Design for Manufacturability

Design for Manufacturability (DFM) practices are initiated as part of the concept-to-design process and refined continually as the product is ramped up to volume by manufacturing. The implications of the DFM practice can significantly improve product quality, work in process (WIP) levels, ramp-up time, and product costs. Data requirements that support the DFM practice include:

• Analysis of the parts list for commonality from product data management (PDM)
• Quality management data surrounding assembly and component failures
• Process performance from the manufacturing execution/quality management systems.

First Article Platform

First article platform in medical devices is normally disappointing as first run yields average about 35% quality. All participants in the supply chain desire visibility around parametric quality data and WIP inventory levels. Integration with back-end product lifecycle management (PLM) and computer-aided design (CAD) systems is desired for feedback loops into refining product design and process routings.

PLM Support

Visiprise solutions are utilized during the request for quote (RFQ)/request for proposal (RFP) design process and is a critical step within medical devices during the design phase. Storage and analysis of product specifications, performance criteria and quality are inherent in Visiprise Manufacturing.

Supplier Programs

Supplier programs are critical in medical devices, based on the volume of suppliers utilized. Visiprise solutions can play a role here based on functionality that supports the following:

Nonconformance reporting Genealogy Field service and repair

Supplier portal and dashboard Incoming inspection Quality and assurance audits

Nonconformance Reporting

Nonconformance reporting and continuous process improvement are very important in medical devices. Visiprise solutions support nonconformance reporting and is inherently based on a continuous process improvement loop. Corrective and Preventative Action (CAPA) reporting for product and process control is collected, visible, measured, and optimized.

Corrective and Preventative Action

Visiprise's Corrective and Preventative Action modules provide complete control over the full lifecycle of corrective and preventative actions. Visiprise Manufacturing's FDA-compliant electronic routing, review and approval process addresses all CAPA lifecycle states - from incident reporting to signoff. Visiprise Manufacturing's CAPA workflows address equipment, process, product, human, environment, and customer actions.

Audit

Managing and controlling audits and audit status is key to regulated industries such as medical devices. Visiprise solutions provide a complete module and interface for conducting internal, supplier and third-party audits. Visiprise solutions provide a structure for scheduling, conducting and following-up on audits. In addition, a complete, reportable audit trail is provided for quick proof of compliance.