Global Quality Framework
Quality Principles
- An integrated quality policy based on global standards
- Management of quality accountability indicators (KPI) across all global sites in line with our Quality First philosophy
- Application of Design by Quality, ensuring quality is built into products from the development stage
Global Quality Framework
Global Standard Quality System
- Application of global standards for core processes and quality control through SOPs (Standard Operating Procedures)
- Unified production and testing operations based on CGMP and ISO requirements, including harmonized test methods and inspection criteria
Global Quality Framework
Risk Management
- Operation of a globally integrated risk management process
- Global escalation flow: Local QA → Global (GAO) QA → Headquarters
- Systematic response to quality issues through root cause analysis, improvement actions, and effectiveness verification based on impact, severity, and scope Transparent, customer-centric communication
Global Quality Framework
Continuous Quality Capability Enhancement
- Establishment of a compliance framework aligned with global regulations, including ISO, FDA, Health Canada, and NMPA
- Enhancement of supply chain quality through a global supplier quality audit system
- Operation of global quality training programs across all sites, covering QA, QC, R&D, and manufacturing