Corrective Action Vs. Preventive Action: What's The Difference?
Standards and regulations such as ISO and FDA stress CAPA, referring to Corrective Action, Preventive Action, creating the impression that they are one and the same thing or a continuous process.
Although they both address nonconformance, the timing and the steps taken to implement those actions shows the difference between corrective action and preventive action.
Corrective Action is initiated after a nonconformity has been detected. It is a reactive measure where any deviation is analyzed after it has occurred to identify the root cause and the appropriate action to be taken to prevent its recurrence.
According to the US FDA 21 CFR 820.100, medical device manufacturers must incorporate CAPA in their Quality Management System (QMS). Any deviation or issue will have obvious causes and root causes. Businesses often address the obvious causes. While this may seem effective in the short term, the problem may persist or lead to unforeseen consequences.
The root cause may be less obvious, but that would be why a deviation was triggered. Businesses must identify this root cause or root causes since there could be more than one, and address them to contain the problem effectively.
Preventive Action, on the other hand, is proactive. It anticipates a potential nonconformity and appropriate controls are implemented to reduce the likelihood of its occurrence. While an existing nonconformity and root cause analysis may be one of the triggers for Preventive Action, it can also happen because of effective quality management systems that help to continuously identify and assess risks, capture trends, and implement controls to prevent their occurrence.
Key difference between corrective action and preventive action include:
- Reactive vs. Proactive: Corrective action is implemented after a nonconformity is reported. Preventive action is predicting a likely occurrence or recurrence of a problem and mitigating the risk.
- Root Cause vs. Risk-Based Approach: A root cause analysis is the key tool to identify the real cause of an issue. Preventive action requires risk assessment and implementing controls.
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When are Corrective Action and Preventive Action Taken?
In a wish to eliminate all issues, businesses may look at CAPA as a solution. However, it is a complex process and must be approached with caution, forethought, and planning. Corrective and preventive action needs a tremendous understanding of the issues and probably the involvement of multiple teams to address an issue. It can also be time-consuming and costly.
Therefore, it must be worth the effort. Also, CAPA itself may introduce new risks. Understanding these risks and their impact is also essential before implementing CAPA. Since CAPA addresses systemic issues, it must be implemented after assessing the following:
- Tracking and measuring the KPIs or key performance indicators to identify the common risks and their performance.
- Capturing issue trends and determining if any of them are recurring. Even in the case of recurring issues, understanding the impact and frequency are key to determining whether they need CAPA.
- Encouraging employee participation in the root cause analysis and risk assessment is essential as they are directly affected and have the necessary insight and inputs for accurate assessment.
- Frequent auditing is a must to identify systemic issues, gaps, and potential risks.
An issue may occur or recurring due to the system or lack of or improper implementation of policies, practices, or procedures. The impact of corrective action must be evaluated, and appropriate controls must be implemented to prevent future recurrence.
Risk analysis may also reveal high-risk areas leading to deviations and nonconformities. In such cases, preventive action must be taken to avoid the risks becoming a real issue. It must be data-driven and collaborative to be truly effective.
Implementing CAPA is a regulatory requirement for medical device companies that are compliant with Good Manufacturing Practice (GMP) as defined by the FDA. The FDA 21 CFR 820.100 requires manufacturers to:
- Ensure that the CAPA system procedure(s) meet the regulation is well defined and documented.
- Demonstrate that the source of product and quality problems have been determined.
- Track trends of issues.
- Ensure the quality and integrity of the data sources for Corrective and Preventive Action.
- Ensure appropriate Statistical Process Control (SPC) is used to detect recurring quality problems.
- Determine whether the RCA is appropriate to the nature of the risk identified.
- Implement appropriate actions based on the root cause analysis findings.
- Track and monitor the effectiveness of the CAPA.
- Document the corrective and preventive actions for product and quality issues.
- Ensure management review of the nonconforming product, quality problems, and corrective action preventive actions.
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Best Practices for Implementing Corrective and Preventive Actions
Reducing deviations not only improves compliance but also minimizes rework, recalls, and warning letters. This helps with improved product quality, lower cost of manufacturing, and improved brand reputation.
Adopting the following best practices will improve the effectiveness of CAPA and ensure continuous improvement of the quality management system. The best practices include:
- Identifying the Issue– The first step is to identify the specific nature of the issue and then weigh its criticality to assess whether CAPA is needed. The end goal must also be clear to know the expected outcome of CAPA implementation.
- Scope the Issue – Determine how large the problem is. Was it a one-time occurrence, or has it been occurring often? If yes, when? How serious is the issue, and so on. This will help with working out all the factors that could have played a role in the issue and addressing them appropriately.
- Minimize Damage – The first response to an issue must be to contain it and minimize the damage.
- Perform a Root Cause Analysis - Once the issue has been contained, check to see if it is likely to recur and what the impact would be. Assess the criticality of the issue, and if the frequency and severity are high, look for a long-term solution using root case analysis. After much planning and deliberation, this is best performed with a cross-functional team to arrive at the correct root cause(s). It should also include risk analysis to understand how any change to the existing approach will impact the issue and whether newer ones will emerge.
- Implement Corrective Action– Identifying the root cause will enable identifying the solutions to mitigate the risk. This should be carried out with employee buy-in so that any changes required are effective and achieve the desired outcome.
- Monitor and Track Effectiveness– Has the CAPA had the desired effect? Is it successful in correcting the error? Monitoring and tracking are essential to ensure this or make further modifications.
- Document- The CAPA process must be documented to demonstrate action has been taken and the required changes made. modified process.
Best Practices for Preventive Action
- To prevent the occurrence of nonconformity, use a data-driven approach to identify, analyze, and eliminate potential causes.
- Determine and implement controls.
- Monitor the effectiveness of the controls.
- Document and review the preventive action process and its effectiveness.
Why is Corrective Action Vs Preventive Action Analysis Important?
First and foremost, CAPA is a mandatory requirement for manufacturers of medical devices. Therefore, it is essential for compliance.
Second, corrective action helps to identify the root cause and improve the quality of processes to ensure the quality of the product/service.
Third, It helps with the continuous improvement of the quality management system.
Fourth, it enables a risk-based approach to quality, another requirement of regulations, to prevent potential problems.
Fifth, it reduces nonconformance and noncompliance while improving product quality and workplace safety.
Sixth, it helps build brand reputation, resource optimization, employee engagement, and customer satisfaction.
Seventh, it helps reduce the risk of warning letters and recalls.
Eighth, it reduces the cost of manufacturing by preventing errors and deviations that can result in rework.
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