The Difference Between Major and Minor Non-Conformances Explained
The difference between major and minor non-conformances lies in the potential severity of their impact.
In this article, we offer advice on defining minor versus major non-conformances as part of your organisation’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 organisation and the standard you are trying to meet. Therefore, it is necessary to create a system of identification 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 essential to have a straightforward way to distinguish whether a non-conformance is major or minor. This can help your organisation prioritise issues effectively.
A good place to start is to describe 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 auditsIinadequate 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. Labelling 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 prioritising 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.