CAPA in Software Testing

Prodigious and effective software quality, performance and functionality are the most crucial elements demanded by clients and end users all over the globe. To fulfil these requirements and to provide full satisfaction to the users, developers, testers, and Quality Assurance (QA) experts use a vast array of testing techniques, which guarantee proper functionality of the software and assures the users of its long life. CAPA, which is an abbreviated version of Corrective Action and Preventive Action, is a technique adopted by the team of testers to resolve and eliminate nonconformities and discrepancies from the software. These non-conformance can be found in numerous elements such as, the service, product, process, from a supplier or in an organization’s management systems. Moreover, by implementing CAPA software developers and testers can ensure that the organization’s business risks are decreased and the improved quality levels are maintained.

What is CAPA in Software Testing?

Corrective Action and Preventive Action (CAPA) or Corrective and Preventive Action are the key elements in any management system. These are the improvements implemented in an organisation’s processes to eliminate causes of nonconformities or other undesirable situations. CAPA is a set of actions that laws or regulations require an organization to take in various situations such as, manufacturing, documentation, procedures, or systems, to rectify and eliminate recurring non-performances. Moreover, it is extremely necessary for the developers to promptly identify and document the discrepancies and nonconformities in the system and report them to the management. The main aim of CAPA is to collect and analyse information, identify and investigate products as well as quality problems, before taking the relevant action, whether it is corrective or preventive. This then allows non-conformance to be dealt with accordingly, which further ensures better quality control management across the board.

Corrective Action and Its Process:

This is the process of reacting to an existing product problem, customer issue and other nonconformity in the system and fixing it. Corrective actions are implemented to correct something that has gone wrong and it describes the actions that are required to fix the problem detected by the programmers or testers. In corrective actions, one is required to understand the problems that are present in the software of application and to use root cause analysis to uncover the real cause of the problem. Moreover, corrective actions are based on a non-conformance events that has happened in the past.

Corrective Action Process:

Corrective actions are implemented in response to customer complaints, unacceptable levels of product non-conformance, issues identified during an internal audit, as well as adverse or unstable trends in product and process monitoring. The process that is followed by testers to implement corrective action are as follows:

  • Locate and document the root cause of the nonconformity.
  • Scan the entire system to ensure that similar nonconformities do not occur in the system again.
  • Analyse the effect of all the nonconformities on the product or service produced, before the nonconformity is discovered and take appropriate actions as per the severity of the situation. This can be done by either recalling the product, notifying the customer, or by downgrading or scrapping the product.
  • Establish a thorough follow up to ensure that the correction is effective and recurrence of the nonconformity is prevented in the future.

Ways of Identifying Various Corrective Action Opportunities:

It is essential to implement corrective action on nonconformities, as it validates the performance and effectiveness of the software system and ensures that it is developed as per client’s requirement and demands. Throughout the development process, tester can find and identify various opportunities of implementing corrective actions. These not only help them in detecting nonconformities in the system, but also allow them to monitor all the stages of the development process. Therefore here are some of the opportunities through which one can identify areas that require corrective action:

  • Conducting workplace inspection.
  • Testing, inspecting, and monitoring of the equipment and system.
  • Consulting the staff.
  • Customer feedback.
  • Through Audit.
  • Via Hazard Reporting.
  • Dealing with any nonconforming product.
  • Reviewing system failures.
  • Reviewing regulatory requirements.

Preventive Action and Its Process:

Preventive Action is pro-active and it mainly addresses the nonconformities that have a potential of occurring in the software again and again. It requires one to conduct trend analysis, which identifies issues that may lead to non-conformances in the future or after the system is being accessed by the user. Furthermore, preventive action determines and eliminates the causes of potential nonconformities and exceptionally prevents their occurrences in the system. In short, potential actions are based on preventing a non-conformance event from happening in the future.

Preventive Action Process:

The process of preventive action is extremely crucial for proper and accurate development of the software. These steps are followed by the testers, which ensures that no nonconformities occur in the system once its development is completed:

  • Proactive steps should be taken to ensure that the potential nonconformity does not occur in the system.
  • Employ process and system analysis to determine how to build in safeguards.
  • Process changes to prevent nonconformity.

Ways of Identifying Preventive Action Opportunities:

In order to identify risks that require preventive actions, adequate monitoring and controls must be in place in a quality system, which can ensure that potential nonconformities and issues are identified and eliminated before they occur in the system. Moreover, if something indicates that a possible problem may develop in the system, then some action must be taken by the experts to prevent it and to eliminate the potential situation. Therefore, during the software development process one should look out for opportunities through which they can identify situations that require preventive actions. Some of these opportunities are:

  • Through the management review process.
  • Process or performance monitoring.
  • Analysis of warranty data and customer feedback for trends.
  • Process analysis.
  • Finding the root causes of the corrective actions.
  • Risk assessments and Failure Mode Effects Analysis (FMEA).
  • Employee suggestions for improvements.
  • Internal or external quality audit findings.
  • Production planning.

Benefits of CAPA in Software Testing:

Both Corrective Actions and Preventive Actions (CAPA) are essential elements of a quality management system. Their ultimate goal is to continuously implement improvements, which ensures that no further actions will be required in the system. Furthermore, by implementing these actions the team of testers can find all the discrepancies in the software and ensure that the same nonconformity or issue does not occur in the system again. This not only saves testing efforts of the testers, but also makes the process of development fast and cost effective. Some other benefits of CAPA are:

  • Ensures better system control management.
  • Minimizes the overall standard of the process.
  • It documents and presents the management reviews, which are checked for effective implementation.
  • Helps with user and client satisfaction.
  • Identifies and eliminates non-conformities.
  • Analysis the root cause of the non-conformities.

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The significance of Corrective Action and Preventive Action (CAPA) is immense during software testing. CAPA is a part of the overall quality management system (QMS) and it is one such technique that allows testers to detect and identify existing as well as potential nonconformities without any hassle or problem. With the assistance of Corrective Action and Preventive Action, one can easily bring about improvements to an organisation’s process. Moreover, CAPA is often undertaken in the system to eliminate causes of nonconformities or some other defects and discrepancies. To ensure that corrective and preventive actions are effective, the systematic investigation of the root causes of the system failure is pivotal and should be implemented by regularly by the testers. Hence, with the use of Corrective Action and Preventive Action, the team of knowledgeable and expert testers can ensure the quality as well as effectiveness of the application or the system, which will further fulfil all the requirements of the client and the end user.

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