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.
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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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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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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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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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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