Focus on Quality
Measuring medical device companies through a lens of compliance auditing is not enough to ascertain and ensure quality… nowhere near enough. There is no disagreement on that…
“…one device manufacturer can meet FDA requirements and still make a poor-quality device, whereas a second manufacturer may not comply with all FDA requirements and yet make a high-quality device.” Jeff Shuren, M.D., J.D., Director CDRH
“We have heard that too much of a focus on compliance with FDA regulations, rather than on device quality, drives some companies to focus on making FDA inspectors happy and checking the quality system regulation requirements boxes rather than focusing on innovating around device quality.” Jeff Shuren, M.D., J.D., Director CDRH
“The Agency realizes that in the past, the focus of the relationship between FDA and industry may have been on managing compliance rather than on a shared goal for continuously improving quality.” Jeff Shuren, M.D., J.D., Director CDRH
Clearly, compliance ≠ quality. It is essential that we transition from a culture of compliance to a culture of quality. The question then becomes, just how do we define quality for the medical device industry?
One dictionary I referenced provides the following definition:
1) the standard of something as measured against other things of a similar kind; the degree of excellence of something.
2) a distinctive attribute or characteristic possessed by someone or something.
Restated, quality is the standard of something, measured against other things of similar kind, describing a distinctive attribute or characteristic possessed by someone or something, to determine the associated degree of excellence.
Okay, so what is that ‘something’ we should focus on so our visibility of quality is not obscured? How do we shift our focus to one that looks beyond compliance to a focus of understanding quality? To answer the question of what a quality focus should be I ask of you to recall a famous quote from Fujio Cho, who was the Honorary Chairman of the Toyota Motor Corporation? I believe he characterized the approach in terms of results when he said…
“We get brilliant results from average people managing brilliant processes – while our competitors get average or worse results from brilliant people managing broken processes”
High-quality performance, by good people, is resultant from high-quality processes that produce high-quality results. Good people and good processes produce good product. It is then clear that our focus must then be on the measurement, management and improvement of product quality resultant from process performance. That is our focus. The first step is in measurement for understanding.
Product quality must be measured in terms of patient safety.
Process performance can be measured across three dimensions that are important to business and regulatory stakeholders:
- Compliance to applicable regulation and standards
- Effectiveness in obtaining results
- Efficiency in operational execution
Product and process performance can be additionally measured in terms of the cost of poor quality (COPQ) associated with each.
Once we measure product and process quality, we can better manage and improve quality.Compliance auditing will always be necessary component to ensure regulatory requirements are being met, however, compliance auditing alone is not enough to ensure quality.We must shift from a paradigm of being focused on compliance to a more holistic quality paradigm that is inclusive of compliance.Additionally, we must do a better job of measuring quality.We cannot manage what we do not measure.Once we move beyond the outdated compliance mindset of measurement and begin to actively measure, manage and improve the quality of our products and processes, we will have then successfully transitioned from a culture of compliance to a culture of quality.