Read the Q&A with Randy Fields, “Senior Execs in for a Rude Awakening Regarding Supply Chain Compliance”Both accountability and liability will play a role in how food companies work with their suppliers moving forward. “The global food supply chain has really been based on trust for the last 70 years,” said Randy Fields, chairman and CEO of Park City Group and Repositrak. In a video interview with Food Safety Tech at the 2015 Food Safety Consortium, Fields explains how companies must go beyond simply “trusting” their suppliers to having a keen awareness of their suppliers’ activities from a compliance perspective.
During an FDA Town Hall at the 2015 Food Safety Consortium, FDA Deputy Commissioner for Foods and Veterinary Watch video of Taylor’s speech: Part I and Part IIMedicine Michael Taylor was asked about implementation of the produce rule from the perspective of Mexico. Taylor touched on the partnership, announced about a year ago, between the United States and Mexico in recognition of the fact that working together will be the only way to move forward in verifying compliance with the new rule. “Our work with Mexico on produce safety is one of the most important things we’re doing right now in implementing FSMA,” said Taylor.
In previous years, supplier compliance was oftentimes built on trust. With FSMA tightening the reigns on compliance via auditing and documentation requirements and unannounced inspections, a higher level of accountability is being placed on companies, from the employees on the manufacturing floor all the way up to the C-suite. However, when senior executives start digging into the level of compliance maintained by their suppliers, they might not like what they find. In fact, they might be downright shocked, according to Randy Fields, chairman and CEO of Park City Group. “Instead of maintaining control over these issues of compliance, by delegating it and not properly supervising it, they’ve [senior management] lost visibility,” Fields says. “They have to be more involved than in the past, because they’re on the hook for it. But, they’re going to discover that their supply chain is nowhere near as compliant as they imagined.” In a Q&A with Food Safety Tech, Fields discusses how FSMA is changing the game for executives in the food business.
Food Safety Tech: In the context of supply chain accountability, increased interaction is now essential between food safety managers and executives. What level of awareness is required in the C-suite?
Randy Fields, chairman and CEO of Park City Group, says the C-suite is not ready for what it is going to discover in terms of lack of compliance in the supply chain.
Randy Fields: Given the change in the law (FSMA), the regulatory world, and increasingly, the world of tort, the unfortunate reality is that the C-suite in nowhere near as aware of the issues of accountability in the supply chain as they need to be. It breaks down into two pieces: First, they have entrusted supply chain compliance to other people in the business; it’s been dropped down too far within the organization without the proper oversight.
Second, they don’t have a good way of measuring compliance—it’s been based on trust. Compliance has become more complex and as a function of the complexity, [senior management] doesn’t have a good set of tools by which they can stay on top of compliance and measure it.
With the change in the law, accountability has legally moved up to the C-suite, because FSMA, for all intents and purposes, brings Sarbanes–Oxley to the FDA. Between FSMA and tort, the way that it’s been is about to change very dramatically, but the surprises are all downside surprises. The consequence of trust without verification is now likely to lead both to litigation and possible criminal conviction. This is a different world.
The basic level of compliance in the global supply chain is far worse than anyone ever imagined. It will be not unlike turning over stones in your backyard in terms of what’s going to crawl out.
“Personal liability is probably the ultimate determinate of whether or not the C-suite starts to pay attention.” –FieldsFST: Is there a larger responsibility on the part of food safety managers to translate the compliance message to the C-suite?
Fields: I think it’s now both the appropriate responsibility and potentially the legal responsibility of food safety managers to insist that their C-suite become aware and provide them both the oversight and the tools by which compliance can be continually and professionally supervised and managed. I think failure to do that represents negligence.
Tort claims are getting more frequent and larger for foodborne illness problems. And now with both civil and criminal penalties potentially being applied by the FDA, it’s a game changer. It cannot be business as usual. This changes the world for food safety managers, and it changes the world for their bosses. We live in a world now where, whether we like it or not, the concept of accountability is about to be more legally enforceable.
The Peanut Corporation of America sentences are exemplary. But strict liability means that there can be a criminal prosecution without intent or even conceptually gross negligence. It is only a matter of fact that you supervised the function that was involved.
There’s a set of issues here that food safety managers should be bringing to the attention of senior executives. It’s beholden on them to say to these guys, ‘you have to pay more attention to this because you’re legally, civilly and criminally on the hook.’
FST: Do these factors have an impact on the type of professionals that are needed within food businesses?
Fields: Yes. I suspect that what will happen over the long term is that food safety will not be as much [about] science as it is compliance. In many companies, the food safety people tend to be the scientists who may not be as interested in the whole compliance problem. Increasingly, it’s the whole problem of compliance, not just the problem of food science.
We typically see within a company that someone manages the insurance part of the supply chain; someone else manages the food safety part of the supply chain, and someone else manages some other part of it: All of that fits under the rubric of compliance. We’re seeing more and more companies beginning to address this holistically.
The “GFSI in the Age of FSMA” three-part series wrapped up in early December, providing the food safety community insight on how leading GFSI schemes align with, and help prepare for, compliance with FSMA. The series was presented by SafetyChain with media partner FoodSafetyTech.
Each GFSI scheme leader from SQF, BRC and FSSC 22000 discussed how their schemes align with FSMA in several key areas, including Supply Chain Controls, migrating Food Safety Plans from HACCP to HARPC, and audit readiness. While each scheme leader provided insights and details on how their scheme aligns with FSMA, common key themes across all three sessions included:
FSMA’s focus on prevention vs. reaction is similar and aligns with GFSI’s objectives; Scheme certifications and ongoing compliance is centered around continuously assessing risks and putting preventive measures in place to mitigate those risks
GFSI’s global approach surrounding a company’s food safety program—to ensure better supply chain controls internally, upstream and downstream prepares companies to manage FSMA’s increased focus on both domestic and foreign supplier compliance
GFSI stringent documentation and recordkeeping requirements—along with unannounced audit protocols—are a strong foundation to help food and beverage companies prepare for FSMA’s “if it isn’t documented you didn’t do it” mantra
The GFSI scheme leaders also spoke about the importance and opportunity companies have to leverage technology tools to help more effectively manage the complexities and requirements of GFSI and FSMA compliance. Series participants were able to see an example of how these automation tools work and the impact they can have on managing a robust food safety program via a post session demo of SafetyChain Software.
Archived recordings of all three sessions—SQF in the Age of FSMA, featuring Robert Garfield, Senior VP, SQF; BRC in the Age of FSMA, featuring John Kukoly, Director, BRC Americas; and FSSC 22000 in the Age of FSMA, featuring Jacqueline Southee, U.S. Liaison, FSSC 22000—are available and can be accessed here.
As part of a federal goal to achieve a 25% reduction in Salmonella illnesses related to meat and poultry products by 2020, USDA’s FSIS has revised and published guidelines for poultry processors. The document, “FSIS Compliance Guideline for Controlling Salmonella and Campylobacter in Raw Poultry”, intends to provide best practices based on scientific and practical considerations for minimizing pathogen levels and meeting FSIS food safety requirements.
The guidance recommends preventive measures that poultry companies can make in the following areas:
Pre-harvest (on the farm)
Sanitary dressing procedures
Further processing practices
Antimicrobial interventions
Management practices
FSIS is also seeking comment on the fourth edition of the updated document.
There has been little change in the number of confirmed Salmonella cases, which sicken more than 1 million people annually in the United States. The guidance is part of FSIS’ Salmonella Action Plan, which was announced in December 2013.
Two rapid test kits have been launched for the identification of salmon species: Chinook (Oncorhynchus tshawytscha) and Sockeye (Oncorhynchus nerka). The tool kits were developed in collaboration with the University of Guelph and allow distributors, food processors and government regulators to positively identify the salmon species in less than two hours.
The test kits are used in conjunction with a portable, real-time PCR system that provides DNA detection. The tools are part of the Instant ID Species product line from InstantLabs, which include seafood identification tests for Atlantic (Salmo salar) and Coho Salmon (Oncorhynchus kisutch as well as Atlantic Blue Crab (Callinectes sapidus) and U.S. Catfish (Ictalurus species).
The human behavior that surrounds us contagious. Read the article about Frank Yiannas’ presentation, Catch the Food Safety Culture Bug. In keeping with this theme, Frank Yiannas, vice president of food safety at Walmart, reviews behavioral science techniques that can be applied to a food safety management system. In part I of this video series from the 2015 Food Safety Consortium, Yiannas reviews the principles of consistency and commitment.
DuPont BAX System X5 PCR Assay for Salmonella detection
Today DuPont announced that the AOAC Research Institute (AOAC-RI) approved a method extension of Performance Tested Method #100201 to include the company’s BAX System X5 PCR Assay for Salmonella detection. Introduced this past July, the PCR assay provides next-day results for most sample types following a standard enrichment protocol and approximately 3.5 hours of automated processing. The lightweight system is smaller and designed to provide more flexibility in testing.
“Many customers rely on AOAC-RI and other third-party certifications as evidence that a pathogen detection method meets a well-defined set of accuracy and sensitivity requirements,” says Morgan Wallace, DuPont Nutrition & Health senior microbiologist and validations leader for diagnostics, in a company release. “Adopting a test method that has received these certifications allows them to use the method right away, minimizing a laboratory’s requirements for expensive, time-consuming in-house validation procedures before they can begin product testing.”
The validation covers a range of food types, including meat, poultry, dairy, fruits, vegetables, bakery products, pet food and environmental samples.
Data can be a very powerful tool, but only if it is used in an effective manner. It needs to be easily consumable and understood by all levels within an organization. “It’s great to collect information, but if you don’t do something with it, you’re not doing yourself, your facility or your employees any favors,” says Holly Mockus, product manager at Alchemy Systems. “It can really trip you up during a regulatory inspection to have all of this information that you haven’t looked at, tracked, trended or reacted to.”
As FSMA places more importance on documentation and record keeping, FDA-regulated facilities will need to not only capture information but also translate data into easily digestible content for management and employees in order to drive continuous improvement. In a discussion with Food Safety Tech, Mockus shares some key points on how companies can transform their data from numbers and statistics into meaningful and actionable information.
Collect meaningful data from the start. From the beginning of the data collection process, be mindful of exactly what outcome the organization wants to achieve. Having an understanding that the data will be measured and acted upon encourages facilities to avoid gathering information just for the sake of collecting it.
Involve the employees who actually collect the data. Data is more meaningful when employees understand why they’re gathering information and are involved in the process from the beginning.
React to the data. If the information reveals a good or bad trend, or that a process or procedure is out of spec, take action. In addition, document how the business reacted to the issue and the corrections that were put in place.
Close the loop for continuous improvement. Establish a closed loop for data collection, focusing on how gaps were addressed, with an emphasis on continuously improving on the process.
Really examine the data collected. Whether collected for a product, process or equipment line, sit down and take a close look at the data. This exercise is intended to reveal redundancies across departments and help reduce record keeping tasks.
Food Safety Tech: How do companies transform data into a meaningful tool for management?
Mockus: That’s such a challenge for us. It should be easily consumable, especially for management and the higher ups in organizations, because they don’t have as much time to sit down and digest a 20-page document that’s full of numbers and statistics. Work towards to summarizing the information in a way that allows executives and plant managers to look at a graph and know instantly what it means; they don’t need to get into the nitty-gritty. Simplifying the scientific data, whether environmental sampling, quality assurance data, or microtesting in general, and taking it down to base a level so that the non-scientist can understand it—I think that’s something we have to work on, especially for those coming under more regulation. Keep in mind that people who look at the tracking and trending [might not] understand graphs and scientific terms.
A lot of people put the data into a graphic format—it doesn’t have to be a line graph or pie chart, it can be a red, yellow, green [indicator] or a scale of justice. Look at the graphics that are meaningful to your specific organization and use those. Be creative, but keep it simple.
FST: When companies set metrics, how can they ensure that those metrics are taking them in the right direction from a food safety perspective?
Mockus: Especially when you have metrics that are tied to performance for a manufacturing facility, you want to be careful how you set them and how you reward them. For example, if your metric for environmental testing is very low or at zero, you’re encouraging your workforce not to find those Listeria niches or areas in which Salmonella can grow, because you’re telling them that they have to be at a zero rate to be incentivized. It’s more about measuring the outcomes of the activities—are we finding the niches and eliminating them so we don’t have those issues versus saying we want to be at “zero”? [It’s important] to work with upper management so that they understand the consequences of their expectations and the incentive programs that they put in place.
After bringing in IEH Laboratories and Consulting Group to reevaluate its practices after an E.coli outbreak that sickened dozens, Chipotle Mexican Grill announced it is implementing a program to ensure it achieves “the highest level of safety possible”. According to a press release issued today, Chipotle is enhancing its food safety program and taking the following actions:
Conducting high-resolution DNA-based testing of all fresh produce prior to shipment to restaurants
Conducting end-of-shelf-life testing of ingredient samples to ensure quality specifications are maintained throughout ingredient shelf life
Engaging in continuous improvements throughout its supply chain leveraging test result data to measure its vendor and supplier performance
Improving internal employee training related to food safety and food handling
The CDC and FDA investigation of the E. coli outbreak is ongoing and the source of the outbreak is still unknown.
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