Tag Archives: FSMA

Dr. David Acheson is the Founder and CEO of The Acheson Group
Beltway Beat

Get Ready to Align Your Supplier Program with New FSMA Rules

By Dr. David Acheson
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Dr. David Acheson is the Founder and CEO of The Acheson Group

FSMA’s preventive controls rule mandates a supply-chain program to “provide assurance that a hazard requiring a supply-chain-applied control has been significantly minimized or prevented.” The rule defines a supply-chain-applied control as “a preventive control for a hazard in a raw material or other ingredient when the hazard in the raw material or other ingredient is controlled before its receipt.”

FDA made a few general updates in the final rule, including changing “supplier program” to “supply-chain program”, and it designated a subpart G with eight sections of regulatory text. Intended to improve clarity and readability, the language reflects its applicability to non-suppliers in a new requirement – that is, a supply-chain control can be applied and/or verified by a non-supplier (e.g., distributor, broker, aggregator). However, the receiving facility must verify the supply-chain-applied control itself or obtain documentation of the verification activity, review and assess the documentation, and document that review and assessment.

There are different compliance dates for the supply-chain program versus the entire rule, aligning  compliance with the dates of FSVP rule and providing greater consistency. This also addresses comment concerns that a receiving facility would be required to comply with the supply-chain program provisions before its supplier must comply with applicable new FSMA food safety regulations.

Does your current program comply with the new rules? If not, how can you bring it in line?

The Supply Chain Program

The rule requires a supply chain program when the receiving facility has identified, through its hazard analysis, that there is a hazard requiring a supply-chain-applied control. The program should address hazards requiring a preventive control that may be intentionally introduced for purposes of economic gain, as well as those unintentionally introduced.

FDA specifies the basic content of a supply-chain program, but allows for some flexibility. The rule mandates that the supply-chain program include:

  • Written procedures for receiving raw materials and other ingredients
  • Preventive control management components that include corrective actions and corrections, review of records and reanalysis
  • Supplier approval and use of only approved suppliers, but FDA is considering the issuance of guidance for temporary use of unapproved suppliers
  • Determining appropriate supplier verification activities
  • Conducting supplier verification activities
  • Documenting supplier verification activities:
    • Onsite audits
    • Sampling and testing of the raw material or ingredient (by the supplier or receiving facility)
    • Receiving facility review of the supplier’s relevant food safety records
    • Other appropriate supplier verification activities based on the risk associated with supplier performance and the raw material or other ingredient

In supplier approval and determination of supplier verification activities, the receiving facility must consider:

  • The hazard analysis, including the nature of the hazard, applicable to the raw material and ingredients
  • Where the preventive controls for hazards are applied
  • The supplier’s procedures, processes and practices related to the safety of the raw material and ingredients
  • Applicable FDA food safety regulations and the supplier’s compliance with them
  • The supplier’s food safety performance history relevant to the applicable raw materials, including results from testing for hazards, food-safety audit results and corrective action.
  • Any other relevant factors, such as storage and transportation practices

Other key points of the rule:

  • There must not be any financial conflicts of interests that influence the results of the verification activities. Payment must not be related to results
  • Domestic inspection by representatives of other federal agencies or by representatives of state, local, tribal, or territorial agencies may substitute for an audit
  • The definition of “supplier” has been revised so that the grower remains the supplier when the harvester is under separate management. The “supplier” is the establishment that “grows” food rather than that which “harvests” food.
  • Foreign suppliers may provide documentation, when applicable, of a written assurance that the supplier is producing the raw material or other ingredient in compliance with relevant laws and regulations of a country whose food safety system FDA has officially recognized as comparable or has determined to be equivalent to that of the United States
  • The provisions for supplier verification in the FSVP rule have been aligned with the provisions for a supply-chain program, so importers and receiving facilities can consider compliance with both the supplier-chain-program rule and the forthcoming FSVP regulations, as to avoid  duplication of verification activities
  • If the receiving facility is an importer in compliance with the FSVP requirements and has documentation of verification activities under FSVP, a supply-chain program is not required even if the receiving facility’s hazard analysis determines that a supply-chain-applied control is required
Michael Taylor FDA

FDA to Weigh In on FSMA Enforcement at Food Safety Consortium

By Food Safety Tech Staff
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Michael Taylor FDA

How will FDA enforce the new FSMA rules? It’s a question that has been circulating throughout industry over the past few months, and it will be answered at this year’s annual Food Safety Consortium conference next month. Michael Taylor, JD, deputy commissioner for foods and veterinary medicine at FDA will deliver the opening plenary presentation on November 18, which will be followed by an “Ask the FDA” interactive town hall meeting. During the afternoon,

Roberta Wagner, deputy director of regulatory affairs at CFSAN
Roberta Wagner, deputy director of regulatory affairs at CFSAN

Roberta Wagner, deputy director of regulatory affairs at CFSAN will discuss FSMA implementation and FDA’s strategies for gaining and maintaining industry compliance with the new rules. The agency will also be participating in several conference sessions dedicated to the FSMA rules that will be finalized by November, including:

  • Foreign Supplier Verification
  • Preventive Controls in Human Foods
  • Preventive Controls in Animal Foods
  • Produce Safety
  • Third-Party Auditing
  • Voluntary Qualified Importer Program

During the event, USDA’s Food Safety and Inspection Service (FSIS) will also be answering questions related to regulatory compliance and food safety issues at a Small Plant Help Desk.

Frank Yiannas, vice president of food safety at Walmart
Frank Yiannas, vice president of food safety at Walmart

Beyond FSMA-related topics, the Food Safety Consortium conference will feature several concurrent food safety and quality assurance tracks, workshops and training programs in compliance, food manufacturing and operations, supply chain management, food labs, and foodservice and retail. Food Safety Culture is an especially hot topic right now, and the conference will address the practical ways to actually measure behavior and start taking action. Frank Yiannas, vice president of food safety at Walmart will deliver a keynote presentation, “Food Safety = Behavior” on Wednesday, November 18.

Robin Stombler, Auburn Health Strategies
In the Food Lab

Five Questions Food Facilities Should Ask About Testing

By Robin Stombler
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Robin Stombler, Auburn Health Strategies

The FDA issued the first of several final regulations aimed at modernizing the food safety system through the use of hazard analysis and risk-based preventive controls. Inherent in this system are a number of requirements that eligible food facilities must follow, such as developing a written food safety plan, monitoring, corrective actions and verification. Laboratory testing is an essential component as well.

Robin Stombler presented “Laboratory Oversight and FSMA: Why and When” at the Food Labs Conference in Atlanta, GA | March 7–8, 2016So, what should food facilities know about laboratory testing within the context of the preventive controls for human food final rule?  First and foremost, the final rule states, “facilities have a responsibility to choose testing laboratories that will produce reliable and accurate test results.”  While a future regulation is expected to address the need for accredited laboratories and model laboratory standards, the preventive controls rule adopts other requirements pertaining to testing. Here are five questions that food facilities should ask about testing and the preventive controls rule.

1. What is the difference between pathogens and microorganisms?

The final rule defines “pathogen” to mean a microorganism that is of public health significance. A microorganism is defined as “yeasts, molds, bacteria, viruses, protozoa and microscopic parasites, and includes species that are pathogens.” Microorganisms that are of public health significance and subject food to decomposition or indicate that the food is adulterated or is contaminated with filth are considered “undesirable.”

2. How must food facilities account for pathogens?

Food facilities must prepare and implement a written food safety plan. One component of the food safety plan must include a written hazard analysis. This analysis must identify known or reasonably foreseeable hazards. These hazards may be biological, which includes parasites, environmental pathogens and other pathogens.

In another example, the food safety plan must include written verification procedures. This is to demonstrate that the facility is verifying that its preventive controls are implemented consistently and are significantly minimizing or preventing the hazards. These verification procedures are intended to be appropriate to the particular food facility, the food in question, and the nature of the preventive control and its role within the facility’s food safety system. With this in mind, facilities must conduct activities such as product testing for a pathogen or an appropriate indicator organism or other hazard, and environmental monitoring.

3. Are there written procedures specific to product testing?

Yes. Procedures for product testing must be scientifically valid and must identify the test microorganisms or other analytes. The procedures for identifying samples, including their relationship to specific lots of products, must be written and implemented. The procedures for sampling, including the number of samples and the sampling frequency, must be outlined. The facility must recognize the laboratory conducting the testing as well as describe the tests that are performed and the analytical methods used. Corrective action steps must also be included.

4. What are the procedures for environmental monitoring?

Similar to product testing, these procedures must be scientifically valid, identify the test microorganisms, and be put in writing. For routine environmental monitoring, the location from which the samples are collected and the number of sites that are tested must be stated. The final rule indicates that the “number and location of sampling sites must be adequate to determine whether preventive controls are effective.”  Written procedures must also identify the timing and frequency for collecting and testing samples. Again, similar to product testing, the laboratory conducting the testing and the tests and analytical methods used must be divulged. Corrective action procedures must also be included.

5. How does the supply-chain program incorporate testing?

A receiving facility is required to document a written supply chain program in its records. A component of that program includes documentation of sampling and testing performed as a supplier verification activity. The documentation must include identification of the raw material or other ingredient (including, if appropriate, lot number) and the number of samples tested. It also means that the tests conducted and the analytical methods used must be identified. The date the test is conducted as well as the date of the test report must be provided, and the identity of the laboratory performing the testing must be revealed. Any corrective actions that were taken in response to a hazard detection must also be reported.

This Q&A provides a glimpse into how the preventive controls final rule for human food incorporates laboratory testing. For more details, access the final rule.

FST Soapbox

Risk in Our Supply Chain: Where Do We Start?

By Traci Slowinski
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FSMA has arrived with the launch of the first two preventive control rules – Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human and Animal Food (or cGMP and HARPC, for short). With these new FSMA rules, the food and beverage industry will now be held accountable for being more proactive versus reactive, and will be responsible for identifying and managing risk throughout their supply chain. Of course, this emphasis on risk can also be seen in other sectors of the industry (i.e., GFSI and ISO), and risk has become the focal point for a number of compliance initiatives.

Supply chain challenges in food safety
Supply chain challenges in food safety (Click to enlarge)

These days a number of supply chain challenges are driving risk. Continued global expansion of the industry is resulting in more import and export activities. We are seeing consumer food trends shift toward riskier food/preparation options. Regulatory agencies continue to work on improving their food safety requirements. And the growing population is putting more demands on our current resources. All of these factors equates to great risk within all stages of the supply chain.

Therefore, it will be important that you understand what risk management entails and have the right tools to identify, assess and control the risks that you find throughout your supply chain.

So where do we start looking for risk? Here are a few examples of where your risk assessments should be performed:

External Partners. You need to build strategic relationships with your external partners (suppliers, contract manufacturers/co-packers, service providers, carriers, etc.) across the supply chain. Building trust through good communication and collaboration is essential to ensure that you can rely on your partners to do the right thing for both parties.

RiskAssessmentSupplyChainRaw Materials. Many hazards can be introduced into a facility through raw materials—whether we are talking about raw ingredients, packaging materials, chemicals, or other components used to produce your product. Some hazards to assess include pathogens, allergens, chemical residues, pests and foreign material.

Storage and Handling. When looking at risk during storage and handling, it is important to address several hazards including allergen control, temperature control, foreign material control, proper segregation and product flow.

Processing. A number of areas in processing can introduce hazards and therefore should be included in your risk assessment. These include improper sanitation, cross contamination/contact potential, foreign material contamination, critical control point deviations, pre-requisite program failures and mislabeling.

Shipping and Transport. Lastly, you must safeguard your shipping and transportation procedures in order to account for any potential risk once the product has left your facility. Areas to consider during your risk assessment include temperature control, condition and sanitation of truck and storage units, loading/unloading practices, security/tampering potential, accident/emergency recovery, and traceability.

For more information on risk management within the food and beverage supply chain, register to attend the free webinar “Supply Chain Management: Does What I Eat Put Me at Risk” on October 28, 2015. Speakers will discuss risk throughout the supply chain, focusing on supplier management and some of the new FSMA requirements. They will provide an overview of risk management and some of the tools that can be used to identify and assess risk. In addition, they will discuss how technology can help companies meet FSMA requirements.
AJ McCardell, Food safety technology
In the Food Lab

New Food Safety Technology Addresses FSMA Rules

By AJ McCardell
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AJ McCardell, Food safety technology

In ongoing efforts to eliminate foodborne illness, the FDA recently issued the next step in rules designed for the enforcement of FSMA. The rules are aimed at modernizing food manufacturing processes after a wave of deadly outbreaks in the past decade stemming from contaminated cantaloupes, apples, spinach, lettuce, peanut butter, ice cream, cucumbers and other products. The rules require companies to draw up and implement written plans for keeping food safe. An important part of any food safety plan is the implementation of methods to verify that the controls put in place are working.

The food industry faces many challenges in meeting these new regulations. Two significant technical challenges for control verification are that the testing process takes too long and the sampling plans are often inadequate.

The pathogen testing process for all commercially available diagnostic tests requires an upfront culture or growth step to allow any pathogens present to multiply to a level that they can be detected by the test in use. This growth step, referred to by microbiologists as enrichment, is especially challenging in heavily processed foods and environmental samples, because the bacteria present in the sample have been stressed and are not in a rapid growth phase at the time of sampling. Advances in diagnostic sensitivity and robustness have reduced the amount of time required for enrichment from three or more days with traditional methods to about 24 hours on average with rapid methods. Even with rapidly growing and low-stress organisms such as E. coli O157:H7, enrichments take more than eight hours before implementing the diagnostic. The time required for this growth step creates a bottleneck in the production and distribution process. Although diagnostic companies are continuously improving the sensitivity of their methods and new methods are constantly being developed, there are practical limitations that have thus far prevented the elimination of the upfront culture step prior to testing. Historically, improvements in the sensitivity of rapid food pathogen diagnostics have been traded for time. In other words, having a more sensitive test means that fewer bacteria are needed for detection and therefore, less time is needed for bacteria to divide during the enrichment step.  Some commercially available assays require as few as 1,000 to 10,000 target cells in the sample for detection. Since the purpose of the enrichment step is to increase the number of target pathogens in the sample to a detectable limit and bacteria reproduce by cell division, further diagnostic sensitivity improvements would need to be greater than ten-fold to have a significant impact on further reducing enrichment times.

Unreliable sampling methods are an even bigger issue for industry. An example demonstrating current practice is a field of 40,000 heads of lettuce with four (.01% of the total) heads of lettuce contaminated by a pathogen. The current best practice is to go into the field and collect 60 (.15% of the total) leaves from the heads of lettuce, mash them together and test them for contamination. The probability of this sampling method finding the four contaminated heads of lettuce in the sample is much less than 1%. When the undiscovered four heads of lettuce are washed with the other 39,996 heads of lettuce, cross contamination occurs and people get sick.

Technology advances that reduce or eliminate the requirement for enrichment and make the sampling process more reliable could have a big impact on improving control verification testing. But, those advances need to be delivered in a practical and affordable manner. I recently learned about a technology that has great potential to make improvements on both of these fronts, especially for the produce industry and any process that is able to use a wash step as a control point. The recently patented OmniFresh sampling system (developed by OmniFresh, LLC) concentrates a sample from the food processing wash water, allowing immediate testing representative of the food being processed. The concentration process is performed during the entire washing cycle for a lot and is consequently representative of the entire lot.

Concentration technology has been used for many years by academic researchers and scientists to collect samples for biological testing.  Ultrafiltration methods for concentrating samples have typically used smaller sample sizes in the 1-10 liter range.  The OmniFresh system allows for very large samples to be concentrated, typical volumes of 400 liters are concentrated to 50 ml.

The concentration process takes about one hour to complete after the first wash cycle.  During processing, a side stream of water from the first wash tank is diverted to the concentrator unit. Tens to hundreds of gallons of wash water, depending on the size of the wash tank and the type and amount of produce being washed, flows into the concentrator. Throughout the sample collection period, large particulates are removed through a course filtration. Using ultra-filtration, bacteria and other small particles are isolated from the large volume of wash water into a much smaller, concentrated final sample. This concentrated sample can then be tested directly by a diagnostic test, eliminating the need for enrichment.1

OmniFresh System with diagnostic platform
The OmniFresh System with diagnostic platform installed at a processing facility. (Click to enlarge)

The wash water in the tank comes into contact with all of the produce being washed, the majority of bacteria is removed from the produce, and it then enters the wash water.2-4 This process, combined with the continuous sampling of wash water, means that low levels of intermittent contamination can be detected without testing high numbers of samples. Field testing of the OmniFresh System has returned promising results. The ability to rapidly screen produce for contamination could also provide a practical lot definition instead of cumbersome field-based definitions that can impact multiple processors.

Improvements in sample preparation and sampling technologies have much to offer the industry. Improved sampling methods which are representative of entire lots identify contaminated food earlier and with high confidence.  Additionally, the negative test result is of much higher quality and will result in an increase in the overall confidence of the food supply.

The OmniFresh technology is one example of the type of improvements that are needed. More research that focuses on these most challenging aspects of control verification testing is needed.

References

  1. Dyer, M.A. (2009). “New biosensors for food safety screening solutions.”  SPIE.
  2. Beuchat, L. R., and Ryu, J.-H. (1997). “Produce Processing Practices,” Emerg. Infect. Dis 3 (4), 459-465.
  3. Sapers, G. M, (2001). “Efficacy of washing and sanitizing methods for disinfection of fresh fruit and vegetable products,” Food Technol. Biotechnol. 39 (4), 305-311.
  4. U.S. Food and Drug Administration. (1998). “Water: Control of Potential Hazards: Wash Water.” Chap. II.B.2.3 in Guide to minimize microbial food safety hazards for fresh fruits and vegetables, by US FDA.
FDA

FDA Awards $600,000 for FSMA Training Center

By Food Safety Tech Staff
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FDA

Today FDA announced its strategy for training the food industry as part of the successful implementation of FSMA. This included awarding a $600,000 grant to the International Food Protection Training Institute (IFPTI) to establish a National Coordination Center. This center will serve an important function in the training process for the food industry.

“One size won’t fit all when it comes to training,” according to an FDA release. “The most important goal that the FDA expects of any training program is the outcome—that it advances knowledge among the food industry to meet FSMA requirements.” The agency indicated that there will be different options and delivery formats for the training, but wants all hands on deck—domestic and international stakeholders from government, industry and academia—to work with FDA on developing and delivering the training to food suppliers.

The major components of the FSMA Training Strategy include:

  • Crafting the FSMA alliance curricula
    • The alliances include the Produce Safety Alliance, the Food Safety Preventive Controls Alliance and the Sprout Safety Alliance
  • Alternate training options
  • Cooperative agreements, including a five-year agreement with the National Association of State Departments of Agriculture
  • Establishing the National Coordination and Regional Centers to support training delivery
  • Delivering the training
    • The three above alliances are developing a Train-the-Trainer program to provide training via an established process. A range of partners will be involved, including the Association of Food and Drug Officials, the Association of Public Health Laboratories, and the Association of American Feed Control Officials
  • A FSMA collaborative training forum co-chaired by FDA and USDA
Traceability in food manufacturing, Honeywell

Traceability Not a Trend. It’s a Reality.

By Maria Fontanazza
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Traceability in food manufacturing, Honeywell

Businesses throughout the food supply chain are using a variety of traceability tools to capture critical information during the path from the field to the consumer. Traceability has always been viewed as an important capability within the supply chain, but FSMA, coupled with retailer and consumer demand, is pushing it to the highest levels yet.

Technology solutions that provide continuous identification and verification include mobile computers, scanners, RFID and mobile printers. While growers, packers, wholesalers, distribution centers and retailers involved in the fresh produce, poultry, meat, and seafood segments are using these technologies, speculation continues about adequate adoption levels.

The larger food providers are embracing track and trace technologies, while smaller business have been much slower to adopt, according to Bruce Stubbs, director of industry marketing at Honeywell Sensing & Productivity Solutions. “It’s going to be difficult to convince the smaller growers to invest in the technology—a lot of them see it as a cost,” he says. “What’s helping is that the retailers are starting to push back and say they are going to require their suppliers to be compliant with [traceability] mandates and if not, they won’t do business with them.”

Out in the field, companies are leveraging scanning and printing technologies, including smart printing technology (essentially a PC with printing capability). The printer hosts data capture and traceability software, providing the tasks and traceability through the software to the scanning devices. It can capture and print the food traceability label, which contains the discreet information, at the point of harvest. At the transportation level, businesses are using mobile computers to scan and capture product information that tracks down to the details from what part of a field, or even which tree in an orchard, a product has been harvested. Traceability technologies are including sensors throughout the cold chain to monitor temperature and humidity as the product is transported from point A to B. All information moves forward into the production facility and the retailer’s distribution center. Once at the retail store level, grocers will be able to pinpoint, within potentially thousands of stores, the specific batches and lots, a key capability in the instance of product issues and recalls.

Traceability is a holistic process, and the potential for its continued growth within the food industry is high. “I see it becoming more prevalent as consumers demand it, and retailers and manufacturers must adapt. I also see them moving away from paper,” says Stubbs. “We’re close; it’s almost like there’s a trickle in the dam right now, but I really believe that over the next couple years, the dam will break and most [companies] will need to adopt [traceability solutions] or they won’t be able to effectively do business with a lot of the food retailers.”

Stubbs also anticipates an increased adoption of 2-D barcodes versus 1-D linear laser barcodes, as 2-D barcodes can contain far more information. “We are at the tip of those technologies—they exist. It’s just the integration of these systems and providing the information in a format at the supplier or food manufacturer level,” he says.

How is your company implementing traceability solutions? What challenges and benefits are occurring as a result?

Mobile FSQA apps

Are Mobile Apps a Game Changer for Food Safety Professionals?

By Maria Fontanazza
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Mobile FSQA apps

Many food safety and quality assurance (FSQA) professionals are constantly on the go in the workplace. They can be found on the floor of a manufacturing facility, off-site conducting supplier audits, or out in the field performing pre-harvest inspections, just to name a few locations during their busy day. “To benefit from food safety automation, these folks need more than the capability of logging into a system through a desktop,” says Levin. “They need a true mobile app that provides automation support out in the field,” says Barbara Levin, senior vice president of marketing and customer community at SafetyChain.

While other industries have been quick to adopt mobile platforms, the food safety industry has been much slower. Adoption is, however, gaining traction. In a recent conversation with Food Safety Tech, Levin talks about the value of FSQA mobile apps in today’s environment, where access to real-time, actionable data is crucial for the food industry.

Food Safety Tech: What common challenges faced by FSQA teams do mobile apps specifically address?

Barbara Levin: Mobile apps allow collection of FSQA at the point of origin, along with immediate access to the information for analysis, CAPA and reporting:

  1. Getting timely feedback on non-compliances for CAPA. When FSQA data is inspected at the end of the shift on paper, finding non-conformances often means rework. The instances in which this happens are too numerous to count. With mobile apps, you receive timely feedback. Information in the system is immediately analyzed to specs, so you’re catching non-compliances at the earliest point possible.
  2. Consistency in following your FSQA programs. This could be your USDA HACCP plan, FSMA HARPC plan, GFSI program, customer quality attributes and other components of your FSQA programs. Program components change all the time (i.e., Specifications, processes, rules in HACCP, GFSI code, forms, workflow, etc). Are FSQA managers confident that everyone is following the most up-to-date program? Is everyone following the workflow and doing everything in the right order? Are they completing tasks accurately? Using the right forms? Unfortunately companies find out that steps are missed or outdated forms were used during an audit; or when missed steps result in expensive rework or in the worst case, a customer rejection, withdrawal or a recall.

    Mobile apps will always have the most up-to-date forms, processes, specs and more. They act as a coach, leading the FSQA team member through the proper steps. When you enter incorrect or incomplete information on paper, it may not be detected until the end of the day or shift. A mobile app will issue an alert if incorrect information is entered; and it won’t let you submit a form if all fields aren’t complete. Because all of the updates are made in the system and pushed out to the app, if the specification changes while an FSQA team member is on the plant floor, when he or she logs in, the latest spec will always be there. You’re ensured that only the up-to-date program is being followed and that only the most up-to-date forms are being used.

  3. A lack of information for continuous improvement trending. If you have multiple facilities and products (resulting in mountains of FSQA paper), it’s a huge, manual task to make all of the data useful and relevant. With mobile apps, all FSQA data is entered “once and done,” making it accessible and actionable for immediate FSQA result tracking, daily KPI reporting and continuous improvement.
  4. Audit readiness. Mobile apps take audit readiness to a different level. With FSMA and GFSI, the saying is, if it’s not documented, you didn’t do it. By collecting FSQA data at the point of origin, all data is time and data stamped and uploaded to your permanent FSQA record. There’s no redundant data entry, mistakes are avoided, and there’s greater record efficacy that helps companies be audit ready, on demand.
Mobile FSQA apps
Mobile forms capture safety and quality data at the point of origin; data is actionable and then uploaded into a central repository for reporting and audit readiness. Image courtesy of SafetyChain Software. (Click to enlarge)

FST: What is the biggest benefit that FSQA mobile apps offer? 

Levin: The first benefit is real-time feedback. If you think about how things were done in the past, using an example of a pre-harvest inspection, you’re out there with a clipboard, making observations and recording non-compliances. Then you have to go back and enter the information into a spreadsheet, or turn it into a PDF, and send it to the food safety manager, who may or may not be sitting at his or her desk. Waiting to get a response equals time lost. And in the food industry, time equals money.

When you’re entering information into a mobile app, it analyzes that information in real-time and according to specifications. When there are non-compliances, alerts are pushed to the FSQA manager – wherever [he or she is located]. The manager can then generate a CAPA, which can then be completed, documented on the mobile device and electronically signed off by the manager. The process is expedited, and expensive rework is avoided.  

The second benefit involves data efficiencies. When data is collected on a mobile device, it’s entered only once and is then immediately available for multiple uses, such as a customer’s certificate of analysis, attachment to GFSI code for audit, or to be produced upon demand for a regulatory inspector. With a manual system, there’s a tremendous amount of redundant data entry. We hear this all the time from food safety folks— that they feel like they’re managing paper instead of food safety programs. When data is entered into a mobile app, it’s accessible immediately to FSQA, operations, vendor purchasing, management – any stakeholder who has a need.

“The Power of FSQA Automation Via Mobile Applications” Download the whitepaperFST: What approach should be taken to encourage the investment in and implementation of an on-the-go FSQA mobile platform?

Levin: I would love to think that in an ideal world, the creation of operational efficiencies that enable a higher level of confidence that you are sending out safer food is enough. Food companies are businesses, and they have obligations to consumers, which they take very seriously. But they also have obligations to their shareholders. When we talk to folks who really want this, it’s very easy to create a business case to senior management based on ROI. When you can close the gap by hours and days in the food industry, that time equals money. Avoiding rework also saves money.  And there’s ROI in faster sales throughput and increased shelf life by reducing hold and release times. We’ve heard from our customers that the solutions have paid for themselves and started to create ROI within three to six months.

Color coding to enable allergen and potential contamination distinction

If You Aren’t Color Coding Yet, You’re Way Behind

By Bob Serfas
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Color coding to enable allergen and potential contamination distinction

Since the introduction of FSMA, food safety has been under a much-needed magnifying glass. Standards for hygiene and accountability are increasing, and companies are implementing more measures to keep consumers safe. One of the ways in which businesses are being proactive is through implementing color-coding plans. If you have not heard of this type of plan yet, it’s time to get schooled; and if you have, this article will provide a quick refresher on why companies are expanding their spectrum on contamination prevention—by literally implementing the color spectrum in their plants and businesses. 

What Is A Color-Coded Plan?

A strategy for a plant or business that designates certain colors for a specific area or purpose designed to promote safety and cleanliness.

Example Plans. Although color-coding plans vary by the needs and demands of each plant, the following are the most popular types of color-coding plans currently being practiced in food manufacturing.

Color coding to enable allergen and potential contamination distinction
Color coding a cleaning brush can help employees make the distinction when dealing with allergens and potential contamination. All images courtesy of Remco/Vikan

Allergen/Potential Contaminant Distinction

Food Processors and manufactures usually have identified potential allergens and contaminants that pose a risk to the production process. Color distinction for equipment or instruments that come into contact with these potential contaminants is an ideal tool for food safety. Determining the amount of items that fall into this category within your facility is the first step to selecting the appropriate amount of colors to implement. The most basic color-coding plan for this purpose would be to select one color to represent tools that come into contact with a particular risk agent and one color to represent those tools that may be used elsewhere. If a plant has more than one risk agent, this plan may be expanded to include several colors. It is important to remember, however, that simplicity is key in color coding and that additional colors should be implemented strictly on an as-needed basis.

Zone Distinction

Many plants already have identified zones in place based on what is produced in each zone or simply due to operating a large plant. This presents an ideal opportunity to color code zones to keep tools in their proper place.  

Shift Distinction

Certain plants that have a large number of employees working different shift times should also consider color coding. Color coding by shift can hold each shift responsible for proper tool use and storage. This approach also allows management to see where work habits may be falling short and where the cost of tool replacement is highest. 

Assembly Process Distinction

Plants that have assembly line-like processes can implement color coding if necessary to differentiate tools that belong to each step. For example, this becomes particularly important in plants that deal with products such as meat; obviously you do not want to use the same tools with raw and processed meat. Color coding eliminates the question of whether or not a tool is meant for each step in the process.

Color coding for cleaning purpose distinction
Implement a two-color-coding plan to distinguish between tools used for cleaning versus sanitation.

Cleaning Purpose Distinction

For many food plants, cleaning and sanitizing are processes that are considered different in purpose and practice. Often, there is a specific list for cleaning and then a separate plan for sanitizing. Implementing a two color-coding plan can distinguish tools that are meant for each process.

Why You Need A Color-Coded Plan

It helps meet FSMA requirements. A major part of complying with FSMA regulations is having proper documentation to prove safety measures. Color-coding plans do exactly that, and most providers of these products can provide you with the necessary documentation.

It reduces pathogens and allergens contamination. For food producers, this is the most important reason to implement color coding. There is nothing worse for a company than experiencing product contamination or a recall; this is one step that may prevent such events from occurring. 

It is easy to understand. Color coding works so well because it is so simple. All employees, even those who may not speak the same language or are unable to read posters and manuals that dictate proper procedures, can easily comprehend it.

It creates a culture that holds employees accountable. Managers enjoy color-coding practice because it is a simple measure that really works to hold employees accountable in the proper use of tools. It becomes much more obvious when a brightly colored tool is out of place, and thus workers are more likely to follow proper procedure.

Dr. David Acheson is the Founder and CEO of The Acheson Group
Beltway Beat

Final Preventive Controls Rules – Devil in the Details?

By Dr. David Acheson, Melanie J. Neumann
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Dr. David Acheson is the Founder and CEO of The Acheson Group

As we review the general applications and requirements for the first two final rules of FSMA (Preventive Controls for Human Food and Preventive Controls for Animal Food), we’re not seeing a big departure from the proposed preventive controls. But with nearly 1,600 pages of reading, we may not have found all the changes yet. Areas of note include: For the first time in history, training is now a regulatory requirement; and a new definition for a “preventive controls qualified individual” that is separate and distinct from the “qualified individual” under the proposed rule. With further analysis of the rule to come, we fully anticipate the devil to be in the details.

In this first article on the final rules, we are pulling out the key points, providing a general perspective of the Preventive Controls for Human Food, and main elements and compliance dates for both Preventive Controls rules.

The Human Food Rule

FDA has emphasized that it has built more flexibility into key requirements of the Human Food rule, including giving facilities the flexibility to consider the nature of the preventive control, the facility, and the its food safety system when establishing the appropriate preventive control management strategies (e.g. monitoring, verification, validation, corrective action).  In addition, the definition of farms, which are exempt from these regulations, has significantly changed to reflect modern farming practices.

The agency views the rule as better protecting public health by adopting a modern, preventive, and risk-based approach to food safety regulation for the future in three key ways:

  1. It creates new requirements for facilities to establish and implement hazard analysis and risk-based preventive controls for human food.
  2. It modernizes FDA’s long-standing CGMP regulations, updating, revising, and otherwise clarifying certain CGMP requirements, which were last updated in 1986.
  3. It clarifies the scope of the exemption for “farms” and makes corresponding revisions to regulations for the establishment, maintenance and availability of records.

The rules generally apply to establishments that are required to register with FDA. Key elements of the rule are as follows:

  1. Facilities must implement a food safety system that includes an analysis of hazards and risk-based preventive controls, including a written food safety plan that integrates hazard analysis of known or reasonably foreseeable biological, chemical, and physical hazards; preventive controls for processes, food allergens, and sanitation, supply-chain controls and a recall plan; and oversight and management of preventive controls to include monitoring, corrective actions/corrections, and verification.
  2. The definition of a “farm” is clarified to cover two types of farm operations not subject to the preventive controls rule (however, farms that conduct activities covered by the Produce Safety rule are subject to that rule):
    • Primary Production Farm. An operation under one management in one general, but not necessarily contiguous, location devoted to the growing or harvesting of crops, the raising of animals (including seafood), or both. The final rule expands the definition to include facilities that pack or hold raw agricultural commodities grown on a farm under different ownership, and to those that solely harvest crops from farms.
    • Secondary Activities Farm. The operation is majority owned by the primary production farm but located separately and is devoted to harvesting, packing and/or holding raw agricultural commodities.
  3. A flexible supply-chain program with separate compliance dates. In general, a manufacturing/processing facility must implement a risk-based supply chain program for raw materials/ingredients for which it has identified a hazard requiring a supply-chain applied control – unless it or its customer controls the hazard using preventive controls according to the preventive controls rules.
  4. Updated and clarified Current Good Manufacturing Practices (CGMPs). In addition, some previously nonbinding provisions have become binding rules.
  5. A new “Qualified Individual” aka the “preventive controls qualified Individual.” This is a more highly qualified position/level in the organization with responsibility to perform the hazard analysis and assign preventive controls, defined under the rule as “a person who has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by the FDA or is otherwise qualified through job experience to develop and apply a food safety system.” The qualified individual is based on education/training as applied to the individual’s assigned job duties—with the assumption that each individual will be a “qualified individual” for his/her assigned role.
  6. Training is a requirement. Foremost is the training required for the preventive controls qualified individual and qualified individuals. Further training may be required under Proposed §117.135(c)(6)–Other Controls, which proposes that preventive controls include any other procedures, practices, and processes necessary to satisfy the requirements of §117.135(a).

The Animal Food Rule

In addition to key elements similar to #1–3 of Human Food (above), this rule:

  1. Establishes CGMPs for animal food production by which facilities that further process a by-product for use as animal food must do so in compliance with CGMPs, but can follow either the human food or animal food CGMPs.
  2. Does not apply to feed mills associated with fully vertically integrated farming operations that generally meet the definition of a farm. However, because FDA expressed concern that this leaves a food safety gap, it plans to publish a proposed rule in the future to require that some feed mill operations implement the CGMPs established by the Preventive Controls for Animal Food rule.