Situation

Nanotech Inc., an early-stage chemical manufacturer in Houston, TX, was ready to transition from lab-scale discovery to regulated pilot production. The team operated from a repurposed warehouse with improvised bench layouts, undocumented SOPs, and no formal quality management system. Leadership needed a compliant facility flow, right-sized capital plan, and ISO 9001:2015 certification to secure customer contracts and investor confidence.

Approach

ROI Consulting assembled a cross-functional task force spanning operations, EH&S, finance, and quality. We benchmarked chemical handling best practices, performed spaghetti diagrams of people and material movement, and modeled alternative layouts with utilities, ventilation, and hazard segregation baked in. Parallel workstreams established CapEx guardrails, authored manufacturing, quality, and safety SOPs, and stitched them into a training and document-control framework. Gap assessments against ISO 9001:2015 clauses informed a corrective action log owned by leadership, culminating in mock and internal audits.

• Developed a phased CapEx plan covering HVAC upgrades, cleanroom partitions, and analytical instrumentation with ROI and payback modeling.
• Created 48 manufacturing, quality, and safety SOPs plus batch records, deviation logs, and change-control forms tied to a digital document vault.
• Delivered ISO 9001:2015 training, performed layered process audits, and coached process owners through registrar evidence reviews.

Results

Within eleven months Nanotech Inc. commissioned a compliant pilot hall, passed its ISO 9001:2015 certification audit without major nonconformities, and unlocked purchase orders with two strategic customers. The disciplined CapEx program kept spend within forecast while sequencing investments to match demand. Standardized SOPs and competency matrices reduced onboarding time and enabled safe, repeatable production runs under third-party oversight.