Tag Archives: GMPs

Prasant Prusty and Arundhathy Shabu

Foreign Material Contamination: Challenges and Management of Risks

By Arundhathy Shabu, Prasant Prusty
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Prasant Prusty and Arundhathy Shabu

Do you recollect the recall of nearly 250,000 pounds of a frozen chicken strips entree product due to a consumer discovering a piece of plastic in one of the chicken pieces, as announced by the USDA FSIS on September 2nd, 2023? Although food manufacturing facilities often implement diligent foreign material contaminant detection and control protocols, recalls due to foreign materials continue to happen. Therefore, it is critical for food businesses to understand the potential routes for foreign material contamination, analyze the challenges they bring, and employ a comprehensive approach to foreign material control and management, utilizing efficient methods to ensure consumer safety.

Origins of Foreign Material Contamination

The extraneous materials found in the food supply are defined by the FDA’s Food Defect Levels Handbook as “any foreign matter in a product associated with objectionable conditions or practices in production, storage, or distribution, including objectionable matter contributed by insects, rodents, and birds; decomposed material; and miscellaneous matter such as sand, soil, glass, rust, or other foreign substances.”

The origins of foreign substances found in food are commonly classified into five categories:

  • Unintentional introduction from the field (stones, metal, insects, unwanted plant material like thorns or wood, soil, or small animals).
  • Accidental inception during processing and handling (bone, glass, metal, wood, nuts, bolts, screening, cloth, grease, paint chips, rust, and similar items).
  • Substances that enter the food during distribution (insects, metals, soil, or stones).
  • Deliberate inclusion of materials in food (employee sabotage).
  • Miscellaneous materials, such as struvite and other similar substances.

Not all foreign materials make a food item unsafe, but they all can have a profound effect on consumer satisfaction, which can result in negative publicity and decreased sales and regulatory compliance.

Foreign Object Contamination Risks and Challenges

Foreign material contamination in the food supply chain presents significant risks including:

Consumer Health Risks. Consuming contaminated food can lead to injuries such as broken teeth, choking, internal injuries, or illness if the foreign material carries pathogens. These incidents can result in severe health consequences, including hospitalization or even death, depending on the nature of the contaminant and the sensitivity of the consumer.

Regulatory Compliance. Regulations enforced by governmental agencies require strict adherence to food safety standards, including contamination prevention measures. Failure to comply with these regulations can lead to fines, legal penalties, product recalls, and even business closure.

Supply Chain Disruption. Contamination incidents can disrupt the flow of products through the supply chain, leading to delays, shortages, and increased operational costs. These disruptions can ripple through the entire industry, affecting a multitude of stakeholders.

Damage to Brand Value. Foreign material contamination incidents can tarnish a company’s reputation and erode consumer trust. News of contaminated products spreads rapidly through traditional and social media channels, leading to negative publicity and brand damage.

Financial Losses. The costs associated with product recalls, legal settlements, and loss of sales revenue can be significant and have long-term implications for profitability and sustainability.

Despite understanding the significant risks associated with foreign object contamination, these events continue to occur. That is because there are significant challenges in preventing and detecting foreign materials in food products, such as:

Supply Chain Complexity. The modern food supply chain is highly interconnected, involving numerous stakeholders, including farmers, processors, distributors, retailers, and consumers. Each step in the supply chain opens doors for contamination, making it challenging to trace the source of foreign materials accurately.

Implementation of Preventive Measures. Establishing effective preventive measures to mitigate the risk of foreign material contamination requires collaboration, investment, and ongoing vigilance. Verification of the efficacy of the employed preventive actions is often overlooked, which may lead to recurring foreign material presence.

Addressing these challenges requires a coordinated effort across the entire supply chain, with a focus on proactive risk management, quality assurance, and continuous improvement. The fundamental point remains that foreign substances should not be present in food items and hence, processors must create, record, execute, and sustain foreign material control programs to tackle these challenges and guarantee the exclusion of such materials from both their products and procedures.

Prevention Strategies

A foreign material management program is a protocol established to avert, identify, and investigate occurrences of foreign impurities within any food processing or manufacturing facility. An effective foreign material control program should adopt a holistic framework, integrating components that assess potential risks throughout the supply chain and establish appropriate preventive and corrective measures against foreign contamination. Following are the three key components to an effective program.

  1. Risk Assessment & Management in Farming

Food manufacturers and ingredient producers, including farmers and agronomists, must understand the specific risks and proper handling procedures of their ingredients to ensure food safety. Risk assessment in agriculture involves identifying hazards and vulnerabilities that could introduce foreign materials throughout the farming process, from planting to post-harvest handling.

Examples of hazards include contaminated water or soil, improper pesticide handling, inadequate pest control, and poor sanitation practices. Risk management involves scrutinizing farming operations to eliminate points of entry for foreign materials. Good Agricultural Practices (GAP) are crucial for controlling food safety hazards and are categorized into eleven segments, covering various aspects of farming practices. Compliance with GAP standards helps minimize the risk of contamination throughout the production process.

  1. Risk Assessment & Management in Receiving, Storage, and Transportation

In the context of receiving, storage, and transportation, the identification of potential sources of contamination is essential, with bulk shipments presenting significant challenges due to their susceptibility to foreign material introduction. Hazards during these stages can arise from various factors, including handling and environmental conditions.

Supplier approval programs serve to both ensure product safety and mitigate foreign material contamination risks. These programs primarily involve assessing suppliers’ food safety measures, including protocols for food handling and foreign object detection. Buyers can enforce measures such as sieving, screening, or employing metal detectors or X-ray machines before packaging, which should be specified in purchasing agreements. Effective risk management strategies involve thorough supplier verification and monitoring processes to ensure adherence to quality standards and practices. Intervention strategies, such as specific protocols for bulk deliveries, and communication with suppliers are required to prevent and address contamination issues promptly.

  1. Good Manufacturing Practices (GMP)

Good Manufacturing Processes are defined by regulatory agencies and developed to ensure that products are consistently produced following set quality standards. They cover multiple aspects of company operations that may allow for the introduction of foreign materials including:

Personnel. GMP dictates policies regarding attire and personal items for personnel involved in food processing, emphasizing the importance of verification programs to ensure the detectability of items within the processing environment.

Premises. Ensuring the proper condition and maintenance of the physical facility minimizes the risk of foreign material contamination. This includes regular upkeep and designated areas of operation to minimize the risk of cross-contamination. Effective waste management systems are also necessary to eliminate potential breeding grounds for contaminants.

Equipment Designing and Utensils. Equipment and utensils must be designed with materials resistant to shattering or splintering that feature smooth, non-porous surfaces for easy cleaning. Regular inspection and maintenance protocols are required to ensure equipment integrity and minimize the risk of foreign material contamination.

Preventive Maintenance. Preventive maintenance programs address equipment malfunctions before they pose a risk of contamination, with scheduled tasks tailored to the usage lifespan of different components. Timely replacement of parts is important to prevent failures that could compromise product safety.

Wood Control. Implementing a pallet management program helps prevent contamination from wooden pallets.

Glass and Brittle Plastic Controls. Food manufacturers are required to have a dedicated program for managing glass and brittle plastic as part of their GMP. This begins with establishing a policy prohibiting the presence or use of glass or ceramic objects in food processing areas or warehouses. A comprehensive inventory of all glass and brittle plastic items in food storage or handling areas, including their locations and protective measures, must be maintained.

Sanitation and Validation. Thorough cleaning and disinfection procedures are integral to maintaining sanitation standards, with validation processes to ensure the effectiveness of cleaning protocols. Comprehensive testing and verification are necessary and required to confirm the absence of contaminants.

Detection and Removal with Ongoing Surveillance. Various detection and removal methods, including sieves, electronic sorting, and centrifugation, can be employed to identify and eliminate foreign materials during processing. Collaboration with suppliers is key to optimizing detection equipment configurations and calibration, ensuring the removal of contaminants throughout the production process.

Innovative Approaches for Foreign Material Control

With technological advancements, innovative approaches have emerged to enhance foreign material detection and prevention processes. One such approach involves the use of advanced imaging technologies, such as X-ray inspection systems and metal detectors, which can identify foreign objects within food products. These systems utilize sophisticated algorithms to distinguish between desired food components and foreign materials, enabling manufacturers to detect contaminants with high precision. For example, X-ray inspection systems can detect metal, glass, plastic, and other dense foreign materials, while metal detectors are effective in identifying metallic contaminants.

The integration of artificial intelligence (AI) and machine learning algorithms has revolutionized foreign material control in the food industry. AI-powered systems can analyze vast amounts of data in real time to identify patterns and anomalies associated with foreign material contamination. This enables proactive detection and prevention measures, reducing the risk of foreign material incidents and product recalls.

For instance, AI algorithms can continuously monitor production lines for deviations from normal operating conditions and trigger alerts when potential contaminants are detected. Additionally, advancements in sensor technology, such as hyperspectral imaging and laser-based systems, offer enhanced sensitivity and specificity in detecting foreign materials, further improving food safety standards. Overall, these innovative approaches underscore the importance of leveraging technology to enhance foreign material control and uphold the highest standards of food safety in the industry.

By building and maintaining competent foreign material contamination management systems and incorporating new technologies, companies can safeguard product quality, protect consumers, and preserve brand reputation.

Checklist

2020 FSC Episode 6 Wrap: Lessons in Sanitation

By Maria Fontanazza
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Checklist

COVID-19 has put a spotlight on the importance of proper handwashing and overall hygiene. In addition to focusing on worker and operational safety, it has also pushed food manufacturers and processors to pay more attention to the location of high-touch areas and how they should be cleaned, sanitized, disinfected and sterilized. During last week’s Food Safety Consortium episode on sanitation, there was discussion about the need to have the right sanitation plan and properly trained people in place. “When it comes to food safety, who are the most important people in the plant? It’s the sanitation crew and employees. They are on the frontlines, ” said Shawn Stevens, founder of Food Industry Counsel, LLC. “If they don’t do their job or are not given the tools to do their jobs, that’s where the failures occur. We need to empower them. We have to invest in sanitation and not be complacent.”

Investing in a sanitation plan is where it all begins, said Elise Forward, president of Forward Food Solutions. Within the plan, companies need to include items such as PPE and sanitation equipment, along with what resources will be needed and what chemicals will be required. “What would it look like in our manufacturing facilities if we had a plan for the pandemic?” asked Forward. “There was so much scrambling: ‘How do we do this and what do we do’. We need to plan for these events.” Forward, along with David Shelep, microbiologist and consultant for Paramount Sciences and Bill Leverich, president of Microbiologics, Inc., offered a strong overview of the right components of a sanitation plan and the common products and technologies used in the process (quaternary ammoniums, sodium hypochlorite, ethyl alcohol, peracetic acid, hydrogen peroxide, and chlorine dioxide). They also provided insight on some of the products and technologies that are being explored in the face of COVID-19—UV-C and hypochlorous acid, which has applications in cleaning biofilms, hand sanitizing, fogging, and surface application (i.e., electrostatic spraying, mopping).

“Cleaning and sanitizing is setting up your production team(s) for success.” – Elise Forward, Forward Food Solutions

View the list of EPA-registered COVID-19 disinfectants.

Beyond sanitation methods, companies need to invest in employee training and be committed to their safety. This means giving employees sick days and not incentivizing them to come to work when they are sick.

Rob Mommsen, senior director, global quality assurance and food safety for Sabra Dipping Company, shared a candid perspective on how Sabra developed an effective and validated Listeria environmental monitoring program (LEMP) following an FDA inspection that led to a swab-a-thon, findings of resident Listeria in the plant, and a huge product recall as a result of the Listeria contamination in the plant (Mommsen stated that Listeria was never found in product samples). “We had to severely alter the way we cleaned our plant,” he said. And the company did, with a number of changes that included taking the plant apart and cleaning it; removing all high pressure water nozzles; changing areas in the plant from low care to high care; keeping movable equipment to certain areas in the plant; changing employee and equipment traffic patterns; and retraining staff on GMPs. The company also changed its microbiological strategy, conducting daily swabbing in certain zones, increasing testing on samples, and implementing a weekly environmental meeting that was attended by senior and department managers. “Fast forward” to 2019: FDA conducted an unannounced audit and noted that Sabra’s environmental monitoring program was one of the best they’ve seen and that the company’s culture was clearly driven by food safety, according to Mommsen.

Fast forward again to 2020 and the pandemic: With work-from-home orders in place and other frontline workers staying home for various reasons, the company saw a change GMP adherence, employee training and the frequency of environmental monitoring, said Mommsen. So Sabra had some work to do once again to re-right the ship, and Mommsen presented it as a lessons learned for folks in the food industry: In addition to employee safety, food safety must be the number one priority, and having the support of senior management is critical; the turnaround time for environmental swabs is also critical and an effective LEMP should consist of both conventional testing as well as rapid detection technology; and an environmental monitoring program requires persistence—it is not self sustaining and there are no shortcuts.

The watch the presentations discussed in this article, register for the 2020 Food Safety Consortium Virtual Conference Series, and view the session on demand.

How ERP Can Help Ensure Food Safety in the Cannabis Edibles Market

By Daniel Erickson
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The popularity of cannabis edibles and infused beverages as a socially accepted and convenient method of marijuana consumption has grown exponentially for consumers in states with a legalized market for both recreational and medicinal cannabis. The edibles industry’s success has been met with many challenges however, as the absence of federal regulation has provided little guidance regarding food safety practices. With consumers generally expecting these products to have the same safety expectations as they do with other food and beverages they consume, many manufacturers have elected to follow FSMA best practices to ensure cannabis edibles’ integrity in the marketplace. Proactive cannabis growers, processors and dispensaries are seeking out ERP software solutions in greater numbers to utilize the technological tools and vendor experience in the food and beverage market to establish greater accountability and plan for current and future compliance requirements.

This year the Cannabis Quality Conference & Expo is co-located with the Food Safety Consortium | October 1–3 | Schaumburg, ILCannabis Edibles Defined

Cannabis-derived edibles are food or beverage products that are made with cannabis or infused with cannabis extract—either consumed recreationally or to manage or alleviate health concerns. Cannabis extractions used in edibles include tetrahydrocannabinol (THC), which is psychoactive, and cannabidiol (CBD), which is not, as well as many derivatives when speaking of “whole plant” benefits. While there are a variety of edibles including gummies, candies, cookies, energy drinks, teas and chocolates, the defining characteristic of these products is that they are meant for human consumption. Public perception is that these products are held to the same safety and quality considerations as mainstream food and beverage products available in the market. With these expectations and lack of oversight, the responsibility falls on the manufacturer to meet those expectations and ensure a safe, consistent, quality edible product.

Safety and Quality Concerns

An unregulated industry at the federal level has resulted in a lack of consistency, predictability and safety in the edibles market. Frequently, it has been found that edibles don’t always produce the same experience from one consumption to the next, resulting from inconsistent appearance, taste, texture and potency. These variances pose a problem from a marketing perspective, as it impacts brand recognition, loyalty and returning customers. Similar to the food and beverage industry, foodborne illnesses, outbreaks, undeclared ingredients and inaccurate labeling provide further concern in an unregulated manufacturing environment. Specific safety issues of the cannabis industry include extraction processes, mold and bacteria growth, chemical exposure, pest and pesticide contamination, employee handling of products and the unintentional ingestion of cannabis edibles. With the high risks associated with this market, it is necessary for proactive growers, processors and dispensaries to adequately address quality and safety concerns that mitigate risk until the eventuality of regulatory oversight.

How ERP Can Help

Implementing an industry-specific ERP software solution that provides security and standardizes and automates business functions helps support cannabis manufacturers by providing the proper tools to track operations from seed-to-sale. With support for best practices and streamlined and documented processes, companies can incorporate safety and quality initiatives from cultivation to the sale of edible products and beyond. Utilizing the expertise of ERP vendors in the area of food safety management, edible manufacturers are provided with the same benefits that food and beverage companies have experienced for decades with ERP solutions. Cannabis ERP software allows your company to track all aspects of growing, manufacturing, packaging, distribution and sales—providing functionality that manages inventory, traceability, recipes and labeling to support quality initiatives.

The following areas supported by ERP can lead cannabis edible manufacturers to succeed in the realm of food safety:

Inventory Control. ERP’s automatic recording and tracking of inventory attributes, including balances, expiration dates, plant tag ID’s, serial and lot numbers and end-to-end traceability, allows cannabis edible manufacturers to maintain appropriate raw material and product levels, reduce waste, evaluate inventory flow, facilitate rotation methods and avoid overproduction. It provides accurate ingredient and cost tracking throughout the greenhouse operations and supply chain by use of barcode scanning that links product information to batch tickets, shipping documents and labels. Maintaining real-time and integrated information facilitates the ability to locate items in the event of contamination or recall. This detailed level of continuous monitoring mitigates the risk of unsafe consumables entering the market.

Labeling. Accurate product labeling is essential for food safety in the cannabis edibles industry, and its importance cannot be understated. Proper labeling and transparency ensure that consumers are provided a consistent experience and also help to mitigate unintentional consumption of cannabis-infused products. Certain states have enacted labeling requirements to increase accountability and mitigate the misrepresentation of cannabis edibles on the label with unverified, misleading or inaccurate information. Employing an automated ERP system assists with label creation that includes nutrient analysis, ingredient and allergen statements, testing notification for bio-contaminants and pathogens and expiration dates to ensure quality—providing a faster and more efficient method for labeling. Accurate labeling is also an imperative component of product recall planning, as traceability and labeling history documented in ERP software helps to identify and locate items quickly in the event of a recall.

Recipe and Formulation Management. To achieve consistency of products in taste, texture, appearance, potency and intended results, complex recipe and formula management are maintained with a real-time ERP solution that delivers tightly managed control. Raw material data, version and revision information and production notes are documented for each batch. The monitoring of key quality specifications such as THC and CBD percentage, containment and impurities testing, etc. are readily handled within the system and allows for the scalability of recipes as needed. Direct access to the calculation of specific nutritional values, which includes ingredient and allergen information, provides accurate labeling and consumer information for product packaging—a valuable asset in the cannabis edibles market. R&D functionality supports the creation of new and innovative edibles and marijuana-infused beverages in a sandbox environment to meet the demands of this consumer-driven market.

Approved Supplier Relationships. Assurance of cannabis edible safety is enhanced through the acquisition of quality raw materials from trusted vendors. An ERP solution plays an essential role in the process as it maintains a supplier list by documenting detailed supplier information and test results to assure in-house qualifications and potency standards are met. A fully-integrated ERP system regulates quality control testing to ensure consistent and approved materials are being used and undeclared substances, harmful chemicals and impure ingredients are unable to infiltrate the supply chain. Failure to meet quality control standards results in ingredients being quarantined, removed from production and disposed of safely, and indicates that a search for alternate vendors is needed. This detailed level of documentation is a best practice for maintaining current and accurate supplier information in the event of a product recall.

Current Good Manufacturing Practices (cGMPs). As the bedrock for the food and beverage industries, following cGMPs establishes an important foundation for the edibles market. An ERP efficiently documents processes to ensure safe and sanitary manufacturing, storage and packaging of food for human consumption. This includes monitoring equipment status, establishing cleaning and hygienic procedures, training employees, reporting illnesses, maintaining food and cannabis handling certifications and eliminating allergen cross-contact risks. Validating procedures within an ERP solution automates documentation of an audit trail and addresses food safety concerns more efficiently than manual methods.

Hazard Analysis Critical Control Points (HACCP) Requirements. Establishing a food safety team that develops a HACCP plan to enact procedures that protect consumers from the biological, chemical and physical dangers of edibles is a recommended best practice for quality assurance, despite the current lack of federal regulations. Critical control points recorded within an ERP solution prevent and control hazards before food safety is compromised. Parameters within the ERP system can be utilized to identify potential hazards before further contamination can occur. Applying these best practices historically used by food and beverage manufacturers can provide an enhanced level of food safety protocols to ensure quality, consistent and safe consumables.

Food Safety Plan. As a requirement of FSMA, a food safety plan provides a systematic approach of identifying and addressing food safety hazards by implementing preventative food safety procedures throughout the manufacturing, processing, packing and storage of products. With a trained Preventative Control Qualified Individual (PCQI) at the helm to coordinate the company-specific plan, an ERP solution automates and records preventative controls, full forward and backward lot traceability, recall plans and employee training records within an integrated system to ensure that food safety policies and procedures are being followed.

With the growth of the edibles and infused beverage market expected to skyrocket over the next four years, the success of growers, processors and manufacturers will continue to thrive off of technological tools and established best practices. Employing the industry experience of ERP software providers that have implemented food safety and quality control procedures will follow suit of the market and be a sought-after resource when federal regulations are imposed. Proactive cannabis businesses are already experiencing a return on investment in their ability to provide quality, consistent products that meet cannabis enthusiasts’ high expectations and keep them ahead of this trending market.

Bill Bremer is Principal, Food Safety Compliance at Kestrel Management LLC
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GFSI in 2017: The Year of FSMA Compliance

By Bill Bremer
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Bill Bremer is Principal, Food Safety Compliance at Kestrel Management LLC

This year is being described as “the year of FSMA compliance,” as many compliance dates for the various FSMA rules fall in 2017. As one might expect, the FSMA law and rules include many aspects of the established Global Food Safety Initiative (GFSI) standard; however, there are also differences in how they are applied to create better food safety enforcement.

At the most basic level, GFSI is an industry conformance standard for certification, while FSMA is a compliance regulation that must be met. However, both work together to ensure companies are effectively managing food safety.

GFSI Conformance

The GFSI is facilitated by the industry network of The Consumer Goods Forum. It provides a very solid foundation and supporting objective of “safe food for consumers everywhere”.

GFSI was originally established based on a growing pattern of food safety outbreaks throughout the international marketplace. This led to the proactive development of GFSI standards as an alternative to the more limited and less effective customer audits in place at the time. An important part of this outcome was that CEOs in the food industry—not a regulatory body—determined the need to address food safety through the GFSI food safety standard.

With its beginning as a benchmarking organization, GFSI has since evolved throughout the food supply chain as a strong means for achieving global food safety. It is now established, growing, and improving across the primary supply chains within the global food market.

As such, much work to address food safety has been accomplished by GFSI over the past sixteen years. In fact, the industry-driven aspect of GFSI along the food supply chain has led many companies to achieve levels of food safety comparable to those required to achieve FSMA compliance. Based on its collaboration of food safety experts, GFSI provides for a significant evolution of food safety programs and supports those requiring FSMA compliance.

FSMA Compliance

During a similar timeframe, the United States identified food safety as a major concern for the public. In the 1990s, a growing number of food outbreaks from biological contamination continued to spread, prompting the addition of controls within both the USDA and FDA. These brought the mandated requirement for Hazards and Critical Control Points (HACCP) and supporting Good Manufacturing Practices (GMPs) to specific industry sectors. However, these efforts were measured to have limited effect, as the outbreaks continued.

By the early 2000s, the public concern for food safety continued, and the FDA was determined to make changes. Along with Congress, the FDA commissioned research into the underlying issues that were resulting in the growing number and severity of food outbreaks. This research was being conducted and analyzed just as GFSI was determining its final group of benchmarked standards. At the same time, GFSI was positioned to be advanced into the U.S. market by food industry leaders, including Cargill, McDonalds, Walmart, Kroger, Coca Cola and Wegmans.

The outcomes from the FDA studies determined that the GMPs (in existence for the past 40 years) were not effectively implemented across the U.S. food industry. Further, the studies indicated that the ability to prevent food safety issues through specific controls would provide a means for reducing the number of foodborne illness.

This effort led to the development of FSMA, which passed in January 2011. Additional FSMA rules have since been published, starting in September 2016. The FSMA rules represent a rewrite of the existing FDA food safety regulations. However, with the FSMA law taking several years to roll out, the existing FDA laws remain in effect until they are replaced. These actions expand the FDA’s jurisdiction now and until full compliance of FSMA.

Bringing GFSI and FSMA Together

The presence of GFSI in the United States, as well as the GFSI certification of many suppliers to U.S. food importers, provides for a synergy between the GFSI standard and the FSMA law being enforced throughout the United States and its foreign suppliers. GFSI’s global focus provides the structure to adapt and meet many of the FSMA requirements, with the ability to expand to all FSMA requirements.

As one would expect, the FSMA law and rules include several aspects of the GFSI standard; however, there are many differences in how each is applied to encourage better food safety enforcement that must be considered. For instance, GFSI has the advantage of providing the time to develop programs, and thousands of companies are certified to the various programs under the standard. Conversely, FDA is implementing FSMA compliance over several years, with 2017 being a big year for compliance (based on the rules’ published dates, company size and industry segment).

In this new order of food safety in the United States, those companies that have achieved GFSI certification should have an advantage over those who do not, provided they can align their GFSI programs with the FSMA law requirements. There is also a benefit to starting with FSMA and moving to a GFSI certification.

Existing GFSI certifications provide an established framework, with many of the program requirements similar to those required by FSMA. For example, personnel are required by both to establish HACCP and Food Safety Plans, as well prerequisite procedures (PRPs) and current-Good Manufacturing Practices (cGMPs). The challenges are ensuring the complete development of these food safety procedures to guarantee they meet both GFSI and FSMA requirements.

As another example, personnel requirements are similar but different under FSMA and GFSI, which calls for training, updating and qualifying resources. Ultimately, advanced HACCP training under GFSI provides the means for establishing a Qualified Individual under FSMA, but it requires expanding the training to include FSMA Preventive Controls and procedures. The resulting plan is the food safety plan that can be based on HACCP but with the proper additions to meet FSMA requirements.

Global Food Safety Conference

The upcoming Global Food Safety Conference (February 27 – March 3 in Houston, Texas) provides an opportunity for those seeking compliance to FSMA or certification to a scheme within the GFSI Standard to get a deeper understanding of food safety. With 2017 being the year of FSMA compliance, it is very appropriate that the Global Food Safety Conference be held in the United States this year. The conference will provide U.S. companies attending, as well as foreign supplier of products to the U.S. market, an educational opportunity and forum to reach out to experts from industry, government, and academia to better understand these two key areas for food safety program development. Some of the topics to be addressed at the conference include the following:

  • Food safety management commitment and corporate governance
  • Required training of food safety roles, including management, staff and operations
  • Specific requirements of the documented food safety program or written programs under FSMA
  • FDA requirements of the past and existing requirements prior to FSMA and the relationship of these as comparable to GFSI
  • Implications for FDA enforcement under FSMA of these previous requirements and program requirements that may need to be formalized under FSMA
  • The proof of evidence with supporting records required by FSMA that may be addressed in part by existing or GFSI-level food safety programs
  • How to adapt a FSMA-level food safety plan and preventive controls cGMPs from existing programs, including GFSI, or develop these to function with existing programs
  • Levels and numbers of qualified individuals, qualified auditors and competent sanitation for oversight and management of FSMA food safety plans
  • Management reanalysis and update of the written FSMA programs to ensure compliance and readiness for inspection by FDA FSMA investigators
  • Process used to ensure compliance with FSMA Preventive Controls and the other FSMA rules being issued in 2017 and 2018, including Foreign Suppler Verification, Sanitary Transportation and Intentional Adulteration

Kestrel has been a long-time advocate of GFSI, performing site certification program development support for hundreds of companies. We have served as a GFSI Stakeholder, Technical Working Group participation, and panelist at previous GFSI Global Food Safety Conferences. We look forward to seeing you at the 2017 GFSI Global Food Safety Conference and to helping you navigate GFSI conformance and FSMA compliance requirements.

Social responsibility in food safety

How Social Responsibility Affects Food Safety

By Maria Fontanazza
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Social responsibility in food safety

Today, the idea of engaging in socially responsible practices goes beyond a feel-good concept. When considering food safety, social responsibility can have a big impact on a company’s bottom line, especially with the increased complexity of supply chains, as more ingredients and products are being imported.

According to Anna Key Jesus, senior director of quality systems at Amy’s Kitchen, social responsibility ties into food safety in a few ways:

  • Increasing market size for large companies equals more imported products as ingredients for processed foods
  • Differing labor laws from country to country, along with their oversight globally, require vigilance regarding employee rights and safety
  • A growing and global social media presence has pushed consumers to demand that food companies engage in socially responsible practices

Jesus, who spoke during a recent webinar, “Social Responsibility As a Driver for Food Safety”, discussed how food companies should be implementing socially responsible practices within their organizations and the ethics of providing a safe environment for workers.

“Any company that willfully operates an unsafe working environment for their employees is less likely to provide a safe processing environment for their customers,” said Jesus, adding that unsafe working environments can lead to increased turnover, employee accidents involving loss of attention or oversight, and the presence of blood borne pathogens or other potential safety events. “These conditions directly impact the safety of products.”

She emphasized the use of the SA 8000 standard to drive social responsibility within companies The auditable standard is based on the UN Declaration of Human Rights and is used across industries to protect the basic rights of workers, specifically calling out the prohibition against child labor and forced labor. “Forced or slave laborers do not live in an environment of personal safety,” said Jesus. “Under the conditions that they are held in, it is nearly impossible to promote GMPs or food safety guidelines. We can state with confidence that there are not good manufacturing practices when slave labor is involved.”

SA 8000 components address the following areas, all of which tie back into continuous improvement:

  1. Child labor
  2. Forced or compulsory labor
  3. Health and safety
  4. Freedom of association and right to collective bargaining
  5. Discrimination
  6. Disciplinary practices
  7. Working hours

Jesus urged food companies to carefully look at their own labor practices, as overworked and exhausted employees are the number one cause of accidents in the workplace. This is not only a legal and ethical issue from an employee perspective, but it also affects the execution of sound food safety practices within manufacturing facilities.