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Our Processes

For nearly 50 years, the West Contract Manufacturing team has established a reputation as a global leader by providing on-time commercialization of projects ranging from product design, to complex, turnkey manufacturing solutions.
 
Our reputation has been achieved not only by focusing on our capabilities, but improving upon them. At West, we treat each milestone with the same level of importance as the final objective — complete customer satisfaction.
  

Lean Six Sigma

The West Contract Manufacturing team operates its' business based on a data driven culture, using Six Sigma process improvement tools and Lean manufacturing principles in all aspects of our business. Teams include employees who have earned black belt and green belt certification, along with Lean leaders, to help drive change and lead the ongoing effort to improve products and processes. Continuous improvements are identified and implemented across many disciplines within the business. They range from the administrative process improvements to validation projects within the development and manufacturing facilities. The intention is to drive costs out of the business while maintaining the highest standard of compliance for our customers and relevant regulatory bodies.
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Quality and Regulatory

 

West understands the quality and regulatory framework required for successful scale-up or transfer of our customer’s medical devices and works with SGS United Kingdom as our notified body. Within the drug delivery and healthcare market, our facilities are ISO:13485 and 14001 certified and cGMP compliant. West is a medical devices contract manufacturer and FDA-registered drug re-packager/re-labeler at select site(s).
 
Key processes include:
    1. Customer feedback and complaint tracking
    2. Compliant QMS
    3. DMF submissions
    4. Qualification of equipment, software and process validation
    5. Key Performance Indicators — KPI
    6. Metrology – CT Scanning, CMMs, etc
    7. Training
    8. Corrective and Preventive Action (CAPAs)/documentation
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Validation Infrastructure

 

  • 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)
  • Cross-functional Support
    • West Analytical Labs
    • Clean room/micro expertise
    • TPE and rubber formulation expertise
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Supply Chain Management

 

The West Contract Manufacturing team is focused on delivering the highest level of customer satisfaction at the most competitive cost through optimizing our total value stream. Building strong partnerships through collaboration is the key to a fully integrated and risk-based supply chain. Our Supply Chain Management structure is based on a continuous reach for Lean integration through three key elements:
  • Planning/operations
  • Procurement
  • Logistics
We develop value-add 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, West Contract Manufacturing facilities have integrated various links in our 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 our customers.  
 
If you are interested in receiving further information on the West Contract Manufacturing team, click here to contact us.