Quality System Design

Solutions:

Regulatory Audit

Readiness-   Responses/Remediation

• We evaluate quality assurance and control functions on handling technical and compliance issues
• As part of this we evaluate the structure of Quality unit, written procedures, self- inspections, errors/ out of trend
• Implement site improvement programs by using SIPOC (….) and Poko-Yoko (mistake proofing)
• Performance metrics, Quality metrics, and level of technical capabilities