Plan Now Pays Later

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 deliverables across the organization is paramount. While regulations often lag behind, organizations prioritizing business-centric processes…

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Developing Quality Relationships

A diagram of the alignment matrix professional.

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 that we often overlook in our personal lives.   Having mentored him professionally, my guidance was…

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What is Essential is Invisible to the Eye

A large iceberg with many words written on it.

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 fox to the Little Prince, “It is only with the heart that one can see…

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Tag you’re it…Supplier Quality

A diagram of the process for identifying and validating vendors.

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 vendor didn’t process a document’ or the ‘supplier forgot to consider local or regional requirements?’ …

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Striving for perfection

A graph of the time and risk curve.

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 years and immersion into Buddhism to truly understand what he was conveying. In hyperbolic geometry…

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Quality is not Overhead

A table with different types of business models.

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 was brought in to help turn around the Quality area. About 2 months later, I…

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Business Centric Solutions for meeting Regulatory Requirements

A flowchart of the process for an article with blue background

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 organizational needs: Defining business practices that meet Regulatory requirements is key for delivering product, services…

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