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How do you define quality?

I recently received an email from the ISPE.  The email asked the following question:

“If the FDA asked you tomorrow, “How do you define quality?” how would you answer?  How would you prove your answer? One way to ensure product quality is to define it as an industry, a definition that until now has not been explored.”

Good question, people intuitively know when a product or service is a quality product or service.  They can sense it, they can see it, but it is difficult to define it.  In Zen and the Art of Motorcycle Maintenance, one definition of quality is that “A person who knows how to fix motorcycles… with Quality… is less likely to run short of friends than one who doesn’t.”  I like this definition, but I am not sure how it would fly with the FDA.

I still am an adherent to Edward Deming’s quality principles.  Deming’s most basic definition of quality uses the following points:

1.       “Quality begins with intent.”

2.       “Quality should be aimed at the needs of the consumer, present and future”.

3.       Quality translates into “less rework” and “Not so much waste”.

From these points Deming defines quality as the on-going interaction between the product, the customer, and training of the customer.   This triangle is a cycle that “continues over and over, with never-ending improvement of quality”.

Although this is from Deming’s 1982 book Out of the Crisis it is more relevant than ever.  I would answer the FDA by paraphrasing these principals this way:

I define quality as delivering a product/service to an end user that satisfies that user’s needs.

This seems so simple, but as most things that seem simple, it’s really very complex.  The difficulty is in knowing what the end user’s needs are (present & future) and then translating those needs into measurable characteristics. 


Mr. Deming elaborates on this theme with his 14 Points of Quality Management.  I will explore each of these 14 points in future blog posts.


Nels Hackl

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