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.
Control of Nonconforming Product. UBS shall establish and maintain procedures to control product that does not conform to specified requirements. LifeScan is to be notified promptly in writing of any non-conformances that may potentially affect product safety, efficacy, quality or stability should product have been released from UBS. LifeScan must approve Use As Is (UAI) non-conformances and their associated investigation/justification/impact analysis.
Control of Nonconforming Product. NOVA is responsible for control of nonconforming product during the manufacturing and storage processes up to shipment to CERUS. NOVA will provide manufacturing variences specific to Product(s) and related to release of Product(s) to CERUS as part of the release package.
Control of Nonconforming Product. Supplier shall have Standard Operating Procedures to control Product that does not conform to Nevro Specifications. The procedures shall address the identification, documentation, evaluation, segregation, and disposition of Nonconforming Product, including a determination of a need for an investigation, which shall be documented. o x x
Control of Nonconforming Product. The supplier shall establish and maintain procedures to ensure that nonconforming product is not inadvertently shipped to SELCO PRODUCTS. The procedures shall provide for identification, documentation, evaluation, segregation (when practical), and disposition of nonconforming product. Disposition shall consist of:
a) Rework to meet SELCO PRODUCTS requirements, or;
b) Accept with or without repair by deviation, or;
c) Reject or scrap.
d) The proposed use or repair of product that does not conform to specified requirements shall be reported to the SELCO PRODUCTS Supply Chain Team for disposition.
e) The description of the nonconformity or proposed repairs shall be recorded to denote the actual condition.
f) Reworked or repaired products shall be re-inspected in accordance with documented procedures prior to shipment to SELCO PRODUCTS
Control of Nonconforming Product. 2.1 When Boeing notifies Seller of a detected nonconformance, Seller shall immediately take action to eliminate the nonconformance on all products in Seller's control. When nonconforming product is determined to be Seller's fault, Boeing will provide Seller with notification. Upon receipt of such notification, Seller shall develop and implement acceptable corrective action.
2.2 Seller shall maintain verification that root cause corrective action has occurred and has resolved the nonconforming condition. At the specific request of Boeing, this verification shall occur after implementation of the corrective action to ensure detected nonconformance has been eliminated. Boeing reserves the right to review the verification data at the Seller's facility or have the data submitted to Boeing.
2.3 When Seller disagrees with the determination of fault, Seller shall submit a Change of Charge (COC) request to the initiator within thirty (30) calendar days from the date of notification. The request must include the reason and documentation/objective evidence supporting the request. Failure to notify Boeing of disagreement with the determination of fault will be deemed to be a confirmation of Seller's acceptance of nonconformance responsibility.
2.4 Boeing reserves the right to reject any root cause and/or corrective action determination provided by Seller, and may request subsequent investigation and/or corrective action to either Boeing or Seller-initiated corrective action requests. If Seller is late in responding to Boeing corrective action requests, or if Boeing requires subsequent corrective action, Boeing reserves the right to withhold acceptance of shipments either at source or destination until Seller corrective action is submitted to Boeing's satisfaction.
Control of Nonconforming Product. Establish and maintain documented procedure for the identification, documentation, evaluation, segregation and for notification to customer of a nonconforming product, and evaluate each nonconformance for its potential to exist in previously produced Items and notify purchase order holder and assigned Special Process Quality Engineer, in writing, within 24 hours of potential or verified non-conformances on Items in transit or delivered. Notification shall include the concise description of discrepancy, parts and serial numbers affected, lot numbers, delivered quantities, and delivery dates, and maintain records of all nonconforming material, assignable causes, corrective actions, and effectiveness of corrective actions for the contractual period specified, and Ensure disposition authority is limited to rework to engineering or return to customer.
Control of Nonconforming Product. 5.8.1 The turnkey supplier shall establish and maintain documented procedures to ensure that product that does not conform to the requirements specified in this document, is prevented from unintended use. This control shall provide for identification, documentation, evaluation, segregation, and disposition of nonconforming product.
Control of Nonconforming Product. 4.18.01 If Cadence suspects non-conforming product has been or may have been shipped to Alimera’s CMO, Cadence shall contact Alimera’s QA Department within one (1) business day. Review Submit All
Control of Nonconforming Product. Nonconforming goods and/or services which deviate from the requirements as specified on the purchase order/contract and relevant drawings and specifications must be documented by the Seller and submitted to the Winchester Interconnect Buyer for consideration and disposition. Non-conforming products shall not be shipped to Winchester Interconnect until authorized by a Winchester Interconnect Buyer/representative and must be identified with authorizing nonconformance document when shipped. If Winchester Interconnect authorizes a deviation, the supplier must maintain a record of the expiration date, quantity and condition and insure compliance with the original or superseding specification when the deviation expires. At no point is it authorized for a supplier to send product to Winchester Interconnect which does not meet the engineering requirements (nonconforming product), without first going through the deviation request process. In the event nonconforming material is identified at the supplier facility, it is immediately quarantine in a designated area pending verification. If Winchester Interconnect may have received the nonconforming material, then the supplier is required to notify Winchester Interconnect of the nonconformance within one business day for appropriate action.
