Tag Archives: compliance

Randy Fields, Repositrak
FST Soapbox

Technology’s Role In The Future Of Food Safety

By Randy Fields
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Randy Fields, Repositrak

As we have all read in the media, when a food safety emergency occurs, a company’s reputation stands to take a significant hit that may be unrecoverable. This phenomenon isn’t going away soon, nor are compliance requirements that pose a threat to the personal freedom of executives. If these aren’t enough reasons to get busy automating your food safety programs, read on.

Randy Fields will be speaking as part of a panel of experts during the Food Safety: Past, Present & Future Plenary Session during the Food Safety Consortium, November 29th at 4:00pm.

The trends toward social and health-related product claims, like organic, the ‘free-froms’ and locally-grown, have had the impact of adding dozens if not hundreds of new suppliers to a retailer’s procurement list. And, it’s important to note, that these generally smaller suppliers are just now approaching their compliance deadlines for FSMA, and if they are very small, still have another year. New trends appear every year, and they will compound the challenge for retailers and wholesalers of knowing exactly who all of their suppliers are, which in turn will worsen compliance issues.

Our studies show that at least 12% of documents that certify organic, ‘free-froms’ and other product label claims have some level of discrepancy or inaccuracy making them invalid, and rendering the systems that rely on vendor self-disclosure near useless. With sales expected to skyrocket within these categories during the next few years, companies need to leverage technology to protect the supply chain, and consider having the system hold purchase orders generated for vendors who are not compliant with requirements.

An alternative is to have the system add a compliance fee to the purchase order that escalates over time or swiftly replace suppliers if they are not willing or not able to comply. That also speeds compliance as news travels quickly if there is a hard-hitting consequence for non-compliance. Either way, it’s important to be able to substantiate any claims to the consumer, since if those assertions are deemed unreliable, retailers and their suppliers risk a breach in consumer confidence and will suffer economically when shoppers turn away from them at the shelf.

And while retailers and wholesalers have begun to turn the Titanic on regulatory and business compliance, they need to continue to diligently find the risks in their supply chain, working even more aggressively to automate their current food safety and quality programs using new technology and procedures. Otherwise, their reputation and their existence are in jeopardy.

Cloud-based compliance management solutions that help retailers, wholesalers and suppliers meet the new food safety requirements can be configured to manage documentation requirements by supplier type vs. requiring the same documents from all suppliers. These systems also go beyond just storing digital copies of documents, and actually manage any form of compliance by reading inside the document to confirm it meets requirements. The benefits of these compliance management tools extend to streamlining new vendor approvals, which can save time and enable the redeployment of resources to more productive business-building activities.

Make no mistake: business and regulatory compliance will continue to be a focal point in the future. This includes addressing potential safety, certification and quality challenges throughout the extended supply chain as nearly one-third of all recalls are due to ingredient suppliers. We believe that in less than three years, retailers will require supply chain visibility from the shelf all the way back to “dirt”. It’s been proven too risky not to have that kind of visibility for ultimately everyone’s customer – the consumer. And now technology companies are on the hook to deliver it.

FoodSafetyTech's Food Safety Training Calendar

FoodSafetyTech Introduces The Food Safety Training Calendar

By Food Safety Tech Staff
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FoodSafetyTech's Food Safety Training Calendar

FoodSafetyTech introduces the industry’s only Food Safety Training Calendar. This calendar is a comprehensive, user-friendly tool that will become invaluable for food industry professionals searching for training courses.

“The calendar is searchable by region, date and category,” says Rick Biros, President of Innovative Publishing Group. “Our primary reason to bring this to the marketplace is to help companies with the daunting task of finding training courses that meet specific criteria, such as the location, topic or timing.”

Calendar categories include:

  • Food Fraud & Food Defense
  • FSMA | PCQI | FSPCA | FSVP
  • GFSI Standards (BRC, FSSC 22000, SQF)
  • General Food Safety
  • Food Science
  • ISO Standards
  • Good Manufacturing Practices
  • HACCP | HARPC
  • Retail & Hospitality
  • Sanitation | Hygiene | Cleaning

Visit the calendar today at www.foodsafetytech.com/trainingcalendar.

If your organization is interested in listing courses in the calendar, please contact Marc Spector at 516-270-5344 or mspector@innovativepublishing.net.

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

FSMA Checklist: Sanitary Transportation of Human and Animal Food Rule

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

The FSMA rule on Sanitary Transportation of Human and Animal Food is now final, advancing FDA’s efforts to protect foods from farm to table by keeping them safe from contamination during transportation. Sanitary Transportation is one of seven foundational rules proposed under FSMA since January 2011 to create a modern, risk-based framework for food safety. The goal of this rule is to prevent practices during transportation that create food safety risks, such as failure to properly refrigerate food, inadequate cleaning of vehicles between loads, and failure to properly protect food.

How much do you know about the Sanitary Transportation Rule? Test your smarts by taking the FSMA IQ Test hereSpecifically, the Sanitary Transportation rule establishes requirements for vehicles and transportation equipment, transportation operations, records, training, and waivers. It applies to shippers, receivers, loaders and carriers who transport food in the United States by motor or rail vehicles. Additionally, it impacts shippers in other countries who ship food to the United States directly by motor or rail vehicle (from Canada or Mexico) or by ship or air, and arrange for the transfer of the intact container onto a motor or rail vehicle for transportation within the United States, if that food will be consumed or distributed in the United States. These requirements took effect April 2017 for shippers, carriers and receivers subject to the rule.

As the FSMA rules move to enforcement status, food companies must prepare to best respond to requirements and to develop programs for compliance, including Sanitary Transportation. This requires companies to document specific verification steps to satisfy regulations and meet food safety transportation requirements.

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 Sanitary Transportation Requirements. To complete your own assessment, review and compare your programs to the questions in Table I.

FSMA Sanitary Transportation rule
Table I. Kestrel Management’s self-diagnostic tool can help a company assess its Sanitary Transportation of Human and Animal Foods programs, as required under FSMA compliance.

Get Compliance-Ready

Companies must have the appropriate systems in place to comply with FSMA Sanitary Transportation of Human and Animal Food requirements 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 Sanitary Transportation programs. Kestrel can also help answer questions, provide input on solutions, discuss how to better manage all your food safety requirements, and change “No” responses into “Yes” responses that promote best practices for FSMA and food safety compliance.

Robert Rogers
FST Soapbox

Validating Your Foreign Material Inspection System

By Robert Rogers
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Robert Rogers

The Food Safety Modernization Act (FSMA) requires that food manufacturing and processing companies identify potential hazards within their production systems and then:

  • Put in place preventive controls to address those hazards,
  • Monitor those preventive controls to ensure their effectiveness &
  • Provide documentation proving compliance with these requirements.

There are also requirements for each company to develop and establish its own plan identifying potential food safety hazards and preventive controls to counter them, and to establish the monitoring procedures that will verify the efficacy and reliability of the preventive controls.

Validating, verifying and monitoring the performance of the systems that ensure that only safe food enters the market enables food manufacturers and processors to meet the specific regulatory standards mandated by the countries where they operate and sell. This enables them to avoid product recalls that are costly and that severely damage brand identity. But these processes, in addition to satisfying regulators, also play a valuable part in protecting the companies from potential liability lawsuits, which can often be even more damaging.

The preventive controls most often used to effectively deal with such identified hazards are inspection systems (checkweighers and metal detection, X-ray and machine vision inspection systems) that quickly and efficiently detect non-standard and contaminated products and defective packaging and reject them from production lines before they can enter the marketplace. The performance of these systems must be validated, verified and monitored on an ongoing basis to ensure that they are performing as intended.

These terms–validation, verification and monitoring–are often used interchangeably, creating confusion within organizations and across industries because people interpret and use these terms in different ways. In fact, each term identifies a distinct process that has a clear purpose and role to play at different points throughout the equipment lifecycle. It is important to understand the purpose of each process to make sure that validation, verification and routine performance monitoring tests are performed to comply with regulatory requirements, particularly where the equipment is designated as a Critical Control Point (CCP).

Validation

The fundamental act of “validation,” when applied to inspection systems that are part of a food manufacturing or processing production line, is conducting an objective, data-based confirmation that the system does what it was designed, manufactured and installed to do. The International Featured Standards (IFS) organization defines validation as “confirmation through the provision of objective evidences, that the requirements for the specific intended use or application have been fulfilled.” In 2008, the Codex Alimentarius Commission defined validation as, “Obtaining evidence that a control measure or combination of control measures, if properly implemented, is capable of controlling the hazard to a specified outcome.” An important part of the validation procedure is the production of detailed data that demonstrates to line managers and to regulators that the system is operating as designed.

The manufacturer of each inspection system will validate its performance before delivery, testing it with generic products and packaging similar to what the customer will be producing. But that is only the beginning of the validation process. Onsite, that same system needs to be validated when inspecting the specific products that the production line where it will operate will be processing and/or packaging. This is ideally done at the time the system is originally installed in a production line, and then becomes one element of a complete program of validation, periodic verification and ongoing monitoring that will keep the system operating as intended and ensure that products are adequately and accurately inspected, and that accurate records of those inspections are kept.

It is critical for producers to remember, however, that the original onsite validation relates only to the specific products tested at the time. As new or additional sizes of products are developed and run on the production line, or packaging (including labeling) changes, the system will need to be re-validated for each change.

Verification

Verification is the process of periodically confirming that the inspection equipment continues to be as effective as when it was first validated. The verification process uses standard, established tests to determine whether the inspection system is still under control and continuing to operate as originally demonstrated. This verification process is conducted periodically at regular intervals to provide evidence-based confirmation that the system continues to be effective as specified. Formal performance verification is typically an annual process, to support audit requirements. It should continue throughout the productive life of the system.

Both validation of an installed system and periodic verification of operating systems can be conducted either internally by the end-user, or by the supplier of the equipment. Validation and verification services are often included as part of equipment purchase contracts.

Monitoring

Routine performance monitoring, as distinct from periodic verification, consists of a series of frequent, regular performance checks, during production, completed to determine whether processes are under control and to confirm that there has not been a significant change in the system’s performance level since the last successful test. The monitoring frequency may be as often as every two hours, depending on company standards, industry standards and/or retailer codes of practice.

If the monitoring process finds that a particular device is out of specification, all product that has passed through the production line since the last successful routine performance-monitoring event must be considered suspect and re-inspected.

In many cases, it is line operators that conduct online performance monitoring. However, many of today’s more sophisticated product inspection systems incorporate built-in performance monitoring software that automates this process and alerts operators when deviations occur. This valuable software feature removes any human error factor from the monitoring activity to help ensure that inspection processes are still being performed properly. It also provides documentation that will guide the end-user company’s QA groups in their continuous improvement efforts, and that will also be a valuable asset in the event of an inspection visit from regulators.

Routine performance monitoring can also have a direct impact on the production line’s OEE. Installing a system with built-in condition monitoring capability that automatically detects when the system may need correction and communicates that information directly to line operators reduces the frequency needed for verification testing, maximizing the line’s production uptime.

Reliance on the experts

Finally, food manufacturers and processors should remember that, while they are knowledgeable experts regarding their products, it is their equipment suppliers that are the experts on the capabilities and qualification procedures of their equipment. That expertise makes them the best source of reliable recommendations on questions from the most effective inspection equipment type for specific product needs, where to place that equipment on the production line for optimum results and how to validate, verify and monitor its performance.

Relying on these experts to conduct onsite validation and to advise on conducting periodic verification and ongoing performance monitoring can reduce both the time needed for the original onsite validation time and that needed for verification and ongoing monitoring procedures, increasing productivity.

Companies can also rely on these experts to be knowledgeable on the most current food safety regulations and the technology that affect equipment validation. It is critical for their success that they stay current on those topics, and sharing that knowledge is a valuable part of their service.

Speed-to-Market, Lifecycle and Regulations

How to stay compliant in an ever-changing marketplace. Attendees will gain an understanding of regulatory compliance for the food and beverage industry, time to market strategies, understanding of food, nutrition and health labeling laws. Recorded: October 5, 2017. Sponsored by Decernis.

Approved

Finding Compliant Suppliers May Be Getting Easier

By Maria Fontanazza
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Approved

Six years ago, following FSMA being signed into law, Associated Wholesale Grocers, Inc. (AWG) knew it had to implement a supplier approval program to comply with the Preventive Controls rule. At the time, it had a manual process for managing the records of its 3000+ suppliers. The company needed an effective place, accessible any day of the year (and at any time), to collect and store all of its corporate and food safety documentation.

“I come from a manufacturing program where I was used to having a very robust supplier approval program,” says Shelly Stegner, director of food safety for AWG, a grocery co-op. “But in distribution companies such as AWG, food safety hasn’t necessarily been the culture, because we don’t do any reprocessing or repacking, or touch the product. When we had to comply with [FSMA], it was a whole new thing for AWG, and we knew we had to roll something out.”

AWG spent about two-and-a-half years looking for a company that could help not only manage documentation but could also give them control over the documents from a visibility perspective. After conducting thorough research, AWG selected Repositrak Inc.’s cloud-based Compliance Management solution. The product was recently launched to help companies during the sourcing process, assisting them with supplier qualification, order negotiation and on-boarding a new supplier. The solution also highlights compliant vendors based on business and safety requirements.

Food Safety Tech: What are the advantages and drawbacks to using an automated solution like Repositrak?

Shelly Stegner: It’s an easy way to keep track and retain all the records that you’ve never been able to retain before. And not only can you retain them, but there are also visual statistics behind the documents (which you don’t have when with hard copies). It’s not just having the documents—it’s actual usable data when you use [Repositrak] that helps drive efficiencies within our company, and it helps decrease our risk and liability with vendors—for example, we know that their certificate of insurance has expired, whereas before [using Repositrak], we didn’t know that.

The drawbacks are cost. Is it the cheapest option out there? No. But is it the most efficient option that we found? Yes. A lot of the companies may have been cheaper, but we would have had to hire an individual to do all the work. There is a cost associated with it, so [some] vendors are hesitant. The other drawback is that the industry overall has many different solutions, so if the supplier is not using Repositrak for their supplier approval program, it’s another point of entry. Maybe it only takes 30 minutes to do it, but it’s still something else that they have to do.

I think it’s becoming easier for vendors with Repositrak as we get more traction and as it becomes more of an industry-known [product]. Suppliers only have to upload documents once, and it automatically reaches all their customers. So for them, the more [suppliers] that are on one system, the easier it is for the whole industry.

FST: What are the challenges to implementing this type of system?

Stegner: For a company that was completely in the Stone Ages, we didn’t even have a list of all of our active vendors—so we thought we had 6000 active vendors, and we only had a little more than 3000. Just getting the information to Repositrak about active vendors and contacts proved to be the most difficult thing for us. Once we got Repositrak the key information, they ran with it.

FST: From time management perspective, what are the savings?

Stegner: Before we had nothing in place. Now, during my third-party audits or when FDA arrives, I can show them where we are in compliance when they ask about our supplier program. It saves me a ton of time in that regard.

Now when I have a recall, I can go into the system and look up a contact, versus waiting to get a contact from a category manager. If I need to issue a recall, I can see if [the vendors] have reviewed our recall program and issue it without waiting on that either.

As far as the time it takes to approve documents, there’s an increased time, but there’s also an awareness that we never had before. So not only are we collecting the documents, but now we are building a whole food safety culture that also has a new awareness and understanding of what it means to distribute safe food.

FST: What are the general challenges you see companies facing, especially in the area of compliance and having visibility throughout their supply chain?

Stegner: I think there’s a challenge with some companies on keeping information confidential because they simply don’t want to share information.

As far as traceability goes, our company is challenged with technology. [There’s] the financial need of upgrading our technology to have the true traceability that has so increasingly become required by consumers from farm to fork. A great deal of technology is needed to understand that in real time.

The farmer has their traceability, and the supplier has their traceability, we have ours, and then there’s the retailer—it’s tying all those together that proves to be a bit of challenge.

Gluten free

FDA Project Finds Gluten-Free Labeled Products Meeting Standards

By Food Safety Tech Staff
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Gluten free

Accurate labeling of gluten-free products is a big deal for consumers who have celiac disease, as they can suffer potentially serious health issues when they eat gluten. FDA set standards for the labeling of gluten-free products in August 2013 (with a compliance date of August 5, 2014) and recently announced results of a sampling assignment that was conducted to assess compliance with the final rule.

Of the 702 samples taken from 250 products labeled as “gluten-free”, FDA found that more than 99.5% of the samples to be in compliance with the agency’s requirement.

“Of the total number tested, five samples from one product source contained gluten in excess of the regulatory limit of 20 parts per million (ppm), for a product-based rate of compliance with that requirement greater than 99.5 percent. A voluntary recall was conducted to address concerns related to the violative samples. In addition to carrying out the recall, the manufacturer conducted an extensive root cause analysis and immediately implemented additional corrective actions to prevent recurrence.” ­ – FDA

The analytical results are available on FDA’s website.

SQFI Logo

SQF Version 8 Released: Understand the Revisions

By Food Safety Tech Staff
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SQFI Logo

A new version of SQF was recently released. To get up to speed on the revisions, experts LeAnn Chuboff, senior technical director at SQFI and Jennifer Lott, food safety & auditing technical manager/senior safety auditor at SGS will walk attendees of an upcoming webinar through SQF V8 and how it connects to FSMA compliance.

Chuboff and Lott will discuss the role of senior management in the process, the need for greater environmental controls, approved supplier programs, and the requirements surrounding food fraud and allergens. They will also help attendees understand the tools and resources available to help prepare for the new version, along with digging deeper into FSMA implementation in the area of risk, supply chain preventive controls, adulteration and allergens.

Learn more during the webinar, New SQF Version 8 and Compliance with FSMA Rules, on April 25, 2017 at 1 pm ET.

Dr. Douglass Marshall, Chief Scientific Officer – Eurofins Microbiology Laboratories
Food Genomics

Microbiomes a Versatile Tool for FSMA Validation and Verification

By Douglas Marshall, Ph.D., Gregory Siragusa
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Dr. Douglass Marshall, Chief Scientific Officer – Eurofins Microbiology Laboratories

The use of genomics tools are valuable additions to companies seeking to meet and exceed validation and verification requirements for FSMA compliance (21 CFR 117.3). In this installment of Food Genomics, we present reasons why microbiome analyses are powerful tools for FSMA requirements currently and certainly in the future.

Recall in the first installment of Food Genomics we defined a microbiome as the community of microorganisms that inhabit a particular environment or sample. For example, a food plant’s microbiome includes all the microorganisms that colonize a plant’s surfaces and internal passages. This can be a targeted (amplicon sequencing-based) or a metagenome (whole shotgun metagenome-based) microbiome. Microbiome analysis can be carried out on processing plant environmental samples, raw ingredients, during shelf life or challenge studies, and in cases of overt spoilage.

As a refresher of FSMA requirements, here is a brief overview. Validation activities include obtaining and evaluating scientific and technical evidence that a control measure, combination of control measures, or the food safety plan as a whole, when properly implemented, is capable of effectively controlling the identified microbial hazards. In other words, can the food safety plan, when implemented, actually control the identified hazards? Verification activities include the application of methods, procedures, tests and other evaluations, in addition to monitoring, to determine whether a control measure or combination of control measures is or has been operating as intended, and to establish the validity of the food safety plan. Verification ensures that the controls in the food safety plan are actually being properly implemented in a way to control the hazards.

Validation establishes the scientific basis for food safety plan process preventive controls. Some examples include using scientific principles and data such as routine indicator microbiology, using expert opinions, conducting in-plant observations or tests, and challenging the process at the limits of its operating controls by conducting challenge studies. FSMA-required validation frequency first includes before the food safety plan is implemented (ideally), within the first 90 calendar days of production, or within a reasonable timeframe with written justification by the preventive controls qualified individual. Additional validation efforts must occur when a change in control measure(s) could impact efficacy or when reanalysis indicates the need.

FSMA requirements stipulate that validation is not required for food allergen preventive controls, sanitation preventive controls, supply-chain program, or recall plan effectiveness. Other preventive controls also may not require validation with written justification. Despite the lack of regulatory expectation, prudent processors may wish to validate these controls in the course of developing their food safety plan. For example, validating sanitation-related controls for pathogen and allergen controls of complex equipment and for how long a processing line can run between cleaning are obvious needs.

There are many routine verification activities expected of FSMA-compliant companies. For process verification, validation of effectiveness, checking equipment calibration, records review, and targeted sampling and testing are examples. Food allergen control verification includes label review and visual inspection of equipment; however, prudent manufacturers using equipment for both allergen-containing and allergen-free foods should consider targeted sampling and testing for allergens. Sanitation verification includes visual inspection of equipment, with environmental monitoring as needed for RTE foods exposed to the environment after processing and before packaging. Supply-chain verification should include second- and third-party audits and targeted sampling and testing. Additional verification activities include system verification, food safety plan reanalysis, third-party audits and internal audits.

Verification procedures should be designed to demonstrate that the food safety plan is consistently being implemented as written. Such procedures are required as appropriate to the food, facility and nature of the preventive control, and can include calibration of process monitoring and verification instruments, and targeted product and environmental monitoring testing.

Melanie Neumann, Neumann Risk Services

Risk Mitigation and Compliance Management Strategies – Tightly Intertwined but Very Different!

Melanie Neumann, Neumann Risk Services

Melanie Neumann of Neumann Risk Services, LLC, (NRS) a global food safety and compliance law firm shares her thoughts on the similarities and differences of risk mitigation and compliance management, as well as the year ahead and what companies should be focusing on with regard to these key risk management topics.

Q.  Risk Mitigation and Compliance Management are often grouped together – in your view what is the key distinction between the two?

A.  The two are very much linked and very much codependent yet they are separate topics that need to be identified, implemented and managed differently.  Independent strategies need to be put together that are different, separate and apart based upon a company’s strategy and risk tolerance.  [more]

Q. What risk mitigation approach is most realistic, and typically deployed by the food & beverage industry?

A.  With risk management, there are 4 types of risk mitigation strategies that are typical. I’ll break down to how you can manage risk very simply – 1) avoid it, 2) limit it, 3) transfer it, and 4) if you can’t do any of these 3, you can accept it.  [more]

Q.  How does your risk management strategy tie into compliance management?

A. Tying it together, risk management identifies the risk, and establishes a way to manage that risk appropriately. Compliance management is assessing whether the process of managing that risk is actually working the way you intended it, and is meeting laws or regulatory requirements if there are any that apply.  [more]

Q.  What are some of the key risk mitigation and compliance management considerations and initiatives companies should be thinking about in 2017?

A.  As companies continue to develop and execute upon their risk mitigation and compliance management strategies – they should be focusing on: 1- Showing your work; and 2 – leveraging your data for positive outcomes.  [more]

Q. Any parting thoughts on what you’ve shared today?

A. Right now, frankly, the stakes are higher than ever.  Liability concerns are greater than ever, too.  “knowledge” is being imputed on companies more than ever before for food safety issues that occurred in the past and rear its head again in the future.  [more]

Learn how SafetyChain’s solutions can help you more effectively reduce risk and ensure program compliance – www.SafetyChain.com