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Enterprise-Wide Quality System
With more than 60 facilities around the world, this company produces in excess of 50,000 medical products each year. Product quality is a regulatory requirement and a corporate standard. When quality violations were noted by FDA in several facilities, the company's senior management began an aggressive initiative to create one of the most advanced quality systems in the industry.
UL partnered with the company on an enterprise-wide quality solution based on a clear assessment of the risk posed by each of the firm's facilities around the world. Our solution gave management direct insight into the status, needs and compliance challenges faced by each facility. Based on these initial assessments and insights, UL developed a comprehensive knowledge solution that provides employees throughout the company with a full range of learning resources including curricula in Good Manufacturing Practices (GMPs) and Standard Operating Procedures (SOPs). In addition, the company implemented UL's Critical Information and Control System (CICS) to distribute, validate, and document comprehension of vital compliance documents and information including regulatory updates, corporate policies and procedures, and internal communications.
The company has reached its initial goal of proficiency for 10,000 employees as part of the company-wide quality system. The long-term goal is to expand UL's solution to all employees at the company's more than 50 manufacturing sites by the end of 2007.
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