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CAPA in Software Testing


What is CAPA?

CAPA (Corrective and Preventive Action) enables you to provide corrective or preventive action request which initiates through review, root cause, corrective action takes and verification stages. It generates multiple number of reports automatically and handover efficient mechanism in order to identify source and the cost of problems.

This concept is used in good manufacturing practices (GMP) and (HACCP/HARPC) or Hazard Analysis and Critical Control Point/ Hazard Analysis and Risk-based Preventive Controls. It is also used as a Regulatory requirement for FDA and ISO for an active CAPA program, which is an essential part of quality system.

Conceptual Terminology

The concept of CAPA clearly identifies perfect sources of data and the proper identification of investigated problems. And, it uses root cause analysis to find the discrepancy or deviation of problems.

Corrective Action:This action is also known as re-work or rectification activity of the product. It is an action for the existing problems, customer issues or other nonconformity to fix and handover resolved issues.

Preventive Action:The process of detecting potential issues and resolving them is called preventive action. It is a proactive methodology which is used to determine potential causes. It is also known as preventive maintenance or risk avoidance.

Corrective Action Techniques

  1. Error proofing
  2. Visible or audible alarms
  3. Process redesign
  4. Product redesign
  5. Training or Modifications of existing training programmes
  6. Improvements of maintenance schedules
  7. Improvements in storage

Action Plan for Defects

  1. Increase the rate of regression testing with respect to all the functions in the product.
  2. It is necessary to adapt some test cases at the time of regression testing to test in real time scenario.
  3. Involvement of different types of devices is an essential requirement in testing. Usually,, tester uses same type of device in different type of testing because of his/her comfort or handy factors. Therefore, the major problem occurs when tester did not applied a serious effort across all the devices.
  4. Root cause analysis is used to analyze and identify the defects. RCA dig-down into the detailed concept to capture critical defects, which helps in further development phases and in-future use.
  5. It is important to conduct domain understanding test on frequent basis. Regular tests would help to reflect awareness about the domain knowledge.
  6. To check the performance and reliability of the system, it is important to set up a reliability check. And, it's also important to ensure that the test environment is properly connected to the system so that it can used on regular basis by the development team to analyze new defects.

Conclusion

Numerous terminologies are evolved to handover a quality or defect-free products. CAPA is one of the best corrective approaches that prevents system from various vulnerabilities. Proper study and synchronised implementation may lead to authentic processing. Lastly, CAPA also ensures better product quality.