At the core of maintaining product integrity are corrective actions and preventative actions (CAPAs). A CAPA report must be written in the event of a deviation, such as a temperature excursion, that could potentially impact the integrity of a healthcare product. CAPAs are an essential component of GxP regulations. A CAPA report consists of an investigation, a corrective action to rectify the deviation and a preventative action to ensure that the deviation does not reoccur.
Supply chain integrity (SCI) team
At Kuehne+Nagel we have formed a centralised, global team to streamline the CAPA process. When a deviation occurs within the supply chain that could affect product integrity, the SCI team steps in to investigate. Liaising with all parties involved—from healthcare stations to airlines and shipping lines—the SCI team collects and analyses evidence about the incident. Once the root cause of the incident has been identified, the team suggests preventative actions, which are tracked to effectively avoid recurrences. The SCI team then complete the CAPA report, which the customer reviews before determining the next step in the release of the products.
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A good CAPA is when all involved parties work together in a timely and transparent manner to understand what happened, to agree and implement tangible actions in order to prevent reoccurrence.”
Marie Daly, Global Head of Supply Chain Integrity.
The SCI team, much like the body’s immune system, keeps data on all the incidents and tracks them to prevent a recurrence. As a result, the number of deviation-of-quality incidents has gone down considerably.
The HyperCare difference
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When shipping high-value products, you might want an extra level of care to avoid deviations which could result in a breach of product integrity. For these cases, we have developed our HyperCare service. Using internet of things (IoT) sensors, your shipments are pro-actively monitored around-the-clock from door-to-door. Potential disruptions are anticipated and the HyperCare team intervene to prevent cargo loss, keeping you well informed at all the defined touchpoints.
Using our HyperCare service gives you:
- Peace of mind knowing that there is a highly trained team monitoring your shipment 24/7/365.
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Proactive communication ensuring that you receive critical updates and timely information, allowing for mitigation plans to be put in motion to guarantee that your healthcare products are always safe.
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Highly trained staff to support you in the event that your shipment encounters any in-transit issues that require immediate action or immediate escalation.
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Continuous improvement mindset, we learn and adapt constantly from all your shipments and make improvements to our processes constantly, to ensure that you have the best customer experience.
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Centralised teams to ease on-boarding, implementation of processes, trainings, and compliance and resolution management.
Use the contact button at the top right of this page to reach out and discover more about how we work to ensure the integrity of your healthcare products.
