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Case study · Deviation management

After a major inspection finding, a deviation backlog divided by 5 in 7 months

Under the pressure of a remediation plan, this site regained control of its deviations by combining a common investigation method, daily management and a targeted task force.

Pharmaceutical CDMO · production site in France2025 – 2026Completed

The results

−79 %overdue deviations243 → 52
−62 %open deviations316 → 121
−41 %average processing time36.7 → 21.5 days
48 → 0deviations awaiting assessment for more than 30 days

Measurements from July 2025 to February 2026. “Overdue” deviations (the backlog) are those whose planned processing time has been exceeded.

The starting point

  • A major finding during an inspection on deviation and CAPA management, with a remediation plan to deliver.
  • About 3,500 deviations a year, i.e. around fifteen per working day, 30% of them classified as major.
  • At the end of January 2025, 412 overdue deviations, 161 of which were blocking batch release.
  • Only 3 investigators in quality assurance, each with their own way of working.

What we did together

  1. June 2025UnderstandInterviews with the teams, analysis of 10 to 15 deviations, feedback to the leadership team.
  2. Adapt the toolsA clear circuit and roles, a common template for describing the deviation (5W2H), a criticality grid leading to 5 possible decisions, a revised procedure.
  3. Decide togetherA collegial decision committee of 45 minutes maximum, by video call, supported for 8 sessions.
  4. Train and coach2 days of training in the ELEMENTAIRE method for 6 investigators, then side-by-side coaching on their real deviations.
  5. Manage every dayA visual board and a 15-minute daily check-in in 3 areas: manufacturing, packaging, quality control (BOOSTER).
  6. Clear the backlogA 2-day task force, then investigators dedicated 100% to handling deviations.

Shorter lead times, especially where it’s critical

Average deviation processing time, by criticality level, in February 2025 and February 2026.

February 2025February 2026
46 deviations in 2 days

The task force’s results, including 43 overdue deviations.

5 investigators out of 6

qualified in the ELEMENTAIRE method, and therefore autonomous.

Visible results

The visual board shows progress to everyone, which keeps people engaged.

Assess at opening

Each deviation is assessed within the flow, without waiting.

Our takeaways

The results don’t come from a tool, but from the combination of a common method, decisions made together and management kept up every day.

€0.9M to €1.1M a yearin non-quality costs avoided (A-QE estimate)

The approaches used

ELEMENTAIRE methodBOOSTER management

Our advice if you’re getting started

  • Entrust facilitation of the management system to assertive people, rather than to the investigators themselves.
  • Communicate every success: it keeps the teams’ energy up.

Worried about your deviation backlog?

Measure it in a few minutes with the free BOOSTER assessment, or let’s talk about your situation.

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