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What is Quality 4.0 and What You Need to Know About It.

Quality 4.0 aligns quality management with Industry 4.0. It represents a “failure is not an option” priority for organizations and their quality leaders. To assist quality leaders and their teams in keeping pace with Digital Transformation and lead the Quality 4.0 charge, this article highlights the key elements and philosophies needed to embrace and execute this important new concept.

At its core, Quality 4.0 is the digitalization of quality, management systems and compliance. It does not focus exclusively on the technology itself, but rather on the improvements in culture, collaboration, competency and leadership that are produced by those technologies.

What is Quality 4.0?

Quality is the essential aspect of all businesses that cuts across all industries. It basically includes, but is not limited to, quality engineering, quality management systems, quality control and quality assurance. Quality 4.0 integrates all these elements utilizing new technologies that can be integrated into management systems, certifications, and more.

A good example of this is Blockchain, offers valuable methods for process traceability, from equipment maintenance and calibration certificate to even process data analysis control. A blockchain is a growing list of records called blocks that are linked cryptographically. Each individual block contains a cryptographic hash of the previous block, a timestamp, and transaction data. By definition, a blockchain is resistant to modification of the data.

“Big Data” and “The Internet of Things” (IoT) data are already used for real-time process monitoring and measurement. Augmented reality, the art of blending the physical-digital environment and helping navigate through it easier is another great example. Greater connectivity, new modes of production, and intelligent processing with computing capabilities allows visualization of data faster and better than ever.

The Intersection of Quality and Technology

Industry 4.0 and its technologies provide new ways for people, machines and data to interact, transforming powerful technologies into accessible commodities, resulting in a disruptive synergy of culture, leadership, collaboration and compliance, resulting in forward thinking quality teams standing ready to resolve many long-standing challenges that have prevented innovation and improvement.

The Foundational Pillars of Quality 4.0

Data – By definition, Quality is data driven, and data driven decision making is the key. Organizations must seek ways to combine data from various systems to ensure accuracy and transparency in their decision making.

Analytics –Traditional quality metrics typically describe what has happened, why it happened and what might happen next, but they fail to determine what actions to take. This type of analysis can be achieved by utilizing Big Data, Machine Learning (ML) and Artificial Intelligence. Successful organizations will develop an analytics strategy after or concurrently with a data strategy or the value of the analysis will be of little value.

Connectivity – The integration of various business information technologies (IT) (e.g., EQMS, ERP, PLM, etc.) with operational technology (OT) (e.g., technology used in laboratories, manufacturing and service) is a longstanding challenge. The key here will be enabling data, processes and people to work together in symbiotic fashion.

Collaboration – The adoption of Enterprise Quality Management Software (EQMS) facilitates execution of collaborative processes with the help of email, automated workflows, portals and even paper documents. The advent of social listening and blockchain have transformed collaboration in recent years, and future success will utilize the disruptive powers of connectivity, data and analytics.

App Development – The creation of created “mashup” apps that combine content from multiple sources into a single interface, represent an emerging tool for operations and management, thus realizing the full potential of interactive apps available today, including wearables, augmented reality and virtual reality.

Scalability – Many companies cite disjointed data sources and systems as significant roadblocks to achieving quality objectives. Cloud computing can be a valuable tool to achieving scalability, along with data lake technologies (A data lake is a system or repository of data stored in its natural/raw format,[1] usually object blobs or files. A data lake is usually a single store of all enterprise data including raw copies of source system data and transformed data used for tasks such as reporting, visualization, advanced analytics and machine learning). Start by assessing the current scalability – or the ability to support data volume, users, devices and analytics on a global scale – of your in-house systems.

Management Systems – As of the writing of this paper, less than a quarter of companies have adopted an EQMS. The resulting core process fragmentation makes it difficult for companies to deploy effective quality technology. Harmonizing and automating processes and systems enables quality staff to shift their focus to innovation and improvement.

Compliance – A large percentage of companies report that ensuring compliance was a key strategic objective for quality management, closely followed by reducing the total cost of quality. Quality 4.0 provides multiple opportunities to automate compliance. Highly configurable, automated and connected EQMS solutions, and tools to automate validation are now available.

Culture – Few organizations and their cross-functional teams clearly understand how quality contributes to strategic success. The improved connectivity and collaboration offered by Quality 4.0 makes a culture of quality attainable.

Leadership – Barely ten percent of companies report that quality is a priority for top management. To confront this, quality teams must align their objectives and clearly link them to the organization’s strategic objectives. Quality leaders must advocate and lead quality across the organization, especially at the executive level.

Competency – Quality 4.0 facilitates an improved baseline competency of workers, as well as better scaling of specialized knowledge. Other technologies including certain social media, Machine Learning, Artificial Intelligence, mashup apps, wearables and VR can yield improvements in training and knowledge sharing.

What Should you do?

  1. Evaluate where you stand on each of the 11 elements of Quality 4.0
  2. Recognize and embrace the potential uses of analytics, apps, data, connectivity and other technologies to influence performance across the enterprise
  3. Establish a Digital Transformation strategy. Align your quality objectives with it.

Current State –

A recent American Society of Quality survey of companies around the world found that only 16% of companies have started any Quality 4.0 initiatives. 63% of companies reported that they have not even started any planning on the topic.

Furthermore, Europe is ahead of the Quality 4.0 race. Nearly a quarter of companies have already started planning on the subject. In the US this number drops to just 6%.

Companies that initiated Quality 4.0 initiatives have stated that they intend to apply the concept for quality data centralization, data security and continuous monitoring anywhere, anytime.

While the initiative is still very new, quality professional must be increasingly aware of it and endeavor to understand the need to create a plan to define their strategies in their companies.

Quality 4.0 will transform all aspects about implementation and quality controls.