General Information Elbit Systems of America SUPPLIER QUALITY SYSTEM AUDIT CHECKLIST Vendor Code: Phone Fax: Vendor Name: Vendor Address: Completed by: Title: Signature: Date: Management Name: Title: Products/Services Description Description Quality System Compliance To ISO9001 AS9100 Appendix QG Other: Main Customer Customer Product/Service Quality Key Personnel Name Title Qualifications Previous Surveys/Approvals Company Date Level Comments 1
1. Is there an up-to-date Quality Manual? (4.2.1; 4.2.2) 2. Are there Quality Procedures/Work Instructions?(4.2.2; 7.5.1b) 3. Is there quality planning/program for each product/order?(5.4, 7.1; 7.2.2; 7.4.3) 4. Is there a process to assure all personnel are aware of the procedures?(4.2.1) 5. Do customers have access to quality management system documentation?(4.2.1) 6. Are the documents required by the quality management system controlled?(4.2.3) 7. Is there a procedure to define the method for controlling external documents? (4.2.3.f) 8. Is product conformity and delivery performance measured?(5.2)(c) 9. Is there a documented quality policy?(5.3) 10. Is the responsibility and authority of the quality parties defined?(5.5.1) 11. Are there quality reviews at management level?(5.6.1) 12. Does the management representative have the freedom/responsibility to resolve matters pertaining to quality?(5.5.2) 13. Is there a plan for training/certification of employees and is it implemented?(6.6.2.e) 14. Are the actual training/certifications documented?(4.2.4; 6.2.2.e) 15. Is each new order reviewed for special product requirements?(7.2.2)(c) 16. Is each change to an order reviewed?(7.2.2)(qg-ib) 17. Is there a requirements specification for each order?(7.2.2)(qg-ib) 2
18. Are there up-to-date development planning documents?(7.3.1) 19. Are there development and testing procedures?(7.3.1) 20. Do the development documents undergo a process of review and approval prior to their release?(7.3.1; 7.3.3; 7.3.4) 21. Are key characteristics identified per design or contract requirements?(7.3.3.e)(c) 22. Is all pertinent data that is required to allow the product to be identified, manufactured, inspected, used and maintained defined? (ie, drawings, part lists, specs, etc.) (7.3.3.e)(C) 23. Is there an up-to-date list of docs/drawings revision? (7.3.3.e) 24. Are Design Reviews conducted and documented?(7.3.4) 25. Are the development products undergoing test and validation?(7.3.6; 7.3.6.1; 7.3.6.2)(C) 26. Are changes documented and approved?(7.3.7) 27. Are obsolete docs/drawings removed?(4.2.4) 28. Are design/development changes controlled per configuration management process? (7.3.7; 7.1.3) 29. Are docs/drawings changes reviewed, validated and approved?(7.3.7) 30. Is there a process of assessment/certification of new suppliers?(7.4.1)(qg-i.b.2) 31. Does the process define actions to take when dealing with suppliers that do not meet the requirements?(7.4.1.c) (QG-I.B.2) 32. Is there a method to assure that the suppliers and their sub-tier suppliers are using approved special process sources?(7.4.1.d) (QG-I.B.2) (C) 3
33. Is there a process of suppliers performance assessment?(7.4.1.b) (QG-I.B.2) 34. Are results of the performance assessments available for review?(7.4.1)(qg-i.b.2) 35. Is there an up-to-date list of certified suppliers (ASL)?(7.4.1.a) (QG-I.B.2)(C) 36. Does the function that has the responsibility for approving supplier quality systems also have the authority to disapprove those suppliers?(7.4.1.e) (QG-I.B.2) (C) 37. Are docs/drawings (specs and quality requirements) attached to each order?(7.4.2.g) (C) 38. May the customer/representative of the customer perform inspection at the suppliers (and sub-tiers) premises?(7.4.2.i) (QG-E & G) (C) 39. Do purchase orders to your subcontractors define all processing and testing requirements?(7.4.2.d) (C) 40. Do POs communicate to sub-tiers the record retention requirements?(4.2.4; 7.4.2.h) (C) 41. Are suppliers required to submit objective evidence of the quality of the product (e.g., COC, test reports, etc)?(7.4.3) (C) 42. Is there an incoming inspection activity to review the required documentation or inspect the product upon receipt?(note 1 & 2) (C) 43. Is there a program whereby verification of the product is delegated to the supplier?(7.4.3 - Note 2) (C) 44. Is there a mechanism for service to delivered products?(7.5.1.4) (C) 45. Are process controls and control plans in place where key characteristics have been identified?(7.5.1) (QG-I.B.1)(C) 46. Are the latest possible in-process verification points identified?(7.5.1) (C) 4
47. Are variable measurements taken, particularly for key characteristics?(7.5.1) (QG- I.B.2)(C) 48. Are production and service provisions carried out under controlled conditions? And do the controlled conditions include(7.5.1) (C) A. Accountability for all products during manufacture?(7.5.1.g) (C) B. Evidence that all manufacturing and inspection operations have been completed? (7.5.1.h) (C) C. FOD prevention, detection and removed?(7.5.1.i) (C) D. Monitoring and control of utilities and supplier such as water, compressed air electricity and chemical product to the extent that they affect product quality?(7.5.1.j) (C) E. Are there clear and concise work instructions?(7.5.1.k) (C) 49. Does production documentation contain the following: (7.5.1.a & b) (C) A. Drawings, parts list, process flow charts, etc. B. A list of specific or non-specific tools and numerical control machines programs and instructions? 50. Are the persons authorized to approve changes to production processes identified? (7.5.1.2) (C) 51. Does the supplier identify and obtain acceptance of changes that require customer approval?(7.5.1.2; 8.2.4)(C) 52. Are changes that affect processes, production equipment, tools and programs documented? (7.5.1.2)(C) 53. Are the changes to production processes assessed to confirm that the desired effect has been achieved without adversely effecting product quality?(7.5.1.2)(c) 54. Are production equipment, tools and programs validated prior to use?(7.5.1.3)(c) 55. Are there procedures requiring the production equipment, tools and programs to be inspected periodically? (7.5.1.3)(C) 56. Are First Article inspections completed prior to production to validate the design data/specification? (7.5.1.1)(QG-H)(C) 5
57. Where servicing is a specified requirement, does the services operation provide for: A. method of collecting and analyzing in-service date B. a process for handling problems identified after delivery, (investigating, reporting, service information. C. control and updating technical documents D. approval, control and use of repair schemes E. process for off-site work, (at customer s facility).(7.5.1.4)(c) 58. Is there a configuration management system to identify any differences between the actual configuration and the agreed configuration?(7.5.3) 59. If used, is there appropriate controls for acceptance authority media, e.g., stamps, electronic signatures, etc.?(7.5.3)(c) 60. Is there a unique identification for each product unit (catalog number/serial number)?(7.5.3; 4.2.4) 61. Is there a Traceability report for the items in each product unit (As Planned/As Build)?(7.5.3)(C) 62. Are there procedure for handling customer property?(7.5.4) 63. Is there an up-to-date list of customer property?(7.5.4; 4.2.4) 64. Is the packaging done in accordance to defined requirements/packaging specs?(7.5.5) 65. Are delivered products accompanied by the docs required by customer?(8.2.4)(c) 66. Is the calibration method compliant with ISO-10012?(7.6)(QG-I.D) 67. Are there instructions for calibration/maintenance for each type of M&TE tool?(7.6)(qg-i.d)(c) 68. Is there an up-to-date list of M & TE tools and their calibration history?(7.6) (QG-I.D) (C) 69. Is there a periodical calibration plan and is it implemented (recall)?(7.6.a) (QG-ID)(C) 6
70. Is an up-to-date calibration tag attached to each M&TE tool?(7.6.c) (QG-I.D) 71. Is there a plan for conducting internal quality audits and is it implemented?(8.2.2) 72. Is an audit report submitted for each audit, including required corrective actions?(8.2.2) 73. Is there follow-up on open corrective actions?(8.2.2.b; 8.5.2) 74. Is there a process for monitoring and controlling identified key characteristics?(8.2.4)(qg-ib1)(c) 75. Is there a process for documenting the measurement requirements for product or service acceptance?(8.2.4)(c) 76. Are there sampling inspections made and according to which standard?(8.2.4)(c) 77. Is there an SPC plan for processes and is it implemented?(8.4) 78. Is there a positive recall system for product that is released prior to completion of all required measurement and monitoring activities?(8.2.4)(c) 79. Is measurement requirements for product/service acceptance documented and does it include: (8.2.4)(C) A. Criteria for acceptance/rejection B. Where in the sequence measurement and test operations are performed? C. a record of the measurement results D. type of measurement instruments required and use instructions 80. Do records provide evidence that the product meets the defined requirements?(8.2.4) 81. Does the supplier perform First Article Inspections to include the inspection, verification and documentation of a representative item from the first production run of a new part?(7.5.1.1)(qg-h)(c) 82. Does the documented procedure define the responsibility for review and the authority for dispositioning nonconforming product?(8.3)(c) 7
83. Is there a process for approving the personnel to make decisions regarding disposition of nonconforming product? (8.3)(C) 84. Is there a process of disposition of nonconforming material, with the participation of all involved parties (MRB board)? (8.3)(C) 85. Is the customer approving nonconforming material dispositions (if contractually required)??(8.3)(c) 86. Is nonconforming material identified by "Nonconforming Material" tag?(8.3) 87. Is nonconforming material passed to segregated storage (MRB)?(8.3) 88. Is there an up-to-date list of nonconforming material in the MRB segregation area?(8.3) 89. Is there a process for handling customer complaints?(8.2.1)(c) 90. Is there a documented process for handling nonconforming product?(8.3) 91. Is analysis Performed to identify root causes of problems/failures?(8.4; 8.5.2.b) 92. Is there action initiated to prevent recurrence of problems/failures?(8.5.2) 93. Are problems/failures brought to management attention?(5.1; 8.5.2) 94. Is there a process for flowing down the corrective action requirement to a supplier when it is determined that the supplier is responsible?(8.5.2.g)(c) 95. Is there a process for actions to be taken when timely or effective corrective actions are not achieved?(8.5.2.h)(c) 8