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.
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To learn more about the history of QMS, check out this infographic.