A Nonconformity Report is a formal record that a specified requirement has not been met. It is commonly used in audits, inspections, and quality management systems to document evidence of nonconformance and to trigger follow-up actions.
What a Nonconformity Report includes
While formats vary by organization and standard, a Nonconformity Report typically documents:
- The requirement or standard that was not met (for example, a procedure, specification, or regulation)
- Objective evidence of the nonconformity (what was observed, measured, or found)
- Location, process, product, or system affected
- Classification or severity level (for example, major, minor, critical)
- Immediate actions taken, if any
- Assigned responsibility and due dates for corrective actions
- Follow-up verification that actions were completed and effective
Use in industrial and regulated environments
In manufacturing and other regulated operations, Nonconformity Reports are used to document:
- Audit findings against standards, internal procedures, or customer requirements
- Process deviations on the shop floor, such as out-of-spec measurements or missed process steps
- Supplier issues, such as nonconforming raw materials or components
- System or documentation gaps in areas like MES, ERP, batch records, or equipment qualification
The report itself does not usually represent a regulatory failure or loss of certification by default. Instead, it becomes an input to corrective and preventive action (CAPA) or similar processes, where root cause is investigated and changes are documented and verified.
Operational role
Operationally, Nonconformity Reports help link events on the shop floor and in information systems to formal quality workflows. They often:
- Originate from audits (internal, customer, or third-party), in-process inspections, or automated system checks
- Feed into electronic quality management systems, document control, and CAPA tracking
- Provide traceable records that can be reviewed in later audits or management reviews
Common confusion
Nonconformity Report vs. Nonconformance: The nonconformance (or nonconformity) is the actual condition where a requirement is not met. The Nonconformity Report is the documented record of that condition.
Nonconformity Report vs. CAPA: A Nonconformity Report describes the issue and evidence. CAPA activities describe how the organization addresses the root cause and prevents recurrence. A single report may lead to one or more CAPA records.
Relation to NCR in audits
The abbreviation “NCR” in an audit context commonly refers to a Nonconformity Report. During an audit, each identified nonconformity is usually documented as an NCR, which then follows the organization’s defined process for review, corrective action, and follow-up verification.