Fixing the Flow: How Data-Driven Root Cause Analysis Increased Yield and Capacity
The Challenge
One of the production lines at a pharmaceutical manufacturing site was experiencing unacceptably low product yield, causing the site to miss its manufacturing plan and drive up cost of goods sold (COGS). Leadership needed to restore yield performance quickly to protect both capacity and profitability.
Our Analysis
Using DMAIC methodology supported by advanced statistical analysis and Monte Carlo Simulation, team conducted a detailed review of production data, including hold times, tank weights, filter flush volumes, sample collection data, and scrap rates.
The analysis revealed multiple root causes:
- Excessive vibration on conveyor belts caused vials to fall, break, and create glass debris, in the process, slowing down the line and also increasing product loss
- Found that gaps in equipment qualification and validation from initial commissioning resulted in performance variability
- Sampling practices were inconsistent and contributed to measurable yield loss
- Material variability in vial stoppers contributed to increased rejects and reduced efficiency
The problem wasn’t a single failure. It was a systemic issue spanning equipment, materials, and methods.
What We Did
We developed and executed a comprehensive improvement plan:
- Planned Maintenance Program: Implemented equipment (especially, conveyor belt) vibration monitoring and preventive maintenance schedules to stabilize conveyor performance
- Update Line (and Related Equipment) Validation: Engaged Engineering, Manufacturing, and Quality to update validation of the line per current standards and to include conveyor belt vibration in validation studies
- Sampling Optimization: Updated the sampling plan based on data trends to reduce unnecessary product loss
- Supplier Collaboration: Partnered with Vendors and Supplier Quality to tighten stopper material specifications and implement improved testing protocols
- Implemented Total Productive Maintenance (TPM) across site leading to significantly fewer equipment breakdowns
- Trained current employees on the new process and updated SOPs and training material for sustaining best practices
The Measurable Results
- 4.6% increase in product yield, restoring full production capacity
- Site began consistently meeting the manufacturing plan, eliminating backlog and delays
- Fewer deviations and improved process stability, reducing investigation workload
- Lower COGS through higher throughput, reduced scrap, and optimized sampling
- A sustainable system of preventive maintenance resulting in improved equipment reliability
- Established a process for improvement of supplier quality through continued performance monitoring