Case study · Quality system management
One month of BOOSTER management to go from 45% to 30% of deviations older than 30 days
As it moved into commercial production, this site had to regain control of its deviations. Daily management delivered results within a month, even before work on investigation began, then the approach was extended to the site’s other entity.
The results
45 → 30 %of deviations open for more than 30 daysin 1 month
65 → 54open deviationsJune → July 2019
35 → 27 daysaverage age of open deviations
4 yearslater, the rituals were still in place
The starting point
- 2019: move to commercial production, with 65 open deviations, 45% of them open for more than 30 days.
- Criticality decided “by feel”, and no investigation approach for minor deviations.
- 42 investigators and 9 quality assurance experts, with different practices.
- At the other entity: inconsistent investigations and recurrences (procedures not followed, documentation errors).
What we did together
- 2019Manage every dayA daily BOOSTER ritual, a “deviation or incident” sorting tree and a criticality grid.
- 2020Speed up on criticalityA 2.5-day “blitz” with dedicated investigators, and 5 investigators coached in the ELEMENTAIRE method.
- 2020Extend to the other entityManagement of deviations (BOOSTER) and CAPAs (FOCUS), including support services, with a recurrence analysis.
- 2022Investigate better5 investigators coached and 4 group coaching sessions, with about 13 people.
What made the difference
Results in 1 month
of management, even before the investigation part.
An expanded approach
from one entity to the other and to shared support services.
Still in place in 2023
4 years after launch.
Tailor-made tools
BOOSTER and FOCUS dashboards designed for the site.
Our takeaways
Daily visual management produces results very quickly. For it to last, the site must also be able to keep its tools alive without us.
The approaches used
Our advice if you’re getting started
- Train someone in-house to maintain the management tools.
- Start with management: the first results give the momentum to work on investigation.
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