Operational Qualification (OQ) Testing Services

Operational qualification is a simulated test performed in the laboratory to provide evidence that a proposed shipping system can meet its intended use of transporting payload or product safely within a specified temperature range consistently.

The OQ testing of the proposed shipping system typically comprises the same two aspects as Design Qualification (DQ):

  • Distribution/Mechanical
  • Thermal Testing 

When performing OQ testing, acceptance criteria will need to be defined prior to execution of OQ testing. Acceptance criteria will be determined by the scope of the OQ; there are two types of OQ: 1) Shipping system OQ and 2) Product-specific OQ.

Shipping System OQ Testing

If performing a shipping system OQ, the acceptance criteria will focus on the shipping system and not specific to a product. For distribution/mechanical testing, an arbitrary product payload can be selected for the testing.

Product-Specific OQ Testing

Acceptance criteria should be representative of shipping temperature and product package integrity requirements, which may be defined previously in DQ or User Requirements Specifications (URS). The selected simulated testing hazards are based on expected shipping conditions, which ideally would be determined by historical shipping data.

To leverage and minimize testing while qualifying similarly packaged products, bracketing is often used while designing the OQ. Bracketing for shipping qualification is testing the worst-case extremes in order to show that all configurations and weights between the worst-case extremes are covered when conducting the OQ.

The following factors are typically considered for bracketing but not limited to:

  • Products in equivalent packaging
  • Minimum and maximum lot sizes for shipment: Full range of potential quantities the end user would like to receive in one (1) shipment or one (1) shipping system
  • Thermal mass range
  • Mass/weight range

Some of the benefits of bracketing are the following: 

  • reduction in the amount of product required for testing
  • reduction in the overall amount of testing needed
  • quicker time to market

With LBX’s experience, we are able to help many clients with various shipping requirements, such as different temperature ranges, transportation methods, and qualifying shipping systems can be expedited through our relationships with shipping systems manufacturers and testing laboratories domestically and internationally.

Distribution/Mechanical OQ Testing

Distribution OQ testing verifies that the proposed shipping system can consistently protect the product payload from typical shipping hazards, such as random vibration and shock (drops), encountered during shipping lanes. Typically, each packaging configuration is tested in triplicate (N=3) at minimum and maximum loads for product-specific OQs. Justification can typically be made to test maximum load only as worst case because the heaviest load is expected to experience the most severe mechanical impact under shock and vibration.


Test Replicates


Minimum Load


Smallest quantity to be shipped in proposed shipper

Maximum Load


Largest quantity to be shipped in proposed shipper

The minimum and maximum load configurations in the shipping system are tested to bracket the range in quantity of products to be shipped in the shipping system. To simulate the shipping hazards, the shipping systems should be tested against standards appropriate to the shipping system type and transportation methods (air/ground/rail). For example, small parcel shipping systems are typically tested against ISTA 3A or ASTM D4169 DC 13, while pallets are tested against ISTA 3B/3E or ASTM D4169 DC 12. Depending on the packaging configuration and expected transportation method determines which testing schedule is selected for the distribution testing of the proposed shipping system.

Thermal OQ Testing

Thermal OQ testing will test the proposed shipping system in triplicate (N=3) typically against simulated thermal profiles that mimic the expected hottest and coldest shipping lanes.

Typical standard thermal profiles are the following: 

  • ISTA 7D
  • ISTA 7E
  • Vendor-specific
  • Customer-specific
  • Modified versions of standard profiles to replicate the supply chain process 

Using an industry standard profile like ISTA 7D and ISTA 7E is the most common approach for qualifying various shipping lanes for thermal testing. If a customer-specific thermal profile is required, the profile should have actual temperature data along the hottest and coldest shipping lanes. For this purpose, the hottest shipping lane would be the hottest temperatures at origin/packout and hottest temperatures at destination/receiving, and the coldest shipping lane would be the coldest temperatures at origin and packout environment and the coldest temperatures at destination and receiving environment. Since gathering temperature data can be a costly study, the industry standard profiles are often selected as a worst-case shipping profile with justification.

Factors to determine which thermal profile standard are the following: 

  • Seasonal (if applicable)
  • Expected shipping duration
  • Specific shipping/Receiving requirements 

The OQ profile is typically the same thermal profile used in the DQ or engineering study. If the DQ was leveraged from the manufacturer, a verification of the profile should be performed to ensure the DQ meets the customer’s shipping lanes and needs. 

To test the worst-case scenario, only the minimum load or maximum load may be tested with justification. The minimum load may be worst-case because the shipping system with the payload would present the lowest thermal mass and therefore more susceptible to thermal fluctuations. A thermal mass analysis can be performed to aid with the justification for testing only minimum load. Maximum load may be worst-case for shipping systems with varying amounts of refrigerant, such as dry ice, that is dependent on the product payload volume.

LBX can develop, evaluate, execute, and summarize the OQ testing for a customer’s review while being compliant with the current industry and regulatory standards. After successfully demonstrating the shipping system’s ability to protect product from physical damage and maintaining thermal shipping requirements, qualification of the shipping system may undergo Performance Qualification (PQ) testing or implementation through continual Process Verification. These next steps are based on the latest industry guidance ISTA PCG-03, ISTA Thermal Shipping System: Performance Qualification (PQ) and Performance Verification (PV) Best Practice Guideline, which LBX helped develop. 

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