History of the Quality Management System
When asked about the birth of today’s quality management system (QMS), the Toyota Production System (TPS) and lean are probably the first thoughts that come to mind. Although these manufacturing approaches have contributed significantly to process improvement and quality management, there’s a lot more history behind how QMS got its start.
Here we travel back in time to explore the true origin of QMS and how it has evolved in recent years to become a widely adopted cloud-based enterprise solution that helps highly regulated companies achieve new product development and introduction (NPDI) success.
THE ORIGIN OF QUALITY MANAGEMENT
The concept of quality management can be traced back to medieval Europe when craftsman guilds developed strict guidelines for how products were inspected for defects. This craftsmanship model with an emphasis on inspections and quality control extended through the early years of the Industrial Revolution.
In the late 19th century, mechanical engineer Frederick Winslow Taylor broke away from traditional European quality practices and developed a new approach, which focused on increasing productivity and profitability without increasing the number of craftsmen or strain on workers. In 1910, Taylor went on to publish “The Principles of Scientific Management,” which lay the foundation for how manufacturers should optimize operational efficiency.1
In the 1920s, engineer Walter Shewhart developed statistical quality control methods to help businesses improve their production processes by reducing variation. Engineer and statistician William Deming collaborated closely with Shewhart and successfully applied Shewhart’s methods to the production of military goods during World War II. This enabled armed forces to speed up inspections without compromising product safety or quality. Shewhart’s methods (also known as the Shewhart Cycle) served as the basis for the Plan-Do-Check-Act (PDCA) cycle, which is a key component of many of today’s quality management systems.2
THE POST-WAR QUALITY REVOLUTION
During the 1950s and 1960s, Japan started to focus on quality in an effort to rebuild its economy after the devastation of World War II. With the goal of producing higher quality consumer goods and minimizing raw material waste, Japanese manufacturers enlisted the help of Deming and engineer Joseph Juran for their quality expertise. Instead of relying solely on product inspections, Japanese manufacturers adopted a total quality strategy which held all workers accountable for improving operational processes. This new total quality approach enabled Japan to produce increasingly higher quality products at lower prices and resulted in an economic boom in the decades that followed.3,4
Around this same period, Japanese car manufacturer Toyota introduced the Toyota Production System (TPS), which focused on continually improving the way in which value is delivered to customers. TPS was the precursor to lean manufacturing which focuses on increasing productivity while minimizing waste.5
AMERICA EMBRACES TOTAL QUALITY MANAGEMENT
In the 1980s, the American economy suffered from its inability to compete with Japan. This led business leaders to embrace the total quality management (TQM) movement. TQM provided manufacturers a framework for implementing effective quality and production processes across their entire organization and served as the basis for operational excellence in the United States.
INTRODUCTION OF SIX SIGMA AND ISO 9000 SERIES
As years passed, the fundamentals of TQM started to fade, and new quality management initiatives emerged.
In 1986, Motorola developed a quality control method called Six Sigma6. By providing qualitative and quantitative tools such as control charts and process mapping, Six Sigma enabled organizations to improve processes and eliminate manufacturing defects. Today, many organizations have adopted Six Sigma to help increase profitability.
In 1987, the International Organization for Standardization (ISO) published the ISO 9000 series of quality management standards. These standards were designed to help companies document and manage the various components of a quality management system so that they could increase customer satisfaction, meet regulatory requirements, and achieve continual improvement.
QUALITY MANAGEMENT SYSTEMS IN THE 21ST CENTURY
In recent decades, we’ve seen a significant shift in the approaches to quality management systems. In 2000, the ISO 9000 series of quality management standards were revised to place greater emphasis on customer satisfaction. And in 2015, the ISO 9001 standard was revised to focus more on risk management.
Embracing the Digital Era With Cloud QMS
Today, companies are moving away from traditional paper-based systems and leveraging digital technologies to better manage and track all the processes and records that are tied to their quality system. As regulations across the globe become more stringent, manufacturers are having to gather more extensive technical data to demonstrate compliance. And although the different regulations share the same basic principles, manufacturers still need to monitor them closely to keep up with the ongoing changes and intricacies that impact their business.
By embracing cloud-based enterprise quality management system (eQMS) solutions, companies can eliminate data silos and communication barriers to quickly resolve quality issues and drive continuous improvement. Advanced solutions like Arena’s product-centric QMS connect product and quality records in a single electronic system. This enables organizations to gain greater control, visibility, and traceability of corrective and preventive actions (CAPAs), device master records (DMRs), standard operating procedures (SOPs), training records, and other quality processes that are essential to meeting regulatory standards such as FDA, ISO, and EU MDR. Because automated change processes and revision controls are applied to this information, companies have greater confidence in passing audits and meeting their commercialization milestones.
Gearing up for next-generation QMS
With the global market size for QMS projected at $21.4 billion by 2030, companies are looking at quality maturity to help them positively impact their total cost of quality.7 Many organizations are facing the challenges of GxP* readiness and compliance as well as evolving regulations like EU MDR for the medical device industry.
At the highest level of maturity, companies are operating within a true culture of quality, with end-to-end quality processes and the ability for metrics to help sustain and improve overall quality. The goal is to reach higher stages of maturity to benefit from increased compliance, higher product quality, and lower overall quality cost.
5 INGREDIENTS OF A NEXT-GENERATION CLOUD QMS
- Compliance Readiness: Because of the strict regulatory requirements, it’s essential that your QMS is compliance-ready and closed-looped for precision and effectiveness. As your company complies with industry rules like ISO 9001, 21 CFR Part 820, and ISO 13485, a purpose-built, integrated Cloud QMS should help eliminate siloed systems, promote collaboration, lower overall quality costs, and enable informed, data-driven decision-making.
- Quality Intelligence and Reporting: Making informed, data-driven decisions requires easy access to complete and accurate quality system data. Your teams should be able to make the best decisions at the right time with the help of robust business intelligence integrated with standard reports. Personalized dashboards should allow users to easily alter information and adjust their views to see the most pertinent information for their function.
- Security: Protect your quality system information in a setting that complies with industry standards by a highly secure, dependable, and effective cloud environment. As your company grows, the cloud solution should scale to meet your evolving business requirements.
- Industry Expertise: The QMS solution provider should have in-depth expertise and understanding of your industry to support your company’s goal toward process collaboration and proactive quality to help improve your next-generation Cloud QMS deployment.
- Modern and Intuitive User Interface (UI): Having a consumer-grade user interface improves user adoption and allows for the inclusion of many users across the organization. Shortening cycle times, lowering error rates, and requiring less training are all benefits of an intuitive user interface. The UI needs to be user-friendly for casual users, yet robust for administrators and specialists.
The shape of QMS in the future
Quality management will continue to play a crucial role in ensuring businesses operate efficiently and effectively while meeting customer expectations. New methods and tools will be developed because of technological improvements to assist companies in assessing and enhancing the quality of their goods and services.
No doubt we’ve come a long way from medieval times and through the Industrial Revolution. Digital transformation will continue to help companies find the fastest, most accurate methods to translate data and information into real value in terms of preventing failure while solving complex problems.
To learn more about the history of QMS, check out this infographic.