Quality Management - 5 July 2017
Out of the box is a much-used expression but with a couple of completely different meanings!
In this blog, I will discuss thinking out of the box. In the next blog, I will discuss the benefits and shortcomings of buying products out of the box. In the last blog, I will explain how you can do both and be successful.
For some companies, thinking out of the box is a core competency that is fundamental to the success of the company and therefore is highly valued and recognized by management. In others companies, it is not valued or encouraged as much.
Striking a balance is what is important in my opinion. In highly regulated industries, like the Life Sciences, following procedures and maintaining processes in a state of control is required. However, it is also necessary to keep facilities up to current standards, use state of art equipment and technology and adopt current best practices and systems.
"Striking a balance is what is important in my opinion. In highly regulated industries, like the Life Sciences, following procedures and maintaining processes in a state of control is required. However, it is also necessary to keep facilities up to current standards, use state of art equipment and technology and adopt current best practices and systems."
All companies go through business cycles where the priorities and focus change. For example, a company might focus on productivity, then product quality, then sales, then cost control and then repeat the cycle. Each of these typically lasts a few years. Frequently a new CEO is hired, management changes occur and the people lower in the organization feel like “here we go again” but that “this will pass with time as well”.
The truth is that change is necessary. There are many examples where companies didn’t change and they eventually lost their competitive advantage. They lost sight of where the industry and technologies were going. They remained stubbornly stuck in their way of doing things until it became a crisis. Companies like General Motors, Polaroid, Xerox and Blockbuster, just to name a few, come to mind. In the pharmaceutical industry, this has led to warning letters, consent decrees, injunctions, fines and plant closures.
Be A Paradigm Pioneer
Changing a company’s paradigms requires out of the box thinkers. It takes courage, hard work, energy and no fear of failure. It is risky! Years ago I learned a term for these types of individuals. They are called Paradigm Pioneers. It was a term to describe the kind of people and behaviors that NASA needed for the US space program to achieve its challenging goals and be successful.
The thing I remember about the term Paradigm Pioneers is why it was chosen. In the US, the pioneers were the first groups of people to go west of the Mississippi River into the Great Plains, the Rock Mountains, and the Pacific coast. They had the courage to face the weather, disease, wild animals, and violent confrontations. Pulling those wagons and walking all the way was hard work and required endless energy. They did not think of failing but rather focused on the opportunity a head of them.
You can be a Paradigm Pioneer in your company when it comes to quality management and EQMS systems. To be successful, one needs to focus on the opportunity ahead, not solely on the efforts that will be required to get you there.
About the Author
Brian Graeff is currently the Head of the Quality Best Practices Unit at SOLABS. Brian’s career in the pharmaceutical industry spans over 40 years during which he held various management positions in Quality Assurance, Quality Control and Production with Sterling Drug-Winthrop Laboratories, AstraZeneca and Sunovion Pharmaceuticals Inc.. Brian retired from Sunovion in 2010, where he served as the VP of Quality Operations. During his career, Brian helped manage many different drug products and APIs with the majority of his experience being with parenteral, respiratory and tablet dosage forms. Brian brings a wealth of experience in pharmaceutical manufacturing, quality management, FDA interactions and CGMP interpretation and implementation to the table.