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Why are there any factories that fail to pass the COSTCO quality audit? Tranwin summarizes the experience and lessons of many consultants. The comprehensive analysis of the auditors' on-site interpretation is as follows:
1. Employees do not understand AQL. Internal auditors do not have internal audit training records or are not familiar with internal audit requirements. The annual training program has no GMP-related training topics, or no assessment records.
2. Some test equipment calibration has expired.
3. The material/product is not stored off the wall and stored by the window.
4. The wall peels off mold, the ground is dirty, there are spider webs, the roof is broken and the area is water.
5. There is no automatic closing of the door/door curtain in the workshop and warehouse. The window is open and no screens are installed. The lights in the production and storage areas are unshielded.
6. Warehouse materials, semi-finished products, finished products without date or batch number identification, can not confirm whether the factory's first-in-first-out is effectively implemented, can not be retroactive.
7. There is no simulated recall record, or no record of traceability in the recall is saved.
8. The factory has no cleaning plan and implementation records.
9. Employees do not understand the quality of the factory and the product safety policy.
10. The production parameters of machinery and equipment are not controlled according to the specified requirements.
11. Food or beverages are brought into production and storage areas.
12. Only individual departments have the goal of setting measurable quality; the implementation of targets is not regularly assessed. When the target is not met, there is no corresponding cause analysis and improvement plan.
13. The internal audit and management review did not include GMP.
14. The list of foreign documents of the factory is incomplete, such as lack of customer standards, relevant regulatory standards for product sales, product standards, etc., and is not issued according to controlled requirements.
15. The risk assessment is incomplete, such as: lack of procedures, incomplete records (physical, chemical, biological aspects of product contamination during production, packaging or storage), control measures, personnel responsibilities, etc.
16. The factory does not have a primary or periodic assessment of the supplier/subcontractor.
17. Wooden pallet storage is not suitable, damaged, no procedures, cleaning inspection records.
18. Training record for pest control personnel/certification of third party pest company. No pest control record. No mousetrap device, fly-killing device, no distribution map, and improper installation.
19. The factory has no pre-operational inspection procedures to verify that the equipment has been effectively cleaned and in good condition.
The above content is part of the reason why the COSTCO quality audit is not successfully passed. It comes from the inspection expert Shanghai Tranwin. For more information, please contact us.
