Quality
Baxter's reputation is built on the quality of its products and services. Baxter's quality systems apply across the product life cycle, including design, development, manufacturing, sterilization, labeling, packaging, distribution and promotion.
Baxter identifies and addresses quality issues using Lean Six Sigma, a data-driven approach to managing and improving business processes. "Lean" focuses on items such as waste elimination, standardization, cycle-time reduction and other means to increase speed and efficiency. "Six Sigma" emphasizes reducing variation that impedes optimal product and process performance. Organizations throughout the company have achieved significant quality gains and financial savings using this approach.
To assess and facilitate compliance with applicable requirements, the company regularly evaluates its quality systems and conducts reviews to identify issues that may affect product and service quality. Baxter also assesses its suppliers of raw materials, components and finished goods. After products are launched, the company executes post-market surveillance activities to monitor the safety, efficacy and quality of products while in use in the marketplace.
Improving Supplier Quality
As a result of Baxter’s diverse product line and global scope, the company conducts business with a broad array of suppliers. Approximately 9,000 “direct” suppliers provide goods and services used to produce Baxter products. Given the nature of Baxter’s business, it is crucial that the company ensures the quality of its supplier base.
Baxter has a number of initiatives to continually improve supplier quality. One is a new global supplier database that integrates all direct supplier data across the company. In 2008, Baxter completed the rollout of this database to 148 user groups within the company, largely manufacturing, purchasing and business-unit personnel.
The system provides several benefits. It only allows purchases from approved suppliers. It also contains copies of all quality agreements between Baxter and its suppliers, which document the roles and responsibilities of each party, the specifications of the products they’re supporting, the ongoing history of the agreement and other information.
This global visibility of Baxter’s supplier base reduces the potential for multiple audits of the same supplier by different user groups, saving time and resources for Baxter and the supplier. It also increases Baxter’s ability to leverage its buying power among fewer suppliers, possibly realizing volume discounts. Perhaps most important, visibility to global supplier data better enables Baxter to set baselines for performance, assess that performance and measure improvement.
Baxter’s vision is to use the supplier-quality and supplier-management process as a strategic advantage. The global supplier database is a key element toward this end.
Real Time Quality Control
Baxter is implementing a tool in its manufacturing plants that monitors manufacturing processes in real time while using sophisticated statistical techniques to identify product components that should be rejected if one or more measured outputs fall outside proscribed ranges. Called multivariate data analysis (MVDA), it enables Baxter to achieve higher operational excellence by automatically discarding parts that do not meet quality standards. The system ensures that critical quality attributes are maintained and that quality is built into the product versus inspecting for quality after manufacture. This operational strategy helps maintain the highest levels of quality while also ensuring that problems are identified, and corrective actions commence, earlier in the process.
Baxter’s implementation of MVDA stems from the company’s interest in Process Analytical Technology (PAT), a framework for quality assurance the U.S. Food and Drug Administration has encouraged healthcare companies to adopt. The framework for PAT enables companies to proactively employ science and innovative technologies in manufacturing processes to create a more predictive manufacturing model. Baxter was one of the first medical device manufacturers to use MVDA.
Baxter first implemented this system in 2007 at its Mountain Home, Arkansas, facility, to monitor the quality of injection-molded parts for disposable medical devices. The company plans to apply the methodology to critical processes throughout the Baxter manufacturing network.
