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