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Failure Investigation
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Item Number: NWRR0604
A procedure that describes the process for reporting a nonconformance, performing and documenting an investigation of a suspected failure, evaluating the potential impact on product, identifying corrective action, and determining the effectiveness of the corrective action. This procedure applies to any suspected failure of incoming raw materials, subassemblies, (i.e., stock solutions, buffers), intermediates, (i.e., bulk product), in-process product, and final product. This 14-page document, including two attachments (Failure Investigation Report, and Failure Investigation Report Log), assigns responsibility for each step of the procedure.
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