Program Guidance & Requirements

Quality Management Plan:

• Region 8 Quality Management Plan
• EPA Requirements for Quality Management Plans (QA/R-2)
• EPA Region 8 Quality Management Plan Crosswalk(12 pp, 43 K, 01/2016)

Policies for EPA Organizations are defined in the internal Agency policies listed below.

• EPA Order CIO 2105.0 - Policy and Program Requirements for the Mandatory Agency-wide Quality System - May 2000. Quality specifications for EPA organizations that produce or use environmental data.
• EPA Order CIO 2016.0 - The EPA Quality Program Policy for Agency products and services.
• EPA Procedure CIO 2106-P-01.0 - The new EPA Quality Program Procedure for Agency products and services issued in October 2008.

Regulatory Requirements

• 48 CFR 46-- Allows Federal Agencies to select a national consensus standard as a basis for their quality specifications.
• 40 CFR 35-- Requires grantee/cooperative agreement holder to comply with 2 CFR 1500.11
  • § 35.588 Award limitations (a) The Regional Administrator will only award section 106 funds to a Tribe or Intertribal Consortium if:  (1) All monitoring and analysis activities performed by the Tribe or Intertribal Consortium meets the applicable quality assurance and quality control requirements in 2 CFR 1500.11
  • §35.6015   Definitions Quality Assurance Project Plan. A written document, associated with remedial site sampling, which presents in specific terms the organization (where applicable), objectives, functional activities, and specific quality assurance and quality control activities and procedures designed to achieve the data quality objectives of a specific project(s) or continuing operation(s).
  • § 35.6055 State-lead pre-remedial Cooperative Agreements
    • (a)(3)(b)(2)(i) The recipient must comply with the quality assurance requirements described in  2 CFR 1500.11
    • (a)(3)(b)(2)(ii) The recipient must have an EPA-approved non-site-specific quality assurance plan in place before beginning field work. The recipient must submit the plan to EPA in adequate time (generally 45 days) for approval to be granted before beginning field work
  • §35.6105   State-lead remedial Cooperative (a)(2)(vi) Quality assurance
    • (A) General. If the project involves environmentally related measurements or data generation, the recipient must comply with the requirements regarding quality assurance described in 2 CFR 1500.11.
    • (B) Quality assurance plan. The applicant must have a separate quality assurance project plan and/or sampling plan for each site to be covered by the Cooperative Agreement. The applicant must submit the quality assurance project plan and the sampling plan, which incorporates results of any site investigation performed at that site, to EPA with its Cooperative Agreement application. However, at the option of the EPA award official with program concurrence, the applicant may submit with its application a schedule for developing the detailed site-specific quality assurance plan (generally 45 days before beginning field work). Field work may not begin until EPA approves the site-specific quality assurance plan.
  • §35.6225 Activities eligible for funding under Core Program Cooperative Agreements.
    • (a) To be eligible for funding under a Core Program Cooperative Agreement…(1) Procedures for emergency response actions and longer-term remediation of environmental and health risks at hazardous waste sites (including but not limited to the development of generic health and safety plans, quality assurance project plans, and community relation plans)

2 CFR 1500.11—Quality Assurance definition; applies to all assistance agreements (tribes, states, other entities)

Quality Assurance Project Plan (QAPP)

• Requirements for Quality Assurance Plans (QA/R-5)
• Guidance for Quality Assurance Project Plans (QA/G-5)
• Region 8 QA Document Review Crosswalk(9 pp, 42 K, 07/2017)
• Uniform Federal Policy (UFP) Quality Assurance Project Plan (March 2012)
• Quality Assurance Project Plan Signature Page Examples:
  • EPA Region 8 Routing Procedures for Quality Assurance Project Plans
  • Grantee Signature Page for Region 8 Quality Assurance Project Plans
  • Contractor Signature Page for Region 8 Quality Assurance Project Plans

Quality Assurance For Contracts

• Quality Assurance Review Form (QARF) for Contract Actions (4 pp, 61 K, 2/2/2016)  
  NOTE: Save this Microsoft Word file to your system and complete the QARF
• Contracts Management Manual

Regulatory Documents

EPA retains the discretion to adopt approaches on a case-by-case basis that differ from these guidance where appropriate. EPA may periodically revise these guidance without public notice.

General Guidance

• Other Relevant Federal Regulations:
  • CIO 5700.7a.1: Environmental Results under EPA Assistance Agreements (PDF)
  • Transmittal of Three Quality Assurance Technical Information Bulletins for the Removal Program, issued July 2006
    • Changes in Quality Assurance Policies for the Removal Program
    • Applicability of Superfund Data
    • Systematic Planning Processes for the Removal Program

Field Operations

Those involved in Region 8 field activities participate in one of the most visible and active phases of the environmental data generation life cycle. Data generated during field activities are vital to Agency decision-making, and ultimately, to accomplishing our mission to protect human health and the environment.

The FOG Guidelines are now established as an EPA QA Field Activities Procedure^[1] and are made up of ten elements that detail a quality management system for all aspects of field activities, including sampling and non-sampling activities such as:

• Record keeping
• Training
• Equipment management
• Audits/corrective action

The QA Field Activities Procedure (aka: FOG Guidelines) applies to all organizations whose EPA employees conduct field activities. Each element is an important and integral component of the whole, which when used together, provides the foundation for defensible field data collection.

The Region 8 Field Operations Lead is responsible for overseeing implementation of the QA Field Activities Procedure (aka: FOG Guidelines).

^[1]EPA QA Field Activities Procedure (aka: FOG Guidelines), CIO 2105-P-02.0, September 23, 2014.

Laboratory Competency

Policy to Assure Competency of Laboratories, Field Sampling and Other Organizations Generating Environmental Measurement Data under Agency-Funded Acquisitions (also known as the FEM Policy)

Environmental measurement is any data collection activity or investigation involving the assessment of chemical, physical, or biological factors in the environment which affect human health or the quality of life. EPA established policies to better ensure the quality of information from data generated, collected and used for making scientific and regulatory decisions (see Ensuring Measurement Competency). 

To assure the quality of our data, all laboratories operated by EPA, including contractor-operated facilities need to maintain a documented Quality System. At a minimum, the system must comply with the requirements of the EPA Quality System as defined by EPA Order 5360.1 A2 May 2000, Policy and Program Requirements for the Mandatory Agency-wide Quality System. This policy contains the specific requirements (see Internal Measurement Competency) .

On March 28, 2011, an EPA policy was issued for all organizations performing environmental analysis to demonstrate their qualifications in the field(s) of analyses to be conducted, prior to performing such analyses, under Agency-funded acquisitions. This requirement is another part of the Agency's continued effort to ensure the quality and validity of environmental measurement data (see Measurement Competency Under Acquistion Agreements).

A policy issued on December 12, 2012 with implementation criteria approved on March 13, 2013 took effect on October 1, 2013 for all organizations performing environmental analysis for the Agency to demonstrate competency under Agency-funded assistance agreements. This requirement is another part of the Agency's continued effort to ensure the quality and validity of environmental measurement data (see Measurement Competency Under Assistance Agreements).

Lab QA Plan Content

The Lab QA Plan needs to provide a demonstration on how it will be performing your analyses appropriately, adequately, defensibly. You should know what the lab will be doing and how it’s activities will be documented. Specifically, the lab provides a current signed QA Plan showing capability to do the approved methods, annual reviews that will be documented, etc.  (From: New Policy Directive on Assuring and Documenting the Competency of Agency Laboratories, March 10, 2004 Memorandum: Assuring the Competency of Environmental Protection Agency Laboratories Agency Policy Directive Approved: February 23,2004)  The Lab QA Plan needs to include the following items listed below:

• Staff training
• Initial and continuing demonstrations of laboratory capability
• Demonstration of individual staff capability and competency
• Active internal quality assurance system including
• Periodic internal audits
• Periodic management reviews
• Validation/verification of method performance
• Documentation of procedures used and results obtained
• Systematic planning of work
• Correction of deficiencies found during audits
• Controls on subcontracting to ensure data quality
• Demonstrating Laboratory Competency
    Independent external assessments
    Participation in inter-laboratory comparison studies/programs

Quality Assurance Tools

• Quality Assurance Training
• Quality Assurance Forms
• Quality Assurance Guidance Documents
  • Guidance on Systematic Planning using the Data Quality Objectives Process (QA/G-4)
  • Guidance for Geospatial Data Quality Assurance Project Plans (QA/G-5G)
  • Guidance for Preparing Standard Operating Procedures (QA/G-6)

  • Guidance for Quality Assurance Project Plans for Modeling (QA/G-5M)

• Quality Assurance Contacts

Quality Assurance Training

Quality Assurance Core Training

• The QA Core Training is required for all Region 8 employees involved in any data collection, generation and/or use; data review and/or research; data management; data reporting; and/or environmental technology.  The following is a list (but not limited to) of job functions/titles required to take the QA Core Training: 
  • Project Officers
  • Contracting Officers
  • Grants/Acquisitions Specialist
  • Work Assignment Managers
  • Project Managers
  • Program Managers
  • All Field, Laboratory, and Data Management Personnel
  • Tribal Technical Project Officers
  • Inspectors and Enforcement Staff
  • Emergency Response
  • Permit and Regulation Writers
  • Legal Support
  • State Program Managers and/or Technical Program Managers/Staff
• The Region 8 QMP outlines the frequency for taking QA Core Training; it is currently every two years. The QMP is expected to be revised in CY2016; the QA Core Training frequency is expected to be changed to every year. 

Introduction to Delegated QA Approving Officer (DAO) Training

• This introductory course informs Region 8 employees about requirements to obtain delegated authority to approve project-level QA documents. This is a required course for anyone who wants to approve project-level QA documents (e.g., QAPPs, SAPs, FSPs).

Conceptual Site Model (CSM) Training

• This course was presented in FY2013 and designed for anyone developing conceptual site models; it included a special focus on CSM use at tribal lands. The course explained why conceptual site models are important to the Data Quality Objectives process. The CSM Worksheet and Template and DQO Worksheet may be useful tools in developing the CSM (see Quality Assurance Forms).

Developing Quality Assurance Project Plans using Data Quality Objectives and other Planning Tools

• QAPP development documents and is the culmination of the Systematic Planning Process. This course introduces key planning concepts such as Data Quality Objectives (DQOs), Data Quality Indicators (DQIs), and Data Quality Assessment (DQA), which when used, will strengthen your QAPP.

Quality Assurance Training for New Tribal Water Quality Coordinators

• QA Training for New Tribal Water Quality Coordinators (Clean Water Act 106).

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Quality Assurance Forms

Data Quality Objectives (DQOs) and Conceptual Site Model (CSM)

Guidance on Systematic Planning Using the Data Quality Objectives Process (QA/G-4):

• CSM Worksheet (XLSX)
• CSM Template (XLSX)
• DQO Worksheet (XLSX)

Region 8 Delegated Approving Officer Resources

• Region 8 QA Document Review Crosswalk
• Region 8 DAO QA Document Tracking Template(1 pg, 17 K)

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Quality Assurance Contacts

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