Alexion Pharmaceuticals: Fastest ever QC batch release
A Quality Control team member used 5S, Kanban and Value Stream Mapping to eliminate sample search time and achieve the fastest batch release in the laboratory’s history.
Pharmaceutical / Biopharmaceutical
Lean Essentials
Blanchardstown, Dublin
1 hr → 0
Time previously spent searching for samples eliminated
Fastest
Batch ever released from Quality Control
5S + Kanban
Implemented across sample storage and glassware
Up to one hour spent searching for samples in the QC lab
A team member in Alexion’s Quality Control Laboratory identified that the process for releasing samples to Certificate of Analysis was taking longer than necessary — and the root cause was surprisingly physical. Staff were spending up to one hour per session searching for samples in the lab fridges.
The issues compounding the problem were:
- No segregation between different products in the sample fridges
- No segregation between different test types
- No segregation between testing statuses (pending, in-progress, complete)
- Glassware was frequently unavailable when needed, requiring washing or searching
- The cumulative effect was extending the time from sample receipt to Certificate of Analysis, risking stock availability
The target was to ensure that batches were always released within the agreed timeframe — and to reduce the overall lead time of the QC release process.
From chaotic fridges to structured, visual management
Key Challenges
The Quality Control team needed to:
- Eliminate the time wasted searching for samples in unorganised fridges
- Introduce clear segregation between products, tests and statuses
- Ensure glassware was always available when needed for testing
- Reduce the overall sample-to-release lead time
- Create a system that would be sustainable — maintained by the team, not dependent on one person
The Lean Solution
After training in Lean tools, the team applied Value Stream Mapping, brainstorming, 5S, Kanban and Standard Work:
- Mapped the full sample release process to identify where time was being lost
- Held a Kaizen event to brainstorm ideas, prioritised using an Impact/Ease chart
- Implemented 5S in the sample fridges — sorting, organising and labelling by product, test and status
- Introduced a Kanban system for glassware — ensuring supply was always available at point of use
- Created standard work documentation for the new fridge organisation and glassware replenishment
8-Step Problem-Solving Process
The team combined multiple Lean tools — Value Stream Mapping, 5S, Kanban and brainstorming — to address both the physical organisation of the lab and the workflow of the release process.
Problem
QC staff spend up to one hour searching for samples. No organisation system in fridges. Glassware unavailable when needed.
Current State
Mapped the sample release process. Identified search time, missing glassware and lack of status visibility as key wastes.
Target
Release all batches within the agreed target timeframe. Eliminate sample search time entirely.
Root Cause
Kaizen event identified root causes: no product/test/status segregation in fridges, no glassware replenishment system.
Countermeasures
5S for sample fridges (sort, organise, label). Kanban for glassware supply. Standard Work for both systems.
Implementation
Fridge reorganisation completed. Kanban cards introduced for glassware. Visual management boards installed.
Evaluation
Fastest batch ever released from QC. Search time eliminated. Team engagement increased as improvements became visible.
Standardisation
Standard Work documented. Plans to extend 5S across the full laboratory, not just sample fridges.
Results and next steps
The combination of 5S and Kanban delivered immediate, visible results:
- Fastest batch release in QC history. With samples now instantly locatable and glassware always available, the team achieved their fastest ever release from sample receipt to Certificate of Analysis.
- Sample search time eliminated. The 5S reorganisation of fridges — with clear segregation by product, test type and status — meant staff could find any sample immediately.
- Glassware always available. The Kanban system ensured glassware was replenished before it ran out — no more searching or washing delays.
- Team engagement increased. Once the team saw visible improvements, they were encouraged to get involved further and maintain momentum.
- Plans to extend 5S across the full laboratory. The success in the sample fridges has created appetite to apply the same approach across the entire QC lab environment.
Learnings
- Team involvement was essential — 5S only works if the people who use the space are invested in maintaining it.
- A Kaizen event alone can’t figure out what’s wrong — you need to combine it with tools like 5S and Kanban to address both the root cause and the physical environment.
- Visual management creates its own momentum. When improvements are visible, people want to contribute more.
- Sometimes the biggest time savings come from the most basic organisational improvements — sorting a fridge properly saved more time than any process redesign could have.
Simple tools, significant impact
This project is a powerful reminder that Lean improvements don’t always require complex analysis or expensive technology. Sometimes the highest-impact change is organising a fridge properly and making sure glassware is available when people need it. The tools — 5S and Kanban — are among the simplest in the Lean toolkit, but when applied with discipline and team buy-in, they delivered the fastest batch release in the laboratory’s history.
LeanTeams has worked with Alexion Pharmaceuticals since 2018. You may also be interested in: Case Study 1 – Packaging Materials and Case Study 3 – Regulatory Artwork. All our case studies are available here.
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