Common use of Quality Assurance Testing, Inspection and Acceptance Clause in Contracts

Quality Assurance Testing, Inspection and Acceptance. The Supplier may furnish and deliver commodities as stated in Section 3 and Annexes incorporated hereto, and any approved Orders hereunder, and the Supplier shall comply with quality assurance testing, inspection, and acceptance terms for the applicable commodity category below: A. The Supplier shall coordinate with a third-party QA contractor, either the USAID identified and funded GHSC-QA contractor (“GHSC-QA”) or a third-party identified by Chemonics (“GHSC-PSM QA”), during implementation of this BOA, the applicable Annex, and any resulting Order(s) and shall implement QA testing, Goods inspection and acceptance within the terms and conditions herein and as specified in the Order issued hereunder. The Supplier shall provide the required sample quantities provided for each relevant line on each Order placed. The required sample quantities are to be provided in addition to the quantities requested on each Order. Chemonics is not responsible for the payment of any products used for sampling or testing. B. The Supplier shall only deliver and tender for acceptance of those Goods that strictly conform to the requirements specified in the BOA, the applicable Annex, and resulting Order. Chemonics, GHSC- QA, and/or GHSC-PSM QA shall have the right to sample, inspect, and test the Goods at the time(s) and location(s) indicated in the BOA, the applicable Annex or Orders issued hereunder, or at any other time at the request of Chemonics, GHSC-QA, and/or GHSC-PSM QA. C. If any Goods inspection or test is made by or on behalf of Chemonics, GHSC-QA, and/or the GHSC- PSM QA on the premises of the Supplier, the Supplier shall provide all reasonable facilities for such sampling, inspection and testing of Goods at no cost to Chemonics, GHSC-QA, and/or GHSC-PSM QA or their inspectors in the performance of their duties to complete sampling. If the shipping of samples is requested, GHSC-QA covers the shipping costs (but not the costs of the samples themselves). The Supplier shall ship the samples using GHSC-QA’s DHL account number which will be provided upon request. D. Chemonics in collaboration with GHSC-QA and/or GHSC-PSM QA will use its best efforts to complete sampling, testing and inspection of Goods as promptly as possible after the Goods are made available. E. Chemonics, GHSC-QA, and/or GHSC-PSM QA will notify the Supplier in writing of the names of any inspectors or inspection firms. It is understood that inspection or testing shall not in any way release the Supplier from any warranty or other obligations under this BOA, the applicable Annex, and the Order. F. The Supplier shall provide Chemonics, GHSC-QA, and/or GHSC-PSM QA all information and documentation reasonably requested and shall render any other assistance reasonably requested, to enable Chemonics, GHSC-QA, and/or GHSC-PSM QA to: (1) Obtain from any regulatory authority authorization to import or waiver. (2) Comply with any of its legal, regulatory and/or contractual obligations or any request by any regulatory authority; and (3) Determine whether the services have been performed in accordance with the BOA, the applicable Annex, and the Order. G. The Supplier shall notify Chemonics, GHSC-QA via XXXXXX@xxx000.xxx, and/or GHSC-PSM QA via XXXXX@xxxx-xxx.xxx of any significant changes that may affect significantly the aspects of specification and attribute, quality, safety and efficacy and regulatory status of the eligible product, including changes of the manufacturing and testing methodology or compliance with current good manufacturing practices and processes/methods. The Supplier shall coordinate significant changes with Chemonics, GHSC-QA via XXXXXX@xxx000.xxx, and/or GHSC-PSM QA via XXXXX@xxxx.xxx and provide information and documentation reasonably requested to document regulatory approvals when appropriate. H. Once commodities have been delivered to the delivery point by the Supplier, Chemonics and/or its designated agent shall inspect the commodities to confirm compliance with the BOA, the applicable Annex, and the Order requirements, including source compliance. Copies of any international shipping documents for all commodities will be required to verify the source of the commodities. If the commodities are compliant with the BOA, the applicable Annex, and the Order requirements, an inspection certificate will be issued by Chemonics. In the event that the commodities are not fully compliant, the Supplier shall be required to remedy any defects or faults prior to acceptance by Chemonics. I. Chemonics, GHSC-QA, and/or GHSC-PSM QA may conduct site audits on a routine basis to ensure compliance with international standards when deemed necessary but will provide the Supplier with notice. Additionally, any systematic or isolated non-conformance or compliance gap that may directly or indirectly affect patient safety, product quality, purity, efficacy, integrity, or where there is a data integrity, validity of data and/or an ethical violation shall be considered a significant finding under this BOA. In the event that the Supplier, Chemonics, GHSC-QA, and/or GHSC-PSM QA become aware of any issue that could meet the definition of “significant” and substantially affect data integrity, patient safety and/or product quality for commodities supplied under this BOA, Chemonics, GHSC-QA, and/or GHSC-PSM QA, shall be entitled to perform audits. In the event that the Supplier becomes aware of any incident that may directly or indirectly affect patient safety, product quality, purity, efficacy, integrity, or where there is a data integrity, validity of data and/or an ethical violation, related to a commodity supplied hereunder, the incident will be reported to Chemonics, GHSC-QA via XXXXXX@xxx000.xxx, and/or GHSC-PSM QA via XXXXX@xxxx-xxx.xxx within two (2) working days of awareness. The Supplier shall complete an investigation or provide a status report and issue a written report, approved by the designated quality personnel of the Supplier, within twenty (20) business days after the Supplier has been informed or becomes aware of the incident. Subsequent report due date will be set if a status report is provided. Chemonics, GHSC-QA, and/or GHSC-PSM QA may work together with the Supplier to resolve concerns related to commodities supplied hereunder. Chemonics, GHSC-QA, and/or GHSC-PSM QA reserve the right to review the investigation report related to commodities supplied hereunder. J. The Supplier shall notify Chemonics, GHSC-QA, and/or GHSC-PSM QA in the event of a Regulatory Authority inspection (e.g., US Food and Drug Administration, European Medicines Agency or any local equivalent thereof) at the manufacturing sites for the products within seventy-two (72 hours) of confirmation of the inspection dates. The Supplier shall keep Chemonics, GHSC-QA, and/or GHSC- PSM QA apprised of the outcome of any inspection and shall provide a copy of any written report or comments, whether written or oral, issued by the Regulatory Authority in connection with, or as a result of, the Regulatory Authority inspection within five (5) days of the Supplier’s receipt. In all circumstances where a warning letter is issued by the Regulatory Authority, the Supplier shall provide a copy within forty-eight (48) hours of such letter to Chemonics, GHSC-QA via XXXXXX@xxx000.xxx, and/or GHSC-PSM QA via XXXXX@xxxx-xxx.xxx. Chemonics, GHSC-QA, and/or GHSC-PSM QA shall have the right to request to review any responses, whether written or oral, provided by the Supplier to the Regulatory Authority in response to inspection results if such responses concern the commodities supplied hereunder. K. Chemonics may, at its sole discretion (1) require the Supplier to repair or replace any nonconforming Goods, or re-perform any nonconforming Services, at no increase in the Price, and with all additional costs, including those arising from the handling, storing and disposition of the non-conforming Goods and the sampling, inspection and testing of replacement Goods shall be the responsibility of the Supplier; and/or (2) exercise any other rights and remedies available to it under the BOA, the applicable Annex, and the Order, or under applicable law and regulation, including, but not limited to, termination of the BOA, the applicable Annex, and/or the Order, call of performance security, and/or assessment of excess re-procurement and other resulting costs. Chemonics will use its best efforts to exercise the foregoing rights within a reasonable time after a non-conformity is discovered and, to the maximum extent practicable, before any substantial change occurs in the condition of the non-conforming Goods, unless such change is due to their non-conformity. L. Without prejudice to the foregoing, FAR 52.246-2, INSPECTION OF SUPPLIES -- FIXED-PRICE (AUG 1996), and FAR 52.246-16, RESPONSIBILITY FOR SUPPLIES (APR 1984), shall apply to the BOA. Pursuant to these provisions— If/when deemed necessary and appropriate, Chemonics GHSC-QA, and/or GHSC-PSM QA may, by written notice to the Supplier, require pre-delivery sampling, inspection and testing of the Goods including, without limitation, physical inspections of the production, warehousing and other facilities involved, the product packaging and labeling; inspection and review of manufacturing records, Certificates of Analysis, analytical reports and documentation; and product sampling and testing by an independent testing facility. In such cases, the Supplier will cooperate fully with Chemonics, GHSC-QA, and/or GHSC-PSM QA, the Sampling Agent and the testing facility and take such steps and supply such information as may be needed in the Order to ensure timely and effective QA. Only Goods that have successfully passed testing may be deemed to be acceptable for delivery. Chemonics, GHSC-QA, and/or GHSC-PSM QA may also direct post-delivery sampling, testing, and/or inspection of the Goods at any point in the chain of supply and distribution when it deems such action to be in the best interests of the Government. The Supplier will fully cooperate with such measures as well. Prompt removal and replacement or correction (as applicable), for purposes of FAR 52.246-2 (g) and (h) shall be deemed, unless otherwise subsequently agreed by Chemonics, to mean ten (10) business days after receiving notification of rejection of Goods or Services. M. If delivery of the Goods (or, with respect to INCOTERMS 2020, issues of a Notice of Availability), is not completed by the required date, or if performance of any Services pursuant to the BOA, applicable Annex, and resulting Order is not completed by the due date (if any) specified, due to any default or delay of the Supplier (including without limitation any default by the suppliers, sub-vendors or suppliers), Chemonics shall be entitled to deduct from payment(s) otherwise due to the Supplier any additional costs of sampling, testing, and inspection caused by such default or delay. Should such default or delay cause an inspection or testing firm to undertake additional inspections or tests, Chemonics shall be entitled, in addition and without prejudice to any other remedies available under or in connection with the BOA to deduct the related costs, along with any additional Sampling Agent charges from any further payment(s) to the Supplier, or, if such payment(s) remain available, to demand or receive a refund from the Supplier.