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Case study · Deviation management

Harmonised decisions, 45% fewer major deviations and an ANSM CAPA closed

For two years, decisions on anomalies and deviations had varied from one person to another, to the point of being hard to explain during inspections. We rebuilt the definitions, the decision rules and a collegial committee.

Pharmaceutical company · 2 production units in France2025 – 2026Completed

The results

−45 %major deviations144 → 79
−31 %deviations in total268 → 185
235events handled through a short circuit
ANSM CAPAclosed on 27 February 2026

Period from 24 November to 9 March, compared with the same period a year earlier.

The starting point

  • For two years, inconsistent decisions on anomalies and deviations.
  • In early 2025, confusing definitions that were hard to explain during inspections.
  • A CAPA opened following an ANSM inspection, to be closed.
  • At the starting point: 268 deviations over the period, 54% of them classified as major, and no events.

What we did together

  1. Understand3 days on site to understand the context and practices.
  2. Define the rulesA 2-day workshop: initial and final criticality, depth of investigation, need for CAPA.
  3. Design the committeeA one-day workshop to design a collegial decision committee.
  4. Rewrite the proceduresThe deviation procedure, the quality software work instruction and the CAPA procedure.
  5. TrainA video and Q&A sessions for everyone involved.
  6. Support, then step back64 committees supported across 4 areas and more than 82 decisions, with coaching that became less and less present.

Every deviation at the right level

Number of deviations by classification, from 24 November to 9 March, the previous year and then the project year.

Previous yearProject year
Autonomous committees

in every area: “the process is in place and working”.

235 events

handled through a short circuit, without a heavy investigation.

More critical deviations

and that’s intentional: investigation is now thorough where it needs to be.

An ANSM CAPA closed

on 27 February 2026.

Our takeaways

The project “crosses the finish line successfully”: the rules are clear, shared and applied by committees that work on their own. The next step is a recurrence committee, to address underlying causes.

× 3return on investment, paid back in 4.8 months (A-QE estimate)

The approaches used

ELEMENTAIRE method

Our advice if you’re getting started

  • Anticipate the influx of events when automatic alarms trigger them.
  • Win over the most reluctant operational staff from the start.

Do your deviation decisions vary from one person to another?

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