Identified Root Causes of Batch Rejections and Implemented Proactive Initiatives, Leading to a Projected 50% Improvement and $4.3M in COPQ SavingsQUALITY EXCELLENCE, OPERATIONAL EXCELLENCE
SITUATION
The Drug Substance Production Team identified batch rejection, deviation, and conditional release issues, leading to significant COPQ. This impacted COGS/expenses and quality risk, both of which were not well defined.
A lean expert in DS operations was requested to help investigate and improve overall performance.
A team of operations and quality leaders was assembled to define the current state and performance:
| Current State | |
| Right First Time | 44% |
| Batch Rejection | 26.5% |
| Post CU Rejection | 12.9% |
| Low Yield Batches | 23.2% |
| Deviation Rate | 71% |
APPROACH
Hundreds of deviations were analyzed using AI and uncovering the following themes and root causes:
| Category | Root Cause | Description |
| Processing Manpower | Human Error | Non-compliance or calculation errors |
| Yield Variability, Reuse Processes | Yield Inefficiency | |
| Analytical Methods | Critical COA Attribute Tests OOS | Linearization and Protein |
| Non-critical COA Attribute Tests OOS | Culture Purity Tests | |
| Testing & Sampling Methods | Tests Not Conducted on Time | Leadtime vs Cycle Time, Logistics & Sampling Failures |
A cross-functional team of leaders was assembled to validate the findings and approve a list of proactive initiatives:
| Proactive Initaitives |
| Training on human errors (calculation & sampling) |
| Applying a reuse process from another site |
| Tech Dev to implement OOS solutions |
| Tech Dev to create new testing strategy and COA |
| Align test lead times with batch cycle time to avoid Conditional Use |
IMPACT
Target Future State Performance (next 12 months):
| KPI | Target Direction | Target % | Target Rate | Target COPQ |
| Right First Time | Increase | 50% | 66% | |
| Plasmid Rejection | Reduce | 50% | 14% | $2.33M |
| Post CU Rejection | Reduce | 75% | 3% | $.822M |
| Low Yield Batches | Reduce | 50% | 12% | $1.02M |
| Deviation Rate | Reduce | 25% | 53% | $.129M |
Implementation involved launching a formal proactive initiative in the QMS system and onboarding the projects into the Drug Substance Operations PMO.
Managers and supervisors from Technical development, MS&T, QC, QA, and Operations committed to governing and driving the PIs to achieve the targetted performance of over $4.3M in COPQ savings.
At OSICS Network, this project is a shining example of our commitment to delivering innovative solutions that drive efficiency and effectiveness in complex supply chain environments. Our expertise in navigating the intricacies of the pharmaceutical industry, coupled with our technological prowess, sets us apart as a leader in consulting services. We are dedicated to empowering businesses with the tools and insights needed to thrive in a rapidly evolving landscape.
We invite you to explore the transformative impact that OSICS Network can have on your business. Whether it’s implementing cutting-edge digital solutions or redefining supply chain strategies, our team is ready to guide you through every step of the journey towards operational excellence. Contact us today to discover how we can tailor our services to meet your unique challenges and elevate your business to new heights.