Locating a nonconformity
One machine was programmed to reject bad parts. But during the inspection, it was found that the machine has rejected some good parts also. In which clause will this nonconformity come?
Assign topic to the user
If the machine was programmed to reject bad parts, we can conclude that the machine is a monitoring and measuring resource. Is that resource calibrated? Was that resource tested for suitability? If the problem is about calibration, I would use clause 7.1.5. If the problem is about not testing suitability, is about not validating the use of the machine, I would use clause 8.5.1 b).
- Article - Seven Steps for Corrective and Preventive Actions to support Continual Improvement - https://advisera.com/9001academy/blog/2013/10/27/seven-steps-corrective-preventive-actions-support-continual-improvement/
- Article - 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/
- Enroll for free in ISO 9001:2015 Internal Auditor Course - https://advisera.com/training/iso-9001-internal-auditor-course/
- Book – Discover ISO 9001:2015 Through Practical Examples - https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/
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Feb 03, 2020