The process to uncover the real root cause of your temperature deviations

Hashim Ahmed, Supply Chain Integrity Senior Analyst at GlaxoSmithKline offers strategies to investigate, mitigate and manage temperature deviations

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Pharma IQ

“We often get temperature deviations in the supply chain, but in most cases we don’t know the root cause” admitted Hashim Ahmed, Supply Chain Integrity Senior Analyst at GlaxoSmithKline during the Temperature Controlled Logistics online forum.

To mitigate the likelihood of temperature deviations and maintain product integrity, Ahmed believes the industry needs to improve the investigation process.

Root cause analysis takes many forms, from pareto and fishbone diagrams to change analysis. The five why methodology may be a simplistic tool for analysis but for logistics, it can prove to be highly effective. The process involves a clear definition of the problem and the continued unravelling of the temperature deviation by asking why for each subsequent finding. The goal is to reach a probable cause that can be followed back retrospectively to the initial issue.

For each deviation, there can be multiple root causes at play. If a company fails to understand the full spectrum of issues impacting product integrity, it will be unable to implement corrective and preventive actions (CAPAs) to resolve the problem.

As Ahmed explained: “If you don’t get to the true root cause, you waste effort and money fixing things which are not necessarily required, and your problem is less likely to recover”.

During the webinar, Ahmed offered the example of a temperature deviation experienced during an air freight shipment. The product temperature range was 5°C -25°C with a service booking of 15°C-25°C. In transit from Cairo to Abu Dhabi, the product experienced a low temperature deviation reaching 3.9°C for a total of 46 hours and a high temperature deviation reaching 38°C for a total of eight hours.

These temperature excursions were due to incorrect product storage in a 2°C-8°C area in Cairo and a lack of temperature controlled facilities in Abu Dhabi.

Using the five why methodology, Ahmed analyzed the issue to understand the underlying root causes for the deviations. In Cairo, it was found that the instructions for the ground handling team were not clear. The cargo lacked visible labels and the 3PL coordinating the shipment used thermal covers which hid temperature information. The 3PL’s standard operating procedures also did not require a clear statement of the product’s temperature range.

In Abu Dhabi, the core issue was found to be a missing lane risk assessment from Cairo to Abu Dhabi following the crossover to a new 3PL. As Abu Dhabi did not have a temperature controlled facility or cool dollies, road transport should have been used from the stopover in Dubai. Without the necessary pre-planning this could not be accounted for in advance.

By understanding these issues fully, Ahmed was able to set realistic and achievable CAPAs to ensure future shipments did not experience the same issues.

The 3PL contracts were updated to include clear booking instructions. All shipments now clearly state the temperature range of the booking, including labels on the outside of thermal blankets. A lane risk assessment was also conducted to design a new route for future shipments going through Abu Dhabi.

Although the investigation process can be complex, Ahmed has found success by ensuring a separation of the financial investigation and the quality investigation. To avoid partners becoming defensive or potentially withholding crucial information to lessen liability, Ahmed recommends “clearly defining in your contracts and SLRs that you need to separate out the processes”.

To Ahmed, the importance of root cause investigations are clear: there is a patient at the end of the supply chain waiting for their medicine. As he explains: “We owe it to our patients to investigate anything that’s gone wrong and make sure that the next time we ship a product out, it’s at the right efficacy and quality level so patients can be confident in the medicine they’re taking”.