Crafting a Quality Culture

Crafting a Quality Culture

Kari Miller, Senior Director of Industry Solutions and Product Management, Pilgrim Quality Solutions

Most people in industry are familiar with W. Edwards Deming, Joseph Juran, Jim Harrington, and others whose ideas are usually grouped under the term Total Quality Management. However, the practices they embrace aren’t just about Total Quality Management; they are about management best practices which embrace a culture of quality.

Often, quality is only noticed when it fails; with media today, quality issues often get a lot of negative attention and the “news” is available worldwide.  Regardless of the industry, pharmaceutical, food, medical device, automotive, chemical or construction, dozens of recent examples demonstrate the potentially high costs of poor quality, estimated at 5%-30% of gross sales for manufacturing and service firms. To avoid the high cost of poor quality, a cultural shift is essential.

Embracing a quality culture will result in reduced risk, improved compliance, lowered costs, and most importantly, an increase in customer satisfaction through an improved customer experience with your organization.  With improved customer satisfaction, comes increased revenues from repeat sales. By transforming an organization to a quality culture and infusing a quality mindset throughout the organization, companies can improve performance and manage risks to address the challenges of the next decade and beyond. In a quality culture, quality becomes more than just a focus on design, engineering and formulation; it’s more about process and change management. So how does a company embrace, integrate and entrench a culture of quality into its organization?

Culture is the basic pattern of shared beliefs, behaviors, attitudes and assumptions acquired over time by members of an organization.

A quality culture is an attitude; it is the shared beliefs, behaviors and assumptions held by members of an organization.  It is a set of values employed by a company to improve the levels of quality in its products and/or services. Instilling a culture of quality must start with leaders that ‘walk the talk’. Gandhi once said “Be the change that you wish to see in the world.”  The best way to establish and maintain a positive quality culture is through clearly defined goals and values, open communication and access to information, a focus on process, teamwork, and last but not least, on experiential learning.

Vision, values, goals and strategy are the guiding principles of a corporation and culture culminates from them. Quality culture refers to the complete awareness, commitment, attitude, and behavior of the organization with respect to quality.  Corporate leadership must effectively communicate and more importantly demonstrate quality as an inherent value of the organization.  Look at Toyota, the poster child of a quality culture.  Everyone in the organization accepted responsibility for quality; this was demonstrated and communicated at all levels in the organization.  In the 1990s however, the company’s goals changed; its number one priority became growth.  Its new goal: to become the world’s largest automotive company.  This shift meant that employees weren’t focused on quality as they once were, and defects went either undetected or unreported, resulting in the 2009 recall of 9 million vehicles, costing billions of dollars.  Toyota’s growth culture replaced its quality first, continuous improvement culture.

Toyota, however, isn’t alone. In today’s economy, everyone is expected to do more with less which may seem diametrically opposed to a quality culture, but it isn’t.  Organizations that embrace quality by putting the customer first and by striving for continual improvement will be able to do more with less while delivering quality.

Continual improvement starts with a focus on process and process improvement, and it involves everyone in the value chain (company, vendors and customers).  Four key assumptions must be embraced if an organization is to focus on process improvement and live a quality culture:

  1. There is a root cause for each defect.
  2. Defects are preventable.
  3. It is better to prevent than correct defects.
  4. Inspection/testing can be reduced for capable processes.

Quality initiatives commonly deployed in an organization to focus on process improvement may include, but are not limited to, Six Sigma, TQM, Lean Manufacturing and Design Controls.  Companies embracing quality initiatives may also deploy guidelines and standards such as GxP and ISO9000/9001. All of these elements are critical to process improvement; however, as the four key assumptions imply, the processes and procedures that need to be well documented, understood, deployed and effective are those that determine the root cause of defects that do occur and prevent them in the first place.  Therefore, best practice nonconformance (NC) reporting, Corrective and Preventive Action (CAPA) and complaint management must be in place and in use across the organization, not just in the QA department.

Improvement activities can fail for a number of reasons. Organizations may have extensive quality control measures in place, but not everyone lives and breathes them.  Quality has not become a natural part of the culture. With the competitive pressures of the economy today, companies cannot afford to have anything but the very best quality. In an action-oriented quality culture, this attitude and willingness must be developed among everyone if the organization is to thrive.

With quality being the job of everyone, information about the company’s sales, customer needs, orders, finances, delivery of parts, productivity, efficiency, the activities of different people and teams, and how one team affects another, are vital.  Employees make decisions about what to do based on information. Limited information means that decisions will not be made based on facts and therefore are more likely to introduce uncertainty into the organization and its processes. Clearly documented processes and procedures, regular training and educational sessions are also important tools in keeping employee’s informed, ensuring factual decision making and teamwork.

A culture of quality requires teamwork.  Teamwork is the natural result of working in an environment where people feel they are part of something bigger than themselves. When personal success on the job is defined by the success of that something bigger, an organization has achieved a critical ingredient for a quality culture. The company’s welfare, and therefore the employee’s welfare, is also directly tied to that of its suppliers and customers.   This is where the culture comes in; open communication, and understanding of values, goals, and access to information are the only way to achieve success in the extended enterprise (company, suppliers, and customers).  When the extended enterprise is focused on process, and everyone understands their inputs, requirements and impact on others, continual improvement can be achieved and everyone wins.

Philip Crosby states that “Quality is the result of a carefully crafted cultural environment.”  Corporate leadership must effectively communicate, and more importantly, demonstrate quality as an inherent value of the organization.  To do that, the following attitudes must be internalized.  Quality does not take time, it saves time.  Quality is not expensive, it is cost effective.  What gets measured gets managed; empower employees with information.  Documentation, training and education save money and empower employees. Problems are opportunities for improvement.  The only real problem is a hidden problem.  When problems do arise, focus on the process not the individual. In the quality culture, focus is on the customer and quality becomes everyone’s responsibility. Customer expectations are exceeded and customers are delighted.

With this improved customer satisfaction comes increased revenues from repeat sales.  Crafting a quality culture in your organization will also result in reduced risk, improved compliance, and lowered costs, improving your competitive edge, thus preparing your organization to address the challenges of the next decade and beyond.

Pilgrim Software’s fully integrated solution suite provides users with a full range of quality tools for documentation, validation, training, audit, inspections, CAPAs, nonconformance, and complaints.  These solutions put all quality history and data at the end-user’s fingertips and turn that data into meaningful information by providing users with key metrics and KPIs, thereby improving decision making for the enterprise.  Minimizing risk by focusing resources on potential problems before they occur will not only improve quality and end-user and customer satisfaction, it enables employees across the enterprise to thrive in a true quality culture.

Kari Miller

Regulatory & Product Management Leader, IQVIA Quality Compliance