Organizations in automotive shall be audited by third party auditors to maintain quality management system certification according to ISO 9001 and IATF 16949. (For more information on auditing, see the article here.) Every year there are certain dominant nonconformities to be observed around the world. And what Top 10 major nonconformities dominated in 2021?
How to classify NC?
If the auditor collects objective evidence of non-compliance with the requirement, the audit results in nonconformity (NC). It shall be written down along with the supporting evidences.
In case of QMS certified for compliance with ISO 9001: 2015 and the IATF 16949 standard, there is no requirement to establish major or minor nonconformity.
But there is some valuable guidance in ISO19011, which is a guideline applicable to the above-mentioned standards. Nonconformity can be graded depending on the context of the organization and its risks! This grading can be quantitative e.g., from 1 to 5 or qualitative like a minor or major nonconformity.
Thus, the gradation of nonconformity is an individual matter to the organization. However, established in internal procedure in the quality management system will already become a mandatory requirement.
Nonconformity in IATF 16949 third party audit
First, the subject of nonconformity raised during the third-party audit of IATF 16949 is a bit different. The type of nonconformities is clearly defined by Rules for achieving and maintaining IATF Recognition 5th Edition for IATF 16949. It contains a clear definition of minor and major nonconformity:
minor nonconformity – failure to meet the requirements of IATF 16949, which, based on experience, does not lead to failure of the quality management system or limitation of its ability to provide supervised processes and products. It could be one of the following situations:
– the reliability of the part of the quality management system related to compliance with IATF 16949.
– individual failure to meet one of the elements of the organization’s quality management system.
critical nonconformity – meeting one or more of the following conditions:
– absence of a system or failure of the existing system to meet the requirements of IATF 16949. Several minor nonconformities in relation to one requirement may lead to a system failure and is thus considered a critical nonconformance.
– any nonconformity that is likely to lead to the delivery of a non-compliant product. A condition that may lead to the unreliability of products or services or significantly reduce the fitness of the products for their intended purpose.
– nonconformity which, based on experience, may lead to a failure of the quality management system or significantly reduce its ability to provide supervised processes and products.
Top 10 major nonconformities in 2021
The top 10 major non-conformities accounted for 40.4% of all major non-conformities in 2021.
Below you will find their statistics.
Download a copy of Top 10 major NC to use it in your work in a superior quality!
Let me invite you to the video series with Paul Hardiman in which we will discuss TOP 10 major NC in 2021!
Hope you found the article interesting.
Thank you for your presence.
Agata Lewkowska Ph.D.
PS. If I can help you with quality management issues, please contact me. You may also join me in my private group on Facebook: ISO 9001 & IATF 16949 QualityWise Group.
For people who want to know more:
Knowledge must have a solid foundation to avoid information noise. Therefore, the article was based on the following literature:
IATF 16949: 2016. Requirements for quality management systems in serial production and the production of spare parts in the automotive industry. 1st edition, 2016
ISO 9001:2015 Quality management systems — Requirements
Rules for achieving and maintaining IATF Recognition 5th Edition for IATF 16949
ISO 19011:2018 Guidelines for auditing management systems
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