Auditing a production area
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Answer:
When I audit a production area, I want to see evidence of:
Operation parameters are defined, are monitored and the process is being controlled;
SOPs if defined, are available and are being followed;
Production and quality control records are being made;
Non-conforming products are removed, identified, corrected or destroyed;
Traceability is in place and working for machines, people and raw materials;
Machines and other equipment have preventive maintenance according to plan;
Operators are competent;
Cleaning processes are in place and validated
The following material will provide you information about auditing production:
- Understanding Product & Service Provision in ISO 9001 - https://advisera.com/9001academy/blog/2014/10/07/understanding-product-service-provision-iso-9001/
- Managing Production and Service Provision using ISO 90 01 - https://advisera.com/9001academy/blog/2017/11/21/managing-production-and-service-provision-using-iso-9001/
- How to establish process validation in the QMS - https://advisera.com/9001academy/blog/2017/01/31/how-to-establish-process-validation-in-the-qms/
- Free online 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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Apr 05, 2019