Quality and Productivity: Then and Now

Chuck Truby

June 1, 1999

6 Min Read
Quality and Productivity: Then and Now

Medical Device & Diagnostic Industry Magazine
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An MD&DI June 1999 Column


In a guest editorial in the June 1982 issue of MD&DI, I addressed the subject of quality and productivity. At the time, the United States had just awakened to the fact that declining productivity and mediocre quality had severely weakened our global competitiveness. I perceived that many companies were responding to the situation by touting what I called "prepackaged or imitative" solutions, and suggested that the act of instituting any quality improvement or cost-reduction program without a strategic plan and total commitment on the part of management would end in failure. For example, among the supposed cure-alls for falling quality and productivity were the then-popular but misunderstood "quality circles"—a first-time attempt, borrowed from the Japanese, at using teams to solve problems. I also suggested that human resource development and employee involvement, documented product assurance systems and system audits, reliable product design, stronger supplier relationships, and value-added regulatory compliance were the major considerations for improving both quality and productivity. I expressed the belief that it was time to go beyond debating the recently enacted FDA regulations and to focus more time and energy on credible, efficient, and effective preventive quality controls.


Seven years later, in MD&DI's July 1989 issue, I revisited the subject of quality and productivity, reflecting on the key elements raised in the earlier editorial. By that time, numerous movements on how to improve quality—both conceptually and in real-world product and service delivery—had been launched in the United States, including those of Juran, Crosby, Demming, and Baldridge, to name a few. I again pointed out that the key to quality success was through human resource development at all levels and an organizational culture shift that would place more focus on the people in the organization and on the company's customers. The one major component of the quality and productivity success formula still requiring our attention, I proposed, was people development—the direct involvement of employees, at every level, in the quality improvement process. It was suggested that even the best-developed and -deployed financial budgets, quality movements, systems, products, and services were only as effective as the people behind them. I also indicated that the perception of regulation as a threat had been superceded by a sound business precept: that preventing defects through a reduction in process variability was the most efficient and cost-effective way to comply with regulations while enhancing quality and productivity.


So how de we define the concept of quality today, as we approach the next millennium? I believe that the subject of quality did, in fact, receive the attention it deserved over the last 20 years, despite the confusion of different movements, the many false starts, the expectations of quick fixes, and the considerable tally of wasted hopes, time, and money. The various initiatives for quality and productivity improvement were not in and of themselves the reason for a lack of success. Most if not all of these undertakings were deployed in a vacuum, with no overall plan in place, no credible measures to monitor results, and no coordination with the culture of the organization. The frequently painful learning process that ensued was perhaps necessary for the quality transition to arrive at where it is today.

Despite its fractious beginnings, the notion of quality has evolved from mere specifications, controls, inspections, systems, and methods for regulatory compliance to a harmonized relationship with business strategies aimed at satisfying both the internal and external customer. Today, quality and value are, first and above all, givens, and the customer expects them. In the successful company, quality, productivity, and regulatory compliance are no longer considered tolerated necessities, fads, or mysteries, nor are they viewed as independent of each other.

Quality and productivity in the successful organization are fully integrated into all of the business processes and are an extension of everything else that has to happen along the path to success, both for the company and for the people involved. Quality, productivity, and, increasingly, speed are becoming a means to a unified end in everything we do. From a regulatory enforcement standpoint, FDA has also focused on quality and productivity, seeking to streamline its processes and improve both regulatory outcomes and approval times. As we move into the 21st century, the success of industry and government agencies working together to make the right decisions on behalf of the end user will require a level of collaboration the likes of which we have never seen before.

The quality transition that has occurred over the past 20 years has served as a platform for learning, forcing us to better know our business, our employees, and our customers. We finally learned that customers aren't interested in quality systems, programs, or movements. What they care about are perceived value, safety, service, and, ultimately, results.


Today, quality and productivity are not only something delivered in a product or service, but are critical to the way companies involve, develop, and delegate responsibilities to employees. Successful companies recognize that an organization isn't positioned for success until its employees are positioned for success, and that such an outlook is important if the firm is to remain competitive and attract and retain the best people. To do so requires that the values of the organization adjust themselves to this new paradigm. The process obviously starts with the total commitment of management and the complete involvement of everyone in the organization. Those policies, systems, structures, skills, and management style that make up the culture of the company must be aligned and synchronized in a way that promotes and encourages the behaviors necessary to continuously improve quality, productivity, operational speed, and compliance.

More than any time since Frederick Taylor, people within an organization are being recognized as legitimate assets of the company, contributing creativity and not just labor. Today, there can be no tolerance for employees who occupy a position on an organizational chart without adding value and continuously learning in the process. The challenge is to determine what is the "right" culture to foster an environment in which creative behavior is encouraged and the full potential of each employee can be realized. A positive cultural change requires carefully planned and scheduled people development and constant reinforcement to enhance initiative, leadership, empathy, time management, goal setting, and interpersonal skills.

In addition to a realignment of the culture of the organization, knowledge of the company's business and of its customers and their expectations must be shared with all employees so that delegation and strategic decision making can be done quickly throughout the entire organization. The bringing together of an accommodating corporate culture and a deeply engrained knowledge of the company's business and customers represents a powerful approach to improving employee performance and the potential for ultimate success of any organization. This vital combination defines quality and productivity today, and, most likely, will do so 20 years from now.

Chuck Truby is president of Chuck Truby and Associates (Wilmington, NC). He was formerly vice president of quality management and regulatory affairs at Steris-Isomedix (Whippany, NJ); vice president of quality management at Sherwood Medical (St. Louis); and corporate director and director of quality assurance at Becton Dickinson Corporate and Becton Dickinson Division (Franklin Lakes, NJ).

Copyright ©1999 Medical Device & Diagnostic Industry

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