2011/04/20Japan、Africa、Asia、Europe、Middle East、North America、Oceania、Latin America
Welcome back to "Under the Hood: Tips, Trends and Resources for OEMs." Since we are just a couple days past the dreaded "TAX Filing Deadline", and a lot of us still have that residual stress from dealing with such an ominous entity; the UnØMktr thought she'd bring up another stress-inducing 'Big Brother' topic: the FDA.
I have no doubt that there a many of you in the Medical, Lifescience, Industrial Automation & Aerospace & Defense industries are well versed and up-to-date on what's happening in the FDA Regulatory front - especially if you are in a Quality position. But for many, constantly changing FDA requirements can be a quagmire, particularly if you have device or instrument that needs Regulatory Certification.
Dotting all YOUR "I's" and crossing all your "T's" can be daunting enough - but now it appears the FDA has shifted the burden of all your supplier's I's & T's to the OEM. What does this mean to OEMs? The FDA has launched an initiative that requires OEMs to properly ensure the components they purchase are safe and effective.
In a recent article featured in MD&DI's Guide to Outsourcing titled "FDA Focus: Managing Supplier Purchasing Controls", the authors (Braulio Ortiz, Michael Neaves, Jim Dabs & Peter Stein) state: "Now more than ever, OEMs need to perform a formidable balancing act between risk, cost, and quality, while maintaining regulatory compliance. Moving forward, OEMs need to think of their suppliers as if suppliers were part of the their in-house production facility."
This can be a tall order. Especially as the growing global business community continues to expand to include foreign suppliers. In an article ("Outsourcing and Assuring FDA Compliance") in January of this year, Chinasourcinginfo.org posed the theory that: "Many companies, especially the start-up companies, are often confounded by the responsibilities they have in assuring that their medical devices and operations are compliant with FDA regulations and standards. In addition, many don’t realize that handing over manufacturing operations to a contractor, an OEM, does not relieve the specifications developer of the responsibility [off the hook] for assuring FDA compliance in the manufacturing process. Nor does the OEM who ships the finished devices back to the customer for distribution relieve them of FDA compliance though they may not be registered with the FDA."
So how can you police your (OEM) house and be responsible for someone else's (ODM) too? The answer is to choose your ODM partner wisely. Select an ODM that has a rigorous Supplier Qualification Process in place. As a bare minimum, your ODM should have expectations of their supply partners that include:
Don't risk your FDA compliance standing by not looking at your ODM partner's pedigree close enough.
Contec is a Systems Integrator focused on delivering cost effective and high reliability computing and displays solutions for OEMS in the Medical, Industrial, and Military, Aerospace & Government industries who require a customized, long life solution. Contec offers an expansive product line including: embedded computers & customized computing solutions; control, DAQ & monitoring systems, advanced touchscreen displays (medical, industrial & commercial grade); All-in-One (AIO) panel PCs; and a wide variety of handheld tablets and laptops. But Contec offers more than just products. For over 20 years we have developed long-term partnerships with our customers. In our total solutions approach we provide Solution Engineering, Project Management, Global Logistics & Supply Chain, Lean Manufacturing, Product Life Cycle Management (PLM), and Post Production Support services.
See you next time, the UnØMktr
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