Emergence of Quality Culture
The concept of Quality Culture began in the early 2000s, when both regulatory agencies and industry were focused in increasing quality throughout the entire life cycle of their products. Whatever an employee’s position is – from technician to C suite executive - every department of the company should be built around quality so that the end goal is to ultimately give the end-user - patients - their quality drug or medical product.
From Quality Culture to Quality Maturity
Developments over the past decade have helped the initiative progress from Quality Culture into Quality Maturity, whereby a company is no longer in the development phase but, by the nature of the organization, is now quality mature. It has taken some companies 10 – 15 years to develop all of the work required to evolve into that place and some, still have not reached it.
How did these institutions advance from Quality Culture (QC) to Quality Maturity? Case studies illustrate how, 15-20 years ago, some companies started QC initiatives, but that’s just what they were – initiatives. They used all the right buzz words, worked on regulatory deficiencies and the issues that triggered the receipt of FDA warning letters, but these activities alone do not equate to true Quality Culture. QC is taking a step back behind that and really integrating quality into their DNA. The question, then, is how do we do that? We start at a micro level, looking at the macro concept of the end-user - the patient - obtaining their quality drug or medical device and taking each necessary step in making the manufacturing processes of those products more micro.