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Case study · Change control

Change control: 697 actions brought back under control in one summer

Hundreds of open change control actions, some with no clear owner, and an actual process far removed from the one expected by the group. With one day of workshop and then three weeks of facilitation, the site regained a shared view and regular management.

Pharmaceutical site of an international group · solid and liquid dosage forms2022Completed

The results

697change control actions mappedinitial status review
13 %of actions with no responsible areareassigned so they could be managed
1 dayof workshop to align process and roles2022–2023 process and RACI
3 wksto launch and fine-tune managementthen coaching of facilitators until the end of September

Status review carried out during the kick-off workshop, in spring 2022.

The starting point

  • 697 open change control actions, 65% of them owned by quality assurance and supplier quality assurance.
  • 93 actions (13%) with no identified responsible area: nobody was really following them up.
  • An actual process different from the one expected by corporate quality, and blurred roles between originator, QA and experts.
  • No common rule for prioritising: everything seemed equally urgent.

What we did together

  1. May 2022Align in one dayThe actual process built with the teams, difficulties listed, comparison with the process expected by the group, then the 2022–2023 process and the RACI.
  2. Prioritise simplyAn impact scale with 3 types (production, regulatory compliance, strategy) crossed with the estimated workload in days, to set 3 priority levels.
  3. Separate the backlogOverdue changes tracked in dedicated management, so as not to slow down new ones.
  4. Share out the follow-up3 specific management systems for system QA, QA and supplier QA; the other actions reassigned to departments (quality control, solid dosage forms, liquid dosage forms).
  5. 22 June 2022Launch and hand overManagement set up, 3 weeks of facilitation and fine-tuning, then coaching of internal facilitators until the end of September.

Where the 697 actions were

Number of open change control actions by area, at the status review.

A common impact scale

each change classified according to what a delay would prevent: producing, staying compliant, or making progress on strategy.

Quantified workload

from 0.25 to 60 days depending on difficulty, to plan what is realistic.

Clear roles

a RACI shared between originators, QA, experts and departments.

Actions tracked like CAPAs

in each area, in the same format and every two weeks.

Our takeaways

Change control rarely seizes up for lack of skills: it seizes up because nobody sees the whole picture and everything has the same priority. An honest map of the portfolio, simple prioritisation rules and management as close as possible to the areas are enough to get the flow moving again.

The approaches used

Change control

Our advice if you’re getting started

  • Start with the status review: knowing who owns what often reveals a large share of orphan actions.
  • Handle the backlog separately: it mustn’t slow down incoming changes.

Are your change controls piling up?

Let’s talk about your portfolio: together we’ll review the status and lay the foundations for simple management.

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