| Score |
Question |
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1. Are there procedures to control and verify the design of the product to ensure it is meeting all requirements? |
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2. Are there plans that identify the responsibility for each design and development activity? |
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3. Are the plans updated as the design evolves? |
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4. Are obsolete design documents removed from production and general use? |
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5. Are the design and verification activities planned and assigned to qualified personnel? |
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6. Are organizational and technical interfaces between different groups identified, documented, transmitted and reviewed regularly? |
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7. Are design input requirements relating to the product identified, documented and reviewed for adequacy? |
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8. Is there a procedure for resolving incomplete or conflicting requirements with those responsible for drawing up the requirements? |
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9. Are design outputs documented and expressed in terms of requirements, calculations and analyses? |
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10. Has the design verification been planned, established, documented and assigned to competent personnel? |
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11. Can the design verification establish that design output meets the design input? |
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12. Are there procedures for the identification, documentation, review and approval of all changes and modifications? |
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13. Is there a requirement to verify the product meets design specifications prior to mass production (e.g., design review/verification)? |
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14. Are the records for design review properly documented and maintained? |
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Total for Element 10 |