r8 qa training annual qapp review sept 20121r8 qa training - qapp annual reviews
TRANSCRIPT
R8 QA Training - QAPP Annual Reviews 1
R8 QA Training Annual QAPP Review
Sept 2012
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 isProcess for QAPP Annual Reviews
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CIO 2105.0* (formally 5360.1) (approved 5/5/2000)
CIO 2105P* (Quality Manual for Environmental Program)
Policy for a mandatory Quality System for all environmental programs performed by 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/).
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• The QMP describes processes and procedures at the organizational level, management and staff functional responsibilities and line of authority. Include all QMP 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 all QAPP elements (QA/R-5 and QA/G-5).
• The Field Sampling Plan (FSP) provides the field sampling details for the sampling event(s).
• The Sampling 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)
SOPs
FSPs/SAPs
QAPP
Putting it all together…
QA Document Types
QMP
Organization
Project
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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.
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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
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A QAPP is a living documentMake changes to the QAPP before activity is conductedSuggest 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
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Defining Significant and Not Significant Changes for Conducting Annual ReviewsNot 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)Sept 2012
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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:
Annual Region 8 QAPP 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/).
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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/).
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How to Reach the Region 8 QA Staff• Regional QA Program Director
– Linda Himmelbauer, 303-312-6020, [email protected]
• QA Staff• Tom Brooks, 303-312-7291, [email protected]• Jennifer Berig, 303-312-6262, berig,[email protected] • Mary Goldade, 303-312-7024, [email protected]• Lee Hanley, 303-312-6555, [email protected] (lead for annual reviews)
• Bill Monson, 303-312-6985, [email protected]• Jeff Pritt, 303-312-7077, [email protected]
Sept 2012