Procedures for Nonconforming Product. (a) You shall establish and maintain a process to control Production Materials and Finished Products that do not meet Specifications and these Requirements or are contaminated. The process shall address the identification, documentation, evaluation, segregation, and appropriate disposition of such Production Materials and Finished Products. The process shall include promptly notifying the Customer of all such non-conformances. (b) Identification of nonconforming Production Materials and Finished Products shall include documentation of the identity and quantity of the nonconforming Production Material and Finished Product, the date the Production Material and Finished Product was identified as nonconforming, the nonconformance, and the identity of the person who determined the Production Material and Finished Product to be nonconforming. (c) Evaluation of the nonconformance shall include an assessment of the risk posed by the nonconformance and a determination of the need for an investigation into the cause of the nonconformance. Where an investigation is conducted, it shall include a review of relevant manufacturing records, data and any other relevant information necessary to determine the cause of the nonconformance and to eliminate these possible causes. If requested by Customer, you shall provide an investigation report to Customer. (d) Segregation of the nonconforming Production Material and Finished Product shall include clearly identifying and holding nonconforming Production Material and Finished Product in a manner that prevents mix-ups. (e) You shall obtain approval from Customer of the proposed disposition of nonconforming Production Material and Finished Product. Nonconforming Finished Product shall not be released for delivery or sale.
Appears in 2 contracts
Sources: Manufacturing Agreement (Kimree, Inc.), Manufacturing Agreement (Kimree, Inc.)