Healthcare shippers, including pharmaceutical, biotechnological, medical device, equipment and diagnostics companies carefully select their transportation providers. Obviously, pricing, reputation, reliability, expertise and infrastructure have always played an important role in selection decisions.
In the last couple of years, however, many healthcare companies have established tighter internal procedures for assessing their vendors, including suppliers of services. Among quality professionals this assessment is known as “qualifying vendors”. Despite continued restructuring efforts in the healthcare industry, quality departments across the United States have experienced rapid growth due to the increasing importance of quality issues.
In fact, the overall supply chain has come under intensive scrutiny by regulatory agencies. This is partly due to the increase use of outsourcing services and also partly due to new and more restrictive Good Distribution Practices (GDP) guidelines. The Food and Drug Administration (FDA) in the United States pays more and more attention to purchasing controls and approved supplier lists, while inspecting healthcare facilities. Rigorous quality standards first adopted by the healthcare industry are being replicated in the transportation portion of the supply chain. Nevertheless manufacturers remain ultimately accountable for product quality.
As a result of enhanced quality standards and a stronger focus on regulatory compliance FedEx Express is experiencing a drastic increase in the number of inquiries about quality safeguards related to general quality matters with FedEx shipping practices and procedures, especially in Western Europe and North America.
Interestingly, healthcare companies have various approaches when it comes to qualifying suppliers. Companies that ship healthcare-related products typically collect relevant quality metrics before committing to a service provider. Most of these shippers start the qualifying process through a paper questionnaire, which can vary from a few elementary questions to several hundred specific ones.
The primary goal of this survey is to gather basic information to identify responsible contacts and to document quality standards in place within a vendor’s organization. Among the vendors asked to complete these surveys are the transportation providers that will ship the healthcare products. The lack of a common industry-wide assessment format is a major challenge for transportation companies who have a large number of healthcare customers. Some healthcare companies have even started to hold their transportation providers to specific, fairly restrictive quality standards (so called “quality agreements”). Healthcare companies relying heavily on a specific preferred transportation provider may not be fully satisfied with a paper evaluation though.
The purpose of an audit at a facility managed by the selected transportation provider is to find and address omissions or weaknesses within the established quality management system. If an initial in-depth onsite qualification audit results in a positive decision for a transportation provider, the initial audit often is followed by less stringent surveillance audits every other year.
Healthcare companies are developing ways to track performance and ensure a more efficient and effective supply chain. FedEx offers many different types of services to support these efforts. For example, quarterly customer business reviews performed by FedEx professionals enable shippers to scrutinize time delivery metrics and other key performance indicators.
Through use of the newest FedEx innovations like the SenseAware platform, temperature measurements can be monitored in near-real time and analyzed afterwards. And, in the event any transportation-related problems arise, shippers can request Corrective and Preventive Actions (CAPA) or file a Supplier Corrective Action Request (SCAR) form or even decide to disqualify a vendor temporarily. Investigations are carried out internally by the vendor to determine root causes and find robust solutions.
Repeated issues can often be prevented effectively by implementing corrective actions. A focused audit may be required by the shipper to verify that non-conformance with established parameters and protocols was indeed addressed by the vendor as an opportunity for continued improvement.
FedEx Express understands the regulatory framework and is sensitive to constraints faced by healthcare companies. We are fully committed to supporting our customers’ healthcare shipping requirements with our broad range of services and finding global solutions to accommodate the increasing amount of quality requests.
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November 10, 2015
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