Initial Production Review Usually conducted on prototype Usually conducted on prototype The review evaluates the manufacturing plan to determine adequacy of: The review evaluates the manufacturing plan to determine adequacy of: Failure Mode and Effect Analysis (FMEA) Tooling and work-holding devices Production machinery Materials handling Test Equipment Inspection system Sampling plan Packaging and Shipping Operating instructions Safety warnings Advanced service information for distributors and dealers Inherently hazardous products should have a limited production run and controlled distribution to collect better information Periodic audits should be conducted to verify or validate quality control systems as part of ISO 9000 requirements
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