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Design Risk

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Design risk
The risk associated with the impact on project cash flow from deficiencies in design or engineering. Also known as engineering risk.
Design Risk
The risk associated with potential flaws in the design of a good or its production and their effect on the project's cash flow. It is also known as engineering risk.
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The letter added that Louisville APL did not establish and maintain adequate procedures for validating the device design to ensure that design risk analysis is conducted and documented and that the device conformed to user needs and intended uses.
Louisville APL Diagnostics, Seabrook, TX (Dallas, TX) by Warning Letter Bulletin
By providing a pre-engineered and fully hardware verified turn-key solution on mid-speed grade Virtex-II Pro devices, Xilinx is helping customers achieve further cost savings while substantially reducing time-to-market and design risk," said Tom Quinn, senior vice president of Sales and Marketing for Samsung Semiconductor, Inc.
Xilinx simplifies QDR II SRAM Memory interfacing with new Virtex-II ... by EDP Weekly's IT Monitor
According to the letter, Lordex failed to ensure that an adequate and effective quality system was fully implemented and maintained at all levels of the organization, and failed to establish procedures and documentation to include design plans, design inputs, design outputs, design reviews, design verification and validation, design risk analysis, design transfer, design changes and design history files.
Lumbar pain-treatment manufacturer violates GMP requirements by Gould, Dawn / Validation Times
 
 
 
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