The difference between major and minor non-conformances lies in the potential severity of their impact.
In this article, we offer advice on defining what constitutes minor versus major non-conformances as part of your organization’s quality management system (QMS).
We also offer several examples of minor and major non-conformances, to help illustrate the differences.
Defining major versus 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,
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.
Examples of minor non-conformances
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.
Examples of major non-conformances
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.
Minor non-conformances becoming major
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.
How isoTracker’s software can help
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.
