Control of Nonconforming Product. 7.18.1 The supplier shall implement a procedure to define the controls, related responsibilities and authority to manage non-conforming product. 7.18.2 The non-conforming product must be contained until the supplier can scrap, rework or obtain deviation approval from Xxxxxx Scientific. Refer to section 7.14.5 of this agreement. 7.18.3 The supplier shall create process work instructions to define and control rework and repair processes. Approval from Xxxxxx Scientific on rework and repair processes does not relieve the supplier of any liability regarding product quality. 7.18.4 All corrected non-conforming product must be re-verified to demonstrate conformity to the requirements. The supplier must properly identify each product or package as repaired or reworked. 7.18.5 The supplier shall immediately notify Xxxxxx Scientific of any defective products found at their facility that may have been delivered to Xxxxxx Scientific and/or its customers. 7.18.6 The supplier shall maintain records of the non-conformance and subsequent actions taken. Xxxxxx Scientific reserves the right to audit any non- conformances. Xxxxxx Scientific may issue a Supplier Corrective Action Request (SCAR) for supplier identified non-conformances with the product(s). 7.18.7 Nonconforming Product or it components returned to the supplier by Xxxxxx Scientific shall be analyzed by the supplier within the timeframe specified by Xxxxxx Scientific or a timeframe that has been agreed upon by both parties taking into consideration the risk associated with the nonconformity. Xxxxxx shall supply sufficient information regarding failure mode and customer use conditions if applicable. The analysis results shall provide an understanding of the root cause of the failure and either the actions to be taken by the supplier that will prevent further occurrences of the nonconformity or justification for no action. All investigations, analyses and corrective actions must be conducted, and all related records and reports must be generated and maintained, in accordance with all applicable regulations. Supporting documentation for each analysis and investigation shall be made available to Xxxxxx Scientific.
Appears in 2 contracts
Samples: Supplier Quality Agreement, Supplier Quality Agreement
Control of Nonconforming Product. 7.18.1 The supplier shall implement a procedure to define the controls, related responsibilities responsibilities, and authority to manage non-conforming product.
7.18.2 The non-conforming product must be contained until the supplier can scrap, rework rework, or obtain deviation approval from Xxxxxx Scientific. Refer to section 7.14.5 of this agreement.
7.18.3 The supplier shall create process work instructions to define and control rework and repair processes. Approval from Xxxxxx Scientific on rework and repair processes does not relieve the supplier of any liability regarding product quality.
7.18.4 All corrected non-conforming product must be re-verified to demonstrate conformity to the requirements. The supplier must properly identify each product or package as repaired or reworked.
7.18.5 The supplier shall immediately notify Xxxxxx Scientific of any defective products found at their facility that may have been delivered to Xxxxxx Scientific and/or its customers.
7.18.6 The supplier shall maintain records of the non-conformance and subsequent actions taken. Xxxxxx Scientific reserves the right to audit any non- conformances. Xxxxxx Scientific may issue a Supplier Corrective Action Request (SCAR) for supplier identified non-conformances with the product(s).
7.18.7 Nonconforming Product or it its components returned to the supplier by Xxxxxx Scientific shall be analyzed by the supplier within the timeframe specified by Xxxxxx Scientific or a timeframe that has been agreed upon by both parties taking into consideration the risk associated with the nonconformity. Xxxxxx shall supply sufficient information regarding failure mode and customer use conditions if applicable. The analysis results shall provide an understanding of the root cause of the failure and either the actions to be taken by the supplier that will prevent further occurrences of the nonconformity or justification for no action. All investigations, analyses and corrective actions must be conducted, and all related records and reports must be generated and maintained, in accordance with all applicable regulations. Supporting documentation for each analysis and investigation shall be made available to Xxxxxx Scientific.
Appears in 2 contracts
Samples: Supplier Quality Agreement, Supplier Quality Agreement