Quality Assurance and Quality Control Clause Samples

Quality Assurance and Quality Control. 3.3.1 Promptly after the Effective Date, the Contractor shall provide quality assurance and quality control systems and quality plans for approval by the Corporation. Such systems and plans shall be in accordance with good industry practice and Field quality plans given in Schedule-II (Appendix-IV- technical specification). 3.3.2 The Contractor shall ensure, and shall procure that its sub-contractors ensure, that the Work is carried out in accordance with the quality assurance and quality control systems and quality plans approved in writing by the Corporation and any other quality assurance and quality control systems and quality plans provided to the Contractor by the Corporation. 3.3.3 All works under or in course of execution or executed in pursuance of the contract, shall at all times be open and accessible to the inspection and supervision of the Corporation and/or his authorized officers- in- charge of the work and all the superior officers, officer of the Quality Assurance Unit of the Department or any organization engaged by the Department for Quality Assurance and of the Chief Technical Examiner’s Office and the contractor shall, at all times, during the usual working hours and at all other times at which reasonable notice of the visit of such officers has been given to the contractor, either himself be present to receive orders and instructions or have a responsible agent, duly accredited in writing, present for that purpose. Orders given to the Contractor’s agent shall be considered to have the same force as if they had been given to the contractor himself. 3.3.4 If it shall appear to the Corporation or his authorized subordinates , Chief Engineer and or Other Engineers in his Office of Quality Assurance or his subordinate officers or the officers of the organization engaged by the Department for Quality Assurance or to the Chief Technical Examiner or his subordinate officers, that any work has been executed with unsound, imperfect or unskillful workmanship or with materials or articles provided by him for the execution of the work which are unsound or of a quality inferior to that contracted or otherwise not in accordance with the contract, the Contractor shall, on demand in writing which shall be made within six months (three months in the case of work costing Rs. 10 Lac and below except roadwork) of the completion of the work from the Corporation specifying the work, materials or articles complained of notwithstanding that the same may have ...

Quality Assurance and Quality Control. The quality control exercised by Seller in its manufacture of the Liquefaction Train System shall be in accordance with the standards set forth in Appendix E (Quality Assurance and Quality Control).

Quality Assurance and Quality Control. In addition to compliance with this Agreement, each Party shall fulfil its responsibilities as set out in the Quality Agreement. Subject always to the provisions of the Quality Agreement, ▇▇▇▇▇▇▇▇▇▇ will not make any modification to the Manufacturing Description (as validated), any other Specification, raw materials, components, or testing without the written consent of Dyax.

Quality Assurance and Quality Control. 1) The Contractor shall maintain a written Quality Assurance and Quality Control (QA/QC) program capable of demonstrating that data has a specified degree of reliability. An acceptable QA/QC Program would be one patterned after a publication such as, the "Handbook for Analytical Quality Control in Water and Wastewater Laboratories", USEPA 600/4-79-019. The Contractor must be able to validate each method used and each analysis performed by that method using the QA/QC Program. 2) The Contractor shall maintain and document continual evaluation of the accuracy and precision of an analytical procedure and the ability of individual analysts to meet laboratory performance for an analytical method or procedure. 3) The Contractor shall participate in the US EPA's Water Supply (WS) Performance Evaluation study or other acceptable Performance Evaluation Studies. 4) The Contractor shall maintain proper sample chain-of-custody procedures. Sample analysis must begin within the holding time. Payment will not be authorized for samples analyzed outside of method holding times unless directed by IDEM/OWQ Quality Assurance Officer. 5) Table 1 specifies the IDEM’s data quality assessment or levels (DQA) for sampling, chain- of-custody, Contractor analyses, and reporting. The Contractor shall process the IDEM samples at data quality assessment 4 (DQA4) unless specified in a Task or authorized by IDEM staff prior to analysis by the Contractor. 6) The Contractor must maintain all QA/QC documentation for five (5) years after the expiration date of this contract and made available for the use of IDEM/OWQ upon request. Table C1. Data Quality Assessment Levels DQA Level Data Type Description 1 Screening Data The results are usually generated onsite and have no QC checks. Analytical results, which have no QC checks or no precision or accuracy information or no detection limit calculations, but just numbers, are included in this category. Primarily, onsite data are used for pre-surveys and for preliminary rapid assessment. 2 Field Analysis Data Data is recorded in the field or laboratory on calibrated or standardized equipment. Field duplicates are measured on a regular periodic basis. Calculations may be done in the field or later at the office. Analytical results, which have limited QC checks, are included in this category. Detection limits and ranges have been set for each analysis. The QC checks information for field or laboratory results is useable for estimating precision, accur...

Quality Assurance and Quality Control. The Study Sponsor will secure agreement from all involved parties to ensure direct access to all study related sites, source data and documents, and reports for the purpose of monitoring and auditing by the Study Sponsor, and inspection by domestic and foreign regulatory authorities. Quality control will be applied to each stage of data handling to ensure that all data are reliable and have been processed correctly. Agreements made by the Study Sponsor with the Investigator/Institution and any other parties involved in the clinical study will be provided in writing as part of the protocol or as a separate agreement.

Quality Assurance and Quality Control. 3.3.1 Promptly after the Effective Date, the Contractor shall provide quality assurance and quality control systems and quality plans for approval by the Corporation. Such systems and plans shall be in accordance with good industry practice and Field quality plans given in Schedule-II (Appendix-IV- technical specification).

Quality Assurance and Quality Control. The Engineer shall provide peer review at all levels. For each deliverable, the Engineer shall have some evidence of their internal review and mark-up of that deliverable as preparation for submittal. A milestone submittal is not considered complete unless the required milestone documents and associated internal red-line mark-ups are submitted. The State’s project manager will require the Engineer to submit the Engineer’s internal mark-up (red-lines) or comments developed as part the Engineer’s quality control step. When internal mark-ups are requested by the State in advance, the State, at its sole discretion, may reject the actual deliverable should the Engineer fail to provide the evidence of quality control. The Engineer shall clearly label each document submitted for quality assurance as an internal mark-up document.

Quality Assurance and Quality Control. In addition to compliance with this Agreement, each Party shall fulfil its responsibilities as set out in the Quality Agreement. Subject always to the provisions of the Quality Agreement, ▇▇▇▇ will not knowingly make any modification to the Master Batch Record as validated), any other Specification, raw materials, components, or testing without the written consent of Dyax. ▇▇▇▇ agrees to inform Dyax within [*****] days of the result of any regulatory development or changes to Product Specifications that materially affect the Production of the Product. ▇▇▇▇ shall notify Dyax of and require written approval from Dyax for changes to Master Batch Records and Product Specifications prior to the Production of subsequent Batches of Product.

Quality Assurance and Quality Control. 6.1 Where Regulatory Inspections or PURCHASER audits identify quality and compliance issues SUPPLIER shall agree to implement corrective and preventative action. 6.2 SUPPLIER shall notify PURCHASER of any regulatory inspections that are announced that may directly or indirectly impact on the PRODUCTS supplied to the PURCHASER. SUPPLIER shall inform PURCHASER of adverse observations from such inspections that may directly or indirectly impact on the PRODUCTS supplied to PURCHASER . SUPPLIER shall review any responses to Regulatory Authorities with the PURCHASER that may directly or indirectly impact on the PRODUCTS prior to submission to the Regulatory Authorities by SUPPLIER. 6.3 SUPPLIER is responsible for the quality control of the PRODUCTS, including testing, documentation review, retention of samples and producing required documentation as defined in cGMPs. 6.4 SUPPLIER shall, where required, develop internal control limits in coordination and agreement with PURCHASER including limits, that support the expiry period of the PRODUCTS in the Details. Where these internal control limits are agreed, batches failing the internal control limits shall not be shipped to PURCHASER until the SUPPLIER conducts and appropriate investigation and the outcome accepted by the PURCHASER. 6.5 SUPPLIER shall supply an agreed Certificate of Analysis (COA) as defined in Appendix 6, and an agreed Certificate of Compliance (COC) as defined in Appendix 7 for PRODUCTS indicating that the batch complies with all agreed specifications and cGMPs prior to dispatch for review and assessment by the PURCHASER. 6.6 PURCHASER shall review and access Certificate of Analysis (COA) and Certificate of Conformance (COC). 6.7 PURCHASER shall confirm the identity of PRODUCTS within 60 days of receipt of PRODUCTS from SUPPLIER . PURCHASER shall undertake any additional tests, as PURCHASER deems appropriate. 6.8 SUPPLIER shall investigate all non-conformities, deviations and out of specification (OOS) results in accordance with cGMPs and shall inform the PURCHASER of the outcome of investigations. 6.9 SUPPLIER shall inform PURCHASER of any incidents that may affect conformance of the PRODUCT to the Specifications. 6.10 SUPPLIER shall retain batch documentation for 5 years. 6.11 SUPPLIER shall retain retention samples from each batch of the PRODUCTS and starting materials in accordance with cGMPs. For the subsequent stages that are conducted at the PURCHASER’s facility, PURCHASER shall retain ret...