1. Quality Management System
1a. Do you establish, document, implement, and maintain a quality management system in accordance with quality standards?
1b. Has a quality manual been generated which documents the quality system, and references all quality flow down procedures?
1c. Do the employees have access to the quality manual, and do they have awareness and understanding of the relevant procedures?
3. Control of Documents
3a. Is there an established procedure describing control of documents?
3b. Do you have a system of document change control?
3c. Is there a system to control obsolete drawings, specifications, forms, and procedures to ensure they are not mistakenly used?
4. Control of Records
4a. Is there an established procedure describing the control of records affecting the quality management system, such as work order routers, receiving/in-process/final inspection data, test results, calibration records, audit reports, training records, etc?
4b. Are the records of quality activities maintained per a procedure?
6a. Are there documented procedures to ensure that the product being purchased meets specified requirements?
6b. Are purchased products verified upon receipt or at the sub-tier supplier’s facility prior to shipment?
6c. Is there a process for evaluating, approving, and maintaining a list of approved sub-tier suppliers?
6d. Do you periodically review and evaluate the performance of your sub-tier suppliers?
8. Design & Development Planning
8a. Are there procedures in place to maintain and control the design verification of the product to ensure that specified requirements are met?
8b. Are design requirements clearly & accurately defined and documented?
8c. Does management ensure that members from all relevant departments (i.e. Quality, Production, Engineering etc.) are involved in product development prior to the incorporation of new designs?
8d. Are the design requirements clearly and accurately defined and documented?
8e. As applicable, are critical / key characteristics identified in accordance with design or contract requirements?
8f. Are design reviews conducted at appropriate stages to evaluate results, identify issues, and plan next steps?
8g. Do new designs go through a documented verification & validation process to ensure that the design and end products meet all customer requirements?
8h. Do required verification & validation tests identify the product being tested, equipment/parameters to be used, objectives, acceptance criteria and results to be recorded?
8i. Are procedures in place to ensure any design/development changes are reviewed, documented, and implemented by appropriate personnel with consideration given to product already delivered to customers?
11. Control of Inspection, Measuring & Test Equipment
11a. Are there documented procedures defining how all inspection, measuring and test equipment within the facility are controlled and maintained?
11b. Is all equipment and tooling used for product acceptance calibrated and traceable to a nationally recognized standard?
11c. Is all calibrated equipment physically identified & traceable as to calibration status and re-certification dates?
11d. When equipment is found to be faulty, damaged, or out of calibration, are procedures in place to perform an assessment of the previous inspection results, including the possible re-call of product for re-inspection?
12. Inspection & Testing
12a. Is there a documented procedure defining inspection & test activities including inspection status (uniquely traceable to inspection personnel) and sample inspection requirements where applicable?
12b. Are there both in-process & final inspection activities in place to verify that all purchase order, drawing, and contractual requirements are met prior to shipments to customers?
12c. Is the statistical quality control (sampling) plan derived from ANSI/ASQ Z1.4?
12d. Is there a procedure defining the inspection, verification, and documentation, of First Article Inspection Reports? (FAIs)
13. Control of Non-Conforming Product
13a. Are there procedures in place regarding the identification, segregation, evaluation, disposition, and customer notification of non-conforming product?
13b. Are records of non-conforming product retained?
13c. Are procedures in place requiring notification to customers when non-conforming material has escaped the supplier’s facility?
14. Corrective & Preventative Action
14a. Are there procedures in place for issuing corrective & preventive action to sub-tier suppliers, and responding to corrective action requested by customers?
14b. Are there activities in place regarding complaint handling?
14c. Is follow-up conducted and documented concerning the effectiveness of corrective action?
15. Handling, Storage, Packaging & Shipping
15a. Are there procedures in place for the handling, storage, and packaging of customer product?
15b. Do you verify final packaging & marking prior to shipping?
15c. Do all materials stored have evidence of inspection?