I do not work in industry, but I’m currently at the 2017 American Medical Device Summit in Chicago. I spoke with Liz Iversen who is the SVP, Chief Quality and Regulatory Officer at Philips. After FDA Recalls and shutting down their Cleveland plant in 2014 they have restructured and put in place new division heads and Liz has worked closely with the CEO, Frans van Houten, to develop a proactive quality culture and implementing a quality transformation. Topics included; evaluating and assessing the culture continuum, challenges and risks, quantifying the business value of a culture of quality, creating and streamlining effective models for evaluating the culture of quality, and developing and sustain the gains of the quality culture and adopting change management.

Philips’ CEO highlights the importance of Quality Culture and is implementing a Quality Transformation in Philips. As we mentioned the Cost of Quality in another post the Philips CEO says “the ultimate cost of not being focused on not being focused on quality is that we do not have a future. It is really the simple, it is really that serious.”
A message from Philips CEO to quality professionals: https://www.youtube.com/watch?v=3ZFiSkjjCVc

So although this is out of my scope. It seems that in order to improve quality culture you need employee engagement and higher level engagement to implement the quality unit as not a barrier but a collaborative unit with the rest of the company to work together to get a quality product out to the patient.