Quality 4.0 focuses on a collaborative approach to quality to ensure that quality is top of mind throughout an organization. The Quality 4.0 initiative is designed to expand the responsibility for quality company-wide to include customers and the supply chain.

A Quality 4.0 strategy helps manufacturing organizations ensure a high level of quality. It touches on all departments within the organization and reaches to the supply chain and beyond. Sound familiar?  With all the hype around Quality Culture, this is yet another piece to the puzzle.

Let’s look into the background of Quality 4.0 and the benefits of transitioning to this approach.

What’s driving Quality 4.0?

The Quality 4.0 term and initiative was spurred by LNS Research, in a study on the topic in 2017.  Quality 4.0, a reference to the fourth industrial revolution, is driven by technologies that lend a new perspective on the importance of quality.

Quality 4.0 integrates modern technology into production-quality systems.  Examples include cloud computing, big data, virtual reality (VR), blockchain, artificial intelligence (AI), machine learning (ML), cyber-physical systems, and the Internet of Things (IoT).  The result is a modern, holistic approach to quality management, allowing manufacturing industries to reach new levels of quality.

A Quality 4.0 strategy positions you to confirm the root cause of your quality concerns.  Using the approach helps ensure quality in new products and processes but also creates visibility into quality issues so the root cause can be mitigated.

How is Quality 4.0 impacting the manufacturing industry?

Quality, particularly in advanced technology product manufacturing, needs to be at the forefront of product design through production and beyond.  Quality 4.0 provides a structured method for infusing quality throughout each step of the manufacturing process. The result is a proactive approach to reducing product risks.

This collaborative technology approach allows manufacturers to leverage smart technology like the Internet of Things (IoT) and robotics to helping them to stay ahead of the technology curve.  These methods are combined with traditional quality processes to not only spur evolution in technology but to do it with quality as a key business driver across the enterprise.

This holistic approach to quality helps streamline regulatory compliance for manufacturers and reduces the risk of recalls and the need for onsite audits.

Quality 4.0 Incorporates Traditional Quality Processes

Quality 4.0 adds a new level of technology tools into the manufacturing processed. However, there are quality-based processes that continue to be essential in this revolution.

  1. Document Management:  Proper documentation is essential to ensuring compliance, so effective document control is critical, regardless of industry.  A quality management system (QMS) should efficiently meet all regulatory documentation requirements. Furthermore, an automated document management process establishes traceability and control throughout the document lifecycle.  You can ensure all documents are current and accurate. In addition, business rules in electronic systems control access to documents and automate review and approval cycles.  Partner with an enterprise training management solution for the keys to compliance.
  2. Reporting: Data and analytics are key drivers of Quality 4.0.  The use of irrefutable data to drive change is vital to making improvements to products or processes. Quality 4.0 relies on fast access to collated data, so you can make better-informed decisions.  An automated QMS helps you get accurate data at your fingertips, so you can review and make sense of the data, and quickly spot trends across the enterprise. Furthermore, internal and external audits rely on the authenticity and availability of data reportability to demonstrate that all good manufacturing practices (GMPs) are followed.
  3. Cloud-Based Systems:  Lack of scalability can be a downfall for those looking to implement a Quality 4.0 strategy that enables scalability and the ability to support the addition of new technology. A cloud-based QMS is a solution to this challenge.  Cloud-based systems grow seamlessly with your company, allowing you to add new processes, people or locations to your system without the need for IT intervention.  In addition, cloud systems allow you to access data from any device and from anywhere in the world.
  4. Corrective Action:  An integrated corrective action process across your enterprise can manage the corrections and controls to eliminate risk and mitigate confirmed root causes. Furthermore, integration with other key QMS processes like complaint management provides insight into trends and risk levels and ensures a seamless system of remediation and preventive actions.

Implementing Quality 4.0 Throughout Your Organization

Manual systems cannot support Quality 4.0. Manufacturers need a faster, more intelligent way to manage their quality processes and comply with regulatory bodies.  In order to track quality within your organization and continually improve processes, you’ll need to have an enterprise system in place that enables your operations.  Modern Quality Management Systems (QMS) integrate processes for collaboration and consistency across the supply chain.  Enterprise QMS automates the processes that align with Quality 4.0, preventing manufacturers from being left behind in this fast-moving quality revolution.

Keep in mind that Quality 4.0 is not just about technology—it’s also about people and taking a collaborative approach to quality across the enterprise.  In this aspect, Quality 4.0 becomes a unified approach to creating a culture of quality that emphasizes continuous learning.


Quality 4.0 enables quality and compliance teams to touch on areas it never reached before, raising the bar on the quality level of our devices.  If you have not started the transition, now is the time to embrace the digital revolution. Quality is now part of the digital landscape. Therefore, your products, your processes, and your systems must evolve to keep up with this momentum and remain relevant in today’s market.  Adopters will improve competitive posture by maximizing the utilization of data for risk management, quality improvements and compliance.

To meet the demands of Quality 4.0, companies need to adopt an integrated approach to quality management.  Cloud-based systems add another layer of flexibility to the QMS by enabling you to access your data wherever and whenever you need it.

AssurX can help you infuse quality into your products and processes, and help you make a seamless transition to a Quality 4.0 approach.  To find out more, request a demo.