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Management

Quality 4.0 | Dr. Milton Krivokuca

Developing a Quality 4.0 Quality Management System

The value of a QMS is its ability to be flexible in supporting continuous improvement and assuring customers are satisfied.

By Dr. Milton Krivokuca
Side view of female engineer holding documents standing by car chassis in car plant.

Image Source: Morsa Images / E+ via Getty Images

April 17, 2024
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Quality 4.0 is receiving frequent attention. Journal articles and webinar/conference presentations address this misunderstood topic from various perspectives. I have spent many hours reading numerous articles published by quality subject matter experts, as well as data scientists and human resources professionals. This article approaches Quality 4.0 from a perspective derived from my experience as the program coordinator for the Master of Science in Quality Assurance (MSQA) program at a university in California.

My experience with quality dates to the early 1980s when the United States automotive industry found themselves in direct competition with Japanese automakers. The U.S. manufacturing industry recognized that quality was an important factor in achieving customer satisfaction and was not to be taken lightly. The birth and the development of ISO 9001 Quality Management System (QMS) was a huge paradigm shift in the approach that industry had applied to internal processes and final product performance. Today, we recognize this time frame as Quality 3.0. It is interesting that this term did not gain recognition until Quality 4.0 was introduced.

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My intense involvement began in the 1990s while I was a quality manager for a manufacturing company. I was tasked with implementing an ISO 9001 system. Since 2001, my career has moved from industry to teaching all areas of quality in higher education, where I have been closely involved with the transition from Quality 3.0 to Quality 4.0. As the coordinator, program operations management is my primary responsibility. Since my department is very ‘lean,’ I also provide the final approval for all new MSQA applicants and function as the program advisor.

My observations of quality learning for the past decade indicate a constant state of transition. Ten years ago, 70% of the students enrolling in the master’s program were from service-related industries. The remaining 30% of students were from traditional manufacturing industries such as automotive and aerospace. For the past four years, the trend of new students has been 60% manufacturing and 40% service-related industries. These manufacturing focused students are from medical devices, laboratories, and bio-pharma industries, where speed and flexibility are critical. Automotive and aerospace quality student enrollments are now negligible. Current trends note many students with non-technical degrees applying to the quality master’s degree program. These future quality professionals were not hired into quality specific processes. They indicated that some aspects of their job assignments included elements of quality, which piqued their desire to learn more about quality. Another factor that impresses me is the student demographics have changed. The typical MSQA student had been a mid-career professional with 10+ years of work experience. Today’s student of quality has less than 10 years of professional work experience.

This background and current environmental status provide the basis for my perspective of Quality 4.0. Quality 3.0 was never clearly or prescriptively defined during the deployment of the original manufacturing QMS realization processes. QMS revisions in 2001 and 2015 included the entire organization and provided guidelines appropriate to service-oriented organizations. The Certified Quality Manager (CQM) product focused Body of Knowledge (BOK) developed in the 1980s, became the Certified Manager of Quality/Organizational Excellence by applying the concept of quality cross functionally throughout the organization as aligned with the ISO 9001 2001 revision. Given this history of a dynamic BOK with the flexibility to change as the business environment requires, a static Quality 4.0 BOK should not be prescriptively developed at this time.

The challenges encountered in Quality 3.0 are fundamentally not very different from those occurring today.

The value of a QMS is its ability to be flexible in supporting continuous improvement and assuring customers are satisfied that products and services satisfy their needs and expectations.

Quality applies to most every organization where an internal process exists to provide the customer with a product or service that is safe and reliable. The established process improvement methodologies and tools as developed and practiced by Quality 3.0 remain effective today. The challenges encountered in Quality 3.0 are fundamentally not very different from those occurring today.

The direct applications of quality concepts need to be evaluated and adopted to apply as current applications exist in today’s business environment. The future quality professional requires skills in the fundamentals of quality and practical knowledge of the current technological and human resources related processes. Making this connection is the catalyst of Quality 4.0, an agile and flexible QMS designed to address the unique objectives of any organization.

I am very optimistic that Quality 4.0 will be successful. My observation, based on the demographics of the future MSQA graduates, reflects a diverse perspective to quality, both technical and non-technical areas, committed to achieving organizational excellence. The basic preparation of this future generation of quality professionals begins with the mastery of Quality 3.0 concepts being adapted to contemporary technological and human resource processes. The preparation of knowledgeable quality professionals comprises a practical approach to successfully applying Quality 4.0.

KEYWORDS: ISO 9001 ISO standards manufacturing metrology Quality 4.0 quality management system (QMS)

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Dr. Milton Krivokuca is Interim Quality Program Coordinator and subject matter advisor of the Master of Science Quality Assurance program at California State University Dominguez Hills, Carson, CA. He has also taught master’s classes in critical thinking and quality theories at several universities. Additionally, he has presented contemporary quality topics at conferences in Europe, Middle East, Africa, and Asia, locations throughout the United States and Canada. He is past chair of ASQ, Quality Management Division, an ASQ Fellow, ASQ Los Angeles Section 700 Simon Collier Quality Award recipient and 2020 ASQ Section 701 Orange Empire Quality Guru of the Year. Quality 4.0 Thought Leader. Dr. Krivokuca was awarded the ASQ 2024 Grant Medal for Meritorious Contributions to Quality Education.

He is also the 2024 Quality Professional of the Year

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