Well I am not sure if the Major and Minor distinctions are recognised by ISO and I don’t think that there is an official definition for what should be a Major Non-Conformance. However they are commonly used distinctions and from a senior management perspective the ability to prioritise Non-Conformance I am sure would be viewed as a good thing. They are also generally recommended by Auditors in their post- audit reviews as a way of ensuring that the important or critical issues are dealt with promptly. As with any form of prioritization, there must be a way of defining what should be a Major non-conformance and trying to put some consistency around that definition so that it represents a logical grouping that is generally viewed as having issues that must be treated with a similar sense of urgency. In other words let’s not make every issue a Major issue as the impact of a Major Non-Conformance would be squandered and that sense of urgency to resolve the Major Non-Conformances would no longer be evident.
A good place to start is with a description of what should represent Major Non-Conformance:
- A system required by the relevant standards is either broken or not working reliably
- An event that would lead to the product not being able to meet the customer’s expectations
- An event, however small, that has occurred before and for any reason does not appear to be getting fixed
These may require specific examples in order to demonstrate what events would be covered under each category. As always there are disagreements on the use of the definition of Major or Minor Non-Conformance. This is because under all ISO standards a Non-Conformance MUST be fixed. So why give a lesser importance to an issue that could potentially lead to it not being fixed? An alternative therefore is to rank them on the basis of urgency of resolution. So the more important or critical issues are assigned a shorter time to resolve and the lesser issues are given more time to resolution. These should be followed with some form of automatic reminders if the resolution deadlines are missed. Finally, let’s us not forget that systems such as these 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. Utilizing a complete quality management and document control system will go a long way in ensuring that minor and major non conformance will be dealt with effectively and quality standards upheld.