Difference Between Major and Minor Non-Conformances

Non-conformances will be specific to your organization and the standard you are trying to meet. This makes it necessary to create a system of identification that is tailored to your organization’s QMS.

Under the ISO 9001 standard,

• major non-conformances require immediate attention and often involve a root-cause analysis, corrective action, and sometimes a follow-up audit (or failure to achieve certification)
• minor non-conformances require correction and preventive action but typically have less impact on certification.

It’s important to have a clear way to distinguish whether a non-conformance is major or minor. This can help your organization prioritize issues effectively.

A good place to start is with a description of what should represent major non-conformance. For instance, this would include situations like these:

• a system required by the relevant standards is either failing or not implemented
• an event would lead to a product not meeting customer expectations and/or failing to comply with regulatory requirements
• an event, however small, has occurred before and for any reason does not appear to be getting fixed.

With a minor non-conformance, there is no significant risk to the final product or service quality.

Some examples are:

• a one-off error on an invoice
• a machine not being calibrated properly
• a missing training record.

Major non-conformances pose a significant risk to final product or service quality. They need to be dealt with fast and in order of urgency.

Examples are:

• documentation not meeting standard requirements
• little or no management review
• lack of internal audits
• inadequate customer feedback processes
• failure to implement corrective and/or preventative action to resolve known issues.

There is a school of thought that major versus minor categorizations are unhelpful.

This is because under all ISO standards, any non-conformance must be fixed. Labeling a non-conformance as minor doesn’t mean it can comfortably be put on the back burner.

An alternative approach is simply to rank non-conformances based on urgency of resolution.

Systems for identifying and prioritizing non-conformances work best when there are regular weekly or monthly reporting reviews to ensure that outstanding matters are followed up and resolved as required by the standards.

isoTracker’s modular, cloud-based quality management system includes software for tracking and monitoring non-conformances and ensuring issues are resolved through proper processes.

Sign up for a 60-day free trial and see how our system can streamline your QMS and help you identify, record, monitor, and resolve both major and minor non-conformances.