Nonconforming Product (NCR)
Quick facts
| Category | Nonconformance identification and disposition |
|---|---|
| Used by | Manufacturing, medical devices, pharmaceuticals, aerospace, automotive and other regulated industries |
| Also called | NCR, NC |
| Related standards | ISO 9001, ISO 13485, AS9100, IATF 16949, FDA 21 CFR Part 820 |
| Related processes | CAPA, material review board, containment, root cause analysis, supplier corrective action |
| Semantic match | nonconforming product process, NCR nonconformance report, disposition of nonconforming material, quarantine and rework |
What is Nonconforming Product (NCR)?
A nonconforming product is any output, whether raw material, in-process work or a finished product, that does not meet a defined requirement. The requirement can originate from a customer specification, a regulatory standard, an internal drawing or procedure, or the organization's own quality management system.
When a nonconformance is identified, it is typically documented on a nonconformance report, commonly abbreviated NCR, which records what was found, where it was found, its immediate disposition and, where warranted, the investigation into its cause.
Nonconforming product management focuses first on containment, ensuring the item is segregated or clearly identified so it cannot be mistakenly used, shipped or mixed with conforming product, and second on disposition, deciding what happens to the nonconforming item itself.
Why is Nonconforming Product (NCR) important?
A disciplined nonconforming product process prevents defective or noncompliant items from reaching customers, protecting both product safety and organizational reputation. Left unmanaged, nonconforming material can be inadvertently reworked, shipped or mixed back into inventory.
Tracking nonconformances also generates the data organizations need to identify patterns, whether by part number, supplier, shift or process step, that point toward a systemic issue worth escalating to a formal corrective action.
A well-run process improves cost visibility as well, since nonconformance records typically capture scrap, rework and disposition costs that feed into an organization's cost of poor quality metrics.
How does Nonconforming Product (NCR) work?
A typical nonconforming product process includes:
- Identification. Detect the nonconformance through inspection, testing, complaint or audit.
- Documentation. Record the item, requirement violated, quantity and discovery point on an NCR.
- Containment. Segregate or clearly tag the nonconforming item to prevent unintended use.
- Evaluation. Assess the significance, including whether similar items may be affected.
- Disposition. Decide whether to use-as-is, rework, repair, return to supplier or scrap the item, typically with defined approval authority.
- Escalation. Route recurring or high-risk nonconformances into the CAPA process for root cause investigation.
- Closure and trending. Close the NCR and periodically review nonconformance trends by type, source and cost.
Nonconforming Product (NCR) vs. CAPA
| Comparison | Nonconforming Product (NCR) | CAPA |
|---|---|---|
| Purpose | Document and disposition a specific nonconforming item | Investigate root cause and prevent recurrence or occurrence |
| Scope | A single item, lot or batch | Often broader, addressing systemic or recurring issues |
| Typical output | Use-as-is, rework, repair, return or scrap decision | Root cause, corrective action and effectiveness verification |
| Relationship | May trigger a CAPA if significant or recurring | Often originates from one or more NCRs |
Real-world examples of Nonconforming Product (NCR)
An incoming inspector at an electronics manufacturer finds a batch of components outside the specified tolerance. The lot is quarantined, an NCR is opened, and the material review board decides to return the lot to the supplier rather than sort and use conforming pieces.
A medical device assembler discovers a labeling discrepancy during final inspection. The affected units are segregated, an NCR documents the finding, and the disposition calls for relabeling under supervision before the units are released.
An automotive supplier notices a recurring dimensional nonconformance across several NCRs tied to the same fixture. The trend prompts a formal CAPA to investigate and correct the fixture rather than continuing to disposition individual parts one at a time.
Regulations and standards related to Nonconforming Product (NCR)
ISO 9001 requires organizations to identify and control outputs that do not conform to requirements to prevent their unintended use or delivery, and to take action based on the nature of the nonconformity and its effect on conformity of products and services. This requirement sits alongside Clause 10.2 on corrective action.
ISO 13485 and FDA 21 CFR Part 820 contain specific requirements for medical device manufacturers to control nonconforming product, including defined responsibility and authority for review and disposition. AS9100 and IATF 16949 add aerospace- and automotive-specific expectations, including material review board processes for disposition decisions.
Regulators and auditors commonly examine whether nonconforming product was properly contained before disposition, whether disposition decisions were made by authorized personnel, and whether recurring nonconformances were escalated appropriately.
Required by
How QT9 helps with Nonconforming Product (NCR)
QT9 QMS nonconforming product capabilities
- Log, quarantine and track nonconforming product from a centralized module.
- Assign approvers to review, approve, reject or verify disposition decisions.
- Link nonconformances directly to CAPA, audits and customer feedback for traceability.
- Trend nonconformance data by type, supplier or root cause with real-time reporting.
- Assign nonconforming product records to suppliers through the supplier web portal.
- Attach cost data to quantify the true cost of poor quality.
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Common mistakes with Nonconforming Product (NCR)
Common mistakes include failing to physically segregate or clearly tag nonconforming material, which risks it being mixed back into conforming inventory, and allowing disposition decisions to be made by personnel without proper authority.
Other problems include treating every nonconformance as an isolated event without reviewing trends, and closing NCRs without addressing whether similar product elsewhere may also be affected by the same underlying issue.
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