Leadership Insights

Defining Quality with Clarity

  If you’re reading this, I’m assuming you earn your living in some sort of Quality Organization, but do you Speak Quality? And if you do, can you speak it fluently, or are you topped out at the conversational level? The reality is, if you’re like many people in Quality Organizations, you may not know. […]

Women’s History Blog: The Women of Science

Throughout history, women have had a significant impact on mathematics, science, and medicine. Despite the political, religious and social constraints of their time, these women sought the unattainable and questioned the unquestionable, often paying with their livelihoods or their lives. These remarkable trailblazers shattered myths, advanced our understanding of the universe, our own bodies and […]

The One Voice Mission: A Quality Opus

I have worked within and around the life sciences community of Quality professionals for more years than I am ready to admit in a public post.  Early on in my career, I listened avidly to every experienced person that I worked with, eager to take in everything anyone had to teach me.  I was the […]

Understanding, Measuring, and Controlling the total Cost of Quality; The Holy Grail of The Modern Quality System

We decided this month to discuss the concepts, principles, and tools that aim to reduce operating costs while promoting and improving consumer-centric quality.  Among this family of principles are those referred to as quality costing analysis models, or “Cost of Quality” (CoQ) models. Industry has been attempting to meet the challenges of measuring and controlling […]

Supplier Quality and the Total Cost of Poor Quality; Understand the Relationship and Avoid the Shortcuts!

During my two decade career, including a decade of consulting, I have integrated with a multitude of organizations, a wide variety of cultures, and a broad spectrum of projects, each with unique objectives, team members, and needs.  This diversity of experience has been its own reward and continues to incentivize me to forego the obvious […]

Be Better Than the Best

  When I was in college, the robotics club held a fund raiser selling t-shirts that said “INNOVATION” – in all caps and BOLD lettering.  I bought one – because I was so sure that someday, I would invent something that would change everything, for everyone. To date, I have not realized that dream.  I […]

Women’s History Month: Names We All Need to Know

  In honor of Women’s history month, I decided to write about the female pioneers in the sciences.  These women blazed the trail that I and so many like me, would eventually follow.  We have all walked in the mighty footsteps left by these amazing women; women who showed us all what could be achieved […]

Part 2: The Evolution of the Clinical Trial; Is Ethnopharmacology the New Frontier?

Last month, Part 1 of this series reviewed the history of some of the protections provided to the American consumer by Title 21 and the Food and Drug Administration.  Last month’s installment focused on the development of the controls designed to evaluate the impact of utilizing our medicines in clinical situations; the history of Clinical […]

Part 1: The Evolution of the Clinical Trial – Is Ethnopharmacology the New Frontier?

Today’s American consumer is accustomed to the protections provided them by The Food and Drug Administration, protections that ensure the medicinal products we are exposed to are pure, safe, and effective. However, the current model of consumer protection applied to medicinal products has been, and continues to be, a product of evolution of knowledge, attained […]

Think Systems: Cause Quality

November, 2012 was celebrated as “World Quality Month.” ASQ CEO Paul Borawski asked this of industry: “What do you use as the best, most inclusive and illuminating definition of quality?” I followed the trail of replies as they posted, and it quickly became apparent to me just how diverse Mr. Borawski’s audience is, and how […]