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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
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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
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Incident Reporting and Management
Organization, Collaboration and Governance for Efficient Changes
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Enhance Safety and Compliance with Smarter Chemical Management
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Partner With Suppliers And Vendors To Improve Quality And Safety
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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
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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
Achieving greater quality in manufacturing, you need the means to implement improvements to an organization’s processes so that they eliminate causes of non-conformities or other undesirable situations. This process is commonly referred to as CAPA or Corrective and Preventive Actions. One cannot achieve compliance with ISO 9001, ISO 13485, GMP and myriad other quality standards without a strong, consistent CAPA process. The consequences of CAPA noncompliance are costly and significant, resulting in damaged brand reputation and, potentially, a company’s long-term profitability. Effective CAPA management software is more than just a regulatory requirement. It’s a good business practice that can reduce company liability and warranty claims and increase customer satisfaction.
CAPA, as the term indicates has two parts to the process. Corrective Action and Preventive Action. Corrective actions are implemented in response to customer complaints, unacceptable levels of product non-conformance, issues identified during an internal audit, or adverse or unstable trends in product and process monitoring. Preventive actions are implemented in response to the identification of potential sources of non-conformity to prevent reoccurrence. CAPA implementation and effectiveness verification are leading indicators of the overall quality system effectiveness.
Intake of the issue and finding all the required information so that the detailed analysis can be conducted. This step also includes identifying and involving the relevant personnel from the company or outside of the company who can help address the issue at hand. Not all source inputs to potential nonconformances are always identified. Information is typically is not measured, monitored or shared across different product lines or business units. Trending data are not always visible to the appropriate level in the organization. Companies tend to look at product and material issues and correcting them and neglect to look beyond into the processes and procedures of their quality system.
A thorough analysis of the issue that has been summarized from step 1. The analysis may include scanning the entire system to determine if issues of similar nature have occurred. Conducting a risk assessment to determine the severity and the potential impact the issue at hand will have on the company’s key stakeholders and principal/values.
You will need to identify everything from problems that may occur from partner sites through final manufacturing, labeling/packaging and distribution lifecycle to any possible customer complaints. Key to recording problems is to drive to the root cause and focus on prevention and correction actions. Locate and document the root cause(s) of the identified non-conformity. Use the various investigation tools such as 5 Why’s, Pareto Analysis, Fishbone Diagram, etc. to be sure that the root cause investigation was done using scientific methods. The more knowledge you have, the faster you can react. Without an integrated system, identifying root causes is little more than guesswork. Assumptions are made based on rumor and conjecture, rather than accurate, reliable data. Islands of information created by multiple data streams lead to inconsistencies and waste. Immediate data and real measuring tools enable managers to determine precisely where and when mistakes are occurring and why.
Create and document the required action plans that will mitigate the identified root causes. Care should be taken to address the corrective action to address the non-conformity at hand and at the same time take preventive actions to be certain that the issues of a similar kind do not occur in the future. The actions may require initiating change control to address all the required changes to be addressed including procedural or documentation changes. Such changes should be communicated to those directly involved – making sure everyone is aware of the changes, understands the changes, and implements the changes. Once source error information is correctly captured, many companies escalate these immediately to CAPAs to begin the investigation process. Everything becomes a CAPA! This behavior may lead to an overload of data that doesn’t inherently provide the important impacts of what’s failing across the organization. With a volume of CAPAs, companies cannot always assure 100% effectiveness of its corrective/preventive action plans; what the trending really tells you and, if the information provided back to the product design is really going anywhere – there’s just too many.
Did the changes have their desired effect and did they have any adverse effects? Effectiveness checks are a critical part of the CAPA process to be sure that effectiveness checks are done in a systematic manner and the information collected through this process is documented for why the information as accepted or not. The CAPA process should be tied to a company’s overall change management strategy to more effective respond to issues as they arise.
Make management aware of and ensure they are on board with all the activities.
Provide that “audit trail” or “evidence” of everything done.
To accomplish the above, companies need the following QMS solutions:
Identify and capture any product or process related nonconformities including customer complaints. Capturing events that happen at the source is a critical part of an effective CAPA system.
A good CAPA management tool provides an effective problem resolution management platform that allows processing the above-identified elements by supporting the processes within it or by working with other parts of the integrated EQMS solution framework.
Many a time, action plans proposed may need to be spun off as change projects whether they be replacing machines, re-validating a specific process or equipment, changing documents, the creation of new documents or ensuring that knowledge is properly propagated, a change management software tool is essential to carry out the complete CAPA action plan objective.
We know the information is knowledge and no process change can be complete without the supporting information in documents are revised and thus aligned with the improvement to the processes that are being worked on.
Knowledge dissemination due to the changes or creation of new content requires that the resources who should be informed and knowledge transferred and assessed are all important part of the effectiveness of how well a CAPA got implemented.
So as you see, for a good CAPA process to work, a company needs to have five core solutions, if not more. The purpose of a highly integrated EQMS solution is to support such integrated processes and thus ensuring the company achieves a high degree of business process automation resulting in the reduction in cost and improvement in brand loyalty.
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