RICHRichard Lubin
Senior Manager, Supplier Quality & Quality Engineering


Richard will be one of the distinguished speakers at the 2nd Annual Medical Device Supplier Quality Conference.


Why is the 2nd Annual Medical Device Supplier Quality Conference important to quality executives?
Even if you have the best design and the best manufacturing processes possible, your product will still fail if you do not have quality components from your suppliers. Supplier Quality is one of the major keys to a successful product.


What initiatives are on the horizon at your organization for supplier quality in 2015?
All divisions across the organization will be working together to establish which site will perform specific supplier audits. Decisions will be based on risk to each division, amount spent with the supplier, and travel expenses. If the owning site determines that there is little risk with the supplier, a local site will be used to perform the audit.


What are three key components that every quality agreement should have?
A) The supplier should understand that they are supplying a product that will be used in a medical device and the minimum quality standards they must adhere to, including regulatory requirements (such as record retention).
B) No changes are permitted to design, materials, and processes used without prior written consent.
C) Confidentiality agreement.


What is one successful communication strategy you have implemented with suppliers?
When issues arise with a supplier, the Supplier Quality Engineer is in direct contact with the supplier’s Quality Engineer. If the issue cannot be resolved to our satisfaction, the Quality Manager will contact the supplier and escalate the issue to higher levels as required until a resolution can be reached.


Can you describe a supplier development initiative that has been mutually beneficial for your supplier and your organization?
E-certifications have reduced the amount of paperwork required to be shipped with the product and paperwork corrections can be made faster.


How do you believe FDA expectations have changed with regards to supplier quality?
The FDA better understands that the supply chain is critical to a medical device’s efficacy and long term reliability.