Professional Documents
Culture Documents
What is it?
Process Flowchart
Floor Plan
Key Characteristics (Product
& Process)
Control Plans
Process FMEA
Process Capability Plan
Packaging Specifications
Work Instructions
Quality System Review
Management Review
APQP > Check
Materials Inspections
Trial Production Run (Not Pilot)
Measurement Systems Evaluation
Process Capability Study
Production Validation Testing
Packaging Evaluation
Production Part Approval
Customer Approval
Production Control Plan
Quality Plan
Management Review
APQP > Act
Production
SPC / Reduction of Variation
Continuous Improvement
Non- Conformance Management
Delivery / Service / Warranty
Monitoring
Customer Satisfaction
Reporting
Management Review
SPC: Statistical process control
SPC / Reduction of variation
• Gauge R&R
• Variation due to Measurement Process
• Reproducibility – variation due to different Operators
• Repeatability – variation due to Gauge itself
• Measurement Variation = R+R
• Total Variation = MV + Product Variation
• QMS Documentation
(Processes, SOPs, WIs)
• Planning Documentation
(Phase 1)
• Design Documentation
(Phase 2&3)
• Flowcharts / Block
diagrams
• Drawings
• Specifications
• Records of Reviews
• Records of Approvals
• Production Part Approval
Issue Manager
info@qualsys.co.uk