Failure Mode and Effects Analysis (FMEA) is a systematic method for preventing failure through the discovery and mitigation of potential failure modes and their cause mechanisms. Actions are developed in a team environment and address each high: severity, occurrence or detection ranking indicated by the analysis. Completed FMEA actions result in improved product performance, reduced warranty and increased product quality.
Production and continual improvement of safe and reliable products is key in the aviation, space and defense industries. Customer and regulatory requirements must not only be met, but they are typically expected to exceeded requirements. Due to globalization, the supply chain of this industry has been expanded to countries which were not part of it in the past and has complicated the achievement of requirements compliance and customer satisfaction. The IAQG has established and deployed the AS9145 Standard, as a step to help achieve these objectives.
This one-day program is designed to provide introductory information for those organizations who are considering transitioning from the Aeronautic, Space and Defense industry to the Food & Drug Administration (FDA), Medical Device Manufacturing market. Reviewing essential information necessary to understand and successfully begin the journey to FDA Medical Device approval, this course will examine many of the controls between the AS9100 Standard and FDA Regulations and identify the similarities.