Nonconformance  >  Non conformance Report Software

Non conformance Report Software

non conformance report software
non conformance report software

Businesses often face many challenges in balancing customer expectations and regulatory needs. To truly ensure that the products or services meet all quality standards, businesses must periodically check for nonconformances. This process helps eliminate issues that can affect the product’s quality.

Request an Online Demo

Understanding Non conformance Report Software

ComplianceQuest’s Non conformance Report Software is a flexible, scalable, next-generation solution that aims to ensure product quality, safety, and compliance. The non conformance software streamlines all the quality processes to manage defects and process deviations and reduce cycle time, focusing on continuous improvements while meeting product quality specifications. The Non conformance software aims to reduce operational costs by minimizing product rework and recalls.

  • Improves customer satisfaction and brand loyalty by addressing non conformances, identifying root causes, and determining corrective action to prevent a recurrence.
  • Standardizes reporting to communicate non conformances efficiently within the company and provide the necessary data at the right time.
  • Improves efficiency and productivity with user-friendly data-gathering tools.
  • A closed-loop centralized system helps capture, track and document non conformance data for better organizational visibility.
  • Reduces CoQ within the organization by improving non conformance rates and resolving non conformances to reduce the risk of warranty and recall costs.
understanding of nonconformance software

Advantages of Nonconformance Management System

Businesses can identify nonconformities in processes, products, or services, in a timely and effective manner using a nonconformance management system (NCMS). Businesses need to correct the errors and prevent future recurrences to improve the quality and performance of the products and services as well as improve customer satisfaction and loyalty. Improved compliance with regulations, industry standards, and internal policies is crucial for businesses to earn customer trust and prevent recalls or warning letters from the regulatory authorities. Improved alignment of operations with legal requirements reduces the risk of penalties or legal issues.

By detecting nonconformity early and resolving them promptly, businesses can save costs and optimize resource utilization by minimizing rework, waste, and resource misuse. Proactive management of nonconformities also reduces potential errors, accidents, or failures. This enables mitigating risks associated with product or service delivery. Organizations can use the NCMS for constant feedback, analysis of root causes, and implementation of corrective actions to learn from mistakes and prevent recurrence.

Access to comprehensive data on nonconformities enables informed decision-making. It allows management to prioritize actions and allocate resources effectively. Consistently delivering high-quality products or services due to effective NCMS enhances the organization's reputation and strengthens its brand image.

Advantages of Nonconformance Management System

Features of Nonconformance Reporting Software

CQ Nonconformance Reporting Solution helps capture, triage, investigate and disposition all nonconformances in a timely and effective manner. The nonconformance software helps create an automated, data-driven process for identifying and managing the nonconformance of both products and processes. Some of the main features of the CQ Nonconformance Report Software include the following:

nonconformance report Software features

  • Streamline all nonconformance recordings from single or multiple sites in one centralized system.
  • A simple, easy-to-use user interface allows documenting instances of nonconformance from one or multiple sites.
  • Comprehensive triaging, risk assessment and documentation of non conformance results help take the required resolution.
  • Enforce containment activities to control or prevent improper usage of nonconforming material.
  • Collaborate with employees from one or multiple sites and divisions to propose different disposition types and hold virtual material review boards.
  • Perform root cause analysis and document its outcome in detail for CAPA evaluation.
  • Evaluate every nonconformance or event against the CAPA requirements of the organization and generate CAPA where required.
  • Reach others within the enterprise and in the supply chain without compromising ownership of the tasks.
  • Use pre-built best practice-based reports or create personalized reports and dashboards based on your requirements.

Six Uses of CQ’s Nonconformance Software

  • A collaborative approach to nonconformance management can help reduce the Cost of Quality (CoQ) that may arise due to internal failures.

  • ComplianceQuest’s Non conformance Management solution uses Einstein Predictive Analytics to capture nonconformance trends, spot key risks, and draw insights from data while focusing on continuous improvement (CI) of the entire quality management process.

  • Use CQ’s Non conformance software to prevent product recalls by catching nonconformances early in the cycle, thus preventing injuries and penalties while ultimately protecting the brand image.

  • Maintain the quality of the product with robust process control to reduce quality gaps and conform to product specifications.

  • Automate non conformance management workflows using CQ’s Non conformance software to identify, document and prevent non conformances, with a specific focus on high-risk nonconformances.

  • Ensure ISO 9001 and FDA 21 CFR 820.90 compliance at all organizational levels.

Automation of Nonconformance

Robust Quality Control: How Intelligent Automation of Nonconformance, Equipment and Inspection Management Processes will Save Time and Costs

Steps to Create an Effective Nonconformance Reporting

Writing a non conformance report is a seven-step process:

nonconformance report steps

  • Non conformance can happen at any stage in the production or operation process. Identify the event and write details of it for the investigation process. Once nonconformance is identified, it leads to CAPA or even product recalls.
  • Once the nonconformance issue has been raised, a nonconformance review team steps in to determine the next actional steps. This involves segregation of nonconformances, review, and addressing of violated quality or safety standards.
  • After the nonconformance review is complete, the next step is to determine the action plan that defines the corrective measures prepared to resolve the non-conformances.
  • Before launching corrective measures, the organization should focus on and document the probable causes that led to the occurrence of nonconformance.
  • Depending on the severity of the nonconformance, it can be closed. This can be as simple as employee training, change in process cycle, or CAPA for systematic or complex concerns.
  • Once the corrections have been implemented, it is imperative to monitor their effectiveness. This step ensures that actions are appropriate and effectively eliminate nonconformances once identified.
  • Documentation is the backbone of NCR. All NCRs must be reviewed and approved, finalizing the nonconformance closure. Every finding and insight must be documented along with actionable plans.

Challenges and Solutions of Nonconformance System

Implementing a Nonconformance Management System (NCMS) comes with its own set of challenges, but there are solutions to overcome these hurdles:

  • Challenge #1 Identifying Nonconformities: One of the greatest challenges organizations face while implementing nonconformance system is being unable to identify nonconformities across various processes or products accurately. Sometimes, subtle issues might go unnoticed without a robust detection system.

    Solution - Robust Detection Mechanisms: Implementing comprehensive monitoring, inspection, and reporting mechanisms help identify nonconformities early. Utilizing technology, automated systems, and regular audits can aid in this process.

  • Challenge #2 Root Cause Analysis: Determining the underlying causes of nonconformities can be complex. Determining the source accurately is crucial to preventing recurrence.

    Solution - Root Cause Analysis Tools: Employing various problem-solving techniques such as Fishbone diagrams, 5 Whys, or Failure Mode and Effects Analysis (FMEA) assists in effectively dissecting and addressing root causes.

  • Challenge #3 Resource Optimization: Allocating resources to address nonconformities without disrupting ongoing operations is another challenge organizations face. Balancing immediate needs with regular workflow can be tough.

    Solution - Effective Resource Management: Prioritizing nonconformities based on their impact and severity helps allocate resources. Creating contingency plans and setting aside dedicated resources can ensure a swift response without disrupting regular operations.

  • Challenge #4 Employee Engagement: Ensuring all employees actively participate in the NCMS is vital. Resistance to change or lack of awareness might hinder the system’s effectiveness.

    Solution - Training and Communication: Providing comprehensive training to employees regarding the importance of NCMS and how they can actively contribute fosters engagement. For effectiveness, establishing clear communication channels for reporting nonconformities and encouraging suggestions for improvement are crucial.

By establishing a culture of continuous improvement, employees are empowered to identify and address nonconformities proactively. Rewarding problem-solving initiatives and fostering a blame-free environment encourages participation. By implementing these solutions, organizations can overcome the challenges associated with Nonconformance Management Systems, ensuring a more effective and streamlined process for identifying, addressing, and preventing non-conformities.

Need for Nonconformance Management Software

The successful implementation of Nonconformance Management Software (NCMS) involves several key steps and considerations. Each organization faces unique challenges. Therefore, the first requirement is understanding the organization’s unique requirements and challenges. Based on this, the scope of the nonconformance management needed covers the types of nonconformities, the processes involved, and the stakeholders it affects.

Several software solutions are available, but not all may suit the organization’s needs. Therefore, researching the NCMS and finding the best fit is crucial. Some of the factors to consider include while implementing nonconformance system include:

  • User-friendliness

  • Scalability

  • Integration capabilities with existing systems

  • Reporting functionalities

  • Compliance with industry standards

Need for Nonconformance Management Software

Develop a detailed implementation plan with timelines, responsibilities, and milestones to track progress and effectiveness. Provide training and support where needed to ensure employee involvement and improve outcomes. Customize the NCMS to fit your organization's workflow and requirements. Configure the software settings, workflows, user permissions, and reporting features to align with your processes. The NCMS must be integrated with other relevant enterprise systems, such as Quality Management Systems (QMS) or Enterprise Resource Planning (ERP) software, for seamless operation and data exchange. Smooth data migration is essential in case of transitioning from manual to digital systems.

Provide comprehensive training to employees on how to use the nonconformance system effectively. To encourage user adoption, highlight the benefits and demonstrate the nonconformance system’s practical applications. The implementation is complete only after testing confirms that the software performs as expected. Validate the system by simulating real-world scenarios and workflows to identify and address issues. Monitor the system's performance post-implementation and gather user feedback. Implement continuous improvement measures based on feedback and changing organizational needs. Provide ongoing support and maintenance to address any issues that arise. Ensure that the NCMS meets regulatory compliance standards. Detailed documentation of processes, configurations, and changes made to the system are crucial for auditing and future reference.

how to use toot cause analysis

How to Use Root Cause Analysis to Transform Your Safety Program

how to use toot cause analysis
Watch Webinar

How to write a non conformance report?

A non conformance report is a written document that is prepared to identify and report discrepancies between the current working condition of a product, service or process and the requirements defined by quality standards within the organization. While non conformance reports are applicable to any part of the organization, it is most prepared for manufacturing, production and operations. Simply put, non conformance reports pave the way to implement CAPA.

A typical Nonconformance Report consist of:

  • Date and time of the occurrence

  • Department of Non-Conformance

  • Identification number (reference)

  • Identifier of the Non-Conformance

  • Person responsible

  • E-signature of the person completing

  • Initial analysis of the nonconformance

  • Cause of the Nonconformance

  • Date of Nonconformance

  • Location of the Nonconformity

  • Description of the Nonconformity

  • Corrective and preventive actions

  • Significant

  • Classification of minor or major

  • Date and time of the occurrence

  • Department of Non-Conformance

  • Identification number (reference)

  • Identifier of the Non-Conformance

  • Person responsible

  • E-signature of the person completing

  • Initial analysis of the nonconformance

  • Cause of the Nonconformance

  • Date of Nonconformance

  • Location of the Nonconformity

  • Description of the Nonconformity

  • Corrective and preventive actions

  • Significant

  • Classification of minor or major

Types of Nonconformance Reporting

Nonconformance reporting involves documenting instances where a product, process, or system deviates from established standards or specifications. Various types of nonconformance reports (NCRs) can be generated based on the nature of the deviation. Here are common types of nonconformance reporting:

Types of Nonconformance Reporting

  • Product Nonconformance: A product nonconformance report is issued when a finished product fails to meet specified quality standards. This can include defects, deviations in dimensions, or any other issues affecting the product's quality.
  • Process Nonconformance: Process nonconformance reports focus on deviations in manufacturing or operational processes. This type of report is generated when a process fails to adhere to established procedures, potentially impacting product quality.
  • Material Nonconformance: Material nonconformance reports involve issues related to raw materials or components used in manufacturing. This can include discrepancies in material specifications, quality, or supplier-related problems.
  • Design Nonconformance: Design nonconformance reports address issues related to product design. This can include deviations from design specifications, errors in engineering drawings, or issues identified during the design phase.
  • Supplier Nonconformance: Supplier nonconformance reports document deviations or issues related to products or materials received from external suppliers. This type of report is crucial for maintaining quality throughout the supply chain.
  • Regulatory Nonconformance: Regulatory nonconformance reports are generated when there is a deviation from applicable regulations or standards. This ensures that the organization is aware of and addresses any compliance-related issues.
  • Customer Complaint Nonconformance: Nonconformance reports may result from customer complaints. These reports capture customer issues regarding product defects, performance, or other concerns.
  • Training Nonconformance: Training nonconformance reports are related to employee training or competence deviations. This can include instances where employees fail to follow established procedures due to inadequate training.
  • Environmental, Health, and Safety (EHS) Nonconformance: EHS nonconformance reports address environmental, health, and safety standard deviations. These reports are essential for maintaining a safe and compliant work environment.
  • Audit Nonconformance: Audit nonconformance reports are generated when internal or external audits identify deviations from established standards or procedures. This type of report helps address and rectify audit findings.
  • Documentation Nonconformance: Documentation nonconformance reports involve issues related to errors or discrepancies in documentation, such as work instructions, standard operating procedures, or quality records.
  • Software Nonconformance: Nonconformance reports may be generated for deviations or issues related to software functionality, performance, or data integrity in organizations utilizing software systems.

Why Organizations Must Implement Nonconformance Reporting Software?

Implementing Nonconformance Reporting (NCR) software is crucial for organizations seeking to enhance their quality management processes and maintain high product or service quality standards. Several key reasons underscore the importance of adopting NCR software:

  • Efficient Documentation: NCR software streamlines the documentation of nonconformities, making it easier to capture, categorize, and store information related to deviations from quality standards.
  • Centralized Data Management: By centralizing nonconformance data, the software ensures that relevant information is easily accessible to authorized personnel. This centralized approach fosters transparency and collaboration.
  • Prompt Identification and Reporting: Automated NCR software facilitates the prompt identification and reporting of non-conformities, enabling organizations to address issues promptly and prevent the escalation of quality deviations.
  • Systematic Investigation and Analysis: NCR software supports systematic investigation and analysis of nonconformities, helping organizations identify root causes, assess the impact, and implement effective corrective and preventive actions.
  • Regulatory Compliance: Many industries operate under stringent regulatory frameworks. NCR software aids in compliance by providing a structured and documented approach to managing nonconformities, ensuring that organizations meet regulatory requirements.
  • Continuous Improvement: NCR software is integral to fostering a culture of continuous improvement. It enables organizations to track and analyze recurring nonconformities, facilitating data-driven decision-making for process optimization.
  • Risk Mitigation: By systematically addressing nonconformities, organizations mitigate risks associated with product defects, safety concerns, and regulatory non-compliance, safeguarding the reputation and integrity of the business.
  • Real-time Monitoring and Reporting: NCR software often provides real-time monitoring and reporting capabilities, allowing organizations to track the status of nonconformities, measure the effectiveness of corrective actions, and demonstrate accountability.
  • Enhanced Collaboration: Collaborative features in NCR software facilitate communication among various stakeholders involved in the resolution process, such as quality control, production, and management, promoting effective teamwork.
  • Data-Driven Decision-Making: NCR software generates insightful reports and analytics, empowering organizations to make informed, data-driven decisions to improve quality processes and prevent recurring nonconformities.
  • Audit Trail and Documentation Control: Robust NCR software provides a comprehensive audit trail, documenting every step of the nonconformance resolution process. This level of documentation control is essential for regulatory audits and internal quality assessments.

Great product, support, and people to work with!

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.

Lia Budiman,
Solution Consultant, Continental Contitech

continental contitech logo
continental contitech logo

Regulatory Compliance of Nonconformance Reports

Businesses across various industries need to ensure regulatory compliance for nonconformance reports. Being compliant involves adhering to specific guidelines and standards set forth by governing bodies. To comply with regulatory requirements for nonconformance reports, businesses need to do the following:

Regulatory Compliance of Nonconformance Reports

  • Understand Regulatory Requirements: Thoroughly research and comprehend the relevant regulations, standards, and industry-specific guidelines related to nonconformance reporting. This includes generic standards such as ISO 9001 (Quality Management Systems) or industry-specific regulatory bodies such as the FDA (Food and Drug Administration) for pharmaceuticals or the FAA (Federal Aviation Administration) for aviation.
  • Documentation and Reporting Standards: Each regulatory body has its own unique nonconformance reporting requirements. Adhere to the specific documentation and reporting standards and ensure they contain details such as the nature of nonconformities, root cause analyses, corrective and preventive actions taken, and follow-up measures.
  • Timely Reporting and Notification: Nonconformities must be reported in a timely manner to the regulatory bodies. Establish clear procedures for promptly identifying, documenting, and reporting nonconformities per regulatory timelines and guidelines.
  • Corrective and Preventive Actions (CAPA): A robust Corrective and Preventive Action (CAPA) plan must be devised and implemented for the identification and correction of the nonconformities. They must effectively address immediate issues and also prevent their recurrence.
  • Compliance Audits and Reviews: Regular internal audits and reviews improve compliance with regulatory requirements. During the audits, verify that nonconformance reports are accurately documented, actions are taken as per standards, and records are maintained properly.
  • Employee Training and Awareness: Train employees on regulatory requirements related to nonconformance reporting. Ensure that staff members responsible for identifying, documenting, or managing nonconformities are well-versed in the regulatory standards and understand their roles in compliance.
  • Continuous Improvement: Implement a culture of continuous improvement to refine nonconformance reporting processes based on regulatory feedback, industry best practices, and evolving standards.
  • Technology and Automation: Utilize Nonconformance Management Software that complies with regulatory standards. These systems often have built-in functionalities for streamlining reporting, documentation, and adherence to regulatory requirements.

The Role of Nonconformance Management Software in Organizational Efficiency

Nonconformance Management Software drives organizational efficiency, quality enhancement, and compliance adherence for sustained success in today's competitive landscape. Implementing automated nonconformance management software helps with the following:

  • Improved Efficiency and Accuracy: NCMS streamlines identifying, documenting, and managing nonconformities. It automates tasks, reducing manual errors and improving the accuracy of data collection and analysis.
  • Data-driven Decision-Making: NCMS generates comprehensive reports and analytics, providing valuable insights into patterns of nonconformities. This data enables informed decision-making for process improvements and preventive actions.
  • Enhanced Communication and Collaboration: NCMS facilitates effective communication among stakeholders managing nonconformities. It ensures transparency and collaboration across departments, leading to quicker resolutions.
  • Auditing and Documentation: The software maintains detailed records of nonconformities, corrective actions, and preventive measures, aiding in audits and compliance checks. It provides a documented trail of actions taken for accountability and learning purposes.
  • Scalability and Adaptability: As businesses grow or adapt to changing environments, NCMS can scale and adapt to accommodate new processes, products, or regulations, ensuring their continued relevance and usefulness.

Quality-centric Companies Rely on CQ QMS

  • affinivax mono
  • verily mono
  • 3m logo mono
  • tupperware mono
  • continental logo mono
  • vyaire mono
  • lifescan mono
  • lundbeck mono
  • cdc logo mono
  • qlik mono
  • csa group mono
  • impossible mono
  • fluence mono

Ensure quality, safety, and compliance with CQ’s Nonconformance Report Software, which is a flexible, scalable, next-generation solution that aims to ensure product quality.

Request an Online Demo

Frequently Asked Questions

  • A nonconforming report (NCR) is a formal document that records and addresses any discrepancies between the actual condition of a product, service, or process and the requirements defined by quality standards, specifications, or regulations. NCRs play a crucial role in quality control and continuous improvement processes. The specific content of an NCR will vary depending on the organization and the nature of the nonconformance. NCRs are valuable tools for ensuring quality and continuous improvement in various industries. Organizations can create a quality culture and achieve operational excellence by documenting and addressing non-conformances.

  • A Nonconforming Report (NCR) can be issued by individuals within an organization with the authority and responsibility to identify, document, and address instances of nonconformities. Typically, this responsibility falls on quality control personnel, inspectors, production supervisors, or any employee involved in the inspection and verification processes. Engineers, project managers, or individuals overseeing specific processes may sometimes issue NCRs if they identify deviations from established standards.

    The issuance of NCRs requires a keen understanding of quality standards, product specifications, and relevant procedures. Individuals issuing NCRs should be trained to recognize nonconformities, document them accurately, and initiate appropriate corrective and preventive actions. This ensures that the nonconformance is thoroughly investigated, addressed, and prevented from recurring, contributing to the overall quality management and continuous improvement efforts within the organization.

  • Nonconformance reporting is critical in quality management as it is a fundamental mechanism for identifying, documenting, and addressing instances where products, processes, or systems deviate from established standards. It is pivotal in maintaining product quality, regulatory compliance, and overall organizational excellence. Nonconformance reporting provides transparency and visibility into quality issues. By promptly capturing and documenting deviations from specifications, organizations can initiate corrective and preventive actions to rectify problems, preventing recurrence. This proactive approach contributes to the continuous improvement of processes and products.

    Nonconformance reporting is essential for regulatory compliance. In industries such as healthcare, aerospace, and manufacturing, adherence to strict regulations is paramount. Timely reporting and resolution of nonconformities demonstrate a commitment to compliance, helping organizations avoid penalties, recalls, and damage to reputation. Nonconformance reporting enhances risk management by identifying potential issues before they escalate. It enables organizations to assess the impact of deviations, implement corrective measures, and mitigate risks associated with product quality, safety, and customer satisfaction.

  • The responsibility of creating a non conformance report is with the Quality Management team. Anyone from the team, including the quality manager or the head of quality from the team, can create a non conformance report.

    • Management can use Non conformance software to gain better visibility across NCRs in real-time to quickly identify systemic issues, minimize cost, and prevent a recurrence.

    • Quality can have a better handle on process control to reduce quality gaps and lead time, improve production yield, and prevent nonconforming products from being pushed to the customer.

    • Manufacturing teams can capture nonconformances, triage quickly, find root causes, and take remedial steps to prevent waste, rework, and delays.

    • The engineering team can leverage the Non conformance software to quickly access all the necessary nonconformance data to perform a risk assessment and eliminate the root cause(s).

    • The operations team can easily retrieve information to reduce review cycle time and implement a data-driven decision-making process to authorize the disposition of nonconforming material.

    • Suppliers can use the Nonconformance software to gain visibility, improve collaboration with internal teams, and minimize lag times to perform supplier corrective actions.

Connect with a CQ Expert

Learn about all features of our Product, Quality, Safety, and Supplier suites. Please fill the form below to access our comprehensive demo video.


Please confirm your details

Request Demo