1. Management Responsibility
All managers at Cheerland demonstrate strong and visible support for the quality system and ensure its implementation throughout the organization.
- Provide Leadership
- Structure the Organization
- Build a Quality System to Meet Requirements
- Establish Policies, Objectives, and Plans
- Review the System
Appropriate allocation of resources is key to creating a robust quality system and complying with the cGMP regulations.
- General Arrangements
- Personnel Development
- Facilities and Equipment
- Control Outsourced Operations
3. Manufacturing Operations
The significant characteristics of the product being manufactured are defined from design to delivery, and control should be exercised over all changes.
- Design, Develop, Document Product and Processes
- Examine Inputs
- Perform and Monitor Operations
- Address Non-conformities
4. Evaluation Activities
Quality systems at Cheerland continually monitor trends and improve systems by monitoring data and information, identifying and resolving problems, and anticipating and preventing problems.
- Analyze Data for Trends
- Conduct Internal Audits
- Quality Risk Management
- Corrective & Preventive Actions
- Promote Improvement