Tag Archives: Supply Chain

Randy Fields, Repositrak
FST Soapbox

The Silver Lining of FSMA Compliance: Leverage the Cloud to Mitigate Risk

By Randy Fields
No Comments
Randy Fields, Repositrak

It may seem counter-intuitive that any government regulation could generate an opportunity for food industry manufacturers, processors and marketers. But that is exactly the case with the Food Safety Modernization Act (FSMA). Manufacturers as well as your suppliers and customers need to invest in and change some business practices to comply with FSMA regulations, and doing so will enable them to bolster other processes and technologies to further cut costs and help mitigate risks not directly associated with food safety.

FSMA requires food manufacturers and your trading partners (both upstream and downstream) to have the documentation for regulatory compliance readily accessible for government inspection, with specific records required for companies that transport food or are deemed to be the procurer of foreign products. When you add these records to the business relationship records that food manufacturers, your suppliers and customers should already be maintaining (such as indemnifications and certificates of insurance that help manage brand risk), the databases start to become very large, very quickly.

The easy part of FSMA compliance for food manufacturers is with your largest customers and suppliers, because they likely have the processes and technologies in place to ensure both companies have the proper documentation. It’s really the group of smaller customers and ingredient providers, which can represent thousands of companies, that may not have the sophistication to supply the data points required under the law. Collecting and managing the information from these firms can be costly and labor intensive.

The good news is that cloud-based technology now exists to help all trading partners in the food supply chain meet FSMA requirements while working to prevent outbreaks and quickly limiting situations when they occur. This technology goes beyond just storing digital copies of documents—it helps to manage compliance with exception-based alerts for expired, missing or inaccurate records. It can also be the basis of an approval process for new vendors that incorporate record compliance. By linking and automating the management of compliance documentation and new vendor approvals, companies save time and allow for redeployment of resources to more productive activities. 

If you are serious about reducing brand risk, linking compliance management data with your purchase order system will swiftly and effectively accomplish that goal. Holding a purchase order for a non-compliant vendor protects the retailer, manufacturers and the consumer, and communicates a commitment to food safety within the entire supply chain. 

So, complying with government regulations such as FSMA doesn’t have to represent a significant one-time investment in technology and ongoing upkeep. Look to cloud-based technology with an eye for streamlining current processes, reducing overhead and supporting new customer or regulatory requirements.  And, being proactive to ensure the safety of your company and your customers will put you in a position to sell more and grow your market share. 

Unleashing the power of the cloud on Food Safety and Food Quality

By Food Safety Tech Staff
No Comments

SafetyChain’s FSQA Tech Talk conversation continues next week with a discussion on why cloud and mobile technologies are becoming a game changer for food safety and quality assurance (FSQA).

As part of an ongoing series that focuses on how technology is being leveraged to solve FSQA execution challenges, the next FSQA Tech Talk session’s special guest speaker will be Michele Eddy, Corporate QA Manager with UniSea.  Eddy will be sharing her experience and insight as to how realtime FSQA data, which is  available, anywhere, and at anytime, is helping to provide sales with immediate quality gradings, better manage HACCP, CAPA, and direct observations for UniSea’s pillars of sanitation,  and how the cloud is making it easier for participants in their supply chain to work together.  Eddy will also discuss use and employee adoption of mobile devices.

The session will start with SafetyChain’s Director of Technical Solutions who will discuss key benefits of the cloud on FSQA, including the ability to have realtime data proactively pushed out and acted upon,  as well as how cloud and mobile devices support FSQA transparency and visibility across the value chain. Also discussed will be common cloud misperceptions including security and employee adoption.

The speakers will be taking questions live from the audience, and FSQA attendees are encouraged to bring their IT folks to participate. Attendees who would like to see what the cloud and mobile FSQA apps look like in action, are invited to stay online after the Tech Talk for a 15 minute demo of SafetyChain’s cloud and mobile solutions. The session is being held on Tuesday, May 19 at 10:00 am PDT, and those interested in attending can visit here for more information and to register.

The FSQA Tech Talks are a part of SafetyChain’s 2015 FSQA Technology Series: “Enabling Technologies – The Food Safety & Quality Assurance Game Changer” – which includes Leadership Forums, FSQA Tech Talks and Executive Briefs. Jill Bender, SafetyChain Vice President of Marketing Communications, said, “SafetyChain has been very proactive these past several years in educating industry on key FSQA challenges such as FSMA, GFSI, cost of quality and more. Input from the thousands of people who have attended our webinar forums was that they’d also like to learn more about how their peer companies are leveraging technology to execute on these challenges – and so the 2015 FSQA Technology Series was born!” “So far more than 1,500 hundred FSQA and food company IT folks have participated in the series, and we’re very excited to continue with fabulous speakers such as Michele Eddy,” Bender continued.

To learn more about SafetyChain’s FSQA Technology series visit www.safetychain.com/2015techseries.

Upcoming FSQA Tech Talks Include:
June 23: Harnessing Cost of Quality
July 21: Conquering HACCP, HARPC and Food Safety Plan Management
Participants of this series need only sign-up once and will automatically receive notice of the next topic and login/call information.  Register here for this complimentary series.

Food Transparency No Longer an Option

By Maria Fontanazza
No Comments

As consumers demand to know the “who, what, when, where and how” of products they purchase, companies must focus on bringing honesty to the table to build trust.

Consumers are becoming more informed about the dangers of certain ingredients and the presence of allergens and pesticides in food. In the future, virtually the only way companies can build and retain consumer trust is through providing transparency in the food chain.

“Transparency will no longer be an option,” says John Keogh, president and principal advisor at Shantalla Inc. “Food businesses have to commit themselves to transparency as the only way to demonstrate to the market how customer-oriented they are.” Keogh discussed the need for companies to be forthright not just about what is in food, but also the entire product journey—the who, what, when, where and how—during a recent webinar by the GMA Science and Education Foundation, “Transparency in the Food Value Chain”.

Drawing on examples such as the horsemeat scandal in Europe, trust is quickly lost when dishonesty rears its head. “We need to bring a level of honesty and ethics into supply chain transparency,” says Keogh. This includes disclosing where the product is made or grown, including the state, in the case of the United States; the province, in the case of Canada; and where Japan is concerned, the prefecture. A recent example is Taiwan’s plans to require prefecture labels of Japanese food imports following the Fukushima Daiichi nuclear power plant disaster, which has raised significant concerns over radioactive contamination in food.

As the supply chain becomes increasingly global and more complex, several factors are compelling transparency. Regulations that address food safety, security, defense, and fraud will all have an impact. The Foreign Supplier Verification Program (FSVP) under FSMA will put pressure on the nearly 200 countries that import products into the United States. According to Keogh, there are 220,000 importers on record, and they have about 300,000 facilities, all of which must be inspected under the FSVP mandate. In Europe, the EU regulation 1169/2011 requires the disclosure of more information to consumers, including mandatory origin labeling of unprocessed meat from pigs, sheep, goats and poultry, mandatory nutrition labels on process foods, and disclosure of allergens in the ingredient list. Companies will also need to consider requirements for Halal and Kosher foods.

Technology plays the key role in driving consumer awareness and demand for more information, but Keogh notes there is a gap between consumer expectations from a data perspective and the ability of companies to actually deliver this data. He offers some examples of emerging technologies that companies can use to facilitate supply chain transparency. Sourcemap is a supply chain mapping solution that allows companies to link from their raw materials sites to the end customers. Companies can generate reports from various metrics and identify the weak links in their supply chain. Trace One is a product lifecycle management solution that has a focused module for transparency. The company also recently announced the first B2B social network for supply chain transparency as well as the full alignment with GS1 standards and embedding fTrace into its platform. Manufacturers using Trace One have visibility on all of their ingredients, suppliers and facilities, and can search for products that may be affected by an ingredient or facility problems related to a recall, for example.

“Food chain transparency has the potential to create new business opportunities for retailers and manufacturers,” says Keogh. Moving forward, companies will need to have a foundation of standards, specifically GS1 Standards, and use them at a deeper level to enable interoperability between the technologies that supply chain partners use. Keogh urges companies to think beyond food safety and food quality to value-based transparency to increase value not just for the end consumer but also for supply chain partners. This will also involve ensuring privacy of data surrounding pricing and proprietary information.

A Supply Chain Or a Growing Spider Web?

By Maria Fontanazza
No Comments

The biggest risk faced by the food and beverage industry could be the supply chain itself.

Two proposed FSMA rules, Risk-Based Preventative Controls for Human Food and the Foreign Supplier Verification Program (FSVP), place high expectations on companies surrounding their supplier controls.

During a recent Tech Talk, “Tackling FSMA Compliance”, Melanie Neumann, executive vice president and CFO of The Acheson Group, offered advice on how companies can use technology to execute on the challenges they will face under FSMA.

Game-Changing Challenges

Globalization.  “We as an industry are sourcing more ingredients than ever before—more by volume, more by way of uniqueness, and more by way of more countries,” says Neumann. “We have more companies that are playing in the global supply chain, and arguably, it’s a growing spider web versus a chain.”

Importer of Record. These days, companies have to keep track of more information than ever. “That’s where technology can come into play,” says Neumann. “We have other challenges like trying to understand who really is the importer of record, because there’s some regulatory vagueness with respect to that definition.”  Variations, such as how the Bioterrism Act and the FSVP define importer of record, can also cause confusion. “We need to take a deep dive within our organizations and ask, ‘Am I the importer of record? Do I need to comply with foreign supplier verification?’”

Foreign supplier awareness.  Some companies can’t name all the foreign suppliers present in their supply chain, and this is compounded by the reality that some foreign suppliers doesn’t understand FSMA. “Some foreign suppliers haven’t heard of FSMA, and we have a very short period of time to compliance to get them ready if you still want to source from them,” says Neumann. “Technology can help us track back and keep record of the supply chain.”

Stay on top of risk instead of letting risk catch up with you

Keeping track of mountains of information while controlling risks within a paper-based environment is quickly becoming obsolete and potentially dangerous. Having the electronic documentation will help prove compliance with requirements. “Gone are the days where we can manage all these requirements in a filing cabinet. The technological solutions out there can help you put everything in an electronic format that is searchable and at your fingertips in minutes. By regulation, you’ll need the information within hours,” says Neumann. “These systems are building in mechanisms to auto-alert you, so if something looks like it is becoming out of spec or compliance, it will raise an electronic hand.  It also helps you keep and meet the record keeping compliance requirement from both a foreign and domestic supplier management perspective.”

Listen to the entire SafetyChain FSQA Tech Talk

Upcoming SafetyChain Webcasts Friday, April 24

Register to attend the Leadership Forum, “Food Supply Chain Risk Management and Operational Best Practices”

FSMA Fridays: Everything You’ve Wanted to Know About FSMA but Were Afraid to Ask

Retail Food Safety Forum

Untangling the Net of Seafood Fraud

By Maria Fontanazza
No Comments

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

Undeclared Allergens Continue to Serve as a Primary Factor in Product Recalls

In the fourth quarter of 2014, undeclared allergens accounted for 50 percent of all FDA food-related recalled units and 83 percent of USDA recalled units.

In the past few months, retailers pulled hundreds of products from shelves after a spice supplier found traces of peanut proteins in their cumin spice – an ingredient that dozens of manufacturers use in products across the country.


Ramifications from the recall, which began in December, still occur daily; over two months after the spice supplier first identified the issue. To some the recall may seem miniscule, however, to the nearly 15 million Americans the CDC says has food allergies, undeclared allergens can be a life-threatening scare.

Despite increasing regulations and industry scrutiny, undeclared allergens continue to serve as a primary cause of food recalls in the U.S. According to the latest Stericycle Recall Index, in the fourth quarter of 2014, undeclared allergens accounted for 50 percent of all FDA food-related recalled units and 83 percent of USDA recalled units.

According to FDA, the most common foods involved in food allergen recalls are bakery products, snack foods, candy, dairy products and dressings. The FDA also identifies the most common allergens causing the recalls as milk, wheat and soy.

Undeclared allergen recalls are often a result of a simple manufacturing operational error, such as mislabeling, mis-packaging or unintentional cross-contamination. In the U.S., manufacturers of FDA regulated foods are required to identify major food allergens on the label; if mistakes occur in manufacturing, companies may be subject to a product recall.

As recent recalls show, the more complex the supply chain, the more complex product recalls become. Globalization of the supply chain also complicates recalls, especially when regulatory agencies from multiple countries have different recall mandates. The Stericycle Recall Index highlights some of these unique challenges in the global supply chain, including accessibility to remote areas.

Companies with proactive recall strategies in place can navigate their supply chain with ease when a supplier or an undeclared allergen issue arises. Having these processes identified prior to an event can save valuable time, money and help a company maintain regulatory compliance, while also concentrating on future growth.

Click here to access the report.

Thermometer, Thermostat, or Smart Thermostat? Supply Chain Quality Approaches

By John McGlinn
No Comments

What can the seemingly straight-forward tools we use to regulate temperature tell us about our approaches to supply chain quality?

The seasons bring with them our sensitivity to weather conditions, and especially to how hot or cold it is, inside or out. We measure those conditions, and we try to regulate them so that we can stay within a safe and comfortable range. In many ways, the processes we use to do these things have analogies in the world of Quality Assurance. What can the seemingly straight-forward tools we use to regulate temperature tell us about our approaches to supply chain quality?


The definition of a thermometer is “a device that measures temperature or a temperature gradient, using a variety of different principles.” Two components are required: it must be able to sense the temperature and any change in it, but then it must also convert that information into some kind of scale using numbers. A key property is standardization, especially when regulating production processes. There should be nothing subjective about a temperature reading. Without standardization and agreement on the scale to be used, the readings are meaningless.

While a thermometer is critical to many production processes (not to mention in medicine, weather and scientific research) it has, by design, some limitations. 1. A thermometer does not initiate a reading. Someone decides to use a thermometer at a certain time to get a reading. In this way, a thermometer is a highly effective, yet passive instrument. 2. It shows a snapshot of what is happening at the moment of the reading. 3. It does not show any comparisons to what happened before, or what comes after, unless it is integrated into a system that goes beyond being the technology of the thermometer, i.e., beyond the” bulb” and the “mercury” it contains.

Supply chain quality tools: Audits and self audits

The analogue to the thermometer in the world of Quality Assurance is an audit. An audit is initiated by some agent (management, legislative enforcement, voluntary compliance with industry standards). Someone or something then takes the “temperature” of a process at some moment in time. It shows just that – what is happening at the moment. It makes the assumption that the next moments in time, until the next audit, will be just as “healthy.”


Rather than a self-contained tool (like a thermometer), a thermostat is a part of a control system. The system has the capacity to sense the temperature of a system, and respond in such a way that the system returns to a certain level, a “set point.” When it senses an anomaly, it responds by switching on either the heating or cooling components, or by regulating the flow of heat transfer materials.

Supply chain quality tools: Reports

The analogue to a simple thermostat in the supply chain quality world is an assortment of reports. They include information that is collected, such as:

  • Certificates of Analysis (COA)
  • Certificates of Compliance (COC)
  • Dynamic questionnaires
  • PDF Forms
  • Certifications

When the reports show that, at that moment, things are “too hot” or “too cold” (in other words, out of specification), then the system responds to what is collected with:

  • Corrective action plan
  • Material specifications, whether new or adjusted
  • Purchase order information
  • Supplier nonconformances
  • Supplier scorecards
  • Supplier rankings
  • Supplier processes (to be used)
  • Supplier procedures (to be used or changed.)

It’s clear that the system is set up to respond. However, it also means that the system may swing between various points of being outside the range of necessary specifications, just as a simple home thermostat may be constantly adjusting to return to a desired temperature, although much of the time it is in a condition of “returning to” rather than “at” a specified temperature. Once it reaches that temperature, it immediately begins to destabilize. Once it reaches a certain boundary, the thermostat kicks in to move back toward the “ideal.”

In the supply chain quality management context, this may allow for material variability that is constantly trying to return to a condition of compliance with specifications.

Smart Thermostat

No modern building is without a “smart” thermostat. What makes smart thermostats truly smart is that they reduce the amount of variability. They are so sensitive to changes that the response is quick and decisive. The variability is broken up into very small stages, and even a small increment triggers a quick correction, making the system much more consistent and stable.

Supply chain quality tools: Material variability management and Statistical process control

Just as a thermostat is really a component of a system, Material Variability Management (MVM) is a “smart thermostat” in the domain of supply chain quality management. Electronic documents flowing at a constant rate through a system, powered by Statistical Process Control (SPC), can spot trends and anomalies much more quickly than the large increments that cause a system to constantly react, getting too hot and too cold, while assuming that averaging the two makes the environment pleasantly warm.

Material Variability Management is based on the physical inspection and/or testing of all critical inputs and sub-assemblies in real time, along with specification verification, as well as approval to ship so that no material that doesn’t meet specifications moves through the supply chain. It is a system that integrates an array of tools such as:

  • Specification collaboration/distribution/sign-off
  • Supplier COA test data capture (manual and computer-to-computer)
  • Production batch tests data capture
  • Outbound COA generation from batch test data capture
  • SPC Analyses including individual test trending of out-of-spec conditions and into problem zone (beyond 3 sigma and approaching spec limits)
  • Ship-to-Control visualizations and range setting
  • Alerts for material problem performance
  • ANSI Z1.4 Sampling data capture and analysis
  • Lab test analysis data capture and comparisons
  • Advanced-BI for user-definable reports and dashboards
  • Material and location QA audits

MVM powered by SPC turns a supply chain quality management system into a truly SMART thermostat. Instead of taking a snapshot of reality and reacting to it, it can sense trends and send early warning signals that prevent the entire system from becoming unstable. Your enterprise deserves state-of-the-art support, especially when the technology is affordable, reliable, will save you money, and will secure your reputation for high quality.

Interview: FSQA Enabling Technologies as a Food Safety and Quality Assurance Game Changer

By Barbara Levin
No Comments

In an interview withFood Safety Tech, Barbara Levin, Senior Vice President and Co-Founder of SafetyChain Software, talks about FSQA Enabling Technologies – the Food Safety and Quality Assurance (FSQA) Game Changer, a series of leadership forums, tech talks and executive briefs that SafetyChain has launched this month.

Barbara-Levin2The focus of the series is how technology can help FSQA teams execute to meet today’s biggest food safety and quality challenges in program management, compliance, continuous improvement, risk mitigation and much more.

Food Safety Tech (FST): SafetyChain is launching a new series, called FSQA Enabling Technologies – the Food Safety and Quality Assurance Game Changer. What is the series about and what will it include?

Barbara Levin: For the past three years, working with thought leaders throughout the food and beverage industry, SafetyChain has helped educate and share insights on critical topics – such as FSMA and GFSI. In 2015, we’re excited to bring the conversation to the next level – to discuss the tools that are available to execute on challenges such as FSMA compliance, managing GFSI programs, risk management/brand protection, audit readiness, cost of quality, supplier compliance, operational KPI performance and much more.

FST: Why is technology an important topic in food safety today as we enter 2015?

Levin: I strongly believe that adoption of FSQA enabling technologies is vital, necessary and inevitable – and the only way food companies are going to be able to scale to meet all of the challenges ahead of them. And industry is realizing this and wants to learn more as technology adoption is becoming more mainstream. Think about the technologies we all use at work and home today – things like employee portals to view our paychecks, email, online banking, all of the apps on our computer tablets – none of us can imagine doing without them now. Well think about suppliers entering Certificate of Analysis info on portals. FSQA folks doing pre-harvest inspections on mobile app forms, getting safety and quality information in realtime to determine if there are non-conformances and CAPAs required. And there are hundreds of other examples. We think these will become a way of life too in food safety and quality. So we’re really excited to provide a forum for this FSQA technology conversation.

FST: What changes have we seen in Food Safety and Quality Assurance enabling technologies that are allowing them to achieve more widespread, mainstream adoption?

Levin: There’s a wrong perception that the food industry lags behind some other industries when it comes to technology adoption. In reality, food companies have automated a lot of their functions – look at finance, human resources, payroll systems, supply chain, purchasing, inventory and such. These functions were automated because it saved time, saved money and created operational efficiencies.

Where there was a lag was in adoption of FSQA technologies. I think that this was because first generation safety and quality technologies were behind the firewall – and as we know food safety and quality folks are not sitting at their desks looking at a computer all day. Instead, they are out in the field doing a pre-harvest inspections, or on the plant floor, or at the supplier site doing an audit, or with the customer… basically they are everywhere except at a desk. But today, there are many cloud-based, mobile food safety and quality technologies that can be accessed anywhere, at anytime – and this has really been a game changer when it comes to adoption. Now, food companies are deploying technologies and gaining the same advantages – saving time, saving money and creating efficiencies that improve FSQA.

FST: What are some of the triggers leading teams to explore technology for the first time?

Levin: The word “more” is key to this answer. FSQA is seeing more regulation (think FSMA), more third party schemes like GFSI to manage, more audits, more pressure to improve operational KPIs and reduce the cost of quality. The only thing there’s not more of usually is people – and so technology is the most efficient way to scale to do “more with less.” Additionally technology is the key to getting FSQA information in the fastest manner possible – for timely CAPAs – and be preventive vs. reactive in ensuring that non-compliant products do not go into commerce.

FST: Where do you see FSQA enabling technologies as having the biggest impact on safety and quality operations?

Levin: For me, FSQA enabling technology can have great impact in these areas:

  • Reducing risk for withdrawals, rejections and recalls;
  • Having real time and continuous information to generate CAPAs and ensure safe, quality food;
  • Managing supplier risk and supply chain controls;
  • Scalability to do more without having to add more people;
  • Being audit ready – for regulatory, GFSI, customer and internal audits all the time – even for unannounced audits;
  • Reducing the cost of quality; and
  • Having actionable data for meaningful continuous improvement.

All of these really come under one umbrella, which is protecting the brand and financial value of your company.

FST: What’s coming up in terms of topics and speakers during the series kickoff?

Levin: The series has three components – Leadership Forums on “big picture” topics, Tech Talks on specific FSQA issues and how technology helps resolve challenges associated with those issues, and executive brief whitepapers on the business side of technology benefits.

The first leadership forum, scheduled for March 13, will feature Bob Butcher, Ipswich Shellfish Company’s FSQA Group Operations Manager, and Jeff Chilton, President of Chilton Consulting Group, and will focus on The Business Case for Food Safety and Quality Technology. Future topics include the Role of Technology in Risk Mitigation and Brand Protection, and Technology as an Enabler to Reduce the Cost of Quality.

The FSQA Tech Talks kick off at the end of March with the following topics:

  • March 31 – Tackling FSMA Compliance: How Automation Enables HACCP-to-HARPC migration, FSMA Reporting, Supply Chain Controls and More
  • April 21 – Harmonizing FSQA – It’s All About the Cloud: How the Cloud and Mobile Technologies Enable Anywhere, Anytime FSQA Data Capture and CAPA Generation
  • May 19 – Facilitating Continuous Improvement: Enabling Actionable Data for Trending, Benchmarking and Reporting Across Your Entire Operation

The first executive brief is available now and is titled, “The Critical Role of FSQA Enabling Technologies for Today’s Food Safety and Quality Operations: Technology as an Enabler to Fundamentally Change How Food Safety & Quality Operations Manage Risk and Meet Key Performance Indicators.”

Additional details on the entire series – along with registration and download information – is available at www.safetychain.com/2015TechSeries.

FST: Who should attend this series, and how can they get more information?

Levin: Folks from Food Safety, Food Quality, Operations, Legal, Financial, Executive and Information Technology Management from all sectors of the food and beverage industry are encouraged to register and participate in the series. Everything is complimentary and new topics and dates will be announced frequently. We also invite FoodSafetyTech readers to let us know what topics they’d like to see – they can email us at info@safetychain.com.

Sangita Viswanathan, Former Editor-in-Chief, FoodSafetyTech

FSMA 2nd Review Cycles: A Q&A on Preventive Controls

By Sangita Viswanathan
No Comments
Sangita Viswanathan, Former Editor-in-Chief, FoodSafetyTech

On Friday September 19, 2014, FDA finally released re-proposals to four of the main FSMA-related rules: Preventive Controls for both Human and Animal Food, the Produce Safety Rule, and the Foreign Supplier Verification Program. The 75-day comment period will close around mid-December, after the proposals are officially published in the Federal Register.

At a recent FSMA Fridays webinar, presented by SafetyChain, Dr. David Acheson and Jennifer McEntire, Ph.D., of The Acheson Group focused on changes proposed to the Preventive Controls rule (for Human and Animal Foods). We present below some excerpts:

Q: What is the further definition of situations where environmental testing will be required?

Dr. Acheson: This is one of three very predictable components of the reproposals coming out. We have been saying for a long time to expect environmental monitoring to come back into the regulations. We all wish we have environmental monitoring everywhere, but this is not practical, feasible or environmentally focused. So what FDA has done now is to say we expect you to look at your environment, especially if it’s ready-to-eat products, and require you to conduct environmental monitoring in those specific areas. The change proposed is not fully prescriptive, and facilities need to conduct environmental monitoring as appropriate to their food products, the facility etc. It is required it specific circumstances where ready-to-eat product is exposed post-processing, and before packaging. Under this reproposed rule, the agency requires you to have strong environmental monitoring procedures as needed, records of these methods, and proof that you have corrective actions built in, when needed.

Q: What is the role of finished product testing in verification of food safety plans?

McEntire: When FSMA rules were initially announced, there was a lot of uncertainty whether FDA would require finished product testing, as in many cases, this would be like looking for a needle in a haystack. Now FDA is asking you to do finished product testing as necessary, as a verification activity to check if your overall food safety system is working well. Companies will need to look at the types of preventive controls that in place, at areas such as sanitation, employee hygiene (hand washing) etc., aspects that FDA does not require to be validated, and use finished product testing as a way to make sure that these are being done the way they are supposed to be. If you think it’s appropriate and if you choose to have finished product testing as part of your verification, make sure to have written procedures, documentation, corrective actions etc.

Q: What are the requirements and responsibilities for controlling suppliers along a company’s supply chain?

Dr. Acheson: Everybody recognizes that controls supply chain risk is an important part of controlling brand risk, AND it is a huge challenge. So it makes logical sense, and we know from experience, that suppliers have and will continue to send out food and ingredients that are not suitable, cause problems and cause recalls. Another reason is based in the Foreign Supplier Verification Program, which is essentially a different take on Supply Chain control. The only difference is that FSVP is a risk control requirement for imported, FDA-controlled foods. It looks at who you are getting food from, is there a hazard in it, and how is that hazard controlled? With the FSVP, we had set a different bar for imported foods than for foods sourced domestically. So this new addition rule tries to align Preventive Controls rule with the FSVP, by adopting a similar approach. So now it doesn’t matter if you source domestically, or from outside, you need to have a strong supplier controls program, and this has to be risk-based.

So look at your ingredients or materials. Do they contain a significant risk? If so, who’s controlling that risk – you or the supplier? For instance, if you are sourcing an ingredient like an herb, which has been associated with a Salmonella outbreak, then yes, there is a risk associated with it. So this ingredient that you are sourcing from different places is a significant hazard, but what you are doing with it is putting it in a blend and then cooking it in a product. So you are controlling that risk, and you don’t need to document that from the suppliers. However, the same ingredient, if you are just using it as a garnish, without a kill step, the control falls back on the supplier. And you as the user, have to make sure that the supplier is controlling that risk. The agency is giving some options, such as audits, testing, verification of supplier programs etc. to manage this requirement. For instance, if your analysis says there’s a significant risk, and it can lead to a significant adverse effect or death, Class 1 type situation, if that ingredient poses that level of risk and you are not controlling it, then an annual audit will have to be conducted of that supplier.

Where does GFSI fit into this? In my view, GFSI will align with this. So if you have a GFSI audit of the supplier, then you are going to be in pretty good shape.

Melanie Neumann, The Acheson Group and Syed Hassan, PepsiCo

Are You Effectively Managing Supply Chain Risk?

By Food Safety Tech Staff
No Comments
Melanie Neumann, The Acheson Group and Syed Hassan, PepsiCo

While there are many tools available to help food and beverage companies manage their supply chain, the integration of electronic systems in ensuring effective connectivity can be a challenge. During a Food Safety Tech conference, a panel of industry experts shared their perspectives on how to use tools to manage and communicate recalls, and the importance of focusing on a food safety management system. Melanie Neumann, executive vice president and chief financial officer of The Acheson Group, cited recall communication programs such as Rapid Recall Exchange and Recall Info Link. “They’re great programs in that they The 2015 Food Safety Consortium Conference (November 17-20, 2015 in Schaumburg, IL) features topics on supply chain risk and vulnerabilities. Register now communicate outbound, downstream to the recipients of recalled products. It gets [product] out of the hands of potential consumer purchasers and consumer consumption,” said Neumann. “Here’s what it doesn’t do: They have no way of knowing whether or not they’re communicating out all of the affected product. It still comes back to industry’s responsibility in effective supply chain management to know you’ve captured all of the affected recalled product that those systems are then used to communicate outbound.”