Tag Archives: documentation

Melody Ge, Kestrel Management
FST Soapbox

8 Tips to Food Safety Program Development for Small and Entrepreneurial Businesses

By Melody Ge
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Melody Ge, Kestrel Management

The FSMA HARPC regulation has been in the implementation phase for approximately a year. Many small and entrepreneurial businesses are in the process of starting or finalizing the development of a food safety plan to comply with FSMA requirements. This includes program development, operational awareness and employee training. Often, small companies find this development more challenging compared to mature companies for several reasons, including a lack of resources or simply not knowing where to start.

The following eight tips can help small businesses that are developing a food safety plan to comply with FSMA.

1. Don’t be scared.

FSMA Preventive Controls is nothing scary. It is simply a series of food safety protocols and related documentation. It might seem overwhelming at the beginning with many documents and changes; however, it is actually a good method and tool to help strengthen operation lines and management.

FSMA helps businesses sustain and streamline processes. It is helpful to first map out the production process from the very beginning (when raw materials are received) through the end (when finished products leave the facility). The more details that are documented on the process, the easier and less time consuming it will be later to prevent potential risks.

2. Be familiar with the process and the FDA hazard types.

Once all processes are mapped, take time to study and get familiar with them. It will be helpful to have a team of individuals with different job functions review process maps together. The objectives are to identify the following:

  • Where is the weakness?
  • Where can weaknesses be controlled?
  • What should be monitored?
  • When is a good time to monitor each process step?

According to FDA, five hazard types need to be considered and prevented: Physical, chemical, biological, intentional adulteration and radiological. These five types should always be kept in mind when reviewing and analyzing the direct production and non-direct production processes.

3. Thoroughly understand the entire supply chain.

Supply chain management is one of the key preventive controls required by FSMA. Just like mapping out the process, FDA requires each business to have a thorough understanding and control of its supply chain to ensure the risks are minimized from raw materials to end consumers. Whether you have foreign suppliers, distribution centers or co-manufacturers, finished product safety must not be compromised by any party. If foreign suppliers are being used, FSVP (Foreign Supplier Verification Program) must be implemented and communicated to vendors.

4. Think in food safety mindset.

If your business has just been established, then congratulations! You have the opportunity to start everything right from the beginning. Take food safety into consideration throughout every step in the process and operation. Considering food safety aspects and preventing hazard types might help you make your next good business decision.

5. Get everyone involved!

Food safety is not only the food safety and quality departments’ responsibilities; it reflects the entire company’s operational structure—from building structure, security, production line, and supply chain to procurement, HR and finance. Get everyone involved, from top management to line workers. Their expertise, experiences and feedback will help the entire program’s implementation and execution. With the inputs from each department function, the food safety program will be more practical to the entire business operation and, therefore, will be more solid and sustained, especially when it comes to ongoing implementation.

6. Designate one project leader.

If FSMA program development is considered a project that the whole company engages in, a project leader is required to make the journey efficient and smooth. The leader needs to have both the company operational experience, as well as food safety knowledge. The leader plays an important role in leading the project, coordinating the timeline, prioritizing work across departments, and communicating with all levels of employees.

7. Keep everything documented and recorded.

Documentation and recordkeeping are core to the entire program. Say what you do by writing down all procedures, policies, programs and SOPs. Do what you say by demonstrating what is contained in all records kept onsite. This is not only for audit purposes, but also for your own business growth. Your own operation data is the best data to improve and modify your processes, if needed. Records can be used for trend study and analysis after years in business. Records can reveal whether methods or programs implemented are working effectively and helping the business. Records can also provide strong support/evidence when there is an unexpected event.

8. Utilize free third-party resources.

There are many technologies linking the entire world together—leverage them to learn from your peers. GFSI-recognized certification programs, such as SQF, FSSC22000 and IFS, are releasing a global market program to specifically help small business start their programs. Webinars and trainings are available on many program development and food safety hot topics to help address challenges, and there are many tools and templates available for download to assist with documentation and recordkeeping.

Although there are a lot of perspectives and aspects to be considered to comply with FSMA, compliance can be achieved one step at a time. Start by mapping out your own production process today.

Martin Flusberg, Powerhouse Dynamics
Retail Food Safety Forum

Automating Food Safety Processes in Restaurants: How 1+1 Can Equal 3

By Martin Flusberg
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Martin Flusberg, Powerhouse Dynamics

With the recent death of Anthony Bourdain, the topic of restaurant food safety is once again on the minds of many people. It has been 19 years since Bourdain’s exposé in The New Yorker (Don’t Eat Before Reading This) and 18 years since his memoir Kitchen Confidential, which became a TV series and has rocketed to the top of the Amazon best seller list since his death. Bourdain identified many issues that restaurants struggle with, including those that affect the safety of the food being served.

While many of the issues chronicled by Bourdain probably continue to this day, there has been a push by the restaurant industry to address food safety over the intervening years, and particularly in the last two or three.

Many restaurant chains have taken steps to automate the HACCP (Hazard Analysis Critical Control Points) food safety reporting process—or at least are exploring that option. The first and most common approach has been to replace time consuming, error prone, manual data collection processes with mobile apps that digitize tasks, may include digital probes to replace manual temperature data recording, and may even track corrective actions. These systems deliver more accurate data than fully manual processes and are faster. They also ensure that the data is easily retrievable, both for management review and for the times that inspectors visit the facility. And, they generally address a broader set of food safety processes than temperature monitoring.

Another approach that has begun to catch on is the installation of fixed temperature sensors—usually but not always wireless—into refrigeration and food warming equipment. These systems will capture and report on temperature at regular intervals—in some cases as frequently as every minute. This eliminates the need to manually check temperatures in monitored equipment as part of HACCP reporting. Moreover, these systems generally offer real-time alerts that can help avoid food safety problems. The more advanced systems track corrective actions and deliver escalating alerts to notify additional team members about issues that have not yet been addressed.

Automated temperature monitoring systems don’t fully take the place of the mobile systems described above since they cannot capture all temperatures and do not address aspects of the food safety process other than temperature monitoring.

Interestingly, the vast majority of restaurant brands that have automated food safety reporting—or are looking to do so—with whom we have spoken have implemented one but not both of these approaches. And yet, the approaches are inherently complementary.

As noted, automated temperature monitoring systems don’t address all aspects of the food safety process, while mobile technology cannot provide real-time warnings about food safety issues so that they can be addressed before they turn into major problems. Moreover, while mobile apps are faster than paper and pencil, they still require staff time. By contrast, automated temperature monitoring systems require no labor for monitored equipment—other than to address problems that are flagged in real-time.

To illustrate the potential of combining these two approaches, consider these results reported to us by one of our customers, a major restaurant chain. This brand started with fixed temperature sensors in refrigeration and other equipment, while continuing to perform manual data collection. They recently added a mobile digital task list app as a test in a group of restaurants. Their findings: What had been a 17-minute HACCP data capture process was now down to two minutes! Not needing to manually capture data now being automatically collected was part of this story, but savings also resulted from the shorter distances the staff now needed to cover to complete the process. Over the course of four checks a day, these savings were significant.

The market for automating food safety tasks and reporting is still in an early stage but appears to be accelerating. The technology is here today and constantly being improved. We would encourage all companies on the retail side of food services to explore technologies that cover the broadest range of capabilities for automating food safety processes.

What To Consider When Developing A Facility Food Safety Plan

By Adam Serfas
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No two facilities will have the same food safety plan, as each should address the specific needs of that facility. Before beginning your draft, there are several critical factors to consider. Use the guide below as a checklist to review before starting or revisiting your own food safety plan—the following tips can be applied to all food and beverage processors and manufacturers.

1. Review current legislation that applies to your industry

The food safety sector evolves rapidly. Keep your finger on the pulse of updates and changes, whether current or forthcoming, to ensure that your plan is current and up to code. You can quickly familiarize yourself with guidelines and regulatory bodies dealing with your industry with a handful of excellent resources. Generally, we recommend starting with the FDA website, and from there you can navigate to resources that are specific to your industry. We also recommend you make use of the FDA’s Food Safety Plan Builder to assist you in meeting requirements for Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventative Controls for Human Food regulation.

2. Identify current potential risks in your facility

Once familiar with your industry requirements and inspection standards, the next step is to identify any current potential food safety risks specific to your facility. Be sure to incorporate employees at all levels while detailing these potential hazards or concerns. Oftentimes, employees at the management level will make note of things different than employees working on the plant floor. And the delivery truck driver’s perspective will vary from those of your janitorial team. Aim to build a comprehensive list, noting everything from obvious high-risk areas, to what might be trivial or unlikely facility hazards. The more robust the list, the easier your food safety plan will be to form later on.

3. Consider your facility layout

Your facility’s physical layout often determines what type of food safety plan is necessary. Ask yourself:

  • Does your facility have natural zones?
  • Is it comprised of multiple buildings?
  • Are certain defined areas more high-risk than others?
    If you answered “yes” to any of these questions, you’ll most likely want to incorporate a zone-based color-coding plan as a part of your food safety plan to ensure that all of your tools remain in their proper location and are used correctly.

4. Review the quality of your current tools
Take stock of your current tools, that includes everything used to make or process your product and everything required to clean the facility itself. Consider the tool quality—are these presentable and acceptable for an inspector to see? Do your brushes have loose bristles? Has your mop seen better days? Tools that are made of low-quality materials or are not in top shape present potential risks for a food-safe environment. Note which tools need to be replaced and perhaps consider incorporating color-coded tools if you have not yet done so, as they are a great way to step up your food safety practices and safeguard against cross contamination.

5. Review and communicate the food safety plan and training procedures

Review your current employee training materials –in particular, your cleaning and sanitation measures and food handling procedures–and hold a meeting to go over current training protocols with your team. Consider the following questions:

  • Are the expectations made clear?
  • Are there references to procedures that are no longer up to date?
  • Is there appropriate signage that can be readily referenced?
  • Is information available for non-native speakers?
  • Are the appropriate channels in place for employees to voice concerns about these training procedures?

Be sure to take notes on each of these items that need to be addressed. One of the most important pieces of a food safety plan – and something inspectors pay close attention to – is that it is properly communicated to all employees. Taking detailed notes as you discuss these procedures will be helpful in documenting your training methodology for the food safety plan and, of course, will help you to ensure that the training procedures themselves are the best they can be.

6. Consider the documentation requirements for your industry.

Your industry might require certain specific documentation for your food safety plan, which can include facility policies, procedures, safety review records, maps and more. Additionally, some governing bodies require that the food safety plan is completed by a certified individual who doesn’t necessarily need to be an employee of the facility. Review all necessary requirements to ensure that you satisfy all of these standards for your next inspection.

Should you have any questions when getting ready to start on your plan, we suggest you reach out to a company that specializes in color-coding tools, as they have experience in creating plans to accommodate all kinds of identified risks and can be a great resource.

Blockchain, Food Safety Supply Chain Conference

Is the Food Industry Ready for Blockchain?

By Maria Fontanazza
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Blockchain, Food Safety Supply Chain Conference

Darin Detwiler will lead a plenary session titled, “Practical Use of Blockchain in Food Safety” at the 2018 Food Safety Consortium | Learn moreOn the heels of the deadly, widespread outbreak of E.coli O157:H7 illnesses linked to romaine lettuce—and 12 years after the infamous spinach outbreak of 2006—the food industry is struggling to find the solution to prevent these outbreaks. “I think it’s indicative that we need to do something different,” said Melanie Nuce, senior vice president, corporate development & innovation at GS1 US, during a panel discussion about blockchain at the 2018 Food Safety Supply Chain conference earlier this month. The panel, led by Darin Detwiler, assistant dean and director, regulatory affairs of food and food industry at Northeastern University, delved into the strengths and weaknesses of blockchain, along with industry readiness and acceptance.

In its most basic form, the technology would allow for the addition of information from every step of the supply chain, from manufacturing to packaging to distribution to retail, and would incorporate elements such as auditing, inspection, batch information, certification of auditors, preventive control plans, HACCP information, and allergen identification.

“Blockchain could be the death of the document.” Simon Batters, Lloyd’s Register

Strengths

The increased demand for transparency and traceability could be one of the biggest drivers for the adoption of blockchain. “[Blockchain] offers us the technology for traceability,” said Simon Batters, vice president of technology solutions at Lloyd’s Register. “It allows us to have an immutable record of a transaction; it won’t solve the food safety conundrum overnight—it’s part of the tool kit that we need.”

The fact that the food supply chain consists of millions of transactions, which could not be tampered with under blockchain, while the data could be used as reference points and for verification—those are strengths. However, Batters pointed out, there should be restrictions on who has permission to write the code and who has access to putting the information into a chain.

The technology would also enable smart contracts whereby shipments wouldn’t be finalized if they didn’t meet the conditions of a supplier, for example. “All parties to a transaction have a view to the entire chain at the same time,” said Nuce. “You have real time visibility. This democratizes that.”

Kathleen Wybourn, director, food safety solutions at DNV GL, calls blockchain “the birth certificate for food.” From a consumer standpoint, it would provide information on a product’s origin—and these days, consumers—especially millennials—are very interested in the story of food from farm to fork.

2018 Food Safety Supply Chain Conference, Blockchain
The blockchain panel, led by Darin Detwiler, Director: Regulatory Affairs of Food and Food Industry, Northeastern University featured (left to right) Kathy Wybourn, Director, Food Safety Solutions, DNV GL; Simon Batters,
Vice President of Technology Solutions, Lloyd’s Register and Melanie Nuce, Senior Vice President, Corporate Development & Innovation, GS1 US.

Weaknesses and Threats

The panel pointed out several areas of improvement (and unknowns that must be answered) before blockchain can be taken to the next level in the food industry.

  • Although the technology could aid in faster transaction times, as the size of the ledger gets larger, and it will become more difficult to manage.
  • Industry involvement: “If you don’t get 100% participation, it’s not going to be successful,” Nuce said. “To have true trace back, everyone has to participate.”
  • Blockchain platforms: Will they be able to interact and share data? What type of blockchain architecture is necessary for this?
  • Poor architecture
  • Need a better grasp on the type of data being used and how it delivers value
  • What impact will it have on the role of certification bodies?
  • Politics and the competitive element: Will certain parties seek to control this space?
  • Will the culture shift be a roadblock?
Melanie Nuce, GS1 US
Read Melanie Nuce’s column, Blockchain: Separating Fact from Fiction

Final Thoughts from the Panel

“Nobody can really tell where this is going to go in the future. I think it’s going to be part of food safety in their roles in one shape or form…I think we’ll see more of where this is headed within the next 12–18 months.” – Kathy Wybourn

“I think it’s going to be a fast-moving dynamic area.”– Simon Batters, who suggested that the organizations that embrace blockchain early may be the ones who show the way

“From an information/standards perspective, you have to have foundational business processes to support any type of technology. That’s what we’ve learned through the pilots.” – Melanie Nuce

“It’s not going to make a company any more ethical… a lot of what we need already exists out there; blockchain is just a tool out there. I keep warning people that this is not the only solution.” – Darin Detwiler

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.