APQP - Advanced Product Quality Planning

APQP had its start with the auto industry (1980s).  Some of its basic principles are taken from ISO 9001, QS 9000, and IATF 16949 (International Automotive Task Force).  Its goal is to provide a guide to assist sharing of development and other key data between suppliers and automotive companies to meet "customer" requirements and support continuous improvement .  Focus is on design, specification compliance, production processes, QC, process capability, product testing  and training.  Obviously compatible with ISO 13485 for the US and EU / Asia.  APQP tools include the 8Ds, SPC, FMEA, 6 Sigma, GR&R+, V&V, design reviews, and similar (see also the US FDA Production and Process Control for devices, pharma, combination devices).  

Some are promoting key elements of APAP for the medical device industry. As you can see by the above, the key elements are already in the US QSR and new QMSR, as well as Europe's MDR / ISO 13485 (and now with the US as well).

jel@jelincoln.com