Tag Archives: FSMA

Reduce Foodborne Illness Causing Microorganisms through a Structured Food Safety Plan

By James Cook
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In 2011 three U.S. government agencies, the CDC, the FDA and the USDA’s Food Safety Inspection Service (FSIS) created the Interagency Food Safety Analytics Collaboration (IFSAC). The development of IFSAC allowed these agencies to combine their federal food safety efforts. The initial focus was to identify those foods and prioritize pathogens that were the most important sources of foodborne illnesses.

The priority pathogens are Salmonella, E. coli O157:H7, Listeria monocytogenes and Campylobacter. To research the most important product sources, the three agencies collaborated on the development of better data collection and developed methods for estimating the sources of foodborne illnesses. Some of this research was to evaluate whether the regulatory requirements already in effect were reducing the foodborne pathogens in a specific product matrix. The collection, sharing and use of this data is an important part of the collaboration. For example, when the FDA is in a facility for routine audit or targeted enforcement, they will generally take environmental swabs and samples of air, water and materials, as appropriate, which are then tested for the targeted pathogens. If a pathogen is found, then serotyping and pulsed-field gel electrophoresis (PFGE) fingerprinting is performed, and this is compared to the information in the database concerning outbreaks and illnesses. This data collection enables the agencies to more quickly react to pinpoint the source of foodborne illnesses and thereby reduce the number of foodborne illnesses.

The IFSAC strategic plan for 2017 to 2021 will enhance the collection of data. The industry must be prepared for more environmental and material sampling. Enhancement of data collection by both agencies can be seen through the FSIS notices and directives, and through the guidance information being produced by the FDA for FSMA. Some examples are the raw pork products exploratory sampling project and the FDA draft guidance for the control of Listeria monocytogenes in ready-to-eat foods.

Starting May 1 2017, the next phase of the raw pork products exploratory sampling project will begin. Samples will be collected and tested for Salmonella, Shiga-toxin producing E. coli (STECs), aerobic plate count and generic E. coli. In the previous phase, the FSIS analyzed 1200 samples for Salmonella for which results are published in their quarterly reports. This is part of the USDA FSIS Salmonella action plan published December 4, 2013 in an effort to establish pathogen reduction standards. In order to achieve any objective, establishing baseline data is essential in any program. Once the baseline data is established and the objective is determined, which in this situation is the Health People 2020 goal of reducing human illness from Salmonella by 25%, one can determine by assessment of the programs and data what interventions will need to take place.

The FDA has revised its draft guidance for the control of Listeria monocytogenes in ready-to-eat food, as per the requirement in 21 CFR 117 Current Good Manufacturing Practice, Hazard Analysis and Risk-Based Preventive Controls for Human Foods, which is one of the seven core FSMA regulations. Ready-to-eat foods that are exposed to the environment prior to packaging and have no Listeria monocytogenes control measure that significantly reduces the pathogen’s presence, will be required to perform testing of the environment and, if necessary, testing of the raw and finished materials. Implementing this guidance document helps the suppliers of these items to cover many sections of this FSMA regulation.

The purpose of any environmental program is to verify the effectiveness of control programs such as cleaning and sanitizing, and personnel hygiene, and to identify those locations in a facility where there are issues. Corrective actions to eliminate or reduce those problems can then be implemented. Environmental programs that never find any problems are poorly designed. The FDA has stated in its guidance that finding Listeria species is expected. They also recommend that instead of sampling after cleaning and/or sanitation, the sampling program be designed to look for contamination in the worst-case scenario by sampling several hours into production, and preferably, just before clean up. The suggestion on this type of sampling is to hold and test the product being produced and to perform some validated rapid test methodology in order to determine whether or not action must be taken. If the presence of a pathogen is confirmed, it is not always necessary to dispose of a product, as some materials can be further processed to eliminate it.

With this environmental and product/material testing data collected, it is possible to perform a trends analysis. This will help to improve sanitation conditions, the performance of both programs and personnel, and identity the need for corrective actions. The main points to this program are the data collection and then the use of this data to reduce the incidence of foodborne illness. Repeated problems require intervention and resolution. Changes in programs or training may be necessary, if they are shown to be the root cause of the problem. If a specific issue is discovered to be a supply source problem, then the determination of a suppliers’ program is the appropriate avenue to resolve that issue. Generally, this will mean performing an audit of the suppliers program or reviewing the audit, not just the certificate, and establishing whether they have a structured program to reduce or eliminate these pathogens.

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Zia Siddiqi, Orkin
Bug Bytes

Stored Product Pests May Be Lurking in Your Facility

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

Pests can be sneaky. Many can compromise food products without anyone realizing they’re present. This is bad news for food processing facilities where an abundance of food products can translate into high pest pressure.

Beetles and moths are two of the main offenders in this environment and are referred to as stored product pests. These creatures can cause safety and legal concerns if they find their way into products, as they are quite adept at doing. They can damage packaging and cause product contamination or alter the taste of products when they secrete chemicals from their bodies, as many do.

This is not only a concern for your business’s reputation and bottom line, but could cost you major points on your next audit. Especially under the new FSMA regulations, prevention must be the emphasis in all U.S. facilities. This represents a shift from previous regulations as the new ones require risk-based preventive controls.

Integrate pest management
Does your company have an integrated pest management plan? Image courtesy of Orkin

The best way to prevent stored product pests and adhere to FSMA regulations is by implementing an integrated pest management (IPM) program. IPM programs focus on proactively preventing pests by inspection, monitoring and eliminating conditions that attract or harbor them using tactics like exclusion and sanitation, using chemicals only as a last resort. Under FSMA, you need to identify potential roadblocks and actively work to remove them. Showing constant improvement over time is an absolute must.

These programs also call for comprehensive documentation to monitor pest issues and ensure improvements are made over time. Auditors love to see documentation, as it shows that you are consciously working to strengthen your pest management efforts with continual improvement. If your facility doesn’t have an IPM program, it’s time to make a change sooner rather than later.

To successfully prevent stored product pests, you need to understand what they are and why they are attracted to your facility.

Types of Stored Product Pests

There are many different species of stored product pests, but they can be classified by four main categories based on their biology and habits:

  1. Scavengers: Eat just about anything, even if other pests have been there first. Pests in this category include the red flour beetle and sawtoothed grain beetle.
  2. External feeders: Feed on the exterior of cereal (grain) and kernel products and work their way inside. Pests in this category include Indian meal moths and cigarette beetles.
  3. Internal feeders: Lay eggs in the grain and feed on kernels from inside. Pests in this category include granary weevils, lesser grain borers and Angoumois grain moths.
  4. Secondary feeders: Eat from the outside in and consume moldy and damp food products. Pests in this category include spider beetles and fungus beetles.

How do you know if you have stored product pests? An infestation becomes apparent when the pests can be observed crawling or flying around. At this point, it’s important to identify the specific species that is plaguing your facility, as this will dictate the appropriate treatment method.  A trained professional can help correctly identify the species and recommend the best course of action to resolve the problem. Stored product pests reproduce quickly, so it’s critical to address any infestations before they have time to multiply and contaminate additional product.

The most common stored product pests are:

  • Sawtoothed Grain Beetle. Can burrow directly through boxes and packaging, so even sealed foods are at risk. They prefer processed food products like bran, chocolate, oatmeal, sugar and macaroni.
  • Indian Meal Moths. One of the most common pests for food processing facilities, the larva feeds on a large variety of different products. Some distinctive signs of an infestation are silk webbing and frass near the surface of the product.
  • Cigarette and Drugstore Beetles. Also able to chew through packaging, these beetles prefer pet food, spices, tobacco and any packaged food.
  • Granary and Rice Weevils. Prefer whole grains or seed products like popcorn, birdseed and nuts. They are recognizable by a snout protruding from their head and their reddish-brown bodies. Grains infested by weevils will be hollow and have small holes.
  • Spider Beetles. Similar to small spiders in appearance, they prefer grains, seeds, dried fruits and meats. They often accompany a rodent infestation because they prefer grain products that are old and moist.

Prevention Tactics

To help prevent stored product pests, incorporate the following tactics as part of your IPM program:

Closely inspect incoming shipments and packages. Look for the signs of stored product pests, like webbing, larvae and live adult insects. Check for signs of damage, especially for holes that can be caused by boring pests. To monitor for pests entering in this way, a quality assurance sample should be placed in a closed, labeled plastic container for later observations to see if any activity is noticed. This will give you a better idea if pests are present and what types may be being introduced via the incoming shipment.

  • Use of pheromone traps. These are the best tool to monitor the pest activity. These traps can also be placed in transportation vehicles to see if the trucks have a resident stored product pest population.
  • Use temperature as a repellant. Most stored product pests cannot live in extreme temperatures. If storage rooms can be maintained at 60°F or lower, stored product pests won’t be able to establish themselves inside.
  • Practice the first-in, first-out (FIFO) approach for products. Deteriorating products are an invitation to stored product pests, so make sure that older products go first and remove any with damages. It is also best to store products off the floor and more than 18 inches from walls, as it makes it easier to clean the surrounding area.
  • Create a sanitation schedule. Keeping a facility free of food debris will go a long way in eliminating attractants for pests. Clean up product spills immediately, and vacuum and wipe down everything on a regular basis. Don’t forget the cracks and crevices!

Keep in mind that being proactive is an important part of this entire process. If you see something, say something. Resolving pest issues as quickly as possible will be beneficial in the long run, as infestations are naturally more difficult to remove and could cost your facility dearly during an audit. A pest management professional will be able to point out the hot spots around a facility and can help to ensure that proactive prevention tactics are in place before anything gets out of hand. If any products are compromised, discard them immediately.

Pest Management: A Team Effort

The stakes are high in the food processing environment, which means pest control must be a priority. The most successful pest control programs are a team effort. Form a strong partnership with your pest management provider and work closely with them throughout the year to proactively prevent pest problems. Reach out to them early and often if you suspect any issues.

It’s also important that your entire staff is aware of pest management initiatives and tactics, which is why many pest management providers offer free staff training courses upon request. Take advantage of the resources available through your provider.

Working with a pest management provider to create a customized, IPM plan will help prevent pests and in turn protect the quality of your products and your business.

Phil Moyer, Unyson
FST Soapbox

Six Considerations When Choosing Your 3PL Provider

By Phil Moyer
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Phil Moyer, Unyson

The third-party logistics provider  (3PL) market is expected grow at a compound annual growth rate of more than 5% through at least 2024, according to Hexa Research. In addition, Aberdeen Research reports that industry leaders have increased the number of 3PLs they work with by more than 20% since 2013. Clearly, companies are outsourcing more of their logistics activities, and there are many factors to consider when choosing a 3PL, especially in the food industry. This article discusses a few essentials to take into account before betting your company reputation on a new 3PL relationship.

1. Experience

Transporting food is a serious and complex business, and it’s one place you don’t want to be a trailblazer. If the 3PL you’re considering doesn’t have extensive experience with products similar to yours, you are better off looking elsewhere. After all, it’s your reputation that will take the hit if things go wrong. This is one area where it pays to check references.

A company’s supply chain can be the weakest link in its food safety program. Learn how to mitigate these risks at the Food Safety Supply Chain conference | June 5-6, 20172. Familiarity With Food Safety

First and foremost, ensure your 3PL understands the ramifications of the latest legislation regarding food handling — including FSMA and HACCP. It should be able to point to material handling data sheets for every item of food it handles. Give the 3PL bonus points if it can personalize the handling instructions to each shipper.

Make sure the 3PL understands the rules in all the geographic areas where you ship, since local regulations can vary.

3. Certified Processes

FSMA requires specific documentation. The 3PL you choose should already be aware of the rules and have processes in place for compliance. It should have taken the initiative to have its processes audited for compliance. After all, compliance with regulations is part of the service it provides for you.

Ask the provider to show you its method for conveying handling instructions to carriers, and how it ensures that carriers follow the instructions. The burden of proof for cold-chain integrity or HACCP compliance falls to you, so don’t entrust your business to a 3PL that doesn’t understand it.

4. Track and Trace, Lot and Expiration Controls

Recalls happen. Your 3PL should have technology in place to provide visibility throughout the supply chain, including the ability to track and trace from end to end. Ask to see its picking process, and how it ensures first-in-first-out (FIFO) lot picking so you minimize spoilage. How does it handle expired or soon-to-expire lots? Can it segregate the goods so it doesn’t actually ship them? How does it notify you of upcoming expirations? Proactive alerting is the ideal mechanism.

5. Size and Locations

Once the 3PL you are considering has proven it understands how to handle food products safely and legally, the next step is to ensure it can provide the coverage you require. It should have offices in or near your distribution points. Ask to see the 3PL’s customer list. You don’t want to be much larger than its current largest customer because it may not be equipped to deal with your volumes. You also don’t want to be among its smallest shippers, because you may not get the attention you deserve.

Make sure the provider is fiscally sound, especially if you are entering this relationship for the long term.

6. Technology

Technology is fast becoming the biggest differentiator for a 3PL. Ask about the systems it uses for collaboration and visibility. Does it have automated picking capabilities? Are your business systems easily compatible if you want to integrate, or does it provide a shipper portal for 24/7 access? What are its future technology plans? A good 3PL should be excited to talk about its technology because it would know it’s a key differentiator. If the provider is reluctant to talk about it or lagging in the technology arena, it will not be a good long-term partner.

Your business depends on a great 3PL, and your customer’s health and safety may rely on it as well. Take the time to thoroughly vet any 3PL you are considering before signing on the dotted line.

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.

Risk, food safety

Does Your Risk Control Program Meet FSMA’s Demands?

By Food Safety Tech Staff
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Risk, food safety

Identifying, prioritizing and managing supply chain risks is critical to maintaining FSMA compliance. Under the Preventive Controls rules, food companies must implement a hazard identification system for any known or foreseeable hazards. During an upcoming webinar, David Acheson, Ph.D. and Miles Thomas will discuss how data can help companies manage supply chain risk, methods for analyzing and prioritizing hazards, and mitigating risk to achieve FSMA compliance. They will also shine a spotlight on global trends in food safety and authenticity threats.

Learn more during the webinar, Don’t Get Blindsided by FSMA! April 27, 2017, 1 pm ET.

FSMA, Food Safety Tech, FDA

FDA Announces Waivers to FSMA Sanitary Transportation Rule

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

As of today, April 6, larger companies are expected to be compliant with the FSMA Sanitary Transportation rule. However, yesterday FDA announced its intention to wave the rule’s requirements in specific cases in which foods did not need to be protected from becoming unsafe. The FDA waivers apply to businesses that have transportation operations subject to State-Federal controls, including:

  • Businesses that have valid permits and inspected under the National Conference on Interstate Milk Shipments’ Grade “A” Milk Safety Program, only when transporting Grade “A” milk and milk products.
  • Food establishments that are authorized to operate when engaged as receivers; shippers and carriers in operations in which food is delivered directly to customers; other locations the establishment or its affiliates operate that serve or sell food directly to consumers.
  • Businesses that transport molluscan shellfish that are certified and inspected under the requirements established by the Interstate Shellfish Sanitation Conference’s (ISSC) National Shellfish Sanitation Program (NSSP) and that transport the shellfish in vehicles permitted under ISSC authority.
Erika Miller
FST Soapbox

When Worlds Collide

By Erika Miller
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Erika Miller

The Foreign Supplier Verification requirements of FSMA have perhaps been less well advertised than those of the Preventive Controls rules, but the compliance dates are fast approaching nevertheless. On May 30, 2017, a new field will appear in Ace, the software system wherein importers declare their imports and, in so doing, fulfill the requirements of many different U.S. regulations. This seemingly innocuous event will have serious and wide-reaching implications for all entities involved in the importation of food intended for consumption in the United States, but perhaps no one will be more affected than brokers and distributors, for they have long relied on the protection of their sources to ensure a share of the profits on their imports.

Exchange knowledge about managing your supply chain at the Best Practices in Food Safety Supply Chain conference | June 5–6, 2017 | LEARN MORE

Brokers and distributors often provide an important service by taking care of the legal requirements to bring a product into the country, and by purchasing large quantities of product that can then be broken down into more manageable quantities for their customers. Nowadays, information that was used to be transmitted to Customs and Border Protection (CBP) on paper forms is entered in Ace, which is a one-stop-shop software system that aggregates data on all imports. This data can then be accessed by several government agencies, including the FDA. Anyone wishing to bring food into the United States for consumption on our shores will be required to declare a Foreign Supplier Verification Program (FSVP) Importer for the food, and the names entered as FSVP Importers will then form a database from which the FDA will work to ensure enforcement of this program.

This FSVP Importer may or may not be the same as the Importer of Record (IOR). Large companies are already re-writing their import contracts to include this requirement, for it’s quite clear already that communication of expectations will be vital to the success of this program. The FDA recognizes that it is possible that unscrupulous parties may enter the name of a party as the FSVP Importer who does not realize their name has been entered; however, the main recourse for the injured party is to better communicate with their supply chain to ensure the issue does not arise again.

Although these technicalities are important to understand, it is perhaps even more interesting to consider the implications of all the FSMA requirements surrounding this rule. For example, FDA’s requirements for records are very clear, and each record must include the name and address of the facility at which it was created, in addition to other information. The rules of FSMA are also quite clear in stating that brokers or distributors cannot provide the necessary food safety paperwork on their own; rather, this documentation must come from the grower, manufacturer, processor—for a true farm-to-fork implementation, in keeping with the spirit of the rule.

What does this mean for the broker who sells to a large company that is perfectly capable of purchasing the large quantities required to “go direct”? Will they be cut out of their livelihoods by being forced to give this information to their customers? This is a question that has been raised in all the FSVP Importer classes held to date, and in reading the rule, it appears clear that the broker is expected to disclose their source. How else is it possible for them to follow the law, and assure their customer that the food was produced with the same level of food safety as if it were made here in the United States?

Foreign Supplier Verification, TraceGains A Comprehensive Guide to the Who, What & How to FSMA’s FSVP Rule

Have confusion regarding some of the specifics to FSMA’s Foreign Supplier Verification Program rule? You’re not alone… Are you the importer? What if you’re a broker? What are the actual contents of a verification program? This comprehensive guide can help answer some of these lingering questions, and will provide you with a couple real examples of FSVP in action.

This is a particularly interesting conundrum because at its heart, this is an issue of information exchange between private companies. Although the FDA does expect that some entity will keep the records to satisfy the requirements of the FSVP, they will not expect this paperwork to be transmitted to any government agency prior to approval of a load for import. Rather, the FDA will send electronic records requests to the entities declared as FSVP Importers later, wherein they will ask for the records related to previous shipments. Should the FSVP Importer declared at import not produce the required documentation at the time of this request, enforcement activities are expected to result (eventually, once the rule has gone into effect and regulation has begun).

It stands to reason that some entities may continue to operate in a fool’s paradise for some length of time, thinking nothing has really changed. This is incredibly dangerous for the business, its reputation and indeed, for the consumer. Times are obviously changing across the globe, and the FDA is doing its best to keep up with the demands of an increasingly complex global society. The broker who enters his own name without understanding the implications of what that means may find himself on the receiving end of a number of records requests from the FDA, with no records on hand with which to fulfill them. This is not an enviable position, and will likely result in an in-person visit from an investigator if the food imported is considered high-risk.

There are, of course, many brokers and distributors who are proactive and concerned about food safety. These are the companies that are sending multiple individuals to FSVP training to stay informed about the changing face of import regulations. Many of these brokers and distributors already gather paperwork such as third-party audit reports and letters of guarantee from their suppliers, but they do not transmit this information to their customers. Should these proactive companies be essentially punished for following the letter of the law? Even if a purchasing department has a warm personal relationship with their broker or distributor, if the C-suite sees an opportunity to save a substantial sum on their commodity of choice while increasing transparency in the supply chain, certainly those decisions will be made without regard for hurt feelings.

What about redaction? Can the brokers or distributors redact the sensitive information from the documents, and transmit them in that way? Perhaps, but after consultation with a brilliant and experienced legal mind, redaction may not be the panacea it first appears. For example, redaction of documents is a boring and redundant task, frequently relegated to the intern or other low-paid office worker due to its repetitive nature. These workers may perform the redaction lackadaisically, or use CTRL-F to find all appearances of the information to be redacted. In doing this, they often miss important information that appears in an image or is misspelled. Additionally, anyone who has spent much time in the food industry understands that this is a small world, and it is often easy to recognize a document simply from the style in which a particular company presents all its documentation. Clues such as colors, partial logos and incomplete redaction can lead to a shrewd individual deducing the original author of the documents quite easily.

Although there are no answers to be had at this juncture, especially considering that the compliance date for these requirements has not yet passed, it is important to think about all these implications, along with many others that are being brought to the forefront through the Importer workshops approved by the Food Safety Preventive Controls Alliance. The FDA readily admits they are learning right alongside industry, and they have every intention of continuing to educate while they regulate. If these issues cannot be hammered out between industry representatives and the FDA directly, it stands to reason the issue will eventually be brought before the courts, where the demands of capitalism will be weighed against those of regulation for food safety. Is there a legal precedent for this situation? If you know of one (or several), please leave the information in the comments below to continue the discussion.

Consumers and Foodborne Illness

Smaller Food Companies Gaining Competitive Edge

By Maria Fontanazza
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Consumers and Foodborne Illness

A recent survey gauged the revenue growth of the top 25 large food companies at just 1.8% versus small and mid-size food companies, which grew at an estimated 11-15% since 2012. Changing consumer preferences for healthier food, non-GMP, organic, gluten free, and fresh foods are presenting an opportunity for smaller companies, which have the ability to react faster and capitalize on consumer demands. In a Q&A with Food Safety Tech, Randy Burt, partner with A.T. Kearney, explains how consumer influence is changing the food landscape and impacting food safety.

Food Safety Tech: Are consumers favoring small and mid-size food companies over large food companies? If so, why? What factors come into play?

Randy Burt: Small and mid-size food companies are winning against larger food companies primarily due to their flexibility and innovation capabilities, according to A.T. Kearney’s recent report “Is Big Food in Trouble”. Consumer demands have changed and smaller companies have been much faster at offering products that align with where the consumer is today and is headed in the future.  Specifically, consumers demand more products that are free-from artificial ingredients/natural, fresh, local, offer, transparency in production practices and novel tastes and textures.  Companies able to hit key elements of those characteristics and communicating an authentic brand story are experiencing tremendous growth.

The start-up, fail-fast mentality embraced by many smaller firms allows them to test and refine products quickly without the set of formal, and time consuming, new product development processes typically required by large CPGs. Many small companies are introducing products to service a consumer need; those that resonate with modern consumer values are winning in the marketplace.  (Note that many small players are failing as well, but there are way more products being launched by food start-ups than there used to be.)

FST: What new pressures do companies face from consumers? How does this impact a company’s tactics in food safety?

Burt: Consumers today expect to know not just how their food tastes but also where it came from and how it was produced. More and more, consumers expect food companies to source food sustainably and treat labor fairly and animals humanely, while eliminating certain fertilizers, pesticides and artificial ingredients.

Food companies have and must continue to develop new food safety protocols and processes to address the changes in production required to meet these consumer expectations.

FST: Is FSMA having an effect on how larger food companies are approaching business decisions mentioned in the report (i.e., acquisitions of small companies, looking at emerging brands)?

Burt: FSMA is having a broad impact on the industry and the impact is probably felt more by the smaller start-ups than the larger firms.  It is an issue that is almost inversely related to the innovation challenge the larger firms face.

Larger firms generally are better positioned to comply with FMSA. The burden of FSMA is felt more heavily by smaller firms as they have food safety processes and protocols that are less mature as compared to larger organizations.

As larger food manufacturers evaluate acquisitions of smaller players, gaps relative to FSMA certainly are a factor due to the potential cost and liability issues, but we have not seen FSMA consistently be a major barrier to acquisitions, just an important piece of the overall set of considerations.

Burt will be speaking during the opening keynote address of this year’s GMA Science Forum on Wednesday, April 19 in Washington, D.C.

Tim Daniels, Autoscribe Informatics
In the Food Lab

Using LIMS to Get In Shape for FDA’s Visit

By Tim Daniels
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Tim Daniels, Autoscribe Informatics

FSMA is a major reform of the U.S. food safety laws. It shifts the emphasis for food safety to preventing contamination during manufacture instead of just responding to it. As part of the implementation process, the FDA will enforce these new rules during routine random inspections at food manufacturing sites. With such a significant change in emphasis, Shawn K. Stevens of Food Industry Counsel LLC, released an FDA Inspection Checklist. The checklist is designed to help food and beverage manufacturers to prepare for an agency inspection and to ensure they have the required controls and checks in place. Before we look in more detail at the checklist, it is worth reviewing some of the underlying requirements.

Some Basic Requirements

One of the fundamental requirements of FSMA is the establishment of an environmental monitoring program at each facility. It defines the testing protocols for appropriate microorganisms and verifies that the preventative measures undertaken are effective. Clear procedures and systems are required to identify the test microorganisms most suited to the risks in their systems. They need procedures to identify the locations from which samples will be collected and the number of sites to be sampled, since the number and location must be adequate to determine whether the preventative controls are effective. They also need to identify the timing and frequency for collecting and testing samples. The tests to be conducted must be specified, including the analytical methods used and the corrective action procedures in the event that testing detects an environmental pathogen or an indicating organism. Just as importantly, all of the data associated with this testing program needs to both be recorded and accessible for audit purposes.

Acquiring and Managing Environmental Monitoring Data

Any environmental monitoring program will come at a cost to the food manufacturer. While the program itself will need to be set up by experts in the field, much of the implementation can be carried out by lesser-qualified technicians. So a key aspect is having the tools to implement a program where the most effective use is made of each resource available, as this keeps costs down. In principle, one such tool is a Laboratory Information Management System (LIMS).  The use of a LIMS is commonplace in QA Labs to record and monitor laboratory samples, tests and results in order to simplify and automate processes and procedures. There is a variety of ways in which a LIMS could facilitate the environmental monitoring process to enable best practice even by non-specialist staff. For example, analysis can be simplified if each set of test results can be automatically linked to respective sampling points in the facility. Out-of-specification test results could be linked to corrective and preventive actions (CAPA). Test failures at a particular sampling point could be used to trigger more frequent testing at that point according to pre-set criteria.

  • The data management capabilities within a LIMS make it possible to:
  • Implement data management strategies that increase security and availability of data
  • Eliminate manual assembly of data for analysis and audit
  • Make data more useful with easy retrieval/visibility

Perhaps most importantly, a properly configured LIMS can provide a suitable framework for set-up and adjustment by the environmental monitoring expert, while reducing the expertise required to operate it on a daily basis.

Laboratory Information Management Systems
The Matrix Gemini Environmental monitoring solution is an example of an information management system that uses the capabilities of a LIMS to record and monitor laboratory samples, tests and results to simplify and automate environmental monitoring in QA Labs. Image courtesy of Autoscribe Informatics

FDA Inspection Checklist

This comprehensive document highlights the steps that companies need to take to prepare for the inspection process, navigate the inspection itself and respond to any criticisms arising from the inspection.

There are three main areas in the checklist where a LIMS could help satisfy FSMA requirements:

  1. Finalizing written food safety systems and making sure certain employees know the plans. LIMS provides the framework to set up documented food safety sampling requirements and track microbial test results over time. This facilitates recall and more detailed investigation should a sample fail.
  2. Well organized and maintained data, and ease of records access. LIMS should be capable of date and time stamping every entry and since it will contain all the test data over time, this can be easily recalled should the need arise. Typically a standard operating procedure would be developed, which will increase testing and start “out-of-specification” actions if abnormal microbial contamination is detected. LIMS can provide a full audit trail for all test data and produce reports showing result trends over time, highlighting variance and peaks in data.
  3. Proper documentation of corrective actions. In the event of failures, investigators will want to focus on the particular sample points and the “out-of-specification” actions that were initiated to investigate and resolve these failures. Typically three months of data is requested around these sample points, although up to two years’ worth of data could be requested. LIMS should allow data to be instantly pulled from the database as a report for further investigation.

FDA investigators will be most interested in what happens in the event of a failure and what learning gets incorporated into your regular regime. What happens when an out-of-specification result is obtained is the crux of preventive testing regimes. Actions might include changing sanitation methods, increasing test frequency or locations in areas of concern, segregating traffic patterns, re-training staff and so forth. Some of these actions, such as increasing test frequency, can be automated. All actions must be clearly documented, which can be done by adding appropriate records directly into the LIMS. This captures the actions that each quality improvement cycle needs in order to discover the likely root cause of any problems and how they may be avoided in the future.

All corrective actions should identify the root cause of the deviation, actions taken to prevent recurrence and, if product safety is not affected, a written conclusion (supported by factual and scientific data) that the deviation “does not create an immediate food safety issue.”

The emphasis should always be on preventive actions to remove potential points of failure before issues get into the final delivered products causing stock loss and costly recalls.

Configuring a LIMS for Environmental Monitoring

While most LIMS in principle provide the capability to handle the requirements of environmental monitoring, the system will need to be configured to do so, and this may not be a trivial exercise. The software will need to be configured to represent user requirements in terms of workflows, screen designs, menu designs, terminology, numbering schemes, report designs and much more. For many LIMS, full configuration for specific applications requires custom coding, which will require re-validation.

Once configured, LIMS can offer a practical way for food and beverage companies to document their sanitation/safety programs and instantly show written evidence of both testing and corrective actions when the FDA comes knocking.

Randy Fields, Repositrak
FST Soapbox

Foreign Supplier Verification Rule: Top 5 Questions Answered

By Randy Fields
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Randy Fields, Repositrak

The Foreign Supplier Verification Rule, part of FSMA, requires the importer of food to meet the same stringent guidelines found within FSMA’s Preventive Controls rule. Companies defined as the importer are now required to deploy a Foreign Supplier Verification Program (FSVP) that ensures their foreign supply partners are producing the imported food in compliance with processes that meet the FDA’s standards for preventive controls and safety.

Companies importing food products must anticipate hazards associated with the imported food and evaluate the risk posed by the food based on the hazard analysis and the supplier’s record of compliance every three years or when new information comes to light. In general, these companies must maintain the integrity of their extended supply chain.

Register for the Food Safety Supply Chain Conference | June 5–6, 2017 | Rockville, MD | in-person or virtualAnd now, the questions:

1.  Are you considered to be the importer under FSMA’s Foreign Supplier Verification rule?

Under FSMA, the importer is the U.S. owner or consignee of an article of food that is delivered to the United States from any other country at the time of U.S. entry. If you are still unsure as to whether you are the importer, try answering the three questions below. If you answer “me” to any of them, you might want to have your food safety team confirm your status as the importer with your foreign suppliers:

  • Who controls the finances of the imported food?
  • Who controls the agent?
  • Who controls the goods? Whose truck picks it up or in whose DC is the product stored?

2.  What comprises a FSVP?

The new regulation puts an additional burden on importers since it requires them to establish and follow written procedures for verifying foreign suppliers and correcting any violations of FDA standards. If you are considered the importer, you must have a separate FSVP in place for each food product and each foreign supplier, even if the same food is obtained from a number of suppliers. Proper documentation is essential to maintaining access to U.S. food markets since this will be the primary means by which FDA will establish compliance with FSVP. If you are not the importer, it might make sense to ensure you have copies of what your importer says he or she has on file.  (Hint: It’s a good idea to trust but verify in this situation.)

3. Can you meet the FSVP challenge?

Any record requested by the FDA must be available within 24 hours and could date two years back. If you don’t have an automated system, it’s time to consider one, as it’s really the only way to manage the range of documents required by a FSVP across a retailer’s or wholesaler’s vast supplier base. (Verification includes on-site audits, sampling/testing, records, certificates of conformance and continuing guarantees.)

4. What is the CEO’s responsibility under FSVP?

Senior executives in the extended retail food supply chain are personally responsible not only for their company’s compliance with FSVP, but also for verifying the compliance of their upstream supply chain.

5.  Why is Now the Time to Take Action?

Implementing a new system with suppliers will take time. It is your responsibility to ensure you and your suppliers are in compliance by the deadline. FSVP compliance goes into effect for most companies at the end of May 2017.

While we like to think of food safety as not being a competitive advantage, it can be used as leverage against the competition. So it’s critical to understand not only what the importer should be doing to comply with FSVP, but also what the supplier can do in advance to help the importer meet its obligations under the law.