All organizations suffer nonconformities in their manufacturing processes. These entities must document and eliminate the nonconformities from recurring.

Through actions that segregate the non-conformity from the acceptable output, the organization has begun the initial step in the non-conformity process. The non-conformity process is implemented to detail the failings or shortcomings of a product, process, or service when they fail to comply with established quality standards.

The non-conformity process is used to detail and describe when and where an organization’s product, process, or service could not conform to specific standards and is utilized to correct the non-conformity. Non-conformances can be found in almost all levels of an organization’s quality management system (QMS), leading to the requirement that NC’s be recorded and reviewed by an organization in a routine manner.

The non-conformity process allows companies to identify output failures and indicate where they need to improve or update any corresponding procedures. The NC process consists of:

A problem statement details issues discovered or noted and identifies the individual or person(s) who found the issue.
A description of the severity of the issue encountered and describes how the issue may affect the QMS operation of the organization. It may also specify how far from the standards the deviations exist (outside tolerance ranges).
How the issue occurred or what part of the process chain might have triggered this?
Any damage control steps (corrective action plan) to be taken to alleviate the situation, are already in place.
A section that details the root cause and any preventive actions that the organization should implement.
A final report that concludes when, how, and where corrective actions were put in place, along with evaluations of effectiveness related to the corrective action taken and any preventive actions implemented to resolve/eliminate the non-conformances.

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