Organizations in the medical device industry are in the process of gaining—and maintaining—their European Union Medical Device Regulation (EU MDR) compliance certifications. 

During ASQ’s annual awards presentation, held just prior to ASQ’s World Conference on Quality and Improvement in Seattle, ASQ recognized 16 people for their contribution to the quality profession. Besides two honorary memberships, 12 medals and two awards were bestowed in numerous categories. 

A  process flowchart is a powerful tool for sequencing each activity in a single process. This time-tested method allows everyone in the organization to be on the same page—or, more specifically, the same map. However, if you want to dig deeper into a process to determine inefficiencies and opportunities for improvement, consider a tool ideal for a more comprehensive scope than the classic flowchart. 

At the individual level, failure isn’t always a welcome event but it is recognized as a path to growth, innovation, and change. Prior to engaging in a particular endeavor, you can look at potential areas of failure and examine possible consequences. If the activity doesn’t involve death, divorce, or disaster—and with a little internal and external encouragement—you will go for it.

Almost 30 years ago the Construction Industry Institute (CII) researched the “Costs of Quality Deviations in Design and Construction,” and concluded that, “The average cost of rework on industrial projects exceeds 12%.” Design deviations accounted for about 80% of the increased cost and construction deviations only 20%.

"Quality improvement will result from people improving their processes and from management improving the system," says Thomas Pyzdek, ASQ Fellow.

My first job after college was as product assurance engineer but quality did not become my career until I began associating with ASQ six years after graduation. Though I was able to adequately fulfill my job responsibilities, I lacked the overarching understanding of the quality professionals’ importance within an organization. 

Although he seems like the consummate quality professional, James Bossert ended up in the quality profession by chance. Today he’s spent more than 35 years in industries from automotive to cell phones to healthcare and consulting. His career has brought him around the country, and around the world. He’s worked in Texas, Michigan, Arizona, North Carolina and New York. Along the way, he’s written two books and edited four. 

Whether your business has a 50-year history or just opened last year, you need to make sure you have a system of sustained success. ISO Q9004: Quality Management Systems–Managing for the Sustained Success of an Organization “provides guidance to management for achieving sustained success of any organization in a complex, demanding, and ever-changing environment.” 

Despite best efforts, auditors find things. It is their job. Why wait until audit day to uncover problems? In the words of Walt Disney, “The way to get started is to quit talking and begin doing.”