Quality management has been a concept from the first time people created goods—higher quality goods represented higher status in society. Since then, the way we create, distribute, and evaluate goods has changed drastically.

Factory production began with the Industrial Revolution, and consequently the need arose for identification and removal of defective goods. In 1924, Western Electric engineer Walter Shewhart proposed a method for statistical quality control, which became popular in the armed forces during World War II. After the war, the method gained popularity in Japan.

This method was the first iteration of the “plan-do-check-act” method. It created the first strategies that went beyond basic inspection and focused on people and processes.

In the late 1970s, the United States found itself responding to automobile and electronics production competition from Japan. That’s when corporate leaders created total quality management (TQM), which remained a major force for much of the late 20th century. Also around this time came the publication of the first version of the ISO 9001 standards, which were slowly adopted by American companies.

Until recently, TQM and ISO standards were the backbone of quality management technology across many industries.

Quality Management in the Past 15 Years: Four Main Characteristics
TQM was a major early force in quality management, but that foundation has evolved into concepts like Six Sigma and Lean Manufacturing.

By far the most significant advancement in quality management in the past 15 years has been the shift to digitalization. The increase in the number of regulations has provided the business case to justify the need to start investing in digitalization of the quality management system (QMS) to sustain a competitive advantage.

Having a sustainable, enterprise-based QMS is now the entry price for companies supplying customers in regulated competitive markets. There’s a great need for a QMS to have the agility to detect issues and respond in real time with accurate and consistent communication. That sparked some of the most impactful changes in quality management in the past 15 years, which can be defined by the following four characteristics:

1. Automation
An automated quality solution allows companies to drive lean production capabilities over time. Through automation and digitalization of the end-to-end manufacturing cycle, organizations can learn from current practices and make continuous improvement decisions. This has been a major advancement of quality systems over the past 15 years—automated systems have taken over paper-based, manual systems to bring tremendous value to organizations.

Automated interaction between employees and the QMS can give accurate information whenever it’s needed. But this can only be accomplished by having an automated system. An automated QMS gives an organization the improved security, better decision making, faster corrective actions, and more efficient risk management that leads to success.
With processes that are automatically tracked, recorded, and logged in a central location, there’s a higher level of visibility and control. This is beneficial—even critical—for processes like corrective action, audit management, and document or record control.

With an automated system, risk management is embedded in all processes. Most importantly, it’s a driving force in the corrective and preventive action (CAPA) process, within investigation and root cause analysis. This provides organizations an advantage when prioritizing responses to adverse events. The risk elements identified during these processes provide objective evidence that drives risk-based thinking and decision making. Without automation, risk would not be inherently linked to these processes.

2. Risk Management
In today’s world, risk management and quality are inseparably linked. Recent iterations of ISO, such as ISO 9001:2016, reflect how risk awareness is an essential component of quality management. Risk plays a number of important roles in a quality system:

• Risk is a compliance benchmark. It’s a common language among all processes and a systematic means by which companies can identify hazards, assess and measure the risk of those hazards, and take action based on the risk. Although individual processes may vary from business to business, the core idea of measuring risk remains the same.
• Risk is a prioritization method. With risk tools, companies can automatically categorize events at the process level. Linking risk with processes like corrective actions, compliance tracking, and audits lets users decide what needs to be dealt with first to avoid potentially negative impacts. Otherwise, organizations would have to prioritize with other methods—like chronological order, which can lead to serious issues getting ignored.
• Risk is a decision-making tool. Risk and risk reporting are the basis for a great deal of enterprise-level decisions. Firms can make decisions with the confidence that they will be reducing risk and avoiding potential adverse events while playing into organizational strengths.
• Risk is a proactive approach to quality. Utilizing risk tools lets users shift from a reactive to proactive position in quality management. You can identify and mitigate potential hazards at an early stage to prevent adverse events, rather than simply reacting to them as they happen.

The past 15 years has seen a tremendous shift—rather than risk management being considered a siloed activity, it is now considered a vital part of every quality activity.

3. Integration
Recent quality systems have seen a drastic advancement in integration. Technology now makes it possible for companies to break down silos and bridge the gaps between departments. This is important as organizations have an ever-growing amount of processes to keep up with an evolving market.

Quality systems should be flexible enough to meet the needs of the business user while having the integration capabilities to link into the related business systems that surround it—another major development of QMS over the past 15 years.

Integrated quality management ensures complete coverage of the product lifecycle, leaving nothing to chance. Even beyond production, an integrated QMS can link with processes like sustainability and customer satisfaction initiatives. This makes quality management the hub for other systems throughout the product lifecycle, rather than just one facet of the lifecycle.

4. Big Data
The most recent innovation in quality management has been the advent of big data. Companies are now leveraging sophisticated reports and business intelligence tools to build a competitive advantage. There has been a shift in the way we collect, analyze, and collaborate on massive datasets that transforms how businesses make decisions and create new products.

Big data allows companies to utilize cloud-based business intelligence and analytics tools to identify new trends or correlations, drive innovation, and support continuous improvements. The advanced reporting solutions of today’s QMS provide the ability to escalate the most important of that information immediately. That way, an entire enterprise can be made aware or take action as soon as something happens—good or bad.

The most recent development in big data is the rise in Industry 4.0. According to LNS Research, Industry 4.0 “blends new technologies with traditional quality methods to arrive at new optimums in operational excellence, performance, and innovation.” In other words, Industry 4.0 doesn’t aim to replace quality systems of the past, but rather utilize advanced technology to enhance it. Some of that technology includes:

• Machine learning
• Artificial intelligence
• Connected devices and operations
• Social media and blockchain
• Cloud computing
• Augmented and virtual reality

These tools enable organizations to overcome quality and business challenges by making decisions backed by data and with cross-functional visibility.

The Road Ahead
Much has changed in the realm of quality management in the past 15 years, and there is no sign of it slowing down anytime soon. Organizations have picked up on the value of having an automated, integrated QMS focusing on risk management and big data.

These types of systems prioritize early detection of issues and timely corrective actions to minimize the impact on production. This maximizes product quality, minimizes production downtime, and reduces extra costs.

Most importantly, the last 15 years have seen a shift in quality framework. Organizations now favor comprehensive frameworks. Even recent ISO standards have placed emphasis on quality system frameworks at a higher level. This helps organizations break down silos and work toward the same quality and business goals.

Although it isn’t obvious what the next 15 years will bring to the world of quality management, it’s clear that there have been tremendous strides made in the past 15 years, and the pace of evolution is only getting faster. 

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Alexa Sussman is a marketing content writer for EtQ. She is responsible for developing and writing content for EtQ, a leading enterprise quality and compliance management software provider.