Corrective and Preventive Actions (CAPA) – Overview CAPA is a structured quality management approach used to identify, address, and prevent issues within processes, products, or systems. It’s essential for compliance with standards ✅ Corrective Actions (CA) These are reactive measures taken after a problem has occurred. - Purpose: Eliminate the root cause of an existing non-conformity or failure. - Process: - Identify and document the issue. - Perform root cause analysis (e.g., 5 Whys, Fishbone Diagram). - Implement corrective measures. - Verify effectiveness through data and audits. Example: A product defect is discovered during inspection. The team investigates and finds a calibration error in the equipment. The equipment is recalibrated and the process updated. 🔍 Preventive Actions (PA) These are proactive measures taken to avoid potential problems before they occur. - Purpose: Identify risks and eliminate causes of possible non-conformities. - Process: - Analyze trends, audit findings, or risk assessments. - Forecast potential failures. - Develop and implement preventive strategies. - Monitor effectiveness over time. Example: Trend analysis shows increasing variation in packaging weight. Before it becomes a defect, the process is adjusted and staff retrained. 📊 CAPA Integration CAPA is often embedded within broader frameworks like: - PDCA (Plan-Do-Check-Act) - FMEA (Failure Mode and Effects Analysis) - Risk-Based Thinking in ISO 9001:2015

1. Learn , How to develop a plan of Actions to :
1.Solve a problem; 2.Eliminate the Root Cause; 3.Avoid Recurrence of the problem,
To save the Three Causes of Resource Waste: Time, Effort, and Money.
DR.M.Abu Rahal
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maysra.aburahal@gmail.com

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Raising A CAPA Is Not An Exercise To Plug Holes!
Sanjay N.

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5. Three Progressive Steps Toward Root Cause
Resolution and Recurrence Prevention of A
problem,
Think of problem-solving as ascending a
strategic staircase composed of three key
stages,
Each designed to reach a sustainable and
measurable solution:
1- Precise Problem Diagnosis
The first step involves clearly identifying and
describing the deviation, whether
operational or systemic.
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Main-Driving steps to reach A perfect CAPA
Milestones on the road to successful (CAPA)

6. 2- Structured Root Cause Analysis
Apply proven tools like the 5 Whys, Ishikawa
diagram, or FMEA to uncover the true source
of the issue—not just its symptoms.
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Main-Driving steps to reach A perfect CAPA
Milestones on the road to successful (CAPA)

7. 3- Corrective & Preventive Actions with
Measurable Impact
Develop and execute well-defined actions
that not only resolve the current issue but
also safeguard against similar future events.
Validate effectiveness using performance
indicators.
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Main-Driving steps to reach A perfect CAPA
Milestones on the road to successful (CAPA)

8. Three Levels of Problem Response
1- Immediate Action ( Correction )
- Called also Remedial action or Reactive
response.
- A quick fix to restore functionality or contain
the issue and mitigate its potential impact.
- Example: Immediate transferring frozen items
from broken-down refrigerator to well-operating
one.
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Understanding the difference

9. Three Levels of Problem Response
2-Treating Action ( Corrective Action )
- A structured approach to eliminate the root
cause of the problem.
- Meaning, treat the case and avoid the
recurrence of it.
- Example: Checking the broken-down refrigerator
and refilling the freon to operate it and may
Conduct a maintenance plan for this case.
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Understanding the difference

10. Three Levels of Problem Response
3- Proactive Prevention ( Preventive Action )
- Measures taken to avoid potential issues before
they occur.
- Example: Conducting RCA and updating
maintenance protocols to prevent recurrence of
breaking-down for All refrigerators
/ Implementing predictive analytics to detect
early signs of system failure.
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Understanding the difference

11. Strategic Pathway to an Effective CAPA Execution
Achieving a robust CAPA requires a
disciplined sequence of actions that
transform reactive fixes into proactive
quality assurance. The journey unfolds
through these key stages:
- Initiate with Clear Problem Definition
Accurately capture the deviation or
nonconformity with supporting evidence
and context.
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Achieving a robust CAPA

12. Strategic Pathway to an Effective CAPA Execution
- Contain and Stabilize the Impact
Implement immediate controls to prevent
further disruption while analysis is underway.
- Conduct Root Cause Analysis
Apply structured tools (e.g. 5 Whys, Fishbone
Diagram) to uncover the true source of failure.
- Design Targeted Corrective Actions
Address the root cause with measurable, time-
bound interventions aligned with operational
goals.
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Achieving a robust CAPA

13. Strategic Pathway to an Effective CAPA Execution
- Formulate Preventive Measures
Broaden the scope to mitigate similar risks
across systems, processes, or departments.
- Verify Effectiveness and Sustainability
Use KPIs, audits, and trend analysis to confirm
long-term resolution and resilience.
- Document and Institutionalize Learnings
Ensure traceability, compliance, and continuous
improvement through formal closure and
knowledge sharing.
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Achieving a robust CAPA

14. 8D (Eight Disciplines)
Originally developed by Ford Motor Company,
In 1987.
The 8D methodology is a structured approach
widely used in quality management to identify
root causes of problems, implement corrective
actions, and prevent recurrence.
Here are its eight steps :
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Problem Solving Methodology

15. 8D (Eight Disciplines)
D1 – Establish the Team :
Form a cross-functional team with the
appropriate knowledge and skills to
tackle the problem.
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Problem Solving Methodology

16. 8D (Eight Disciplines)
D2 – Describe the Problem:
Define the issue clearly and precisely using
tools like 5W2H (Who, What, Where,
When, Why, How, and How Much).
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Problem Solving Methodology

17. 8D (Eight Disciplines)
D3 – Implement Temporary Containment Actions :
Apply interim measures to isolate the problem and
protect customers or processes until a permanent
solution is found.
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Problem Solving Methodology

18. 8D (Eight Disciplines)
D4 – Identify Root Cause and Escape Point :
Investigate why the issue occurred and why
it was not detected earlier. Tools like the
Ishikawa (Fishbone) diagram and
the “5 Whys” are commonly used here.
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Problem Solving Methodology

19. 8D (Eight Disciplines)
D5 – Verify Permanent Corrective Actions :
Ensure that the proposed solution
addresses the root cause effectively and
will prevent recurrence.
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Problem Solving Methodology

20. 8D (Eight Disciplines)
D6 – Implement Corrective Actions :
Deploy the solution and validate its
success using actual performance data.
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Problem Solving Methodology

21. 8D (Eight Disciplines)
D7 – Prevent Recurrence :
Update procedures, processes, and
systems to institutionalize the fix and
prevent similar issues in the future.
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Problem Solving Methodology

22. 8D (Eight Disciplines)
D8 – Congratulate the Team :
Recognize the team's contributions and
celebrate their success in resolving the
problem.
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Problem Solving Methodology

23. Professional Notes:
📌 Note:
When this “operational staircase” is integrated within a PDCA
framework, it transforms into a strategic tool to reduce waste
and reinforce a culture of sustainable improvement.
📌 Note:
These levels align with ISO 9001 principles. Transitioning
from reactive to proactive management reflects
organizational maturity and strategic foresight.
📌 Note:
Embedding these steps within a PDCA cycle and linking them
to risk management frameworks elevates CAPA from a
compliance tool to a strategic driver of operational
excellence.
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24. 07/14/2025 24 maysra.aburahal@gmail.com