What is Corrective Action Preventive Action (CAPA)?


    What is CAPA? The CAPA quality process, in a nutshell, consists of the specific improvements a regulated organization makes to its processes to eliminate defects and non-conformities.

    Effective CAPAs are the backbone of your quality management system, acting as the mechanism for fixing problems and optimizing your processes.

    Let's dive in and take a look at everything you need to know about the CAPA process.


    CAPA meaning


    The CAPA acronym isn't unusual: the world of quality management is full of acronyms.

    SOPs. NCRs. GxP. And CAPAs.

    So what does 'CAPA' mean?


    What does CAPA stand for?


    CAPA stands for 'corrective and preventive action'.

    As the name suggests, CAPAs are about problem-solving. And it's a two-step process: when something goes wrong, a CAPA is executed to 'correct' the immediate issue, then to 'prevent' it reoccurring with a tweak or improvement that addresses the cause.


    What is the definition of CAPA?


    CAPA is defined as a systematic approach used in various regulated industries, including manufacturing, healthcare, and quality management, to identify, investigate, and address problems or non-conformities in products, processes and systems.

    The purpose of CAPA is to rectify existing issues and prevent their recurrence in the future.

    A CAPA system is therefore a crucial part of the modern quality management system, since quality in general is all about ensuring the integrity and quality of the products and services your company provides.


    Learn how to establish a CAPA management system


    We can see how important this is when we consider that over half of the causes of a business failure can be attributed to internally generated problems that weren't properly addressed.


    What does CAPA stand for


    The Shewhart Cycle, more commonly known as Plan Do Check Act, is a classic quality management approach that enshrines CAPA procedures.

    In this case, the 'check' and 'act' portions of the cycle are synonymous with CAPAs: systems and processes are checked, problems are found, then those problems are fixed with corrective and preventive actions.


    What does CAPA stand for


    What is CAPA in practice?


    What does a CAPA system look like in real life, then?

    Remember, establishing CAPAs requires a commitment to quality and continuous improvement. It's an ongoing process that helps you identify and resolve issues proactively, ensuring that your business operates efficiently and delivers high-quality products or services.

    And it's not always something businesses get right.

    CAPA requirements for medical devices marketed in the United States are laid out in FDA 21 CFR 820.100(a) - and failure to instil proper CAPAs is a consistent leading cause for FDA audit failure and the sending of Form 483s as a slap on the wrist.


    FURTHER READING: 5 major CAPA medical device requirements



    Analysis of FDA warning letter citations sent to drug companies between 2015 and 2023 reveals a similar pattern.

    'Quality unit and investigations', 'complaints handling', 'process validation', and even 'cleaning validation & techniques', are all major recurring warning letter triggers which could have been avoided with robust CAPAs in place.


    FDA warning letter citations



    CAPA meaning in quality


    CAPAs and quality really go hand-in-hand. CAPA corrective actions and preventive actions, after all, are how your organization can eliminate quality weaknesses and ensure your products and services are optimized.

    CAPAs are essential for maintaining high standards and ensuring continuous improvement, so you'll find them in any mature and effective quality management system.

    The CAPA process typically involves several steps:

    1. Identification: Recognizing a problem or potential issue.
    2. Evaluation: Assessing the significance and impact of the problem.
    3. Investigation: Determining the root cause of the issue.
    4. Action Plan: Developing corrective and preventive actions to address the root cause.
    5. Implementation: Executing the action plan.
    6. Follow-Up: Monitoring the effectiveness of the actions taken.


    Your quality system should contain CAPA procedure documents to record how your organization intends to detect and react to defects and nonconformances. They should also lay out how each step will be executed and closed out to ensure CAPA success.

    And because CAPAs are so critical for modern regulated businesses, it's important that you choose the right tools and systems to manage them efficiently.

    Dedicated CAPA software can accelerate and automate your CAPA processes, providing bespoke workflows and analytical reports to help you keep up with your CAPA demands at scale.


    FURTHER READING: Learn how to write a CAPA report



    When is a CAPA required?


    A CAPA is required whenever a non-conformity or potential issue is identified that could impact your product quality, safety, or compliance.

    CAPA 'triggers' can occur from routine inspections, audits, customer complaints, or internal reviews.

    It's important that your business gets these observation mechanisms in place so defects and nonconformances don't go unnoticed and unaddressed.


    CAPA in manufacturing: an example


    To illustrate in more detail when a CAPA would be needed, let's consider a CAPA example in a drug manufacturing setting.

    CAPA example kick-off: A batch of pharmaceutical product fails quality inspection due to a defect in its critical quality attributes (CQAs).

    Corrective Action:

    1. Identification: The defect is identified during quality control.
    2. Evaluation: The extent of the defect is assessed, and it's determined that the issue affects the entire batch rather than just a single tablet. Past batch records are analyzed for the root cause and potential recurring issues.
    3. Investigation: The root cause is traced back to an error in the operation of piece of equipment: the reactor temperature has been set too low, causing residual starting material which has affected drug purity
    4. Action Plan: The reactor is properly set and the affected batch is discarded and reworked.
    5. Implementation: The reactor updates are made, and batch production resumes 
    6. Follow-Up: Additional inspections are conducted to ensure the batch defect does not recur.


    Preventive Action:

    1. Identification: Potential equipment operation error is identified as a risk.
    2. Evaluation: The risk is assessed, and it's determined that an SOP and staff training could prevent future issues.
    3. Action Plan: Operating staff are trained on the importance of reactor temperature control, and a new SOP is rolled out to cover this activity
    4. Implementation: Training and new documentation are rolled out to educate staff on the importance of good equipment operation
    5. Follow-Up: The effectiveness of the training and the integrity of the manufacturing process is monitored regularly.


    Why is CAPA important?


    CAPAs are crucial for several reasons:

    • Quality Assurance: They help maintain high product quality and compliance with your industry standards

    • Customer Satisfaction: By addressing and preventing issues, CAPAs ensure that customers receive reliable, high-quality products, reducing complaints and churn

    • Regulatory Compliance: Many regulated businesses are required to have CAPA processes in place to comply with regulatory standards. CAPA in pharma companies, for instance, is a routine activity for ensuring drug efficacy and safety.

    • Continuous Improvement: CAPAs promote a culture of continuous improvement, helping your business to constantly enhance your processes and products.


    Getting your CAPAs in place


    Understanding what CAPA is and its importance in quality management is essential for any organization committed to excellence.

    By implementing effective CAPA processes, and even adopting CAPA and nonconformance management software, your organization can address existing issues, prevent future problems, and continuously improve your operational strength and maturity.

    Whether in manufacturing, pharmaceuticals, or any other industry, CAPAs play a vital role in ensuring quality, compliance and customer satisfaction.