Time for What Matters: Quality 4.0 and Beyond

by Diane Kulisek | Aug 2, 2022 | Analytics, Audits, Blog, Certificates, Classification, Compliance, Consulting Group, Documents, Engineering, FDA, Guidance, Inspections, Labeling, Pharma, Pharmaceuticals, QMS, Quality, Quality Systems, Registration, Regulatory, Requirements, Risk Management, Safety, Software, Standardization, Standards, Testing, Tools, Updates, Verification

There is one concept that I have heard called “The Great Equalizer.” Time. A minute is a minute, for each of us. A minute is the same unit of measure, regardless of how much money either of us may have. Time must be spent, whether we want to spend it or not. How we spend our time matters, especially when we are choosing whether to spend our time doing something well… or doing something over. When enjoying what we love, with whom we love, time flies. Time spent suffering, can seem endless.

I have been looking into the emergence of Quality 4.0. The American Society for Quality provides an overview of the concept¹that describes the evolution of Quality 4.0 as a parallel to developments within industry (summarized) as follows:

Quality 1.0 – Prior to 1890, work was done locally and manually, inspection and measurement were relied upon to assure quality and labor conditions were not as important as productivity.
Quality 2.0 – From 1890 to 1940, automation increased production scale and speed while railways expanded locations manufacturing could take place. Standards were introduced for minimally acceptable quality levels. Finance-based quality measures, such as costs of scrap and rework, were established, and worker performance was assessed based upon quality costs.
Quality 3.0 – from 1940 to 1995, computers and robotics reduced reliance upon human beings. Continual improvement, organizational excellence and globalization emerged with emphasis upon customer expectations. Focus shifted from product-based quality to process-based quality. Management standards based upon best practices were defined.
Quality 4.0 – from 1995 to present, machine learning, pattern recognition, virtual reality (VR), augmented reality (AR) and artificial intelligence (AI) are applied to business processes. Communications exponentially expand. Global economies begin to become integrated through blockchain technology. Human involvement with wealth creation shifts from production processes to business systems.

Having spent half of my career in the Quality 3.0 era, and half in the era of Quality 4.0, I have observed many struggles to rise above prior eras. I love what I do, so time has flown for me. For those stuck in those struggles… the suffering may seem to be going on forever.

No matter what our perspectives may be or how they may differ, time is the one thing money cannot buy. It matters how we spend it. Quality 5.0 is coming² and, although formative, it speaks of massive integration between humans and machines, digital neural interfaces, levelling of the economic playing field, increased longevity, global quality of life, ecological healing, and prolonged existence of humankind off-planet. I want to be ready for that!

Need help moving your enterprise toward Quality 4.0… or Quality 5.0? EMMA International can help! Contact EMMA by phone at 248-987-4497 or by email at info@emmainternational.com.

_{² “Quality 5.0 Should Take Quality Beyond the Quality in Quality 4.0” Business Process Improvement Blog; retrieved July 21, 2022 from: https://business-process-improvement-blog.blogspot.com/2020/12/quality-50-should-take-quality-beyond.html}

Diane Kulisek

Ms. Kulisek serves as a Senior Quality Engineer and Senior Regulatory Affairs Specialist for EMMA International’s Technical Operations team. She has experience in technical writing, quality management systems, regulatory enforcement remediation, corrective and preventive action management, electronic data management systems, cybersecurity, and design controls for the medical device industry. Ms. Kulisek also has significant past experience in quality engineering and management for mass-produced consumer products, electronics, aerospace and commercial filtration industries. Ms. Kulisek holds a Master of Science in Engineering with a concentration in Civil, Industrial and Applied Mechanical Engineering Management from California State University, Northridge (CSUN) and a Bachelor of Arts in Biology with a concentration in Environmental Biology, also from CSUN. She also holds a Graduate Certificate in Program Management from West Coast University, a Lean Six Sigma Green Belt from Six Sigma Systems, Inc., and Certifications for multiple EU MDR and EU IVDR topics from Greenlight Guru. Ms. Kulisek maintained American Society for Quality Certifications for more than twenty consecutive years as a Quality Engineer (ASQ CQE) and as a Manager of Quality / Organizational Excellence (ASQ CMQ/OE).