1. Are Quality Targets (KPI) established? Do they match with the Quality Policy?
2. Is the effectiveness of the Quality System periodically checked?
3. Are there any supporting procedures and methods provided to the Quality Manual?
4. Is there any Quality System Certification or renewal plan available?
5. Are the requirements in the customer contracts checked before receiving of an order?
6. Are contract changes well documented and distributed over the whole organization?
7. Are there any management regulations and clear standards provided for the control of environmentally harmful substances in the products of the audited company?
8. Is the proof of non-content of environmentally harmful substance existed for the purchased product?
9. Is there a clear definition for responsibility for product development (department and persons)?
10. Is the content of quality assurance sufficiently considered in order to prevent the occurrence of problems?
11. Is an APQP for each product existing and is a design review implemented?
12. Is a customer approval or release obtained before a design change?
13. Are the documents checked or approved by persons with appropriate authority?
14. Are always latest versions of customer engineering standards/specifications be used?
15. Are standards available for the selection of supplier and contract manufacturer?
16 Is there control and guidance of the quality status of suppliers and contract manufacturer sufficient?
17. Are the tools (Jig & tool, Mold, and Devices etc.) provided by the customer well maintained and managed?
18. Are the products identified clearly and is the control for the prevention of the incorrect part mixing sufficient?
19. Is there a traceability system for each single product or lot?
20. Are actual working matching by compared with control plan?
21. Are work instructions for operator available and are they satisfying?
22. Is the handling for control of abnormalities clearly defined?
23. Is an effective preventive maintenance system for production equipments available?
24. Is the change point control regulated regulated by procedures and securely implemented?
25. Are the countermeasures against re-occurrence of defects in the past implemented satisfactory?
26. Are 4M changing point(Man,Machine,Material,Method) controlled for each procees?
27. Are FMEA revised as needed?
28. Are working condition of special process and Jigs control condition clearly defined?
29. Is the production plan at each workplace indicated and its accomplishment controlled?
30. Are there corresponding procedures available for control of design changes or design delays?
31. Is the input to the production control system safeguarded by a multiple check system?
32. Are the inspection and test results appropriately recorded and maintained?
33. Are the inspection standards for incoming inspection and testing provided and maintained?
34. Are the conditions of each inspection and measurement equipment maintained satisfactory?
35 Are the periodic calibration records of the measuring instruments available?
36. Are the work places for inspection and testing (e.g. space, lightning etc.) satisfactory?
37. Is the special validation of the newly starting products securely carried out?
38. Are the procedures for disposal of the non-conforming product and doubtfull product securely implemented and carried out?
39. Are the defective products analyzed and the analysis results utilized for the quality improvement activities?
40. Are the corrective actions taken in order to prevent the reocurrence of non-conforming product?
41. Are the quality information analyzed and preventive measures for the non-conformance taken?
42. Are the methods that prevent damages and deterioration of the product taken?
43. Is the control of product from warehousing to shipment and arrival at the customer handled satisfactory?
44. Is the safekeeping of Quality Records requested to the contract manufacturer?
45. Are the production parts approval records (PPAP) kept in the archive and maintained?
46. Is an internal quality audit plan available and carried out as scheduled?
47. Are the corrective actions recorded and the effectiveness properly evaluated/confirmed?
48. Is an education and training plan avaliable?
49. Is the effectiveness of education and training periodically evaluated?
50. Are statistical methods implemented in the control plan and utilized properly?