Baxter's quality management system provides a single, global company-wide standard for quality. It supports a consistent approach to managing quality across the product life cycle, including design, development, manufacturing, sterilization, labeling, packaging, distribution and promotion. It helps to address the complexities of managing quality across interconnected businesses, regions and manufacturing operations, enhancing Baxter’s ability to meet standards and to adapt to changes in a multifaceted regulatory environment.
The company regularly evaluates and reviews its quality management system to identify and correct issues that may affect product and service quality, and pursues continuous improvement through a range of data-driven methodologies. Simplifying processes is one focus, which increases efficiency and prevents potential quality issues from occurring. Baxter also assesses its suppliers of raw materials, components and finished goods to help enhance their performance. After products are launched, the company executes post-market surveillance to monitor product safety, efficacy and quality while in use.
When Baxter identifies a potential quality or patient safety issue with one of its products or determines that products manufactured or marketed by the company do not meet company specifications, published standards or regulatory requirements, it investigates and takes appropriate preventive and corrective actions. This may include patient risk mitigation, such as training healthcare professionals and/or patients, notifying customers about revised labeling, correcting problems at the customer location, withdrawing products from the market and other actions.
Baxter takes any self-identified quality or patient safety issues or findings by regulatory authorities very seriously, and establishes comprehensive plans to address them. While executing these corrective actions, the company also assesses the potential to leverage these improvements more broadly.
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