The Future of the Dairy Industry : How FSQ Digitalization in Infant Formulas Can Avoid Contamination, Recalls, and Costly Litigation

The global dairy industry, a cornerstone of the food sector, spans a diverse range of products, from milk and cheese to yogurt and various dairy derivatives. Valued at USD 893 billion in 2021, the industry is projected to experience a compound annual growth rate (CAGR) of 5.2% from 2021 to 2028. 

Despite its significance in providing nutrition worldwide, the dairy industry grapples with challenges such as inflation, labor shortages, microbial contamination, technology adoption barriers, temperature control issues, and traceability concerns. Addressing these challenges becomes crucial as the industry expands to ensure the production of safe and high-quality dairy products. 

In this blog post, we will first explore the current state of the dairy industry, shedding light on the specific challenges faced, particularly in infant formulas. Then, we will delve into the available solutions within the market, with a particular focus on digital solutions that promise enhanced management of these challenges. Our exploration will highlight the role of FSQ (Food Safety and Quality) digitalization, with a specific spotlight on Novolyze's innovative platforms and its unique solutions tailored to fortify the dairy industry against contemporary challenges.  

Current State of the Dairy Industry 

Undoubtedly, the dairy industry contends with persistent challenges that intricately weave into the fabric of its operations, compelling a closer examination of its current state. The relentless force of inflation exerts pressure on the industry, disrupting operational costs and overall profitability. Simultaneously, the scarcity of labor in production plants amplifies concerns surrounding operational quality, necessitating effective training strategies to mitigate the impact of resource shortages. 

Microbial adaptation and resistance, especially from pathogens like Listeria monocytogenes, Escherichia coli (E. coli) and more particularly Cronobacter sakazakii for infant formula, pose significant risks in the dairy industry. Contamination can occur at various production stages, making it challenging to ensure thorough removal. Bacteria can adapt to their environment, forming biofilm for some or surviving months even year for others, further complicating the decontamination process.  

Proper temperature control during pasteurization, transportation, storage, and distribution is crucial to prevent the growth of harmful microorganisms in dairy products. Inadequate temperature control can lead to spoilage and compromise the quality of the products and even the safety in case of pathogen microorganisms.   

Major players in the dairy industry have encountered traceability challenges during specific recall incidents, shedding light on the critical need for enhanced traceability measures. Indeed, the significance of implementing enhanced traceability measures is further emphasized by the Food Traceability Final Rule, which plays a crucial role in the FDA’s New Era of Smarter Food Safety Blueprint and implements Section 204(d) of the  FDA Food Safety Modernization Act (FSMA) 

Consequently, establishing robust traceability systems in the dairy industry is an indispensable facet of robust food safety and quality management, enabling companies to swiftly identify and recall specific product batches in response to quality and safety concerns.    

As the dairy industry grapples with these challenges, the pressing issue of traceability aligns seamlessly with the transformative potential of digital solutions. Infant formulas, constituting a significant challenge for the industry, are distributed widely, with the Baby Milk & Infant Formula market generating substantial revenue, reaching US$50.67 billion in 2023 and anticipating annual growth at a rate of 5.56%. 

Indeed, infant formula is subject to stringent nutritional standards and the imperative of remaining pathogen-free. Given the vulnerability of newborns to pathogens such as Listeria, E. coli, C. Sakazakii, and Salmonella, the stakes are exceptionally high, with potential risks including severe illnesses, irreversible brain damage, or even fatalities. 

However, the path to ensuring the safety and quality of infant formulas is riddled with complexities. Contaminated dry ingredients, while capable of preventing bacterial growth, present formidable challenges for effective decontamination. Dry ingredient plants, opting to avoid water for factory cleaning and sanitation, add layers of complexity to an already intricate process. 

In addressing these complexities, infant formula production plants require highly qualified operators who can efficiently oversee the intricacies of food safety and quality management. The scarcity of resources is typically addressed through outsourcing, involving third parties such as laboratories or specialized services for cleaning, sanitation and environmental monitoring. The third parties are  entrusted with specific responsibilities in contributing to the successful implementation of Food Safety and Quality measures. This phenomenon can introduce bias such as having contractors judging their own work or unclear communication leading to wrong decision-making process.   

The Safety and Quality measures of pasteurization, sanitation and environmental monitoring, form the front line in preventing infant formula contamination. Yet, as industry grapples with these challenges, a beacon of hope emerges through digitalization. 

The integration of digital solutions promises to revolutionize how these challenges are approached and managed, offering unprecedented tools for enhancing traceability, mitigating contamination risks, and building adaptive food safety plans. In the following section, we delve into the transformative impact of FSQ (Food Safety and Quality) digitalization in the infant milk industry, exploring its benefits and applications. 

FSQ (Food Safety and Quality)  Digitalization in Infant Milk industry and Its Benefits 

How  the infant milk industry manages those challenges?   

Managing challenges in the infant milk industry requires continuous validation and verification of critical control points. One of the big challenges is the records still in paper. Using the right technology for validation, such as surrogate microorganisms or advanced modeling, ensures efficiency. Verification measures require to be scalable, allow quick reaction is key to anticipating and adapting to the FSQ management system. Such adaptation and agility must be built around digital solutions.     

FSQ digitalization offers various benefits, including :

  • shorter reaction times in case of deviations
  • improved visibility of dead angles in food safety and quality strategy
  • easier trending of historical data
  • simplified training and onboarding of workers
  • enhanced worker retention through user-friendly workflows. 

Novolyze presents a unique approach that offers a centralized platform for overseeing the food safety and quality measures and making informed decisions. Leveraging patented technology, Novolyze facilitates initial validation using state-of-the-art methods and streamlines the verification process. 

Empowering Precision and Efficiency with  the Digital Smart Process Control 

Digital Smart Process Control emerges as a powerful tool, enabling the comprehensive validation and verification of Critical Control Points (CCP). This technology calculates worst-case pathogen lethality, particularly beneficial in the context of infant formula pasteurization.  

Monitoring becomes more accessible and more standardized, leading to less human error. The Smart Process Control (SPC) solution further aids in suppressing both overprocessing and underprocessing, providing advantages in addressing inflation challenges and enhancing food safety compliance. This comprehensive solution ensures CCP monitoring and precise pathogen lethality calculations for the whole production sequence, with workers acknowledging information through signed reports. Documents are easily retrievable in the event of an audit or crisis management, while a user-friendly dashboard assists managers in analyzing data and sharing insightful information related to process performances. 

Elevating Hygiene Standards: The Role of Sanitation Complete in Infant Formula Plant Management 

A crucial addition to this digital arsenal is the Sanitation Complete solution, designed to support efficient master sanitation schedule management built around evolving Sanitation Standard Operating Procedures (SSOP). Implemented in infant formula plants, Sanitation Complete triggers inefficient SSOP, fosters accountability, and aids in the training of new workers. This solution allows the creation and management of a master sanitation schedule while documenting task forms Alerts on failure and overdue tasks assist managers in prioritizing actions, underscoring the importance of preventing plant contamination to avert major crises.  

Visualizing Safety: The Impact of Environmental Monitoring on Infant Formula Manufacturing 

Environmental monitoring emerges as the linchpin to ensure efficient detection, analysis, and adaptation in the production process. Combating the inertia associated with the mindset of "we always did it this way," Novolyze's Environmental Monitoring platform promotes agility and continuous improvement. Microorganisms, highly adaptive in stressful environments, necessitate agile and evolving mitigation measures. Environmental monitoring provides infant formula manufacturers with a contextual understanding of risks, enabling them to take appropriate adaptive measures. For instance, visualizing contamination evolution through a heat map display helps focus on root causes and prevents the spread of bacteria. Predictions based on historical data guide the evolution of sampling plans to enhance detection efficiency. 


In navigating the complexities of the dairy industry, especially concerning the safety of infant formulas, FSQ digitalization emerges as a transformative force. The integration of digital solutions, exemplified by Novolyze's innovative platforms, promises not only to mitigate challenges such as contamination risks, traceability issues, and operational complexities but also to revolutionize how safety and quality are managed. By combining technology, expertise, and adaptability, Novolyze contributes significantly to securing and advancing practices in infant milk production while simultaneously reducing costs. As the dairy industry evolves, the embrace of digitalization stands as a beacon of hope for enhanced safety, efficiency, and overall success. 

Novolyze can help elevate your food safety program, reduce your recall risk, and ensure compliance. Learn more:

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Bibliography :

  1. Kent, R. M. (2015). Novel Approaches to Improve the Intrinsic Microbiological Safety of Powdered Infant Milk Formula. 
  2. Jason, J. (2012). Prevention of Invasive Cronobacter Infections in Young Infants Fed Powdered Infant Formulas. 
  3. Sen, K. O., & Durakbasa, S. (2017). Implementation of Digitalization in Food Industry. 
  4. Freund, A. (2021). The Signs of Digitalization on Food Safety Issues: A Literature Review Focusing on Traceability.