A Cold Chain Audit and Storage Checklist for Shipping Perishables

What’s the big deal with cold chain audits? After all, any shipper or third-party logistics (3PL) provider who works in and around the cold chain certainly understands how vital it is to have visibility into temperature-controlled shipments from the point of origin to final delivery. Theirs is a world where even the slightest excursion from the mandated temperature range—at any point in the journey—could result in the loss of an entire load. The consequences can reach far beyond a hit to the corporate bottom line on a ledger sheet when that happens. It also jeopardizes the organization’s reputation, and in extreme cases—in which spoiled product reaches consumers—illness and even death are possible.

Cold chain audits exist because hope is not a strategy and ignorance is not a defense. At some point along the cold chain—whether it’s a regulatory agency, receiver, retailer, supply chain partner, or consumer—someone is going to say the two words that stop every shipper cold in their tracks: Prove it. As in, prove to me that this load did not deviate from its desired temperature range. A documented audit of data, collected by temperature loggers throughout the shipment’s journey, is your best defense in those situations. Having that proof at your fingertips—ready to share with others—provides peace of mind, assurance, and confidence to everyone.

While audits can apply to any temperature-controlled cold chain, from pharmaceuticals and medical products to fine artwork, this article focuses solely on perishable foods.We’ll look closely at cold chain audits, the associated policies and protocols, and their timing. We also provide a cold chain audit checklist, which shippers, 3PLs, and other partners can use for any perishable food shipment, whether going across town, coast to coast, or around the world.

The Ramifications of Poor Cold Chain Management

A top priority of the U.S. Food and Drug Administration (FDA) is establishing and maintaining food safety standards that reduce food waste and safeguard consumers’ health.

Recycle Track Systems, citing statistics from the United Nations Food and Agriculture Organization and the U.S. Environmental Protection Agency, notes that the world wastes about 1.4 million tons of food every year—and the U.S. discards more food than any other country (80 billion pounds). Some estimates indicate as much as 75% of food waste occurs during production and distribution.

What happens when contaminated food slips through the cold chain checks and balances is even more staggering. The World Health Organization estimates that unsafe food causes 600 million cases of foodborne diseases and 420,000 deaths annually.

Many of these foodborne illnesses can be traced to the cross-contamination of foods, failure to maintain acceptable temperature ranges, and other conditions throughout the cold chain. For instance, the presence of E.coli is a threat to ground beef, fresh produce, and unpasteurized milk. Listeria and salmonella contaminations are other foodborne illnesses often associated with fresh food products.

Cold Chain Audits Help Provide Proof of Compliance

 In 2016, the FDA enacted the Sanitary Transportation of Food (STF) Act, an extension of the Food Safety Modernization Act (FSMA). That might seem like a whole lot of alphabet soup, but let’s spell out what this means for you as a stakeholder running a cold chain:

The STFA is a series of regulations requiring shippers, 3PLs, carriers (by motor vehicle and by rail), receivers, and other persons involved in the transportation of food to use sanitary transportation practices to ensure food is not transported under conditions that might render the food unsellable or inedible.

A Closer Look at the STF Act Guidelines

There are 13 elements of the FMSA / STF Act to consider when transporting perishable food products, and each of these elements can be covered in a cold chain audit. Having documented proof of solid cold chain custody protects shippers and their supply chain partners from potential fines for violations. The STFA framework includes six main areas of emphasis:

1. Temperature Monitoring & Control

The proof is in the data collected by temperature loggers such as Tive Tag. This data provides a valuable audit trail for compliance needs.

2. Validation

Shippers must ensure that their suppliers also follow the stringent FSMA and SFTA guidelines and that environmental monitoring programs are in place to guard against food contamination.

3. Cross-Contamination

A cold chain audit provides assurance that food was segregated from non-food items in the same trailer/container/railcar, and that there was no backhauling of hazardous materials or improper disposal of wastewater associated with any mode used to transport food.

4. Sanitation

The STFA guidelines also cover the packing of transportation units and storage facilities. All transport vehicles and equipment used for loading and unloading must be sanitized before use, the proper packing materials must be used for each food shipment, and all surfaces must be cleaned regularly.

5. Training

Management and employees must be trained on the basics of proper food safety practices.

6. Food Safety Plan

The SFTA also mandates that companies have and follow a documented food safety program and that they follow good manufacturing practices (GMPs).

Cold Chain Audits Help Hold All Partners Accountable

While it may appear that shippers and 3PLs who are responsible for determining the appropriate transportation operations carry the lion’s share of the burden in the cold chain, the truth is they are hardly in this endeavor alone. Carriers and receivers also have roles to fulfill to ensure a smoothly-running cold chain. Still, it is the shippers’ responsibility to document and communicate procedures to all parties. The success of cold chain deliveries depends on it.

Carrier selection is another important relationship in the cold chain. Don’t let the lowest-price solution put blinders on your selection process. The least-expensive carrier might not be the best choice and, in fact, might be mismanaging your food products—putting you more at risk for spoilage and fines.

Having the right partners is essential to the foundation of any cold chain; equally important is verifying they’re doing their assigned tasks according to your expectations.

Cold Chain Audit Tools Assess Risk & Gauge Performance

Identifying potential risks and assessing cold chain vulnerabilities are also at the heart of cold chain management. While some might use the terms assessment and audit interchangeably, each is used at a different point in cold chain management—and has a distinct purpose.

• An assessment measures the effectiveness of the cold chain management process. Its purpose is to identify gaps, issues, and other risks in your cold chain. An assessment gives management a holistic view of where they should deploy additional resources and take corrective actions to eliminate risks.
• An audit determines whether the cold chain operates as intended according to the policies and protocols in place. Cold chain policies are the overarching rules designed to achieve the objectives of moving perishable foods. Cold chain protocols define the set of steps or procedures that must be followed to fulfill the policies. Regulatory agencies can request audits anytime; you can also schedule them annually or quarterly, depending on corporate needs. 

Together, these policies and protocols help ensure adherence to what generally are considered the three most basic cold chain rules:

• Never Warmer Than (temperature): Each fresh or frozen item has an acceptable temperature range during storage, transport, and handling. Frozen meats, refrigerated dairy products, and certain fresh produce should not rise above the product-specific temperature range to maintain its quality. Along those same lines, certain fresh produce should not be allowed to drop below a temperature where freezing becomes a risk.
• Maximum out of Refrigeration Time: Some products can move in and out of refrigerated environments as many as 42 times from the point of origin to the final destination. This rule sets the standard for how long each item can remain outside a temperature-controlled environment before compromising quality.
• FEFO Stock Rotation: In simple terms, this refers to rotating stock to ensure the items that will expire the soonest get moved to the front of the line.

Any cold chain food safety initiative—complete with assessment and audit guidelines, policies, and protocols governing cold chain storage, transportation, and handling—stands a much better chance of succeeding when everything is documented in writing and is accessible by all stakeholders.

A Cold Chain Storage Supply Chain & Audit Checklist

There’s much to track regarding cold chain management and the handling, transportation, and distribution of temperature-controlled food. Tive, a leading provider of cold chain temperature tracking solutions, offers the following checklist to help you prepare for a cold chain audit. Some of these items pertain directly to shippers, while others are for your supply chain partners. Sharing this checklist with them ensures they can be ready for an audit, as well.

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• Collaborate with 3PL and carrier partners to implement written procedures regarding temperature handling and sanitation practices for different perishable load types during loading, transportation, and unloading.
• Use a data logger to record data related to temperature-sensitive products, and be sure it’s placed correctly.
• Ensure temperature measuring equipment is correctly calibrated and recorded.
• Ensure in-transit and storage temperatures remain in the acceptable range, and are recorded appropriately.
• Create and maintain a repository of temperature profiles for past loads.

• Ensure proper segregation of raw foods and ready-to-eat foods.
• Maintain records of all invoices and shipper-to-carrier agreements for at least 12 months.
• Develop processes to manage temperature variations that may occur during loading and unloading.
• Ensure drivers and warehouse personnel receive thorough training regarding refrigeration units and loading/unloading processes for temperature-sensitive foods.
• Upon delivery, ensure any affected cold chain items are quarantined and discarded to prevent unsafe products from reaching consumers.
• Report any incidents of temperature excursions to the manufacturer and other supply chain stakeholders as soon as possible.
• Ensure all supply chain partners—including suppliers, warehouse personnel, and carriers—can assure the integrity of the cold chain throughout transport.

Food For Thought: Tive Tag Solution Helps You Be Ready for Cold Chain Audits

As crucial as assessments and cold chain audits are, neither would be worth the time and effort without the most important tool of all: temperature data loggers. The integrated data provided by Tive Tag temperature loggers enables swift, confident decision-making—across the cold chain—and provides the documented proof needed to successfully manage temperature-controlled shipments from beginning to end. 

Tive Tag is the most cost-effective, easiest-to-use temperature logger on the market today. Simply stick Tive Tag on a shipment, tap using your iPhone or Android, and ship it! Tive Tag begins to record temperature data, and won’t stop until the shipment reaches its destination.

Contact us today to schedule a demo and start a deeper discussion.