Evolution of Quality Culture in Pharma: From Initiatives to Excellence

by Stephen Tyrpak, Associate VP of Medical Device Operations; US & Canada, Local Equity Partner at PQE Group

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.  

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Technician Training for Quality Integration 

It is also important to determine how we instill quality in technicians. Those are easy concepts. The technicians must be on-boarded with the idea of the criticality of quality in their jobs. They need to understand why they are doing their job, not just how they are doing their job. The technicians must be trained and educated on the importance of quality and how it must be fully integrated into their responsibilities.  

Middle Management's Role in Quality Assurance 

Next, let’s look at middle management. This level of management is responsible for meeting Quality Key Performance Indicators (KPIs) and determining what is necessary for all of the processes required of the organization. Therefore, middle management must focus on ensuring processes and policies are in place and making certain that they really work and are providing the necessary results.  A good example is, if middle management is responsible for a full product line for an aseptic product, then it is in charge of everything, from the incoming inspection of the vials all the way through to the formulation, to the sterilization, to the filling, to the manual visual inspection. Middle managers must set themselves and their teams up for success throughout that entire process. Their KPIs are easy; middle manager’s processes, objectives and concerns include confirming factors such as:  Are product defects going down? Is the company experiencing fewer regulatory inspection failures and findings in those different areas?   

Site Executive Management and Regulatory Compliance 

The focus of site executive management, on the other hand, is “can we pass regulatory inspection?” and how that looks in terms of that specific site and what site executive management is are doing as a whole to create a quality culture. That starts with the all members of management. How are they communicating the importance of quality? What are the resources they are providing their teams to support quality? What initiatives are they taking besides using just buzz words to provide the resources, both in personnel but also with respect to equipment, to provide these employees and areas what they need to ensure a quality product is delivered? 

Corporate Executive C Suite and Quality Culture 

Finally, we look at the corporate executive C suite. These folks are the ultimate decision makers whose ultimate responsibilities should lead to quality drugs or medical devices being brought to patients. The difference between the corporate and the local teams is the culture part of Quality Culture because, for example, for someone in the US to tell a site in India how they should develop a culture to instill quality is not realistic. Recently, we are seeing a disconnect in corporate institutions sometimes placing too much of a focus on the quality side and not enough on the culture side. And it appears that a big push is happening that allows sites speak to the corporate side which sometimes, for some cultures, can be difficult. It’s hard for local site employees to tell the executive C suite what is needed in all those different areas.   

Facility Renovation and New Site Development 

There are pharmaceutical facilities that are rather old, which are going through renovation keeping quality in mind; these older manufacturing facilities and sites need to go back to ensure they have everything in place – where and how every aspect of the facility needs to be. For the many new facilities currently being developed, or those planning to be built, this provides a perfect situation to start from scratch, ensuring the use of the right equipment and good manufacturing practices.  

Cultural Differences and Quality Culture 

If an organization is building a new site, it should be built with quality culture at top of mind so that in the future there is no need to re-do anything; the hardest thing to do is to revamp a full facility and an organizational culture.  Some manufacturers try to copy and paste what another large pharma group has put in place; this doesn’t work because people are different in different sites, different countries, and different cultures. Quality Cultures must be tweaked to fit those specific strengths or weaknesses. PQE supports clients in understanding good industry practice and how to customize it for their quality system.   

Utilizing Metrics for Quality System Maturation 

It is important to understand how to use certain metrics to actually create a more mature quality system. What that means is, the organization must clearly comprehend what it is trying to get out of each of those silos mentioned earlier – the technician, the middle management, the executive management at the site level, and the C suite executive management. It is important to know the full picture regarding where KPIs are built-in, what they ae measuring, and what the outputs are. The entire company needs to know that everything leads to the same site vision. 

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