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Question |
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1. Is product adequately identified throughout the manufacturing process according to documented procedures? More info |
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2. Is applicable inspection and test, or process control documentation, traceable to production lot quantities and dates of manufacture? More info |
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3. Does the manufacturing floor exhibit evidence of organized product flow and does the entire facility, including administration, exhibit good housekeeping practices? More info |
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4. Are first article inspections performed as necessary to verify conformance directly after manufacturing process setup, changeover, tooling change-out or machine adjustment? More info |
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5. Does the supplier conduct process or machine capability studies? More info |
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6. Are documented operating procedures provided and maintained for each step or operation within the manufacturing process, and are these instructions available to production employees during training and as routinely needed? More info |
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7. Is a process control flowchart developed and implemented for each product or component, illustrating workstations, production sequences, material flow and check or control points/stations? More info |
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8. Are records maintained for routine and special steps or operations within the manufacturing process (i.e., equipment failure)? More info |
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9. Are there documented procedures for identifying the inspection and test status of product throughout the manufacturing process? More info |
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10. Does the supplier ensure that product cannot be further processed or used until it has passed all required testing and inspection to that point? More info |
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11. Do handling and storage procedures address damage, deterioration and contamination prevention? More info |
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12. Are quality records readily retrievable and stored so as to prevent damage, deterioration or loss? More info |
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13. Are relevant product, manufacturing processing and quality system documentation retained for a period of five years? More info |
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14. Has a statistical training program been implemented and is there documented evidence that it is continuous? More info |
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15. Are control charts (or other statistical methods) maintained and regularly reviewed for process performance and modification of control limits? More info |
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16. Has a short-term Cp=Cpk goal of at least 1.33 been set for capability? More info |
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17. Has a long-term Cp=Cpk goal of at least 2.00 been set for capability? More info |
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18. Is first article inspection, test and review conducted per the Electro Scientific Industries First Article Inspection procedure or comparable? More info |
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19. Is a documented preventive maintenance program maintained on all production equipment and machines? More info |
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20. Is Preventive Maintenance (PM) data used to adjust PM schedules, drive corrective action and to reduce unscheduled downtime? More info |
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21. Are there procedures defining product identification requirements for all products? |
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22. Are in-stock and in-process materials properly identified and controlled? |
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23. Where traceability is a specified requirement, do individual products or batches have a unique identification? |
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24. Are assemblies properly marked and tracked through the assembly process to ensure no steps in the process flow are missed? |
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Total for Element 5 |