Our expertise
Expertise for every quality problem on your sites
Deviations, CAPA, human error, batch records, release: each area of expertise addresses a specific problem, with a method proven on more than 30 sites and measured results. We deal with the emergency, then with what caused it.
Where to start?
Describe your problem or browse the table: we’ll show you which expertise to activate, or the combination that works best.
| Topic | Your situation | What we do | Expertise to activate |
|---|---|---|---|
| Deviations, CAPA and change control | Our deviation backlog is exploding | A task force to put out the fire, and a method so it doesn’t flare up again. | |
| Deviations, CAPA and change control | Our CAPAs and change controls are drifting | Visual management and short rituals to regain control of delays. | |
| Deviations, CAPA and change control | The same errors keep coming back | The real causes of error, and shop-floor rituals that stop it from returning. | |
| Production and release | Our batch records keep coming back for correction | Simplified records, right first time, reviewed on the line. | |
| Production and release | Our batches are waiting to be released | We manage the flow to find the bottleneck, and we remove it, often in batch record review. | |
| Production and release | Our critical checks let errors through | Fewer checks, but genuinely effective ones, such as the V.A.K. check. | |
| Inspection and compliance | We’ve just had an inspection finding | We clear the backlog, make investigations reliable, then stop the drift from coming back. | |
| Inspection and compliance | An inspection is coming and we’re not ready | We take stock of open items and bring in reinforcements to clear the backlog in time. | |
| Inspection and compliance | Our investigations don’t find the real cause | Step-by-step investigations, and CAPAs that finally address the cause. | |
| Teams and organisation | We need extra hands, right now | Consultants trained in our methods, available at short notice. | |
| Teams and organisation | Our quality teams are swamped | We measure the real workload, prioritise, and reinforce where it’s needed. | |
| Teams and organisation | Our month-ends are a scramble | A predictable release flow, paced by its bottleneck. | |
| Teams and organisation | Our change controls are poorly described or poorly assessed | Change owners trained to describe, a multidisciplinary committee to assess impact, risk and effort. | |
| Teams and organisation | Quality is seen as the site’s police officer | We measure the quality culture of each population, align leadership and make Quality pragmatic. | |
| Teams and organisation | Our departments work in silos | A common goal for the leadership team, then departmental objectives consistent with it. | |
| Teams and organisation | Our teams are running without getting anywhere | An organisation aligned with processes: everyone knows what they own, and the medium term is no longer sacrificed. |
No situation matches exactly? Describe your problem to us: we’ll get back to you within 48 hours.
All our expertise
Each area of expertise, the problem it solves and a result measured on our assignments.
Deviation management
Decide fast, investigate step by step and manage the deviation portfolio.
Quality system management
Visual management, short rituals and automated indicators for deviations, CAPA and change control.
Reducing human error
Find the real causes and put in place the shop-floor rituals that prevent error.
Batch records
Simplify records and restructure their review flow.
Batch release flow
Make release visible, manage it and remove its bottlenecks one by one.
Quality culture
Evolve the quality culture from leadership to the shop floor, with concrete everyday tools.
Quality organisation
Align the Quality organisation with processes to gain capacity without extra pressure.
Documentation and training
Documentation and training that are genuinely useful at the workstation.
Change control
Change controls that get closed: well described, assessed in committee, managed through to closure.
Effective Quality Brigade
Consultants trained in our methods and equipped with our tools, available at short notice.
Polton
Our investigation AI: it decides nothing, but it augments investigators’ work.
The same way of working, whatever the expertise
In two days rather than two weeks, with our assessment tools.
A first project carried out together, which sets the rules and framework for your site.
Your teams replicate the approach, with our coaching on the shop floor.
Tapering support, until the approach lives on without us.
Frequently asked questions
How do I know which expertise to start with?
Start with the problem that costs you the most today: backlog, delays, recurring errors, blocked batches. Our free BOOSTER and FOCUS assessments, or a thirty-minute conversation with us, are usually enough to identify the right entry point.
Can several areas of expertise be combined?
Yes, and it’s common: quality system management often goes hand in hand with a deviation project, and simplifying batch records often goes with the release flow. We sequence the projects so as not to overload your teams.
Do you step in in emergencies?
Yes. Most of our clients call us after an inspection finding, when facing a backlog or blocked batches. We start by dealing with the emergency, then tackle what caused it.
Can you provide operational reinforcements?
Yes, with the Effective Quality Brigade: consultants trained in our methods and equipped with our tools, available at short notice to investigate, clear a backlog or fill a vacant position.
Do your methods apply to every site?
They have been deployed on more than 30 sites: CDMOs, pharmaceutical companies, biotechs, solid, liquid and sterile dosage forms, from SMEs to multi-site groups. We adapt them to each site, its organisation and its QMS.
Not sure where to start?
Tell us about your situation in thirty minutes. We’ll tell you which expertise to activate first.