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Why is Joseph Juran's quality design concept so critical in modern manufacturing?
In today's rapidly changing market environment, companies are facing increasing challenges, especially in terms of product development and service quality. The Quality by Design (QbD) concept proposed by Joseph Juran has become a key tool to solve these challenges. The quality design concept emphasizes taking quality into consideration from the beginning during the product development process to ensure that the final product can meet customer needs and expectations.
Quality refers not only to product characteristics, but also to the reliability of these characteristics and customer satisfaction.
Juran’s quality design concept does not exist alone, but is closely related to the Juran Trilogy he proposed. This includes quality planning, quality control and quality improvement, of which quality design is undoubtedly the cornerstone of success. According to Juran, quality should be planable, and he argued that most quality crises and problems stem from poor quality planning.
The logic behind living in "quality design"
The logic of quality design originates from customer needs, which means that companies must fully understand customer expectations before product innovation. Julan's process includes several key steps: first determine the design goals, secondly identify the target market and customers, then conduct demand research, then design product features and ensure that the production process can achieve these features, and finally, establish process controls to ensure that the design into actual operations.
The final activity of the quality design process is to implement the plan and confirm the success of the transformation.
Such a systematic approach is not just a statistical design method, it also requires the cooperation of a professional team. These teams must be directed by a leader who is responsible for the overall success, who reports directly to the executive, and ensures that all members are working toward clear and measurable common goals.
Customer-centered optimal design
In the process of implementing quality design, companies often face the challenge of balancing multiple customer needs. Because different customers may have conflicting needs for a product, such as cost, speed, and flexibility. Quality design aims to specify and optimize these trade-offs through a series of tools and methods in order to meet customer expectations.
Every new product launch is accompanied by certain trade-offs, and quality design provides the tools to make these trade-offs explicit and optimized.
Control mutation and operation transfer
Quality design also includes modern tools for controlling variation, tools designed to forestall potential problems before they occur. This process involves measuring and understanding variation through historical data, testing, and modeling, and then using standard statistical techniques to predict, analyze, and eliminate the impact of undesirable variation. Not only that, quality design also requires continuous evaluation of actual performance and comparison with established goals to ensure continuous improvement throughout the life cycle.
Quality design in the pharmaceutical industry
In its report, the U.S. Food and Drug Administration (FDA) emphasized the importance of quality design, particularly in the synthesis and manufacturing of pharmaceuticals. The core of quality design is that quality must be built on the basis of a full understanding of the product and its manufacturing process, and ways to incorporate quality into the design. This marks a significant change from the "quality post-design" approach since the 1990s.
International Cooperation and Guidelines
In addition to the United States, international conferences such as the International Conference on Harmonization of Technical Requirements for Pharmaceutical Registration (ICH) have also played an important role in advancing the goals of quality design. ICH provides a unified set of guidelines to help manufacturers integrate quality design into their operations. This series of guidelines covers everything from drug formulation development to pharmaceutical quality systems, demonstrating the global promotion of quality by design efforts.
As today's manufacturing industry faces more and more challenges, can Joseph Juran's quality design concept become the key to the continued success of future enterprises?
