New GHTF proposed documents - CAPA and Audits of Control of Suppliers

Marcelo

Inactive Registered Visitor
#1
Heya all, GHTF released two new proposed documents, one of them is the long-waited capa doc, and the other one is a new audit document, on manufacturer control of suppliers.

Guidance on corrective action and preventive action and related QMS processes - http://www.ghtf.org/sg3/sg3-proposed.html

Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers - Part 5: Audits of manufacturer control of suppliers - http://www.ghtf.org/sg4/sg4-proposed.html

Please post your opinions on the documents here so we can discuss if necessary.
 
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A

adamsjm

#3
I read the Global Harmonization Task Force’s Proposed Document (22nd September 2009) on "Quality management system –Medical Devices – Guidance on corrective action and preventive action and related QMS processes" last night. It contains elements from APQP, 8D problem solving, and Management Review from QS9000 and TS16949. In implementation they they will be very similar. The GHTF's document adds some more clarity descriptors than the automotive side.
 

Marcelo

Inactive Registered Visitor
#4
Adam, thanks for sharing the info. I still have nont had the time to read it, and i was not following it´s development, so it´s great to know that it uses know and proven practices...this will surely help the ones in need of a better CAPA system.
 
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