Management expertise · GARDER LE CAP method
Deviations, CAPAs and change controls piling up, clean-up task forces every year, swamped teams: it’s often your delays that run your quality. We put in place simple, visual, automated management that gives you back control from the third week.
64 → 18open deviations
31 → 1deviations more than 30 days overdue
50 % → 0CAPAs closed late
85 → 27 %change controls closed lateResults measured on several production sites, between the start of the approach and the end of the support, then confirmed one to three years later.
A quality system, however well designed, doesn’t work if it isn’t managed.And sometimes, regular management alone is enough to prevent drift.
If answering takes you more than five minutes, your management is probably ineffective, or non-existent.
Tracking the open items in your processes and how they evolve, week after week, gives a direct view of their health. Three situations are possible.
You are in balance: the team absorbs the normal flow. Watch out for the first workload peak, which can destabilise everything.
Danger: the team can no longer keep up with the flow. Lead times get longer and the quality of handling deteriorates.
You’re regaining control: the situation improves week after week.
We don’t sell you software: we put in place a management routine your teams sustain on their own.
An approach tuned to each process: BOOSTER for deviations, FOCUS for CAPAs, READY for change controls, FINISH for release. You start with the one that costs you the most.
BOOSTERFOCUSREADYFINISH
Physical or digital, it shows at a glance the open items, blocked files and the actions decided to unblock them. It is tailored to each process and simple to update.
visual managementblocked files
15 minutes a day for deviations, 30 minutes a week for CAPAs and change controls. The substance of the files isn’t dealt with there: we decide what moves them forward.
daily ritualdecisions
One tool per process, fed by an extract from your QMS or connected directly. Your indicators are up to date at all times, and you save at least one day of reporting a month.
real-time KPIsreporting
We measure the real handling workload, based on our benchmark: 2.5 h per minor deviation, 6 h per major, 21 h per critical (medians). Your teams’ capacity is sized on facts.
workload / capacitybenchmark
A member of your team is trained to run the management system, with our support and coaching. Your teams are autonomous from the third week, then we adjust the support to the size of the backlog.
internal leadautonomy
412 deviations in backlog and 161 blocked batches. BOOSTER management across 3 areas: visual management and a 15-minute daily ritual, plus a 2-day task force.
Overdue CAPAs every month, actions without an owner and limited visibility. FOCUS management: visual management of CAPAs and a 30-minute weekly ritual, extended to shared support services.
No prioritisation, the 30-day GMP deadline not met, delivery delays. Daily quality and production management with dated actions, then weekly management of CAPAs and change controls, until the internal lead was autonomous.
It means continuously tracking open items in quality processes (deviations, CAPA, change control, release), making blocked files visible and regularly deciding on actions to unblock them. Without management, these processes are driven by delays and release emergencies.
The key indicator is open items and how they evolve week after week: stable signals balance; rising, danger; falling, regained control. It is complemented by the number of overdue files and the average processing time.
Because they scatter information: everyone receives their reminders, but nobody sees the whole picture or what is blocking. Management puts a shared view back at the centre, with visual management and a ritual where decisions are made.
The first management rituals are running from the third week. The time needed to clear the backlog then depends on its size, hence support adjusted to each site.
No. Visual management can be physical or digital, and we provide an Excel tool per process, fed by a simple extract from your QMS, or connected directly for real-time indicators.
Sometimes, yes: regular management is often enough to prevent drift and clear a backlog. When the causes run deeper, for example weak investigations or recurring human errors, we combine it with our other expertise.
Tell us about your situation in thirty minutes. We’ll tell you which process to start with.