Getting Control of Supplier Controls

It seems that for one reason or another supplier controls are a requirement that slips through the cracks of even some of the largest medical device organizations. Those of us in the medical device field should know better since 21 CFR Part 820 clearly includes requirements that medical device manufacturers shall have controls over purchased products or services related to medical device being manufactured.

Despite the regulation clearly stating that controls should be exhibited, there are shortcomings throughout the industry. This should be an easy requirement to fulfill since quite simply it begins with having adequate supplier selection criteria and ends with maintaining the specified requirements in a supplier quality agreement. In my experience auditing medical device manufacturers there appears to be a lack of understanding how to adequately install a supplier control system and how to craft supplier quality agreements.

Some information that is useful regarding these activities can be found with relative ease on the internet at:

FDANews.com - http://www.fdanews.com/ext/files/Conference/FISPresentations/Trautman-SupplierControls.pdf

FDANews.com - http://www.fdanews.com/conference/detail?eventId=2927

MedicalDeviceSummit.com - http://www.medicaldevicesummit.com/Main/Blogs/10.aspx

MDDIOnline.com - http://www.mddionline.com/article/fda-focus-managing-supplier-purchasing-controls

MasterControl.com - http://www.mastercontrol.com/supplier_management/supplier-quality-agreements-your-benefits.html

Training Opportunities:

ASQ.org - http://asq.org/training/supplier-management-for-the-medical-device-industry_SMMDI.html

FDA.gov - http://fda.yorkcast.com/webcast/Viewer/?peid=dd2d4823b14a4e4ca6d60eae43c5ac9c

MJB - 3/20/2013