$450M Infant Formula Manufacturer (FDA/cGMP-Regulated), Preparing for Sale
Client Challenge
Leading infant formula manufacturer preparing for sale needed rapid identification of operational inefficiency and cost reduction
Seven core processes and all supporting systems (SAP, PLM, LIMS) required assessment under FDA/cGMP/CFR Title 21 constraints
A 9% workforce optimization target had to be validated without harming operations
Client Solution
BAS™ Deployment: Rapid Lean Complexity Value Stream Mapping across Order-to-Cash, Procure-to-Pay, Record-to-Report, Demand Planning, Manufacturing, SCM, and Laboratory
Team Leadership: Assembled and managed a 20-person client matrix team with Gemba Walks throughout
Root Causes: Isolated PLM/PDM naming inconsistencies, an obsolete lab method (45 minutes reducible to 5 with identified technology), and night/weekend coverage gaps causing line downtime
SIOP: Recommended overhaul of a planning system driven solely by customer orders as forecasts
Executive Delivery: Executive summary and presentation delivered directly to the CEO
Client Impact Results
Savings: $2.8M identified — 18.9% OpEx reduction
Value Classification: 59% of process work was NVA or NVA-Essential
Shadow Systems: 43% of overall cost consumed by non-sanctioned systems
Workforce: 9% optimization validated as achievable without operational impact
Lab Procedure: Main daily procedure reducible from 45 minutes to 5
Client Technologies
BAS™ methodology
SAP
PLM
LIMS
Complexity Lean Value Stream Mapping
FDA/cGMP/CFR Title 21 compliance assessment
SIOP framework analysis
