By Lisa Helmonds, Vice President of Quality and Operations, MWA Consulting, Inc. 

In Quality Systems, Part 1: Deviation Management and Investigations, we learned about deviation management and investigations. In this second part of the series, we will discuss how to develop an effective CAPA system and why it is important to do effectiveness checks. This blog post will explore what corrective action/preventive action (CAPA) is, its importance, and how it can benefit businesses.

What Is a CAPA System?

CAPA stands for corrective action/preventive action, and it is a critical process in quality management systems that helps organizations identify and correct problems to improve processes and prevent recurrence of these problems. It is required by many regulatory agencies, including the U.S. Food and Drug Administration (FDA) and Notified Bodies in EU countries, meaning that noncompliance can lead to penalties.

CAPA is a systematic process used to identify, investigate, and correct quality issues. Comprehensive CAPA management involves identifying the true root cause of the problem, developing and implementing corrective actions/preventive actions (as applicable), and monitoring their effectiveness to prevent the problem and similar problems from happening again.

Effective CAPA management can provide many benefits to businesses through improved quality. By identifying and correcting quality issues, companies can reduce defects, improve their product quality, reduce costs of materials and products, increase return on investment (ROI), increase customer satisfaction, and in some cases, increase safety of company products. There is a cost savings when completely resolving the problem can reduce costs associated with scrap, rework, and warranty claims. It also promotes continuous improvement in quality management systems, which leads to a competitive advantage by demonstrating a commitment to quality as a differentiating factor.

Developing a CAPA Plan 

Once you have completed the investigation, it’s time to develop a CAPA plan to ensure the problem has truly been resolved. Have you ever implemented a CAPA and thought you corrected the problem only to have it repeated in the not-too-distant future? This may be due to not performing a thorough investigation into the root cause of the problem. In a busy, hectic environment, it may be common to jump to the first conclusion of what the root cause may be instead of performing a thorough investigation. This often leads to ineffective CAPAs. Utilize the tools available to assist with this effort. Utilize metrics, if available, and proven tools such as the 5 Ws (Who, What, When, Where, and Why), the 4 Ms (Man, Machine, Method, and Material), the fishbone diagrams, etc.

In order to establish a CAPA plan, you must first identify the problem, determine its significance, and understand and document the risks and liabilities. A justification should be part of the risk assessment if you cannot implement the required CAPA. Then, as with any project plan, you need to establish the resources, responsibilities, timelines, and additional work needed to implement the CAPA. Corrective actions and prevent actions should ensure proper accountability and be measurable, specific, achievable, and timely.

Effectiveness Checks 

Performing effectiveness checks is a way to assess the efficiency and success of a particular action, program, or intervention in resolving the problem. Effectiveness checks are also helpful in evaluating the health of the overall CAPA system. An effectiveness check includes a determination of the extent to which a project, policy, strategy, or initiative has produced the desired outcomes and has not had negative impacts.

The effectiveness check process typically involves establishing clear objectives by defining the intended goals and outcomes that the mitigation tries to achieve. The purpose is to measure the effectiveness of a specific intervention, identify areas of improvement, and inform decision-makers for future actions, determining specific metrics or indicators that can be used to assess the outcomes or impacts of the intervention. Once the relevant data and information has been collected, the data – both quantitative (e.g., surveys, measurements) and qualitative (e.g., interviews, observations) – will be analyzed to determine whether the intervention has achieved its objectives and to what extent.

At this point, you will draw conclusions about whether the intervention has been effective, and you will document the outcome, including the strengths and weaknesses of the outcome.

During inspections, investigators are looking to see the effectiveness of quality system to detect, segregate, evaluate, and correct failures. They will assess the good manufacturing practice (GMP) and technical knowledge of involved personnel, look at the number of failures experienced along with the types and significance of the failures, and note the timeframe to complete failure investigations. They will also check to see if the investigation extended to other batches of the same drug product or other drug products that may have been associated with the failure and the timeliness and effectiveness of the CAPA system and if effective preventive actions were implemented. Finally, they are looking to evaluate the trending and quality reporting tools.


In summary, a well-functioning CAPA program is vital for organizations to identify and resolve problems before they escalate into more significant issues that can lead to customer complaints, product recalls, or regulatory action. By implementing effective CAPA management processes, your company can improve their quality management systems, reduce waste (thus reducing costs), and increase customer satisfaction. It also demonstrates the company’s commitment to quality and continuous improvement. While we can’t eliminate deviations, investigations, and CAPAs, how well problems are investigated and appropriate corrective and preventive actions are implemented can not only benefit patients, but also decrease the cost of producing products in the long run, potentially passing some of these savings to the customers.

By conducting effectiveness checks, you can make informed decisions about the continuation, modification, or termination of specific interventions. Remember these investigations will be read by inspectors long after you have written them and when you are not around to answer questions about your CAPA system. They will be shared with regulatory agencies, company staff, and management, as well as external auditors. They need to tell the complete story of what happened and how you fixed the problem, including appropriate justifications.

About the Author 

Lisa Helmonds focuses on developing and maintaining relationships with MWA Consulting, Inc. clients, implementing training programs, and ensuring that MWA’s consulting team continues to offer the highest quality services in the industry. Lisa has over 30 years of industrial training in the areas of manufacturing and quality Assurance in the pharmaceutical and medical device industries. She has extensive GxP knowledge, has worked with several startups and large companies, and understands the challenges facing the industry. She holds a B.S. in Zoology from the University of Rhode Island and an MBA from Santa Clara University.

Additional Information 

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