ISO 9001 and root cause analysis

Answer:
An organization performs quality control on its products (clause 8.6). During quality control, an organization can detect product nonconformity (clause 8.7).
Also, an organization performs monitoring and measurement (clause 9.1.1) and analysis and evaluation of performance (clause 9.1.3)

Either because one particular product non-conformity is considered very serious, or because it is a recurring product non-conformity, an organization can decide that performance should be improved. For that reason, a corrective action should be developed (clause 10.2). Developing an effective corrective action must include determining the root cause of the product quality issue.

Let us suppose that the organization is not satisfied with the level of non-conformities on product X. So, the first step is to focus the effort of improvement, by performing a symptom diagnosis using, for example, a Pareto chart: https://www.screencast. com/t/cw2cpildI

After this initial screening the organization needs:
· to determine probable causes;
· make some tests or investigations to find root-cause(s);
· develop alternative solutions;
· select the best one;
· implement the solution;
· check the effectiveness of that solution

The following material will provide you with information about root cause analysis:
- ISO 9001 – How to use root cause analysis to support corrective actions in your QMS - https://advisera.com/9001academy/blog/2016/03/01/how-to-use-root-cause-analysis-to-support-corrective-actions-in-your-qms/
- Free webinar – Measurement, analysis, and improvement according to ISO 9001:2015 - https://advisera.com/9001academy/webinar/measurement-analysis-and-improvement-according-to-iso-9001-2015-free-webinar/
- book - Discover ISO 9001:2015 Through Practical Examples - https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/