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Modernizing Food Recall Management

“Recall” is the one word food companies never want to hear. But recalls are a fact of life, so it’s the wise manufacturer, wholesaler, and retailer that prepares for the inevitable. What does it take to have fast, effective food recall management? The short answer is that you need to modernize your supply chain so you can act quickly based on high-quality data. Let’s take a look.

“Modernize” is today’s food and beverage buzzword

The Food Safety Modernization Act (FSMA) has been in effect for almost a decade, so modernizing the food and beverage supply chain isn’t a new idea. Designed to improve the security and safety of the U.S. food supply, FSMA focused on preventing food-borne pathogens across the food system. It also encouraged companies to be proactive instead of reactive when it comes to food safety — including how they deal with food recall management.

Now, the U.S. Food and Drug Administration (FDA) has ratcheted up its food safety efforts. On April 30, 2019, it announced the New Era of Smarter Food Safety, which it describes as “a new approach to food safety, leveraging technology and other tools to create a safer and more digital, traceable food system.” To be rolled out over the next decade, it’s “also about simpler, more effective, and modern approaches and processes.”

In other words, more modernization that builds on FSMA. The “ultimate goal is to bend the curve of foodborne illness in this country by reducing the number of illnesses.”

Then, in July 2020, the Administration released the “New Era of Smarter Safety Blueprint” that

“ … outlines achievable goals to enhance traceability, improve predictive analytics, respond more rapidly to outbreaks, address new business models, reduce contamination of food, and foster the development of stronger food safety cultures. It outlines a partnership between government, industry, and public health advocates based on a commitment to further modernize our approach to food safety.”

The Blueprint also includes a Food Traceability Proposed Rule (formal title: “Requirements for Additional Traceability Records for Certain Foods.”) It would implement Section 204(d) of FSMA, with requirements to “help the FDA rapidly and effectively identify recipients of foods on its Food Traceability List to prevent or mitigate foodborne illness outbreaks and address credible threats of serious adverse health consequences or death.” The list includes fruits and vegetables, fish, shellfish, cheeses, nut butters, eggs, herbs, and ready-to-eat salads.

What does modernization mean for food recall management?

It’s clear that FSMA and the New Era of Smarter Food Safety have recalls in mind when they mandate modernization or propose procedures to attain it. However, with or without the influence of regulations, rules, blueprints, and lists, modernization boils down to two things for food recall management: digitization and traceability.

A digital supply chain with end-to-end traceability delivers speed and high-quality data, the most crucial aspects of food recall management. Digitization — eliminating the physical paper trail in favor of a cloud-based management system — enables end-to-end traceability, and end-to-end traceability means you have rich, actionable data available in real time so you can find products quickly, make informed decisions, and act with authority and assuredness.

Digitization and traceability also expediate food recall management because they allow you to easily share information with your trading partners and regulators. If you’re a manufacturer or wholesaler, you’ll keep retailers up to date so they can take the recalled product off the shelves. Consumers benefit too, because they’ll get recall alerts and know to return the product or dispose of it as instructed.

Modernizing food recall management also helps mitigate the very things that can trigger a recall in the first place, such as poor visibility into the supply chain, lack of accountability, or an insufficient safety culture. Indeed, it’s up to companies to fix such shortcomings internally through training and establishing safety protocols, but digitization and traceability will carry and facilitate safety across the entire supply chain.

For instance, you can attach critical tracking events (CTEs) and key data elements (KDEs) to every product’s digital profile, creating an indelible provenance you can trace up and down the supply chain. You’ll see where a product has been, where it is (or is supposed to be), and where it’s going. During a recall, you can “reach into” your supply chain and extract the product quickly.

Final thoughts

As we move into 2021, F&B companies have absolutely no excuses to put off modernizing their supply chains and recall management systems. A poorly handled recall can result in catastrophic financial loss and cause irreparable damage to your reputation. And companies that don’t modernize will likely find themselves pursued by regulators, ostracized by trading partners, shunned by consumers, and, ultimately, out of business.

rfxcel can help. Our award-winning Traceability System (rTS) is the basis of a modernized, digital supply chain with fully customizable and scalable solutions that yield complete end-to-end traceability. It is the foundation of a digital supply chain and a successful food recall management system that operates with surgical precision.

For example, our Serialization Processing (rSP) solution assigns every product a unique digital ID that lets you locate affected products quickly, remove them from circulation, and record and verify that every recalled item was destroyed. Furthermore, rSP generates last-mile data that helps you identify the source of outbreaks and their scope for better consumer safety efforts.

Coupled with rSP, our Raw Materials Traceability (rRM) and Finished Goods Traceability (rFG) solutions build a digital supply chain that aids food recall management by maintaining a validated, traceable pedigree for every product. Track the transformation of raw materials into finished goods with total forward and backward traceability. Track lot to unit or unit to lot all the way to the consumer. Attach key data to every critical tracking event digitally. And if there’s a recall, see how exposed you are and respond rapidly by notifying affected customers and trading partners and changing the disposition of all units/lots to “RECALL” to prevent them from being included in any ship event. You can also use your data to aid investigations.

Contact us today to speak with one of our F&B supply chain experts. They’ll give you a short rTS demo that will show you how an rfxcel digital supply chain with end-to-end traceability will modernize your operations and optimize your food recall management.

Industry Reaction to Delayed Enforcement of DSCSA Saleable Returns

The Healthcare Distribution Alliance (HDA) sponsored a meeting on October 28 with more than 100 pharma industry stakeholders to discuss how the Food and Drug Administration’s (FDA) 3-year delay of enforcing the U.S. Drug Supply Chain Security Act (DSCSA) Saleable Returns Verification Requirement will affect its constituents.

This was the first formal meeting about the FDA announcement and marked the beginning of industry discussion that will no doubt continue well into the future. Below are some of the key points raised at the meeting:

Continue with the VRS. The prevailing sentiment is to continue the Verification Router Service (VRS) effort. The enforcement delay was not intended to stop progress, but to give the industry time to ensure readiness.

The industry needs a plan. As one meeting participant correctly called out, the intent to make progress is not good enough. “We need a plan,” they said. To jumpstart this effort, rfxcel and other VRS providers will draft a 2021 road map to work toward DSCSA readiness. The road map will focus on the VRS, but may also address authorized trading partners (ATPs) and other requirements.

VRS is still a “go.” Will the pharma industry really need the VRS in 2023, the year the DSCSA stipulates full serialization of the pharma supply chain? After a healthy discussion, the consensus was that, yes, the VRS will most likely be necessary. Some in the industry anticipated the “retirement” of VRS in 2023 because wholesale distributors would at that time be performing their own verification of serial numbers. However, not all wholesale distributors agreed with this assessment.

Final thoughts

For details about the FDA’s October 23 announcement, see our blog post. And visit our website regularly for more updates about the Saleable Returns Verification Requirement and the VRS.

rfxcel is the industry leader in DSCSA compliance and the VRS. If you have any questions about the delay and what you need to do to be ready for 2023, contact us today.

FDA Delays Enforcement of DSCSA Saleable Returns Requirement

Note: For the latest industry reaction to the FDA’s announcement, read our update here.

In a policy document published on October 23, the U.S. Food and Drug Administration (FDA) announced it was delaying enforcement of key aspects of the Drug Supply Chain Security Act (DSCSA) that will affect wholesale distributors and dispensers. The regulations were due to go into effect on November 27 of this year; now they won’t be enforced until November 27, 2023.

The delay, the second since 2019, pertains to the requirement to verify saleable returns under the DSCSA law. It also included guidance for wholesale distributors concerning transaction statements under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Here are the details.

Wholesale distributors: product identifiers

The FDA announced that it did “not intend to take action against” wholesale distributors that did not verify product identifiers before further distributing returned products as required under the DSCSA.

It explained that wholesale distributors, other trading partners, and stakeholders had expressed concern about industry readiness to implement the Saleable Returns Verification Requirement since the delay in November 2019. Specifically:

  • Challenges developing interoperable, electronic systems to enable verification and achieve interoperability between networks
  • More time needed to test verification systems using real-time volumes of returned product with all trading partners
  • Significant delays testing verification systems due to the COVID-19 pandemic, especially because logistics and supply chain experts were reassigned from DSCSA preparation to responding to the pandemic

Wholesale distributors: transaction statements

The FDA also addressed transaction statements under the FD&C Act. This is a little complicated, so we’ll take it one step at a time.

Section 582 of the FD&C Act requires manufacturers, repackagers, wholesale distributors, and dispensers to exchange transaction information, transaction history, and a transaction statement — known collectively as “T3 information” — for transactions involving certain prescription drugs.

Section 581 of the FD&C Act requires transaction statements to include a statement that the entity transferring ownership — wholesale distributors in this case — had systems and processes in place to comply with verification requirements under Section 582.

Now, “prior to November 27, 2023, [the] FDA does not intend to take action against” wholesale distributors whose transaction statements do not include the statement required under Section 581. See pp. 7–8 of today’s announcement for full details about this change.

Distributors: product identifiers for suspect/illegitimate products

Distributors have also received a 3-year reprieve concerning requirements for product identifiers. The FDA said it did “not intend to take action against” dispensers that did not verify the statutorily designated portion of product identifiers of suspect or illegitimate product before November 27, 2023.” Section 582 of the FD&C Act stipulates how dispensers must investigate suspect and illegitimate products.

Final thoughts

If you’re a wholesale distributor or dispenser and have questions about these changes to the saleable returns verification requirement — or anything else about the DSCSA — we can help. rfxcel is the industry thought leader in DSCSA compliance, including the Verification Router Service (VRS), and we are ready to help you make the most of this extra time.

Contact us today and our supply chain experts will show you how our award-winning rfxcel Traceability System will fully prepare you for the DSCSA. We’ll answer your questions, address your concerns, and customize a solution that will ensure you’re compliant. The extra breathing room is nice, but the time to act is now.

DSCSA 2020: November Is Coming & It’s Time to Comply

Note: The FDA has delayed enforcement of the DSCSA for dispensers and wholesale distributors. Read the details here.

The next deadline for the U.S. Drug Supply Chain Security Act (DSCSA) is November 27. That means there’s only a little more than a month to comply. DSCSA 2020 means different things to different stakeholders. Here’s what you have to do if you’re a dispenser or a wholesale distributor.

DSCSA 2020 for dispensers (pharmacies, clinics, hospitals, healthcare systems, etc.)

If you’re a dispenser — an independent pharmacy or a pharmacy in a hospital, clinic, grocery store, or anywhere else — DSCSA 2020 means that you must be able to authenticate and verify all the medicines you buy before you can sell them to consumers.

You must meet two key requirements by November 27:

  1. You can buy and sell only products encoded with product identifiers (PIs). A PI contains a lot number, an expiration date, and the product’s standardized numerical identifier (SNI). The SNI includes the National Drug Code and a unique alphanumeric serial number.
  2. You must verify every product at the package level, including the SNI.

Because the clock is ticking and we want to help, our DSCSA Strategic Advisor Brian Files is hosting a special DSCSA 2020 Q&A session this Thursday, Oct. 15, at 12 p.m. PST/3 p.m. EST. Send your questions today, and Brian will answer them in this live Zoom event.

If you haven’t begun to prepare, Brain will tell you it’s critical to start now. Contact us. We have a proven a track record of success with DSCSA compliance. We have in-house DSCSA experts who will analyze your needs, explain what you need to do, and build a scalable solution tailored to your operations.

Also keep in mind that you must also be able to exchange “T3” information about every drug you buy and who handled it each time it changes ownership in the United States. T3 information” includes Transaction Information (TI) about a product (e.g., proprietary or established name or names and the strength and dosage form); Transaction History (TH), an electronic statement with the TI for every transaction going back to the manufacturer; and a Transaction Statement (TS), which is an electronic statement confirming the entity transferring ownership. We know all about T3 information. Read more about it here.

DSCSA 2020 for wholesale distributors

If you’re a wholesale distributor, DSCSA 2020 means must verify returned products before you can reintroduce them to the supply chain. You’ll do this through the Verification Router Service (VRS), an automated system that verifies if a PI is valid. You’ll initiate a verification request to a manufacturer to verify the PI of the returned product.

There are multiple VRS providers, and each is responsible for determining if a specific group of PIs is valid.  You can call any VRS provider to verify if a PI is valid, but if they do not manage the PI in question, they will automatically route your verification request to the provider that does. All of this happens in real time, and VRS ensures that information is accurate and up to date.

rfxcel is the thought leader in the DSCSA saleable returns verification requirement and the VRS. We implemented a VRS pilot for the Food and Drug Administration and extended industry testing of the VRS. Contact us today, and we’ll share our expertise in supply chain track and trace, serialization, and compliance solutions to make sure you’re ready for DSCSA 2020. We’ll also be happy to share our final report about the FDA pilot.

Final thoughts

The DSCSA was enacted to promote patient and consumer safety by facilitating product tracing in the pharma supply chain and ensuring the authenticity of products. DSCSA 2020 is the next step in verifying drugs.

November 27 will be here before you know it. If you’re a dispenser or a wholesale distributor, we can help. Reach out to us now and our supply chain experts will show you how our award-winning rfxcel Traceability System can ensure you comply with DSCSA 2020.

Defining Supply Chain Parent-Child Relationships

Over the years, there have been countless instances of counterfeit drugs entering the supply chain. This is problematic, as counterfeit drugs put consumers at risk, even causing injury and death. To help resolve this issue, many stringent compliance regulatory systems have been put in place for the pharmaceutical industry and other industries. One example is traceability and serialization, which includes aggregation.

What is aggregation?

Aggregation creates and maintains a parent-child relationship for the packaging levels and the product owner’s information. It creates the parent-child relationship by associating the aggregated unit, which is the parent, with each carton’s various serial numbers. For example, a basic mapping of aggregation may look like this:

Unit-level pack aggregations (lowest level) → bundle pack aggregation → case aggregation → pallet aggregation (highest level).

Aggregation increases safety and efficiency in the pharmaceutical industry and is an essential part of serialization in the supply chain. Aggregation helps track a package throughout its entire journey – from the time it is packaged to the moment it reaches the consumer.

Why is aggregation necessary in supply chain management?

Increases traceability and transparency

Aggregation makes it much easier to trace products through each step of the supply chain. It also makes it easier to “interpret” what’s in your supply chain. This increases traceability and transparency, which offers a variety of benefits, including:

  • Increased trust from stakeholders
  • Important supply chain data
  • Increased resiliency during a crisis, such as a pandemic, a recall, political unrest, or a natural disaster

Increases efficiency

Because aggregation and parent-child relationships eliminate the need to scan individual units, they create a quicker, more efficient flow in your supply chain. Furthermore, they’ll make your supply chain more accurate because there are fewer opportunities to make mistakes. Last, increased efficiency means saving on costs and time, as less scanning helps companies take care of returns and recalls more quickly.

Increases safety

With aggregation and the resulting parent-child relationships, safety is increased in your supply chain. Because aggregation increases accuracy and transparency, the risk of accidentally selling counterfeit products goes down. This means customers can trust that your product is authentic and do not have to fear any harm that can come from these counterfeit products.

Final thoughts

Working with a track and trace company helps improve aggregation within your supply chain, which, in turn, increases efficiency, transparency and safety. By making these improvements to your supply chain, you’ll help prevent counterfeit drugs from entering it. Contact us today to learn how our track and trace system, rfxcel Traceability System (rTS), can simplify and accelerate your processes with aggregation today.

4 Ways Serialization Companies Can Optimize Your Supply Chain

Global compliance regulations are growing increasingly difficult to keep up with. Luckily, companies don’t need to keep up with these regulations on their own. Learn how serialization and track and trace companies can aid this process and help maintain compliance.

Increase risk management

One way that serialization companies can optimize your supply chain is by providing increased risk management. By tracking a product to the unit level, serialization helps prevent the sale of fraudulent products. This is especially important with items such as pharmaceuticals, which if counterfeit, can result in death or injury. Furthermore, with serialization, shortages can be detected, and replacements shipped, more quickly, which increases customer satisfaction.

Increase efficiency

Serialization companies can also help increase your supply chain efficiency. By having the ability to track every product, the returns processing and recall management system becomes simplified and quicker. There will be an increase in marketing efficiency as well, due to punctual information on product sales. For example, if sales are lower than expected, marketing techniques can be adjusted.

Create trust

Working with a serialization company helps create trust among everyone involved in the supply chain. This is because serialization provides complete data for each product and the entire supply chain. Sharing this information fosters transparency, which creates trust among stakeholders, including manufacturers and customers. This trust can increase profitability and decrease the chances of your operations breaking down, especially in times of crisis.

Strengthen supply chain resiliency

With serialization, tracking products becomes easier. This results in more accurate demand management. Therefore, you’ll have a better ability to predict how much supply is needed and you are less likely to end up with excess products, which increases overhead and manufacturing costs. Serialization and traceability also give you a more accurate and detailed view of what is happening in your supply chain and allows you to put it in context of political and economic events. This means you can make a more educated forecast of how events might affect operations and adjust accordingly to create a stronger, more resilient supply chain.

Final thoughts

Global compliance regulations are changing, but that doesn’t mean you need to worry about falling behind. Working with a serialization and track and trace company not only helps you maintain compliance, but will offer all of the benefits mentioned above as well. Contact us to learn how we can help you simplify and accelerate your processes with our rfxcel Traceability System (rTS) and ensure you comply with regulations everywhere you do business.

Why We Need Wine Industry Track and Trace, Part 2

Welcome to Part 2 of our wine industry track and trace miniseries. In Part 1, we talked about how track and trace technology can help protect the wine supply chain by building product provenance, fighting counterfeits and illicit trade, streamlining logistics, and building consumer confidence and trust.

Part 2 gets into the details of the wine supply chain — its key actors and their responsibilities for wine industry track and trace. There’s a lot to cover, so let’s get started.

The wine supply chain, defined

The wine supply chain has the same core stakeholders as other supply chains: producers, distributors, and retailers. In its 2009 Wine Supply Chain Traceability Guideline, GS1 says these can be characterized as large companies with “significant technology requirements”; small- to medium-sized enterprises, many with niche specialty products and branding; and “support companies that provide materials, transportation, storage, and other services that are also impacted by traceability.”

GS1 further divides the supply chain into seven stakeholders: grape growers, wine producers, bulk distributors, transit cellars, fillers/packers, distributors, and retail stores. We describe these below, including their roles in wine industry track and trace.

Supply chain actors and their roles in wine industry track and trace

Ingredients and final products can change hands many, many times, so all actors must keep meticulous records and follow GS1 labeling standards to ensure wine industry track and trace. The requirements do get complicated, but there are a few fundamentals to keep in mind:

  • Global Location Numbers (GLNs)
  • Global Trade Item Numbers (GTINs)
  • Serial Shipping Container Codes (SSCCs)
  • Application Identifiers (AIs)
  • GS1-128 barcodes
  • Human-readable codes
  • Universal Product Codes (UPCs) and European Article Numbers (EANs)

Grape growers

Grape growers are responsible for the production, harvest, and delivery of grapes. Wine industry track and trace begins with them, so they must keep detailed records about receiving, shipping, and the vineyard itself. The latter includes the type of vines, annual production record, origin and chemical content of water used for cleaning and irrigation, and treatments (e.g., fertilizers, pesticides, fungicides).

Key data for track and trace describes the “plot” or “block” where grapes are grown. This land is identified with a GLN allocated by the grower and should include five pieces of information:

  1. The vineyard’s name and address
  2. The identifier for the plot
  3. Size of the plot/number of vines
  4. Vine variety
  5. Contact details

Every shipment of grapes the growers send should have a GLN and the date of harvest so the receiving winery can have this provenance for the wine it makes.

Wine producers

Wine producers receive the grapes and produce, manufacture, and/or blend wine products. Key wine industry track and trace data follows the grapes as they’re transformed into wine, so producers must keep accurate records of the procedures they use to make every wine. This includes:

  • The grape growers’ GLNs
  • The wine producer’s own GLN
  • The location(s) at the winery where grapes or juice are processed, including de-stemming, crushing, chilling, and pressing
  • A GTIN for each product
  • An SSCC for shipping containers (e.g., tanker trucks)
  • An AI (315n) to indicate the quantity dispatched in liters
  • An AI (10) to indicate the batch number

Bulk distributors

Bulk distributors receive wine in bulk from wine producers and send it to transit cellars. They also store, dispatch, process, sample, and analyze bulk wine. The wine they receive has been identified with a GTIN and a batch number; like their downstream and upstream trading partners, they must keep records about what they receive and dispatch, including recording the SSCCs and AIs associated with bulk wine containers.

Bulk distributors are identified with GLNs. Bulk wine containers, such as storage tanks, may hold only one product, or they may hold mixed products with mixed batch numbers; these have different labeling requirements. Generally, they’re identified with an SSCC allocated by the bulk distributor. When put into barcode form, the SSCC is “represented in a GS1-128 symbol.” The containers may also require a GTIN and AIs for batch and quantity.

Transit cellars

Transit cellars are responsible for the receipt, storage, dispatch, processing, sampling, and analysis of bulk wine, plus keeping records about what they receive and dispatch. They may be part of a filler/packer company at the same site or at another location. They can also be a third-party service provider.

For wine industry track and trace, every container a transit cellar sends must be identified with an SSCC, a GTIN, a batch number, and the quantity of wine in liters. This information is encoded in a GS1-128 barcode and in human readable form. To ensure track and trace in the wine industry, transit cellars must record every SSCC, GTIN, and batch number of every item they ship.

Fillers/Packers

Fillers/Packers receive containers of bulk wine from a bulk distributor or a transit cellar. Their job is to put the wine into smaller containers, such as bottles, bags, kegs, and barrels, then send cases, cartons, pallets, or “other logistics units” to finished goods distributors. For wine industry track and trace, here are how these units should be labeled:

  • Cases and cartons sold at retail are identified with a GTIN and a barcode with an EAN/UPC symbol. A lot number encoded in a GS1-128 barcode should also applied as an “add-on.” Cases and cartons that will not be sold at retail are identified with AIs and GTINs encoded in a GS1-128 barcode.
  • Pallets are marked with SSCCs. Filler/Packers can also include a GS1-128 barcode with AIs containing other information that maintains the parent-child relationship between the pallet and its contents.
  • Point-of-sale units (e.g., bottles, cans, jugs, bags in boxes) are identified with a GTIN and have a barcode with an EAN/UPC symbol for scanning at the time of purchase. In the EU and elsewhere, units must display a lot number assigned during the filling process. This information can be in human readable form.

Fillers/Packers also receive the “dry goods” that come in contact with wine, such as bottles, caps, and corks, and must label them with SSCCs, GTINs, and batch numbers. Fillers/Packers also have to record other information about dry goods, such as the water used to wash filling equipment and any chemicals used for cleaning.

Distributors

Distributors receive, store, and dispatch finished goods to retailers. They are also responsible for inventory management, and may repack or re-label goods at a retailer’s request.

If cases, cartons, and pallets are not broken up before being shipped to a retailer, the identification from the filler/packer (e.g., SSCC, GTIN, EAN/UPC symbols) does not change. If items are repacked, each gets a new SSCC. (The original SSCC must be crossed out or obscured). Distributors must record the SSCC, GTIN, and lot number of the items they ship and link these to the GLN of the recipient.

The “Traceability data and GS1 Standards” for items shipped by distributors are as follows (quoted verbatim):

  • SSCC of the inbound pallet and GLN of its supplier
  • SSCC of the outbound pallet, either unmodified or newly created
  • Links between the SSCC of the newly created pallet and the SSCC of the pallets used in its creation and, if applicable, the GTIN and lot number of each carton shipped to the retailer
  • GLN of the retail location to which the pallet is dispatched

Retail stores

Retailers receive wine from the finished goods distributor for retail sale. The wine is usually delivered in cases, cartons, and pallets, and records of their SSCCs and lot numbers must be kept. Individual units sold to the final consumer are identified with a GTIN-13 allocated by the brand owner. UPCs or EANs ensure products are scanned/traced all the way to sale to consumers. If a retailer returns goods to a supplier, it must ensure it doesn’t break the wine industry track and trace links that have been established.

Final thoughts

The wine supply chain is complex. Wine industry track and trace will help protect it, make it more efficient, improve communication among stakeholders, and fulfill consumers’ ever-growing expectations for more information about the products they buy.

rfxcel is ready to help. Our rfxcel Traceability System simplifies wine industry track and trace. From raw materials to finished goods, our solutions ensure you build a data-rich provenance for your products, communicate clearly with all your trading partners, comply with industry and government requirements, and give consumers the information they demand. Contact us today to schedule a demo and see what we can do.

The L1-L5 Solution Providers, Explained

Jargon. For better or for worse, it’s a fact of life — more so for people like us who work in the highly technical field of supply chain management. From ANSI to XML, an alphabet soup of shop talk can rain down upon us without warning, often leaving us scratching our heads (or at least searching online). L1-L5 solution provider? What does that mean?

And if we say rfxcel is an L4 and L5 solution provider, what does that mean? With as little jargon as possible, let’s find out. (Hint: It has nothing to do with alleviating back pain.)

What does the “L” stand for in L1-L5 solution provider?

The “L” in “L1-L5 solution provider” stands for “level,” as in the level of serialization in a supply chain. To put a finer point on it, it means the level of serialization and information management in a supply chain. And if you hadn’t guessed, there are five levels:

  • Level 1: Device
  • Level 2: Packaging
  • Level 3: Site
  • Level 4: Enterprise
  • Level 5: Network

The list above progresses from the smallest or most localized level, the L1 device level, to the most expansive and all-encompassing level, the L5 network level. Generally, L1, L2, and L3 are grouped together because they’re happening where products are created and packaged; L4 and L5 are paired together in the realm where those products enter the greater supply chain to make their way to their final destinations.

When talking about L1-L5, let’s work backwards from largest to smallest. This way, we can “zoom in on” the details and put everything in a more vivid context.

Level 5: Network

L5 is where rfxcel has its roots and where we built our reputation for supply chain excellence. The network level is where all serialization and regulatory data is managed, including with your trading partners, regulatory authorities and their repositories, and customers. It ensures you’re communicating with partners and complying with regulations.

Level 4: Enterprise

rfxcel’s roots also run deep in L4, which manages and verifies all your serialization and regulatory data/compliance reporting before sending it to L5. It also generates your serial numbers and manages all your business processes. When you design your solutions for L1, L2, and L3, you must decide how they will integrate with your L4 solution.

Level 3: Site

This is where we enter your actual manufacturing facilities and processes. L3 manages the line systems (i.e., L2) at your site to ensure that they are working optimally. L3 is optional; if present, it serves as the “middle man” between L4 and L2, requesting serial numbers from the former and allocating them to the latter.  L3 will also verify the L2 data before it is submitted to L4.

Level 2: Packaging

L2 systems control the L1 hardware and manage the serial numbers which are printed and applied on packages by L1 devices. L2 systems will communicate with the L4 (or L3,f present) to send/receive serial numbers as needed.

Level 1: Device

L1 comprises devices on a packaging line that enable serial numbers to be affixed to packaging and products, such as barcode printers, label printers, and labelers. It also includes cameras and scanners used for quality control, such as visual inspections of products and labeling.

rfxcel is an L4 and L5 solution provider that integrates with L2 and L3

As we said above, we’ve built a reputation for excellence for L4 and L5, the enterprise and network levels. This is our business: Creating innovative software solutions that optimize key supply chain requirements and functions — from the nuts and bolts of serialization and regulatory compliance to environmental monitoring and data analytics — and bring true end-to-end track and trace capabilities to any supply chain.

Our solutions ensure you’re communicating with all your trading partners, all regulatory bodies and their repositories, and your customers. We’ll help keep your lines running smoothly. We’ll yield rich, actionable data that you can use to improve your operations, connect with your customers, and build consumer trust and brand reputation.

We create one uniform, harmonized supply chain that takes care of everything from unit-level serialization and global compliance network needs to closing the last mile all the way to the person buying your product.

Final thoughts

All levels are important. They rely on one another to make things work. When you’re planning a serialization solution, you have to think very carefully about how they’ll interact and communicate.

rfxcel makes sure your data is accurate, travels quickly between and among levels, and meets the requirements of your partners and government authorities — no matter what systems you have in place now or will get in the future. Interconnectivity and interoperability are the cornerstones of all our implementations.

If you have questions about L1-L5, are looking to build a solution, or are considering switching solution providers, contact us today to talk with one of our supply chain experts and see what our award-winning rfxcel Traceability System can do.

Why We Need Wine Industry Track and Trace, Part 1

It was tempting to write about wine industry track and trace as a film noir (or a film pinot noir, as it were). There would be clandestine grape-stomping, midnight rendezvous in terraced vineyards, rogue chemists, cases stuffed with euros and dollars, sting operations and FBI raids, people taken away in handcuffs. In the closing scene, the one-time victim would celebrate triumph over those who did them wrong.

This much drama for wine industry track and trace? Yes, though it’s about much more than the serious work of fighting counterfeits and illicit trade. It’s about using technology to build provenance, streamline operations, and satisfy customers.

Part 1 of our two-part story covers the basics of wine industry track and trace. Part 2 will get into specifics. Let’s start our investigation.

Seriously, why do we need wine industry track and trace?

Not all supply chains are created equal. For example, if you read our Seafood Transparency Trilogy, you know a large, geographically diverse, and fragmented supply chain poses many challenges.

Plus, some products are more complex than others, which means they have more complex supply chains. From raw materials/ingredients to what consumers expect (or demand), supply chains vary wildly depending on what’s being made, where it’s being delivered, and even “the culture” of the product.

As you might have guessed, wine has a complicated supply chain. GS1, in its 2009 Wine Supply Chain Traceability Guideline, said, “The wine supply chain has always been complex and fragmented and with more distant suppliers and ever-more demanding customers, the unique characteristics of this supply chain bring challenges to implementing an effective traceability system.”

If you wanted to get technical, you could argue that there are actually two wine supply chains.

First, there’s a supply chain for “table wine” or “mass market wine.” Depending on where you live, you’ll find these in your local grocery store, in a wine/spirits shop, or in a state-owned store (an “ABC Store,” “package store,” or “state store”). This supply chain has many actors and the product changes hands many times. The product itself changes dramatically as it moves from raw materials to a finished good. Stakeholders typically have access to technology, including track and trace technology.

The second supply chain is for “fine wines,” which are produced in much smaller quantities than table wines. Though these vintages are sold in “regular” wine shops, they’re often reserved for boutique settings frequented by aficionados with deep pockets (or at least bigger budgets they’ve set aside for their passion). The steps of production and distribution may be very localized, resulting in a supply chain with far fewer actors than for mass-produced wine. For example, a winery in Burgundy, France, might do everything from growing the grapes and bottling to distributing pallets, cartons, or cases to local retailers. Because of their size, they may not have access to the latest track and trace technology.

So, why do we need wine industry track and trace? Here are the key reasons:

  • It’s a complex, fragmented supply chain.
  • There are diverse ingredients and raw materials, ranging from fertilizers and water to bottles, corks, and caps — and, of course, grapes.
  • Wine is heavily regulated.
  • Consumers of all stripes want the full provenance for what they’re drinking.

Wine industry track and trace will improve operations for all, ensure compliance with regulations, and satisfy consumer demand for detailed information and transparency.

Two other reasons for wine industry track and trace

Like other industries, wine has business and professional organizations for its supply chain stakeholders. There are trade publications and trade shows. It does big promotions. It has all the trappings of a large, important industry.

Unlike other industries, however, wine has a following. It is more than a product. Wine is a global culture unto itself. And this means there are aspects to its history and very existence that have ramifications for the supply chain.

For starters, there’s a thriving counterfeit market and illicit trade. Granted, this isn’t unique to wine, but the intricacies of the production process and the many facets of supply and demand make it an especially daunting problem. These stories from 2020 give an idea of its scope:

Furthermore, there’s a thriving, passionate collectors’ scene around the world. There’s a huge private trade, in-person and online clubs, mega-exclusive events and dinners, and auctions with nosebleed prices. And there’s lots of money changing hands. A desirable bottle of wine can cost as much as a car. Or a house. The 2019 auction market alone was valued at more than $520 million.

As a cautionary tale that combines the scourge of counterfeiting with the rarefied air of the highest echelons of the wine elite, there’s the fascinating case of Rudy Kurniawan. If you don’t know the story, start here. You might want to grab a glass of wine — just make sure you know where it really came from.

So, counterfeiting and illicit trade are major problems, including in collectors’ circles, where today’s wines are tomorrow’s pricey classics. Provenance, therefore, is vitally important across the supply chain, which is another compelling reason for wine industry track and trace.

Final thoughts

In our faux noir introduction, we said the victim triumphed in the end. What we meant was that wine industry track and trace protects everyone in the supply chain, from winemakers and their trading partners to everyday consumers and auction houses.

Producers can prove the provenance of their ingredients and final products. They can create a story about their wines, connect with consumers, and build and safeguard their brand reputation. Distributors and retailers can maintain the chain of ownership and help ensure only genuine products make it to market, all while streamlining and automating logistics. Consumers can know more about the wines they buy, such as where the grapes were grown, when they were harvested, and if they were treated with pesticides. For fine wines that may become collectors’ items, provenance can be “passed down” as a bottle or case or entire cellar ages, providing much-needed proof that a wine is what it’s label says it is.

As the leader in track and trace technology, rfxcel can help. Our award-winning rfxcel Traceability System is perfectly suited for wine industry track and trace. For example, our Raw Materials Traceability and Finished Goods Traceability solutions create the entire product provenance with detailed data about every aspect of production. Our Integrated Monitoring solution rides along with products as they move through the supply chain, protecting them from environmental excursions, diversion, and theft. With our MobileTraceability app, you can see and control your supply chain from virtually anywhere in the world.

Talk with one of our supply chain experts today to learn more about what we can do. And check back soon for Part 2 of our wine industry track and trace series.

Russia Chestny ZNAK Track and Trace: A Refresher Course

Russia is in the midst of creating the world’s most ambitious — and strict — supply chain track and trace system. Its National Track and Trace Digital System, known as Chestny ZNAK (and sometimes translated as Honest SIGN or Honest BADGE), is on track to be fully operational in 2024. Chestny ZNAK track and trace requirements are tough, and they’ll cover virtually every type of product you can imagine.

No matter what role you play in the supply chain, you have to understand how the system works and what the regulations mandate. Let’s examine Chestny ZNAK track and trace, from its origins to what it requires.

The origins of Chestny ZNAK track and trace

On December 29, 2017, Russian President Vladimir Putin signed Law No. 425-FZ, officially inaugurating the Chestny ZNAK track and trace system. Its goal is to streamline quality control, protect against counterfeits, and monitor supply and demand and expenditure. The regulations cover 12 product categories: medicines, furs, footwear, bottled drinking water, tires, tobacco, dairy, wheelchairs, bicycles, light industry, perfumes, and photo cameras and flashbulbs.

Chestny ZNAK is run by the Center for Research in Perspective Technologies (CRPT), a public-private partnership akin to the European Medicines Verification Organization. Its principal partner, with a 51 percent stake, is business giant USM, which was founded in 2012 and has interests in many of Russia’s key sectors, including metals/mining, telecom, technology, and internet.

According to USM, Chestny ZNAK is the country’s first public-private partnership in the IT sector and the first of its kind at the federal level. Private investments totaling more than 200 billion rubles ($2.5 billion) are expected over the next 15 years.

What are the requirements?

Chestny ZNAK track and trace regulations are arguably the strictest in the world. Companies that do not comply face fines and other penalties, including “deprivation of liberty” (prison), and can in essence be banned from doing business in Russia.

The requirements vary by industry, and deadlines and labeling requirements have changed, but the fundamentals have remained constant: serialization, aggregation, unit- and batch-level traceability, crypto codes, and electronic reporting and records management.

Products must be marked with 2D Data Matrix codes with an 85-character alphanumeric sequence that contains at least four groups of information: a Global Trade Item Number (GTIN), a serial number, a verification key, and a verification code (i.e., crypto code). Furthermore, the owner of goods must create a Universal Transfer Document (UTD) at the moment of ownership, then transfer it to the CRPT.

The crypto codes are an important part of Chestny ZNAK track and trace. At first, every code had to have 88 characters, but a federal decree in August 2019 that amended the procedure for applying drug labelling codes cut the requirement to 44 characters. The CRPT issues the codes, which only authorized representatives can request/receive. rfxcel is an approved partner of the CRPT; more on that below.

For the pharma sector, it’s prudent to note that Chestny ZNAK track and trace requires over-the-counter (OTC) drugs to be labeled, scanned, and recorded in the system. This is a significant departure from the EU Falsified Medicines Directive (FMD) and the U.S. Drug Supply Chain Security Act (DSCSA).

These are the broad strokes of the Chestny ZNAK track and trace regulations. There are other requirements — such tracking products with Universal Transfer Documents (UTDs), which must be sent to the CRPT when ownership of goods changes — but we won’t get into those here. For a full accounting of the regulations in all the industries, download our white papers.

How does it work?

Chestny ZNAK track and trace is a five-step process that calls for complete traceability all the way to consumers. Let’s walk through these steps.

First, the CRPT sends the manufacturer, wholesaler, retailer, or importer — referred to as “economic agents” in the regulations — a unique digital code for every product that must be affixed to the packaging. Only a CRPT-authorized representative can request codes. Every product is logged in Chestny ZNAK’s catalogue of marked goods.

In the second “logistics” step, the digital code becomes an immutable “passport” that legitimizes the product at every step of the supply chain. Every transfer of ownership must be recorded.

Next, the product arrives at the location where it will be sold or dispensed. The receiver scans the item, Chestny ZNAK receives a transfer confirmation, and it’s ready for sale.

Fourth, the product is sold or dispensed. The seller is required to have a point-of-sale cash register, a system connected to the internet that typically includes a touchscreen, a scanner to read 2D Data Matrix codes and other codes, a credit card scanner, and a printer. The product is scanned at checkout and the cash register reports to Chestny ZNAK that “the code has left circulation.” If the scanned data doesn’t match what’s in the catalogue of marked goods, the product is counterfeit or otherwise illegitimate and cannot be sold.

In the last step, the consumer takes over and becomes the final supply chain quality control checkpoint. Using the Chestny ZNAK app for smart devices, described as “your main assistant for product quality tracking and counterfeit detection,” a person scans the 2D Data Matrix code on the product and gets instant access to rich information directly from Chestny ZNAK. If a scan reveals a “violation” — meaning the product is counterfeit or not in compliance with marking regulations —  consumers can report it directly to the CRPT. They can also send questions about how the app works and suggestions to improve it

Here, we want to point out that the Chestny ZNAK track and trace app reminds us of our own MobileTraceability app, only for consumer use. Both can show the date, time, and place of production, the expiration date, and details about the product’s journey from the farm or factory to the store. Our MobileTraceability app is a powerful tool for track and trace in any industry. Check out our short video about how it works in the food and beverage supply chain.

Final thoughts

If you follow our blog, read our white papers, or follow our news, you know rfxcel is the leader in Chestny ZNAK track and trace compliance. That’s a bold statement, but we think we have the facts to back it up:

  • We’re an official integration, software, and tested solution partner with the CRPT. We’ve demonstrated that our solutions, particularly our signature rfxcel Traceability System (rTS) and Compliance Management (rCM), can meet the stringent Chestny ZNAK track and trace requirements and ensure companies stay compliant.
  • rTS works seamlessly with Chestny ZNAK track and trace, including a Russian-language user interface that makes integration and startup much quicker.
  • We’ve prepared for Chestny ZNAK since 2018.
  • We’re one of the few providers with active implementations in Russia.
  • We’ve tripled our workforce in Russia over the last year. Our team in Moscow provides our clients, which include major global consumer goods and pharmaceutical companies, the quickest time to market while fully automating their compliance reporting.

Contact us today learn more about how we can help you with Chestny ZNAK track and trace. No matter how far along you are in your preparations to meet the requirements, you should talk to us — even if you’re already working with another provider. Our powerful software ensures companies in any industry remain compliant with the complex regulations.