Katy Jones, Foodlogiq
FST Soapbox

Supplier Management: Grow Strategic Partnerships and Drive Value Across the Supply Chain

By Katy Jones
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Katy Jones, Foodlogiq

According to a report by Kroll and The Economist Intelligence Unit, 17% of companies experienced some type of vendor, supplier or procurement fraud in 2015. While fraud is one of the more extreme examples of supplier management complications, the manufacturer-supplier relationship is notoriously fickle and can result in serious issues if attention and care is not reciprocal from the beginning.

With great communication and even better processes in place, your suppliers have the potential to become strategic partners for your brand, helping drive your values across the supply chain while also helping you achieve overarching business goals.

Do Your Homework

In order to foster positive supplier relations, it is important to consider all available options and carefully assess them before engaging. In the research phase, it is critical to get as many references as possible to ensure you align with a potential supplier when it comes to safety practices and brand values. Looking at a supplier’s history is an effective way to gauge how your partnership will pan out and catch any red flags before they become a bigger problem for the brand, whether that be poor communication habits, dishonesty about products or inconsistent record keeping.

FSMA deadlines for compliance with the Foreign Supplier Verification Program (FSVP) are right around the corner. With the changing regulatory landscape, thoroughly investigating potential suppliers is crucial, especially if they are outside of the United States, as the stakes are much higher. Under the FSVP, importers are essentially “guilty” until proven “innocent”—a sharp contrast from how foreign suppliers were previously handled by the FDA. The standards for imported food are stricter than ever, as are the consequences for companies that are found working with foreign suppliers without verification. With the FSVP, the FDA can halt all importations completely as long as they have reason to believe the supplier is not compliant with the program.

Communication Is Key

At the cornerstone of any good relationship is communication; the same goes for relationships within the food industry.

Once a supplier has been thoroughly vetted and is officially on the team, the key to maintaining a successful relationship is transparency. Without full transparency with suppliers, you can’t offer consumers reliable information about their food. At the same time, manufacturers need to be straightforward with their needs to ensure suppliers are able to uphold their expectations. By thoroughly communicating plans and expectations, you and your suppliers can effectively work together to achieve future goals.

At the start of a working relationship with a supplier, it is important to comprehensively onboard and train them in your plans and processes to avoid a lack of understanding down the line. By setting up an all-encompassing onboarding system, inclusive of checklists and background documents on procedures and standards, you can help ease growing pains and empower your new food supplier to become a trusted partner. For instance, if you use a specific supply chain technology, your suppliers should know ahead of time so they can receive adequate training on the solution. This will help streamline communication and minimize any bumps in the road.

Regular Check-Ups

While safety and contamination issues are undesirable, they are inevitable. When faced with an outbreak or contaminant in your supply chain, suppliers become your most crucial resource. A poorly handled recall can wreak havoc on a food manufacturer, with the potential to ruin a trusted brand. Having the correct protocols in place with suppliers to ensure proper procedures are followed quickly and efficiently is critical. In order to make sure suppliers are complying with standards, keeping complete records and maintaining proper safety practices, it is essential to perform regular supplier audits.

With the addition of new technologies in the last few years, monitoring supplier performance and implementing corrective actions has never been easier. There are companies that offer supplier management and food safety management software to enable manufacturers 24/7 end-to-end visibility into their food supply chain and suppliers’ practices, while simplifying communication. Supplier management software offers a single platform that allows a brand to safeguard important supplier documentation, submit proper records to regulators when audited, streamline supplier audits and compliance records, and communicate corrective actions.

Overall, supplier management software with end-to-end supply chain visibility is a great way to keep up with suppliers and rest assured that your company’s food safety guidelines are being followed at all times.

Keeping Consumers Safe and Happy

With the current state of food safety, keeping suppliers in check is absolutely crucial for brands. As the FDA is increasing regulations with the adoption of FSMA, manufacturers must be able to trust their suppliers to uphold these new standards. If there are any slip-ups, your brand is held accountable. At the same time, with the increasing number of high-profile recalls and foodborne illness reports, consumers are on high alert, and winning their trust is harder than ever; today’s conscious consumer expects total transparency from their food brands, something only achieved through a strong supplier management program.

Fortunately, given advancements in technology, manufacturers can now foster more proactive relationships, assess supplier performance and achieve mutual goals across the chain smoothly.

While good supplier management requires time and resources, it is worth the investment. Putting in the effort to foster strategic partnerships with suppliers is key to mitigating safety and contamination issues, meeting the FDA’s regulations, as well as keeping consumers safe and happy.

Gina Kramer
Food Safety Think Tank

Technology Enables More Effective Handwashing

By Gina R. Nicholson-Kramer
2 Comments
Gina Kramer

At the 2016 Food Safety Consortium, Gina Kramer will be moderating the Listeria Detection & Control Workshop | December 7–8 | Schaumburg, IL | LEARN MOREOn October 15, Global Handwashing Day was observed by millions of people in more than 100 countries. The point of the day is to heighten awareness around the importance of handwashing, which is a critical part of preventing sickness and spreading germs.

sanitimer
The SaniTimer

As food safety professionals, proper handwashing is a critical part of prevention as well.  Ensuring that employees understand and execute on the practice is essential to preventing product contamination and protecting consumers.

I would like to introduce you to a new handwashing tool for the food industry, the SaniTimer. A chef who is passionate about food safety performance by food employees developed this innovation. I love this new product and its practical application to food safety and public health in assisting in proper food employee behavior.

I encourage you to watch the video, and please share your thoughts about the technology.

Bill Bremer is Principal, Food Safety Compliance at Kestrel Management LLC
FST Soapbox

FSMA Preventive Controls Corrective Action Requirements

By Bill Bremer
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Bill Bremer is Principal, Food Safety Compliance at Kestrel Management LLC

FSMA Preventive Controls and Food Safety Plans must document specific use and management of corrective actions within Food Safety programs to satisfy the regulations and meet associated compliance dates. This requirement recently took effect under the Preventive Controls Rule on September 19, 2016 for companies with more than 500 corporate employees; food companies with fewer than 500 corporate employees have an additional year.

TEST YOUR FSMA SMARTS! Take the FSMA IQ TESTAs the FSMA Preventive Control rules move to enforcement status, food companies must prepare to best respond to the requirements and, correspondingly, to add the required written corrective action programs and records within Food Safety Plans. This may include providing an additional level of evidence that the company distributes safe food products to and from the United States.

With pending scheduled inspections on the horizon and the expanded authority of the FDA to conduct at-will inspections, it is critical for these programs to be written, verified and maintained at all times.  Important to note, even if this is a previously established program, you must be in compliance with the provisions of Section 117 of FSMA.

Learn more about FSMA Preventive Controls  at the 2016 Food Safety Consortium in Schaumburg, IL | December 7-8, 2016 | REGISTERThe more formalized programs and supporting evidence of compliance must include internal audits by Qualified Auditors, with coordinated oversight by your Qualified Individuals. Inspectors now have the authority to enforce the “letter of the law”. Additionally, organizations under the Preventive Control Rule must have multiple Qualified Auditors, in addition to Food Safety Plan Qualified Individuals, to oversee corrective action audits for evidence assurance.

Self-Diagnostic Assessment Tool

The following self-diagnostic assessment tool can help organizations better determine their current state of planning when it comes to implementing and managing corrective actions under FSMA Preventive Controls. To complete your own assessment, review and compare your programs to the questions below.

FSMA, Corrective Actions checklist
Table I. Kestrel Management’s self-diagnostic tool can help a company assess its level of corrective action programs for FSMA compliance.

Get Compliance-Ready

Companies must have the appropriate programs to comply with FSMA corrective actions or face possible willful non-conformance, which can include fines and criminal penalties under FDA enforcement. The questions in Table I will help companies identify areas to consider regarding their corrective action programs. Kestrel can also help answer questions, provide input on solutions, discuss how to better manage all of your food safety requirements—and change “No” responses into “Yes” responses that promote best practices for FSMA and food safety compliance.

Deirdre Schlunegger, CEO of STOP Foodborne Illness
Food Safety Culture Club

Time to Reflect and Honor Food Safety Heroes

By Deirdre Schlunegger
1 Comment
Deirdre Schlunegger, CEO of STOP Foodborne Illness
Robert Tauxe, CDC
CDC’s Robert Tauxe will be honored by STOP Foodborne Illness at a fundraiser during the 2016 Food Safety Consortium.

STOP Foodborne Illness is honored again this year to be given the opportunity by Food Safety Tech to hold a fundraising event at the Food Safety Consortium on Tuesday, December 6 at 7 p.m. in Schaumburg, Illinois (Chicago area). We are honoring Robert Tauxe, M.D., MPH, deputy director of the CDC’s Division of Foodborne, Waterborne and Environmental Diseases at the National Center for Emerging and Zoonotic Infectious Diseases with the Advancing Science for Food Safety Award; Scott Horsfall, representing The California Leafy Green Marketing Association with the Food Safety Training Award; and Jeff Almer, whose mother died from foodborne illness for the Food Safety Hero award. We will have a silent auction, music and food. This is a time to pause and thank those who have positively influenced our food safety system and we hope you will join us.

STOP Foodborne Illness is a national nonprofit public health organization dedicated to the prevention of illness and death from foodborne pathogens.

  • Advocating for sound public policy
  • Building public awareness
  • Assisting those impacted by foodborne illness
Scott Horsfall Dan Sutton Jeff Almer
Scott Horsfall Dan Sutton Jeff Almer

Last year’s Food Safety Heroes were Nancy Donley, former spokesperson for Safe Tables Our Priority and STOP Foodborne Illness and Frank Yiannas, vice president of food safety at Walmart.

FDA’s Michael Taylor Joins in Honoring Food Safety Heroes

 

Katy Jones, Foodlogiq
FST Soapbox

The Clock is Ticking: Technology to Effectively Manage Recalls

By Katy Jones
3 Comments
Katy Jones, Foodlogiq

It seems there isn’t a day that goes by without a food recall being announced. National brands like General Mills, Kellogg’s and Kraft alone have all experienced major recalls over products contaminated with such hazards as E. coli or undeclared allergens in the last few months. Food recalls are incredibly costly to a company, but can be handled effectively and efficiently with good planning, proper execution and the right technology to back it up.

Fortunately, the food industry is moving in the right direction to encourage better recall management by way of regulations under FSMA. Underscored by these federal mandates, the industry as a whole is moving away from a reactive approach to quality and safety issues within the supply chain, instead adopting a preventative plan of action.

The Multiplier Effect: How One Ingredient Can Lead To Multiple Recalls | Learn more at the 2016 Food Safety Consortium | December 7-8 | Schuamburg, ILRecalls are inevitable in the food industry, and in reality every company has, or will, experience one at some point. What sets a company apart essentially boils down to how they prepare for and react to a recall situation. If a company has done its due diligence to prepare for the inevitable (i.e. putting a recall team in place and implementing the right traceability technology), dealing with a quality or contamination issue can be less painful. Additionally, taking the right preventative steps can ensure a recall situation is proactively handled, rather than leading to a brand’s nightmarish public meltdown.

Getting Beyond “One-up and One-Back”

The industry has relied on a more linear approach to supply chain transparency—the “one-up and one-back” method (OUOB). Knowing where a product has come from one step back in the chain and where it is being sent or sold one step forward is no longer enough. To properly prepare for a recall, and manage product quality, it is imperative that a company employ whole chain traceability software, rather than relying solely on the movement of product within its own four walls.

The OUOB traceability approach is especially dangerous when handling high-risk, perishable foods, like produce or meat—which are often the culprit for recalls. According to a recent study in the Journal of Business Logistics titled, “Tracing Bad Products in Supply Chains” by Kaitlin Wowak, assistant professor of management at Notre Dame, “perishable products, like fresh produce and meats, flow through the supply chain very quickly. And while federal regulations mandate that firms have traceability one step up and down the chain, this may not be sufficient for these perishable products. In those situations, there is often a gap in the information received about the product, say a positive Listeria test, and where that product went in the supply chain.”

Root Cause Analysis is Key

When faced with a recall situation, time is of the essence. The time it takes for the recall team to identify the root cause of an issue and remove it from the supply chain could be the difference between sick consumers and serious brand implications. Being fully cognizant of the entire supply chain via a whole-chain traceability solution allows you to visualize a contaminant’s exact location; this information ultimately helps a brand streamline and manage the issue quickly and effectively.

Wowak’s research profiles a series of recall scenarios. One that was studied found that 50% of the food removed from the supply chain during that recall was actually affected—the other half was perfectly fine. Take the example of a batch of tainted tomatoes in your supply chain. Without being able to identify the root cause at the lot level, a company might be forced to remove all of the tomatoes from its supply chain.

Rather, by utilizing end-to-end traceability software, they can identify the specific farm, pack date and lot from which the produce originated. Tracing that information through each step in the supply chain—hether the tomatoes ended up on a pizza, in a can of salsa, or in a farmer’s market—allows the brand to manage the bad products without disrupting their entire chain or wasting perfectly good produce.

Unfortunately, without the visibility of whole-chain traceability, companies do not have the option to cherry pick tainted vs. untainted food from their chain. This is especially relevant as up to 40% of food in the United States goes to waste, according to the NRDC.1

Centralized Recordkeeping

When faced with a safety or quality issue, communicating information to relevant parties is necessary throughout the process. Especially with FSMA coming into play, if a company experiences a quality issue, they must promptly notify regulatory establishments and be sure to submit documentation and data in an immediate manner for investigative purposes. This can be hindered if a brand does not have a good handle on their supply chain data and must spend hours sorting through file cabinets, emails, or Excel sheets for proper documentation, or coordinating with suppliers for records. The longer it takes to comply with federal regulations and submit data around a recall, the more likely consumers, and the brand, are at risk.

The industry’s shift towards a preventative approach to safety is hitting a milestone as FSMA compliance periods have already taken effect. With this change, the FDA will no longer tolerate poor handling of contamination or quality issues. A company cannot get away with blaming a partner’s lack of transparency, or a supplier’s inconsistent records— the brand is now always accountable. In the coming months, we can anticipate added scrutiny from auditors, more mandatory recalls, even the shutting down of facilities due to noncompliance or negligence around safety concerns.

Having a robust supplier management system in place enables a company to be prepared for a recall situation. With all of your product and supplier data in one place, companies can quickly gather and allocate necessary data like audits and assessments to the appropriate officials, complying with the new required recordkeeping rules. By streamlining the availability of key information, and supporting seamless communication, a brand can be empowered to navigate a quality or safety issue.

As testing across the supply chain increases and the demand for fresh food rises, recalls are not going away. Fortunately, the move to a preventative approach to safety comes at a time where traceability technology is more comprehensive than ever. Food companies have the opportunity to invest in themselves with end-to-end traceability, arming the brand for the inevitable occurrence of a safety or quality issue. By enhancing visibility of the supply chain via an all-encompassing whole-chain platform, it is possible to track a product through each stopover to the consumer, from farm to fork. At the same time, housing all data in one efficient platform can ease the pressure of liaising with supply chain partners and regulatory bodies and streamline communications when faced with a safety situation.

While recalls are an inescapable part of the food industry, what sets a brand apart is how well they prepare and arm themselves with the technology to stay ahead. Implementing supplier management and whole-chain traceability software can help a company stay one step ahead of a recall, which makes all the difference when consumer wellness and brand reputation are on the line.

Reference

  1. Gunders, D. (August 2012). “Wasted: How America Is Losing up to 40 Percent of Its Food from Farm to Fork in Landfill”. NRDC Issue Paper. Retrieved from https://www.nrdc.org/sites/default/files/wasted-food-IP.pdf
Bill Bremer is Principal, Food Safety Compliance at Kestrel Management LLC
FST Soapbox

Post-FSMA Food Safety Inspection: Are You Ready?

By Bill Bremer
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Bill Bremer is Principal, Food Safety Compliance at Kestrel Management LLC

Note: FSMA will include the scheduled compliance inspection as part of the implementation of rules. This will occur in the next several years for many food companies.

With FSMA rules moving to the compliance stage, food companies must prepare appropriately to best respond to the requirements and, correspondingly, to additional inspections. These inspections are in addition to others, including GFSI with its emphasis on unannounced level audits for some schemes. For example, these audits may be required by the code (as with SQF) or as part of customer arrangements per certification contracts.

Learn more about FSMA Inspection Readiness at this year’s Food Safety Consortium in Schaumburg, IL | December 7-8, 2016 | REGISTERWith the growing potential for inspections and audits, a well-planned program and response must be developed, implemented and tested to achieve a most successful outcome. This is an important area to address, especially given the many changes in compliance under FSMA, greater scrutiny under GFSI, and a rapidly changing responsibility for food safety management resources.

For companies experienced with past FDA compliance audits, the new rules and Section 117 cGMPs will require more formalized programs and strong evidence of compliance through internal audits and oversight by Qualified Individuals (QI). The inspectors will look to focus heavily on new requirements and the “letter of the law”. Additionally, organizations under the Preventive Control Rule must have multiple Food Safety Plan QIs, qualified audit resources and competent sanitation management, along with competent plant operators. It is critical to have established roles, planning and testing as part of any inspection readiness program.

Self-Diagnostic Assessment Tool

The following self-diagnostic assessment tool can help organizations better determine their current state of planning when it comes to developing inspection readiness. To complete your own planning assessment, review your progress compared to the questions in Table I.

FSMA Inspection checklist
Table I. Kestrel Management’s self-diagnostic tool can help a company assess its level of inspection readiness and preparedness for FSMA compliance.

Get Compliance-Ready

Companies must have the appropriate plans and resources to comply with FSMA and certifications or face possible violations that can include fines and penalties under FDA enforcement. The questions in Table I will help companies identify areas to consider for Inspection readiness. Kestrel can also help answer questions, provide input on solutions, discuss how to better manage all of your food safety requirements—and change “No” responses into “Yes” responses that promote best practices for FSMA and food safety compliance.

Zia Siddiqi, Orkin
Bug Bytes

From HACCP to HARPC, and Integrating Pest Management

By Zia Siddiqi, Ph.D.
3 Comments
Zia Siddiqi, Orkin

September 19, 2016 is a date that many of you probably had circled on your calendars. It marked the first date in which many food processing companies had to be in compliance with the FSMA preventive controls final rule.

It’s okay if you’re still revising your food safety plan. The regulations are so sweeping that some companies are still struggling to figure out if their plans are in compliance. At the heart of this law is a change in the philosophy of how we deal with contamination. Now, the focus is on preventing contamination rather than responding to it after it occurs.

This proactive approach to safety must be kept in mind when discussing how food safety plan requirements have changed. For many food manufacturing facilities, it means a change from HACCP to HARPC.

Hazard Analysis and Critical Control Points, or HACCP, should be more familiar to you. First developed in the late 1950s and early 1960s to provide safe food for astronauts in the U.S. space program, HACCP became the global standard for food safety in the 1980s, as large, multinational companies sought to ensure that their supply chains were safe.

HACCP evolved over the years into an effective, efficient and comprehensive food safety management approach. The system addresses food safety through the analysis and control of biological, chemical and physical hazards from raw material production, procurement and handling, to manufacturing, distribution and consumption of the finished product.

The seven principles of HACCP include:

  1. Conduct a hazard analysis
  2. Identify critical control points
  3. Set critical limits
  4. Establish monitoring actions
  5. Determine corrective actions
  6. Develop verification procedures
  7. Institute a record-keeping system

How are HACCP and HARPC different?

Following the passage of FSMA, the FDA instituted a new set of food safety standards, known as Hazard Analysis and Risk Based Preventive Controls (HARPC).

HARPC shouldn’t be seen as a replacement of HACCP standards. Rather, it’s an evolution of them. The following are some key changes.

You Must Anticipate Potential Hazards. One of the big changes in moving to HARPC standards is that your food safety plan must identify any and all reasonably foreseeable food safety hazards and include risk-based preventive controls for them. This moves beyond HACCP’s critical control points and asks that food processors look at how to minimize risk from the second food enters their facility to the second it ships out.

This includes naturally occurring hazards as well as hazards that can be intentionally or unintentionally introduced to the facility. The potential hazards that have expanded under HARPC include:

  • Biological, chemical, physical and radiological hazards
  • Natural toxins, pesticides, drug residues, decomposition, parasites, allergens and unapproved food and color additives
  • Naturally occurring hazards or unintentionally introduced hazards
  • Intentionally introduced hazards (including acts of terrorism)

You should review the potential hazards—both seen and unseen—that could impact your facility to determine the risks that you should analyze for your plan.

HARPC Applies to Almost All Food Processing Facilities. The HACCP standards generally did not apply to all food processors. HARPC, however, covers many more U.S. processors. There are six major exceptions, however.

  • Food companies under the exclusive jurisdiction of the USDA
  • Companies subject to the FDA’s new Standards for Produce Safety authorities
  • Facilities that are subject to and comply with FDA’s seafood and juice HACCP regulations
  • Low-acid and acidified canned food processors
  • Companies defined as “small” or “very small” businesses
  • Companies with a previous three-year average product value of less than $500,000

Do these changes mean that your existing food safety plan needs to be scrapped? Not at all. An existing HACCP plan can be modified with the help of a Preventive Control Qualified Individual (another new requirement) to comply with HARPC guidelines. This person needs to be intimately familiar with potential hazards and the risk-based preventive controls for them.

This may sound daunting at first, but moving to HARPC from HACCP will be an easier shift than starting from scratch. The key adjustments that you would need to focus on include identifying risk-based preventive controls for the hazards previously mentioned. Just remember, these hazards should be expanded to include both naturally occurring and unintentionally introduced hazards.

How Does Integrated Pest Management Fit into a Food Safety Plan?

Much like HARPC, Integrated Pest Management (IPM) focuses on being proactive. It emphasizes prevention, focusing on facility maintenance and sanitation, before considering chemical options for pest management.

An IPM plan is benchmarked with regular monitoring and analysis of effectiveness. This may seem cumbersome, but one shouldn’t overlook the value of documentation as a management tool. Collecting data and putting it in context with detailed analysis can be an effective way to prioritize your pest control efforts.

Detailed analysis accounts for things such as normal seasonal cycles, deficiencies in maintenance, exclusion, sanitation and harborages, just to name a few. This analysis can also help improve pest control efforts by prioritizing areas needing attention, especially when your staff is limited by time or resources.

Integrating IPM into your HARPC plan should include analyzing the risks of what could encourage pests to enter your facility, such as doors left open or incoming product shipments. Consider your pest control provider an expert source in how to assess all risks associated with pests and how to establish preventive controls for them.

Despite preventative efforts, unexpected pests will be inevitable. More emphasis will be placed on establishing action thresholds for different pests. This can be a problematic topic, because there are not scientific or broadly accepted threshold values for food processing pests.

Every facility, and often zones within facilities, will likely be different. Identify logical zones—ingredients, processing, packaging and warehousing—and sensible threshold values for each key pest in these zones. Furthermore, establish what the appropriate response should be at certain thresholds. The escalating responses to different levels of pest activity often include things such as automatic authority for certain limited types of pesticide application, more intensive monitoring and inspection, and, of course, higher management notifications, which might lead to more extensive measures.

IPM plans should be reviewed on an annual basis to ensure your program remains as effective as possible. Written food safety plans that follow the HARPC approach and comply with the FSMA rule should be reanalyzed whenever there is a significant change at the facility that might increase a known hazard or introduce a new one. Review the plan at least every three years, if no significant changes occur.

Even if your facility’s deadline for compliance with HARPC standards is a year or two away, now is the time to take a look at your plan and make sure you’re in compliance.

Bill Bremer is Principal, Food Safety Compliance at Kestrel Management LLC
FST Soapbox

Qualified Food Plant Safety Individuals

By Bill Bremer
3 Comments
Bill Bremer is Principal, Food Safety Compliance at Kestrel Management LLC

The new requirements under Section 117 cGMPs of FSMA mandate that a “Qualified Individual” oversee the hazard analysis, preventive control process and Food Safety Plan. The expectation is that a plant operator designates qualified resources who are adequately represented during all food processing and handling at registered sites. In addition, the Qualified Individual stipulation requires that the organization provide resources to maintain the company’s GMP program and food safe processing, and to oversee key regulatory activities.

Learn more about FSMA compliance at this year’s Food Safety Consortium in Schaumburg, IL | December 7-8, 2016

Qualified or Competent Individual under FSMA Hazard Analysis and Risk-Based Preventive Controls

The organization must provide Qualified Individuals in all areas to ensure the food safety of product processing, production and distribution. The key roles under “Qualified Individual” are described under Subpart C Section 117.126. This statute requires that the food safety system and plan requirements must be overseen by Qualified Individuals. This includes development of a Food Safety Plan—prepared, or its preparation overseen, by one or more preventive controls Qualified Individuals. Additionally, the statute, as described in cGMPs, indicates that experience, education, certification and other qualifications are appropriate for companies to determine Qualified Individuals.

Other FSMA requirements under Section 117 include the following (as summarized and aligned for specific cases):

  • 117.160(b) (1) Validate that preventive controls required under 117.135 are adequate to control hazards in the facility’s Food Safety System prior to development of the Food Safety Plan by Qualified Individual, or:
    • 117.160 (b) (2) validation of preventive controls within 90 days or a reasonable timeframe after production of applicable food begins by Qualified Individual.
    • 117.160 (c) food not applicable based on factors such as the nature of the hazard (including allergen, sanitation controls, recall plan, supply chain program or determined non-applicable hazards), as determined by Qualified Individual.
  • 117.165 (a) (4) As appropriate to the facility and its role in the Food Safety System, review records that are effective and make decisions about corrective actions by a Qualified Individual.
    • 117. 165 (a) (4) (i) Maintain records of monitoring and corrective actions within seven working days after the records are created by Qualified Individual.
  • 117.170 (c) (2) (ii) Reanalysis by the Qualified Individual every three years for the written justification of the Food Safety Plan exceeding 90 days after production of applicable food.
    • 117.170 (c) (2) (e) Preventive controls Qualified Individual must perform (or oversee) the reanalysis.
  • 117.180 Requirements applicable to a preventive controls Qualified Individual and Qualified Auditor are described in this section with the introduction of the Qualified Auditor-level resource.
  • 117.180 (a) One or more preventive controls Qualified Individuals must do or oversee:
    • Preparation of the Food Safety Plan
    • Validation of preventive controls
    • Written justification for validation that exceeds the first 90 days of production.
  • 117.180 (a) General processes and controls.
    • Overall sanitation of the plant must be under the supervision of one or more Competent Individuals assigned responsibility for this function.
  • 117.190 Implementation records required for this subpart.
    • Records that document applicable training for preventive controls Qualified Individual and Auditor.

These requirements under FSMA list the necessity of multiple Qualified Individuals, Qualified Auditors, and Competent Individuals for sanitation. Accordingly, all management and personnel must know, understand and be trained for the food safety aspects of their jobs.

Self-Diagnostic Assessment Tool

The following self-diagnostic assessment tool can help organizations better determine their current state of planning when it comes to determining and deploying the various Qualified Individuals in meeting FSMA. To complete your own planning assessment, review your progress compared to the questions below.

Food Safety Plan, Qualified Individuals, Checklist
Table I. Kestrel Management’s self-diagnostic tool can help a company assess its level of Food Safety System and Plan preparedness for FSMA compliance for the Qualified Individuals and personnel necessary to meet FSMA requirements.

Get Compliance-Ready

Companies must have the appropriate resources to comply with FSMA or face possible violations, fines and penalties under FDA enforcement. The questions in Table I will help companies identify the areas in which they need to focus attention. Kestrel can also help answer questions, provide input on solutions, discuss how to better manage GFSI certification—and change “No” responses into “Yes” responses that promote best practices for FSMA compliance.

FSMA Preventive Controls: Are You Prepared?

Get the checklist to assess your company’s readiness level. It’s a crucial part of the compliance process.
Randy Fields, Repositrak
FST Soapbox

Food Safety Collaboration across the Value Chain

By Randy Fields
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Randy Fields, Repositrak

FSMA is the law of the land and the FDA is starting to enforce compliance, so now is the right time to discuss what’s working and what isn’t in terms of trading partner collaboration. Just how are companies successfully coordinating the movement of goods from the point of production and processing to the American consumer and ensuring food safety throughout the value chain?

Risk reduction continues to be the focus of collaboration between trading partners, with the understanding that failing to meet compliance requirements can mean big fines for companies and jail time for executives. We’ve seen a marked increase on this topic in the sessions at trade shows and conferences, and the number of webinars and other educational opportunities has soared during the past year. Most importantly, the number of meetings continues to increase between retailers, suppliers and carriers where the discussion of food safety compliance and risk reduction is high on the agenda.

Eliminating risk is always top of mind for a company’s lawyers and accountants, but recent issues have caused other company functions to increase their collaboration with contacts at trading partner companies. On the retail side, merchandisers are holding vendors accountable for compliance and requiring food safety documents for new suppliers at signup. Purchasing is reconfiguring the purchasing process to suspend or stop PO generation and payment if a supplier is out of compliance. And, store operators are alerted to potential safety concerns, so they can act expediently on behalf of their consumers.

For suppliers, sales teams are getting necessary training on food safety, and they are using this knowledge to engage customers and protect their brand equity with consumers. Their supply chain and IT managers are also managing to the new FSMA normal of managing dozens of new documents and present written records in accordance with the 24-hour requirement. For their part, transportation companies are working to meet new FSMA requirements that demand assurance in writing that food was transported under proper sanitary conditions.

What’s Driving This Collaboration?

Similar to Sarbanes-Oxley, CEOs are responsible for verifying the compliance of their supply chain under FSMA. Given these risks, companies have started to automate their management of compliance documentation. Forward-thinking companies are even moving beyond compliance document management and are applying the same technology to ensure that important product information like gluten-free items and allergen-related declarations are properly documented.

Collaboration is supported in today’s environment by technology, which saves companies both time and money by leveraging automation to ensure the accuracy of documents (e.g., indemnifications and insurance), providing executives with information on which to make better business partner decisions.

Collaboration is a critical cog in the wheel of the value chain that helps provide the consumer with a safer food supply while reducing both brand risk to suppliers and retailers and health risk to all. The industry needs to strengthen its working relationships to ensure this effort continues without constraints.

Deirdre Schlunegger, STOP Foodborne Illness
Food Safety Culture Club

Ten Years and Counting: Advocating Change

By Deirdre Schlunegger
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Deirdre Schlunegger, STOP Foodborne Illness

According to the CDC, people from 26 states were reported to have E. coli O157:H7 from fresh spinach: This month marks 10 years since this outbreak wreaked havoc on the lives of 205 confirmed persons, three of whom lost their lives. Something in the system, and the process, definitely needed to be fixed. A sea change was in order.

At the 2016 Food Safety Consortium, STOP Foodborne Illness will have a fundraiser to honor heroes in food safety. |December  6, 2016, 7–9 pm | LEARN MOREAmong those whose lives were irrevocably changed was Rylee Gustafson, a young woman whom STOP Foodborne Illness considers not only a friend and constituent, but also a powerful advocate for change. She was 9 years old when she volunteered to choose what her family was going to eat that day. She chose spinach, and what should have been an insignificant event—dinner with her family—became a monumental force in her life. Rylee was knocked down, but she got back up and has been telling her story, changing people’s lives, and enlightening government and industry decision-makers ever since. Subsequently, Rylee has influenced the life of every American.

Thanks to the hard work of advocates like Rylee, the question of how to create a food safety culture has been making its way into the consciousness of America. In October, STOP Foodborne Illness will be hosting a webinar addressing the very question of creating and sustaining a food safety culture. “Food safety culture” has become a buzz word in the industry. but what steps can be taken to strategically ensure that it not only happens, but that it thrives?

Together with Frank Yiannas, vice president of food safety for Walmart, Mike Taylor, senior fellow at Freedman Consulting, and Steve Schluneger, principal of Intrinsic Leadership, I will present and answer these questions and more during this webinar.

Thanks to the generosity and technical prowess of Food Safety Tech, and our esteemed guests, this event is sure to be a powerful and enlightening discussion.

The webinar is titled, Food Safety Culture: We Know Why, Let’s Talk About How. It takes place from 1-2 pm CST on October 11, 2016. The cost of registration before October 4 is $129. Register here.

Please join us!