Tag Archives: documentation

Compliance, food safety

Leveraging FSVP Compliance: Do Less, Get More

By Benjamin England, Nicole Trimmer
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Compliance, food safety

With an ever-expanding international food trade and new government demands for food safety and supply chain transparency, the U.S. regulatory landscape is becoming increasingly more complex. FSMA (especially the Foreign Supplier Verification Program) aims to shift responsibilities for imported food safety from FDA to importers in an effort to reduce the regulatory burden on FDA. New regulations bring new burdens to food trade stakeholders, requiring significant investment. However, many of the data obligations of the FSVP rule dovetail with other agencies’ requirements.

Investments in one dataset can be leveraged to improve a company’s overall compliance related to international trade. The key is to integrate FSVP requirements into a strong regulatory compliance program without breaking the bank. This requires identifying data overlap, utilizing compliance integration to work smarter, not harder, leveraging the window of opportunity to collect more (and necessary) data from your foreign suppliers, and calling in the right help when needed.

TRUST…..BUT VERIFY: 2018 FSMA Focuses on Supplier Verification Activities | Learn more at the Food Safety Supply Chain Conference | June 12–13, 2018 | Rockville, MDToday’s International Supply Web

No longer can we reasonably talk about establishing, monitoring and maintaining a supply “chain” when importing anything. International trade in food and its ingredients is rarely bilateral—except for perhaps fresh produce, meat and seafood. Instead, food moves throughout a complex supply web of international transactions. Most processed food now contains ingredients from multiple countries, leading to food safety verification challenges and country of origin questions for finished goods.

The international supply web includes farms (land and aquaculture), agriculture cooperatives, food grade chemicals manufacturers, color and flavoring formulators and manufacturers, raw materials processors and fabricators, finished food processors & packers, warehouses, transportation companies, cooking, canning and irradiating facilities, shippers, exporters, product and commodities brokers, importers, wholesalers, retailers and e-tailers. Any (or all) of these players may be small operations located in different countries or multi-national conglomerates operating on several continents. There is very little food consumed in the United States that is not affected, in some way or another, by international commerce and trade.

Shift to a Preventive System

In 2011, Congress passed FSMA with the goal of moving U.S. food safety from a reactive to a preventive system, and integrating HACCP-like principles into the production of all food. Over the ensuing years, FDA issued seven major regulations that address various facets of food safety.

The Foreign Supplier Verification Program (FSVP) rule was included as a way to ensure that foods imported into the United States are produced in a manner that meets U.S. safety standards. FSVP requires that “importers,” which can be the distributors or retailers of products, verify and document the steps taken to ensure safe production of animal and human food. While the exact FSVP requirements vary depending on the commodity, the FSVP process often includes developing, maintaining and documenting a food safety plan and, as its name suggests, verifying that foreign suppliers are controlling for appropriate hazards. Developing and implementing these plans requires a wide variety of skills, including hazard analysis and risk assessment, establishing preventive controls, developing recall plans, and careful documentation of the process. FSVP also requires that verification activities be carried out by parties who have specific preventive control training, or “PCQIs” (Preventive Control Qualified Individuals).

Most importantly, FSMA and the FSVP rule shift the burden of safety from FDA to the importer. With increased interconnectedness, flaws in food safety documentation can become magnified throughout the system. Note that FSVP covers food safety only—not necessarily food traceability or food security defense—although there are opportunities for crossover ROIs. To achieve FSVP compliance, you need to know who is handling your food before it is imported, what they know about food safety, and how they apply food safety principles.

Cross-agency Data Usage

Approaching FSVP as a stand-alone regulatory compliance initiative is expensive and inefficient. Many activities and data elements that must be kept for other government agencies and their compliance programs should be linked together. The data your foreign suppliers must provide to international carriers for advanced notice to U.S. Customs and Border Protection (“CBP” or “Customs”) by importing carriers (airlines, trucking companies and vessel operators) is relevant to both Customs entry and FDA food safety compliance and documentation. This overlap presents an ideal opportunity to relieve the burden of the new FSVP requirements and kill two birds with one stone. And the overlap and leveraging opportunities are actually quite substantial—if one knows where and how to look for them.

For example, the USDA’s National Organic Program (NOP) regulations specify requirements for the processing, handling and labeling of raw materials and processed goods to meet organic standards. Organic labeling and marketing claims are affirmative assertions that the labeled food has not been exposed to processing steps, processing chemicals or particular substances (e.g., sewage sludge, ionizing radiation) that would cause it to fall out of the regulatory bounds of an organic food product. Where organic processing and handling crosses over to food safety, leveraging organic compliance documentation buttresses the safety of the resulting food—and the importer’s FSVP program.

Additionally, much of the information that the importer must know to properly classify their product under the Harmonized Tariff Schedule (HTS) is the same information that the importer needs for their FSVP plan; the importer must know the products, what they are made from, how they are processed, and how they are intended to be used to both properly classify and verify the safety of their product. Because FDA requires the importer to verify that its foreign supplier has a system that meets the domestic food safety standards, the foreign supplier must also be able to identify its own ingredient and raw material suppliers and their systems for food safety, as applicable. Therefore, the food importer’s FSVP process promotes documentation compliance with CBP’s and other government agencies’ requirements governing the country of origin of materials for applicability of preferential duty rates (e.g., under a free trade agreement) and country of origin labeling.

Another example of data overlap is the FSVP requirement for supplier verification and the responsibility to show correct valuation of your product for Customs. FSVP requires that you verify your suppliers and ensure your product is genuine, and Customs requires that you declare an appropriate valuation and identity for your shipment. If Customs investigates your shipment and determines your valuation is incorrect, it may trigger the Department of Commerce to investigate whether there are anti-dumping and countervailing issues going on with the product.

Issues with anti-dumping and countervailing duties are extremely time-consuming and expensive. In both 2008 and 2016, federal authorities investigated rumors of companies circumventing anti-dumping duties by transshipping food products through third countries (to conceal actual origin of the material). When Customs investigated a honey processing plant, they found evidence that the purported processor of Vietnamese honey was receiving finished product from China and relabeling it as originating from Vietnam. When importers declared imported Vietnamese honey, Customs determined from trace mineral testing that the honey was, as they suspected, Chinese. Customs seized the product. The lesson to learn from this is to know your suppliers and the actual supply web. In the case of country of origin violations, not verifying the country of origin can be costly. Where CBP finds negligence is involved, the agency can look back five years to recoup lost duty plus interest, and can even reopen old liquidated entries and assess monetary penalties. In completing your FSVP plan, requesting documentation demonstrating origin is a small additional step that furthers the strength of CBP-required documentation to support the origin declaration at entry. That’s leveraging.

Document, Document, Document

Under the Customs Modernization Act of 1993, the compliance watch-words for all importers (and customshouse brokers) are “record keeping,” “shared responsibility,” “reporting,” and “due diligence.” Anything that is required for a proper importation is subject to CBP review and audit—whether the requirement arises as supply chain and source data under the Seafood Import Monitoring Program (SIMP) under the National Marine Fisheries Service (NMFS), or organic labeling and compliance under USDA’s NOP regulations, or speciation documentation under the Lacey Act enforced by U.S. Fish and Wildlife (USFW), or FSVP implemented by FDA. Therefore, the engagement between food importer and foreign food supplier forced by FSVP opens the opportunity for the importer to clarify and shore up its documentation obligations for many other coexisting regulatory regimes.

A clear demonstration of this fact is borne out by the regular process that ensues when CBP issues to an importer of record a Customs Form 28 (or “CF28”). The CF28 is a CBP request for additional information relating to an imported shipment. The importer is usually required to respond within 30 days of its issuance. But ordinarily the CF28 is issued months (and sometimes years) after the importation occurred. Therefore, the CF28 process represents a significant challenge to the importer’s record keeping and compliance documentation systems, and legal liability to the importer’s bottom line.
Documents needed to respond adequately to a CF28 include contracts, purchase orders, packing lists, shipping documents, declarations to government authorities throughout the import process, powers of attorney, country of origin certifications, emails and other communications discussing any of these documents. CBP requests these documents to confirm the proper electronic data was submitted with the importation. And, of course, CBP is checking to see if the importer is attempting to circumvent U.S. import or export laws that may deprive the government of revenue.

The identity and location of an importer’s trading partners (including the foreign supplier and its suppliers), contracts between and among them (e.g., related to description, processing methods, equipment used, quality and condition of goods), origin documentation, proofs of packing and shipping, etc., are all subject to production via the CF28 process. Penalties for errors in the documentation that result in a regulatory or administrative action are imposed upon the importer (for failing to document or exercise due diligence in performing its function as an importer under U.S. law).

The FSVP regulation presents an ideal opportunity for the importer to establish and populate a compliance program that integrates its FDA import regulatory obligations with those of CBP and other regulatory agencies, as applicable. Failing to take this rare opportunity—at a time when foreign suppliers are expecting probing questions from their U.S. trading partners—is a mistake.

Because the government is more connected, it is essential to change how you prepare for and respond to issues that arise. Just as the FDA’s FSVP rule aims to move food safety from a reactionary to preventive system, coordinated proactive compliance with all government agency requirements will be necessary for the future. Further, with new regulations, your customs broker may not be equipped to deal with certain areas or when administrative matters escalate. But how do you prepare for any eventuality when the enforcement possibilities seem endless?

When preparing your FSVP plans, reviewing your Customs documentation, and reviewing other government agency requirements, it is critical that you think through all the potential issues that may arise with your product or its supply chain, and address them proactively in your documentation. What might an inspector or compliance officer think about the information provided? Is it thorough, clear, and logical? Does it tell a consistent narrative? What if another agency sees this information? Will they have further questions? The ultimate goal is accurate and thorough data for submissions to FDA, Customs and any other partner government agencies.

Key Steps to Prepare for the Worst-case Scenario

Lastly, let’s not forget that part of being prepared is preparing for the worst-case scenario. What happens when you are confronted by an issue? We recommend taking four key steps. First, marshal your resources (documents, documents). Second, ask, “Who are the key players in the story (e.g., which agencies are involved or could possibly be involved, and what are they requesting)?” The third question, a bit less straightforward, is, “How must I respond? (e.g., is the agency within its regulatory authority and required time constraints; are there conflicts of interest; what is the potential legal exposure to risk for different actions)?” Finally, do a gut check: Are the examinations subjective in nature or qualitative (rather than quantitative)? Is any required testing appropriate for the product? If you feel you cannot confidently answer these questions using current staff, we recommend you prepare for import issues by selecting professionals who have experience with integrated agency regulations and legal compliance requirements. The keys to expediting the process when working with multiple government regulatory agencies are integrating your compliance to ensure you have a true green-means-go light before you ship and being able to present a clear and consistent regulatory narrative to all agencies. This requires a clear understanding of how the government regulatory requirements actually intersect.

Glen Ramsey, Orkin
Bug Bytes

Implementing Pest Management Changes for FSMA

By Glen Ramsey
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Glen Ramsey, Orkin

Preparation is the key to success for any ongoing endeavor. In an industry where your enemies are fighting for survival at the expense of your business, you must be ready for anything. Your opponents are crafty, adaptable and more prevalent than you think.

No, I’m not describing your competitors. I’m talking about pests—a major threat to the integrity of food products and a threat to any facility’s bottom line. Whether it’s stored product pests contaminating inventory or rodents spreading pathogens as they skitter across equipment, pests are a risk that should be minimized.

With FSMA in full effect, preparation is more important than ever. FSMA mandates a proactive approach to food safety, and by extension, pest management. It’s important that the pest management program is exhaustive and integrates seamlessly into the overarching food safety plan.

Most, if not all, food processing facilities currently use an integrated pest management (IPM) program to help minimize the chance of pest problems, but FSMA puts more emphasis on being proactive to keep pests far from products at all times. Naturally, this doesn’t mean that a pest sighting in a facility is the end of the world, but it means that it should be resolved quickly, investigated and documented to help prevent such an occurrence from happening again.

Specifically, FSMA has numerous stipulations that trickle down to pest management.

  1. Hazard analysis. First, a comprehensive inspection should be done to identify the high-risk areas in your facility where pests may take residence. Entry points, potential food and water sources and harborage areas should all be noted.
  2. Preventive controls. Include regular facility maintenance reviews and a strict sanitation regimen in your food safety plan to help minimize the use of chemical pest management treatments.
  3. Monitoring. Use devices and employees to keep tabs on pest activity and conducive conditions to ensure preventive controls are working and executed across the facility.
  4. Corrective actions. Implement and enforce pest management solutions such as exclusion strategies (e.g., weather-stripping, door sweeps, vinyl strip doors), traps (e.g. pheromone traps, insect light traps, bait boxes), air curtains and repellants to help manage pest activity.
  5. Verification. Schedule regular service visits with your pest management professional to verify corrective actions are working to reduce pest problems over time. These visits should include an annual facility assessment and pest trend analysis, both of which help determine potential areas of improvement over time.
    6. Record keeping and documentation. Document every action taken to prevent pests. That includes corrective actions and their results to prove that your written IPM and food safety plan has been implemented and is effective in helping to manage pests at the facility.

With these key components accounted for, it will be easier to be prepared for pests. But, even still, the real-world implementation of these tactics might not be abundantly clear. That being the case, let’s take a look at what food processing facility managers can start doing today to help protect their facilities and demonstrate a proactive approach to food safety.

So, what’s the best way to be more proactive in preventing pests?

Well, that question has a plethora of possible answers, but four of the most important are sanitation, exclusion, staff training and monitoring.

Sanitation

Perhaps the most important of all, sanitation helps to eliminate two key attractants—food and water—that draw pests inside a facility. Any spot where food particles or moisture is collecting, pests will be looking to find.

But sanitation shouldn’t seem daunting. Here are some actions you can start doing today to step up your sanitation program:

  • Wipe down equipment regularly to break down the buildup of organic materials.
  • Wipe off countertops and sweep floors in common areas where food is present, then sanitize with an organic cleaner afterwards to eliminate any remaining odors.
  • Take out the garbage at least daily, and keep dumpsters at least 50 feet away from the building to avoid giving pests a harborage location nearby with an easy path to get indoors. Make sure to cleanse garbage bins and dumpsters regularly, or they’ll become attractive to pests, too!

Exclusion

A big part of preventing pests from getting inside a facility is simply blocking them out using exclusion.

During an inspection, a pest management provider will walk around the interior and exterior of the facility and look for any potential entry points for pests. They should recommend you seal any cracks and crevices they notice, as many pests can fit through extremely tiny gaps. For example, mice can fit through a hole the size of a dime. Gaps should be sealed with a water-resistant sealant to keep pests and moisture out.

In addition, make sure to keep windows and doors closed as much as possible or use screens to block pests. Automatic doors can help in this way, especially when paired with an air curtain to blow flying pests away from entrances. Pests can often come in through the biggest gap of all: The front door!

Staff Training

It’s always better to have a team behind you. Training employees on the basics of an IPM program and what they can do to help will take some of the weight off your shoulders.

Many pest management providers offer free staff training sessions, which can help employees understand what to look for around their work areas and what to do in the case of a pest sighting. Consider creating your own pest sighting protocol to make it clear what employees should do if and when a pest is spotted. They’ll need to record when, where, how many and what kind of pest(s) were seen at the time to give your pest management provider the best chance to create a customized solution to resolve the issue. If you can catch one of the pests in a container for future identification, that’s even better.

Monitoring

While employees can help by keeping an eye out for pests, it’s important to have ongoing monitoring techniques to measure pest activity around the facility.

Monitoring devices are a great way to do this, and your pest management professional can help you place them strategically around the hot spots in your facility. Fly lights, bait stations, pheromone traps and more can capture pests and serve a dual purpose. First, they’ll reduce pest populations around the facility, and, second, they’ll allow you and your pest management provider to see how many pests are present in certain areas.

Over time, this will give you a feel for which pest issues have been resolved and which continue to be a problem. That can determine the corrective actions taken and the long-term food safety plan, which will demonstrate a commitment to constant improvement. That’s a great thing to have on your side, especially when an auditor happens to stop by.

Documentation

I know, I know—this wasn’t one of the four “answers” listed, but it’s still incredibly important! Documentation helps ensure you get credit for being so prepared.

It’s recommended that facility managers keep a few documents on hand to keep things simple. The food safety plan, annual assessments, sighting reports, a list of service changes over time, a list of monitoring devices and proof of your pest management professional’s certification are all important documents to keep updated and ready to go. That way, you can rest easy knowing you’re prepared at a moment’s notice.

It is never too early to start preparing. Pests aren’t going to stop searching for a food source anytime soon, so don’t stop your proactive efforts to keep them at bay. Your financial department will thank you.

Steven Burton, Icicle Technologies
FST Soapbox

Food Recall Strategies: What You’re Missing (And What You’re Risking)

By Steven Burton
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Steven Burton, Icicle Technologies

You’ve heard the horror stories of product recalls: The Peanut Corporation of America in 2009, Blue Bell ice cream in 2015, and Darwin’s Raw Pet Foods this year. Beyond the nightmare scenario, the truth is that food recalls are common—even for companies that take food safety seriously, train effectively and keep excellent records. Yet all of these things, when done properly and efficiently, go a long way to reduce the impact and severity of a recall.

Unfortunately, many food manufacturers, although required to have a written recall plan, aren’t ready for the challenge. Without the proper systems in place, businesses needlessly risk their customers, reputation, revenue and future.

Risks Of Inadequate Recall Strategies

Resolving a recall can take years and potentially millions of dollars in fines, product shipping and disposal cost, production line downtime, lawsuits, and lost market share as consumers lose trust in the company. But there are two strategic errors that can amplify these consequences—and they both have to deal with traceability.

The first problem we frequently see is lot codes not being specific enough. Rather than breaking up production into discrete lot codes so the scope of recalls can be as limited as possible, some facilities just run the same lot code for many production runs. The record we have seen so far is three years! When a recall occurs,this results in a recall of massive scope that can easily bankrupt a company.

The second problem that is even more common is a lack of dynamic documentation. Assembling transactions using disconnected records from different departments can be time-consuming and error-prone. When you’re under pressure from regulators or auditors to connect the dots between an ingredient and customers through complex, multi-stage production processes using such a record system, it can cause stress and potential audit failures.

These two missing pieces make recalls larger, more time-consuming, and more expensive than necessary due to a lack of precise traceability. Let’s take a look at the two ways you can fill these gaps in your system and mitigate the consequences of recalls.

Get Specific with Ingredients, Suppliers and Lot Codes

Streamlining your product lines and packaging options lists is a straightforward way to reduce potential headaches in the event of a recall. The more products and packaging options with which you work, the more complex it will be to pinpoint and resolve food safety failures. Anyway, this type of housekeeping is beneficial as far too many companies have large lines where only a small subset of their products sell well at decent margins. Larger, more mature organizations tend to thin down their lines to optimize for profitability, and smaller companies can often benefit from doing the same.

The next strategy you can employ to mitigate the consequences of a recall is by being ultra-precise when it comes to your records and lot codes. The more narrowly you refine your lot coding system, the fewer items you’ll have to recall. Let’s look at a specific example of how this could have saved two companies millions of dollars.

In 2010, Hillandale Farms and Wright County Egg recalled about 550,000,000 eggs, one of the largest recalls in the history of the United States. Although the company was able to resolve the specific dates and facilities where the contaminated product originated, they had 53 million hens laying, so this level of resolution may not have been adequate enough. Had they implement traceability lot codes down to the hen house level, they may have been able to contain the recall.

Automate Your Traceability To Be Audit Ready, All The Time

The challenge of maintaining an overly broad product line or providing customized packages is that you create hundreds or thousands of variants in your products. When records are maintained manually, it becomes extremely difficult to manage recalls effectively. An Excel spreadsheet may keep a record of everything, but it’s certainly not dynamic or time-efficient when undertaking mass balance calculations.

The key here is to adopt software that you can incorporate into every department. Shipping, receiving, accounting, production—when all the records are kept in a central database, checking and updating those records becomes much easier. But the best systems don’t just centralize your collected data; they automate your data collection.

Dynamic documents automatically update each other. When a supplier changes, an ingredient lot gets swapped out, or products are shipped out, all the connected records for every department are automatically updated. No user mistakes, no failure to update the notes—just seamless, streamlined, auto-updating records.

There’s no better way to track complex production processes, control hazards, and collect all the necessary information necessary to breeze through audits than by using an automated system. With all your documentation interconnected, you don’t have to piece together the puzzle or play connect the dots—it’s all done for you, and that means you won’t waste millions on recalling products unnecessarily because you couldn’t pinpoint the exact path every ingredient took on the way to the customer.

Recalls are detrimental in every way, but they happen, so don’t get caught off guard. A little bit of proactive technology will go a long way in keeping your business afloat if you ever do face the nightmare of a recall.

Jordan Anderson, PAR Technology Corp.
FST Soapbox

Advocate for Change to Establish a Food Safety Culture

By Jordan Anderson
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Jordan Anderson, PAR Technology Corp.

Many times food companies will simply say, “We have to change our culture” or “We’ve always done things this way”, but this attitude will not remedy potential outbreaks or help develop food safety protocols.

As author and businessman Andy Grove once said, “Success breeds complacency. Complacency breeds failure. Only the paranoid survive.” This statement could not apply more to the food service and manufacturing industry.

The first step to change is convincing your organization from the top down to buy in; getting your executive team to accept the cultural change from manual paper-based approaches to digital food safety is paramount.

Common objections will be the investment and positive record of accomplishment. Taking a proactive and preventative approach to everyday food safety compliance will have a positive ROI over time while ensuring the utmost brand protection.

Presenting the potential damages of being linked to a foodborne outbreak is a great place to start. It typically will open the eyes and slightly intimidate each audience member. After all, executives and board members do not like to hear “profit loss”, “stock plunge”, and “tainted brand image”.

While this can all seem overwhelming, it does not have to be. Preparing a strategy and evaluating the processes needed to fulfill this goal will help alleviate the red tape to get this off the ground.

However, before we prepare a strategy, it is important to understand the basic premise behind food safety and how technology can enhance it.

In essence, food safety fundamentally revolves around individual human behavior. Human behavior in turn, is largely driven by culture. In order to successfully develop a food safety culture, an operation must possess impeccable leadership and incorporate the highest standards of food safety.

Most notably, the HACCP plan and individual processes created are a reflection of the human behavior that shapes and molds the culture of an organization. In large organizations, the challenges are often compounded by an increased number of locations and stakeholders (employees, suppliers, customers, etc.) Within these operations, food safety culture and human behavior can potentially become compromised due to the nature of the organization, or attitude and work ethic of the stakeholders.

Technology can assist in the development and maintenance of larger food safety cultures through the use of extensive and dynamic procedures. Human behavior can be shaped by the resources available in today’s food safety tool box. We can now overcome the arduous “pencil whipping” of safety checklists via handheld, wireless and cloud-based technologies. Such technologies are ubiquitous today in the form of apps downloaded from the internet, cell phones, reporting platforms and omnipresent communications.

History has shown that in challenged cultures, individuals often behave as though they are not a part of the whole, and operate as one, rather than as a team that is linked together under one vision and shared effort. However, during the processing, handling and storage of food, we need all stakeholders to act as a collective operation and function as one. The growing adoption of technology is the fundamental turning point that can help drive human behavior and food safety culture in a positive direction.

The introduction of FSMA has brought both challenges and opportunities to the food safety industry—the requirement to document and record actions of a larger food safety plan is one of them. Conceptually speaking, you are only as good as your records say you are. In this context, we are faced with both the challenge of maintaining a positive and efficient food safety culture, in addition to the burden of increased regulatory compliance.

However, FSMA and the innovative technological era have guided the industry to a crossroads of sorts. I suggest embracing the FSMA mentality and implementing food safety technology into your operations. This will not only protect and preserve your organization, but perhaps more importantly, it will define your food safety culture, and implement a positive change into your brand.

Dana Johnson Downing, TraceGains
FST Soapbox

Six Signs Your Quality Department Is Still in the Dark Ages

By Dana Johnson Downing
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Dana Johnson Downing, TraceGains

Increasingly, we turn to technology to simplify tasks in our personal and business lives. Platforms like Facebook and Twitter allow us to connect, shop, advertise and publish with just a few clicks. LinkedIn is where people turn to prospect for new business, publish articles, discuss issues within industry groups, and look for a job. Need a ride? Apps like Uber and Lyft can usually get you where you’re going cheaper and more easily than a taxi. Devices like Google Home and Amazon Echo can listen to your voice commands to play music, manage your shopping list, adjust your lights, or tell a joke. And experiments are underway for driverless cars, which could make us the last car-owning generation.

Food safety documentation

With technology automating and solving so many tasks, how is it possible that food production is still dependent on paper-driven and manual processes?

The current way of doing things in the food and beverage industry is outdated, labor intensive, and—most importantly—error-prone. Under FSMA, companies need to be able to justify their decisions and processes, and of course, document them. It’s not only critical for brand protection—it’s a regulatory requirement. Ignorance is not bliss. Now, senior management is obligated to demonstrate their commitment to food safety and they risk criminal prosecution if their operations don’t measure up. There’s too much at risk to keep doing things the same old way. The following are some signs that your quality department is still in the Dark Ages.

1. You’re using clipboards.

In defense of clipboards, they were a wonderful invention. They are quite well suited for gathering signatures on petitions to save the whales or signing up for a PTA bake sale. But if you’re still using clipboards to log temperatures or document sanitation procedures, then your food safety records are not as current and organized as they could be. Inputting data later is not an effective use of time. Processes like these not only take away from the core competencies of your quality team, but they also make staff spend more time analyzing everything manually, which could lead to costly mistakes or inaccuracies. Tablets and PCs have replaced paper-based logs and other quality recordkeeping. Why make your staff do a task twice? By digitizing these records, you can ensure that your records are up-to-date in real time and reduce the likelihood of errors made during transcription. Trust me, your staff will thank you for rescuing them from extra data entry. Plus, the modern workforce expects digital solutions.

Filing cabinet, food safety documentation
Still using a filing cabinet to store documentation? All images courtesy of TraceGains

2. You’re still using a physical filing cabinet to store food safety documentation.

If you’re putting your food safety plan, supplier documents and certificates of authenticity (COAs) in a filing cabinet, you have a transparency problem. Your department isn’t the only one that needs access to those critical documents. And if everyone has their own paper copy, then you are going to have problems with version control. Solve your transparency and version control problems by keeping critical documents in the cloud where the data can be extracted, analyzed and shared internally and externally across your supply chain.

Food safety documentation
Three-ring binders are no longer an appropriate place to store important information.

3. Three-ring binders are for middle school, not food safety.

If your idea of ensuring compliance involves keeping COAs in a three-ring binder, you probably still have a flip phone, too. Seriously, 1980 called and they want their Trapper Keeper back. Whether your documents are in filing cabinets or binders, you still don’t have the transparency you need to efficiently share that information with your peers and other departments. Plus, your audits are sure to drag on longer than necessary if you are doing audits with stacks of three-ring binder instead of using an online platform where you can show the auditor any documentation they need with just a few clicks of a mouse.

4. Your suppliers send critical food safety documents to you via e-mail.

Email is a great way to communicate. It’s just not the best way to gather and manage supplier documents. Admit it; we all get behind on email, and sometimes things slip through the cracks. What happens if an out-of-spec allergen declaration gets buried under the 586 emails you receive each day? I can tell you, it’s certainly not good. The alternative is allowing your suppliers to upload those documents into a platform, so they are immediately available to you and anyone else in the company that you’ve given access to the system. Leveraging a platform, you also have access to a dashboard that can quickly show you which suppliers are in compliance and which ones have issues that need to be addressed. And if you have incoming certificates of authenticity (COAs), you can sit back and rely on software to read those documents for you and spot anything that doesn’t match your specifications or purchase order details. Isn’t it time that you not only collected supplier documents, but really use that data within the documents to better manage your incoming material to ensure food safety and quality?

5. You rely on file sharing to store your food safety and quality documentation.

SharePoint and other file sharing systems may look more modern than the paper alternative, but they weren’t designed specifically for vendor management or supply chain transparency. They can file and retrieve, but it’s not automated document management. Ask yourself how long do you or fellow employees spend searching for requested documents? Perhaps you need certain documentation for your GFSI/FDA audit, but different pieces of information are stored in various locations, either in a shared drive like SharePoint or a custom vendor portal. Every minute counts when it comes to document retrieval. These systems are often a little more than an electronic filing cabinet. They can store the information electronically, but unless it’s gathering, analyzing, validating and sharing that data across all departments, you still don’t have an automated system.

Spreadsheets, food safety documentation
If you’re still using spreadsheets, consider moving data to the cloud.

6. Spreadsheets are the main source of tracking your data.

While quality managers at competing companies are investing in the latest technology, other food companies are still inputting supplier lists and data in spreadsheets. Often, managers are reluctant to move their data to the cloud, opting instead to stick with what they know by using a spreadsheet that lacks a comprehensive system to track supplier performance in real time. This is a major disadvantage when different departments need one source of the truth about supplier performance and trend data about incoming material. Not only are spreadsheets hard to share and keep up-to-date, but the majority of them also contain errors.

  • A report by Ray Panko, a professor of IT management at the University of Hawaii, found that 88% of spreadsheets contained errors.
  • Coopers & Lybrand found that 91% of spreadsheets with 150 rows or more produced results that were off by more than 5%.
  • In a sample of 22 spreadsheets, KPMG found that 91% contained serious errors.

If your executives think automated supplier, compliance and quality systems are a “nice-to-have,” chances are you are still operating in the Dark Ages. This final advice is true no matter what software your business is thinking of implementing. Whatever the aims of the system, you must choose a long-term partner. Make sure your vendor can solve these six problems and meet the needs of your business now and in the future.

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Sanitation and FSMA: Is Your Program Deficient?

By Maria Fontanazza
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Proper sanitation plays a crucial role in the FSMA Preventive Controls rule, and FDA is paying more attention during facility inspections. However, many companies currently have deficient sanitation programs, according to Bill Bremer, principal at Kestrel Management, LLC. “It’s a key aspect of FSMA and requires that you have key personnel or a qualified sanitation manager either at each site or over each site (if it’s not local). That’s in FSMA,” he says. “In most cases, and for high-risk companies, sanitation must be supported by validated environmental testing programs (i.e., the typical swab-a-thons that FDA has done under FSMA). Sanitation chemicals that are used must be diligently approved for use and validated. In addition, chemicals must be appropriately applied, which is a big issue. These areas are key inspection points for FDA under FSMA, as well as for customer requirements. Sanitation has been elevated with FSMA and Preventive Controls, and it has to be addressed at a higher level—and for the most part, it isn’t.”

Bremer was invited by DNV-GL to discuss the importance of sanitation as a goal of FSMA in a Q&A with Food Safety Tech.

Food Safety Tech: Let’s first talk about the importance of a proper sanitation program. What are the factors at play here and what are the deficiencies with current sanitation programs?

Bill Bremer: We’re starting to conduct major sanitation program process improvements or process assessments for companies big and small. What we’re seeing in some of the key areas is that chemicals are not validated with the chemical provider. That includes the fit for use for them as well as the training of the people using them (i.e., if it’s liquid, it has to be diluted at right level and confirmed at right parts per billion).

Before you sanitize, you’re supposed to clean (in some cases it’s called debris removal). You can’t sanitize unless surfaces that are being sanitized are clean. We’re finding that cleaning isn’t done appropriately and thus companies are sanitizing over dirt, and you can’t sanitize over dirt or debris.

We’re also running into cases where the cleaning is done, and because it looks clean, a company is not sanitizing, so you run into another issue with those missed steps. And, this entire process needs to be validated and you must have records on it. You also have to support it with environmental programs, especially for high risk. So that means swabbing to make sure that once you clean and sanitize, you prove that the activities have ultimately removed any bacteria, germs or allergens from the process.

This is a high-profile area for FDA to inspect.

Some of the common deficiencies are with the program itself and the documented procedures to follow. It’s a weak area. Sometimes, a company will have different cleaning and sanitation programs documented (e.g., shift-by-shift or site-by-site), which leads to people who do the cleaning not following a standard set of instructions. It really gets down to both the programs and lack of qualified supervision and management of the cleaning and sanitation process.

Food Safety Tech: What methods should companies employ to meet FSMA requirements?

Bremer: This is an area where a diligent documentation program review is not always conducted. It’s assumed that we see the cleaning process—you see the foaming up of the cleaner, the sanitizer is all good—and we may see the cleaning record, but it’s not an SSOP, or standardized sanitation operating procedure.

However, when you look deeper and look at the documented programs, there very weak and unclear, and they need to be updated. That is one of the first things that we would investigate for a company. It’s also the qualification and training of the people—whether at the lower level or the management level, you have to be trained appropriately and the training has to be current.

Then we look at the physical process: Are they really doing debris removal in the cleaning process prior to sanitizing to make sure there’s no residue left for sanitation to be effective?

We also look at the environmental programs: Do they have a well-developed environmental program swab test? Are they using a third-party lab to validate their results? Today there are automatic test readers [that enable in-house] results. If you perform this in house, you need to have qualified people do it—and you should be checking those results with a third-party laboratory or service.

A proper sanitation program is an imperative. It’s an area where FDA is going to be investigating companies, even if they don’t have any record of products being recalled. If you look at the Blue Bell case, the big issue was that they didn’t do a good job of sanitizing their drains for Listeria, which got out of control and then it spread through the air system and to their suppliers, as well.

Melanie Neumann, Neumann Risk Services

Today’s Inspection and Audit Reality: The New Normal

By Melanie J. Neumann
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Melanie Neumann, Neumann Risk Services

Food industry inspection and audit protocols are evolving at a rapid pace, and rightly so. This is not surprising given today’s regulatory, audit and ever-changing risk landscapes, which are driving further complexity and expansion of requirements to ensure the industry is, “audit ready, all the time.”

This evolution of inspections and audits has been primarily triggered by newer regulations such as FSMA and private standards, such as GFSI and its certification programme owners (CPO’s, fka Scheme Owners) like SQF, BRC, FSSC 22000, IFS, etc. Heightened customer demand and consumer visibility into food safety incidents –many thanks to mainstream and social media– and the resulting increased demand for information has also fueled this evolution, compelling industry to focus on higher levels of transparency, both internally and throughout the supply chain.

The changes above are driving the food industry to face a new reality. One where the following questions continue to rise to the surface:

  • How have “yesterday’s” inspection and audit expectations changed from what companies are experiencing today?
  • Based on this evolution, how will “tomorrow’s” inspection and audit expectations change?
  • In short, what does the new reality or the “new normal” look like now for inspection and audit readiness?

We will take a look at what some of the first inspections are shaping up to look like under the Preventive Controls for Human Food (PCHF) Rule and the Foreign Supplier Verification Program (FSVP) Rule. Some common themes and some tips to successfully manage regulatory inspections as well as audit readiness tips are set forth below.

More Inspectors

Roll out the welcome mat because more inspectors are coming to the party. We are seeing an average of three to upwards of six regulatory inspectors performing the inspections under the PCHF rule. This may cause an initial shock wave but when you stop to consider the rationale it has a certain level of reasonableness to it. Industry has invested in its personnel for nearly two years in updated training to meet new FSMA regulations such as preventive controls qualified individual (PCQI) training, updated current GMP training and perhaps qualified auditor training, if applicable. It makes sense that FDA needs to make a similar investment in its people to ensure its inspectors are prepared to knowledgeably perform FSMA-related inspections.

FDA has implemented a robust training program for its inspectors. Regarding PCHF inspections for example, only inspectors who have successfully completed the PCQI training plus FDA’s internal training will lead other inspectors through the facility inspections as an in-field training exercise. So, the good news is at least one inspector is fully trained under FDA’s training program standards. This said, with more inspectors, there are more eyes, and with more eyes, more opportunities to see risk through different perspectives. It’s best to be on your game, with a tested playbook so you have confidence you are prepared when the team of inspectors arrive at your facility. Conduct a mock inspection against your policies, procedures and food safety plan that have been updated for the new PCHF and other applicable FSMA requirements. You will be thankful you did.

Digging Deeper

Into Records: FSMA and the seven rules that comprise it requires more controls, monitoring and verification activities by the food industry, thus naturally giving inspectors more records to access and review. Further, FDA received expanded records access authority upon the signing of FSMA. FSMA allows FDA to access records relating to articles of food for which there is a reasonable probability that the use of, or exposure to, the article of food will cause serious adverse health consequences or death to humans or animals. Before FSMA the standard FDA had to meet to access records was “credible evidence”; now its “reasonable probability”—a standard that is far lower and subjective—allowing access to more types of records than before. Another new addition is FDA now may access records beyond those relating to the specific suspect food if the agency reasonably believes that other food articles are likely to be affected in a similar manner.

Example: If you have a potential problem on production line 1, and you firmly believe the issue is contained to line 1, but that line is in even arguably close physical proximity to line 2, depending on the issue an inspector may invoke this new authority and ask for all records associated with line 2 in addition to line 1 for the same time period to be sure that the situation indeed did not spread or otherwise impact line 2. (e.g. confirm no risk for cross contamination or allergen cross-contact).

This should not mean it’s open season on all your records, but it certainly means more records are open to review and scrutiny, so having a robust record retention and management system becomes mission-critical. How sound is yours? Record-keeping and document management have long been important to GFSI / CPO’s. However, many food companies do not have a certification from one of these entities, which begs the question whether the scope of your third-party audit, or that of a supplier you are currently evaluating for approval, adequately evaluates this important area.

Into your Hazard Analysis: Inspectors are spending significant time reviewing the adequacy of the hazard analysis performed as part of the requirement of the food safety plan under the PCHF Rule and as part of the foreign supplier verification plan requirement under the FSVP rule. If facilities do not identify all the hazards of concern that require a preventive control associated with their facility and foods they produce, then the rest of the food safety plan falls apart. If you work with peanuts to produce peanut butter and identify Salmonella as a hazard requiring a preventive control but not aflatoxin or peanut allergen you have likely missed the mark.You may not have the appropriate preventive controls, monitoring, verification activities, validations and corrective actions identified in your hazard analysis and food safety plan to control for the most significant hazards your facility / the finished food is facing from a food safety risk perspective. (note the identification of hazards requiring preventive controls is highly dependent on the food, facility, processing methods of the manufacturer, upstream supplier and will vary if products are RTE or nRTE)

How are auditors tackling this issue? Many third-party audit firms have invested in providing PCQI training for its auditors so they are better prepared to evaluate the sufficiency or gaps in the hazard analysis. It is a good idea to ask your audit firm what updated skills and training have been given to its auditors to ensure you are getting the assistance you need.

Continue to page 2 below.

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.

Shawn K. Stevens, Food Industry Counsel
Food Safety Attorney

Are You Ready for an FDA Inspection?

By Shawn K. Stevens
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Shawn K. Stevens, Food Industry Counsel

Don’t miss the Plenary Mock Food Safety Trial: Sam I Am who made Green Eggs and Ham is represented by Shawn Stevens vs. Food Safety victims represented by Bill Marler. Judged by Steve Sklare | November 30 at the 2017 Food Safety Consortium | Learn moreWith FSMA regulations coming into effect, food companies must prepare for the arrival of FDA investigators, as the agency has made it a priority to inspect U.S. food facilities, and they won’t always show up announced. Prior to an investigator’s arrival, it’s important to iron out several details in order to be adequately prepared. The following are 10 questions that every company should add to its pre-inspection checklist and make sure they are addressed before the inspection.

  1. Where will you meet? Pinpoint a place where you will host the FDA investigators. It should be a space that has enough room for them to review records, but it should not provide access to records (paper or digital) that could be viewed unsupervised.
  2. Who are the Designated Individuals? Assign a primary and secondary Designated Individual (DI) for each facility. This person serves as the liaison with the FDA investigators and should coordinate vacation time to ensure that one DI will always be available if FDA arrives. Although not required, the DI should also complete Preventive Control Qualified Individual Training.
  3. Has the written food safety plan been finalized? And, do the primary and secondary DIs know its components (i.e., GMPs, Sanitation Programs, Preventive Control Plan, Recall Plan, Environmental Monitoring Program, Foreign Supplier Verification Plan, Sanitary Transportation Plan, Food DefensePlan, and Produce Safety Plan)?
  4. Are records readily accessible? The DI should be able to immediately access any supporting records from the past three months for FDA review (FDA requires that most records are maintained for at least two years, but investigators usually ask to review the preceding three months).
  5. Have corrective actions been documented? When a deviation occurs, you must document all corrective actions. These actions should identify the deviation’s root cause and actions to prevent recurrence. If product safety is not affected, this should include a written conclusion that the deviation “does not create an immediate or direct food safety issue.”
  6. Have you conducted environmental monitoring and environmental sampling? If your company processes ready- to-eat food products that are exposed to the environment prior to packaging, FDA will require you to have an environmental monitoring program. In addition, the agency will collect 100–200 microbiological samples from your facility, so you need to know exactly what FDA will find before it arrives. By conducting your own FDA-style facility swabbing, you’ll be able to identify and immediately correct any hidden problems. It’s also important to develop your swabbing and testing plan with the help of legal counsel so that  the final testing results are confidential.
  7. Do you have a “No Photographs” policy? If not, you should. FDA Investigators will often insist on taking photographs while inspecting the processing environment. If your corporate policy prohibits visitors from taking photographs, you may in some cases be able to prevent FDA from taking pictures as well.
  8. Do you have a “Do Not Sign” policy? Sometimes, FDA Investigators will insist that a company representative sign a statement or affidavit during an inspection. You’re not legally obligated to do sign such a document. You should develop a policy stating you will neither sign nor acknowledge any written statements presented by FDA Investigators.
  9. Have you identified a suitable “on call” food industry lawyer? Add a food industry lawyer familiar with the inspection process to the company’s emergency contact list. This lawyer should be notified and remain “on call” during the inspection and serve as a resource to help answer any regulatory or investigator-related questions that arise during the process.
  10. Did you conduct a mock FDA inspection? One of the most effective ways to prepare for an FDA visit is to conduct a mock inspection. Food industry consultants and/or lawyers can visit your facility and play the role of the Investigator. Ask them to review your programs to identify possible regulatory shortfalls, and work with you to implement strategies that will strengthen your programs and reduce your regulatory exposure.

There are several more points to add to your pre-inspection checklist. To get the rest, attend the webinar, FDA Inspection Readiness Checklists, on March 28.

Randy Fields, Repositrak
FST Soapbox

Sanitary Transportation Rule: Ignore at Your Own Peril

By Randy Fields
1 Comment
Randy Fields, Repositrak

FDA posted the FSMA rule on the Sanitary Transportation of Human and Animal Food in April. The majority of retailers, wholesalers, suppliers and carriers will have one year to comply with this new rule. The sanitary transportation rule sets out to prevent practices that would introduce contamination risk during the transportation of food through the supply chain.

For retailers, wholesalers, suppliers and carriers, the final rule is really the sleeper regulation among the new FSMA laws. You probably have your HAACP plans and preventative control procedures in place, but do you have the necessary documents in place with your carriers to meet the FDA’s requirements?  And, are those documents easily accessible?

Under FSMA, you must address all FDA record inquiries within 24 hours, and these inquiries can go back two years, plus 12 months beyond the expiration of related service agreements. Failure to respond to an FDA records inquiry is considered a “prohibited act” and can land you in hot water with both the FDA and Department of Justice, which acknowledged they will enforce FSMA through civil and criminal penalties. That’s a game changer.

You are now required to ensure that transportation equipment does not cause the food it is carrying to become unsafe. You must also maintain adequate temperatures throughout your portion of the supply chain and prevent cross contamination. And, you must train your personnel in sanitary practices. All of these factors—processes and procedures, agreements and formal training of personnel—must be documented and made available to the FDA. Put simply, compliance with FSMA is proven through documentation because according to the FDA, if it is not documented, it did not happen!

So what’s the best way to comply with the new rules? Having the information on paper in filing cabinets simply won’t do. Can you imagine searching for specific confirmation that an employee received the proper training in a bank of file cabinets? Even with an efficient system, that could be like looking for a needle in a haystack. Collecting the information in spreadsheets is only slightly better, as it simply digitizes the disorganization.

Retailers, wholesalers, suppliers and carriers need to start their compliance process by reviewing and understanding all of the FSMA rules, guidance procedures and responsibilities. You ignore them at your own peril.

Then, consider automating your recording keeping system.  It is really the only way to efficiently collect and manage the documentation needed to comply with the new law.  When reviewing technology options, make sure you choose a system that is not only easy to use by frontline workers, but also provides sophisticated reporting and alerts to point out potential problems in real time. And, if possible, the solution should do more than just report on food safety activities. As long as you’re investing in a technology to meet FSMA requirements, you might as well implement a system that can potentially save money in other areas such as managing business or training documentation, new vendor approvals, or carrier optimization.

The bottom line is that the sanitary transportation rule will require that you devote additional resources to make the entire extended grocery channel more risk free for consumers and companies alike. And the best way to do that is to implement new technology that gives visibility to product transfers from point of production or processing to the point of purchase, and documents each step along the way.