Chapter 5

Documentation and Records

QMPs, QAPPs, Facility Manuals, and SOPs are prepared, reviewed, approved, issued, used, and revised. As described in Chapter 2, Chapter 7, and Chapter 8, all these documents, including revisions, must be reviewed for conformance with the quality system requirements and approved by authorized personnel before general use.

The following is a discussion of NRMRL procedures for documents and records, including computer-resident records. Records shall be maintained by the TLP so that all NRMRL research activities can be reconstructed.

ORD Policy 13.2 "Paper Laboratory Records" has additional requirements.

5.1 EPA Records Management Policy

EPA Records Management Policy (EPA 2161 is established by Office of Environmental Information and documented in the EPA Records Management Manual 2160. This procedure applies to all records, as defined under the Federal Records Act (44 U.S.C. 3101), regardless of media (including paper, microform, electronic, audiovisual, and record copies of Agency publications). All locations of NRMRL comply with

The management process that ensures that records accurately reflect completed work and/or fulfill statutory and contractual requirements, including any specific record keeping requirements is defined in EPA Directives 2160 and 2161. These documents define requirements and responsibilities for record transmittal, distribution, retention, protection, preservation, traceability, disposition, and retrievability and include the roles and responsibilities for management and staff. Following these EPA Directives ensures compliance with all statutory, contractual, and assistance agreement requirements for records from environmental programs and provides adequate preservation of key records necessary to support the mission of the organization. NRMRL has a designated Records Management Officer and each Division/location has a person designated as the Records Management Liaison.

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5.2 Project Documentation and Records

The official records and documentation developed on a project-specific basis (the project file) is the responsibility of the EPA Technical Lead Person for that project and is subject to EPA records management policy. The two Record Schedules most commonly used for ORD projects are 501 and 503. Schedule 501 (applicable to QA Category I and II projects) requires permanent retention and is used for project files of all scientific research projects conducted by Agency personnel in the ORD laboratories that directly support rule-making, enforcement, regulatory, or policy decisions and research of high programmatic relevance which, in conjunction with other ongoing or planned studies, is expected to provide support of Agency rule-making, regulatory, or policy decisions. Also included is research of significant national interest, such as projects that might be monitored by the Administrator, or technology transfer projects that may be critical to the award of a patent or other important commercial or legal decision. Schedule 503 (applicable to QA Category III and IV projects) requires retention for twenty years and is used for projects conducted by Agency personnel in the ORD laboratories that provide demonstration or proof of concept projects such as method validation studies, and basic, exploratory, conceptual research to study basic phenomena or issues. Includes characterization of health or ecological mechanisms and/or endpoints in order to improve the understanding of the interaction of environmental compounds, conditions, or processes with human and other life forms; and also includes the development of assays or methods for detecting or estimating the influence of a particular environmental agent on a specific health or ecological endpoint. The level of QA documentation required is dependent upon the type and QA Category of the project as determined by the graded approach discussed in Section 2.1 of this QMP. Any specific requirements should be identified in the project QAPP. When a project is completed as determined by the TLP, the project file is eligible for archiving. This is accomplished by the TLP in conjunction with the Division's Records Liaison.

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5.3 Research Laboratory-Specific Documentation and Records

Documentation and records that may not be directly applicable to individual projects, (e.g., refrigerator temperature logbooks, instrument logbooks, standard preparation logbooks, balance calibration logbooks) are maintained in the location where they are used. The most generally applicable Record Schedule is 502. Schedule 502 requires retention for five years and is applicable to notebooks or logs kept by scientists in the course of performing routine, non-programmatic activities such as maintenance of equipment and excludes laboratory notebooks related to scientific research projects that are covered by EPA 501 for projects related to rulemaking and EPA 503 for projects related to basic, exploratory research. Pages from these general logbooks should be copied and placed in the project file. All staff using the equipment or preparing standards are responsible for recording the appropriate information. When the logbooks are full or no longer needed, the logbooks or outdated SOPs are turned over to Records Liaison for appropriate retention, storage, and disposition. (For more details, see ORD Policy 13.2 Paper Laboratory Records. Research notebooks are the responsibility of the individual researcher. ORD policy 13.2 covers the requirements for research notebooks.

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5.4 Software Documentation and Records

NRMRL is required to maintain software quality documentation and records consistent with EPA Office of Environmental Information Policy. ORD's Policy can be found in Chapter 9.

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5.5 NRMRL Quality Documentation and Records

NRMRL policy is that quality system documents (e.g., the NRMRL QMP and other laboratory/division specific QA documents) developed directly by the NRMRL DQA, Division QAMs, or at the direction of the QAMs shall be controlled by NRMRL or Division QA Offices. Although the Division QAM may keep copies, records of reviews of QMPs, QAPPs, Facility Manuals, SOPs, final reports, journal articles, internal audit reports, etc., are the responsibility of the TLP. The Agency is in the process of developing standards for electronic data storage as part of the EPA Enterprise Architecture. This QMP will reference and provide a link to those standards when they are approved.

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