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.
One very important part of the whole manufacturing process is the proper sourcing and management of vendors that provide goods and services to the regulated company. This is one area in which it is very important to assess risk in order to properly manage production.
Every company should develop a program to assess and evaluate risk to determine the most critical vendors of their manufacturing process. Regulated companies have additional considerations when evaluating critical vendors. Such a program should focus on factors that can potentially disrupt the supply chain such as single source, regulatory compliance, unique capabilities of the vendor, and limited sub-tier suppliers to a key supplier. Both proactive and reactive monitoring should be utilized when managing critical vendors.
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.
This paper will cover critical vendors that supply manufacturers (customers) of regulated products. The focus will be limited to first tier vendors. The process and best practices discussed are focused on regulatory areas of scrutiny but are able to be applied to other areas of quality concern.