Company: Novo Nordisk
Role: Lean Partner / Transformation Lead
Context: Regulated pharmaceutical manufacturing
Scope: End-to-end batch release process across Production, QC, QA, and support processes
Context
In regulated pharmaceutical manufacturing, batch release lead time is a critical driver of service level, inventory exposure, and planning reliability.
At site level, batches met quality requirements, but time to release was long and highly variable, creating downstream pressure on Supply Chain and delivery commitments.
The challenge was not compliance.
The challenge was flow, ownership, and visibility across the release system.
The End-to-End Release Flow (as-is)
The overall release lead time consisted of multiple interconnected stages across functions:
Production & QC execution
- Formulation completed
- Filling completed
- Environmental Monitoring (EM) executed
- QC laboratory analysis of in-process and finished product samples
QA controls
- Batch documentation review
- QA review and approval
Exception handling
- If any deviation occurred, the deviation had to be:
- Investigated
- Documented
- Approved
Only after all steps were completed could a batch be released.
Each step was compliant, but the system had no explicit flow expectations, no stage ownership, and no shared understanding of delay.
The Real Problem
The visible problem was “slow release.”
The real problems were structural:
- Release was managed as a functional sequence, not an end-to-end system
- There were no explicit expectations for how long each stage should take
- Deviations were handled locally but blocked the entire flow
- Data existed, but no stage-level KPIs showed where time was actually lost
In short: no one owned release performance as a system.
My Mandate & Authority
I was asked to lead a data-driven reduction of batch release lead time, with responsibility to:
- Decompose the release process into explicit, measurable stages
- Define realistic stage targets aligned with compliance requirements
- Create transparency across functions without compromising quality
- Enable leadership to manage release performance based on data, not anecdotes
I worked hands-on across Production, QC, QA, and Supply Chain, while aligning leadership around shared flow ownership.
What I Did
1. Defined explicit release stages and targets
I translated the end-to-end release flow into clear stages with agreed target times:
- Formulation completed: target 1 day
- Batch documentation review: target 7 days
- QA review and approval: target 7 days
- Deviation closure (if applicable): target 35 days
This replaced implicit assumptions with explicit, system-wide commitments.
2. Introduced stage-level KPIs and transparency
- Designed stage-based KPIs to track actual vs target performance
- Visualised delays by stage, batch, and function
- Made it visible where and why batches were late, without blame
- Enabled comparison across batches to distinguish systemic issues from outliers
3. Shifted the conversation from urgency to flow
- Used data and hypothesis testing to identify true delay drivers
- Reframed discussions from “why is this batch late?” to
“which stage is blocking flow?” - Aligned functions around system performance, replacing local optimisation
Results & Impact
Hard outcomes
- Batch release lead time reduced by 35%, measured end-to-end
- Release variability significantly reduced, improving planning reliability
- Faster availability of finished goods without compromising compliance
Structural outcomes
- Release managed as a stage-based flow system, not a QA sub-activity
- Clear ownership and expectations established for each release stage
- KPI-driven performance follow-up embedded into daily and weekly routines
- Deviation handling recognised and managed as a flow constraint, not an afterthought
Key Insight
In regulated environments, release delays are rarely caused by quality requirements themselves.
They are caused by missing stage ownership, unmanaged queues, and invisible waiting time.
By making release stages explicit, measurable, and transparent, speed and reliability improved without increasing risk.
Öner TANK 