Quality

Our Core Value of Leadership in Quality is the backbone of every decision we make at West. 

We partner with our customers in protecting millions of patients as they receive critical medicines. At West, this quality focus includes excellence in manufacturing, scientific and technical expertise, and management. A Patient First Focus is part of West’s DNA, and we take our responsibility to maintain patient safety very seriously. As you walk through our global manufacturing sites, you can find the saying “Every Dose, Every Time — 100% Commitment” in multiple languages, reminding team members of our pledge.

This commitment took on refreshed meaning in 2020 when West partnered with customers on COVID-19 solutions, as well as meeting increased demand for all products. West’s Quality team initiated several actions to ensure that the business maintained its state of compliance and met our customer requirements:

  • Added staff to support expanded operations
  • Accelerated product transfers to leverage network capacity
  • Initiated qualification of new equipment, warehouses, building expansions
  • Notified customers on product moves and changes within the manufacturing sites
  • Managed supplier quality as they ramped up production to meet increased demand


In addition, pandemic restrictions and isolation of the manufacturing sites drove the creation of a Remote Audit program. West hosts hundreds of customer audits in a year, along with notified body audits, which are required to maintain our ISO certifications. The Remote Audit program allows customers to view the required information and interface with the site teams so that the compliance requirement of audits can be achieved.

A key metric in monitoring our process quality is Cost of Poor Quality (COPQ), which captures scrap, rejects, rework, customer returns/credits, and yield losses. In addition to pandemic-related activities, the team continued to drive COPQ initiatives to decrease the overall level of COPQ as a percentage of Cost of Goods Manufactured (COGM) in 2020. West’s COPQ in 2020 achieved a 13% reduction over the previous year (6.0% versus 6.9%). When compared to external benchmarking (measured as a percentage of sales), West has surpassed the industry average of 4.2% to a level of 3.6% in 2020.

The theme of West’s Global Quality Week in 2020 was COPQ, to emphasize the importance of decreasing COPQ across the organization. Team members from all functions learned about COPQ as a method to focus on opportunities for improvement, quantify the financial impact of waste and inefficiency, and highlight to management the needs of the organization. Our One West Team connected globally to discuss these topics through a series of virtual events and interactive opportunities.

In 2020, two new groups were formed in our Quality function, Digital Quality and Design Quality. The Digital Quality team was formed to support West’s Digital Transformation. The Design Quality team was created to continue providing a focused support of Quality for the design and development of West products. By uniting under one group within Quality, the team will harmonize on processes and resources to support West’s R&D activities.

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