Indicator #8 - 10 Metal Stamping Quality Indicators for Medical Device Mfrs
Quality Indicator #8
Careful Supplier Selection, Monitoring, and Evaluation
This is the eighth in Kenmode's blog article series entitled "10 Metal Stamping Quality Indicators for Medical Device Manufacturers" to help medical device manufacturers evaluate the level of quality in their metal stamping suppliers. The series will consist of 10 articles, published weekly. Each article will focus on a single quality indicator.
The medical device OEM typically deals with a global supply chain. According to the report published in October 2011 by the United States Food and Drug Administration (FDA), entitled Understanding Barriers to Medical Device Quality, “Supplier monitoring and management is widely identified as a continuing source of significant quality risk in the value chain. Risks are primarily around uncontrolled material or process changes, particularly when suppliers have an imperfect understanding of how their components affect end-product quality. Supplier management is a challenge particularly when dealing with a large, globalized supply base. For instance, one medical device company interviewed deals with close to 4,000 individual suppliers across North America, Europe, China, East Asia, and India.”
Metal stamping firms themselves use a range of suppliers to provide finished products to the OEM, such as heat treating, metal plating, cleaning, and other peripheral operations that rely upon specialists. In order to ensure quality, the metal stamper must maintain a rigorous selection process to identify best-in-class suppliers, based on their expertise and track record, as well as a system of ongoing management and evaluation of suppliers, including regular, timely feedback. When required, the metal stamper should be able to submit a detailed report to the OEM on their top-tier suppliers and the certifications they hold.
The FDA identifies best practices in supplier management as follows: “Companies that manage their suppliers well do so through a number of best practices. They carefully select and contract with their suppliers, often with deep involvement from the internal quality organization, and they identify vendors that deal with the most critical aspects of their product and invest heavily in training and monitoring them. Finally, they are highly disciplined about cutting off even preferred suppliers once it is clear that quality performance has dropped.”
To reduce quality risk, medical device manufacturers need to inquire about their metal stamper's current supplier management processes and request documentation that supports these processes.
Read the entire blog series to learn more about the 10 Quality Indicators for Selecting Metal Stamping Suppliers:
Indicator #1 - Top Management Commitment and Company-Wide Engagement in Quality
Indicator #2 - Adherence to Global Quality Standards ISO 9001 and ISO 13485
Indicator #3 - In-House Engineering, Design, and Tool Build Expertise
Indicator #4 - Risk Management for Complex Products
Indicator #5 - Robust Launch and Qualification Processes
Indicator #6 - Prevention-Focused Process Control
Indicator #7 - Rigorous Change Control Processes
In addition to the blog article series, Kenmode has also developed a 15-page eBook for medical device manufacturers which provides details on the 10 metal stamping quality indicators.