Case study · Batch release flow
GO FAST programme: €6M of stock released and an anomaly backlog almost halved
In a group with €71M of blocked stock across 6 sites, we launched task forces to release batches, by managing anomalies and supporting investigations.
The results
−€6Mof blocked stock at the first siteJune → Dec. 2023
−45 %open anomalies212 → 117
−49 %overdue anomalies119 → 61
2 days → 3 hfor record review by the second site’s QA technicians
The starting point
- €71M of blocked stock across 6 group sites: batches produced but not yet released.
- At the first site, investigations that weren’t getting started.
- At the second site (injectables, 550 people), more than 460 open deviations.
- Quality assurance record review that could take 2 days.
What we did together
- 2023Launch a task forceThe GO FAST programme: a dedicated team to release waiting batches.
- Manage anomaliesDaily management of anomalies (BOOSTER), to decide fast and move each file forward.
- 2024Support investigations31 anomalies investigated in 29 days on site, with no major pushback from quality assurance.
- Manage production and chemistryAt the second site, management of production and chemistry deviations.
- 2025Make it lastThe creation of a 5-investigator Product Quality Support department, coached in the ELEMENTAIRE method.
Nearly half of the anomalies cleared
First site, before and after GO FAST (steering committee, January 2024).
BeforeAfter
31 anomalies
investigated in 29 days on site, with no major pushback from QA.
Chemistry open items: 126 → 96
at the second site.
2 days → 3 hours
for record review by QA technicians.
A dedicated department
of 5 investigators, created in 2025.
Our takeaways
Investigating cause and impact at the same time, by the same person, with a step-by-step method: that’s what releases batches. Without a lead or management involvement, however, the change meets resistance.
The approaches used
Our advice if you’re getting started
- Appoint a lead and involve management from the start.
- Entrust the cause and impact of a deviation to the same person, with a step-by-step method.
Are your batches waiting too long to be released?
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