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 Chapter 7



It is the policy of NRMRL that systematic planning shall occur for all NRMRL research products. Depending on the scope of research, as well as on any contractual or Agency requirements, planning documents (including QAPPs) appropriate to the scope are developed. The NRMRL DQA and Division QAMs participate in NRMRL and Divisional planning meetings as directed by senior management.

NRMRL has established minimum QAPP requirements for various research types (see Appendix B). As described in Chapter 2, a graded approach is in place, and is used for both intramural and extramural activities. The overall intent is to allow flexibility, while still meeting NRMRL's interpretation of Agency policy for QA.

Effective quality planning requires clear identification of project goals and intended use of data. The EPA TLP for the project in consultation with project participants, and division QA personnel as needed, determines the appropriate QAPP requirements to be used.

The process for identifying the QA requirements for extramural projects was described in Chapter 4 of this QMP. The Management Controls presented in Appendix A require the generation of a project tracking list by each branch for all their TLPs and includes both intramural and extramural projects. This tracking list is reviewed and updated every six months to ensure that all projects are identified. This procedure helps to ensure that all projects are identified and have appropriate documentation of their systematic planning process. For intramural projects, the Quality Assurance Review Form (Appendix D) is also used to document the QA requirements.

It is the NRMRL TLP's responsibility to identify and involve any and all appropriate sponsoring organizations, responsible official(s), project personnel, stakeholders, scientific experts, etc. (e.g., all customers and suppliers) in the planning of the project. This is true for both intramural and extramural projects. Once the planning is complete, project documentation should include (at a minimum) a complete description of the following:

  • the project's goals, objectives, questions, and issues to be addressed,
  • the project's schedule, resources (including budget), milestones, and any applicable requirements (e.g., regulatory requirements, contractual requirements),
  • the type of data needed and how the data will be used to support the project's objectives,
  • the quantity of data needed and the specification of performance criteria for measuring data quality,
  • how, when, and where the data will be obtained (including existing data) and identification of any constraints on data collection,
  • specifications of needed QA/QC activities to assess the quality performance criteria (e.g., QC samples for both the field and laboratory, audits, technical assessments, performance evaluations, etc.), and
  • how the acquired samples will be analyzed (either in the field or the laboratory), evaluated (i.e., QA review, validation, verification), and assessed against the quality performance criteria and for its intended use.
Once all project planning is complete and documented, it is the NRMRL TLP's responsibility to submit the QAPP to the designated QA Manager within each Division. The QA manager performs a review against QAPP requirements and issues documentation to indicate whether planning requirements have been met and an assessment of whether project goals can be met. The documentation from the QA manager shall include either an approval or a non approval. Approval shall include concurrence by the TLP's Branch Chief as indicated by their signature on the QAPP signature page or the document indicating approval by the QAM. In the case of non approval, detailed review comments shall be provided to the TLP. Resolution of all findings shall be accomplished and documented before any research is started.

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