Quality problems drain time, money, and trust. Most of them could be avoided, but too many teams stay trapped in a cycle of reacting instead of preventing.

CAPA, ‘Corrective and Preventive Action’, exists to break that cycle. It’s a core element of every quality system, yet many teams still blur the line between fixing an issue and stopping it from happening again.

This post clarifies the difference, why it matters, and how to use both approaches effectively in manufacturing environments.

Qu'est-ce qu'une action corrective par rapport à une action préventive ?

Toute entreprise utilisant un systèmeGestion de la qualité (SGQ (système de gestion de la qualité) ) sait à quel point les actions correctives et préventives sont importantes pour l'amélioration continue et la satisfaction du client.

Surtout si ce site SGQ (système de gestion de la qualité) est basé sur ISO 9001:2015, la norme internationale qui spécifie les exigences pour un site SGQ (système de gestion de la qualité).

Selon la norme ISO 9001, les différences entre les actions correctives (également connues sous le nom de réflexion basée sur le risque) et les actions préventives sont les suivantes :

8.5.2 Actions correctives : "L'organisme doit prendre des mesures pour éliminer les causes des non-conformités afin d'éviter qu'elles ne se reproduisent.

8.5.3 Actions préventives : "L'organisme doit déterminer les actions à entreprendre pour éliminer les causes des non-conformités potentielles afin d'éviter qu'elles ne se produisent."

En termes simples, l'action corrective permet d'éviter la récurrence, tandis que l'action préventive permet d'éviter l'occurrence. L'action corrective est menée après qu'une non-conformité s'est déjà produite, tandis que l'action préventive est planifiée dans le but d'empêcher la non-conformité dans son intégralité.

Exemple de mesures correctives ou préventives

Supposons que la non-conformité consiste à briser l'écran de votre téléphone. La mise en place d'une protection d'écran ou d'un étui sur votre téléphone serait une action préventive. L'achat d'un étui de téléphone pour éviter d'autres bris serait une action corrective.

L'essentiel est que la réparation de l'écran cassé n'est ni une action préventive ni une action corrective. Il s'agit d'une solution. En effet, les actions correctives et préventives doivent viser à empêcher la survenue d'une non-conformité, et non à corriger la non-conformité elle-même. Il est important de ne pas confondre ces actions avec des solutions.

Vous avez remarqué que l'achat d'un étui de téléphone relève à la fois de l'action préventive et de l'action corrective ? Tant que la solution empêche la récurrence ou l'occurrence, il n'y a pas d'action qui relève exclusivement de l'action préventive ou de l'action corrective.

Corrective vs. Preventive Action: Comparison Table

Aspect

Corrective Action

Action préventive

Déclencheur

A problem has already occurred

A potential issue is identified

Objective

Eliminate the cause of a nonconformity

Prevent the nonconformity from happening

Timing

Reactive

Proactive

ISO Clause

8.5.2

8.5.3 (replaced by risk-based thinking in 2015)

Tools

5 Whys, Root Cause Analysis, CAPA form

FMEA, Risk Assessment

Exemple

Fixing a defective batch process

Introducing predictive maintenance


Interpreting the Table

Corrective and preventive actions focus on different moments in the quality cycle.
Corrective action deals with the past, it investigates what failed, identifies why, and removes the cause so the same issue doesn’t repeat.

Preventive action looks ahead. It relies on tools like FMEA and risk assessment to uncover potential weak spots and take steps before they lead to nonconformities.

The most effective quality systems use both approaches. They solve problems quickly but also learn from them, strengthening processes to make future issues less likely.

Actions correctives et préventives pour une croissance continue

Les actions correctives et préventives sont destinées à durer. Ce sont des solutions qui doivent être mises en œuvre à long terme.

Mais comment ?

L'un des moyens de garantir Amélioration continue par le biais d'actions correctives et préventives consiste à se concentrer sur l'étape de vérification du cycle planifier-faire-vérifier-agir (PDCA). L'examen des résultats de l'étape "faire" est essentiel pour adopter de nouveaux processus et s'assurer que les responsables de processus ne reviennent pas à l'ancienne façon de faire les choses.

En outre, une analyse des causes profondes peut être utile pour identifier correctement le type d'action corrective à entreprendre. En remontant jusqu'à la racine de la non-conformité, on peut découvrir quelles actions seraient les plus efficaces pour éviter que cette non-conformité ne se reproduise.

Graphique illustrant des exemples d'actions correctives et préventives

Processus d'action corrective

  1. Identifier la cause première de la non-conformité
  2. Déterminer l'ampleur de cette non-conformité
  3. En fonction de la gravité de la non-conformité, prenez les mesures qui s'imposent.
    1. le rappel de produits
    2. informer les clients
    3. le déclassement ou la mise au rebut d'un produit
  4. Assurer le suivi des mesures prises et veiller à ce que la correction soit efficace et que la récurrence ait été évitée.

Processus d'action préventive

  1. Dresser la carte des différentes non-conformités susceptibles de se produire dans l'atelier.
  2. Prendre des mesures proactives pour créer un plan d'action pour ces éventuelles non-conformités
    1. Système de gestion et procédures documentés
    2. Audits de processus
    3. Des instructions de travail plus claires
    4. Formation complémentaire
    5. Communication fréquente entre les équipes impliquées
    6. Examen de la gestion

CAPA Process: From Detection to Prevention

A CAPA system only works when it’s treated as part of daily operations, not paperwork. The goal is simple: find what went wrong, fix it, and make sure it can’t happen again. Whether the trigger is a customer complaint, an audit note, or something spotted on the floor, every CAPA should follow the same path from discovery to prevention.

Step-by-Step CAPA Workflow

1. Identify and record the issue
Write down exactly what happened, where, and who found it. Clear details at this point make the rest of the process faster and more accurate.

2. Contain and investigate
Stop the problem from spreading like hold product, stop a line, whatever’s needed. Then dig into why it happened using tools like 5 Whys or a Fishbone chart.

3. Plan and apply the fix
Once the real cause is clear, put in a focused action that removes it. That could mean changing a work instruction, adjusting calibration, or providing refresher training.

4. Check that it worked
Follow up to see if the fix held. Use data, inspections, or trend reviews over time. If the issue shows up again, the cause wasn’t fully addressed.

5. Build prevention into the system
Use what you learned to strengthen other areas. Ask where the same weakness could exist and close those gaps before they create trouble.

CAPA and the PDCA Cycle

You can map CAPA steps to the PDCA approach:

Plan: Identify, contain, and analyze
Do: Apply corrective action
Check: Confirm results
Act: Extend preventive measures across the system

A well-run CAPA turns a single issue into lasting improvement. Each one adds a bit more resilience to the process and a bit less risk to tomorrow’s production run.

Common CAPA Challenges, and How to Avoid Them

Even when the process looks good on paper, CAPA can still miss the mark. The problem usually isn’t the people doing the work. It’s the system—too much admin, unclear roles, or weak follow-up.

Frequent Problems

Too much paperwork
CAPA turns into a document chase. Teams end up managing forms instead of fixing what failed.

Root cause not nailed down
When the analysis stops at symptoms, the same issue keeps showing up. Sometimes it’s a different product, same cause.

No real follow-through
Corrective actions get written up, but no one checks if they worked. The issue slips back into production a few months later.

How to Keep It on Track

  • Give one person ownership. Someone has to be clearly responsible for closing each CAPA.

  • Use simple digital tracking. A shared dashboard beats buried spreadsheets every time.

  • Watch live data. Seeing trends early helps you focus on what’s actually risky, not what’s just loud.

Tools like Tulip help with this part. You can build CAPA tracking into the workflow, tie it to production data, and see what’s moving or stuck. Less paperwork, better visibility, fewer repeats.

CAPA in Regulated Industries:

In regulated manufacturing like medical devices, pharma, aerospace, electronics CAPA isn’t optional. It’s a compliance requirement.

FDA 21 CFR Part 820, ISO 13485, and GMP rules all expect companies to keep a documented system that not only fixes problems but also prevents them from coming back.

What’s Different in 2025

The FDA has now completed its update to align the Quality System Regulation with ISO 13485:2016. That change, finalized in 2024, pushes manufacturers to treat CAPA as part of an integrated, risk-based quality system, not a checklist that sits on the side.

It’s the same direction ISO 9001 took years ago when “preventive action” became part of risk management. The expectation is that teams think about risk before a failure happens, not after. That mindset should show up everywhere, from product design and process development to production monitoring and post-market work.

What This Means Day to Day

  • CAPAs need to be tied to data and formal risk assessments.

  • Auditors will want proof that actions worked, not just plans or meeting notes.

  • Preventive steps should appear as part of ongoing QMS reviews, not as one-time fixes.

The takeaway is simple: regulators now expect CAPA to live inside the rhythm of operations. It has to connect to real risks, show measurable follow-through, and feed continuous improvement, not just satisfy an audit form.


Foire aux questions
  • What’s the difference between containment and corrective action?

    Containment is a short-term control. It keeps the problem from spreading i.e. by holding product, stopping a line, or isolating material. Corrective action goes deeper. It removes the cause so the issue can’t repeat.

  • How do internal audits support preventive action?

    Audits reveal patterns and weak spots before they turn into nonconformities. The findings often feed into risk assessments and preventive steps within an ISO-based quality system.

  • Can poor CAPA documentation lead to regulatory findings?

    Yes. Auditors often cite incomplete CAPA records like missing root cause details, verification results, or closure evidence. It’s one of the most common reasons for FDA 483s in medical device inspections.

  • How does change management affect CAPA effectiveness?

    A CAPA can fail if process changes never take hold. Training, communication, and follow-up checks keep improvements in place once the record is closed.

  • Can machine data trigger preventive actions automatically?

    It can. Live production data such as temperature swings, cycle time changes, or abnormal vibration can flag early risk. When connected to digital quality systems, those signals can start a preventive review before any defect appears.

Améliorez votre processus de gestion CAPA avec Tulip

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Illustration d'un jour dans la vie d'un CTA