Definition
A nonconformance (also written non-conformance or NCR) is any product, process, material, or service that does not meet a specified requirement. In a quality management system, nonconformances are formally documented, contained, investigated, and resolved through corrective action. The terms nonconformance and nonconformity are often used interchangeably, though nonconformity is the ISO 9001 preferred term.
Nonconformance vs nonconformity
Nonconformance is commonly used in aerospace (AS9100) and automotive (IATF 16949) industries. Nonconformity is the term used in ISO 9001 and ISO 13485. Both refer to the same concept — a departure from a specified requirement. The distinction is industry convention, not a difference in meaning.
The nonconformance process
A typical nonconformance process follows these steps:
- Detection and documentation
- Immediate containment to protect the customer
- Disposition of affected product (use as-is, rework, scrap, return to supplier)
- Root cause investigation
- Corrective and preventive actions
- Effectiveness verification
- Record closure
Types of nonconformances
- Internal nonconformances — found before product leaves the facility.
- External nonconformances — found by the customer.
- Supplier nonconformances — incoming material fails to meet requirements.
- Process nonconformances — a procedure or standard is not followed.
Cost of nonconformance
The cost of nonconformance (CONC) includes direct costs such as scrap, rework, warranty, and returns, and indirect costs such as customer dissatisfaction, lost future business, and audit findings. Studies consistently show that the cost of finding and fixing a nonconformance increases by an order of magnitude at each stage — detection at source is always cheaper than detection at the customer.
Nonconformance management software
Small manufacturers often manage nonconformances in spreadsheets or shared drives. Dedicated nonconformance management software provides audit trails, workflow automation, and reporting dashboards. Options range from lightweight tools priced for SMBs to full enterprise QMS platforms. Key features to look for include NCR number generation, disposition workflow, CAPA linkage, and export for customer or audit reporting. See our comparison of NCR software for small manufacturers.
Free nonconformance report templates
RCA Toolkit provides free NCR templates in Word and PDF format. Each template is structured for audit readiness and aligned with ISO 9001, AS9100, and IATF 16949 requirements. Download free NCR templates.