USEPA REGION 4 Quality Management Plan ( For training purposes only)

Quality is a Lousy Idea- If it’s Only an Idea!

Have you heard these phrases before? Quality Assurance Quality Control Quality Assurance Project Plan Quality Management Plan Quality System Data Quality Objectives Data of Known Quality Now are you really confused?

What is a Quality Management Plan? “A quality management plan (QMP) documents how an organization structures its quality system and describes its quality policies and procedures, criteria for and areas of application, and roles, responsibilities, and authorities. It also describes an organization’s policies and procedures for implementing and assessing the effectiveness of the quality system”. EPA Requirements for Quality Management Plans – EPA QA/R-2 (March 2001).

A little background history May 30, 1979 – EPA established a Quality Assurance Policy It states: The EPA must have a comprehensive quality assurance effort to provide data that are scientifically valid, defensible, and of known precision and accuracy - this is the goal of the Agency’s quality assurance program.

Then came (the most recent QA Policy)…… May 5, 2000 EPA Order A2 It provides the Policy and Program Requirements for the Mandatory Agency- Wide Quality System.

Why should I care! The order is applicable to: The direct measurement of environmental conditions or releases, including sample collection, analysis, evaluation and reporting of environmental data. Also, there is secondary data to consider. Sound Familiar???

EPA ORDER A2 This Order establishes the policy and program requirements for the preparation and implementation of Management Systems pertaining to QUALITY and contains the minimum requirements for the mandatory Agency-wide Quality System

What is a Quality System? A quality system is the sum total of the policies and procedures that are developed and implemented to ensure that quality is built into programs and work products. Thus a quality system covers both policy and process.

EPA ORDER A2 The Agency–wide Quality System provides the necessary elements to: PLAN IMPLEMENT DOCUMENT ASSESS the effectiveness of QA and QC activities applied to environmental programs conducted by or for EPA to obtain sufficient and adequate data quality.

The Quality Management Plan for Region 4 Establishes a structured and documented management system which describes an organization's roles, responsibilities, policies and procedures as they relate to the generation and use of environmental data.

It states: (Policy Statement) “It is the policy of Region 4 that all decisions which are made to protect human health and safeguard the environment will be based on data of sufficient known quality to support the level of decision required.”

Region 4’s Quality Management Plan (QMP) What does it do for me (or to me)? 1.All field data sampling/collection activities conducted by EPA or funded by EPA - must have an approved QAPP! (This is also stated in the EPA Policy) 2.Defines Region 4’s QA Responsibilities 3.Establishes the EPA Region 4 Designated Approving Official for QAPP review/approval. 4.Establishes QA training requirements. 5.It defines the use of secondary data, and the QA associated with it. 6.The Plan was signed by ALL Division Directors and the Regional Administrator.

Who Needs a QMP?? All Federal Agencies Non-EPA organizations funded by EPA are required to document their quality system in a QMP (or equivalent document): 48 CFR 46 - For contractors 40 CFR 30, 31 and 35 – For assistance agreement recipients; and Other mechanisms, such as consent agreements in enforcement actions.

Is this a Requirement? EPA itself is required to have a regional QMP that must be approved by the Office of Environmental Information (OEI) located at EPA headquarters in Washington, D.C. In addition, individual projects developed within EPA must have an approved QAPP.

What’s the Difference Between a QMP and QAPP?? A QMP documents the organizations structure and overall quality system as it relates to their environmental program. A QAPP is a project-specific document that details the project management, data acquisition, assessment/oversight and data verification/validation/review activities for an environmental project only.

Are QMPs Good Forever? No - An EPA approved QMP is good for 5 years. When the five years are up, the grantee or consultant must resubmit a QMP for a new round of review and approval by EPA. The EPA Region 4 QMP is also only approved for 5 years. Our most recent QMP was approved in July 2007 and it expires on July 2012.

A Happier Region 4 QA Community To Summarize: Implementing the EPA Region 4 Quality Management Plan (QMP) and The State of Kentucky’s QMP, and providing Quality Assurance Training to the Kentucky Divisional Programs will lead to a Happier Region 4 QA Community!!

EPA Region 4 Quality Assurance Section Contacts Marilyn Maycock (706) Denise Goddard (706) Ray Terhune (706) Charlie Appleby (706)