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When we are sick, we always believe in medical products that they must provide relief. We ensure that the medical care we receive is not defective. It is fortunate that failures are not often experienced in the field of medical devices and healthcare. Often failure can occur, and investigations are conducted to explain why it occurred.
Corrective Action Preventive Action (CAPA) is a process conducted to investigate, identify causes, take corrective action, and resolve problems to prevent recurrence of the same failure. Its main purpose is to assure that the problems will never be experienced again and that there is a permanent solution to the problem.
CAPA can be applied to manufacturing, product design, product distribution and transportation, test verification and validation, and many other areas. In the pharmaceutical industry, CAPA helps address these issues by investigating programs that implement all measures designed to approach biological manufacturers, medical device and drug manufacturers.
The system also helps ensure that everyone in the industry maintains a smooth and quality system.
To succeed and manage the problems we can apply the following steps:
1. Management System: Establish a good and effective management system to track events using a centralized software system to prevent departmental confusion and investigate any incidents that occur while working.
2. Collect data to determine the root cause: While applying this method, all necessary data is collected and no data is overlooked. It is performed without bias so that the root cause of the problem is likely to be determined. The information collected usually depends on the issue at hand or the event under investigation. Most data can include; Lot numbers, environmental conditions, training documents, names of persons involved, materials used during the investigation and part numbers.
3. Root Cause Analysis (RCA): It is performed after data collection. If the root cause is omitted it is better to give reasons and justification to explain why the root cause was undetermined.
4. Perform impact and risk assessment: The assessment will consider the impact of the problem or incident on the product. It shows how the product looks to other products and what the product is.
5. Determination of CAPA and document changes: During the investigation to eliminate the root cause of the problem, CAPA is determined and implemented. Documentation is done and managed following the individual procedures used.
6. Make a conclusion: This gives a summary of the key factors highlighted by the incident, impact, risk assessment and any corrective and preventive actions.
7. Initiate Effectiveness Tests (ECs): This will help develop internal monitoring to address how to deal with successful investigations. It should take place in a safe environment where the community in that area follows specific steps, procedures and focuses on determining the root cause of the problem rather than conducting it in a treasure hunt.
