Cleanroom Assessment

6 P = P Assessment

P1 Product

• Specifications
• Quality
• Cleanliness
• Cleaning time
• Packaging conform spec

P2 Production Tools

• Cleanliness specification
• Transport tooling cleanliness
• Cleaning tooling
• Inspection tooling
• Covering

P3 Procedure

• Inspection & Cleaning steps
• Cleanroom cleaning
• Garments/Gowning
• Cleanroom monitoring
• Packaging

P4 Plant

• Work Center design/layout
• Cleanroom cleaning
• Cleanroom monitoring

P5 People

• Training materials
• Quality Gowning/Garments
• Operational performance

P6 Parts

• Specifications
• Cleanable
• Production start w clean parts
• DN/MN in place