R8 QA Training

1. R8 QA Training Annual QAPP Review R8 QA Training - QAPP Annual Reviews

2. I’m QA Man. I’m here to help you with QAPP Annual Reviews. The outline for this presentation is: • Refresher of what a QAPP is • Process for QAPP Annual Reviews R8 QA Training - QAPP Annual Reviews

3. CIO 2105.0*(formally 5360.1) (approved 5/5/2000) CIO 2105P*(Quality Manual for Environmental Program) Policy for a mandatoryQuality System for all environmental programs performedby or directly for EPA through EPA-funded extramural agreements The Order is to ensure that environmental data obtained/collected by the Region or delegated State, Local and Tribal Governments are of sufficient quantity and adequate quality for their intended use and are used consistent with such intentions. *These documents can be found in the QA website (http://www.epa.gov/region8/qa/). R8 QA Training - QAPP Annual Reviews

4. QA Document Types • The QMP describes processes and procedures at the organizational level, management and staff functional responsibilities and line of authority. Include allQMP elements (QA/R-2). • The QAPP is the document that details the who, what, when, where, why and how of the project objectives (data quality objectives). Include allQAPP elements (QA/R-5 and QA/G-5). • TheField Sampling Plan (FSP) provides the field sampling details for the sampling event(s). • TheSampling and Analyses Plan (SAP)provides the field and analytical details for the sampling event(s). • Standard Operating Procedures (SOPs) describe specific procedures (e.g., sampling techniques or field analytical methodologies) used. These are attached to the approved QA Document(s). Note: • FSPs, SAPs, and SOPs are subsets of a QAPP • FSPs and SAPs may be addendums to a previously approved QAPP or a stand alone document, if all QAPP elements are included (QA/R-5 and QA/G-5) Organization QMP Putting it all together… Project QAPP FSPs/SAPs SOPs R8 QA Training - QAPP Annual Reviews

5. The QAPP • Is the“blueprint”for obtaining the type and quality of environmental information/data needed for the identified decision or use. • Provides the description of who is to do what, when, where, how, and why. • Must be complete, addressing all QAPP elements, regardless of project size. • REQUIRED for EPA funded projects on any information/data collection activity. • REQUIRED for every project generating environmental data including EPA conducted/directed projects. R8 QA Training - QAPP Annual Reviews

6. QAPPs must be reviewed at least annually* *CIO 2105-P-01-0 EPA QUALITY MANUAL FOR ENVIRONMENTAL PROGRAMS 5.2 QAPP Responsibilities and Application 5.2.2 QAPP Implementation and Revision R8 QA Training - QAPP Annual Reviews

7. A QAPP is a living document • Make changes to the QAPP before activity is conducted • Suggest maintaining a log of the changes throughout the year A QAPP or change in a QAPP must be approved prior to any data gathering work or use R8 QA Training - QAPP Annual Reviews

8. Defining Significant and Not Significant Changes for Conducting Annual Reviews Not Significant – no change of the data quality objectives • Examples include but are not limited to the following: • New sampling equipment replacing old equipment and no change in sampling procedures • Additional or new sampling location and no change in sampling procedures or data quality objectives • Change in staff or administration personnel or title and no change in overall direction or management of the project activities. Significant – any change in data quality objectives • Examples include but are not limited to the following : • Change in the Work Plan’s or Statement of Work’s direction or data collection • New parameter to be analyzed (analyzing metals now adding radionuclides) • New media to sample (sampling water now adding fish tissue sampling) • New sampling method ( approve method now adding/changing to alternative method) • Addition or deletion of a subset QA document (change to the FSP, SOP, SAP) R8 QA Training - QAPP Annual Reviews

9. Annual Review Process for QAPPs • Annual reviews must be documented • How to Document Review: If there are no significant changes: • The QAPP can be reviewed using the: • AnnualRegion 8QAPP Review Crosswalk* (a shortened version of the Region 8 QA Document Review Crosswalk)and • Annual QAPP Renewal* • Distribute this Crosswalk and approved Renewal to individuals listed in the originally signed QAPP • Note: the QAPP’s original cover page remains unchanged stating the project performance period (example: Oct 2011 to Sept 2015) *These documents can be found in the QA website (http://www.epa.gov/region8/qa/). R8 QA Training - QAPP Annual Reviews

10. Annual Review Process for QAPPs cont. If there are significant change(s): • A complete review of the QAPP must be conducted using the: • Region 8 QA Document Review Crosswalk • The complete revised QAPP is submitted for review and approval (with new signature page) • The original cover page may continue to state the project performance period (example: Oct 2011 to Sept 2015) if the overall project continues as originally planned These documents can be found in the QA website (http://www.epa.gov/region8/qa/). R8 QA Training - QAPP Annual Reviews

11. How to Reach the Region 8 QA Staff • Regional QA Program Director • Linda Himmelbauer, 303-312-6020, himmelbauer.linda@epa.gov • QA Staff • Tom Brooks, 303-312-7291, brooks.tom@epa.gov • Jennifer Berig, 303-312-6262, berig,jennifer@epa.gov • Mary Goldade, 303-312-7024, goldade.mary@epa.gov • Lee Hanley, 303-312-6555, hanley.lee@epa.gov(lead for annual reviews) • Bill Monson, 303-312-6985, monson.bill@epa.gov • Jeff Pritt, 303-312-7077, pritt.jeff@epa.gov R8 QA Training - QAPP Annual Reviews