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Nonconformances
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Item Number: NWRR0605
A procedure that describes the identification and documentation of nonconforming materials and product, including: initiation of a nonconformance report; review of the nonconformance report; evaluation and approval of the nonconformance report; corrective action completion; effectiveness checks; record keeping; cancellation of a nonconformance report; and nonconformance summary reports. This procedure applies to nonconformances involving incoming raw materials, subassemblies (i.e., stock solutions, buffers), intermediates (i.e., bulk product, in-process product), and final product. The 12-page document, Including four attachments (Nonconformance Report, Notice of Nonconformance Report Cancellation, Nonconformance Report Log, and Cause Codes for Nonconformances), assigns responsibility for each step of the procedure.
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