Corrective Action (CAPA) – Complete Guide (ISO 9001, ISO 14001 & ISO 45001)

Introduction

Every organization may face problems such as customer complaints, product defects, workplace accidents, audit findings, equipment failures, or environmental incidents. Simply fixing the problem is not enough—the organization must identify the root cause and prevent the issue from happening again. This process is called Corrective Action (CAPA).

According to ISO 9001:2015, ISO 14001:2015, and ISO 45001:2018 (Clause 10.2), organizations must react to nonconformities, eliminate their causes, implement corrective actions, and review their effectiveness.

Problems can occur in every organization.

A customer may receive incorrect material.
A chemical spill may occur.
An employee may report an unsafe condition.
An internal audit may identify a nonconformity.
A safety inspection may find blocked emergency access.

Simply correcting the immediate problem is not always enough.

The organization should also understand:

What happened?
Why did it happen?
Why was it not detected earlier?
What action is required?
How can recurrence be prevented?
Was the action effective?

This is where Corrective Action and CAPA become important.

CAPA is commonly used to describe a structured approach for addressing problems, their causes, and prevention of recurrence.

In an Integrated Management System (IMS), corrective action can support:

ISO 9001 – Quality Management
ISO 14001 – Environmental Management
ISO 45001 – Occupational Health & Safety

Good corrective action does not simply fix the problem—it addresses the cause and verifies that the problem is unlikely to happen again.

What is Corrective Action?

Corrective action is action taken to eliminate the cause of a nonconformity or undesirable situation in order to prevent recurrence.

For example:

Problem

A chemical drum is found damaged during warehouse inspection.

Immediate Correction

The damaged drum is isolated and safely handled.

Corrective Action

Investigate why the drum was damaged and improve the relevant handling/storage controls.

The first action controls the immediate situation.

The second action addresses the underlying cause.

What is CAPA?

CAPA stands for:

Corrective Action and Preventive Action.

The term CAPA is widely used in quality, safety, environmental, pharmaceutical, manufacturing, and other management systems.

In modern ISO management-system thinking, the emphasis is strongly on:

Correcting nonconformities.
Determining causes.
Preventing recurrence.
Considering similar problems elsewhere.
Continually improving the management system.

Therefore, organizations should not treat CAPA as simply filling out a form.

Correction vs Corrective Action

These two terms are important.

Correction

Action taken to eliminate a detected nonconformity.

Corrective Action

Action taken to eliminate the cause of the nonconformity and prevent recurrence.

Example

Problem: Emergency contact board contains an outdated phone number.

Correction: Replace the incorrect number.

Corrective Action: Review the process that controls emergency-contact information and add periodic verification.

The correction fixes the immediate problem.

The corrective action improves the system.

Why is CAPA Important?

CAPA helps organizations:

Prevent recurring problems.
Improve processes.
Reduce incidents.
Improve customer satisfaction.
Improve environmental performance.
Improve workplace safety.
Address audit findings.
Identify root causes.
Strengthen controls.
Support continual improvement.

Without effective corrective action, the same problem may occur repeatedly.

CAPA in an Integrated Management System

CAPA can be applied across the three major IMS areas.

Standard	CAPA Focus
ISO 9001	Product, service and process quality
ISO 14001	Environmental nonconformities and impacts
ISO 45001	OH&S incidents, hazards and nonconformities

A common CAPA process can be used while considering the specific requirements of each management system.

CAPA and ISO 9001

Under ISO 9001, corrective action can be related to:

Customer complaints.
Incorrect products.
Wrong quantity.
Damaged material.
Process errors.
Documentation errors.
Supplier issues.
Delivery problems.
Internal audit findings.

Example

Problem: Customer receives incorrect quantity.

Correction: Arrange the required correction with the customer.

Root Cause: Quantity verification was not effectively completed before dispatch.

Corrective Action: Improve dispatch verification and train responsible employees.

Effectiveness: Monitor subsequent dispatches for recurrence.

CAPA and ISO 14001

Environmental corrective action can address:

Chemical spills.
Waste segregation problems.
Incorrect waste disposal.
Environmental incidents.
Excessive resource consumption.
Leakage.
Environmental compliance issues.
Audit findings.

Example

Problem: Chemical leakage found near storage area.

Correction: Stop/control the leakage and clean the affected area safely.

Root Cause: Damaged packaging was not identified during inspection.

Corrective Action: Strengthen packaging-condition inspections.

Effectiveness: Monitor subsequent inspections and confirm no recurring leakage.

CAPA and ISO 45001

Safety corrective action may address:

Workplace accidents.
Near misses.
Unsafe conditions.
Unsafe acts.
HIRA control failures.
PPE non-compliance.
Emergency drill gaps.
Unsafe stacking.
Manual-handling incidents.
Fire-safety findings.
Internal audit findings.

Example

Problem: Emergency exit found partially blocked.

Correction: Remove the obstruction immediately.

Root Cause: Emergency-route inspection was not adequately included in the workplace inspection process.

Corrective Action: Update the inspection checklist and establish responsibility for periodic verification.

Effectiveness: Review subsequent inspections and confirm the route remains clear.

When is CAPA Required?

CAPA may be initiated when there is:

Nonconformity.
Customer complaint.
Accident.
Near miss.
Environmental incident.
Audit finding.
Repeated unsafe condition.
Repeated process failure.
Legal/compliance issue.
Significant inspection finding.
Emergency drill failure.
Repeated employee complaint.
Supplier-related problem.

Not every minor observation necessarily requires a formal CAPA.

The organization should determine the appropriate response based on the significance and risk of the issue.

Sources of CAPA

CAPA can originate from:

Internal Sources

Internal audits.
Workplace inspections.
HIRA reviews.
Environmental inspections.
Quality inspections.
Management reviews.
Employee suggestions.
Near-miss reports.
Incident investigations.
Mock drills.

External Sources

Customer complaints.
Supplier problems.
External audits.
Certification-body findings.
Regulatory inspections.
Legal/compliance findings.
External stakeholder feedback.

CAPA Process

A practical CAPA process can be:

Identify Problem

↓

Immediate Correction

↓

Evaluate Risk

↓

Investigate Cause

↓

Root Cause Analysis

↓

Develop Corrective Action

↓

Assign Responsibility

↓

Set Target Date

↓

Implement Action

↓

Verify Effectiveness

↓

Close CAPA

↓

Continual Improvement

Step 1 – Identify the Problem

The first step is to clearly describe what happened.

A good problem statement should answer:

What happened?
Where?
When?
Which process?
What requirement was not met?

Weak Statement

Safety issue found.

Better Statement

During the warehouse inspection, one emergency exit route was found partially obstructed by stored material.

The second statement provides much more useful information.

Step 2 – Immediate Correction

Control the immediate problem.

Examples:

Remove obstruction.
Replace damaged material.
Correct the document.
Clean the spill.
Provide missing PPE.
Repair damaged equipment.
Correct wrong information.

Immediate correction should not be confused with root-cause corrective action.

Step 3 – Evaluate Risk

Before deciding the corrective action, evaluate the significance of the problem.

Consider:

Severity.
Likelihood.
Frequency.
Legal implications.
Environmental impact.
Customer impact.
Worker-safety impact.
Potential recurrence.

Higher-risk problems may require stronger and faster corrective action.

Step 4 – Investigate the Problem

Collect relevant information.

Possible sources include:

Photos.
Inspection records.
Training records.
Work instructions.
Previous incidents.
Previous audit findings.
Interviews.
CCTV where available.
Maintenance records.
Material records.
HIRA.
Environmental aspect records.

The objective is to understand what actually happened.

Step 5 – Root Cause Analysis

Root Cause Analysis (RCA) helps determine why the problem occurred.

Common methods include:

5 Why Analysis.
Fishbone/Ishikawa Diagram.
Fault Tree Analysis.
Process analysis.
Barrier analysis.
Cause-and-effect analysis.

The selected method should be appropriate to the issue.

5 Why Analysis Example

Problem

Emergency exit was blocked.

Why 1

Why was the exit blocked?

Because material was temporarily placed near the exit.

Why 2

Why was material placed there?

Because there was insufficient temporary storage space.

Why 3

Why was temporary storage space insufficient?

Because storage planning did not define a designated temporary holding area.

Why 4

Why was this not identified?

Because the workplace inspection did not specifically check temporary storage practices.

Root Cause

The storage/inspection process did not adequately control temporary material placement.

Corrective Action

Define a designated temporary storage area and include temporary-storage control in the inspection checklist.

Fishbone Analysis

A Fishbone Diagram can investigate possible causes under categories such as:

People.
Process.
Equipment.
Material.
Environment.
Method.
Measurement.

For example, if damaged material is repeatedly found:

People

Insufficient training.
Lack of awareness.

Process

Weak handling procedure.
Inadequate inspection.

Equipment

Damaged pallet.
Unsuitable handling equipment.

Material

Weak packaging.
Improperly packed material.

Environment

Congested storage area.
Poor access.

The investigation should be based on actual evidence rather than assumptions.

Step 6 – Develop Corrective Action

The action should address the identified cause.

Examples:

Revise SOP.
Improve inspection checklist.
Provide training.
Change storage arrangement.
Repair equipment.
Introduce additional control.
Improve identification.
Modify workflow.
Increase monitoring.
Add management verification.

The action should be specific and measurable where possible.

Step 7 – Assign Responsibility

Every corrective action should have a responsible person or department.

Example:

Action	Responsible
Revise SOP	HSE / Process Owner
Employee training	HR / Department
Storage improvement	Warehouse
Equipment repair	Maintenance
Effectiveness monitoring	Department Head

Avoid assigning CAPA simply to "Management" when a specific process owner can be identified.

Step 8 – Set Target Date

Each action should have a realistic target date.

For example:

CAPA No.	Action	Responsible	Target Date
CAPA-01	Update inspection checklist	HSE	15-08-2026
CAPA-02	Conduct employee training	HR/HSE	18-08-2026
CAPA-03	Verify effectiveness	HSE	30-09-2026

The target date should be based on risk and complexity.

Step 9 – Implement Corrective Action

The responsible person should complete the action and maintain evidence.

Evidence may include:

Revised SOP.
Training attendance.
Photographs.
Inspection records.
Purchase records.
Maintenance records.
Updated checklist.
Monitoring data.
Meeting minutes.

Step 10 – Verify Effectiveness

This is one of the most important parts of CAPA.

Ask:

Did the corrective action actually solve the problem?

Do not close CAPA merely because the action was completed.

Example

Action:

Employee training completed.

This confirms the training occurred.

But effectiveness should ask:

Has the unsafe condition reduced after training?

Possible verification:

Repeat inspection.
Observation.
Review of incidents.
Review of near misses.
KPI monitoring.
Audit.
Sampling.

Effectiveness Verification Example

Finding

PPE compliance was low.

Action

Employee training completed.

Effectiveness Check

Conduct three subsequent workplace observations.

Observation	PPE Compliance
Week 1	95%
Week 2	100%
Week 3	100%

The organization can then determine whether the corrective action was effective according to its defined criteria.

Step 11 – CAPA Closure

CAPA can be closed when:

Immediate correction is completed.
Root cause is identified.
Corrective action is implemented.
Evidence is available.
Effectiveness is verified.
Responsible person/authorized reviewer approves closure.

CAPA Record Format

A practical CAPA form may contain:

Field	Details
CAPA No.
Date
Source	Audit / Complaint / Incident / Inspection
Department
Description of Problem
Requirement
Immediate Correction
Risk Evaluation
Root Cause
Corrective Action
Responsible Person
Target Date
Completion Date
Evidence
Effectiveness Criteria
Effectiveness Result
Status	Open / Closed
Verified By
Closure Date

Integrated CAPA Example

Consider a chemical warehouse where a damaged chemical bag is found.

Problem

Damaged chemical bag found during warehouse inspection.

ISO 9001 – Quality

Potential product damage and customer complaint.

ISO 14001 – Environment

Potential chemical leakage and waste generation.

ISO 45001 – Safety

Potential employee chemical exposure.

Immediate Correction

Isolate damaged bag.
Prevent further handling.
Assess condition.
Use appropriate PPE.
Follow applicable SDS/emergency procedure.

Investigation

Review:

Storage arrangement.
Handling activity.
Pallet condition.
Packaging.
Employee handling.
Previous damage records.

Root Cause

Example:

Damaged pallet was used for material storage and was not identified during the pre-use inspection.

Corrective Action

Improve pallet inspection.
Remove damaged pallets.
Train warehouse personnel.
Include pallet condition in inspection checklist.

Effectiveness Verification

Review pallet inspections and material-damage records over the defined monitoring period.

This is an excellent example of IMS-based CAPA thinking.

CAPA and Incident Investigation

CAPA often follows incident investigation.

For example:

Incident

Employee slips near warehouse entrance.

↓

Investigation

Wet surface identified.

↓

Root Cause

Water entered the area during cleaning and no temporary warning/signage was provided.

↓

Corrective Action

Improve cleaning procedure and introduce temporary warning signage.

↓

Effectiveness

Monitor the area during subsequent inspections.

CAPA and Near Miss

Near misses can also be used for preventive improvement.

Near Miss

A pallet almost falls because of unstable stacking.

Immediate Action

Restack the material safely.

Investigation

Review:

Stacking height.
Pallet condition.
Material arrangement.
Employee practices.
Storage instructions.

Corrective Action

Improve stacking controls and provide employee awareness training.

This can prevent a near miss from becoming an actual injury or material-damage incident.

CAPA and Audit Findings

Auditors may identify nonconformities.

A suitable response should include:

Correction.
Cause analysis.
Corrective action.
Implementation.
Evidence.
Effectiveness verification.

Example

Audit Finding:

Emergency exit inspection records were not maintained as required.

Correction:

Conduct inspection and complete the required record.

Root Cause:

The responsibility for maintaining the inspection record was not clearly assigned.

Corrective Action:

Assign responsibility and include record verification in the periodic inspection process.

Effectiveness:

Review subsequent records to confirm consistent implementation.

CAPA and HIRA

CAPA findings may indicate that HIRA controls need review.

For example:

Finding

Employees are repeatedly exposed to a manual-handling risk.

CAPA Investigation

The existing HIRA control may not be effective.

Action

Review:

Hazard identification.
Risk rating.
Existing controls.
Additional controls.
Training.
Work method.

The HIRA should be updated when the organization's process requires it.

CAPA and Environmental Aspects

Environmental findings can indicate that environmental controls require improvement.

Example:

Finding

Mixed waste found in designated segregated waste bins.

Root Cause

Employees were not clearly aware of the segregation categories.

Corrective Action

Improve signage.
Conduct awareness training.
Review waste-bin identification.
Include segregation in workplace inspections.

Effectiveness

Monitor waste segregation during subsequent inspections.

CAPA and Legal/Compliance Issues

If a legal or compliance requirement is not met, the organization should:

Identify the requirement.
Control the immediate noncompliance.
Assess risk.
Determine cause.
Take corrective action.
Verify compliance.
Maintain evidence.

Legal requirements should be managed carefully and, where necessary, supported by competent professional advice.

CAPA Prioritization

Not all CAPAs have the same priority.

A simple classification can be:

Critical

Potential for serious injury, major environmental impact, major customer impact, or significant compliance risk.

Major

Significant recurring problem or system weakness.

Minor

Limited-impact issue that does not represent significant immediate risk.

The organization's approved procedure should define the actual classification criteria.

CAPA Tracking

A CAPA register helps monitor open and closed actions.

CAPA No.	Date	Source	Issue	Responsible	Due Date	Status
CAPA-001	___	Audit	Exit obstruction	Warehouse	___	Open
CAPA-002	___	Near Miss	Unsafe stacking	Warehouse	___	Closed
CAPA-003	___	Inspection	Waste segregation	HSE	___	Open

A CAPA register should be reviewed periodically.

CAPA Status

Common status categories include:

Open.
Under Investigation.
Action in Progress.
Awaiting Verification.
Effective.
Closed.
Not Effective / Reopened.

If effectiveness verification shows that the problem continues, the CAPA may need further investigation or stronger action.

CAPA Common Mistakes

1. Only Correcting the Immediate Problem

Example:

Blocked exit removed.

But the reason why it became blocked is never addressed.

2. Weak Root Cause

Employee mistake.

This may not explain why the system allowed the mistake.

3. Training as the Only Corrective Action

Training may be useful, but it is not always sufficient.

4. No Effectiveness Verification

Completing an action does not automatically prove effectiveness.

5. Unrealistic Target Dates

Actions should have practical deadlines.

6. No Evidence

Completed actions should have appropriate supporting evidence.

7. Repeated CAPAs

If the same problem keeps returning, the root cause or corrective action may not be adequate.

8. Closing CAPA Too Quickly

Do not close before effectiveness is established where required.

9. No Risk Consideration

CAPA priority should consider the significance of the issue.

10. Treating CAPA as Audit Paperwork

CAPA should improve the actual process.

How to Make CAPA More Effective

1. Write a Clear Problem Statement

Avoid vague descriptions.

2. Separate Correction from Corrective Action

Fix the current problem first, then address its cause.

3. Use Evidence

Base the investigation on actual information.

4. Identify System Causes

Look beyond individual mistakes.

5. Use the Right RCA Method

5 Why, Fishbone, or another suitable method.

6. Choose Strong Controls

Where appropriate, improve the process rather than relying only on awareness.

7. Assign Clear Responsibility

One responsible owner should be identified.

8. Set a Target Date

Track completion.

9. Verify Effectiveness

Use measurable evidence where possible.

10. Share Lessons Learned

Apply learning to similar processes where relevant.

CAPA and Hierarchy of Controls

For safety-related CAPA, corrective actions should consider the hierarchy of controls.

Generally:

Elimination.
Substitution.
Engineering Controls.
Administrative Controls.
PPE.

For example, if employees repeatedly face a manual-handling hazard:

Weak Action

Give another safety training.

Stronger Approach

Evaluate whether the manual handling can be:

Eliminated.
Reduced through mechanical handling.
Controlled through equipment.
Improved through work methods.
Supported by training and PPE.

Training and PPE may remain important, but they should not automatically be the only solution.

CAPA Continual Improvement Cycle

Problem Identified

↓

Correction

↓

Root Cause

↓

Corrective Action

↓

Implementation

↓

Effectiveness Verification

↓

Lessons Learned

↓

Process Improvement

↓

Continual Improvement

CAPA Do's

✔ Clearly describe the problem.

✔ Take immediate correction where required.

✔ Evaluate risk.

✔ Investigate the cause.

✔ Use evidence.

✔ Identify root causes.

✔ Assign responsibility.

✔ Set realistic deadlines.

✔ Maintain evidence.

✔ Verify effectiveness.

✔ Review similar processes where relevant.

✔ Update procedures/risk assessments when required.

CAPA Don'ts

❌ Do not simply blame an employee.

❌ Do not close CAPA without evidence.

❌ Do not confuse correction with corrective action.

❌ Do not use training as the automatic solution to every problem.

❌ Do not ignore recurring problems.

❌ Do not skip root-cause analysis for significant issues.

❌ Do not leave CAPAs without responsible persons.

❌ Do not set unrealistic target dates.

❌ Do not forget effectiveness verification.

❌ Do not treat CAPA only as an ISO audit requirement.

Practical CAPA Example – Warehouse

Finding

During a monthly warehouse inspection, one chemical container was found with damaged outer packaging.

Immediate Correction

The material was isolated and the packaging condition was assessed according to the applicable procedure/SDS.

Investigation

The team reviewed:

Material handling.
Pallet condition.
Storage arrangement.
Previous damage records.
Employee handling practices.

Root Cause

The pallet condition was not adequately checked before material placement.

Corrective Action

Introduce pallet-condition inspection.
Remove damaged pallets.
Train warehouse personnel.
Update inspection checklist.
Monitor material damage for the defined period.

Effectiveness Verification

Subsequent warehouse inspections and damage records are reviewed to determine whether similar damage has recurred.

Result

If the defined effectiveness criteria are achieved, the CAPA can be closed.

Personal Experience

From my experience in warehouse safety and ISO management systems, the biggest mistake in CAPA is treating the finding as something that needs to be closed for the auditor. A good CAPA should improve the actual workplace. For example, if a chemical package is repeatedly damaged, simply replacing the package is not enough. We need to understand whether the problem is related to pallet condition, handling method, storage arrangement, employee training, packaging, or inspection controls. When the root cause is addressed and effectiveness is verified, CAPA becomes a useful tool for continual improvement rather than just paperwork.

Key Learning

Correction fixes the immediate problem.
Corrective action addresses the cause.
Root Cause Analysis is important for significant problems.
CAPA can support ISO 9001, ISO 14001 and ISO 45001.
Corrective actions should be risk-based.
Evidence should support the investigation.
Responsibility and target dates should be clear.
Effectiveness verification is essential.
Repeated problems require deeper investigation.
CAPA should improve the management system.

Frequently Asked Questions (FAQ)

Q1. What does CAPA stand for?

CAPA commonly stands for Corrective Action and Preventive Action.

Q2. What is the difference between correction and corrective action?

Correction fixes the immediate nonconformity. Corrective action addresses the cause to prevent recurrence.

Q3. Is CAPA required for every small observation?

Not necessarily. The organization should determine the appropriate response based on the nature, significance, and risk of the issue.

Q4. What can trigger CAPA?

Audits, customer complaints, incidents, near misses, environmental incidents, inspections, repeated problems, and other significant nonconformities can trigger CAPA.

Q5. What is Root Cause Analysis?

RCA is a systematic method used to determine the underlying cause of a problem.

Q6. Is 5 Why the only RCA method?

No. 5 Why is one method. Fishbone, Fault Tree Analysis, barrier analysis, and other suitable methods may also be used.

Q7. Is training always a corrective action?

No. Training may be appropriate, but the organization should determine whether stronger process, engineering, or other controls are required.

Q8. What is effectiveness verification?

It is checking whether the implemented corrective action actually achieved the intended result and prevented recurrence.

Q9. Can one CAPA cover ISO 9001, ISO 14001 and ISO 45001?

Yes, where the same problem affects multiple management-system areas. However, applicable requirements of each standard should still be addressed.

Q10. How long should CAPA records be maintained?

The organization should follow its documented information/record-retention requirements and applicable legal or contractual requirements.

Q11. What happens if CAPA is not effective?

The issue should be reassessed, the cause and action reviewed, and additional or stronger corrective action implemented as necessary.

Q12. Is CAPA useful for near misses?

Yes. Near misses can provide valuable information for preventing future incidents.

Conclusion

Corrective Action and CAPA are important tools for improving an organization's management system.

A strong CAPA process does not stop at:

"Problem Found → Problem Fixed."

It goes further:

"Problem Found → Correction → Root Cause → Corrective Action → Implementation → Effectiveness Verification → Continual Improvement."

In an Integrated Management System:

ISO 9001

CAPA helps improve:

Product/service quality.
Customer satisfaction.
Process performance.

ISO 14001

CAPA helps improve:

Environmental controls.
Spill prevention.
Waste management.
Environmental performance.

ISO 45001

CAPA helps improve:

Hazard controls.
Incident prevention.
Workplace safety.
OH&S performance.

For a chemical warehouse, CAPA can be especially valuable because one problem can affect quality, environment, and worker safety at the same time.

The most important principle is:

Do not ask only "How do we fix this problem?" Ask "Why did this happen, and what can we improve so that it does not happen again?"

That mindset turns CAPA from an audit requirement into a practical continual-improvement tool.

Discussion

How does your organization manage CAPA? Do you use 5 Why, Fishbone Analysis, or another Root Cause Analysis method? Share your experience in the comments.

About the Author

Written by Mahesh Chand

Warehouse Safety Professional | Chemical Warehousing | Fire Safety | ISO 9001 & ISO 45001

Mahesh Chand has 12+ years of professional experience in chemical warehousing, industrial safety, warehouse operations, fire prevention, HIRA, risk assessment, emergency preparedness, and ISO management systems. Through Trading Hatke, he shares practical workplace safety knowledge, real industrial experience, and easy-to-understand safety guidance to help safety professionals, students, and organizations build safer workplaces.

📌 Follow Trading Hatke for more practical safety guides, warehouse management tips, and ISO best practices.

Disclaimer: This article is intended for educational and informational purposes only. ISO requirements should be interpreted and implemented according to the applicable standard editions, organizational procedures, applicable legal requirements, and competent professional advice. This article does not replace the official ISO standards or professional investigation/consulting.

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Tuesday, June 30, 2026

Corrective Action (CAPA): Complete Guide with Examples, Flowchart & ISO 9001, ISO 14001, ISO 45001 Requirements

Corrective Action (CAPA) – Complete Guide (ISO 9001, ISO 14001 & ISO 45001)

Introduction

What is Corrective Action?

Problem

Immediate Correction

Corrective Action

What is CAPA?

Correction vs Corrective Action

Correction

Corrective Action

Example

Why is CAPA Important?

CAPA in an Integrated Management System

CAPA and ISO 9001

Example

CAPA and ISO 14001

Example

CAPA and ISO 45001

Example

When is CAPA Required?

Sources of CAPA

Internal Sources

External Sources

CAPA Process

Step 1 – Identify the Problem

Weak Statement

Better Statement

Step 2 – Immediate Correction

Step 3 – Evaluate Risk

Step 4 – Investigate the Problem

Step 5 – Root Cause Analysis

5 Why Analysis Example

Problem

Why 1

Why 2

Why 3

Why 4

Root Cause

Corrective Action

Fishbone Analysis

People

Process

Equipment

Material

Environment

Step 6 – Develop Corrective Action

Step 7 – Assign Responsibility

Step 8 – Set Target Date

Step 9 – Implement Corrective Action

Step 10 – Verify Effectiveness

Example

Effectiveness Verification Example

Finding

Action

Effectiveness Check

Step 11 – CAPA Closure

CAPA Record Format

Integrated CAPA Example

Problem

ISO 9001 – Quality

ISO 14001 – Environment

ISO 45001 – Safety

Immediate Correction

Investigation

Root Cause

Corrective Action

Effectiveness Verification

CAPA and Incident Investigation

CAPA and Near Miss

Near Miss

Immediate Action

Investigation

Corrective Action

CAPA and Audit Findings

Example

Correction:

Root Cause: