GLOBAL COMMITMENT TO QUALITY EXCELLENCE
Grace is committed to total quality excellence in its support of key business processes as defined through its global Quality Management Systems (QMS). Through these business processes, quality goals are aligned with the strategic direction of the organization. Grace's commitment to quality includes:
- A demonstrated ability to consistently provide quality products and services that meet or exceed our customer and regulatory compliance requirements;
- The empowerment of employees to be innovative in the actions they take to improve Grace's performance and its Quality Management Systems;
- Addressing customer satisfaction through an effective application of its Quality Management Systems, including processes for continual improvement and the prevention of product, process, and service nonconformity;
- A well-defined, controlled change management process that ensures a high level of service in a technologically complex and fast-paced environment.
Grace's quality documentation provides an overview of its quality policies and requirements. They are a source of reference for all matters dealing with quality throughout the organization and are available for inspection by our customers, potential customers, and quality auditors. The scope of these documents varies by site and may include:
- ISO 9001:2015
- ISO 13485:2016
- EXCiPACT GMP
- IPEA Excipient GMP
- Kosher and
- Various FDA or global regulations used for the control and manufacture of food and pharmaceutical chemicals.
Under the Grace Quality Management System, all our global facilities are certified to ISO 9001.
- The Grace North American Quality Management organization manages a QMS with a scope covering the Grace corporate offices, R&D, Technical Services, and labs in Columbia, MD, and manufacturing/warehouse sites throughout North America.
- The Grace European Quality Management organization manages a region-specific QMS with a scope covering development, manufacturing including warehouse/logistics, sales and technical services throughout the EU
- Other global manufacturing sites manage their QMS locally to allow for regional language or business differences. However, these local systems have been designed to meet the intent of the North American Quality Procedures (QPs) and their policies are available upon request.
Grace does not supply products for direct consumer use, and the majority of Grace products are supplied for industrial usage. Grace products that may reach a consumer are sold to Grace customers who can employ them as components of cosmetics, food, food packaging or pharmaceuticals. The materials present in these products are typically composed entirely of chemicals listed on the USEPA's Safer Choice chemical ingredient list. Information and details of Grace product recalls, withdrawals, or alerts due to known or potential safety concerns are as follows:
Recalls, withdrawals or alerts, either required or issued for known or potential safety reasons, of Grace products that could reach a consumer and are directly or indirectly regulated by a governmental agency over the period 2015-2019: 0
Recalls, withdrawals, or alerts issued for known or potential safety concerns for all other Grace products over the period 2015-2019: 0
Further information on product recalls in general within the United States can be found here: https://www.recalls.gov/