Optimize the batch release process by identifying critical focus areas and implementing structured action tracking. Align cross-functional teams to improve performance, reduce delays, and enhance compliance.
Approach
- Conduct value stream mapping and assessment of batch release processes across manufacturing nodes
- Pinpoint ten critical areas affecting batch release, with primary focus on deviations, change controls, and CMO release.
- Designate owners for each focus area to drive process improvements.
- Record all action items in a Smartsheet dashboard, assigning owners and timelines for execution.
- Configure automated alerts for action items due within the next seven days or past due.
- Periodically update status, revise timelines, and document key observations.
Results
- 30% Cut batch release delays by 30% by addressing top three bottlenecks.
- Improved documentation and tracking allowing streamlined visibility, escalation and action ownership
- 40% Automated notifications and structured monitoring resulted in a 40% faster resolution of pending action items.
- Established clear ownership and expectations across ten critical areas, ensuring alignment between teams.
- Sample Process Improvement Summary
Segment: Quality / Regulatory · Services: quality-regulatory