Appendix A

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.

Policy

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:

1. 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;
2. promoting (by words, actions, and involvement) the NRMRL quality system;
3. promoting (by words, actions, and involvement) continuous quality improvement within NRMRL;
4. providing facilities that are conducive to the production of data of known and appropriate quality to meet the needs of the research being conducted;
5. providing adequate resources (including full-time equivalents [FTE], contractor support, and travel) for the operation of the NRMRL quality system within their management unit;
6. 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;
7. 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);
8. the Director of Quality Assurance (DQA) will be the decision maker on unresolved quality issues within NRMRL that are not resolved at the division level.

Management Control

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.

Ramifications

1. 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.
2. 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.
3. 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 were collected.
4. 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).
5. 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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