Corrective and preventive action (CAPA) can be viewed differently by employees within pharmaceuticals and medical device companies. Some see CAPAs as simply an onerous task given to them to complete in order to “stay compliant,” while others look at CAPAs as simply a number based metric that needs to be reduced. However, the best view of CAPAs is as a complete system with a life-cycle made up of phases. The CAPA system should not be viewed as simply the required outcome of a deviation or event, but instead, a beginning to end system that not only provides the tools for the identification, evaluation, and investigation of a deviation, but also the tools to determine, implement, and check effectiveness of a resolution. It is clear that CAPA and its associated tools is the mechanism that enables a quality system to be “self-correcting.” Using this phase-based system will provide a systematic approach to review the Quality system data. Benefits of this approach include:

• Assurance that quality issues are resolved
• Rework and scrap numbers are reduced
• Customer complaints are reduced
• Promotion of continuous improvement
• An aligned method for problem solving
• Regulatory requirements are met
• Business needs are met

http://www.propharmagroup.com/blog/why-capa-so-important-anyway-0

Agreeing with neb2, I would add that it order to simply put it in words and grasp it. It is a system that is used to avoid or eliminate undesirable outcomes or events. It is there to make sure we do not end up with any risk. In order words, it eliminates or reduces the probability of a undesired consequence and in return our company, product, market, and customer are satisfied at a maximum.

This is how I understood CAPA and this is how I would explain it to someone who did not have any idea what CAPA is.

Hi All,

I would agree with the many point above made about CAPA. Since first learning about I can truly see why it is needed in companies to repair non-conforming products. It is really a system designed to prevent and repair issues as they arise. As was mentioned CAPA can be done on both a quality system and non-conforming product, allowing for you to investigate the root of the issue so it can be fixed. I believe this
identifying of issues is the main benefit of having CAPA.

-Andrew Nashed

I think that the previous answers work to describe the idea of CAPA well. It’s basically saying that you will not make the same mistake twice. If you know something is not functioning correctly or well and you continue to do it wrong, it would make sense the FDA (or governmental figure) would not be willing to overlook. In a way, it is a protection against a much bigger problem. It helps you minimize risk and prevent a lawsuit and loss of customers.

Hi All,

I would also like to agree with all of the responses above. To put it in simpler terms, Corrective Action is based on a nonconformance event that has happened in the past, and Preventative Action is based on preventing a nonconformance event in the future. Thus, if you both the two together, CAPA is an integral part of a continuous improvement program for the company. It’s a fundamental element of quality management, and therefore, quality professionals use Corrective Actions to work on reported nonconformance and propose a method to address these deviations, but Preventative Actions address potential deviations and take steps to make sure they’re avoided in the first place. It certainly helps reduce the amount of potential risks and unsatisfied customers!

Corrective Action is-based on a nonconformance event that has happened in the past. Preventive Action is based on preventing a nonconformance event in the future. Corrective and Preventive Actions are integral parts of a continuous improvement program. To correct or prevent a problem, you have to accurately define the root cause, or your efforts are likely to miss the mark. You may take care of the problem in the short term, but without getting to the root, the issue has high potential to happen again.An effective CAPA will prevent the noncompliance from reoccurring. An effective CAPA system can help prevent a warning letter during an audit. Cost of quality rises substantially as defects come to light closer to the customer another benefit of CAPA is the ability to capture quality issues early in production, thus helping to reduce cost of quality with synergistic processes.

Besides being a document, a CAPA is multiple phases that a company goes through the implement what the CAPA is stating. Overall it has an identification, evaluation, and investigation of a deviation, of procedures. It can also be a tool to determine, implement, and check the effectiveness of a resolution. CAPAs are more prominent after audits are performed and a 3rd party entity examines your companies processes. The biggest concerns that the CAPA addresses is customer safety, impact on regulatory documents, impact on internal documentation, product design, or performance.

I would also like to touch upon the importance of CAPA. CAPA is extremely essential in the manufacturing area. It gives the early benefit of identifying current and potential issues in a product before it goes into production or as early as possible. Since, it is more costly to the company when a quality issue arises after reaches the customer. Therefore, catching and fixing defects beforehand is always financially beneficial for the company. CAPA has been proven to be effective from time to time in every place that it has been practiced. Without CAPA, a company cannot build an effective quality system.

The purpose of CAPAs is to ensure that the product is up to the highest consumer standards. The preventative actions are required to foresee every possible negative outcome. These preventative actions are used to anticipate what can go wrong and try to fix it before the device reaches the market. Since it is impossible to foresee everything, corrective actions are in place to fix issues once it has already been on the market and must be fixed. These CAPAs are put in place to create the safest and most effective medical devices and refine based on those already released.

CAPA is required under 21CFR820.100 It requires manufacturers of medical devices to have clearly documented procedures for corrective and preventive action. CAPA is important to continuous improvement processes. CAPA can help to lower the cost of quality because of it ability to capture quality issues early in production, thus helping to reduce cost of quality with synergistic processes.

CAPA, Corrective and Preventative Actions, works to fix and improve products based on information gathered. CAPA consists of analyzing information received and classifying any problems. Based on this, certain actions are completed in order to prevent the problem from occurring repeatedly. With CAPA, the best form of the product is created and released. CAPA works to continuously improve products, while removing any issues that may arise. This is very important when it comes to medical devices or pharmaceutical products especially because they are used form of contact with humans. As a result, if there is an issue or way to better the product for the most efficiency, it would be useful to make use of CAPA. This way there will be a decrease in the probability of any harm occurring in humans. CAPA is very beneficial to all companies as it allows for the best product to be created.

A CAPA really just provides a systematic way for companies to address nonconformances, fix them, and prevent them from happening again. One benefit of using a CAPA to do this rather than just doing it in a haphazard manner is it makes the process much more efficient and therefore can ultimately reduce impact to product in the field. In addition, I think Sanam raised a good point about how a good CAPA system will trigger a thorough root cause investigation that will hopefully prevent the problem from occuring again.

I agree with this. CAPAs are meant to self correcting actions that a quality system intakes to ensure products and processes are in conformance. I would like to add some of the minor cons that may occur with opening CAPAs.
- CAPAs are meant to resolve issues by ideally identifying the root cause. I have seen firsthand CAPAs that have been initiated and closed but do not resolve the actual root cause and instead act as a "band-aid" resolution. Usually this leads to the opening of another CAPA to solve the originally problem and address the root cause. This varies company to company and how in depth the quality system is.
- Complex CAPAs can result in long time lines and expensive resolutions
- CAPA investigations can open the door to more questions and additional findings that may or may not need to be addressed.