Major Non-Conformance Vs Minor Non-Conformance

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Major Non-Conformance	Minor Non-Conformance
Total breakdown of system, control, or procedure. Absence of an ISO 9001 requirement	Failure to conform to a requirement which (based on judgment and experience) is not likely to result in QMS failure
A number of minors related to the same clause	A single observed lapse or isolated incident
An nonconformity that would result in probable shipment of nonconformity or un-inspected product A condition that may result in the failure or materially reduce the usability of product for intended purpose; A nonconformity that experience and judgment indicate will likely result in QMS failure or materially reduce its ability to assure controlled processes and products	Minimal risk of nonconforming product or service
Majors represent serious problems in the system that must be addressed with attention and resources on a priority basis. It puts the business at risk with customers and the Registrar.	Minor nonconformities have little likelihood of allowing nonconforming product or service to be delivered or causing a breakdown of system control. It does indicate that there are occasional lapses that must be formally addressed through corrective action.
Examples:   No documented procedure for any required element of the standard Document changes routinely carried out in an unauthorized manner Critical purchases made from unevaluated suppliers Product shipped without required inspection and tests	Examples: A drawing marked up with unauthorized changes A purchase order released without review and approval An inspection instrument past its calibration date A training record not available

1 Comment

Filed under Audit, ISO, Software Quality Assurance

Tags: Audit, Category pf NC's, ISO, Non-Conformity, Quality Control