Tag Archives: preventive measures

Daniel Erickson, ProcessPro
FST Soapbox

Recall Risk Reduction: An ERP’s Role

By Daniel Erickson
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Daniel Erickson, ProcessPro

Consumer safety is of paramount importance and product recalls are a necessary means to this end. Product recalls are a serious, complex, and costly issue affecting the food and beverage industry in the United States. The FDA estimates that there are around 48 million cases of foodborne illness each year—causing one in six Americans to get sick from contaminated food. In addition to affecting public health, recalls have a dramatic effect on manufacturers by creating economic problems, damaging a company’s reputation, and imposing potential legal penalties and liabilities. In the search for a business management solution to better prepare themselves for and reduce the risk of recalls in their operations, many food manufacturers have discovered that technology, specifically ERP software, is key to lowering the risk of food and beverage product recalls.

An industry-specific ERP solution is a centralized business system with key industry features providing a system of record-keeping, with the tools to support the preparation and reduction of recall risks. While a manufacturer is ultimately responsible for a product recall, an ERP solution is essential in supporting and championing overall recall readiness and reduction. With the streamlined and automated inventory, manufacturing, and quality control processes managed within the software, critical steps and data that assist in recall mitigation are documented—including supplier verification records, audit logs, receipt records, quality testing, lot tracking, and shipment logs. The key to prevention of a product recall is preparation, which can be handled efficiently through an ERP’s functionality specifically in the following areas.

Supplier Management

An ERP facilitates best practices for supplier management and risk assessment within the solution to assure the acquisition of quality raw materials from trusted vendors. Its role is to maintain an approved supplier list for each product ingredient, documenting detailed supplier information, quality control test results, and risk level to ensure in-house and customer-specific standards are met. For approved or activated suppliers, information regarding materials that can be purchased through the vendor, applicable certifications, quality control results, and other pertinent supplier information is stored within the centralized data system of the ERP. A risk assessment for each vendor is also documented to ensure that any potential inherent risk(s) from vendor-issued recalls and to finished goods are limited.

In addition to activated suppliers, an ERP solution also assigns and manages qualified alternates to provide vetted selections should a primary supplier’s materials become unavailable. This positions a company well in the supply chain, as the investigative work has already been conducted on other suppliers, limiting the need and risk associated with onboarding an unknown supplier in a moment of crisis. Vendors are recorded within the system and ranked in order of preference and/or risk level so that they can be identified and put into use quickly if a supplier becomes unavailable—providing the preparation and leverage that companies need to mitigate the risk to safety in the supply chain. In a product recall situation, when a supplier notifies a customer of a contaminated ingredient, the supplier management feature within the ERP solution provides for a qualified replacement vendor that can fulfill the needed raw material quickly and efficiently.

Inventory Control

An ERP system offers end-to-end traceability, maintaining a comprehensive record that tracks raw ingredients, work-in-progress, and final products throughout the supply chain using barcode scanning to link product and lot information to batch tickets, QC testing results, shipping documents, and labels. This full forward and backward lot traceability is necessary to provide a documented audit trail imperative to locating raw materials or finished goods quickly within the initial 24-hour time period of a product recall. With full manufacturing, inventory, and reporting integrations, the ERP supports sound manufacturing practices that assist with recall preparedness – maintaining current Good Manufacturing Practices (cGMP), FDA reporting, GFSI compliance, and other industry-specific regulations to provide a documented audit trail with the ability to adapt as compliance requirements change.

Managing protocols to ensure the quality of inbound and outbound materials is essential in minimizing recall risk across the entire supply chain—from raw materials to the delivered final product. With an industry-specific ERP solution, formulas, recipes and instructions are maintained, scaled and verified to ensure consistency of products within the manufacturing process. This instills preventative measures throughout the production cycle in the form of process steps and quality control test specifications to bolster safety and quality. Quality features such as quarantine status and other status capabilities permit the isolating, removing and disposing of raw ingredients and finished goods that fail to meet quality control standards—triggering an alert to notify the purchasing department to investigate the issue. Having the ability to remove ingredients and finished goods from inventory or production prevents contaminated items from reaching store shelves and consumers, which reduces overall recall risk.

Inventory control practices are an important part of the functionality within an ERP solution that help to reduce overall recall risk. This includes managing and reporting of shelf life and expiration dates to maintain precise and lean control of inventory and reduce variances. Automated inventory transactions with the use of an ERP’s warehouse management solution (WMS) follow industry best practices and improve efficiency to ensure the accuracy of shipments, transfers, and material returns. This real-time visibility allows for the maintenance of FIFO inventory practices necessary to reduce the risk of spoilage.

One of the leading causes of contamination for food and beverage manufacturers that results in a recall event is a lack of allergen control throughout the supply chain and production process. An ERP system helps to track, manage and record the handling, storage and batch steps of raw materials from farm-to-fork. This includes stringent sanitary practices, lot tracking, raw material segregation and process controls to avoid allergen contamination or cross-contamination. Accurate product labeling is also a significant factor in reducing risk and an automated system that generates nutritional and product package labels plays a key role in a company’s recall prevention. To meet the needs of consumers and regulators, an ERP solution automates label creation to include accurate ingredient and allergen statements, nutrient analysis, expiration dates, lot and batch numbers, and regulatory specifications. The labeling history documented in the software allows products to be identified and located quickly in the event of a recall.

Reporting

Utilizing the recall functionality in the ERP solution allows companies to plan and test their recall process in advance. Performing mock recalls permits regular measurement and improvement of procedures to ensure rapid, accurate, and thorough responses by all company stakeholders in the event of a recall. A successful simulated exercise identifies 100% of recalled ingredients/products and notifies appropriate entities in a timely manner. Evaluation and documentation of mock recall exercises help expose inefficiencies, process gaps and procedural adjustments, which are designed to improve recall readiness and minimize consumer exposure to potentially dangerous contaminants.

As proof or documentation of adherence to specific processes, reporting is essential to demonstrate that these processes have been completed—without it, an integral component is missing. Across the supply chain and throughout the manufacturing process, documentation and reporting accentuate steps that have been taken to prepare and reduce recall risk. Risk-based assessments in supplier management, lot traceability reports, and mock recall reporting all provide a starting point of analysis to allow for adjustments to be made across the business. In a recall situation, the system is able to create lot tracking reports that encompass raw ingredients through shipped finished goods. These reports can be produced in minutes, rather than the hours it takes if data is stored within separate software programs.

Due to the amount of time and money that food and beverage companies invest in getting their products to market, it is imperative that preventative measures are taken in order to avoid a product recall. Forward-thinking manufacturers can help prepare for and reduce recall risks by utilizing several important features in ERP software—including supplier management, inventory control, and reporting. Using the tools at their disposal, a company can mitigate liabilities and protect their brand to turn a potential crisis into a future filled with opportunities.

Karen Everstine, Decernis
Food Fraud Quick Bites

COVID-19 and Food Fraud Risk

By Karen Everstine, Ph.D.
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Karen Everstine, Decernis

While foodborne transmission of the novel coronavirus is unlikely , the virus has significantly affected all aspects of food production, food manufacturing, retail sales, and foodservice. The food and agriculture sector has been designated as a “critical infrastructure,” meaning that everyone from farm workers to pest control companies to grocery store employees has been deemed essential during this public health crisis.* As a society, we need the food and agriculture sector to continue to operate during a time when severe illnesses, stay-at-home orders and widespread economic impacts are occurring. Reports of fraudulent COVID-19 test kits and healthcare scams reinforce that “crime tends to survive and prosper in a crisis.” What does all of this mean for food integrity? Let’s look at some of the major effects on food systems and what they can tell us about the risk of food fraud.

Supply chains have seen major disruptions. Primary food production has generally continued, but there have been challenges within the food supply chain that have led to empty store shelves. Recent reports have noted shortages of people to harvest crops, multiple large meat processing facilities shut down due to COVID-19 cases, and recommendations for employee distancing measures that reduce processing rates. One large U.S. meat processor warned of the need to depopulate millions of animals and stated “the food supply chain is breaking.” (An Executive Order was subsequently issued to keep meat processing plants open).

Equally concerning are reports of supply disruptions in commodities coming out of major producing regions. Rice exports out of India have been delayed or stopped due to labor shortages and lockdown measures. Vietnam, which had halted rice exports entirely in March, has now agreed to resume exports that are capped at much lower levels than last year. Other countries have enacted similar protectionist measures. One group has predicted possible food riots in countries like India, South Africa and Brazil that may experience major food disruption coupled with high population density and poverty.

Supply chain complexity, transparency and strong and established supplier relationships are key aspects to consider as part of a food fraud prevention program. Safety or authenticity problems in one ingredient shipment can have a huge effect on the market if they are not identified before products get to retail (see Figure 1). Widespread supply chain disruptions, and the inevitable supplier adjustments that will need to be made by producers, increase the overall risk of fraud.

Reconstructed supply chain
Figure 1. Reconstructed supply chain based on recall data following the identification of Sudan I in the chili powder supply chain in 2005. Data source: Food Standards Agency of the U.K. National Archives and The Guardian. Figure from: Everstine, K. Supply Chain Complexity and Economically Motivated Adulteration. In: Food Protection and Security – Preventing and Mitigating Contamination during Food Processing and Production. Shaun Kennedy (Ed.) Woodhead Publishing: 26th October 2016. Available at: https://www.elsevier.com/books/food-protection-and-security/kennedy/978-1-78242-251-8

Regulatory oversight and audit programs have been modified. The combination of the public health risk that COVID-19 presents with the fact that food and agriculture system workers have been deemed “critical” has led to adjustments on the part of government and regulatory agencies (and private food safety programs) with respect to inspections, labeling requirements, audits, and other routine activities. The FDA has taken measures including providing flexibility in labeling for certain menus and food products, temporarily conducting remote inspections of food importers, and generally limiting domestic inspections to those that are most critical. USDA FSIS has also indicated they are “exercising enforcement discretion” to provide labeling flexibilities. The Canadian Food Inspection Agency (CFIA) announced they are prioritizing certain regulatory activities and temporarily suspending those activities determined to be “low risk.” GFSI has also taken measures to allow Certification Program Owners to provide certificate extensions due to the inability to conduct in-person audits.

While these organizations have assured stakeholders and the public that food safety is of primary importance, the level of direct regulatory and auditing oversight has been reduced to reduce the risk of virus transmission during in-person activities. Strong auditing programs with an anti-fraud component are an important aspect of food fraud prevention. Adjustments to regulatory and auditing oversight, as necessary as they may be, increase the risk of fraud in the food system.

There is a focus on safety and sustainability of foods. The food industry and regulatory agencies are understandably focused on basic food safety and food sustainability and less focused on non-critical issues such as quality and labeling. However, there is a general sense among some in industry that the risk of food fraud is heightened right now. Many of the effects on the industry due to COVID-19 are factors that are known to increase fraud risk: Supply chain disruptions, changes in commodity prices, supplier relationships (which may need to be changed in response to shortages), and a lack of strong auditing and oversight. However, as of yet, we have not seen a sharp increase in public reports of food fraud.

This may be due to the fact that we are still in the relatively early stages of the supply chain disruptions. India reported recently that the Food Safety Department of Kerala seized thousands of kilograms of “stale” and “toxic” fish and shrimp illegally brought in to replace supply shortages resulting from the halt in fishing that occurred due to lockdown measures.

High-value products may be particularly at risk. Certain high-value products, such as botanical ingredients used in foods and dietary supplements, may be especially at risk due to supply chain disruptions. Historical data indicate that high-value products such as extra virgin olive oil, honey, spices, and liquors, are perpetual targets for fraudulent activity. Turmeric, which we have discussed previously, was particularly cited as being at high risk for fraud due to “‘exploding’ demand ‘amidst supply chain disruptions.’”

How can we ensure food sufficiency, safety, and integrity? FAO has recommended that food banks be mobilized, the health of workers in the food and agriculture sector be prioritized, that governments support small food producers, and that trade and tax policies keep global food trade open. They go on to say, “by keeping the gears of the supply chains moving and actively seeking international cooperation to keep trade open, countries can prevent food shortages and protect the most vulnerable populations.” FAO and WHO also published interim guidance for national food safety control systems, which noted the increased risk of food fraud. They stated “during this pandemic, competent authorities should investigate reported incidences involving food fraud and work closely with food businesses to assess the vulnerability of supply chains…”.

From a food industry perspective, some important considerations include whether businesses have multiple approved suppliers for essential ingredients and the availability of commodities that may affect your upstream suppliers. The Acheson Group recommends increasing supply chain surveillance during this time. The Food Chemicals Codex group recommends testing early and testing often and maintaining clear and accurate communication along the supply chain.1 The nonprofit American Botanical Council, in a memo from its Botanical Adulterants Prevention Program, stated “responsible buyers, even those with relatively robust quality control programs, may need to double- or even triple-down on QC measures that deal with ingredient identity and authenticity.”

Measures to ensure the sufficiency, sustainability, safety and integrity of foods are more closely linked than ever before. In this time when sufficiency is critical, it is important to avoid preventable food recalls due to authenticity concerns. We also need to stay alert for situations where illegal and possibly hazardous food products enter the market due to shortages created by secondary effects of the virus. The best practices industry uses to reduce the risk of food fraud are now important for also ensuring the sufficiency, sustainability and safety of the global food supply.

Reference

  1. Food Safety Tech. (April 24, 2020). “COVID-19 in the Food Industry: Mitigating and Preparing for Supply Chain Disruptions “. On-Demand Webinar. Registration page retrieved from https://register.gotowebinar.com/recording/1172058910950755596

*Foodborne transmission is, according to the Food Standards Agency in the U.K., “unlikely” and, according to the U.S. FDA, “currently there is no evidence of food or food packaging being associated with transmission of COVID-19.”