How to Write a Non-Conformance Report? Examples & Templates

Master non-conformance reporting, prevent recurring quality issues, and simplify NCRs with customizable tools and real-time tracking.

Key Takeaways

• NCRs document deviations from standards or procedures, providing a basis for corrective actions and supporting consistent quality management across products and processes.
• Regulations such as ISO 9001, ISO 13485, and FDA 21 CFR require NCRs with proper documentation, impact assessment, investigation, corrective actions, and full traceability.
• Effective NCRs follow all seven steps, including identifying the issue, documenting it, classifying severity, analyzing root causes, creating corrective actions, implementing and verifying them, and formally closing the report.
• Common NCR mistakes like vague descriptions, missing root cause analysis, weak corrective actions, and incomplete records can trigger regulatory findings and recurring quality problems.
• The Alpha TransForm pre-built NCR app makes non-conformance reporting easy with customizable data fields, offline data capture, photos and signatures, real-time integration, and instant corrective action tracking – all without coding.

What Is a Non-Conformance Report & Why It Matters

A non-conformance report (NCR) formally documents any deviation from specifications, standards, procedures, or regulations. It plays a central role in quality management, acting as both documentation of issues and the foundation for corrective action.

The Definition & Purpose of NCRs

NCRs document when products, processes, or services fail to meet requirements, whether those come from internal standards, customer expectations, or regulatory mandates. Their purpose is to ensure issues are logged, tracked, and resolved while preventing recurrence through corrective actions. 

In highly regulated sectors like aerospace, pharmaceuticals, or food production, NCRs are essential proof that processes are under control and deviations are addressed.

The Costs of Poor NCR Documentation

Weak or incomplete reporting leads to recurring problems, wasted resources, and compliance risks. Consequences often include:

• Direct costs such as scrap, rework, and warranty claims
• Reputational damage and lost customer trust
• Product recalls or legal action
• Regulatory findings or penalties

For example, the annual cost of non-compliance in individual companies ranges from $2.2 million to $39.2 million, with increasing trends over the years. By contrast, strong NCR systems reduce quality costs, improve efficiency, and build long-term customer confidence.

Regulatory Requirements

Several frameworks mandate proper NCR management:

• ISO 9001:2015 – control of nonconforming outputs (Section 8.7)
• ISO 13485:2016 – added requirements for medical device manufacturers
• FDA 21 CFR 820.90 – procedures for identifying, documenting, evaluating, and disposing of nonconforming product

These standards demand more than recordkeeping; they require impact assessment, investigation where needed, corrective action, and full traceability from detection through resolution.

Documenting non-conformances thoroughly ensures compliance and prevents recurring quality issues.

7 Essential Steps to Write an Effective Non-Conformance Report

Creating an effective NCR follows a structured process, ensuring issues are properly documented, analyzed, and resolved to improve quality and prevent recurrence.

1. Identify & Control the Non-Conformance

Once a deviation is found, immediately mark, tag, or segregate the non-conforming item or process to prevent unintended use. Record who found it, the date, time, and location. This step prevents defective products from reaching customers or advancing in production.

2. Document the Issue Clearly

Provide a detailed description including measurements, observations, and comparisons to specifications. Include lot numbers, serial numbers, and process parameters, and attach objective evidence such as photos, test results, or reports. Clear documentation ensures investigations are accurate and actionable.

3. Classify the Severity

Assess the potential impact to prioritize actions:

• Critical: Could affect safety or essential performance
• Major: Impacts function, reliability, or compliance
• Minor: Deviation that should be corrected
• Incidental: Cosmetic or inconsequential issues

Severity classification guides resource allocation and the depth of investigation.

4. Conduct Root Cause Analysis

Determine the underlying cause using methods like the 5 Whys, fishbone diagrams, or fault tree analysis. Document the approach and evidence supporting conclusions. For complex or recurring issues, consider a cross-functional team to ensure multiple perspectives are addressed.

5. Develop Corrective & Preventive Actions

Create specific, measurable steps to address the immediate problem and prevent recurrence. Assign owners, deadlines, and success criteria to the steps to keep track of their progress. Applying the hierarchy of controls (e.g., elimination, substitution, engineering, administrative, and protective measures) helps ensure long-term effectiveness.

6. Implement & Verify

After implementation, monitor effectiveness through inspections, audits, or data tracking. Set timeframes based on the process and verify that corrective actions have truly resolved the underlying issue. Continuous monitoring may be needed for complex systems.

7. Close the Report

Formal closure requires review and approval by authorized personnel. Ensure all actions are completed and verified, and maintain records following the retention policies. These documents provide historical insights, support audits, and help identify trends for ongoing improvement.

Critical Elements Every Non-Conformance Report Must Include

A complete NCR includes several essential components to ensure proper documentation, analysis, and resolution. Missing any of these elements can compromise your quality management system and may lead to regulatory issues.

1. Identification Information

Each NCR should have a unique identifier, typically a sequential number, date, product or process reference, and related documents (batch records, purchase orders, or customer complaints). 

Include where the issue was detected (incoming inspection, in-process control, final testing, customer feedback) and who found it. This helps track trends and identify gaps in your quality processes.

2. Detailed Description

The description should clearly explain what requirement was not met and how the actual condition deviates. Reference relevant standards, procedures, or specifications, and provide measurements, photos, or test results when possible. A precise description answers: What was expected? What was observed? How and where was the issue detected? How widespread is it?

3. Impact Assessment & Risk Evaluation

Assess how the non-conformance affects product quality, safety, compliance, and customer requirements. Consider actual and potential consequences, including products already in the field. Risk evaluation helps prioritize responses, determine product disposition, and guide the depth of investigation.

4. Containment Actions

Document immediate steps taken to limit impact, such as quarantining inventory, stopping production, inspecting work-in-progress, or notifying customers. Record what was done, when, and by whom. These actions protect customers and demonstrate proactive quality control.

5. Corrective Action Plan

Detail actions to address root causes and prevent recurrence. Include responsible individuals, target completion dates, and verification methods. In regulated environments, note approvals, reviewers, and any modifications requested. A well-documented plan ensures accountability and effective resolution.

Non-Conformance Report Templates for Different Industries

While the core elements of non-conformance reporting are consistent across industries, some sectors require tailored NCR templates to meet regulatory and operational needs.

Manufacturing NCR Template

Manufacturing NCRs focus on material traceability, production parameters, and equipment identification. Templates typically include fields for lot numbers, work orders, machine IDs, and operator information. 

Disposition options, such as rework, repair, use-as-is (with justification), or scrap, should be included. Templates should also support MRB (Material Review Board) decisions, capturing impact on delivery schedules, inventory, and costs.

Medical Device NCR Template

Medical device NCRs must address stringent regulatory requirements. Templates should include UDI (Unique Device Identification), risk classification, and patient safety considerations. 

They should also cover FDA Medical Device Reporting (MDR) or EU vigilance reporting requirements and help determine whether the issue requires correction, removal, or recall.

ISO 9001 Compliant Template

ISO 9001:2015 organizations need templates aligned with the standard, referencing the applicable clause or internal procedure. 

Fields should document responsibilities and authorities, support risk-based thinking, and capture the implications of the non-conformance on other QMS processes. It should also include provisions for changes to the QMS resulting from corrective actions.

Documenting non-conformances thoroughly ensures compliance and prevents

recurring quality issues (image courtesy of eclipsesuite).

Construction & Engineering NCR Template

Construction NCRs address spatial location, building codes, and structural considerations. Templates should identify affected areas, relevant drawings, and applicable standards. 

They often require approvals from architects, engineers, inspectors, or clients, and should document variance requests or design changes resulting from the non-conformance.

Digital Solutions for Non-Conformance Management

Paper-based NCRs are increasingly being replaced by digital solutions that streamline reporting, improve visibility, and enhance compliance—especially for organizations with complex operations or multiple sites.

Benefits of Digital NCR Systems

Digital NCR systems reduce processing time through automated workflows, instant notifications, and elimination of physical routing delays. They improve data integrity by enforcing required fields, standardizing inputs, and preventing unauthorized changes. Real-time dashboards, automated escalations, and enterprise-wide access increase visibility.

For regulated industries, electronic systems create audit-ready records with complete trails, compliant electronic signatures, and automated retention. Organizations often report 50–70% faster processing and higher compliance during audits.

Key Features to Look For

Effective NCR software should offer:

• Pre-built NCR Template: Standardized templates ensure consistent documentation of non-conformances, reducing missed details and accelerating the corrective action process with customizable fields for specific industry requirements.
• Image Capture with Markup: Photographs that can be annotated by inspectors can add a new level of critical detail and information to the process and can inform repairs.
• Data Capture: Comprehensive field data collection captures precise measurements, timestamps, and vendor information, enabling accurate non-conformance identification and providing complete evidence for root cause analysis.
• Media & Signatures: Photo annotations and digital signatures create objective visual evidence of non-conformances, reducing disputes while ensuring accountability and traceability throughout the correction process.
• Offline Operation: Uninterrupted data collection in remote locations prevents documentation delays, ensuring immediate non-conformance capture and seamless sync when connectivity returns to maintain audit trails.
• Device Friendly: Mobile-optimized interfaces enable field teams to quickly document non-conformances at the point of detection, reducing response times and improving correction effectiveness.
• Integration & Workflow: Automated system connections initiate immediate corrective action workflows and root cause tracking, guaranteeing a systematic and manual-free approach to addressing non-conformances.
• Reporting: Real-time trend analysis and completion tracking help identify recurring non-conformance patterns while verifying that corrective actions effectively resolve quality issues.

Streamline Non-Conformance Reporting with Alpha TransForm

Alpha TransForm software includes a pre-built NCR app template that makes creating, managing, and resolving non-conformance reports simple, fast, and paper-free. The customizable mobile app allows manufacturing and construction teams to capture detailed observations, photos, annotations, audio, and digital signatures—offline or online.

Easily customize this NCR app to match your quality processes. Capture vendor names, barcodes, dispositions, and rework hours directly on the production floor or worksite. Tie the app into your existing systems to instantly trigger corrective actions, update records, and streamline workflows.

Key Features:

• Offline data and image capture with mark-ups, sync automatically when online
• Voice-to-text notes and digital signature collection
• Optimized for tablets and smartphones
• Easy template customization to match your quality processes
• Built-in dashboards for rapid insight and data sharing
• Integration with existing systems for real-time corrective action tracking

Alpha TransForm isn’t just for NCRs—you can quickly build apps for inspections, incident reporting, and digitizing paper forms. Trusted by quality-conscious global manufacturers, it combines offline reliability, rich data collection, advanced business logic, and seamless system integration—all without writing a single line of code.

When one of our customers—Igloo—digitized their quality control processes with Alpha TransForm, they achieved $145,000 in cost savings while dramatically improving accuracy and efficiency. Try our app today and learn how companies can transform their quality management without coding expertise.

Digital NCR systems reduce paperwork, streamline workflows, and create audit-ready records.

Frequently Asked Questions (FAQs)

What's the difference between a non-conformance and a deviation?

A non-conformance is an unplanned failure to meet a requirement, found during inspection or use. A deviation is a pre-approved, temporary departure from standards with risk controls to maintain quality despite the variation.

How long should a non-conformance report remain open?

NCR timelines depend on severity and complexity. Critical issues need containment within 24–48 hours and corrective action within 30 days. Minor issues may take up to 90 days, with effectiveness verification extending timelines if needed.

Who should be responsible for approving non-conformance reports?

Approval typically falls to quality assurance, with cross-functional input. Minor NCRs may be approved by supervisors, while major or critical issues require quality management, operations leadership, and sometimes regulatory or specialized personnel involvement.

Can I use the same NCR template for different types of issues?

A standardized NCR template promotes consistency, but Alpha TransForm lets you easily customize it for different issue types, adding fields for product details, process parameters, or other specific requirements as needed.

How do I ensure my team properly documents non-conformances?

Provide clear procedures, user-friendly templates, and role-specific training. Reinforce with examples, reviews, and coaching. Regular quality meetings and a culture that values thorough documentation ensure NCRs become a tool for continuous improvement, not just reporting errors.