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Quality Systems 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. […]

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 […]

Measurement System Analysis and Test Method Validation; A Critical Difference

Measurement System Analysis and Test Method Validation; A Critical Difference   In the previous installment of the blog, we discussed our industries’ need to validate test methods in order to demonstrate that our measurement methods are capable of identifying variances inherent to production methods.  Demonstrating suitability must include attempting to quantify or classify the variances […]

Should We Improve the Process, or the System We Use to Measure the Process? Measurement Systems Analysis and The Limitations of the Gauge R &R

Should We Improve the Process, or the System We Use to Measure the Process?   Measurement Systems Analysis and The Limitations of the Gauge R &R     If you’re reading my blog, you probably are required to comply with regulations foreign and/or domestic in order to be successful.  What’s more, in order to comply […]

Quality by Design: Part 2

Coda dedicated last month’s installment of the blog to review initiatives undertaken by the Food and Drug Administration that were developed in order to improve regulatory strategies, and agency systems and tools.  The improvements we highlighted, among others, were developed and implemented in the hopes of contributing to industries’ efforts to develop new and safe […]

Quality by Design Part 1

In the past, Coda’s blog has covered many initiatives undertaken by the Food and Drug Administration that were developed in order to improve regulatory strategies, and agency systems and tools.  These improvements were developed and implemented in the hopes of contributing to industries’ efforts to develop new and safe therapies as quickly as possible and […]

The Difference Between?

The Difference Between? Working in such a tightly regulated and hugely competitive industry and dealing with technologies that can at times be controversial, I expect to hear heated debates or energetic discussions regarding the nature and/or value of regulations, cutting edge technologies, or free market price wars.  Because of the nature of our industry, I […]