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Case study · Quality system management

More than 700 deviations a year: daily management that reduces the backlog from the first month

Delivery delays, the 30-day deadline not met, no prioritisation: we put in place daily management shared by quality assurance and production, then trained a lead until they were autonomous.

Pharmaceutical company · injectables unit of about 200 people2023 – 2025Completed

The results

23 → 16overdue deviationsin 1 month
−4 to 5 daysaverage processing time2023 → 2025
2 unitsmanaged from early 2025, ahead of other sites
35 %of deviations linked to the reject rate, identified by our analysis

“Overdue” deviations: those past the 30-day deadline.

The starting point

  • More than 700 deviations a year, in a unit of about 200 people.
  • No prioritisation: the oldest weren’t handled first, and the 30-day deadline wasn’t met.
  • Delivery delays, with an impact on revenue and customer satisfaction.
  • Successive reorganisations: a loss of visibility, and no real partnership between quality assurance and production.

What we did together

  1. FrameWorkshops on roles and responsibilities, and tools adapted to the site’s quality software.
  2. Manage every dayQA and production together, a daily extract, a visual board and the first-in, first-out rule.
  3. Date every actionAn owner named for each action, and priority handling of the backlog.
  4. Extend and make autonomousWeekly CAPA management, and coaching of the leads until they are autonomous.

What made the difference

“The lead is autonomous”

both management systems were launched successfully, and the production manager is “very satisfied”.

A deviation / event filter

to take deviations linked to the reject rate out of the heavy circuit.

An A3P workshop

co-led by the client and A-QE on quality management, in September 2025.

Then investigation

after an audit finding, QA asked for ELEMENTAIRE support.

Our takeaways

Management restored visibility and a shared language between quality assurance and production. The next bottleneck lies elsewhere: batch record review, a question of resources.

The approaches used

Our advice if you’re getting started

  • Manage in pairs, QA and production: each sees what is blocking on the other side.
  • Handle in order of arrival: it’s the simplest rule for melting the backlog.

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