Non-conformance Management Software

Non-conformance issues can arise in any stage of production, from internal processes to supplier and customer interactions. Managing these issues efficiently is critical to ensuring product quality, maintaining compliance, and minimizing downtime. With our Non-Conformance Management Software, you can quickly identify, track, and resolve non-conformance events across your organization, ensuring smoother operations, higher quality standards, and improved regulatory compliance.

Stop Letting Nonconformances Get Lost in the Process

A nonconformance is more than a quality issue. If it’s not properly investigated and resolved, it can lead to rework, scrap, customer complaints, repeat failures, audit findings, and increased cost of poor quality.

Yet many organizations still manage NCRs using spreadsheets, emails, paper forms, and disconnected systems.

This makes it difficult to answer critical questions:

Which nonconformances are still open?
Who is responsible for resolving them
Which corrective actions are overdue
What caused the problem?
Have corrective actions actually worked
Are the same problems happening repeatedly?
Can we demonstrate the complete history during an audit?

Nonconformance management software gives your quality team a structured, traceable way to answer all of them.

Manage the Complete Nonconformance Lifecycle

From the moment a problem is identified to the moment its effectiveness is verified, keep every activity connected.

1 — Report

Create a nonconformance record whenever a product, process, service, document, supplier, or other requirement fails to meet specified criteria.

2 — Assess & Assign

Evaluate the issue and determine its priority. Assign the nonconformance to the appropriate person with clear responsibilities, and deadlines.

3 — Investigate

Document the investigation and understand what happened before deciding how to fix it. Give teams the information they need to investigate systematically.

4 — Find the Root Cause

Don't just correct the immediate problem. Identify why the nonconformance occurred using structured root cause analysis methods

5 — Take Corrective Action

Define actions that address the identified root cause. Assign each action to a responsible person, establish deadlines, and monitor progress until completion.

6 — Verify Effectiveness

Verify whether the action actually prevented the problem from recurring. Record verification results, evidence, and approvals before closing the nonconformance.

7 — Close & Improve

Once all requirements are satisfied, close the nonconformance with a complete, traceable record. Use historical data to identify recurring problems and opportunities for continuous improvement.

One Place to Manage Every Nonconformance

Internal Quality Issues

Capture nonconformances identified during manufacturing, inspection, testing, or routine operations.

Audit Findings

Create and manage nonconformances resulting from internal, external, supplier, or certification audits.

Supplier Nonconformances

Track supplier-related quality issues and follow corrective actions through resolution.

Customer Complaints

Convert relevant customer complaints into structured investigations and corrective actions.

Inspection Failures

Connect failed inspections with NCRs so quality issues can be investigated rather than simply recorded.

Process Nonconformances

Identify deviations from established procedures, specifications, processes, or quality requirements.

See Your Nonconformance Status at a Glance

Quality teams shouldn’t have to open spreadsheets and search through emails to understand their NCR workload. A centralized dashboard can provide visibility into:

Open NCRs

Know how many issues require attention.

Overdue Actions

Identify corrective actions that need immediate follow-up.

NCR Aging

See how long issues have remained unresolved.

Recurring Issues

Identify problems that continue to occur.

Root Cause Trends

Understand the causes behind your quality problems.

Corrective Action Effectiveness

Monitor whether actions are actually preventing recurrence.

Nonconformance Management Features

Centralized NCR Management

Maintain every nonconformance in a centralized system instead of scattered spreadsheets, emails, and paper records.

Automated Workflows

Automate how nonconformances move from reporting through investigation, corrective action, verification, and closure.

Root Cause Analysis

Provide a structured approach for identifying the underlying causes of quality problems.

Corrective Action Management

Assign corrective actions, owners, deadlines, and required evidence.

Automated Notifications

Keep responsible users informed about assigned actions, approaching deadlines, and overdue activities.

Evidence & Attachments

Keep documents, reports, investigation evidence, and other supporting information connected to the NCR.

Review & Approval

Route records through defined review and approval processes before final closure.

Effectiveness Verification

Document whether corrective actions achieved their intended results.

Complete Audit Trail

Maintain a history of activities, changes, reviews, approvals, and closure.

Dashboards & Analytics

See where nonconformances are occurring, how long they remain open, and which problems are recurring.

Who Can Use This Software?

Our Non-Conformance Management Software is built to meet the needs of key personnel in quality management and production teams:

Quality Managers: Take control of your organization’s non-conformance events and drive compliance with regulatory requirements.
Production Managers: Track and resolve quality issues in production quickly to minimize delays and maintain operational efficiency.
QC/QA Technicians: Log non-conformance events accurately and provide essential data for root cause analysis and corrective actions.
Root Cause Analysis Specialists: Identify, analyze, and eliminate the causes of non-conformances to prevent future issues.
CAPA Coordinators: Ensure that corrective and preventive actions are defined, tracked, and closed out effectively.
Regulatory Affairs Managers: Ensure that your company is meeting all industry regulations and standards, keeping your organization audit-ready at all times.
For Everyone Committed to Quality: You don’t need a specific job title to benefit from this software. If you wish to improve quality, productivity and profitability, you should use this Non-Conformance Management Software to ensure that you follow best industry practices.

Key Features of Our Non-Conformance Management Software

Our Non-Conformance Management System is more than just a tracking tool—it’s a robust, configurable solution designed to improve your quality management processes, ensure compliance, and provide deeper insights into your operations.

Permission-Based Access for Better Control

Our non-conformance software is built with role-based permissions to ensure that only authorized users can perform specific activities. This enhances security, reduces the risk of errors, and ensures that critical tasks are performed by the right people. Module managers or authorized personnel control who can initiate, approve, or edit non-conformance records (NCRs), ensuring clear accountability.

Flexible NCR Origins and Customization

Our system allows you to initiate NCRs from multiple origins — whether internal, customer-related, or supplier-driven. This flexibility ensures that you can capture non-conformance events from all areas of your business, improving oversight. Additionally, the Non-Conformance system offers customization options so you can tailor the software to your specific needs, from default settings to workflow processes.

Custom Fields for More Detailed Tracking

Easily add custom fields to NCRs to track additional information specific to your organization’s processes. In addition to standard fields like title, department, category, and failure mode, you can capture the unique data you need to improve quality control and enhance reporting.

Initiate and Track CAPA Actions

Easily initiate CAPAs directly from NCRs. The details from the NCR are automatically transferred to the CAPA module, making it simple to create a corrective or preventive action plan without duplicating data entry. This seamless integration accelerates issue resolution and helps you maintain comprehensive records for compliance.

Send NCRs to the Material Review Board (MRB)

If necessary, you can send NCRs to the Material Review Board (MRB) for further review. The responsible person can assign selective members of the MRB to review the NCR and provide feedback, ensuring thorough evaluation before disposition.

Advanced Search & Analytics

Our software offers advanced search capabilities that allow you to retrieve NCRs based on specific criteria. Whether you’re looking for trends, performance issues, or root causes, you can drill down into your data and generate customizable charts and reports for in-depth analysis and continuous improvement.

Efficient Data Sharing & Reporting

Easily share NCR records with internal and external stakeholders via email. The system automatically includes any attachments, ensuring that everyone involved in the resolution process has access to the most up-to-date information.

Categorize and Analyze Non-Conformance Events

Easily associate each NCR with a category and failure mode. Disposition types are defined by category, ensuring each non-conformance is categorized properly for analysis. This streamlines the investigation process and ensures that corrective actions are targeted and effective. Plus, you can reference and link multiple NCRs to track related events and their resolutions.

Configurable Email Alerts for Timely Action

Our system allows you to initiate NCRs from multiple origins —whether internal, customer-related, or supplier-driven. This flexibility ensures that you can capture non-conformance events from all areas of your business, improving oversight. Additionally, the Non-Conformance system offers customization options so you can tailor the software to your specific needs, from default settings to workflow processes.

Involve Suppliers and Customers Directly

Our software allows supplier representatives to be assigned as responsible persons for NCRs related to their site, ensuring that non-conformance events are addressed at the source. Similarly, customer representatives can also initiate NCRs related to their organization, ensuring all stakeholders have a voice in the quality management process.

NCR Dashboard for Real-Time Visibility

Our intuitive NCR dashboard provides a real-time snapshot of all open NCRs. Track the current status of each NCR, see the required actions, due dates, and who is responsible for the next steps. This dashboard ensures that no issue falls through the cracks and that every NCR is managed efficiently and effectively.

Disposition Actions with Multiple Reviewers

Disposition actions are critical to closing NCRs, and our system allows multiple users to provide input. Each NCR can have different disposition types, sent to various users for review and approval, ensuring that the final resolution is thoroughly vetted before closure.

Collaborate with Discussion Notes and Attachments

Keep all relevant information in one place by adding discussion notes and attachments to NCRs. Authorized users can document additional context or insights that can aid in the resolution process, ensuring that all relevant information is captured for future reference.

Edit Capabilities for Ongoing Adjustments

Authorized users can make changes to NCR records as needed. Whether it’s correcting data, updating statuses, or modifying resolution plans, the system’s edit capabilities ensure that your team can adapt to changing circumstances and keep all records accurate and up to date.

Resolve Issues Before They Escalate With Automated Workflow

Our Non-Conformance management system will help you proactively identify and address issues with automated workflows. So you can ensure timely corrective actions and prevent escalation to improve operational efficiency and compliance.

Our NCR Management Workflow Procedure

Check our procedure step by step

For Manufacturing

Nonconformance management software in manufacturing helps track product and process deviations by automating reports, assigning corrective actions, and ensuring timely resolution. It centralizes data, improves traceability, and improves decision-making by providing real-time insights into quality issues. This reduces downtime, waste, and ensures consistent product quality, boosting efficiency.

For Pharmaceutical Industry

In the pharmaceutical industry, nonconformance management software ensures compliance with regulatory requirements (e.g. FDA, GMP). It helps track deviations, document investigations, and monitor corrective actions. By automating workflows and providing audit trails, the software reduces the risk of non-compliance, prevents costly recalls, and improves product quality and regulatory readiness.

For Biologics Industry

For biologics, nonconformance management software tracks deviations from production to final product release. It streamlines root cause analysis, automates corrective actions, and supports regulatory documentation. This software enhances product safety, ensures batch consistency, and reduces the risk of regulatory non-compliance, improving overall efficiency.

For Chemical Industry

This software manages non-conformances in raw materials, production, and testing in the chemical industries by automating reporting, root cause analysis, and corrective actions. It helps ensure compliance with environmental, safety, and regulatory standards (e.g. REACH, EPA), reduces risks, and ensures product integrity, thereby enhancing quality control and operational efficiency.

About QIA

Founded in 1994 in Houston, Texas, the Quality Institute of America (QIA) originally focused on consulting, auditing and training for quality management based on ISO standards and requirements. Today, we specialize in software development to help clients improve profitability through effective management systems. Our QISS products automate workflows to ensure compliance and efficiency across various management systems and global regulations.

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What Our Clients Say About Us

QIA is a very customer-focused business. QIA is a very good company, good people, and I encourage people to look into them for their businesses.

Since 1995, EagleBurgmann has used QIA services including QISS-QMS software. We recommend QIA to anyone who might need such services without any reservations.

I wish to congratulate QIA on the great job they did for Sheppard US Air Force Base in Wichita Falls TX and the Manpower Office the past 9 months.

I am very satisfied with QISS and its capabilities to manage my quality management affairs. The customer service is the key to having a full service software team on my side.

Great, have used almost all features and modules, has made my life extremely easy as software does most of the management functions and keep a track of planned activities with automatic notifications. Certainly, the most user friendly QMS software of at least five others that I have used. i would strongly recommend it to others.

I like the ability to maintain our QMS and HSE documents in the document module. Prior to the implementation of QISS, files were located sporadically in different locations, and it was difficult to search for them as well as make sure current revs were being utilized by all employees.

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Frequently Asked Questions

What does a marine surveyor do?

A marine surveyor inspects ships, cargo, and equipment to ensure safety, compliance, and condition. They specifically inspect cargo tanks and holds for the acceptability of cleaning from prior cargo before new cargo is loaded, particularly for sensitive chemical cargo. Marine surveyors also witness cargo loading, perform cargo sampling, and oversee cargo tank sealing to ensure proper handling and compliance with regulatory standards.

What specialized knowledge is required for cargo surveying?

Understanding of cargo loading, stowage, securing practices, and international regulations related to cargo handling. Surveyors also investigate cargo damage claims and develop loss prevention strategies.

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