Introduction
A Non-Conformance (NC) occurs when a product, process, or service fails to meet its specified requirements. These requirements can be defined by the customer, internal quality standards, or regulatory bodies (like the FDA or ISO).
In a Product Lifecycle Management (PLM) environment, a non-conformance is a critical data point. It indicates a “break” in the digital thread that must be documented, analyzed, and resolved to ensure the integrity of the final product.
Real-World Examples of Non-Conformance
Non-conformances can happen at any stage of the lifecycle. Here are common examples:
- Manufacturing: A mechanical part is 0.5mm outside the tolerance specified in the CAD model.
- Design: A software module fails to encrypt user data as required by the security specifications.
- Documentation: A critical test report is missing the signature of the authorized engineer.
- Supply Chain: A batch of raw material arrives with a certificate of analysis that doesn’t match the purchase order requirements.
- Service: A technician uses a tool that hasn’t been calibrated according to the maintenance schedule.
The Handling Process: The Non-Conformance Report (NCR)
When an NC is identified, the organization must follow a structured handling process, usually documented in a Non-Conformance Report (NCR):
1. Identification and Segregation
The non-conforming item must be clearly identified and, if possible, physically segregated to prevent its accidental use or delivery.
2. Documentation
The NCR should record:
- What happened (the deviation).
- Where and when it was found.
- The specific requirement that was not met.
3. Disposition (The Decision)
A quality board or “Material Review Board” (MRB) decides what to do with the item. Typical dispositions include:
- Rework: Fix it so it meets the original requirements.
- Repair: Fix it so it is functional, even if it doesn’t meet original specs (requires customer approval).
- Scrap: Destroy the item.
- Use-as-is: Accept the deviation if it doesn’t affect safety or performance (requires justification).
Pro-Tips for Managing Non-Conformances
- Don’t Fear the NC: Encourage employees to report non-conformances. A “hidden” error is a ticking time bomb; a reported NC is an opportunity to improve.
- Focus on Trends: One NC is an incident; five similar NCs are a trend. Use your PLM data to spot patterns that indicate a systemic issue.
- Be Specific: Instead of writing “The part is broken,” write “Part #123 shows a 2mm hairline crack on the stress-bearing flange.”
- Link to CAPA: Not every NC requires a CAPA, but every major or recurring NC should trigger a Corrective Action investigation.
Non-Conformance in the PLM Digital Thread
Handling NCs within a PLM/ALM platform provides a massive advantage over manual systems:
| Feature | Manual Handling (Paper/Email) | PLM Integrated Handling |
| Traceability | Difficult to link to the original requirement. | Instant link between the NC and the failed specification. |
| Speed | Notifications can sit in inboxes for days. | Automated workflows alert the MRB instantly. |
| Analysis | Manual tallying of errors in spreadsheets. | Real-time dashboards showing NC rates by part or supplier. |
| Visibility | Siloed in the quality department. | Visible to design engineers to inform future versions. |
How Visure Solutions Streamlines NC Handling
Visure Requirements ALM Platform ensures that no non-conformance is left unresolved:
- Automatic Requirement Violation Alerts: If a test result (ingested from an automated tool) fails to meet a requirement, Visure can automatically flag a non-conformance.
- Disposition Workflows: Manage the approval process for “Rework” or “Use-as-is” with electronic signatures that comply with 21 CFR Part 11.
- Traceability Matrix Integration: See exactly which requirements are most “prone” to non-conformance, allowing you to strengthen the design or the manufacturing instructions.
- Closed-Loop Quality: Seamlessly escalate a serious Non-Conformance into a full CAPA process within the same platform, maintaining a single source of truth.
Conclusion: Turning Deviations into Quality
A Non-Conformance is more than just a mistake; it is a vital signal from your manufacturing or design process. By handling these deviations with transparency and technical rigor, companies protect their customers and their reputation.
With Visure, managing non-conformances becomes a streamlined, data-driven process. We help you bridge the gap between “finding an error” and “improving the product,” ensuring your quality standards are always met.
Check out the 14-day free trial at Visure and experience how AI-driven change control can help you manage changes faster, safer, and with full audit readiness.
