CAPA Software for Medical Device | When and What Should Trigger a CAPA?
Article Context:
CAPA
CAPA – Corrective Action and Preventive Action is a technique in the quality management system that investigates and tackles quality concerns by identifying and evaluating fundamental root causes and applying corrective and preventive actions. So the life science industry must understand when to launch a CAPA, how to address it, and what process to follow.
This blog discusses the differences between Corrective Actions and Preventive Actions, their criteria for initiating a CAPA, how to handle CAPA, and the processes to be followed to be compliant.
CAPA (Corrective and Preventive Action) is a methodological strategy for mitigating risk and improving the process. It is done by identifying the sources of potential issues, investigating the root cause, resolving them with corrective actions, defining preventive measures to prevent the issues from recurring, and documenting the entire process to ensure compliance.
When to request CAPA?
The goal of a CAPA is to avoid and resolve difficulties that are detected; however, not every issue justifies the use of a CAPA. It is crucial to understand the conditions for initiating a CAPA and dealing with systemic or systemic issues—the items that signify a system-wide failure.
Criteria for a CAPA Request
The scenarios listed below will assist in determining whether to open a CAPA.
1. Is there a risk to patient safety or death because of this issue?
When a product fails, and the issue is severe enough to produce harmful impacts when released to the market or receive negative feedback, it is time to open a CAPA.
2. Is the issue proven to be systematic, or have there been repetitive occurrences?
Repetitive occurrences are more challenging to assess because “many” can indicate “two” or “hundred,” and the key to determining risk is risk estimate. As a result, the risk assessment will estimate the risk connected with the issue and pave the way for anticipating the amount of investigation that needs to be undertaken, the scope of the issue, and how to handle the issue. This results in the CAPA initiation.
In the initial framework, a sequence of issues or non-conformances initiates a CAPA but can initiate change management to address and improve depending on the severity. As a result, it is unlikely that recurring issues will result in a CAPA. Other techniques in the quality system are ideal for dealing with systemic issues in such cases.
Difference between Corrective and Preventive Action
When it comes to CAPA, the greater emphasis is on corrective actions rather than preventive measures. Corrective is reactive and preventive measures are proactive.
For example, we take medication prescribed by the doctor for high blood pressure. This is a reactive or corrective approach; but, if we look at the underlying issue, such as obesity increases the risk of high blood pressure, the proactive or preventative method is to reduce the additional pounds.
This is the difference between corrective action and preventive action. Corrective measures are to correct the current issue that may or may not recur the issue whereas the preventive measures to prevent the issue from becoming a real problem in the future.
Corrective Action and Preventive Action
The goal of CAPA is to correct and prevent a recurrence of the problem. This is only achievable if the problem is identified and reported as a CAPA. So, take remedial action when a CAPA is detected, which could be through an internal or external audit or feedback from the market or end-users.
For example, you may have observed a problem within the manufacturing unit that occurs every day and reported it as a non-conformance because it is not significant. The corrective measure is to train the employee in the production unit on the method so that the problem does not reoccur. It could be both a corrective and preventive action.
Corrective actions are not a permanent solution; it is a resolution given for an issue that has occurred already. It is defined as a “reaction to the issue that occurred”
As a preventive strategy, consider inspecting more frequently with each method you follow and placing in all the necessary precautions so avoiding product recalls or product failure. In context with the preceding example, you determined that the product in the manufacturing unit does not fulfill the set specification. To be proactive, with the problem occurring in Product A, cross verifying the issue with Product B and Product C is a preventive measure.
Below are some of the familiar preventive actions that industries follow
- Internal audits
- Timely review of raw or supplier material
- Review Non-conformances and perform risk assessments to check for possible hazards.
- Preventive maintenance checks for calibration and manufacturing units.
- Establish employee training, maintain the standards and check for their progress on the procedures and processes followed.
- Conduct disaster recovery and be prepared.
Creating preventive measures and resolving the issues from reoccurring and then reviewing them will establish a quality management system in an organization rather than being reactive in the first place. The life science industries not meeting the regulatory aspects are more likely reactive. Regular monitoring and systematic process reviews should be viewed as opportunities for continuous improvements to provide the best and safer products to be compliant.
The reason industries receive FDA warning letters is not because they have a significant number of CAPAs or because they do not initiate CAPAs. They do not adequately document their CAPAs and do not take proactive measures.
Final Thoughts
What is easy? Reacting to the issue with corrective measures as and when they occur or implementing preventive measures with a proactive approach before the issues arose as problems? Corrective action is required to address the current issue and preventive measures to reduce the risk of adverse effects in the future when the systemic issue becomes a non-systemic one to eliminate the systematic issue. As a result, it is preferable to be proactive rather than reactive. Continuous inspections, frequent reviews of the procedures and process, placing validation checks may seem complicated but can save costs, resources, and time-consuming corrective actions.
If you are still relying on paper and finding it difficult to document and manage quality procedures and processes, we are just a step away. Email sales@complianceg.com to know more about the intelligent quality management software built especially for life sciences industries to market safer products in adherence with compliance and industry regulatory standards.
FAQ's
How do you measure the effectiveness of CAPA?
The effectiveness of the CAPA is best measured using both qualitative and quantitative data. The qualitative data will aid in gaining insights into the problem and determining root causes, as well as understanding the problem and its resolution. Quantitative data, such as numerical data collection and predictive hypotheses, will aid in predicting issues in the near future and/or assessing effectiveness.
What CAPA phase comes after the implementation phase?
Following the implementation phase, the CAPA Process enters the verification and effectiveness check phase. The CAR and PAR must be verified and checked for effectiveness, ensuring that the defined Corrective and Preventive actions are effective and appropriate, that the issue has been resolved and will not reoccur, and that the process followed is in accordance with regulatory standards.
In which step of the CAPA system is root causes identified?
The root cause of the issue is investigated and identified in the analysis step which is used to guide the investigation into the cause of the problem. The primary goal of this analysis is to identify the root cause of the problem using appropriate data, and the results are organized and documented.