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.
While examining a privately-owned sailboat, as a certified Vessel Examiner with the US Coast Guard Auxiliary, I realized the importance of profiling the Coast Guard's quality focus. What could it teach us about quality? It turns out, a lot.
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.
Regular use of FMEA leads to continuous improvements in processes and products. By proactively addressing potential issues, it enhances reliability, safety, and overall quality.
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.
If you’re in manufacturing, no matter the industry, quality is top of mind. It must be, or you won’t be in business long. Yet, with all the focus, there are big misses all the time in companies large and small, which leads to an interesting question: If quality gets so much attention, why are recalls still increasing? Further, what can we do about it?
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.