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Case study · Quality system management

15-minute rituals: deviation backlog from 20 to 2, and no more overdue CAPAs

On a site with 1,300 deviations a year, we started small: a pilot workshop, short rituals and a visual board. The results were judged good enough to aim for a group standard.

API manufacturer · site of about 800 people2021 – 2022Completed

The results

20 → 2overdue deviations in the pilot workshopSept. 2021 → Apr. 2022
5 → 0CAPAs closed late in the pilot workshopJuly 2021 → Apr. 2022
13 → 6overdue deviations in a 2nd areaOct. 2021 → Apr. 2022
5 → 4rituals per week: there is less to handle

“Overdue” deviations: open for more than 30 days. Measurements taken from the site’s weekly reports.

The starting point

  • 1,300 deviations in 2020, and many CAPAs closed late.
  • Whether a deviation was opened depended on the person.
  • Criticality assessed without taking detectability into account, and an investigation depth unrelated to risk.
  • Investigations carried out at the end of the deadline, on day 30, and about 10% of unnecessary CAPAs (65 in one year).

What we did together

  1. Start smallA pilot workshop of 80 people, then a 2nd area, then preparation of the next ones.
  2. Manage through ritualsA 15-minute daily deviation check-in and a 30-minute weekly CAPA check-in, in front of a visual board (BOOSTER and FOCUS).
  3. Equip decisionsA 2-day workshop: “deviation or not” filter, criticality grid, depth of investigation.
  4. Train and coach2 days of introduction, 7 individual 3-hour coaching sessions, 4 group sessions and an online platform.
  5. 2022WidenA 2nd wave: 29 people coached remotely, after the online training.

The backlog melts week after week

Deviations open for more than 30 days in the pilot workshop.

“Calmer inspections”

with consistent deviation reports that anyone can present (production QA manager).

“The same method for everyone”

the site creates its own internal qualification pathway.

A group standard

targeted thanks to the pilot’s results.

The key: perseverance

keep up the rituals, even when everything is going better.

Our takeaways

Success depends less on the tool than on discipline: short rituals, kept up every day, that move blocked issues forward.

The approaches used

Garder le capBOOSTER assessmentFOCUS assessment

Our advice if you’re getting started

  • Start with a pilot scope: visible results convince the next areas.
  • Keep the rituals going over time: perseverance is what delivers the result.

Are your deviations and CAPAs piling up?

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