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Case study · Deviation management

A deviation system redesigned across 4 sites: 64% fewer minor deviations in 22 weeks

Before producing its first batches for the US market, this group needed a common, fast method for handling its deviations. We redesigned the system with headquarters, then rolled out the ELEMENTAIRE method across 4 sites.

Biopharmaceutical group · headquarters and 4 sites in France2024 – 2025Completed

The results

−64 %minor deviations1 751 → 635
−42 %major deviations648 → 376
56 → 44 daysaverage closure time for major deviations
80 → 53 daysaverage closure time for critical deviations

Comparison of the 22 weeks before and the 22 weeks after roll-out (November 2024 to September 2025).

The starting point

  • Criticality that didn’t reflect the real level of risk.
  • “Student syndrome”: investigations started too late, at the last minute.
  • No standard method from one site to another, and a lack of responsiveness.
  • Validation batches for the US authorities (FDA) scheduled for Q2 2025: the method had to be running routinely before then.

What we did together

  1. End of 2024Align the groupA 2-day workshop with headquarters: a group procedure, a new “event” category, a classification decided after the investigation.
  2. Equip the systemThe circuit rebuilt in the quality software, adapted first to the pilot site, then to the second site.
  3. Train and coach2 days of training, then side-by-side coaching on real deviations and group coaching.
  4. Decide in committee31 decision committees supported on the first two sites.
  5. Roll out across 4 sites132 coaching sessions and 68 online masterclasses.
  6. Train at scaleAbout 945 people enrolled in the “Investigation” online module, with 80% completion on average.

Low-stakes deviations leave the heavy circuit

Number of deviations by classification, over the 22 weeks before and the 22 weeks after roll-out.

22 weeks before22 weeks after
1,431 events

handled through a short circuit, in 9 days on average.

Faster closures

−21% lead time on majors, −34% on criticals.

10 coachees out of 12

on target at the most engaged site.

945 enrolled

in the “Investigation” online module.

Our takeaways

A common method isn’t enough: it has to rely on decision committees and available investigators. Where participation was lower, a strengthened classification committee and dedicated investigators made the difference.

≈ €2.8M a yearin estimated savings, for a return on investment of 13.5 (A-QE cost model)

The approaches used

ELEMENTAIRE methodELEMENTAIRE online

Our advice if you’re getting started

  • Target the audience for online training: if it’s too broad, it creates frustration.
  • Where participation is low, appoint dedicated, cross-departmental investigators.

Are your deviations classified at the right level?

Measure the health of your deviation handling with the free BOOSTER assessment, or let’s talk about your situation.

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