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For electromechanical products, a Design Completion Checklist-Electromechanical Devices ISO Template should be completed and evaluated. QP1100-2 DESIGN COMPLETION CHECKLIST FOR ELECTROMECHANICAL DEVICES covers items inside the device, hardware, labeling, software, and more. At the completion of each design/development activity, a review of the results should be performed.
Reviews should be objective, unbiased examinations by appropriately trained employees who were not directly involved in that design activity. The design team should keep a record of all such reviews and necessary actions that arise from them. Review results and actions arising from them should be documented in report form and signed by Management employees as complete and accurate.
All changes made as a result of review findings should likewise be documented. Reports should include conclusions and recommended follow-up and should be disseminated in a timely manner to appropriate organizational functions, including management. The Product Development Team should keep all such reports in the Design & Development file.