REMOVAL_1995 - Laserfiche WebLink

Home Browse Search

Access to archived information should be controlled to maintain the integrity of the data. Procedures should be developed to identify those lJ individuals with access to the data. 2.7 ORGANIZATION PERFORMING FIELD OR LABORATORY OPERATIONS Proper design and structure of the organization facilitates effective and efficient transfer of information and helps to prevent important procedures from being overlooked. The organizational structure, functional responsibilities, levels of authority, job descriptions, and lines of communication for all project activities should tie established and documented. One person may cover more than one organizational function. Each project participant should have a clear understanding of his or her duties and responsibilities and the relationship of those responsibilities to the overall data collection effort. The management of each organization participating in a project involving data collection activities should establish that organization's operational and QA policies. This information should be documented in the QAPjP. The management should ensure that (1) the appropriate methodologies are followed as documented in the QAPjPs; (2) personnel clearly understand their duties and responsibilities; (3) each staff member has access to appropriate project documents; (4) any deviations from the QAPjP are communicated to the project management and documented; and (5) communication occurs between the field, laboratory, and project management, as specified in the QAPjP. In addition, each organization should ensure that their activities do not increase the risk to humans or the environment at or about the project location. Certain projects may require specific policies or a Health and Safety Plan to provide this assurance. The management of the participating field or laboratory organization should establish personnel qualifications and training requirements for the project. Each person participating in the project should have the education, training, technical knowledge, and experience, or a combination thereof, to enable that individual to perform assigned functions. Training should be provided for each staff member as necessary to perform their functions properly. Personnel qualifications should be documented in terms of education, exper-ience, and training, and periodically reviewed to ensure adequacy to current responsibilities. Each participating field organization or laboratory organization should have a designated QA function (i .e. , a team or individual trained in QA) to monitor operations to ensure that the equipment, personnel , activities, procedures, and documentation conform with the QAPjP. To the extent possible, the QA monitoring function should be entirely separate from, and independent of, personnel engaged in the work being monitored. The QA function should be responsible for the QA review. ONE - 4 Revision 1 July 1992 1