In the medical device industry, reliability is critical. Manufacturers conduct extensive testing to ensure devices meet required standards, such as 95/95 or 95/99 confidence and reliability, assessed using Minitab Statistical Software.

FMEA evolved as a risk management tool across industries. AIAG's 5th edition is for the automotive industry, while FMEA 4th edition suffices for healthcare.

Employing FMEA (Failure Modes and Effects Analysis) ensures ongoing enhancements in processes and products. By preemptively tackling potential challenges, it fortifies reliability, safety, and overall quality.

Good products don’t just happen. Quality depends on processes, and a process approach outlines the steps for success. Like so many elements of quality, it requires methodical attention to detail and planning. 

ECR Engines, a division of Richard Childress Racing, is in the business of extracting maximum performance from conventional, push-rod 5.87 Liter V8 engines for NASCAR competition.