Root Cause and CAPA Essentials
Almost every deviation record contains a sentence that reads like a cause and is not one. This course is about finding the sentence that is, and turning it into actions that can be shown to have worked.
Two investigation tools used properly, a way past “human error”, corrective and preventive actions that address the cause rather than the symptom, and the effectiveness check that clause 1.4(xiv) requires and most sites treat as paperwork.
Five things you will take back to site
One outcome per lesson. Each is practised in the lesson and tested at the end of it.
- Tell a cause from a symptomRecognise when an investigation has stopped at the event and not reached the condition that allowed it.
- Choose and run the right toolUse Five Whys and the Ishikawa diagram for the events they suit, set them up properly, and stop when the evidence runs out rather than when the form does.
- Get past human errorDistinguish slips, lapses, mistakes and violations, and find the condition that made the error easy, which is where the fix lives.
- Turn a cause into actionsWrite corrections, corrective actions and preventive actions that address the cause, using the hierarchy of controls to pick actions that hold.
- Show that it workedSet an effectiveness check that could fail, monitor it, and know what to do when it does.
Structured so that it stays with you
Short courses are usually forgotten within a month. This one is built around the few things that are known to make material stay: hearing it as well as reading it, being asked to recall it, and meeting the same ideas again in a different form.
Narrated throughout
Every topic is narrated, so you can listen and read together, or listen alone. Hearing and reading the same material is one of the simplest ways to make it stay.
Orientation in thirty seconds
Each topic opens with the whole argument in four lines. You know where you are going before you start, which is when new material is easiest to place.
Pause and answer
Every topic stops once and asks you a question about what you have just read, with feedback either way. Recalling something is what fixes it; re-reading it is not.
Three things to remember
Each topic ends with three sentences. Not a summary of everything, but the three things you would want back in six months.
A check at the end of every lesson
Three questions per lesson, then a twenty-question final assessment. Every question is answerable from the three things to remember. Nothing is tested that was not taught.
One case, worked through
A workshop that gives you a real situation and four decisions to make in writing, before you see how an experienced person would handle it.
Five lessons, in the order the work happens
Each lesson has three narrated topics and ends with a three-question knowledge check. After Lesson 5 comes the workshop, the final assessment, the job aids, and a short page on what to do in the next few weeks.
| Lesson | Title | What it covers | Basis in EudraLex Volume 4 |
|---|---|---|---|
| 1 | What a root cause is | Layers of cause, and the sentence that only looks like one. | Chapter 1, 1.4(xiv), 1.8(vii) |
| 2 | Getting to the cause | Defining the problem, then Five Whys and Ishikawa: when to use each, and when to stop. | Chapter 1, 1.4(xiv) |
| 3 | Human error is not the end | Slips, lapses, mistakes, violations, and the conditions behind them. | Chapter 1, 1.4(xiv) |
| 4 | Turning a cause into actions | Correction, corrective, preventive; the hierarchy of controls. | Chapter 1, 1.4(xiv); ICH Q10, 3.2.2 |
| 5 | Making it stick | Effectiveness checks that can fail, and what the CAPA system tells management. | Chapter 1, 1.4(xiv), 1.5 |
Who this course is for
Anyone who investigates, writes or approves an investigation or a CAPA. Production, QC, engineering and QA. It assumes you have seen a deviation record. It does not assume you have led an investigation.
Where it sits in EU GMP
Chapter 1, clause 1.4(xiv) requires investigation to the root cause, corrective and preventive action, and monitoring of effectiveness; clause 1.8(vii) repeats the duty for significant deviations. ICH Q10, section 3.2.2 describes the CAPA system, and Q10 is Part III of EudraLex Volume 4, so it is EU GMP.
Basis
EudraLex Volume 4, Chapter 1, clauses 1.4(xiv), 1.5 and 1.8(vii); Part III, ICH Q10, section 3.2.2
If you want the whole subject in an afternoon, and to still have it in six months, this is the course to start with.
Enrolment gives access to all five lessons, the narrated topics, the workshop, the final assessment and the printable job aids. Work through it at your own pace; your progress is saved.
