Orientation to Quality Assurance A brief overview

Quality Assurance Team Region 7 Quality Assurance Team Diane Harris, RQAM 913-551-7258 Bob Nichols 913-551-7966 Leslye Werner 913-551-7858

Presentation Goals Review EPA QA Requirements Define Environmental Data Answer the question: What is a QAPP? Identify resources available for assistance

Agency Requirements ANSI/ASQ E4 – 2004 EPA Order 5360.1 A2 American National Standard Specifications and Guidelines for Quality Systems for Environmental Data Collection and Environmental Technology Programs Basis for EPA Quality System EPA Order 5360.1 A2 EPA Requirements Documents CFR References Contractors Grantees

When does QA Apply? “…all environmental programs performed by EPA or directly for EPA through EPA-funded extramural agreements shall be supported by individual quality systems…” EPA Order 5360.1 A2 Which means for P2 projects….

When does QA Apply? Any environmental data generation or use performed by or for EPA (i.e., paid for by EPA funds) requires an approved QA Project Plan prior to the start of the environmental data generation or use.

What is Environmental Data? EPA’s Official Definition: “Any measurements or information that describe environmental processes, location, or conditions; ecological or health effects and consequences; or the performance of environmental technology”

What is Environmental Data? For EPA, this includes environmental data: Collected directly from measurements Produced from models Compiled from other sources Databases Literature Direct measurements: water samples, soil samples, GPS data Produced from models: IUBEK model for Pb; From other sources: this is where the “use” of environmental data comes in; can be from other governmental and non-governmental organizations, agencies, businesses, etc.

What is the benefit of QA? Get the right environmental data for the project Want to avoid too much/too little data Provides for a way to evaluate data to make sure it meets project needs Allows for a graded approach Quality should be based on Nature of the decision Intended use of the data Saves resources Always cheaper to do things right the first time!

Quality Assurance Project Plan Purpose: Document type and quality of data for environmental decisions Responsibility: Written by the Project Manager. Reviewed and confirmed by the Project Manager, appropriate managers with the assistance and approval of the QA Manager Guidance: EPA QA/G-5 Requirements: EPA QA/R-5

Quality Assurance Project Plan Project Management Measurement/Data Acquisition Assessment/Oversight Data Validation and Usability

A. Project Management of QAPP Title and Approval Sheet Table of Contents Distribution List Project/Task Organization Problem Definition/Background Project/Task Description Quality Objectives and Criteria for Measurement Data Special Training Requirements/Certification Documentation and Records

B. Measurement/Data Acquisition Sampling Process Design (Experimental Design) Sampling Methods Requirements Sample Handling and Custody Requirements Analytical Methods Requirements Quality Control Requirements Instrument/Equipment Testing, Inspection, and Maintenance Requirements Instrument Calibration and Frequency Inspection/Acceptance Requirements for Supplies and Consumables Data Acquisition Requirements (Non-direct measures) Data Management

C. Assessment/Oversight Assessments and response actions Reports to management

D. Data Validation and Usability Data review, validation, and verification requirements Validation and verification methods Reconciliation with user requirements

QAPP Format Use references Attach standard forms, checklists, etc. Attach if not readily available Attach standard forms, checklists, etc. Identify any element that is not applicable Modified formats

QAPP Approval For non-state grantees: Submit to project officer to begin process Approvals Project officer Regional QA Manager 20 working days for review/comment Any comments will go through project officer Will be returned for modification if significant issues are found

QAPP Approval For States:: IDNR, KDHE, MDNR, and NDEQ Approved Quality Management Plans Delegates QAPP approval QAPPs follow their QA approval process Does not have to be forwarded to EPA for approval unless project officer requests it Does NOT eliminate the need for a QAPP; it is still required Contact state QA officer for more information

Resources http://www.epa.gov/quality/qa_docs.html Agency’s Quality Staff website R-5 G-5 http://www.epa.gov/region7/index.htm QAPP checklist Volunteer Monitor’s Guide Examples QA Training Contact your project officer and QA Manager

Wrap-Up Remember the graded approach: there is more than one way to get to quality data! Quality data Quality data Quality data