Tag Archives: FSMA

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

Part II: FSMA IQ Test

By Food Safety Tech Staff
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More than 400 people took Part I of the FSMA IQ Test. Read on for the results, and then take Part II of the FSMA IQ test (results of which will be posted next week).

Part I

  1. FSMA requires all records for the reevaluation of cGMPs every three years. FALSE
    • Only 31.8% got it right
  2. Implementation records are required for every FSMA requirement. TRUE
    • 77% answered correctly
  3. Plant borders not under the operator’s controls are not included within cGMPs. FALSE
    • 81% answered FALSE
  4. Under some circumstances, FSMA requires that conformance of a customer’s control of a hazard is required. TRUE
    • 85% got it right
  5. Under FSMA cGMPs, you must be able to identify at least 95% all possible contaminated product. FALSE
    • Results were almost split: 48% answered TRUE; 52% answered FALSE
  6. Monitoring of frequency of preventive controls must be conducted by the operation as part of the food safety plan. TRUE
    • 95% answered correctly.

Part II

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Joann Givens, FDA

What to Expect Now that the First Big FSMA Compliance Dates Are Here

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Joann Givens, FDA

The first major compliance dates have arrived for the preventive controls rules for human and animal food under the FDA Food Safety Modernization Act (FSMA). Some members of the food industry have expressed concern and uncertainty about enforcement measures that may accompany September 19, 2016. That’s the date when larger businesses must comply with certain new standards. Human food facilities must meet preventive controls and Current Good Manufacturing Practice requirements (CGMPs); animal food facilities must meet CGMPs. (The larger animal food businesses have an additional year to meet the preventive controls standards.)

Joann Givens, co-chair of the FSMA Operations Team Steering Committee and director of FDA’s Food and Feed Program in the Office of Regulatory Affairs, addresses questions that have been raised about what the next few months will look like for human food facilities required to comply with the CGMP and preventive controls requirements and animal food facilities required to comply with the CGMP requirements.

What happens next in terms of FDA enforcement of these new standards?
We know that this is new territory for food companies; it’s new territory for us too. For years we’ve been talking about the FSMA rulemakings and our implementation plans. Now, an important compliance date is here for some companies. As we enter this new chapter, the FDA’s primary focus will continue to be on education, training and technical assistance to help companies comply with the new requirements.

A top priority for FDA is providing the framework for industry’s implementation of preventive controls and CGMP requirements. We recently issued draft guidance documents that provide more detail on how to comply with the new standards, and there are more guidances to come, about two dozen planned over the next few years. We intend to continue this dialogue and collaboration with regulated industry to ensure that everyone understands and engages in their respective roles in food safety.

This first year of compliance will affect the larger businesses, generally those with 500 or more employees. Many businesses of that size already have a HACCP (Hazard Analysis and Critical Control Points) program; we don’t expect them to need to make many changes to come into compliance. Aspects of the CGMP and preventive controls rules are similar to HACCP, a food safety system that started with industry. (The human and animal food rules have staggered compliance dates; smaller businesses have a year or more additional time to comply.)

Does the focus on education mean that companies won’t really be held to these standards yet?
No. The FDA’s mandate is to protect public health and, when necessary, the agency will act swiftly. But keep in mind that our primary goal, not just in the first months but going forward, is to work with the food industry to create a culture of food safety, a culture of compliance with procedures, processes, and practices that we know will minimize the risk of serious illness or death.

What is the best thing covered food facilities can be doing now?
The best thing that people in the food industry can do is take the measures required by the new rules – not just the letter of the law but what it represents in terms of transforming the food safety system. They should look at the big picture, at areas in which they could be vulnerable and proactively take action. Promptly responding to problems, even if they aren’t yet violations, can prevent them from getting to the point at which there is a concern about the safety of the food.

In addition, facilities should set up a thorough system for documenting what they do. The better the records, the more a company can demonstrate that it is meeting the legal standard. Put processes and procedures in place to prevent problems in the first place, and consider having some redundancy in the system so that if one measure fails, another can take its place.

If there is a problem, state or federal investigators will ask questions like: When problems came to your attention, what did you do? Were you proactive in looking for the problems in the first place? If you could not find a solution, did you get the right expertise? Did you educate your employees?

Where can companies go wrong?
A company’s approach should not be: “The government was here and did our inspection. We’re safe for X amount of time.” Rather we want facilities to be confident that if FDA or the state walks in tomorrow, they’ll be able to demonstrate what they’re doing to meet the new food safety requirements.

And it really is up to the management of a company to create that culture by attending to the facility and its production processes and making sure that everyone in the production chain understands what is expected and has the training and education they need to get the job done.

What is the ultimate goal?
The purpose of these rules is to create a preventive, food safety system that is self-sustaining. Everybody in a food facility should be systematically operating in a way that complies with the law.

The preventive controls requirements fulfill the paradigm shift toward prevention that was envisioned in FSMA and, in combination with CGMPs, will help protect consumers into the future.

We want to see people doing the best they can. It’s a marathon, not a sprint. They’re learning; we’re learning. We are very committed to educating while we regulate to align understanding and expectations.

This article has been republished with permission from FDA. The original version can be viewed on FDA’s website.

Katy Jones, Foodlogiq
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The Clock is Ticking: Technology to Effectively Manage Recalls

By Katy Jones
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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
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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.
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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.

Allergens

Allergen Management: Best Practices For Food Manufacturers

By Evan Rosen
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Allergens

Allergenic foods are a serious safety risk. While harmless to most of the consumer population, they are harmful and even life threatening to some, causing serious medical reactions, such as anaphylactic shock, when foods with the allergenic protein are consumed. Scientific research and legislation have helped us understand a great deal about managing these food allergens in manufacturing. Yet so much more needs to be done in making these risks safer for the growing allergic population. In 2013, the CDC reported that food allergies among children increased by half from 1997 to 2011. As these numbers continue to rise for children and adults alike, what are the best practices for food manufacturers to include in managing food allergens? Here’s what you need to know.

Evan Rosen is participating as a panelist in the session “Rubber Meets the Road: Practical Compliance with FSMA and Preventive Controls” at the 2016 Food Safety Consortium. The session will be moderated by Rajan Gupta and Dana Johnson Downing of TraceGains | LEARN MOREResearch and Development for Allergen Programs

Thorough development and foresight are essential for any food manufacturer to succeed when implementing an allergen program in its processing. It is wise for food manufacturers to select the individuals in their company who are a good fit to lead the allergen program. When developing your program, create an “allergen map” to understand where allergenic ingredients are located in your plant and how they travel while products are processed.

The R&D stage is the optimal time to plan every step of the allergen management process—from supplier sourcing to cross contact in processing, to labeling and every step in between—before the risks are actually encountered. This is in line with the new preventive controls approach to be taken with FSMA’s Food Safety Plan model.

Purchasing, Labeling and Storing Ingredients

When purchasing ingredients from suppliers, your supply sources should be just as stringent about allergen management as you are in order to reduce liability. Require your suppliers to have an allergen map of their own and lettered documentation declaring that the items you are purchasing are free from contact with food allergens. The FDA food label law currently recognizes the top eight food allergens as:

  • Peanuts,Tree nuts—including almonds, walnuts and hazelnuts, among others
  • Milk (not to be confused with lactose intolerance)
  • Eggs
  • Wheat
  • Soy
  • Fish
  • Crustacean shellfish (crab, lobster, crawfish, etc.)

Also, be mindful of allergens that apply to the country of export, such as Sesame Seeds, Sulfites and Mustard Seed in Canada.

When receiving and storing supplier ingredients, check the labeled contents for any updates and tag the units that contain allergens so they can be easily identified and stored separately. A pictorial system is very effective. Ensure that each unit is tightly sealed, as even slight amounts of leaked allergens can pose recalls and elevated risks to your consumers.

Processing and Cleaning Cross-Contamination

Human error is only one factor that predisposes risk of cross-contact; production timing, processing lines, facility traffic, protein structure (e.g. powder, liquid, paste) and even the type of equipment used can be a game changer when it comes to the proper handling of allergens. In order to prevent allergen cross contact, scheduling long lines of products with common allergens is recommended to minimize changeovers. Dedicate unique tools, utensils and equipment that will handle the allergen if possible, as every piece contacting an allergen must be washed before handling allergen-free processing.

Assign plant employees to specific locations to avoid risk of cross-contact travel—color coding uniforms helps a great deal in managing this concept. Manufacturing equipment that is designed for easy cleaning is also ideal. For cleaning procedure of cross-contact removal, wet cleaning methods are most effective followed by dry methods. These procedures should be validated using a recognized protein-specific test method such as lateral flow or ELISA. When flushing, be sure to keep the flushed material isolated from all allergen-free areas. Careful separation and mindfulness is key to a successful allergen program.

Staff Training and Education

In order for any allergen program to be effective, all plant, production staff, contractors and visitors must be aware of the importance of it and understand the impact it has on consumers. Incorporating different learning methods helps to communicate this to them. Occasional testing and validation of applying this knowledge ensures the integrity of your allergy-free claims and establishes trust. Passion and commitment also play a vital role in achieving success in your program as a whole.

From purchasing ingredients to staff education and cross-contact prevention, one can see that plenty of work and forethought goes into having an allergen management program. With these best practices in place, food manufacturers can be well prepared for the increasing demand of allergen safe products for consumers across national and international markets.

FSMA, Food Safety Tech, FDA

FDA Sheds Light on FSMA’s Preventive Controls

By Food Safety Tech Staff
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FSMA, Food Safety Tech, FDA

Today, September 19, marks the first major FSMA compliance date. Larger companies (500 employees or more) must meet certain requirements of the Preventive Controls for Human Food final rule related to current good manufacturing practice requirements. In anticipation of the questions surrounding these requirements, FDA has released a Q&A with Joann Givens, co-chair of the FSMA Operations Team Steering Committee and director of the agency’s Food and Feed Program in the Office of Regulatory Affairs.

“We know that this is new territory for food companies; it’s new territory for us too. For years we’ve been talking about the FSMA rulemakings and our implementation plans,” says FDA’s Joanna Givens. “Now, an important compliance date is here for some companies. As we enter this new chapter, the FDA’s primary focus will continue to be on education, training and technical assistance to help companies comply with the new requirements.”

8 Food Industry Trends Fueled by FSMA

By Lori Carlson
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FSMA is fostering a surge in technology solutions, analytical tools and training products marketed to the food industry in the name of achieving FSMA compliance. And while many of these products were available pre-FSMA (especially in other industries like the life sciences), FSMA’s momentum has fueled the adaptation of solutions to meet the specific needs of the food industry for achieving and maintaining regulatory compliance. This article is a summary of emerging trends in food safety management by producers, manufacturers, distributors and retailers through the application of technology, educational tools, monitoring and detection systems, and other support mechanisms.

Want to learn more about FSMA trends and compliance? Attend the 2016 Food Safety Consortium in Schaumburg, IL | December 7–8 | LEARN MOREWhether by the spark of FSMA or because it makes practical sense (and most likely, a bit of both), businesses are integrating their food safety programs with enterprise initiatives and systems for managing compliance and risk to achieve increased visibility and harmonization across the organization.  The most popular trends fueled by FSMA largely reflect technology solutions to achieve this integration.

Subsequently, solutions that support risk assessment, supply chain management, real-time monitoring, corrective action, self-assessment, traceability, and training management are most attractive and lucrative from an ROI perspective. And while it may be hard to find a one-size-fits-all technology solution depending upon the needs of the organization, technology service providers are quickly raising the bar to meet these growing needs as organizations strive to reduce risk and increase compliance. Other top trends at the periphery of technology solutions include the mobilization of food safety personnel and increased availability of on-demand training and detection tools to bring the FSMA movement full circle.

1. Software-as-a-service (SaaS) technology solutions quickly gained a following in the food industry in recent years to achieve an automated food safety and quality management system (FSQMS) solution.

The substantial management components and recordkeeping requirements of the FSMA rules has accelerated the food industry’s need for automated solutions to document program management, queue workflows and distribute notifications for corrective and preventive action (CAPA). Understanding this need, many SaaS providers evolved with FSMA to provide functionality that dovetails with new regulatory requirements.

2. Increased availability of risk and vulnerability assessment tools is of significant importance in meeting many requirements of FSMA’s rules.

The regulatory language of all FSMA rules is steeped in risk analysis to support the prevention of food safety hazards and threats. This creates a demand for user-friendly tools and training courses to help food businesses analyze and update their management systems within the context of these new requirements. Risk and vulnerability assessment tools currently available to the food industry are diverse in functionality and vary in scope and cost.

For example, FDA’s free online tool, FDA-iRISK 2.0, assesses chemical and microbiological hazards in foods through process models, which quantify risk across scenarios and predict the effectiveness of control strategies.  Commercially available food hazard assessment tools based on HACCP/ HARPC principles include Safefood 360° and EtQ, which provide risk assessment modules as a part of their SaaS platform.

Universities, trade associations, and commercial risk management and consulting firms came together to produce two very different food fraud vulnerability tools to support the industry. SSAFE by the University of Wageningen RIKILT, Vrije Universiteit Amsterdam and PricewaterhouseCoopers (PwC) is a free online tool and mobile app, which guides users through a decision tree and assessment questionnaire to determine fraud opportunities, motivators and gaps in existing controls. EMAlert by the Grocery Manufacturers Association (GMA) and Battelle is a subscription-based online tool to assess vulnerability from economically motivated adulterants (EMA’s). Individuals conducting vulnerability assessments are recommended to periodically access food risk databases such as the U.S. Pharmacopeial Convention’s (USP) food fraud database to stay informed of historical and emerging threats to the supply chain.

And in support of FSMA’s Food Defense rule, the FDA developed a free food defense software tool, Food Defense Plan Builder (FDPB), to help food businesses identify vulnerability to intentional adulterants and terrorist attacks on the food supply chain.

3. SaaS platforms, app-friendly assessment tools and FSMA recordkeeping requirements are creating a natural pathway for the increased use of mobile devices and electronic recordkeeping and verification.

From supply chain management to effective traceability to regulatory compliance, efficient document management and on-demand data retrieval is a must have of the modern FSQMS. Food businesses recognize the inherent obstacles of paper-based systems and increasingly trend towards rugged mobile devices and electronic recordkeeping to make better use of personnel resources, technology solutions and data. FSMA is helping leverage this trend two-fold through increased requirements for documentation and verification of food safety management activities and by not requiring electronic records to additionally meet the provisions of 21 CFR part 11 (electronic recordkeeping).

4. An increased demand for more effective, frequent and accessible training must be met across an organization to maintain an adequately trained workforce responsible for implementing FSMA.

To keep up with this demand—as well as the training demand imparted by GFSI schemes and fact that a company’s FSQMS is only as good as those who develop and operate it—food businesses are turning to online and blended learning courses to increase training frequency and effectiveness. In Campden BRI’s 2016 Global Food Safety Training Survey, 70% of food processors and manufacturers responded that they received training deficiencies during audits as the result of a lack of refresher training and/or lack of employee understanding.

In an effort to help close this gap and meet new implementation requirements of FSMA, food safety training providers are increasing offerings of eLearning courses, which provide targeted content in shorter duration to meet users’ needs in an interactive (and often multilingual) format. Shorter and more frequent targeted training is proven to increase knowledge retention and job performance. E-Learning training solutions can be found through dedicated training service providers as well as universities, trade associations, regulatory agencies, scheme owners, certification bodies, and other compliance organizations.

Depending upon the training provider, online training may be distributed through a learning management system (LMS) to provide additional training tools, assess training effectiveness and manage the training activities and competencies of all participants.

5. Targeted monitoring and verification activities such as product testing, environmental monitoring or water quality testing are helping to increase the demand for pathogen testing and push the frontier of improved rapid pathogen detection methods.

In a recent Food Safety Tech article, Strategic Consulting, Inc. noted more than a 13% annual increase in pathogen testing by contract food laboratories as determined by a recent industry study conducted by the group. The study additionally identified turn-around-time as the second most important factor for suppliers when choosing a contract lab. Increased access to rapid pathogen testing—and in particular, detection without time-dependent cultural enrichment—are primary needs of food businesses as regulators and customers push for enhanced monitoring and verification via testing mechanisms.

Currently, there are numerous rapid methods based on DNA, immunological or biosensor techniques. These methods can detect foodborne pathogens in relatively short amounts of time ranging from a few minutes to a few hours. But they often require pre-processing strategies to reduce matrix interference or concentrate pathogens to meet the level of detection (LOD) of the assay.1 These strategies increase the overall time of the assay and are largely the next hurdle for improved rapid detection.

6.  Food businesses are experiencing a wave of self-assessment followed by CAPA as organizations work to analyze and update their food safety systems and protocols within the context of applicable FSMA rules.

This trend has the potential to be the most beneficial to the supply chain and consumers as it provides a distinct opportunity for food businesses to reconsider previously overlooked hazards and vulnerabilities and upgrade food safety controls along with the management system. Seeing the FSQMS with fresh eyes—outside of the framework of a familiar standard—can lead to significant improvements in food safety management, product safety and quality, and even operational efficiency.

7.  For many food businesses, heightened regulation has spurned the need for dedicated staff to support compliance efforts.

Many food businesses are subject to multiple rules—some of which require a dedicated individual such as the Preventive Controls Qualified Individual (PCQI) to assume responsibility for the implementation of various provisions. And food businesses are not exempt from the acute need for qualified individuals with a food safety skill set. Across the industry, from service providers to retailers and everyone in between or at the fringe, executives understand that it takes tireless leadership and knowledgeable staff to produce safe food.

8. More than any other trend, communication on FSMA, food safety and related topics is easily the most prevalent exhibiting exponential activity over the past five years.

Whether in support or contention with the proposed (now final) rules, FSMA promulgates constant dialogue about food safety, what it means and how it should be implemented. The constant flurry of communication provides both benefits and deterrents to understanding the new regulations and identifying effective solutions for compliance. This dichotomy creates a significant need for authoritative and easy-to-understand information from consolidated sources within the industry such as trade associations, risk management organizations and food safety schemes. The divide has also helped fuel the need for information hubs like the Global Food Safety Resource (GFSR) that aggregate critical regulatory information, food safety solutions and best practices to reach a global community.

Reference

  1. Wang, Y. and Salazar, J.K. Culture-Independent Rapid Detection Methods for Bacterial Pathogens and Toxins in Food Matrices. Comprehensive Reviews in Food Science and Food Safety. 2016; 15(1): 183-205.
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.