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.
What is Corrective Action vs Preventive Action (Preventative Action)?
Any company using a Quality Management System (QMS) knows how important Corrective and Preventive Actions are to continual improvement and customer satisfaction.
Especially, if that QMS is based on ISO 9001:2015, the international standard that specifies requirements for a QMS.
According to ISO 9001, the differences between Corrective (also known as risk-based thinking) and Preventive actions are:
8.5.2 Corrective Actions: “The organization shall take action to eliminate the causes of nonconformities in order to prevent a recurrence.”
8.5.3 Preventive Actions: “The organization shall determine action to eliminate the causes of potential nonconformities in order to prevent their occurrence.”
In simple terms, corrective action prevents recurrence, while preventive action prevents occurrence. Corrective action is carried out after a nonconformity has already occurred, whereas preventive action is planned with the goal of preventing a nonconformity in its entirety.
Corrective vs Preventive Example
Let’s say that the nonconformity is breaking your phone screen. Putting a screen protector or a case on your phone would be a preventive action. Purchasing a phone case to prevent additional breakage would be the corrective action.
The key here is that fixing the broken screen is neither a preventive action nor a corrective action. It is a solution. This is because corrective and preventive must be actions taken towards preventing a nonconformity from happening, not fixing the nonconformity itself. It is important not to confuse these actions as solutions.
Notice how buying a phone case is both a part of preventive and corrective action? As long as the solution prevents recurrence or occurrence, there is no one action that exclusively belongs to either preventive or corrective.
Corrective vs. Preventive Action: Comparison Table
Aspect | Corrective Action | Preventive Action |
Trigger | 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 |
Example | 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.
Manage and track all deviations, quality events, and CAPAs
Capture quality events and CAPAs, assign the appropriate people to each event, and require certain fields as the event moves throughout different states of the investigation process.
Corrective and Preventive Action For Continual Growth
Corrective and preventive actions are meant to stick. They are solutions that need to be carried out long-term.
But how?
One way of ensuring continuous improvement through corrective and preventive action is to focus on the check step of the plan-do-check-act (PDCA) cycle. Reviewing the results from the Do stage is essential to adopting new processes and ensuring that process owners do not backslide into the old way of doing things.
In addition, a root cause analysis may be helpful in correctly identifying what kind of corrective action should be taken. Drilling down to the root of nonconformity can unveil what actions would be most effective in preventing that nonconformity from happening again.
Corrective Action Process
- Identify the root cause of the nonconformity
- Determine the magnitude of that nonconformity
- Depending on the severity of that nonconformity, take appropriate action
- recalling products
- notifying customers
- downgrading or scrapping product
- Follow up with the actions taken and ensure that the correction is effective and recurrence has been prevented
Preventive Action Process
- Map out the different possible nonconformities that may occur on the shop floor
- Take proactive steps to create an action plan for those possible nonconformities
- Documented management system and procedures
- Process Audits
- Clearer Work Instructions
- Additional Training
- Frequent Communication between Involved Teams
- Management Review
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.
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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.
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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.
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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.
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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.
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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.
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