Wednesday, January 8, 2020

Minor Nonconformity and Major Nonconformity

Minor Nonconformity

• Failure to conform to a requirement which (based on judgement and experience) is not likely to result in QMS failure
• A single observed lapse or isolated incident• Minimal risk of nonconforming product or service
• 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
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.
Major Nonconformity
• Total breakdown of system, control, or procedure
• Absence of an ISO 9001 requirement
• A number of minors related to the same clause
• 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 judgement indicate will likely result in QMS failure or materially reduce its ability to assure controlled processes and products
:• 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 testsMajors 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.

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