Our Priorities > Supporting Patients and Consumers Ensuring Manufacturing Quality
Quality control in manufacturing follows the same strict guidelines at our headquarters in north suburban Chicago, Illinois, and at our plant in Shanghai, as well as at all of our other facilities.
Abbott has numerous processes in place to ensure that we meet the highest safety and quality standards in the design, development, manufacture, delivery and labeling of our products. We strive to make important enhancements to these processes each year. As industry and available technology continue to advance, we incorporate information management tools into our processes that allow us to identify and react to potential issues before they become quality concerns. We also continue to harmonize our quality and compliance processes on a global basis, and we have simplified our company’s quality policies to make them easier for employees to understand and follow. Abbott also continues to expand and implement our global internal certification programs – helping to ensure that employees have the necessary skills to perform key quality and safety activities.
Our product quality assurance programs are led by the Abbott Quality and Regulatory organization, which reports directly to our Chairman and CEO and also is accountable to the Public Policy Committee of our Board of Directors.
We have a rigorous audit program to ensure that policies are implemented correctly and closely followed. Regular audits of our suppliers ensure that Abbott’s quality standards and health and safety policies are implemented correctly and followed closely. We also employ a “quality by design” approach, focusing on improving manufacturing efficiencies and consistent delivery of products that fulfill customer needs. Additionally, we use “human factors” engineering to anticipate the mistakes people are most likely to make in using a product, and then design the product in a way that minimizes the risk of such mistakes.
Abbott also employs and adheres to robust manufacturing quality standards at sites around the world. We use a common quality management system throughout the company, and when we acquire new businesses, we use due diligence and rigorous analysis to ensure that their quality standards and requirements quickly conform to our expectations.
Our quality system is supported by policies, processes, procedures, training and resources that ensure the safety and efficacy of the products we design, manufacture and distribute. We regularly monitor all of our processes and assess our products against approved specifications before distribution. A risk-based audit program ensures that we conduct regular audits at our global manufacturing sites. The Abbott Quality and Regulatory organization is itself routinely challenged and assessed through internal audits and regulatory inspections. We also carefully monitor and audit our suppliers to ensure that they meet high standards of quality, safety and ethical behavior.
Abbott takes potential quality and safety concerns about our products very seriously, and we work quickly to address questions from customers, patients, consumers and the general public. We investigate each instance in accordance with our corrective and preventive action plans, and we communicate findings and lessons learned to the appropriate regulators, to industry peers, if appropriate, and across our global business. In addition, Abbott continuously monitors global information to identify emerging issues and significant events with the potential to impact product quality or availability. Abbott is prepared to implement the appropriate actions to ensure an uninterrupted supply of high-quality, effective products to our customers.
Note: All data reflects Abbott activities in 2012. Some content has been adjusted to remove data specific to AbbVie, which became a separate company on Jan. 1, 2013.