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What is a Non-Conformance Report (NCR)?
A Non-Conformance Report (NCR) is a formal document used to record and address instances where a product, process, or service fails to meet specified requirements or standards. NCRs are critical for quality control, compliance, and continuous improvement within manufacturing, construction, engineering, and service-based industries.
Definition
A Non-Conformance Report (NCR) is a quality management document that identifies, describes, and tracks deviations from expected standards, specifications, or procedures, enabling corrective and preventive action.
Key takeaways
- Identifies deviations: Highlights failures to meet standards or requirements.
- Supports corrective action: Drives processes to fix and prevent recurrence.
- Ensures accountability: Tracks responsibility and resolution timelines.
- Used across industries: Crucial in manufacturing, construction, healthcare, and aviation.
- Part of QMS: Integrates into quality management systems like ISO 9001.
When NCRs are issued
- Product defects
- Non-compliant materials
- Process deviations
- Safety violations
- Documentation errors
- Supplier non-compliance
Components of an NCR
- Description of non-conformance
- Reference to standards or specifications violated
- Date, location, and responsible parties
- Evidence (photos, test results, reports)
- Severity or classification level
- Immediate containment actions
- Corrective and preventive action plans
- Follow-up and closure approval
NCR workflow
- Detection: Issue identified by inspectors, auditors, or team members.
- Documentation: NCR is formally recorded.
- Evaluation: Assess severity and impact.
- Containment: Stop production or isolate defective items.
- Root cause analysis: Use tools like 5 Whys or Fishbone Diagram.
- Corrective actions: Implement solutions.
- Preventive actions: Ensure issue doesn’t recur.
- Verification & closure: QA/QC signs off.
Types of non-conformance
1. Minor non-conformance
Low-risk deviations; little effect on quality or safety.
2. Major non-conformance
Significant deviation requiring urgent corrective action.
3. Critical non-conformance
Severe deviations affecting safety, compliance, or product performance.
Benefits of using NCRs
- Improves product and service quality
- Enhances regulatory compliance
- Identifies systemic issues
- Strengthens supplier performance
- Reduces risk and costly rework
NCR vs. CAPA (Corrective and Preventive Action)
| Aspect | NCR | CAPA |
|---|---|---|
| Purpose | Identify deviation | Fix root cause & prevent recurrence |
| Scope | Specific incident | Broader improvement process |
| When used | When non-conformance occurs | After root cause is analyzed |
Examples of NCR usage
- Construction: Non-compliant concrete strength
- Manufacturing: Defective batch of components
- Healthcare: Failure to follow sterilization protocol
- Software: Non-compliant code or security flaws
Related concepts
- Corrective Action (CA)
- Preventive Action (PA)
- ISO 9001 Quality Management System
- Quality audits
- Root cause analysis
Sources
- ISO 9001 Quality Management Standards
- ASQ – Quality Tools & Resources
- Project Management Institute (PMI)
Frequently Asked Questions (FAQ)
1. Who can issue an NCR?
Any authorized inspector, auditor, or team member responsible for quality.
2. Can an NCR stop production?
Yes, especially in cases of major or critical non-conformance.
3. Are NCRs mandatory in ISO-certified organizations?
Yes, they are part of corrective action requirements.
4. How long should NCRs stay open?
Until corrective and preventive actions are verified as effective.
5. Can suppliers receive NCRs?
Yes, for materials or services that fail to meet requirements.
