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Online training · ELEMENTAIRE method (course in French)

Investigate your deviations with the ELEMENTAIRE method, at your own pace

Online training since 2019, taken by more than 1,000 people

A step-by-step approach so you never sit in front of a blank page again: know which tool to use and when, adjust the effort to the level of risk, and deliver clear, consistent reports.

Sign up for the trainingSee the content

The investigator’s blank page

A new investigation starts, and it’s always the same. We’ve been trained: 5M, 5 Whys, 5W2H… But which one to use, and when? So we put it off. And we end up three days before closure with not much to show, rushing an investigation we’re not very proud of.

And when the inspection approaches, each investigator has improvised their own method and report format: a patchwork that isn’t always understandable, which ends up in the inspector’s hands. The ELEMENTAIRE method was recognised as good practice by an FDA inspector, on a site where it was deployed.

What is the ELEMENTAIRE method?

A standard investigation approach that applies to all deviations from the moment the event is detected. It structures and guides nine steps:

  1. Describing the event
  2. Initial assessment: is it a deviation?
  3. Identifying and handling impacts
  4. Searching for initial causes
  5. Assessing criticality and depth of investigation
  6. Searching for root causes
  7. Identifying and handling wider impacts
  8. Defining CAPAs
  9. Writing the final report
Proportionate effortAs GMP recommends, the depth of the investigation is adjusted to the level of risk.
Objective riskThe risk level is assessed according to severity, occurrence and detectability.
Cumulative toolsWell-known, recognised tools, added one after another according to the level of risk.
A first common toolThe situation comparison diagram, used for all deviations.

What the training includes

Lifetime accessand updates with every improvement
22 lessonsin 10 sections, one per investigation step
1.5 hours of videoin sequences of 4 minutes on average
Exercises at every stepquizzes, open questions, point-and-click cases, cases from your daily work
12 ready-to-use toolsto start investigating right away
15 cheat sheets9 on investigation tools, 6 on decision tools
1 assessment toolsimple to use
1 coaching gridor self-coaching grid, to measure skills development
1 sample procedurefor deviation handling
1 online communityto ask your questions to the coach and other trained people

A course designed for practice

Each section corresponds to a step of the method, and each lesson combines a short video with concrete exercises: open questions, quizzes, generic point-and-click cases, and cases drawn from your daily work. For each lesson, you download the corresponding tools and cheat sheet, and you unlock an achievement at each major step completed. Stuck on an exercise or a question specific to your site? The community answers, either the Académie’s coach or another trained person.

12 tools and 15 cheat sheets

12 ready-to-use tools

  • 5W2H form (Word)
  • 5W2H form (PowerPoint)
  • Description template
  • Hazard, Risk, Impact template
  • Risk handling history
  • Condition comparison diagram
  • Condition comparison table
  • Sample Severity × Occurrence × Detectability matrix
  • Romanesco diagram
  • CAPA description template
  • Investigation report template
  • A3 shop-floor investigation template

9 investigation cheat sheets

  • The investigation steps
  • The 5W2H
  • Hazard, Risk, Impact
  • The situation comparison diagram
  • The condition comparison table
  • The Romanesco diagram
  • Sequential search for wider impacts
  • Relevant CAPAs
  • The investigation report

6 decision cheat sheets

  • The deviation or no deviation filter
  • Severity × Occurrence × Detectability criteria
  • The criticality matrix
  • The investigation depth matrix
  • The wider impact assessment matrix
  • The CAPA needs assessment matrix

What trained people say

“I can’t wait to get the inspectors’ feedback on our investigation method: it’s the first time I’ve had such a complete, structured method on a site!”
Operational Quality Manager
“The method helps me a lot: I waste less time getting my investigations started, and now my reports sail through quality assurance!”
Investigator
“By applying the method from the training, I finished my investigation in two days, when before it would have taken me more than a week. And the QA approver was very happy with the result!”
Investigator

Testimonials anonymised, for reasons of confidentiality with our clients.

Complete online training path, with hands-on practice

Immediate access to the training and the community.

Sign up for the trainingRoll out the approach on my site

Frequently asked questions

Who is ELEMENTAIRE Online for?

Investigators, technicians and Quality managers who handle deviations in the pharmaceutical industry, and who want a structured method to get started quickly and write consistent reports.

How long does the training take?

The course has 1.5 hours of video, split into sequences of 4 minutes on average, plus the exercises. You go at your own pace, with lifetime access.

Can the method be rolled out across a whole site?

Yes. The online training suits one person or a small team. To roll out the full approach on a site, with coaching of investigators and committees, we support you directly.