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Medical device makers are adopting digital transformation as a means of increasing their agility and efficiency.
FREMONT, CA: Manufacturers have challenges as output requirements increase, as the majority of processes are manual and systems operate in silos. Today's workers lack quick access to the information they need to conduct their jobs, which considerably raises the danger of non-compliance and poor quality on the shop floor.
A linked shop floor enables facilities to support manufacturing 24 hours a day and increase productivity. Capabilities such as real-time analytics/monitoring and business intelligence tools can assist manufacturers in gaining a better understanding of their processes. They can uncover and act on insights more quickly while also making more informed decisions on the fly.
This holistic, data-driven approach can help manufacturers increase their agility and efficiency while preserving quality and compliance.
Two foundations of a smart ecosystem: Industry 4.0 and Quality 4.0
Complex devices, small batch sizes, increasing demand, high mix orders, and escalating costs complicate shop floor management. Industry 4.0 is a manufacturing model that enables organizations to address these difficulties, expand their production capacity, and optimize their processes. This concept’s heart is a modern manufacturing execution system (MES) that prepares medical device makers to deal with quality difficulties, regulatory compliance challenges, and change.
On the other hand, Quality 4.0 is derived from Industry 4.0. It is described as the deployment of intelligent technology to increase operational efficiency and product quality. Quality 4.0 facilitates the seamless integration of smart systems with legacy systems such as manufacturing execution systems (MES), enterprise resource planning (ERP), product lifecycle management (PLM), or compliance training programs throughout the value chain. It facilitates end-to-end processes that aid in the resolution of difficulties more quickly.
By identifying and resolving quality issues early on, analysis of operational data (or quality information) enables proactive risk management. Real-time quality data analysis enables organizations to boost productivity and manage resources according to risk and necessity.
Compliance with Next-Gen regulatory requirements
Digital processes enable the shop floor to respond more quickly to changing production requirements and to new regulatory requirements. Cloud apps with built-in mobility, advanced analytics, and user-friendly and adaptable user interfaces provide decision-makers with more agility and visibility.
These current applications are designed for uninterruptible operation, and it enables businesses to make configuration changes on the fly and alleviates the strain associated with episodic and massive validation operations.
Training to enhance quality management
A linked shop floor enables flexible and adaptable training approaches necessary for smart production. Information can be supplied to workers seamlessly at specified stages in the production process when delivered as relevant digital processes and work instructions. This decreases the complexity of learning and promotes alignment with new procedures.
Businesses can expect improved results from training programs that transition away from isolated, content-driven events and toward a deeply contextual, social learning experience integrated into daily workflows. Training becomes more streamlined and linked with quality goals by categorizing training information according to job functions and then providing it via a content-centric experience. This strategy ensures that staff is appropriately taught and always access the most up-to-date procedural content necessary to perform their duties.