Sandy Carson, Marketing Communications & Events Manager, Pilgrim Quality Solutions
“Quality isn’t an act, it’s a habit.”
Aristotle said it first. But it doesn’t take a philosopher or a scientist to recognize that excellence doesn’t happen overnight. Just ask the drum major in the local high school band or the prima ballerina in the regional ballet company. It takes ongoing commitment to reach the pinnacle and continuous improvement to remain there.
The QA director at a leading pharma or medical device company know this, too. Very well. The practice of continual improvement starts with a unified, enterprise-wide commitment to ongoing best efforts and to process improvement.
In fact, to build and sustain a corporate “Culture of Quality,” organizations must be proactive in seeking process improvements which enhance overall product and service quality. Only then will they achieve improved customer satisfaction, a reputation for excellence, and ultimately, increased revenue from new and repeat sales.
Quality is Everyone’s Job
So while continual improvement starts with a focus on process and process improvement, organizations must first get everyone across the value chain (company, suppliers and distributors) on board the same train. Unfortunately, for too many Life Science companies that are struggling today, they haven’t even completed that first step yet. Quality has not become a natural part of their own employee culture. Most likely, it’s not yet a daily habit outside the QA function. If they want their environment to evolve into a process-oriented quality culture, then they must nurture the quality habit among every member of the organization.
Typically, this begins with companies deploying such Quality initiatives as Six Sigma, TQM, Lean Manufacturing and Design Controls, and most commonly, guidelines and standards such as GxP, ISO 9000/9001, and FDA regulatory compliance standards. These are ambitious and broad initiatives, and it takes time for employees to get comfortably adapted to their principles.
Build a Unified Front
OK, so what happens next, when everyone does eventually get on the same page? The next step is to narrow their collective focus on process improvement and building a quality culture. To do so, they must recognize that problems are opportunities for improvement, and then embrace three key assumptions:
- There is a root cause for each problem.
- Problems are preventable.
- It is better to prevent than correct problems.
Collectively, they must recognize, as the key assumptions imply, that the processes that need to be effectively documented, understood, and deployed are those that help determine the root cause of defects that do occur and then go on to prevent them from happening again. Those practices are:
- Complaint management,
- Nonconformance (NC) reporting, and
- Corrective and Preventive Action (CAPA).
These processes must be in place and in use across the organization, not just in the QA department.
Let CAPA Show the Way
In typical Life Sciences organizations, CAPA is a reactive tool used to remedy defects, deviations, complaints or other incidents of poor quality. To the FDA, CAPA is at the core of nearly all quality management systems and is the driver of operational excellence. It is critical to have this process in place as defects are bound to occur, and every organizational member needs to live and breathe it.
According to John Avellanet, Managing Director and Principal of Cerulean Associates LLC, a lean compliance and FDA consulting firm, more than 30 years of research into organizational habits and routines has shown that there are four critical steps to turn quality into an organizational habit. An effective CAPA management process engages those four steps, and to ensure that effectiveness, an organization must have an understanding of the current habit loop or routine of weak and ineffective CAPA procedures.
In a whitepaper he has authored, Turning Quality into an Organizational Habit and How Your CAPA Process Can Lead the Way, Avellanet points out that many companies typically engage a 3-part CAPA routine or habit loop that circles back to simply “a return to normalcy.” He argues that to attain Quality and make it an organizational habit, that 3-part loop is insufficient. Normalcy will not ensure that a defect or problem will not reoccur. It’s essential that a fourth stop on the loop is made — to use the first three actions (steps #1-3) as “the springboard into creating other effective quality routines” (step #4).
Essentially, applying lessons learned through the CAPA process (i.e., identifying a root cause) will enable companies to zero in on future potential problems before they occur. This will not only improve quality and end-user and customer satisfaction, it enables employees across the enterprise to thrive in a true quality culture.
“First you make your habits, then your habits make you!” *
New habits create a culture where new values, such as compliance or product quality, become ingrained. A quality management software system eases the pain of building new quality habit loops by automating and even enforcing new behaviors. This reduces the time spent doing the work of building each new quality habit, and achieves the benefits of more effective processes, reduced noncompliance and improved product quality at a much faster pace.
Remember that drum major and the ballerina? They know that excellence doesn’t happen overnight. But organizations that get busy establishing good habits are most likely to take center stage.
Turning Quality into an Organizational Habit
Your CAPA process can lead the way. Learn the four critical steps for turning quality into an organizational habit and more.