Glossary

Quality investigation

A quality investigation is a structured review of a quality event to establish facts, impact, cause, and required actions.

Nonconformance, MRB and CAPA (NCR)Non-Conformance and CAPA

A quality investigation is a structured review of a quality event to understand what happened, assess its impact, identify likely cause, and define any required containment, disposition, correction, or corrective action. In manufacturing, it is commonly used when a defect, deviation, nonconformance, customer complaint, process excursion, or test failure needs documented evaluation.

A quality investigation typically gathers objective evidence from production records, inspection results, equipment data, operator input, material traceability, work instructions, and system logs. The record may document the affected lot, serial number, operation, requirement, finding, risk or impact assessment, root cause analysis, and follow-up actions.

The term should not be confused with routine inspection, which detects or verifies product characteristics. It is also not the same as CAPA, 8D, or RCCA, although a quality investigation may lead to those workflows when systemic cause or corrective action is required. In regulated or quality-sensitive operations, the investigation record is often part of the quality system evidence used to support traceability and decision making.

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Related FAQ

Should non-conformance be hyphenated?

Most quality and manufacturing standards use the hyphenated form “non-conformance” or “nonconformity” as a single word. In practice, you should follow your organization’s controlled document style guide and keep usage consistent across QMS procedures, work instructions, and records for traceability and audit clarity.

What is the meaning of nonconformance?

In regulated manufacturing, a nonconformance is a documented failure to meet a specified requirement, whether from a customer, drawing, spec, standard, procedure, or regulation. It is not just a defect; it is any verified deviation that must be recorded, evaluated, and dispositioned under change control and traceability rules.

What are the different types of non conformance?

In regulated manufacturing, “types” of nonconformance are usually defined by impact and source, not a single universal list. Common distinctions include critical/major/minor, product vs. process vs. documentation, internal vs. supplier vs. customer, and recurring/systemic vs. isolated. Your exact categories must be defined, documented, and applied consistently in your QMS.

How do you distinguish between a minor and major non-conformance in aerospace?

In aerospace there is no single universal definition of minor vs major non-conformance. Each OEM, prime, or Tier 1 typically defines severity in its quality system and contracts. Distinction is usually based on impact to safety, airworthiness, fit/form/function, regulatory or customer requirements, and the amount of rework or re-inspection needed. Plants must follow their approved, documented criteria and apply it consistently with traceability and review.

Related Glossary

Nonconforming Material (NCM)

Material that does not meet specified requirements and is identified for segregation, review, disposition, or control.

Back-testing

Back-testing is the evaluation of a model or rule set using historical data to see how it would have performed.