming years, these
technologies will become more visible. Producers and consumers will benefit from a safer food supply network
with greater visibility and traceability, which will help organizations build confidence in their products and
their brands.

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About the Authors
NICOLE RADZIWILL
Nicole Radziwill is VP Global Quality & Supply Chain Practice at Intelex in Toronto, Ontario. She
uses data science and applied machine learning to enhance quality and catalyze innovation in in-
dustrial systems. Nicole is a Fellow of the American Society for Quality (ASQ), a Certified Six Sigma
Black Belt (CSSBB), a Certified Manager of Quality and Organizational Excellence (CMQ/OE), and
editor of Software Quality Professional with a PhD in Quality Systems from Indiana State. She is one
of ASQ’s Influential Voices and blogs at http://qualityandinnovation.com.

GRAHAM FREEMAN
Graham Freeman is a content writer and editor at Intelex Technologies in Toronto, where he writes
on topics relating to quality management.

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