1. Orientation to Quality Assurance
A brief overview

2. Quality Assurance Team
Region 7
Quality Assurance Team
Diane Harris, RQAM
Bob Nichols
Leslye Werner

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

4. 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 A2
EPA Requirements Documents
CFR References
Contractors
Grantees

5. 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 A2
Which means for P2 projects….

6. 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.

7. 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”

8. 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.

9. 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!

10. 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

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

12. 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

13. 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

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

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

16. 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

17. 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

18. 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

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

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