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Enable cross-functional collaboration and accelerate your product lifecycle with a cloud-based platform for innovation
Design Process and Quality System Development Tools in Product Lifecycle
Get full visibility over your product design processes and make collaboration easy to get your products to market faster, compliantly
Design Quality: Connecting Design to Documentation
Transform customer complaints to valuable sources of insights for continuous improvement through smart automations and integrated regulatory reporting
Challenges with Triage and Investigation in Complaints Management Process
Say goodbye to paper! Modernize your processes with connected document, training, and change management
Manufacturing Challenges and Industry Trends Towards Digital Transformation
Transform quality into an enabler: boost efficiency, increase satisfaction, and trim costs with a fully connected, AI-powered quality management solution
Frost Radar for Quality Management Systems Names ComplianceQuest Leader
Enable risk-based thinking throughout your quality processes with a fully integrated risk management solution
Automation of the Risk Management Lifecycle with AI and Analytics
Increase supplier performance, reduce costs, and streamline your supply chain with integrated supplier quality and collaboration tools
The Ultimate Guide to Next-Generation Supplier Management [e-Book]
Identify and minimize safety events. Prevent accidents, safeguard workers, and ensure their well-being and health
Safety Essentials: Key ‘Must-have’ Components for Safety Management at Any Enterprise
Proactively and accurately monitor and measure your company’s impact on the environment to improve performance and reach your environmental and sustainability targets
Environmental & Sustainability Management
Electronic and Automated Approach to Audit Management
Managing the Tools of the Trade
Manage Operational Risk Tracking, Evaluation, Mitigation and monitoring
Leveraging CAPA for Continuous Improvement
Ensure your laboratory is compliant with systematic and efficient laboratory investigations
Incident Reporting and Management
Organization, Collaboration and Governance for Efficient Changes
Conduct smart management review meetings with a tower of data to improve your quality and safety systems
Gain 360 degree vision into enterprise wide Safety risks
Enhance Safety and Compliance with Smarter Chemical Management
Ensuring Quality across Departments & Locations
Partner With Suppliers And Vendors To Improve Quality And Safety
Create Loyalty by Addressing Customer Complaints Smartly
Bring Consistency to Permit Practices
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Streamline Permit Management and Ensure Compliance
When Learning Propels Organizational Growth
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Assuring Quality Products and Services
ComplianceQuest covers the whole spectrum of customers, industries and regions across the world. Whether it is a small, medium or enterprise sized manufacturer, companies choose ComplianceQuest for its end-to-end Product Lifecycle, Quality, Safety and Supplier Management Solutions.
Leveraging AI to Create a Safer Workplace Environment
Why an EHS Solution Built on Salesforce Works Better Than One Built on AWS or Azure
Humans: The Real Superheroes of Artificial Intelligence (AI) in Quality Management
ComplianceQuest Medical Devices QMS Success Stories eBook
Complaint Handling Process for MedTech and Life Science Companies
Audit Management
Aphria (now Tilray) CIO talks about their implementation of ComplianceQuest, Rootstock and Salesforce
Unlocking the Value of Complaints
Why You Need to Digitally Transform Your QMS
The Ultimate Guide to ISO/IEC 17025:2017 Compliance
Safety Technology Trends to Watch in 2023 (Infographic)
Data-driven Safety – Strategic Resources for Monitoring of Key Performance Indicators
American Society of Quality Lean Six Sigma Conference
23 Feb, 2025
Phoenix, AZ
Transform to a fully connected business with a next-generation AI-powered Product Lifecycle, Quality, Safety, and Supplier management platform, built on Salesforce.
Our connected suite of solutions helps businesses of all sizes increase product, quality, safety, and supplier as they bring their products from concept to customer success.
Where Your Career Takes Flight: Join our dynamic team and be part of an innovative, collaborative and rewarding workplace culture.
Impact Through Action: How the ComplianceQuest team supports social causes and community engagement
The Pulse of ComplienceQuest: Our newsroom shares stories of innovation, progress, and change
Stronger Together: How our partnerships drive success and innovation
NC CAPA: Driving Proactive Quality with Precision and Continuous Improvement.
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 NCR and 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.
Standards and regulations such as ISO and FDA stress CAPA, referring to Corrective Action, Preventive Action, creating the impression that…
Requirements of CAPA in ISO 13485 Corrective Action Preventive Action helps businesses fix quality issues following root cause analysis to…
ISO 45001:2018 defines nonconformity as “not meeting the stated, implied, or obligatory requirements of standards, rules, or laws”. In other…
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.
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.
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.
Creating a CAPA report requires an organized and systematic approach.
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,
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
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
Occupational Health & Safety (OH&S) – Incident, Nonconformity and Corrective Action
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MDSAP Quality Management System (QMS) Assessment Checklist (Part 4): Nonconformity, Corrective Actions and More
Checklist | April 6th, 2022
Field Safety Corrective Action (FSCA) For Medtech Companies
Checklist | October 4th, 2021
Five Steps Corrective and Prevention Action (CAPA) Reporting Template
Checklist | July 12th, 2021
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
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.
If you lack a formalized CAPA plan, how will you effectively identify the root cause and resolve the issue? However,…
The CAPA plan must be fool-proof to ensure compliance while…
Creating and sustaining a safe work environment is a continuous,…
One of the most important quality system elements is the…
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