Managing Critical Vendors Version 2.0

The manufacture of medical products, drugs and devices is highly regulated all over the world. All aspects of the manufacturing process, from product design to product delivery, require documented procedures. Key points in the process also require quality oversight and where needed testing. Risk assessment to determine the critical areas of the process is now mandatory for regulated companies and is required for non-regulated companies that follow the ISO 9001 quality management system starting in 2015.

While a risk assessment or risk evaluation can be used as a tool to develop a plan to address potential issues, no plan is 100% perfect and sometimes unforeseen problems occur. When issues arise that affect a critical vendor, an action plan needs to be developed to mitigate the situation and prevent a disruption to the supply chain. This is especially true if the cause of the issue is related to regulatory compliance. This paper will cover the key aspects of how to handle the management of a critical vendor that is under scrutiny and how to minimize the impact on the supply chain.