CAPA in Software Testing

CAPA, is also addressed as Corrective Action and Preventive Action. This is also a regulatory requirement by both FDA and ISO, which requires an active CAPA program as an essential element of a quality system.

CAPA also helps with customer Satisfaction. The ability to correct existing problems or implement controls to prevent potential problems is equally important for continued customer satisfaction.

Quality Issues which are not caught/fixed soon enough have their own financial impact.

Corrective Action is the process of reacting to an existing product problem, customer issue or other nonconformity and fixing it.

Preventive Action is a process for detecting potential problems or nonconformance’s and resolving them.

Action plan for Defect Slippage:
1. Increase the regression testing wrt all the functions.
2. Adopt some validation test cases during regression. i.e. testing wrt a real time scenario.
3. Ensure that different kinds of devices are used during testing. Usually during the different rounds of testing the same device types are used for testing by the tester. This happens when the device type to be selected is at the users discretion. The user is more comfortable using the same type of device. This results with not all device types being tested.
Here Device would relate to cross compatibility.
4. Perform the RCA(Root Cause Analysis) on the defects found after testing and arrive at the area where the most no of defect arises. Concentrate on this area.
5. Check domain understanding among the team from time to time. Regular domain understanding sessions would help in increased awareness.
6. Set up a reliability system (system which can be used to check performance and reliability). Ensure that the Test Environment is connected to this system. Regularly send the crash logs to the development team to analyze if any new defects were responsible for the crash.

Action plan for Productivity Increase:
1. Regular domain knowledge training and brown bag sessions with respect to testing to increase knowledge and help with easier testing.
2. Assign testers with a correct/good mix of documents. Example Complex Test Case execution with Simple test case execution. This averages out the test productivity wrt easy and hard. Ensure that this kind of mixture is consistently implemented across all the members of the team.
3. Constant motivation and feedback.