Where is quality going?

By Kelly Huckabone

December 2019

If you look at quality from a historical perspective, it was very much engrained within the manufacturing industry. This goes way back to the early days of Ford when Henry Ford quote “Quality means doing it right when no one is looking.” Ford became renowned for his revolutionary vision: the manufacture of an inexpensive automobile made by skilled workers who earn steady wages and enjoyed a five-day, 40-hour work week. How did he do this? By building quality into the workmanship and using a standardized approach to manufacturing.

If you look at Toyota and the deployment of TPS (Toyota Production Systems) it is based on a similar approach. Toyota Production System organizes all jobs around human motion and creates an efficient production sequence without Muda (“waste”). Work organized in this way is called standardized work. It is made up of three elements: take time, working sequence and standard in-process stock.

Every quality system must fundamentally create a process which is repeatable and sustainable by adopting a standardized approach to completing work, using standard operating procedures and training. Anyone managing a quality system knows you should see a reduction in complaints, errors, and defects if the fundamental requirements are met.

Now that we understand where quality came from, it’s important to consider: where is quality going? As we continue to change processes at warp speed, the need for systematic quality management is greater than ever. It needs to be incorporated into every software program deployed and every change to key processes.

Building quality into each change and project will ensure documentation is completed, training is established, issues are resolved, and communication is maintained.

Quality has been built into many different types of organizations. Unity™ Lab Services, part of Thermo Fisher Scientific, operates within the service industry, and we are mostly a virtual and remote organization. We are committed to quality as an integral part of our business and culture. We use KPIs to manage our business and utilize Master Control for our document management system. We have a strong CAPA and audit program in place. We encourage and invest in training and have a solid training program for our engineers. Our company-wide process of continual improvement is pervasive at Thermo Fisher Scientific.

As 2020 fast approaches, take the time to reflect on what quality means to you and your organization, and don’t be afraid to ask questions. Engagement is the most critical factor in building and maintaining your culture of quality.

On behalf of our quality team, Happy New Year!

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About the Author

Kelly Huckabone is the North American Audit Program Manager who oversees the Unity Lab Services internal and external customer and supplier audit programs. Kelly is a certified risk manager, lead auditor with the American Society for Quality (ASQ), and has been conducting audits for over 25 years for different quality systems, including ISO 9001, 13485, and 17025, as well as Health Canada and the FDA.

Contact me at kelly.huckabone@thermofisher.com if you have any questions.