Quality Assurance

Facets of Quality Assurance - Strategic Initiatives

Quality Planning

Specification Review & Requirement Understanding
Setup Validation & Certification - MOC
Training Material Certification
Determination of CTQs
Sampling Plans
Control Plan
Personnel Certification

Quality Control

Periodic Personnel Calibration
Quality Tracking — Pre-Ship & Outgoing
Control Charts
Defect Directory
Quality Review Meets

CAPA

Analysis of Quality Result
(Ext & Int)
Action Item tracker

*Tech, Control & Containment

*Reaction, Systemic Correction & Recurren. Prevention

Effectiveness Monitoring
Lessons Learned

* Feedback to Quality Planning

Strategic Initiatives

Quality Intelligence Combines BR, Technology
Best Practices Assimilation
Small Group Activities
Six Sigma