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What is Quality 4.0? Is it a buzzword for defining the next generation of quality management systems? Does it refer to the digital transformation and automation of quality workflows? Or, does it refer to quality in an era of Industry 4.0?

All good questions and the answers are a resounding yes for each of them.

But it is certainly much more than a buzzword. Following the best practices of Quality 4.0 will help quality leaders run a data-driven process for quality management within their respective organizations. It’ll help drive continuous improvement (CI) of all quality processes, ensuring that key quality and, therefore, business metrics improve over time.

At ComplianceQuest, we recently organized a webinar, in partnership with FDA News, on this topic. Nikki Willett, CSO/VP of Industry Solutions for EQMS at ComplianceQuest, was joined for discussion by Tim Fischer, a renowned quality management leader with over 30 years experience in manufacturing, auditing, implementing GMP quality systems and FDA/Supplier remediation.

The key highlight of the chat revolved around what kind of impact Quality 4.0 initiatives can have on an organization. Read on to find out more.

Impact #1: Data Visibility

The first step to your Quality 4.0 efforts is to implement a next-generation EQMS. This EQMS must easily integrate with the rest of your business systems including ERPs & CRM. It must become the “single source of truth” for all key quality-related data.

Want to find out how many complaints came up this month? Have these complaints been categorized by risk? Have they been escalated to CAPA? Is the right team member who can take corrective action connected to the EQMS system, so he/she can update on progress?

Your quality management system enabled by a next-generation EQMS can make it easier for a quality leader to answer each of the questions above, with data at their fingertips. Data visibility, transparency, accessibility, and ease of information flow are all critical for Quality 4.0.

Impact #2: Efficiency

In the webinar, one common question that we heard multiple times was – How can we do what we do faster and better? Quality leaders are grappling with two broad-level goals: One, stay on top of regulatory requirements, and ensure compliance at all levels. Two, use quality as a key driver to deliver competitive advantage.

Quality 4.0 initiatives, powered by a cloud-based EQMS like ComplianceQuest, will drive efficiency into the entire organization and help achieve both these goals. One of the key reasons for this efficiency is that the CQ EQMS offers an integrated suite of solutions for Audit, CAPA, Change, Document Management, Complaint Handling, Supplier Management, Training, etc. This modular approach makes the solution scalable, flexible, and customizable. An enterprise can pick and choose modules of relevance for their organization and scale up, both in terms of users and solutions, as needed. Thanks to this unified approach, it is easy for quality leaders to automate the entire process of quality management.

Impact #3: Aligning People & Process

People and process are two aspects of every quality workflow. The role of people (for example, a complaints handling coordinator) is to recognize challenges and risks, take ownership, ask the right questions, and seek help as needed. The process ensures that people know what is to be done, thanks to standard operating procedures (SOPs), established workflows, and an automated EQMS system. Bringing together people, processes and data is the key role of a next-generation EQMS. True digitization will ensure this alignment is established.

Impact #4: Speed to Market

For any enterprise, especially in today’s rapidly changing world, time-to-market is critical. Automation and digitalization of quality processes will speed up the process of getting a product out to the market. It adds efficiency to the process of getting regulatory approvals and also uses predictive intelligence to aid efforts of risk management and error prevention.

Impact #5: Systems Thinking & Evidence-based Decision Making

Next-generation EQMS systems also make it easy to gather data, assimilate reports on quality events, track key metrics and access relevant dashboards. This data is also available anytime, anywhere with mobile capabilities.

Access to data, coupled with ease of integration, helps with a “systems thinking” approach to quality management. It makes it easier for quality leaders to make decisions holistically, with a pulse on how different processes and teams interact with each other, how the information flows, and its context in the organization.

There is no doubt that Quality 4.0 initiatives, supported by the right EQMS solution, will truly make a difference to quality management operations. If you’d like to get into a little more detail on this topic, feel free to write to us here: [email protected]

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