September 29, 2022

Market changes and disruptions such as the global pandemic are driving companies to adopt Industry 4.0 in their manufacturing operations. Many companies are investing in smart manufacturing by digitizing all levels of production. However, they have yet to grasp the concept of Quality 4.0 as a quality management strategy.

Industry 4.0 is helping companies increase manufacturing efficiency, spur product innovation, and improve supply-chain performance. And yet a study by LNS Research shows that among companies with an electronic quality management system (EQMS), only 16% reported that their EQMS are connected with their manufacturing operations. This lack of integration between quality management and manufacturing is a major obstacle for most companies pursuing Quality 4.0.

What is Quality 4.0?

Industry 4.0, also known as the fourth industrial revolution, refers to the interconnected use of digital technology in manufacturing. Likewise, Quality 4.0 refers to the use of mature digital technology to optimize quality management. It calls for the alignment of EQMS with Industry 4.0.

“Much of the market isn’t focusing on Quality 4.0, since many quality teams are still trying to solve yesterday’s problems,” according to the Quality 4.0 Impact and Strategy Handbook, published by LNS Research. Those problems include unconnected systems, lack of cross-functional efforts, and siloed quality teams.

Those challenges, however, should be the main reasons why quality teams explore Quality 4.0 principles. There is continual internal pressure to keep pace with manufacturing operations’ increases in digitization. Furthermore, there is external pressure to keep pace with customers’ expectations.

For example, a company that adopts Industry 4.0 is less likely to wait for a machine part to break before it is replaced. Instead, an automated machine maintenance process will include a schedule of future replacements, allowing potential issues to be caught – and resolved – early. Imagine if this company still relies on paper and spreadsheet quality procedures. The quality team needs to gather data manually from machine operators and the machines themselves. If the process calls for post-replacement testing, that’s yet another data set that will have to be collected manually.

It befits any company’s quality team to upgrade from a paper-centric quality management system to an EQMS. Furthermore, the plan should include a phased EQMS integration with manufacturing operations to increase efficiency, reduce costs, and ensure regulatory compliance.

5 Building Blocks of Quality 4.0

It’s important to keep in mind that Quality 4.0 is not meant to replace traditional quality management. In all likelihood, your existing QMS already has the necessary building blocks for a Quality 4.0 foundation.

If your company still relies on a manual or hybrid QMS, your first step should be to upgrade to an EQMS. If you already have an EQMS, your next focus should be on implementing continuous improvement efforts, specifically within five core areas: Document Management, Training Management, Corrective and Preventive Actions, Change Management, and Audit Management.

Document Management

In a regulated environment, document management is key to compliance, as all processes that affect product safety and quality must be documented. In addition, you need to ensure data integrity. Your records must be reliable and accurate, as well as stored and managed properly.

Documentation of quality processes can require multiple revisions and approval cycles. You can significantly reduce the review and approval turnaround time (routing, follow-up, escalation) with a fully automated document management process. An EQMS will provide a secure virtual collaboration workspace where users can add their input to documents in real-time. As a result, your organization operates much more efficiently within the document control lifecycle.

Even if your manual system is compliant, maintaining it may become increasingly difficult as your organization moves to Industry 4.0. It’s only by adopting Quality 4.0 that you can fully realize all the benefits of smart manufacturing.

Training Management

The study cited in the LNS Research e-book showed that 35% of survey participants have an automated training management process. However, there’s no indication that their systems (typically an LMS) are connected to smart manufacturing processes.

As manufacturers implement new technologies, there lies an inherent risk of inadequate training, especially if these technologies are implemented quickly. In fact, the lack of properly documented training is a major source of noncompliance in operation controls.

Employee training and training management must be able to keep up as manufacturers continue to implement groundbreaking technologies. For example, if a manufacturer begins to implement the use of wearable sensors and augmented reality technology, the quality team must be able to deploy the appropriate employee training and competency tests quickly to remain compliant with regulatory requirements.

With Quality 4.0, training will be connected with new processes in the factory to ensure that employees are trained properly. Another big advantage of such integration is the capability to pinpoint training gaps. The quality team will be able to readily see who needs specific training, and when. It’s only when you can identify the gaps that you’ll be able to develop a plan to resolve them.

Corrective Action and Preventive Action (CAPA)

Regulatory compliance (36%) and reducing the total cost of quality (22%) are the top reasons why life science companies automate their CAPA process, according to LNS Research.

Quality 4.0 can significantly accelerate CAPA with the help of preconfigured workflows and best-practice tools. Manually collecting data for root cause analysis (RCA) is time-consuming and error-prone. Applying 5 Whys, 8D, Failure Mode and Effects Analysis (FMEA), and other methods from scratch for each CAPA event can be cumbersome.

By contrast, an EQMS provides a standardized CAPA process that utilizes RCA best practices within repeatable workflows. The system requires that quality teams define roles (initiator, reviewer, SME, etc.) that establish accountability throughout the organization. The system will be able to automatically track CAPAs and escalate them when necessary. All of these capabilities combined can dramatically cut down CAPA turnaround time and collect important data to improve internal processes.

Change Management

Uncontrolled change can jeopardize product safety and reliability. It’s the reason why regulations require that changes in equipment, materials, design, and processes must be assessed, reviewed, and approved.

A manual quality system with a compliant change control process may still be inadequate in terms of change management. In other words, a system that can control individual changes will not be effective in managing the entirety of changes with any reliability or control.

Quality 4.0 requires connectivity of processes to gain visibility on how each change and all changes will impact product quality. Likewise, any changes in the manufacturing operations will be visible with the integration of Quality 4.0 and Industry 4.0.

Audit Management

Audit Management is a big driver for digital technology. When lockdowns due to the pandemic made in-person audits impossible, manufacturers scrambled to adopt the capability to conduct remote assessments. There’s no turning back now that the U.S. FDA and European Union regulators have embraced remote audits.

An EQMS provides a centralized platform that facilitates remote audits and RRAs with permanent capture of all records within the system. First and foremost, it ensures all documents and information that users, stakeholders, and auditors need reside in one place. In addition, it streamlines the entire audit management process, from audit preparation and scheduling through execution, observations, verification, and completion.

An EQMS, a prerequisite for Quality 4.0., will increase your organization’s audit readiness, whether in-person or remote. Furthermore, it will ensure that even in the face of external disruptions such as a pandemic, you’ll be able to conduct audits and avoid delays in regulatory submissions.


What is Quality 4.0 and how does one attain it? If your team is asking this question, it’s time to assess your QMS, especially the five core areas mentioned above. The goal of Quality 4.0 is alignment with Industry 4.0 for seamless manufacturing operations and quality compliance.

Most companies are prioritizing Industry 4.0 to increase efficiencies and optimize the supply chain. The onus rests on quality professionals to make a case for synergizing quality and manufacturing strategies. Take the initiative to increase companywide awareness about the need to marry smart manufacturing and smart compliance. To do that, the entire organization should aim for the interconnectivity of Industry 4.0 and Quality 4.0. You need both to compete and succeed in a more technology-driven landscape.


Related Reading: Have You Transitioned to Quality 4.0?

About the Author

Stephanie Ojeda is Director of Product Management for the Life Sciences industry at AssurX. Stephanie brings more than 15 years of leading quality assurance functions in a variety of industries, including pharmaceutical, biotech, medical device, food & beverage, and manufacturing.