Our Processes

A Robust Quality Management System

Pharmaceutical, biotech, generic and medical device companies trust West and our ability to deliver high-quality containment, delivery and manufacturing solutions. West manufactures over 40 billion components annually. That’s 110 million every day or 5 million per hour. As a high-volume manufacturer with decades of experience, the West Contract Manufacturing team understands the quality and regulatory framework required for successful scale-up or transfer of compliant medical devices.

Key quality processes include:

1. Customer feedback and complaint tracking
2. Compliant risk-based QMS
3. Qualification of equipment, software and process validation
4. Key Performance Indicators — KPI
5. Metrology – CT Scanning, CMMs, etc
6. Training
7. Corrective and Preventive Action (CAPAs)
8. Supplier Management Process

Quality Systems and Staff

• Dedicated quality engineering/validation team(s)
• Validated product data management software
• Incoming inspection capability – FTIR, DSC, Extraction

Extensive Validation Experience

• Molding processes
• Assembly processes
• Software (Control Systems, ERP System, Metrology)

West Support

• West Analytical Labs
• Cleanroom/micro expertise
• TPE and rubber formulation expertise

Optimizing the Value Stream

West Contract Manufacturing is focused on delivering the highest level of customer satisfaction at the most competitive cost through optimizing total value stream. Building strong partnerships through collaboration is the key to a fully integrated and risk-based supply chain. The Supply Chain Management structure is based on a continuous reach for Lean integration through three key elements:

• Planning/operations
• Procurement
• Logistics

The West Contract Manufacturing team develops value-added partnerships with suppliers and customers, creating strong communication channels for information-sharing and operational improvements.

Supported by an integrated, global ERP system and using cGMP and Lean practices, the West Contract Manufacturing team has integrated various links in its supply chain through the establishment of JIT, VMI and Kanban stock models, which contribute to minimizing overall lead-time and inventory in the supply chain and maximizing value-add opportunities for customers.