Quality

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 products to the market— and to the patient—quickly and efficiently. Quality product and system controls are designed to ensure compliance with our high standards and applicable cGMP’s, ISO standards and regulatory requirements. We continuously work to improve our customer satisfaction scores for quality and have established metrics in place to measure our progress, including:

• Timeliness and quality of response to customers
• Reduction in quality issues
• On-time delivery
• Reduction of defect and out of specification (OOS) rates 

Our Out of Specification (OOS) metric, which is OOS Complaints per billion pieces shipped, continues to show steady improvement, with a 2019 OOS score of only 6.6 complaints per billion pieces shipped—our lowest number ever since we commenced tracking this metric. West’s global sites hosted more than 300 customer audits in 2019, receiving less than one major observation per audit, an exceptional result.

Our continuously improving quality metrics are a testament to an unrelenting focus on our quality culture, which connects team members to the patients who ultimately use our products. This culture is driven by our Leadership in Quality Core Value as well as a cadence of Patient First Focus themed events and communications. West’s Global Quality Week in 2019 continued with this Patient First Focus theme, highlighting the importance of data integrity, and emphasizing the need for our team members to ensure quality in everything we do.

Product quality has always been a top focus for West— producing high quality product for our customers and patients is “what” we do. A recent focus has also been on the “how,” which is the quality of our processes. 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.

We realize that our Core Value of Leadership in Quality not only applies to product quality, but to everything that we do—laboratory testing, services, administrative and business process, as well as manufacturing processes. Improving process quality improves COPQ and reduces variations, which in turn improves the quality of the output from the process. This makes the output more predictable, eliminating additional inspections, rework loops and other type of mitigation activities to assure product quality is achieved. Improving process quality reduces overall risk to West, our customers and the patients we serve.