Validation Documents Process Optimization and Cost Reduction

Abstract

Every manufacturing and regulated site, performs multiple Validation Documents; being this area one of the most material cost and man hour consuming of the site. FMEA and Design Documents are constantly generated and revised during any Validation activity. The main scope of this study is to reduce the material cost, man hour and any possible quality issue during the generation of these documents increasing the efficiency of the area. Also, it will benefit the identified customers of these documents. To achieve the scope, and align the process to customer expectations Lean Six Sigma methodology was used with DMAIC (define, measure, analyze, improve, control) as core. Key Terms ⎯ Design Documents, DMAIC, Failure Mode and Effect Analysis, Process Improvement.