Resiliency in medical device supply chains is normally viewed from the OEM standpoint, but interesting insights are revealed in a new white paper from the MedAccred program as issues are considered from the Supplier perspective.
MedAccred
‘Supplier Perspective Provided to Best Practices in Supply Chain Resiliency and Quality Working Group’, is the second MedAccred white paper on resiliency, following the recent publication of, ‘Supply Chain Resiliency in Medical Device Manufacturing: The Core Foundations’.
Resiliency interruptions are often seen as internal to the Supplier, such as defective parts and product recalls, or as external factors such as natural disasters, political, economic or pandemic-related. While these factors can interrupt the supply chain, it is wrong to think business is stable outside these events.
For Suppliers, often many levels down the supply chain, instability can also result from: OEM knowledge of the critical processes that affect the final medical device product; flow down of OEM technical source information; quality of the Supplier’s processes, systems, equipment and capability; and competency of the Supplier’s employees.
Ed Engelhard, vice president of corporate quality at Solar Atmospheres, a provider of commercial vacuum heat treating services for the medical device industry, is a member of the Best Practices in Supply Chain Resiliency and Quality Working Group. In the white paper, he examines each of these factors and shows how they can be solved.
“For some OEMs there may not be visibility to the farthest end of the supply chain. This may be especially true if manufacturing has been turned over to another party,” says Engelhard. “Yet, Suppliers may conduct critical processes during manufacture that cannot 100% be verified for compliance using inspection, so a lot of trust must be placed on the Supplier’s process capability to meet application requirements.”
Engelhard concludes: “QMS certification as a sole quality oversight program is lacking in the technical rigour needed to assure that declared technical competencies by Suppliers are being met, but the MedAccred program fills that gap with subject-specific and highly-experienced Auditors focused solely on the technical matters at hand, using industry-agreed audit criteria developed by recognised industry subject matter experts, looking at a mix of witnessed and historical jobs processed by the Supplier to assure compliance to a highly detailed level.”
OEM Subscribers to the MedAccred audit and accreditation program include Baxter, Becton Dickinson, Boston Scientific, Edwards Lifesciences, Medtronic, Philips Healthcare, Roche Diagnostics and Stryker.
Bob Lizewski, VP for MedAccred, said: “I am very grateful to Mr. Engelhard for his ongoing contributions to the Best Practices Supply Chain Resiliency and Quality Working Group. This new white paper provides an alternative perspective on the challenge of building resilient supply chains in the medical device industry, and gives us valuable insight into how these issues may be addressed through an industry managed and collaborative approach.”