Everyone is a little bit confused about the concept of Corrective Action & Preventive Action (CAPA). What is CAPA? What is the difference between CA and PA? also How and Where to implement?
CAPA is important in any organization for problem solving and improvement. For every problem we find out the root cause of problem and then take a corrective and preventive action to avoid future failure. But what is exactly those action.
This article will explain you everything in details.
What is CAPA?
CAPA is a systematic approach used to investigate, identify, and resolve issues related to quality. It is made up of two key components:
- Corrective Action (CA): Actions to eliminate existing defect to prevent it from happening again.
- Preventive Action (PA): Actions to prevent potential defects (Future problem) before they occur.
Together, both actions work to improve our processes, reduced defects, and increase our product quality.
Understand both terms in more details with real-life manufacturing related examples.
What is Corrective Action?
Definition – The action taken on the Root cause (i.e. cause of non-conformity) to prevent the recurrence.
To avoid the re-generation of this problems/defects / non-conformity / customer complaints in the future, we take action on causes which are present in the process, this action is known as the corrective action.
Corrective action is taken when a problem has already occurred. The goal is to find out the root cause of the problem and prevent it from happening again.
Steps in Corrective Action:
- Identify the Problem: Understand what the issue is. This could be a defect in a product, customer complaint, a machine breakdown, or a failure in a process.
- Analyze the Root Cause: Use tools like Fishbone Diagrams (Ishikawa), 5 Whys, or FMEA (Failure Mode and Effects Analysis) to identify the root cause of the problem.
- Implement the Corrective Action: After identifying the cause, put corrective actions in place. This can be corrections or changing a process, engineering change, updating machinery, or retraining staff.
- Verify the Effectiveness: After implementing the action, check for the results to ensure the problem is resolved and that the action has worked as intended.
Real-World Example of Corrective Action:
Let’s consider a factory that produces metal brackets, and the customer quality team notices that a batch of brackets fails due to a defect in the welding.
1st Step: The problem is identified — Brackets are fails in quality tests due to poor welds.
2nd Step: The root cause is found to be faulty welding equipment, which has not been calibrated correctly.
3rd Step: Corrective action is taken by recalibrating the welding equipment and ensuring all future machines are properly maintained.
4th Step: The team verifies the effectiveness by testing the next batch of brackets, and the weld quality improves, with no defects.
So, in conclusion,
Whatever actions you take after the defect/failure, which can be correction, training or Poka-Yoke, and fool-proofing all are the corrective action only.
What is Preventive Action?
Definition – The action taken on potential causes of non-conformity to prevent the occurrence.
The problem can possibly occur in the future so we take the action before to avoid the generation of problems/defects / non-conformity / customer complaints in the future.
So, we take action earlier on the possible/potential causes of failure known as preventive action.
Preventive action focuses on preventing problems before they happen. It is more about predicting potential risks and take measures to avoid those risks from turning into issues.
Steps in Preventive Action:
- Identify Potential Risks: Analyze the process or system to find out potential failures. This can be done using tools like Risk Analysis, FMEA, or historical failure data.
- Evaluate the Impact: Understand the potential consequences if these risks occur.
- Develop and Implement Preventive Measures: Put some procedures or standard systems in place to address those risks before they become a problem/failure.
- Monitor and Review: Regularly review the preventive measures to ensure they are in place and working as per planned.
Real-World Example of Preventive Action:
Consider a manufacturing company that manufactures springs for automotive braking systems. During a regular review, the team notices that several minor quality issues have occurred in the past due to improper storage conditions of raw materials.
1st Step: The potential risk is — improper storage of raw materials could lead to contamination or damages of spring wire.
2nd Step: The team evaluates the impact — storing raw materials at incorrect condition could leads to damaging wire and customer dissatisfaction due to product failure.
3rd Step: A preventive action is taken by implementing a more stringent storage protocol. This includes damage free storage rack and handling systems. No manual handling allowed for specific wire grades.
4th Step: The effectiveness is monitored over time by reviewing failure data and ensuring no further storage-related issues arise.
When is corrective & Preventive action implemented?
Corrective Action used:
- To resolve the customer complaint.
- To resolve the unacceptable non-conformity (defect, Failure, etc.)
- If any major change or process shift is observed during the Statistical Process Control (SPC) study.
- To eliminate the concern’s observed during the audits (System Audit, Process Audit, Customer Audit, etc.)
Preventive Action Used:
- While making the Failure Mode Effect Analysis (FMEA). During new project development, we identify the potential source of non-conformity (Failure, defect, etc.).
- After the corrective action there is a side effect, to avoid this failure before they occur we take preventive action.
Try to clear the Confusion : When both corrective and Preventive actions used such as 8D report.
Now many persons are confused about, what is the corrective and preventive action mentioned in our 8D report, concerning the action plan report we need to submit to the customer.
In the customer complaint or any failure scenario, first we have to take action to avoid the same complaint/failure in the future. The steps are to find out the root cause and take action on the root cause. Here we take corrective action.
Now, after taking corrective action, there is a chance of side effect or other change due to your corrective action. It may create another new failure or defect in your process. Therefore, we identified those defects/failures earlier and take action on the causes of those defects/failures is considered as preventive action.
How to Implement an Effective CAPA System?
- Document Everything: Ensure that all actions taken for corrective and preventive measures are well documented. This helps in audits, traceability, and transparency.
- Employee Training: Regularly train employees on Corrective Action Procedure and Preventive Action Procedure so they are equipped to identify issues, suggest improvements, and follow through with actions.
- Root Cause Analysis: Always conduct thorough root cause analysis for corrective actions. Without understanding the root cause, the solution may only be a temporary fix.
- Monitoring and Review: Continuously monitor the effectiveness of the corrective and preventive actions. Regular reviews help to make sure that the process remains effective and relevant.
Conclusion
CAPA is a key term of quality management, particularly in industries like manufacturing, where product consistency and efficiency are important. By effectively applying both corrective and preventive actions, businesses can not only solve existing problems but also create systems that reduced or avoid future problems. This leads to improved product quality, higher customer satisfaction, and overall more efficient process operation.
To sum up:
- Corrective Action deals with fixing problems that have already occurred.
- Preventive Action focuses on preventing issues before they arise.
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