Finding root cause and proper implementation of corrective and preventive action can play an important role in manufacturing of high quality products in pharmaceutical industries.
When we are sick, we always trust the medical product believing that they will certainly provide relief. We get assured that the medical care we receive is not faulty. It is so fortunate that failure is not frequently experienced in medical devices and healthcare. Oftenly failure can occur, and the investigation is carried out to explain the reasons why it occurred.
Corrective Action Preventive Action (CAPA) is, therefore, a process which is carried out to investigate, identify the causes, take corrective action and solve problems preventing the repetition of the same failure. Its main objective is to give assurance that the problems will never be experienced again and there is a lasting remedy to the problem.
CAPA can be applied in disciplines like manufacturing, product design, distribution and transportation of products, testing verification and validation and many other disciplines. In pharmaceutical industries, CAPA helps to solve these problems by investigating the programs applying all the steps formulated to approach biological manufacturers, medical devices and pharmaceutical manufacturers.
The system also assists by making sure that everyone in the industry maintains a smooth and quality system.
In order to succeed and manage the problems we can apply the following steps:
1. Management System: Deploy a good and effective management system for tracking events using a centralized software system so as to prevent departmental confusion and investigate any incident that occurs while working.
2. Collect Data to Determine the Major Cause: When applying this procedure, all the data required is collected, and no data is overlooked. It is performed without bias so as to determine the root cause of the problem possibly. The data collected usually defer depending on the issues addressed or the event under investigation. Mostly the data may include; lot number, environmental condition, training records, names of the individuals who took part, labeled materials used during the investigation and the part number.
3. Root Cause Analysis (RCA): This is performed after collection of data. When eluded by the root cause it is good to give the causes and justification to explain the reason why the root was undetermined.
4. Perform Impact and Risk Assessments: The assessment will take to consider the impact of the issue or the event on the products. It will show how the product to another product and showing what the product is all about.
5. Determining CAPAs and Document Changes: During the investigation to eliminate the root cause of the problem, CAPA is determined and executed. Documentation is done and managed following the separate procedure used.
6. Form a Conclusion: This gives a summary of the event, impact, risk assessments and the root cause highlighted by any corrective and preventive action.
7. Initiate Effectiveness Checks (ECs): This will help in developing inside monitoring to solve how successful investigation can be dealt. It should be performed in a safe environment where the community in that area follows the specific steps, procedures and focuses on determining the problem root cause instead of conducting it in a treasure hunt.
In conclusion, when unexpected issue or event occurs, a company need to conduct a well-documented investigation to show the procedure of giving a remedy or a therapy through process change, revising internal documentation and changing of the packages configuration to help in solving the critical problem which may arise.