What is a Nonconformance?
ISO 9000 defines it as the non-fulfillment of a requirement.

When an organisation is subject to an audit, it is this ‘monster’ that must be avoided at any cost. A nonconformance is often interpreted as somebody not doing their work properly. It is also seen as a sign of failure and becomes a nightmare for business owners, for those in charge of resolving the nonconformances, and for those working in the affected areas.

This article will provide you with a detailed guide on how to successfully handle nonconformances and how to improve the corrective action process to ensure that these issues do not reoccur.

Why do nonconformances occur?

Among several sources, nonconformances are mainly generated because:

  • The requirements are not known or aren’t interpreted correctly
  • There is insufficient knowledge about the possible sources of these requirements (i.e. Applicable Standard, Customer, Regulatory Bodies and our own organisation)
  • Implementation and/or maintenance is not done in an effective way
  • Existent issues are inadequately addressed (ineffective Corrective Action and/or Problem-Solving processes)
why do nonconformances occur

Most common nonconformances

In the latest publication from November 2022, International Automotive Task Force (IATF) statistics revealed the most common major and minor nonconformances that were found by auditors globally in the last 12 months.

The highest cases of Major nonconformance with IATF 16949 were “problem solving” and “nonconformity and corrective action (ISO 9001)”.

These figures include minor nonconformances that were escalated to a major nonconformance from the previous year. This is because the IATF 16949 rule 5th section states that in cases where corrective actions plan for a minor nonconformity are not implemented effectively, a new major nonconformity shall be issued against the corrective action process and the previous minor nonconformity reissued as a major nonconformity.

Manufacturers need to avoid being issued a major nonconformance because this results in the automatic suspension of an organisation’s IATF 16949 certification, which in turn is seen as a big risk factor for customers and their future business.

So, it’s critical to address minor nonconformances with urgency.