Management Controls to Track and Ensure Implementation of
NRMRL's Quality System
Management Controls to track and ensure consistent
implementation of NRMRL's quality system (August 30, 2006)
The implementation of the quality system is a management function that requires
consistent and persistent oversight by line management. In order to ensure that
all scientific research conducted by or for NRMRL is compliant with the agency's
quality policies, line management must identify all research projects and insist
that they are conducted in accordance with the NRMRL's QMP and other agency
quality related policies, e.g., the EPA Order 5360.1 A2, Policy and Program
Requirements for the Mandatory Agency-wide Quality System, the EPA Quality
Manual for Environmental Programs 5360 A1, the information quality guidelines
(IQG's), EPA's Laboratory Competency Policy, peer review, ORD publication
clearance procedures, ORD Policies and Procedures for Quality Assurance, and
EPA's Records Management Policy and Guidance, EPA 2160. These policies are
the backbone of sound science within EPA in general and ORD in particular.
The NRMRL policy on quality assurance (QA) [as stated in NRMRL's QMP] is:
- to ensure that NRMRL meets EPA QA requirements as defined in EPA
Order 5360.1, A2 (or the most recent change to the Order);
- to implement a quality system that guides QA planning for individual
projects and QA reviews of all activities in NRMRL;
- to ensure that continuous improvement is practiced in the
implementation of the NRMRL quality system; and
- to ensure that adequate resources (including FTEs, contractor support,
and travel funds) are provided to implement the NRMRL QMP across the Laboratory.
The following are the basic QA responsibilities of all branch chiefs, all division directors,
and the Laboratory Director:
- ensuring that EPA quality policy is implemented in NRMRL by including
quality responsibilities in the performance standards of all NRMRL Division
Directors, Branch Chiefs, QA personnel, and Technical Lead Persons (TLPs)
as appropriate to their management unit or function;
- promoting (by words, actions, and involvement) the NRMRL quality
- promoting (by words, actions, and involvement) continuous quality
improvement within NRMRL;
- providing facilities that are conducive to the production of data
of known and appropriate quality to meet the needs of the research
- providing adequate resources (including full-time equivalents [FTE],
contractor support, and travel) for the operation of the NRMRL quality
system within their management unit;
- reviewing NRMRL quality planning documents (e.g., QMP, QAPPs, SOPs, etc.) as appropriate to their management unit; concurrence by the branch
chief with the approval by the QAM will be indicated by the signatures of
both on the approval form of the planning document;
- ensuring that research products distributed outside of NRMRL (i.e.,
published reports [both paper and electronic], journal articles,
symposium/conference papers, extended abstracts, and computer
products/software/models/databases) are reviewed by the QAM and
approved prior to distribution (research products shall be subjected
to QA review and ORD clearance procedures prior to being distributed
outside of NRMRL);
- the Director of Quality Assurance (DQA) will be the decision maker
on unresolved quality issues within NRMRL that are not resolved at the
To implement NRMRL's quality system on all environmental data collection/gathering
activities, it is necessary to identify all projects1 being conducted by or for
NRMRL and have a QAPP approved prior to the initiation2 of the project activities.
NRMRL's quality system applies to both intramural and extramural projects alike.
It applies to all contracts, cooperative agreements, grants, and interagency
agreements as well as intramural projects. Therefore, it is of primary
importance that all projects be identified and tracked with respect to QA
requirements. To help identify projects, especially intramural projects, each
division must document the procedure they use to evaluate, review, and select
new in-house research projects. To track all projects (intramural and
extramural), each branch chief will compile a list3 that will identify all
projects in the branch by the WAM/PI/TLP and other pertinent information. It
will be updated every six months and sent concurrently to the division director,
division QAM, and the NRMRL Director of Quality Assurance (DQA). The QAM will
discuss any potential issues (i.e. QAPPs not submitted for a project identified
on previous reports without any comment on the list identifying the reason(s),
projects with QAPPs submitted but not approved that span more than one reporting
period without appropriate notation) with the Division Director. The Division
Director will then forward the completed list (with his/her comments as necessary)
to Laboratory Director with a copy to the NRMRL DQA. The DQA will summarize the
annotated division reports for discussion with the Laboratory Director.
In addition, NRMRL's DQA will meet and discuss with the Laboratory Director the
Quality Assurance Annual Report and Work Plan (QAARWP) before it is submitted to
the Quality Staff. Special emphasis will be placed on the resources committed to
QA by each division relative to the number of FTEs, the number of projects and
the importance/complexity of the projects within the divisions.
- Conformance with the quality system as described in NRMRL's QMP
within a division, branch, or project, is necessary to receive a
performance rating of fully successful for the critical job element(s)
(CJE) with QA implications of the individual's (division director,
branch chief, or TLP) performance standards.
- Products containing data obtained without a specific approved
QAPP or distributed outside of NRMRL before receiving ORD Clearance
(which includes QA approval) cannot be used in promotion packages,
and no credit will be given to the branch or division for these products.
The QAPP must have been approved before reportable data collection
efforts were begun. All product packages must identify the QAPP under
which the data were collected.
- Project data obtained without an approved QAPP cannot be presented
at any symposium or meeting; therefore the project/data cannot be used
to justify travel to the meeting. All ORD Clearance Forms for conference
or symposium presentations must identify the QAPP under which the data
- Projects or products not complying with QA, Peer Review, and
Clearance policies cannot be used as part of an award nomination
(either S-award or STAA Award).
- Funding for projects will be withheld if QAPP approval is not
received prior to data collection including travel funds to field
sites for sample collection.
Appendix A: Footnotes
1 A project is a focused data collection/gathering
effort directed to address a specific problem or hypothesis that is intended to
result in a product which will be distributed outside of NRMRL. Each project as
defined needs its own identifiable QAPP.
2 For QA planning purposes, a research project
begins as soon as a TLP is prepared to collect/gather data for inclusion in
research product (e.g., report [both paper and electronic], journal article,
symposium/conference paper, extended abstract, computer product/software/model/database)
which will be distributed outside of NRMRL.
3 The details of the types of information to be
compiled are still being determined. It is proposed that the information include
(by branch and TLP) the project title, planned products, QA ID number,
QA Category, applicable NRMRL QAPP requirements (see Appendix B),
date of QAPP approval, date of QA approval of the product(s), and comments.
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