This is Dan Schoettlin, Director of Quality Assurance with LungLife AI, and today I want to talk about, "Why do we implement quality systems?" When asked, many people say we implement quality systems because various regulations require them. Starting with this reasoning is a major driving factor that results in quality systems that are inefficient and ineffective at achieving their intended purposes.
The first and simplest reason we implement quality systems is to enable LungLife to meet its goals, both short term and long term. For us specifically, this translates into predicting the resources required to develop, implement and support our lung cancer diagnostic tests; delivering products that effectively and reliably meet the demands of patients and physicians; identification of events that could impact test reliability and take appropriate actions to prevent losses; and have effective means to measure our performance as a clinical laboratory.
The quality system directly influences how LungLife achieves this. The quality system dictates how LungLB® test development is planned and executed; how test results are produced and delivered to physicians; how our products are monitored for issues and improvements; and most importantly, the quality system provides the means to measure LungLife's ability to execute actions in achieving its goals.
A highly effective and efficient quality system gives our business its greatest chance at success. With this said, regulations should not be underappreciated, but instead, all regulations should be given respect as they represent good business practices that have been vetted by expert committees that collectively represent countless years of applied education and real-world experience. At LungLife, we view them as a framework that ensures our products meet a level of quality that is required to successfully achieve our goals. And like all frameworks, regulations don't identify the end state, but instead form a foundation to be built upon and continued with for the life of the company. The onus is on our entire team to understand the foundation as defined by applicable regulations, and from there, build up a quality system that can meet all our demands. When this is achieved, we will have created an unbreakable tool that is capable of adapting to the needs of patients and physicians in the ever-evolving field of early lung cancer detection.