In the Industry 4.0 methodology, there is a seamless integration of machines, people and assets into a digital ecosystem that acts as a single source of data and analytics. Industry 4.0 processes are finding use in almost all modern manufacturing setups in various sectors including medical device, automotive and aerospace.
The data generated, if harnessed properly, can suggest improvements and course corrections, sometimes without the need for human intervention, using underlying next-generation technologies such as Machine Learning/Artificial Intelligence (ML/AI) and perhaps Augmented Reality (AR)/Virtual Reality (VR) in certain cases.
Industry 4.0 also means that we now have access to truly big data and it is up to manufacturers to harness the power of this data and convert into insights. These insights can drive Continuous Improvement (CI) across the supply chain.
In the life sciences, healthcare and manufacturing, the percolation of Industry 4.0 can be seen in the use of the following technologies:
- Smart manufacturing: Integration of operating technologies with data enables better view, control and efficiency of the entire supply chain from the design of devices to procurement, manufacturing and even customer service and complaints handling.
- Robotics and flexible automation: Administrative and repetitive clinical tasks are increasingly being entrusted to robots to free up resources for more critical work. Flexible automation also promotes safety in the workplace, reduces bottlenecks, improves productivity and enhances job and customer satisfaction, among others.
- Mobile Integration – For the executives on the move, for teams collaborating remotely and for the tech-savvy B2B partners or customers, this has become crucial and businesses are increasingly developing solutions with the mobile in mind.
However, there is one missing link. Industry 4.0 can give the manufacturer data and insights, but the key to acting on these insights will come from a robust Quality 4.0 process. And, to make this a reality, an EQMS to drive automation of these processes for quality leaders is crucial.
Quality 4.0 Strategy – The Need
Life sciences and healthcare businesses face three main challenges today:
- Customers expect a high level of quality and will shift loyalties quickly based on quality and cost perceptions
- Tighter markets and tougher competition force businesses to allocate resources for innovation, research and quality improvement more sparingly
- A stringent regulatory environment pushes up the stakes for compliance, where nonconformity can affect the reputation of the brand, and even cost them a license
Therefore, they need Quality 4.0 strategies and tools that provide a unified view of processes across the organization and leverage data for preventing and correcting problems. Quality professionals require solutions that can help identify the root causes of problems, predict trends and forecast patterns to enable them to effect continuous improvement. A Boston Consulting Group survey of quality professionals reveals that they believe sensors and tracking and electronic feedback loops will be crucial for driving impact from design to procurement, manufacturing, marketing and customer service functions.
Some of the key ingredients of Quality 4.0 for manufacturing in this ever-changing environment are:
- Quality and product processes that are well-integrated.
- Processes that meet compliance requirements.
- Traceable design and change controls.
- Bills of materials (BOMs) that are linked directly to quality records.
- A closed-loop quality and CAPA process that ensures quicker resolution of customer problems.
- Improved quality compliance and supplier management processes.
- Document management system and version control
- Enabling cross-functional collaborations between teams in remote locations and across the supply chain and reinforce a quality culture.
- Performance, responsiveness and productivity of the teams
An enterprise quality management system such as the one from ComplianceQuest leverages the cloud-based platform from SalesForce.com and is built to automate Quality 4.0 systems. It offers features such as document management, CAPA, audit management, complaints handling, non-conformance and equipment management, among others using next generation technologies for predictive analytics supported by dashboards and report generation. To request a demo, email us at firstname.lastname@example.org