Quality

This Patient First Focus helps our team remain focused on quality, as they know what they do every day will impact the life of a patient. This connection to the patient helps support our ‘Every Dose, Every Time — 100% Commitment’ mindset.

This focus on quality includes excellence in manufacturing, scientific and technical expertise, and management. At the manufacturing level, this means producing clean, sterile, high-quality components designed to minimize disruption to the supply chain and to deliver safe, effective drug product to the market — and to the patient, quickly and efficiently. 

Since the beginning of the pandemic, we continued to see an increase in demand for our products. To support this demand, West’s capital investments included  13 site expansions, 30 facility modifications and over 400 new pieces of equipment, all while keeping pace with growing demand.

This tremendous growth required flexibility and innovative thinking, and the Quality team initiated several actions to ensure that the business maintained its state of compliance and met our customer requirements:

• Accelerated product transfers to leverage network capacity
• Initiated qualification of new equipment, warehouse and building expansions
• Added staff to support expanded operations
• Provided reliable business support in our Quality Lab testing, which saw a 28% increase in sample volume over previous year

We continued to focus on reducing Cost of Poor Quality (COPQ), a key metric in monitoring our process quality which captures scrap, rejects, rework, customer returns/credits, and yield losses. The team continued to drive COPQ initiatives to decrease the overall level of COPQ as a percentage of Cost of Goods Manufactured (COGM). This resulted in a favorable COPQ/COGM ratio as compared to the prior year. 

A key area of focus was also an increased level of supplier quality management. In 2021 we established a Supplier Management Program, organizing the manufacturing site-level Supplier Quality function  to support and be aligned with the existing Corporate Supplier QA group. This will provide the necessary framework to deploy best in class supplier qualification, monitoring and feedback programs across all suppliers.

During our Annual Global Quality Week, the theme “Right First Time” or RFT reinforced that RFT is a behavior and approach to ensure that processes are capable of meeting West and our customers’ requirements. This mindset is understanding that getting something done quickly but then having to fix errors is not a way to operate. Taking the time up front to build a capable process that allows us to run quickly without errors is more valuable to West and our customers. We saw high participation and engagement, as our team members connected globally to discuss this topic through a series of events and interactive activities. 

Our culture of quality goes well beyond the Quality Function. We strive to have Leadership in Quality and a Patient First Focus evident throughout each area, function and level within the company, all working together as One West Team towards supporting our purpose of improving patient lives around the globe.