quality management Quality management ensures that an organization, product or service consistently functions well. It has four main components: quality planning, quality assurance, quality control and quality improvement. Quality management is focused not only ...

, a nonconformity (sometimes referred to as a non conformance or nonconformance or defect) is a deviation from a

specification A specification often refers to a set of documented requirements to be satisfied by a material, design, product, or service. A specification is often a type of technical standard. There are different types of technical or engineering specificati ...

, a

standard Standard may refer to: Symbols * Colours, standards and guidons, kinds of military signs * Standard (emblem), a type of a large symbol or emblem used for identification Norms, conventions or requirements * Standard (metrology), an object th ...

, or an expectation. Nonconformities or nonconformance can be classified in seriousness multiple ways, though a typical classification scheme may have three to four levels, including critical, serious, major, and minor. While some situations allow "nonconformity" and "defect" to be used synonymously, some industries distinguish between the two; a nonconformity represents a failure to meet an intended state and specification, while a defect represents a failure to meet fitness for use/normal usage requirements. This can be seen in the international software engineering standard ISO/IEC 25010 (formerly

ISO/IEC 9126 ISO/IEC 9126 ''Software engineering — Product quality'' was an international standard for the evaluation of software quality. It has been replaced by ISO/IEC 25010:2011. The fundamental objective of the ISO/IEC 9126 standard is to address s ...

), which defines a nonconformity as the nonfulfillment of a requirement and a

defect A defect is a physical, functional, or aesthetic attribute of a product or service that exhibits that the product or service failed to meet one of the desired specifications. Defect, defects or defected may also refer to: Examples * Angular defec ...

as the nonfulfillment of intended usage requirements.

Classifying nonconformity

When ensuring

quality Quality may refer to: Concepts *Quality (business), the ''non-inferiority'' or ''superiority'' of something *Quality (philosophy), an attribute or a property *Quality (physics), in response theory *Energy quality, used in various science discipli ...

of a product or a service, classification of a nonconformity is important, as it provides an opportunity to better reduce nonconformity. Many quality management practices will do this using a relatively simple three- or four-level classification system. For example, U.S. federal agencies such as the National Aeronautics and Space Administration have used a simple three-tier system for quality requirements of government-acquired supplies and services: minor, major, and critical nonconformance. However, some industries may develop their own, custom ranking systems. An example from the

automotive industry The automotive industry comprises a wide range of company, companies and organizations involved in the design, Business development, development, manufacturing, marketing, and selling of motor vehicles. It is one of the world's largest industry ...

uses a 10-point system for finer granularity, where, for example, a one represents "none" (no effect), a six "moderate" (vehicle or item operable, but comfort or convenience items inoperable), and a 10 "hazardous without warning" (when a potential failure mode affects safe vehicle operation without warning). Regardless of size, these classification schemes exist to help drive discovery and correction of nonconformities (and defects).

Sources of nonconformity

The causes of nonconformities are not unlimited and therefore determinable. Common causes for deficiencies to arise include: * poor communication (or miscommunication) * poor documentation (or lack of documentation) * poor or limited training of personnel * poor motivation of personnel * poor quality materials (or lack of appropriate materials) * poor quality tools and equipment (or lack of appropriate tools and equipment) * poor or dysfunctional operating environment

References

ISO standards Pharmaceutical industry Quality management {{management-stub