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October 9, 2024

Designing Seamless Quality Assurance Across the Cold Chain

Written by SmartSense | Pharmacy Safety, Food Safety, HACCP, FSMA, Supply Chain, Vaccines, Grocery, Food Service, Patient Safety, Healthcare

Wholesalers and retailers in the food manufacturing and pharmaceutical industries must ensure the effective delivery of pathogen-free food and critical medications to their customers who rely on them for their health and well-being. To do so successfully requires accurate, real-time data across the cold chain, from the manufacturing floor to the warehouse to point of sale.

It is, therefore, a top priority for executives to implement an IoT Sensing-as-a-Service solution to ensure seamless quality assurance. When empowered by data-driven decision-making tools, safety and QA managers are guided by descriptive insights about on-the-ground operations to streamline workflows and thus reduce risks related to safety and product loss.

Ensuring quality in food manufacturing with greater connectivity

The focus of foodborne outbreaks in the news often highlights instances of contamination occurring at well-known restaurant brands or retailers. However, given nearly 40,000 food and beverage processing plants nationwide, more attention should be focused on food safety at the point of manufacturing and production.

Each of these plants is a crucial link along the cold chain. Their operations are indispensable to consumers who rely on safe, fresh food to meet their health and nutrition needs. In today’s complex production, distribution, and warehousing networks, an essential component to safeguarding and streamlining the flow of food is the substitution of manual tasks by IoT automation.

Integrating automation technologies into food manufacturing systems

The integration of automation technologies into food manufacturing systems has many benefits:

  • Infuse operations with better safety mechanisms and practices
  • Increase employee productivity
  • Enhance quality control
  • Improve efficiency
  • Reduce cost


When selecting the right IoT technology, food manufacturers should consider the level of interoperability that potential partners can provide. More open systems allow for greater flexibility and customization, thereby supporting consistent quality control to ensure that:

  • Brand standards are aligned with regulatory compliance requirements.
  • Products meet the same standards consistently.
  • Risk of foodborne illness outbreaks and product recalls is reduced.

Weathering the effects of climate change in the cold chain

palm trees in the wind

Climate change threatens to disrupt critical links in the cold chain that ensure food access. Extreme weather events, such as hurricanes, wildfires, tornadoes, and flooding, have diverse negative effects on supply chains, among them:

  • Shorter growing seasons
  • Less availability of raw materials
  • Damage to transportation infrastructure
  • Increased transportation and energy costs
  • Obstacles to the shipment and delivery of goods


In response to climate threats, government agencies are implementing more stringent regulations that are likely to increase the cost of compliance and affect supply chain efficiency. Integrating a Sensing-as-a-Service solution into the manufacturing infrastructure can counter these potential expenses by automating processes and providing real-time intelligence to guide successful efforts toward continuous operational improvement.

Increasing sustainability by balancing sources and reducing food waste

Restaurants and food retailers are challenged to find the right balance when sourcing food from small, local producers with minimal infrastructure and large, industrial producers with massive infrastructure. It is important to understand the benefits of both sources.

On the one hand, the sustainability of local sourcing coupled with the stimulus to local economies through the support of small businesses is a powerful vehicle for empowering consumers to be more eco-conscious. On the other hand, the volume that large food manufacturers can produce is essential to feeding growing populations. Both missions are equally important to ensure a sustainable production process that helps protect the environment, the economy, and the customer.

Investing in food safety and quality also aligns with sustainability initiatives because of their associated benefit of reducing food waste. As much as 40% of the food supply in the U.S. is wasted. Food manufacturers can reverse this needless trend with a Sensing-as-a-Service solution.

As visibility increases throughout the cold chain, data related to the quality and safety of food products and their environments multiplies. Once that data is analyzed, intelligence reports are generated providing information to help executives make better decisions about waste. When a quality assurance or compliance professional can identify which batches of food have been compromised during an excursion, that insight prevents them from discarding uncompromised products, which leads to less waste and more sustainable operations.

Finetuning pharmaceutical monitoring for optimal warehousing

pharmaceutical products on conveyor going into a warehouse

Pharmaceutical wholesalers and retailers need to ensure the safe and effective delivery of critical, hard-to-get medications. Like food producers, they service customers—in this case patients—who rely on efficient supply chains for their health and well-being. Fortunately, Sensing-as-a- Service solutions with real-time visibility of a warehouse’s ambient conditions is available to them to meet regulatory compliance requirements and ensure inventory safety and efficacy.

Responding to new regulations for OTC medications

Monitoring temperature and humidity of storage conditions for over-the-counter medicines (OTCs) has always been recommended by the CDC, but not strictly regulated or enforced. Because OTCs are not refrigerated, their governance has been considered less important compared to refrigerated medications.

Lately, however, FDA regulatory bodies and State Boards of Pharmacy have been paying more attention to distribution centers that handle OTCs. Recent recalls, for instance, have motivated them to scrutinize storage conditions.

This makes sense, since OTCs exposed to exceedingly cold or hot temperatures can degrade them, thereby posing a risk of negative side effects and decreased effectiveness. In response, two solutions can help protect OTCs and other critical medications from temperature excursions: warehouse heatmapping and cross-docking.

Warehouse heatmapping using MKT

Ambient temperature varies between the zones of a warehouse — especially large warehouses that operate with a spoke–hub distribution paradigm. Similar to those in refrigeration assets, these zones maintain a precise temperature profile that can be optimized for inventory safety and product quality.

Conducting a thermal heat mapping study is a critical step to ensure that a pharmaceutical warehouse meets FDA and National Association of Boards of Pharmacy (NABP) regulatory requirements, especially when specialty medications are involved. Mapping involves placement of temporary sensors throughout the various warehouse zones to gather temperature and humidity data that reveals the coldest and warmest areas of the warehouse.

This data is analyzed to generate a report identifying the Mean Kinetic Temperature (MKT) for each zone. The MKT subsequently provides accurate guidance for the correct placement of permanent sensing capabilities throughout the facility.

Cross-docking strategies to minimize storage

Cross-docking is a logistics strategy to speed up delivery times while minimizing warehousing and handling costs. Pharmaceuticals are unloaded directly from incoming transport vehicles, sorted, and reloaded onto outgoing transport vehicles traveling to the same destination.

Cross-docking has two basic strategies:

  • Pre-distribution: pharmaceuticals are unloaded, sorted, and repacked according to pre-determined distribution instructions that have already identified the customer before the product leaves the supplier.
  • Post-distribution: sorting is deferred until the proper facility and customers are chosen, based on demand.

Cross-docking strategies provide the following benefits:

  • Faster delivery times: optimizes the supply chain.
  • Increased accuracy: eliminates the need for manual handling.
  • Better responsiveness: reacts rapidly to changes in demand through real-time tracking.
  • Reduced inventory costs: minimizes the need for warehouse space.
  • Improved sustainability: reduces the number of required shipments, transport vehicles, emissions, and distribution costs.

SmartSense Podcast: How does IoT enable workflow streamlining in cold chains?

For food and pharmaceutical manufacturers, logistics providers, and retailers, the opportunities to mitigate unnecessary risk and reduce product loss with IOT capabilities are extensive and cost-effective.

In this IoT One podcast, Gil Dror, Chief Technology Officer, and Sammy Kolt, Chief Product Officer, discuss the ways IoT is making a significant impact on the healthcare and food services industries to enhance safety measures, ensure compliance with regulations, and maintain stringent quality control standards.

Read more about how SmartSense supply chain monitoring solutions can streamline your organization’s quality assurance operations.

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