Quality Management - 19 July 2017
This is the third blog in a series about the expression “Out of the Box” and how it relates to the Life Sciences industry. In the first blog, I discussed thinking out of the box. In the second blog, I discussed the benefits and shortcomings of buying out of the box software. In this third blog, I am going to discuss why companies must do both to be successful.
I started my career in the pharmaceutical industry in the 1970’s. The 70’s and 80’s were great decades for the industry. Great strides were being made in treating diseases and symptoms that affected many people such as cancer, asthma, high cholesterol, and ulcers. Several billion dollar drugs were in the market. As a result, drug company profits were very high. More manufacturing facilities were built to keep up with the demand. There was little concern about quality, productivity, and efficiency.
Then in the 90’s all that started to change! Patents started to expire, and generic competition entered the market. Pharmaceutical manufacturing went global. Consumer and political pressure regarding industry profits started. The boom time of 80’s and 90’s was slipping away. Too much inefficient manufacturing capacity existed. The facilities, manufacturing infrastructure, and quality systems were not kept current. Plants started to close.
"Once the downward spiral starts, it is hard to stop. Reduced sales result in less income. Profit margins shrink, providing less money to invest in new and better technology. It takes bold action to stop the spiral."
Once the downward spiral starts, it is hard to stop. Reduced sales result in less income. Profit margins shrink, providing less money to invest in new and better technology. It takes bold action to stop the spiral. It requires a new vision, strong leadership and “paradigm pioneers” (see blog #1).
As a quality manager, you must strive to have an effective and efficient quality organization. Create a quality organization that is viewed as providing a competitive advantage to the company, adding value and protecting the company’s “License to Operate”. In order to do all of these things, you must have a good Enterprise Quality Management System (EQMS).
Take a look at your quality system and your quality system metrics. Is the system’s performance where you want it to be? Does your system incorporate industry best practices and is it capable of meeting current regulatory compliance expectations? Maybe it is time to upgrade your quality system. Contact an EQMS provider to find out how they can help. Consider buying out of the box EQMS software to help change the quality management paradigm! Take a bold step and think out of the box!
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.