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Business Centric Solutions for meeting Regulatory Requirements

March 25, 2019

Struggle with explaining Regulatory Requirements to upper management?  Regulated industries have two masters: the regulators and CEOs; so why not develop strategic tools to serve both? Let’s use a process approach to determine how well your current practices meet your…

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A table with different types of business models.

Quality is not Overhead

September 18, 2019

Three days after starting a new job, I met the CEO in the elevator and introduced myself. Without skipping a beat, he said he was familiar of who I was, stating that I was that highly paid “Quality Overheadâ€. I…

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A graph of the time and risk curve.

Striving for perfection

November 20, 2019

The greatest life lesson occurred while in my High School Geometry class.  During discussions of hyperbolic equations, the teacher turned around from the board to profound that, “Man is like a hyperbola, always striving to their asymptote.† It took me…

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A diagram of the process for identifying and validating vendors.

Tag you’re it…Supplier Quality

May 12, 2021

The childhood game of ‘tag’ is fun, I still enjoying playing with young children.  However, in business the game of ‘tag’ is often used as an excuse for pushing responsibilities on to vendors/suppliers.  How many times have you heard ‘the…

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What is Essential is Invisible to the Eye

May 12, 2021

Reading bedtime stories continues to be an important communication tool for young (and old) people.  Antoine de Saint-Exupery’s classic, The Little Prince was part of the cycle for each of my children and now grandchildren.  The great secret from the…

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A diagram of the alignment matrix professional.

Developing Quality Relationships

October 22, 2022

For years, I have been mentoring a successful Quality/Regulatory friend who recently asked for guidance on dealing with personal relationships, focusing on his career and personal relationships.  We discussed how we have established goals and requirements in our business lives…

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IoT presentation on Telemedicine

August 15, 2023
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Plan Now Pays Later

May 15, 2024

Typically, initial planning neglects to account for potential failures in manufacturing, clinical testing, or handling post-marketing complaints. This oversight can lead to significant setbacks. Prioritizing planning for success over acknowledging potential setbacks isn’t the most optimistic approach; instead, understanding the…

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