How to Audit the New AIAG/VDA Design and Process FMEAs
Patsy L. Brown, Consultant/Trainer, Brown & Associates Quality Consulting, Inc., Pine Bluff, AR, USA
Keywords: FMEA, Auditing, IATF 16949
This presentation will provide auditors – both internal and external – with a framework for auditing FMEAs that have been conducted according to the new AIAG/VDA failure mode and effects analysis (FMEA) guidelines.
The presentation will begin with a summary of the changes to the FMEA process in the AIAG/VDA FMEA guidelines. The new seven step process will be identified and details of the structure, function, and failure analyses will be illustrated for both design and process FMEAs. Changes to the evaluation criteria will be discussed and the use of “Action Priority” in lieu of the risk priority number (RPN) will be addressed. Linkages between the design FMEA, process FMEA, and control plans will be discussed.
Requirements for the use of FMEAs in the IATF 16949:2016 will be presented. Based on these requirements, the presentation will highlight the necessary audit points needed to demonstrate that the “shall” requirements of the standard are being met. Then, audit questioning routines and determination of facts to be verified during the audit of the FMEAs will be presented. Audit trails and approaches to following them through the AIAG/VDA process will be presented.
The presentation will conclude with determination of what objective evidence is necessary to demonstrate conformance to requirements of the quality management system and IATF 16949.