Non-Conformance Corrective and Preventive Action (NC CAPA)

Non-Conformance Corrective and Preventive Action (NC CAPA)

Non-Conformance Corrective and Preventive Action (NC CAPA)

To avoid rework, product recall, and decreased productivity, every organization needs a robust nonconformance (NC) management process. Non-conformance is a sign that something is not going according to plan in service, process, product, or in the system itself. The existence of nonconformance implies that some aspects of a company’s standard operating procedures are not met, need modification, or must be updated. A well-designed nonconformance management process helps catch quality issues before the product leaves the company’s four walls. This is extremely important to reduce the cost of quality and prevent product recalls.

Businesses can seamlessly conduct root cause analysis (RCA) by taking the digital route. Digital transformation of the NC management process allows the organization to easily detect, assess, review, and run a CAPA (corrective action/preventive action) process. A robust EQMS software must include an NC CAPA system, which is essentially two separate processes. One is a nonconformance management system, and the second is a CAPA management system.

A good NC CAPA system must be data-driven and collaborative, allowing for easy approvals, verification, and final closure after corrective and /or preventive action has been taken.

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What is NC CAPA?

Dealing with non-conformances and customer complaints is the foundation for addressing problems. Having moved from paper-based systems, many organizations are enhancing the process by managing real-time CAPAs while ensuring that stakeholders take proper actions throughout the digitally connected enterprise.

NC CAPA provides the essential visibility and oversight to eliminate nonconformities by identifying the root cause and implementing necessary corrective and/or preventive actions associated with product nonconformity. NC CAPA can significantly drive quality performance while driving up efficiency in the quality management process.

You need a proactive approach to manage nonconformity by integrating several processes, from detecting the problem to determining the root cause, implementing CAPA, documenting, reporting, and tracking. To ensure that nonconformities are managed well, you should have a robust management review process by conducting periodic audits and tracking progress on open CAPAs. You also need to analyze process changes and their impact to ensure that the new processes do not come with their own set of nonconformities and other risks.

Guidance on corrective action and preventive action and Related QMS processes

why NC CAPA is required

Why is NC CAPA required?

NC CAPA is required to reduce or eliminate the source causes of nonconformity to prevent a recurrence. CAPA follows the PDCA (Plan-Do-Check-Act) cycle to address unforeseen events. The first step is identification, where businesses search for nonconformities in their processes and/or products and assess the severity level to determine how to take proper action. Nonconformities can be raised through customer complaints or internal or external audits.

By performing CAPA, businesses can reduce the Cost of Quality (CoQ), including all costs such as appraisal, internal failure, and external failure costs within your organization. There are numerous techniques to improve your Corrective Action and Preventive Action approach, including Root Cause Analysis (RCA), APQP (Advanced Product Quality Planning), Failure Mode and Effects Analysis (FMEA), and 5 Whys-technique. ComplianceQuest published a whitepaper on how next-generation EQMS improve complaints management for medical device companies. Discover why embracing digital transformation and automation has become a no-brainer in today’s context.

Difference between NC and CAPA

Communicating the differences between nonconformances (NC) and corrective/preventive actions (CAPAs) is crucial because consistency in using your organization’s quality management system will contribute to the accuracy of your metrics.

In ISO 9001:2015, there’s a defined process flow for nonconformity and CAPA. A nonconformity happens whenever a task isn’t fulfilled and doesn’t meet product requirements. When it is identified, the next step is to take corrective action to address nonconformities from continuing to break your operations. Once CAPA is considered the right move, a corrective action request should be launched to initiate a root cause investigation so that the nonconformity will not happen again.

difference between NC and CAPA

countermeasure ladder for corrective and preventive actions

Countermeasure Ladder for Effective Root Cause and Preventive Actions

countermeasure ladder for corrective and preventive actions
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How to Create a Corrective Action and Preventive Action Report?

Corrective Action and Preventive Action Report

Creating a CAPA report requires an organized and systematic approach.

  • Assign a CAPA number to track the issue throughout the CAPA process.
  • Provide all the details of the issue, including all relevant information, such as what product was involved, when and where the issue occurred, and who was affected.
  • Perform a root cause analysis to identify the underlying causes of the issue.
  • Once the root cause has been identified, develop CAPAs to address the issue and prevent it from happening again.
  • Finally, you need to document all actions taken in the CAPA report, including the date the issue was reported, the date the CAPA was taken, and the owners responsible for each action.

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We have rolled-out CQ across our company to automate various elements of QMS requirements such as Document Management, Complaints, Non-conformances, Corrective Action (8D and A3), Supplier Management and Audit Management. We have been using the software for more than 2 years. We are glad to see how well the system is being used across the company. We have several thousand users on the system currently and working to scale the usage further. CQ solution has been configured to meet our needs, works elegantly across languages, across time zones, and business verticals. With integration between CQ and SAP to exchange critical data, the process automation provides a lot of productivity.

CQ configuration team and support have worked hard to ensure that our needs continue to be met. They consistently go above and beyond. We cannot be more pleased with our use of CQ QMS capabilities and would definitely recommend to anyone who is looking for a modern cloud based EQMS solution especially if you want a scalable EQMS solution.

Lia Budiman,
Solution Consultant,

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ComplianceQuest Best Practices for NC CAPA

In today’s rapidly changing world, monitoring and maintaining a quality product is critical to its effectiveness. NC CAPA system is an integral component to performing quality improvements as it helps businesses to enhance processes, methods, and business in a structured and well-documented way. It lays the foundation for a QMS system. ComplianceQuest’s CAPA Management Solution can help make a strong connection between operational excellence and quality with the help of a well-established CAPA system. Using the robust system offers numerous benefits and higher ROI for the business, including

  • Improved customer satisfaction, safety, and security
  • Enhanced productivity and better product quality
  • Eliminating the cost of regulatory non-compliance (fines, penalties)

Properly documented CAPA requirements can determine the root cause of nonconformances, system outages, or process problems, address them, and eliminate them from recurring. Integrating with nonconformance management, ComplianceQuest’s robust CAPA process can help you to

  • Shorten quality gaps and lead time, increase production yield, and prevent nonconforming products and the associated customer satisfaction by improving process control.
  • Perform investigation and risk assessment to eliminate the root cause by accessing necessary nonconformance data.
  • Minimize review cycle time by retrieving information easily and authorizing the disposition of nonconforming material for data-driven decisions.

Conduct root cause analysis seamlessly with ComplianceQuest’s data-driven and collaborative NC CAPA system

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Frequently Asked Questions

  • To prevent nonconformity effectively, every organization must implement a robust quality management system. All employees must be trained to understand the basics of quality system requirements, procedures, and guidelines and assigned responsibilities for their responsibilities.

    While using QMS to prevent nonconformity, remember the following guidelines

    • Your QMS system should properly define procedures, guidelines, and instructions, and documentation should be followed and implemented accurately.
    • The corrective action request (CAR) process should properly manage and control within the agreed time scale, ensuring the implementation and monitoring of solutions.
    • Employees involved in this process should actively participate in and monitor the activities of the corrective action request processes. And then should follow up with all corrective action requests.
  • FDA 21 CFR 820.100 defines CAPA as an important subsystem that can

    • Identify and investigate product and quality problems by collecting and analyzing data

    • Prevent a recurrence by taking appropriate and effective CAPA

    • Verify or validate proper corrective and preventive actions

    • Communicate CAPA to the people involved

    • Provide relevant information by enabling management review

    • Document CAPA initiatives with clarity

  • CAPA involves multiple workflows. Any action that has been taken in one process could have an impact on another process. An effective Corrective and Preventive Action plan can provide a holistic view of the process flows and enable a data-driven approach to the nonconformance. However, manual systems don’t have this visibility and transparency. This disrupts the ability to identify the root cause, especially while collaborating with diverse stakeholders.

    A cloud-based solution like ComplianceQuest can help you overcome many challenges by providing a robust CAPA workflow and enabling businesses to correct and prevent issues effectively. Moreover, to improve compliance, ComplianceQuest’s Corrective and Preventive Action solution helps to facilitate automation change management and documentation. A few leading regulatory requirements, such as OSHA, FDA, MDR, and cGMP, are aligned with CAPA solutions to improve compliance.


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