Corrective Action Reports Sample Clauses

Corrective Action Reports. A corrective action is the process that occurs when the result of an audit or quality control measurement is shown to be unsatisfactory, as defined by the data quality objectives or by the measurement objectives for each task. The corrective action process involves the Task Leader, the Project Manager, and the Task QA Officer. In cases involving the analytical process, the corrective action will also involve the analyst. A written report (Figure 7) is required on all corrective actions. Since the tasks of this study involve a validation process to ensure data quality for pollution control technologies, predetermined limits for the data acceptability have been established in the measurement and data quality objectives. Therefore, data determined to deviate from these objectives require evaluation through an immediate corrective action process. Immediate corrective action responds quickly to improper procedures, indications of malfunctioning equipment, or suspicious data. The analyst as a result of calibration checks and internal quality control sample analyses will most frequently identify the need for such an action. The Task Leader will be notified of the problem immediately. The Task Leader will then take and document appropriate action. The Task Leader is responsible for and is authorized to halt the work if it is determined that a serious problem exists. The Task Leader is responsible for and is authorized to implement any procedures to prevent the recurrence of problems.

Corrective Action Reports. The CAR, at a minimum, shall include the date of failure, item, lot number and size, detailed failure description, failure analysis to identify the root cause for the failure, failure history, proposed corrective action and validation plan to assess the effectiveness of the corrective action, and proposed disposition of the failed item and lot, and containment actions. Containment will address all suspect products, including end items in plant and already delivered to the Government as well as material work in process, at receiving, or in transit. The CAR shall identify why the defect was not detected, impact to similar product or processes, and the process controls in place or planned to prevent the problem from recurring. The Government may not accept product at any time while the CAR is pending based on the impact of the failure in question. The CAR shall not be considered closed until the Government has concurred on the report. Concurrence by the Government is required prior to shipment of any potentially affected production units. Failures occurring during Government conducted testing are subject to this requirement.