How to Use FMEA to Risk Assess Pathogen Testing Methods

By Maria Fontanazza

All methods are not equal, and companies must understand the testing methods used on a Certificate of Analysis.

A Certificate of Analysis (COA) can provide a company with a level of confidence in the quality and purity of its product. However, the company should be able to take the document and understand how the results were gathered, says Maureen Harte, President and CEO at HartePro Consulting, and Lean Six Sigma Master Black Belt. Using Failure Modes and Effects Analysis (FMEA) can help a company identify, quantify and assess risks associated with pathogen detection methods, and should be integrated into a HACCP strategy.

Food Safety Tech: What are the challenges a company faces when assessing results on a Certificate of Analysis (COA)?

Maureen Harte: [Companies] lack the background information to really understand what goes into a COA, and they trust that what is coming to them is the highest quality.

FST: What questions should a company ask?

Harte: They need to consider everything that goes into the testing method itself.

•    What is the origin of the COA?
•    Who’s doing the testing?
•    What’s the complexity of the method?
•    What is the overall quality of the method?
•    How traceable is it?
•    How well can I trust that this result is the true result (are there false negatives)?

FST: How is FMEA used to evaluate pathogen testing methods?

Harte: FMEA helps us understand the differences between testing methods by individually identifying the risks associated with each method on its own. For each process step [in a test method], we ask: Where could it go wrong, and where could an error or failure mode occur? Then we put it down on paper and understand each failure mode.

For example, most methods have an incubation step. A simple failure mode would be that the incubator isn’t at the correct temperature, or that it has been incubated too long or not long enough. You go across the board for each step, identifying potential failures and the severity. Is there potential that we wouldn’t identify the pathogen? If so, what would happen to the customer? You also rate how often it might happen with the test method. What’s the frequency of it? The last thing we rate is detection. With or without controls, how easy would it be for the personnel in the lab to identify or detect that this problem occurred?

We rate these three factors: severity, frequency and detection, and whether we detect [the pathogen] before it goes out to the retailer or consumer. Then we multiply the ratings and come up with a risk priority number (RPN). We add all RPNs for each step and figure out risk, and the potential for error, for each test methodology.

Image courtesy of Roka Bioscience

FST: How does using FMEA integrate into a HACCP strategy?

Harte: It could be integrated into the HACCP strategy. HACCP deals with identifying potential safety risks, and the key to identifying the risks and proactively trying to eliminating them. That’s what the FMEA is doing as well. I think the integration of FMEA could help identify the critical control points and where the failures will occur. That would be the most streamlined approach.

Harte’s Tips

• Don’t fully trust the COA unless you understand what the result means.
• Get involved with the labs that are providing the testing to ensure you have the most comprehensive information surrounding the COA.

Harte is presenting “Behind the Certificate of Analysis: Risk Assessment in Pathogen Testing Methods” at the Food Safety Summit on Thursday, April 30, 12:30-1:00 pm.

Untangling the Net of Seafood Fraud

By Maria Fontanazza

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Achieving complete traceability is a must to combating seafood fraud. How is industry getting there?

The length and complexity of the seafood supply chain has created an ideal environment for fueling the mislabeling of the world’s most highly traded food commodity. Considering 91% of all seafood consumed in the United States imported, the ethical and economic impact of seafood mislabeling is enormous. While increased demand is putting pressure on the seafood industry, federal agencies are laying the groundwork to aggressively attack the rampant mislabeling problem.

“Illegal unregulated and unreported fishing is a huge global phenomenon that distorts markets and skews estimates of fish abundance,” said Kimberly Warner, PhD, senior scientist at Oceana, during a recent webinar on food fraud. The goal is to achieve complete transparency and traceability, keeping the “who, what, when, where, and how” with the fish. “Right now when fish are landed, they are required in the United States to list the species, where it was caught, [and] how it was caught. But that information is not following seafood through the supply chain.”

Simply put, seafood fraud is as any illegal activity that misrepresents the seafood one buys. According to Oceana, this can include not disclosing the real name of the fish or its origin, not providing an accurate weight, adding water or breadcrumbs, not declaring the presence of additives, or selling “fresh” fish that was previously frozen.

There are several motivations behind seafood fraud, says Warner. Some businesses want to increase profits and avoid profits; others want to hide illegally caught seafood or engage in trading endangered or threatened species, or mask seafood hazards; and some companies are just ignorant to the requirements of seafood labeling.

The lack of reliable and trustworthy information poses a challenge to consumers who want to make informed decisions when purchasing seafood. While proactive consumers use guides such as “Seafood Watch”, a program offered by the by Monterey Bay Aquarium, in many cases they still do not have enough information to make a decision with complete confidence.

Supply Chain Traceability

Last month the Presidential Task Force on Combating Illegal, Unreported, and Unregulated Fishing and Seafood Fraud released its final recommendations for creating a risk-based traceability program that tracks seafood from harvest to entry into U.S. commerce. The ambitious action plan seeks to tackle the following goals:

•    Combat IUU fishing and seafood fraud at the international level
•    Strengthen enforcement and enhance enforcement tools
•    Create and expand partnerships with nonfederal entities to identify and eliminate seafood fraud and the sale of IUU seafood products in U.S. commerce
•    Increase information available on seafood products through additional traceability requirements

Key dates on the plan’s timeline include identifying the minimum types of information and operational standards by June 30, which will be followed by a 30-day comment period; engaging the public on principles used to define “at risk” species by July and releasing final principles and “at risk” species by October 2015; and building international capacity to manage fisheries and eliminate IUU fishing, with an interagency working group developing an action plan by April 2016.

Bait & Switch: Quick Stats Behind Seafood Mislabeling

•    Red snapper is the most commonly mislabeled fish (up to 28 species were found to be substituted, a large amount being tilapia)
•    74% of fish are mislabeled in sushi venues
•    38% of restaurants mislabel seafood
•    30% of shrimp samples misrepresented
•    Chesapeake Blue Crab cakes: out of 90 sampled, 38% mislabeled, with 44% coming from the Indo-Pacific region

Statistics generated from studies conducted by Oceana in which the organization gathered seafood samples nationwide.

How can consumers protect themselves?

Warner’s advice: Ask the folks behind the seafood counter where they purchase their seafood from and whether it is farmed or fresh. If you can, buy the whole fish, because it’s harder to disguise when whole. And finally, if the price is too good to be true, it probably is. “Expect to pay more for wildly caught, responsibly fished seafood,” she said.

Related content: InstantLabs Launches DNA-based Atlantic and Coho Salmon SpeciesID Test Kits to Combat Seafood Mislabeling

April 8, 2015

Does Your Company Really Understand GMO Labeling?

By Maria Fontanazza

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Consumers want to know what’s in their food, from artificial sweeteners and high-fructose corn syrup to dyes and pesticides. The latest hot-button issue surrounds foods made from genetically modified organisms (GMO) and the demand for companies to indicate on labeling whether a product contains GMOs.

In a recent Q&A with Food Safety Tech, James Cook, Food Scientific and Regulatory Affairs Manager at SGS, briefly discusses the challenges and misconceptions surrounding GMOs and labeling.

Food Safety Tech: What are the biggest challenges food companies face in communicating that their products are GMO-free?

James Cook: The biggest challenge for a company is to determine what words or phrases can be used concerning the regulations and/or laws of country that the product will be received into. Companies want to use GMO free, a terminology recognized by consumers, which is actually prohibited in certain locations such as the European Union (EU), and discouraged by the FDA.

FST: How has public (consumer) awareness of this issue complicated matters?

Cook: There is a diverse difference in dealing with the consumers in the EU that have a clear knowledge and unfortunately outrage to GMOs, and the consumers from the United States, where some have no idea what GMOs are.

FST: Are there misconceptions among consumers that present additional challenges to food companies?

Cook: The biggest misconceptions are: Everything created by humankind is evil, food crops have never changed, and the government and the industry are lying. Another misconception is that in the future, we will have enough food to feed the world population, without making significant changes in the way we produce food.

FST: What are the most critical developments regarding state and federal labeling laws that we need to know about?

Cook: At this time, the Vermont law is the only breakthrough for the requirement [of] GMO labeling in the United States. If some non-government organization obtains passage of their bill through U.S Congress then this law will not come into effect. If this law becomes effective, we will have many states issuing and passing a similar law, as their consumers will want to know why this is required in Vermont but not in their states.

On April 16 Cook will be offering more insight on the topic during a GMO Labeling webinar. Register for the webinar now.

FST: Where do you see the GMO issue headed over the next year or so?

Cook: We will have some sort of GMO labeling law in the United States. Whether this law only affects one state or all of the U.S. is still unknown. Even if this is not solved, more locations in the United States will continue to ban the growing of GMO crops. Eventually these bans will make it into the courts, because you are dictating to a farmer what crops they can grow and sell.

FST: What key questions will you address during the GMO Labeling webinar?

Cook: What does my company need to do in order to verify to a Non-GMO program?
Does one have to review the entire supply chain in order to prove the product is GMO free?
Why isn’t GMO product just labeled as such in the USA?
Why the vast difference of GMO policies between EU and USA?

April 8, 2015

Food Safety Culture: Measure What You Treasure

By Lone Jespersen, Brian Bedard

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A culture of food safety is built on a set of shared assumptions, behaviors and values that organizations and their employees embrace to produce and provide safe food. Employees must know the risks and hazards associated with their specific products, and know why managing these hazards and risks in a proactive and effective manner is important. In an organization with a strong food safety culture, individuals and peers behave in a way that represents these shared assumptions and value systems, and point out where leaders, peers, inspectors, visitors and others may fail to protect the safety of both the consumers and their organizations.

A number of factors influence these organizations, such as changing consumer demographics, emerging manufacturing hazards, and the regulatory environment. The United Nations predicts that the number of people over 60 years will double by 2035, the number of diabetes patients will increase by 35% (International Diabetes Federation), and the number of individuals living with dementia will increase by 69% (Alzheimer’s Disease International). This poses an increased urgency for food manufacturers, as these population cohorts are more susceptible to foodborne infections or may have challenges with food preparation instructions.

Much has been published on food safety culture, and we owe it to the front-runners to use their work to go deep into practical, everyday challenges and to continuously strengthen organizational and food safety culture.¹ An element common to most of these publications is a reference to the importance of behaviors.^2-8
There is a renewed recognition of the importance of individual behaviors specific to food safety and personal self-discipline in food processing and manufacturing organizations. Employees throughout the organization must be aware of their role and the expected food safety behaviors, and held accountable for practicing these behaviors. Embedding food safety culture in an organization can be very challenging given the need to carefully define appropriate behaviors, the difficulty in changing learned behaviors, and the complexity of objectively evaluating the level of food safety culture in a company. This article is an attempt to define useful food safety behaviors and to describe a behavior-based method that you can use to measure the maturity of your organization’s food safety culture.

Defining measurable behaviors

Behaviors is the element that, when combined with results, creates performance.⁹ Behaviors, if used to measure and strengthen food safety culture, must be defined carefully in a consistent, specific, and observable manner. Martin Fishbein and Icek Ajzen, authors of multiple publications on the Reasoned Action Approach, teach us how these three factors can be used to predict and explain human behavior, attitude, perceived norms and perceived control.10 They also teach us that behaviors can be defined consistently by including four elements (Figure 1).

Figure 1: Four components to a consistently defined behavior

Case: CCP operator on a baked chicken line. I work in a chicken processing company and am responsible for monitoring the internal cook temperature of chicken breasts after the product has gone through the oven. One of the important behaviors for my role could be defined as “Measure temperature of chicken after oven at predetermined time intervals”. This behavior is consistent, as it includes all four elements of the behavior definition (Table 1). The content of the behavior is defined in a way that makes it relevant for me, the CCP operator, and I am clear on the assumptions made by others on the processing line about my behavior. The behavior is observable and most people would be able to enter the processing area, observe the behavior and assess if it is performed as needed, YES or NO.

Leaving out any of the four elements of a behavior definition or becoming too general in your statements leads to poorly defined behaviors that are difficult to use as an assessment of behaviors, and ultimately as a measure of the sites for food safety culture (Table 1).

Scenario	Behavior	Action	Context	Target	Timing
Consistent, relevant, and observable	Measure and record temperature of three chicken pieces every hour at end of oven	Measure and record temperature	End of oven	Three chicken pieces	Every hour
Missing definition elements	Measure temperature at pre-determined intervals	Measure temperature	Not defined	Not defined	Pre-determined time intervals
Not specific	The product is cooked and checked every hour	Not defined	Not defined	The product	Every hour
Not observable	The product is cooked and check to see if it meets standard	Checked	Not defined	The product	Not defined
Table 1: Scenarios of defining behaviors

Behaviors are observable events and for this to be true, a behavior must be defined objectively in a language clear to everyone involved. It can be helpful to target a grade-six readability level, as it forces everybody writing the behavior to avoid words that are not understood in plain language.

Using behaviors to measure food safety culture

Assuming that behaviors are defined in a consistent, specific, and observable format, how do we decide the critical few behaviors that get measured? A suggested method is the use of the food safety maturity model (Table 2). The model outlines five capability areas that a processor or manufacturing company can use to measure its current state and to set priorities and direction. One capability area is Perceived Value that describes how an organization might see the value of food safety. The maturity level ranges from a low level of maturity of “Checking the box because regulators make us” to a high level of maturity for “food safety is an enabler for ongoing business growth and improvement”. Consistent, specific, and observable behaviors can be defined for each of these stages of maturity. By assessing the performance of these behaviors we can aggregate these assessment scores into a site or organization measure of the maturity of the site or organizational food safety culture. It is important to note that the maturity score does not measure “good or bad” culture. The measure is one of progression along the food safety maturity model scale, and can therefore be used to highlight areas of strength and help prioritize areas of improvement for the individual organization.

Table 2: Food Safety Maturity Model. The Food Safety Maturity Model was developed by Lone Jespersen in collaboration with Dr. John Butts, Raul Fajardo, Martha Gonzalez, Holly Mockus, Sara Mortimore, Dr. Payton Pruett, John Weisgerber, Dr. Mansel Griffiths, Dr. Tanya Maclaurin, Dr. Ben Chapman, Dr. Carol Wallace, and Deirdre Conway.

For more details on the food safety maturity model, visit www.cultivatefoodsafety.com.

Call to Action

The organization’s culture will influence how individuals throughout the group think about safety, their attitudes towards safety, their willingness to openly discuss safety concerns and share differing opinions with peers and supervisors, and, in general, the emphasis that they place on safety. However, to successfully create, strengthen, or sustain a food safety culture within an organization, the leaders must truly own it and promote it throughout the organization.⁸

The call-to-action for food industry leaders and regulators is to embrace a standardized measure of food safety culture to allow for comparison and sharing within an organization and between companies. “Food safety is everybody’s responsibility” was the theme of the recent GFSI Global Food Safety Conference in Kuala Lumpur, but to act on this with food safety culture as the ultimate outcome, we must adopt standardized measure. The GFSI benchmarking technical working group is an ideal forum to continue this dialogue.

During the upcoming GMA Science Forum April 12-15, 2015 join the conversation at a practical and detailed level. The preconference Food Safety Culture workshop takes place April 12, with facilitators from leading organizations; the Food Safety Culture Signature Session on April 13 will discuss what our industry requires to enable this level of standardization and collaboration. For more information and to sign-up, visit http://www.gmaonline.org/forms/meeting/Microsite/scienceforum15.

References

Schein, E. H. (2010). Organizational culture and leadership. San Francisco: Jossey-Bass.
Ball, B., Wilcock, A., & Aung, M. (2009). Factors influencing workers to follow food safety management systems in meat plants in Ontario, Canada. International Journal of Environmental Health Research, 19(3), 201-218. doi:10.1080/09603120802527646.
Hanacek, A. (2010). SCIENCE + CULTURE = SAFETY. National Provisioner, 224(4), 20-22,24,26,28-31.
Hinsz, V. B., Nickell, G. S., & Park, E. S. (2007). The role of work habits in the motivation of food safety behaviors. Journal of Experimental Psychology: Applied, 13(2), 105-114. doi:10.1037/1076-898X.13.2.105.
Nickell, G. S., & Hinsz, V. B. (2011). Having a conscientious personality helps an organizational climate of food safety predict food safety behavior. Food Supplies and Food Safety,189-198.
Jespersen, L., & Huffman, R. (2014). Building food safety into the company culture: A look at maple leaf foods. Perspectives in Public Health, (May 8, 2014) doi:DOI: 10.1177/1757913914532620.
Seward, S. (2012). Assessing the food safety culture of a manufacturing facility. Food Technology, 66(1), 44.
Yiannas, F. (2009). In Frank Yiannas. (Ed.), Food safety culture creating a behavior-based food safety management system. New York: Springer, c2009.
Braksick, L. W. (2007). Unlock behavior, unleash profits (Second ed.) McGraw-Hill.
Fishbein, M., & Ajzen, I. (2009). Predicting and changing behavior: The reasoned action approach. London, GBR: Psychology Press.

April 7, 2015

Newer Regulations Clarify Food Microbiology Parameters for Labs

By Jacob Bowland

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Accuracy and validity of food test results hinge on purified water and annual water testing.

Laboratory-grade water literature is well documented among the large life science water manufacturers. General levels of resistivity, total organic carbon (TOC), particles and bacteria in water classify into Types 1, 2, or 3, with Type 1 having the most stringent requirements. Each type is useful for a different application depending on the procedure:^1,2,3

Type 3. Generic applications where water will not come into contact with analytes during the procedure
Type 2. Standard applications such as media and buffers
Type 1. Critical applications such as GC, MS, HPLC analyzers⁴

Achieving high-quality water requires purification through a polishing step such as deionization (DI), reverse osmosis (RO), ultraviolet light (UV), filtration or distillation, which removes specific impurities.^3,5

This classification system gets muddled, as different agencies have their own standard that examines different end-point analysis and levels:

ISO (International Organization for Standards)
CLSI (Clinical and Laboratory Standards Institute)
ASTM (American Society for Testing & Materials)
USP (United States Pharmacopoeia)^2,5

With all these standards and testing in place, many labs assume that their installed DI water supply is clean, yet in reality, the water in general would be closer to Type 3 rather than the required Type 1.

The problem with using lower quality water in food testing labs is that the accuracy and validity of tests will be compromised. Many of the analyzers requiring Type 1 water would recognize contamination from lower quality water, creating difficulty in identifying actual contamination or yielding false positives. False positives can result due to microorganism contamination in the water that is amplified through the testing procedure. In addition, dirty water can damage expensive machinery, because tools in the laboratory that are designed for a high-purity water supply can malfunction when less-pure water is used. For example, a system with microfilters can become rapidly clogged with lower quality water, introducing the possibility of flooding when tubing bursts, if left unnoticed.

Newer regulations in regards to ISO 11133:2014, along with ISO 17025:2005, provide clarity on food microbiology water parameters for the laboratory. ISO 11133:2014 “Microbiology of food, animal feed and water–Preparation, production, storage and performance testing of culture media” describes how water for culture media must be purified. The purification recommended is distilled, demineralized, DI, or RO, and stored in an inert container. To verify purity, labs must regularly test the water to assure microbial contamination is kept to a minimum. Regarding 17025:2005, which refers to food microbiology requirements for accreditation, there should be daily, weekly and monthly testing of the laboratory’s water source to verify required quality for microbiological water. Daily testing examines resistivity of water; monthly testing examines the water’s chlorine levels and aerobic plate counts; yearly testing examines heavy metals in the water. Therefore, accuracy and validity of food test results critically revolve around producing purified water and annual water testing.

Bibliography
1. Veolia. (n.d.). Water Quality. Retrieved from: http://www.elgalabwater.com/water-quality-en-us
2. Puretec Industrial Water. (n.d.). Laboratory Water Quality Standards. Retrieved from: http://puretecwater.com/laboratory-water-quality-standards.html
3. Millipore. (n.d.). Water in the Laboratory. Retrieved from: http://www.emdmillipore.com/US/en/water-purification/learning-centers/tutorial/OPab.qB.IxUAAAE_MkoRHe3J,nav
4. Denoncourt, J. (2010). Pure Water. Retrieved from: http://www.labmanager.com/lab-design-and-furnishings/2010/09/pure-water?fw1pk=2#.VRrT7fnF-Cn
5. The National Institutes of Health. (2013). Laboratory Water, It’s Importance and Application. Retrieved from: http://orf.od.nih.gov/PoliciesAndGuidelines/Documents/DTR%20White%20Papers/Laboratory%20Water-Its%20Importance%20and%20Application-March-2013_508.pdf

Jacob Bowland is Product Manager at Heateflex and Steven Hausle is Vice President of Sales and Marketing at Heateflex.

April 6, 2015

FSMA to Expand Lab Responsibilities, Partnerships Essential

By Maria Fontanazza

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Partnerships between research and regulatory labs should strive to bridge information gaps with the goal of harmonizing standards, integrating lab networks, and expanding surveillance programs.

FSMA will add more responsibility to a laboratory’s plate, stressing the need to maximize research and develop an integrated approach to prioritizing risks. Under its general requirements, research and regulatory labs will be expected to examine performance standards, cooperate with federal partners within HHS and the Department of Homeland Security, and build a domestic capacity that encompasses federal, state and international partners.

Partnerships between research and regulatory labs should strive to bridge information gaps with the goal of harmonizing standards, integrating lab networks, and expanding surveillance programs. During the Food Labs Conference in March, Palmer A. Orlandi, PhD, CAPT, U.S. Public Health Service Sr. Science Advisor in the Office of Foods and Veterinary Medicine at FDA, discussed how partnerships in the era of FSMA are crucial to facilitate innovation. “We’re not necessarily looking for someone to take our responsibilities, but we’re looking for someone to walk with us to do this,” said Orlandi.

For research and regulatory analytical capabilities to move forward, several needs and goals must be addressed:

Needs

•    Burden sharing
•    Expansion of the scope of testing programs (and the methods to support them)
•    Development of sampling strategies
•    Risk-informed prioritization strategy

Goals

•    Capacity building
•    Methods that are rapid, sensitive, specific, easy to use, robust and portable
•    Ability to test at the source
•    Database of information that shows susceptibility for contamination and root cause, while also providing solutions for prevention
•    Targeted and statistically significant surveillance, with the ability for sharing

Examples of capacity-building partnerships include the Food Emergency Response Network (FERN), which is run by FDA and USDA. FERN is comprised of more than 170 state and federal labs, and has gone beyond its roots in emergency capacity, expanding into a food safety network that also participates in large-scale surveillance. The Integrated Food Safety System incorporates a Lab Task Group with seven subcommittees to develop standards in areas that include accreditation, methods, regulatory requirements, reporting, and sampling. International partnerships are currently being forged in Mexico and Canada.

View excerpt from Palmer Orlandi’s presentation about Partnerships & Innovation at the Food Labs Conference

What’s Next: Innovation, Technology and the Possibilities

Portable technology: A user-friendly, handheld rapid-screening instrument that requires minimal sample prep and is cost effective. Think Tricorder. Will it be possible to wave an instrument over a head of lettuce and detect bacterial contamination? What about detecting a spectrum of approved or unapproved pesticides or active pharmaceutical ingredients?

“This is where we would like to go,” said Orlandi. “Is it pie in the sky? Absolutely. But if you don’t ask the big questions, if you only take the incremental steps, you’re only going to get so far.”

Orlandi pointed to X-ray fluorescence, which takes less than two minutes to perform sample analysis and ion mobility spectrometry, which can detect a small range of selected compounds in just 30 seconds, as technologies that have future potential.

FDA has a goal of bringing such innovative technologies to bear through its Broad Agency Announcements, a program that provides funding from $200,000 to $50 million to harness new technologies.

Orlandi also cited the Whole Genome Sequencing (WSGS) Collaborative as the next big technology. The GenomeTrakr is a federal and state network of 24 labs that collect and share genomic data from foodborne pathogens. This enormous data flow provides the ability to sequence and transmit and store data, involving domestic and international partners. One application example includes identifying antimicrobial resistance markers.

As FSMA increases industry requirements, “partnerships are going to spawn our capabilities to harmonize standards that will involve, then leads to mutual reliance,” said Orlandi. “We rely our partners’ data and their processes. This will lead to greater capabilities for surveillance and data sharing. All of these combined will lead to a greater food safety network.”

Related Content: Five Questions with Palmer Orlandi

April 1, 2015

Innovative Publishing Names Maria Fontanazza Editor-in-Chief of Medical Device Summit and Food Safety Tech

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Innovative Publishing names new face for Medical Device Summit and Food Safety Tech.

Washington Crossing, PA – April 2, 2015 – Innovative Publishing Company has named Maria Fontanazza the editor-in-chief for its B2B online publications Medical Device Summit and Food Safety Tech.

Fontanazza has more than a decade of experience in journalism, marketing and communications within the medical device industry. While at UBM Canon for more than eight years, she served in various editorial roles, including as the managing editor for Medical Device + Diagnostic Industry (MD+DI). She has authored hundreds of articles that have appeared in domestic and international industry publications and has moderated educational sessions and panel discussions at various industry events.

“Maria will be a strong addition to our team and will be responsible for growing our delivery of original in-depth reporting on important industry issues and expanding our reach on social media,” says Rick Biros, president and publisher of Innovative Publishing.

Fontanazza brings direct medical device industry knowledge from her role at Secant Medical, Inc., where she was the Marketing Communications Manager and Market Research Manager, and will bring her experience in a highly regulated industry to covering critical food-safety issues.
“I am excited and honored to be joining the Innovative Publishing team, which is made up of seasoned professionals who share an entrepreneurial spirit that drives us to do things differently so we have greater impact on the industries we cover,” says Fontanazza. “I look forward to increasing industry awareness of important issues and provoking discussions that promote more collaboration between industry and regulators.”

Innovative Publishing Company LLC (IPC) delivers industry-specific opportunities for business growth and professional development through an integrated B2B platform that includes online publishing, conferences, webinars and hybrid events. IPC launched Medical Device Summit @MedDeviceSummit in 2010 and Food Safety Tech @FoodSafetyTech in 2012. Our focus is to provide game-changing knowledge and expert opinions about breaking news, innovative technology, emerging trends and ever-changing international regulations. Our mission is to aid in the advancement and progress of global industries that contribute to a healthier world.

March 31, 2015

Why Everyone Should Care About Food Safety

By Matt Shipman

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Food safety poses a global health problem. According to the World Health Organization, contaminated food can cause more than 200 diseases – and food- and water-borne diseases that cause diarrhea are estimated to kill two million people each year worldwide.

And food safety is not just someone else’s problem.

“Foodborne illnesses are a significant problem in the United States, with massive impacts on public health and the economy,” says Ben Chapman, a food safety expert and researcher at NC State. And the numbers back Chapman up.

According to a 2012 report from researchers at the Emerging Pathogens Institute, Resources For the Future, and the U.S. Department of Agriculture’s Economic Research Service, foodborne illness is estimated to cost the U.S. more than $14 billion annually. (The estimate takes into account factors such as medical costs and productivity losses.)

And a 2011 report from the U.S. Centers for Disease Control and Prevention (CDC) reported an estimated 9.4 million episodes of foodborne illness each year in the U.S. from known pathogens. An additional 38.4 million cases are estimated to come from unspecified or unknown pathogens. In total, foodborne illnesses are thought to contribute to 48 million illnesses annually – resulting in more than 128,000 hospitalizations and 3,000 deaths. It is, in short, a big deal.

So what are these foodborne illnesses? And how much damage does each of them cause? In advance of World Health Day, we wanted to explain a handful of the relevant pathogens implicated in foodborne illness.

Campylobacter

Campylobacter is a genus of bacteria, many of which can cause an illness called campylobacteriosis in humans, with symptoms including diarrhea and abdominal pain. People can contract campylobacteriosis from undercooked chicken, from cross-contamination via raw chicken, or from drinking unpasteurized milk.

According to the 2012 paper, campylobacteriosis affects 845,000 people annually in the U.S., costing the nation an estimated $1.747 billion every year and leading to 8,463 hospitalizations.

Listeria monocytogenes

This is a bacterium that causes listeriosis, which is characterized by fever, muscle aches, and sometimes by gastrointestinal problems, such as diarrhea. Listeriosis can be contracted from an incredibly broad range of foods.

According to the 2012 study, listeriosis costs the U.S. $2.577 billion annually, despite the fact that there are only 1,591 illnesses per year. But 1,455 of those illnesses require hospitalization – and 255 result in death.

Norovirus

Noroviruses are the most common cause of foodborne illness in the U.S., affecting an estimated 19-21 million people each year. Symptoms range from vomiting and diarrhea to fever and headache. Transmission comes from ingesting infected feces or vomit particles – for example, by touching a contaminated surface and then touching food or touching your mouth.

According to the 2012 study, noroviruses cost the U.S. $2 billion per year, with more than 14,000 hospitalizations and approximately 150 deaths annually. NC State is a leader in norovirus research, and home to NoroCORE – the Norovirus Collaborative for Outreach, Research, and Education. NoroCORE pulls together norovirus research from 18 institutions, with funding from the U.S. Department of Agriculture.

Salmonella enteritidis Image credit: U.S. Department of Agriculture. Obtained via Wikimedia Commons. — Salmonella enteritidis
Image credit: U.S. Department of Agriculture.
Obtained via Wikimedia Commons.

Salmonella enterica

This is one species of the pathogen that has myriad of subspecies and types – more than 1,400 of which are known to cause human illness. Infection with Salmonella species causes salmonellosis, with symptoms including diarrhea, fever, and cramping. Salmonellosis can be contracted from a variety of sources, ranging from poultry to peanut butter to mangoes.

According to the 2012 study, the subspecies within S. enterica alone costs the U.S. $3.3 billion each year, causing more than one million hospitalizations and almost 400 deaths annually.

What are researchers doing about this?

The four pathogens listed above are just a few of the rogue’s gallery of bacteria and viruses that can cause foodborne illness. But researchers are constantly learning more about these health risks.

“New technology and new research on pathogens, practices and prevention are improving our ability to identify and address foodborne illness,” Chapman says. “The field is really opening up. It’s an exciting time to be involved in food safety research.”

Between now and April 7, we’re planning to publish a series of posts on various aspects of food safety – what we know, what we don’t know, and what we’re working on. We also hope to offer insights to help folks lower the risk of contracting foodborne illnesses. We hope you’ll learn something new.

Note: This article originally appeared on NC State News, and has been published here with permission. You can find all of NCSU’s posts related to food safety here.

Citations:

Batz, Michael B., Sandra Hoffmann, and J. Glenn Morris, Jr. “Ranking the Disease Burden of 14 Pathogens in Food Sources in the United States Using Attribution Data from Outbreak Investigations and Expert Elicitation” Journal of Food Protection, Vol. 75, No. 7, 2012, Pages 1278–1291. doi:10.4315/0362-028X.JFP-11-418
Scallan, Elaine, et al. “Foodborne Illness Acquired in the United States—Major Pathogens” Emerg Infect Dis, Vol. 17, No. 1, 2011. doi:10.3201/eid1701.P11101

March 25, 2015

5 Tips for Better Supplier Document Management

By Chelsey Davis

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What’s the best way to collect supplier documentation? You might read that sentence and think there is no best way…and you would probably be correct. There really is no best way to gather documentation other than sending a representative out to a supplier’s facility for an audit and document gathering. But we simply don’t have enough personnel to go that route.

Christopher Staub is a corporate raw materials coordinator with Advanced Food Products. Part of his job role is to ensure proper supplier documentation is in place for incoming raw materials. As a current TraceGains user, Staub offers his tips on how to help with supplier document management.

Let me preface this by saying that one year ago, we had almost all of our supplier documentation in order, but it was already outdated, with some documents even as old as 2002. We needed updated information, and so began my journey of document collection…with plenty of pains along the way. For example, one of my least favorite tasks was explaining to a supplier the process of scanning a document to an email and then adding that scanned document as an attachment to an email. The best part? After this time-consuming process, I found out that the supplier could have simply attached the digital copy to begin with. This ultimately gave me quite a few headaches, but, to be honest, I think the actual aching came from me banging my head against the wall. Of course, this was a rare case. On some occasions, suppliers would actually have an efficient two-day turnaround on large quantities of documents. This was the perfect scenario! In the end, we managed to gather roughly 95 percent of all the documents my company requires, but as my example above illustrates, it was no easy feat.

With that being said, I would like to offer these tips to help you with your supplier document management.

1. Ensure Reference Numbers Are Consistent

Nothing is worse than getting responses from suppliers informing you that they cannot provide the documents you requested because they don’t know what materials for which the request was made. This is simply because your reference numbers aren’t matching theirs. To avoid this conundrum, make sure the ingredient name and part numbers that you have in your system match that of your suppliers. This will save you a lot of time and back-and-forth emails in the long run.

2. Approve and Store Documents Quickly

Typically, I try to approve and store new documents within a day of receiving them. If you are collecting a large amount of documents, you don’t want to get behind in the reviewing/approving process, especially when you have automatic emails going out to suppliers. You will not gain any bonus points if the supplier has to send you an email stating that the document in question was sent over a month ago simply because you did not have the document reviewed and stored correctly.

3. Accept Many Different Document Forms in Different Formats

Action Forms and questionnaires are great for collecting and extracting data, but will be rendered useless if a supplier does not/refuses to fill them out. It makes sense when you think about it… If I were a supplier, I wouldn’t want to fill out multiple questionnaires from hundreds of different purchasers–that would be exhausting. To help remedy this situation, I suggest setting up your systems to accept any supplier document in as many file formats as possible, so long as the document satisfies your requirements.

4. Keep Emails Clear and Concise

When you do need to email a supplier, make sure emails are as clear and as short as possible. With suppliers presumably receiving a significant amount of emails daily, it’s imperative that you get to the point as quickly as possible. Don’t make it the supplier’s job to sift through an agonizingly long email. Keep it simple.

5. Make It Personal

When all else fails, give the supplier a call. And while we do live in a digital age, sometimes a simple call will make all the difference and produce results. I’ll admit, I am a Millennial and would rather send a text or an email versus having to call someone. But the fact is, calling works.

Do you have additional tips regarding supplier relationships or document management? Leave a comment below and share.

March 24, 2015

What Matters When Considering a Food Safety Audit?

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Food companies need to get audited and their personnel need to get trained frequently, and this is a growing trend in the evolving regulatory landscape and a highly competitive and global supply chain. However, what matters the most to food companies when getting audited? How significant is auditor competence as an attribute? How about the time that the audit takes, and the time to get the report? Or for training, what role does technology play?

To understand this, Eurofins conducted a blind survey of industry participants – nearly 600 respondents answered questions related to Certification and food safety Training.

Some of the highlights included:

Ultimately, the following factors influenced food companies’ decision to go through food safety certification:

Customer Requirements/Requests Relationships;
Industry Standard; and
Value Proposition.

When it came to training, the top three influencers to go through Food Safety Training were identified as:

Developing Competence (Gaining, Improving, Growing)
Relevance and Subject of Training Cost and Time