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Kari Miller

Quality Insider

What Gets Measured Also Gets Managed

Crafting a quality culture always comes down to process improvement

Published: Thursday, January 10, 2013 - 10:02

Most people in industry are familiar with W. Edwards Deming, Joseph Juran, James Harrington, and others whose ideas are usually grouped under the term total quality management (TQM). However, the practices they embrace aren’t just about TQM; they are about management best practices that embrace a culture of quality.

Often, quality is only noticed when it fails; quality issues often get a lot of negative attention by the media, 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 percent to 30 percent 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 important, 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?

An attitude of quality

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 or services. Instilling a culture of quality must start with leaders who “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 demonstrate quality as an inherent value of the organization. Look at Toyota, the poster child of a quality culture. Everyone in the organization accepts responsibility for quality; this is demonstrated and communicated at all levels in the organization. During the 1990s, however, the company’s goals changed; its No. 1 priority became growth. Its new goal was to become the world’s largest automotive company. This shift meant that employees weren’t as 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 the current 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: 
• There is a root cause for each defect
• Defects are preventable
• It is better to prevent than correct defects
• Inspection and 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 ISO 9000 and ISO 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 how to 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 quality assurance department.

Improvement that works

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 today’s economy, 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 everyone’s job, information about the company’s sales, customer needs, orders, finances, delivery of parts, productivity, efficiency, activities of different people and teams, and how one team affects another is 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 employees 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 something bigger, an organization has achieved a critical ingredient for a quality culture. The company’s welfare, and therefore the employees’ welfare, is also directly tied to that of its suppliers and customers. This is where the culture comes in; open communication, understanding the company’s values and goals, and access to information are the only ways to achieve success in the extended enterprise—the company, its suppliers, and its customers. When the extended enterprise is focused on process, and everyone understands their inputs and requirements as well as their effect on others, continual improvement can be achieved, and everyone wins. 

Philip Crosby said that, “Quality is the result of a carefully crafted cultural environment.” Corporate leadership must effectively communicate, and more important, 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.

Focus on process

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. 

Crafting a quality culture in your organization will also result in reduced risk, improved compliance, and lowered costs, improving your competitive edge and preparing your organization to address the challenges of the next decade and beyond.

Minimizing risk by focusing resources on potential problems before they occur will not only improve quality and end-user and customer satisfaction, it also will enable employees across the enterprise to thrive in a true quality culture. 


About The Author

Kari Miller’s picture

Kari Miller

As regulatory and product management leader for Pilgrim Quality Solutions, an IQVIA company, Kari Miller is responsible for driving strategic product direction and delivery of industry best practice solutions to Pilgrim’s customer base. Working with customers, industry analysts, regulators, and Pilgrim’s development, professional services, and support groups, Miller and her team are responsible for translating market and industry requirements into industry-leading enterprise quality management solutions that meet the needs of the heavily regulated life sciences market. She also consults with Pilgrim’s customer product advisory board and is responsible for the product roadmap, product partner relationships, and overall product development


True Gardeners shall never surrender

Thank you for your golden words and rules, Mrs. Miller. I observe - from my quality professional point of view - that the majority of quality people I know are still not ripe to be harvested for Quality Culture. Maybe they were not fertilized enough, may be wrong fertilizers were administered to them, maybe their parasitic diseases were not taken care of properly. For sure, we - Quality Professionals - must maintain a hold on our fishing lines, or the big tuna fish beneath our boat will be lost forever. And - as any gardener - any angler must be patient, too.