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What is Quality by Design (QbD) and how will it change the future of product development?
In today's rapidly changing market environment, Quality by Design (QbD) is becoming an integral part of the product development process. First proposed by quality expert Joseph M. Juran, QbD aims to ensure breakthrough progress in products, services and processes through a systematic approach. This methodology is not only applicable to the automotive industry, but is also widely adopted by the U.S. Food and Drug Administration (FDA) in the drug discovery, development and manufacturing process.
The core concept of quality design is that "quality can be planned".
Basic steps of quality design
Juran's quality design model consists of the following steps:
- Establish design goals and criteria for the project.
- Define target markets and customers.
- Explore market and social needs.
- Develop new design features to meet needs.
- Develop or re-develop production processes to achieve these characteristics.
- Develop process controls to transfer these new designs into actual operations.
In the process of quality design, integrated planning is crucial. A team is needed whose goal is to be responsible for the success of new products. The leader of this team needs to be fully responsible for the entire new product development process, from opportunity definition to customer purchase, use, service and recommendation to others. Every team member has a role in ensuring the success of a new product. Additionally, clear and measurable goals should be established within the team to ensure that everyone involved is aligned in their efforts towards a common goal.
Customer-centric optimization strategy
The starting point and end point of quality design are customers. Every new product launch involves some kind of trade-off, especially among multiple customers. Different customers may have conflicting demands, and even within the same customer, demands may compete with each other. For example, production capacity and speed may conflict with operating costs, while functional diversity may affect ease of use. Quality design provides a series of tools and methods to help companies identify and optimize these trade-offs to better meet customer needs.
Quality design faces innovation head on, emphasizing creative approaches and functional design.
Control variability and transfer to operations
Controlling variability is a very important part of quality design. These tools and methods measure and understand existing variability by using historical data, testing, and modeling to predict, analyze, and eliminate the negative effects of variability. Process control consists of three basic activities:
- Evaluate actual process performance.
- Compare actual performance to goals.
- Take action on differences.
QbD Practice of US FDA
The FDA's quality-by-design program emphasizes building quality into the product development and manufacturing process, rather than simply performing quality control after the design is completed. Since the 1990s, this concept has been gradually incorporated into the FDA's review process, and the implementation of QbD has also promoted quality improvement in the pharmaceutical industry, as described in the report "Drug Quality in the 21st Century: A Risk-Based Approach."
FDA encourages pharmaceutical companies to demonstrate how they apply the principles of quality by design in their new drug applications.
International conferences promote QbD
Internationally, FDA works with regulatory agencies such as the European Union and Japan to strengthen the promotion of quality by design. The international conference's guidelines provide uniform recommendations to help manufacturers implement quality design in their own operations. These guidelines are built on in-depth market knowledge and process understanding, facilitating the integration of manufacturing and risk management.
Looking to the future
As quality design continues to be applied and developed, we can expect changes in the product development process. This is not just a simple design improvement, but an evolution of the entire business operation model, aimed at providing customers with higher satisfaction and value. So, in this wave of change, how can your business adapt and use quality design to create more successful products and services?
