Originally Published MDDI August 2005
Regulatory Outlook
Evaluating Management’s Commitment to Quality System Compliance
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What is your vision for executive management leadership in your company? The following are signs that your management’s attitude toward quality system compliance reflects compliance with 21 CFR 820.20, Management Responsibility:
• Management takes an active role in establishing and updating the quality policy.
• Quality objectives are established and periodically monitored to ensure targets are met; employee performance and compensation are linked to quality objectives that are shared among different functional groups.
• The quality policy is publicized throughout the plant with posters; employees are periodically reminded of the quality policy’s significance at company meetings.
• Senior management actively requests summaries of key quality indicators, and management reviews elicit active discussions regarding opportunities for improvements in product quality and regulatory compliance. Meaningful corrective and preventive actions are generated during these reviews.
• Commitment to quality systems compliance is evident through priority levels and resources (personnel, equipment, support) assigned to quality improvement and compliance projects.
• Decision making is objective and based on facts; decisions made concerning discrepant material are not overridden by upper management for what they term are business reasons.
• A person walking into the company would sense that quality is important based on discussions at meetings, job candidate interviews, observations of manufacturing and test areas, employee morale, and visible signs showing quality trends and policies.
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