People Create Quality

People make quality happen. A ‘quality’ outcome requires a combination of good people working with a good process to produce a good outcome. Interesting, because it is also people who design the processes used to do the work to produce the products that other people need. Furthermore, the quality of the process clearly impacts the quality of the product. How does your organization measure the quality of process and product?

I have been reading a book about the baseball industry written by Ben Reiter; Astroball, The New Way to Win It All. The book basically explains how a new leadership team overcame the bias inherent in the human observation needed to form the basis of their player decisions. They challenged the aspect of decision-making, necessary to building their roster, with the goal of producing a world class baseball team. They did this through being better informed.

The decision-making process was modified to reduce the subjective bias inherent from managing with intuition and emotions in favor of algorithms that utilized information to provide them with objective evidence of player performance. However, people still made the decision of whom to choose. The difference was that they trusted their new process to provide them with foundational information that they could trust, and utilized that information to obtain ball players that better demonstrated the talent and characteristics of the skill-set they required. They didn’t stop there. The management team fully understood that past performance was not a perfect predictor of future results. They taught their newly acquired ball players about their decision-making process. They explained to them just what it was that they saw in the data they used, how they wanted each player to perform within the system, and what result they expected as an outcome of their performance. They trained their players to focus their game on their individual competencies to improved their ability to execute within the Astros’ system. 

The Astros utilized information/data to improve their decision-making process and they improved their ability to objectively manage player/personnel decisions by utilizing that information. Additionally, they trained their players with that information to focus them on the outcome they desired. This resulted in going from ‘worst to first’ and winning the World Series.

There is a lesson here for the medical device industry. The takeaway here is that we can also turn something technical into something special. We can make better decisions without sacrificing the combination of knowledge and intuition developed as an outcome of our experience. We just need to add a foundational process to provide organizational information that we can trust, and utilize that information to make better decisions that enable us to ensure a quality outcome in our business through improved performance. What game-changing information should leaders focus on to improve the quality of operational performance?

Accountable leaders within the medical device industry have a significant responsibility to ensure patient safety through a Quality Management System (QMS) that provides management control over the operational quality of the processes they utilize to provide safe and effective products to the market. This can only occur through performance measurement efforts that enable leaders to understand product and process performance issues within the system. Performance management begins with the measurement of:

1)   Product Quality (PMS) to provides post-market surveillance (PMS) of the ongoing benefit-risk to the patient of the product provided to the market and identifies emerging opportunities for improvement.

2)   Process Quality (QMS) to measure the quality of the QMS through aggregation of process quality by measuring compliance to requirements, effectivity in producing results and efficiency in operational execution. 

3)   Cost of Poor Quality (COPQ) to measure the failure costs of product and process quality issues, enabling the management of improvement initiatives to provide a return on the investment (ROI) in quality improvement.

These measurement components identify operational constraints associated with the management of quality. Transformational performance improvement can best occur by targeting these identified constraints, through focused performance improvement initiatives, to satisfy your stakeholders in providing the safe and effective products the market expects, for the patients we serve.

There has never been a better time to implement such a holistic and game changing measurement strategy. While manufacturers have always been required to regularly evaluate and document the clinical outcomes of their device to demonstrate continued safety and performance, the measurement component of PMS has recently become a renewed focus of attention with the new Medical Device Regulation (MDR) that was adopted in 2017. The requirements for measuring quality are fast becoming more highly regulated as a critical requirement, and will be made visible through improved reporting mechanisms such as EUDAMED, currently under development.

Larry Mager