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R9 Laboratory SOP 820
QUALITY ASSURANCE CORRECTIVE ACTION PROCEDURES
Summary
This procedure applies to all work performed in the EPA Region 9 Laboratory, by ESAT or EPA personnel, and all laboratory personnel can use this procedure to initiate corrective actions related to quality assurance issues. This procedure does not include safety, environmental compliance, or facilities matters which are covered under seperate procedures, nor does it include corrective actions taken during analyses when quality control standards or samples do not meet method requirements. Problems with quality control standards or samples during analyses are addressed immediately and documented in the laboratory logs and/or data package. These procedures are covered in the respective analytical SOPs. However, if a particular problem associated with quality control samples or standards persists, a corrective action process as outlined in this SOP would be appropriate. Corrective actions shall be initiated and resolved as soon as practicable after discovery of a problem.
In order to insure production of data of the required quality, control of the entire data generation process must be maintained. "Control" can be defined as the process of maintaining system operation, integrity, and output within specified limits, and proper documentation of the operations. These limits are specified in the methods, SOPs, Quality Assurance Plan and include what are generally accepted good laboratory practice standards. When loss of control occurs or indications are that it is in danger of being lost, the initiation and documentation of corrective actions is necessary to restore control or prevent loss of control. Loss of control does not have to occur for corrective actions to be initiated. A laboratory corrective actions data base has been created to facilitate initiation and documentation of actions taken when these types of quality assurance issues arise. All laboratory personnel are responsible for ensuring that systems remain in control and initiating corrective actions when loss of control is indicated, so access to the data base is available to all. The corrective action report and subsequent actions are monitored by the Laboratory Quality Assurance Officer who ultimately signs off when the corrective actions are completed. Systems are continuously monitored for indications of loss of control.