Overview of the Board’s Quality Management Plan

Topics in this Session

Quality System Overview Overview of the contents of the Board’s

Quality Management Plan Planning Documents – What they are and

what they are good for

Quality Systems Overview

What is a Quality System?

“A quality system is the means by which an organization manages its quality aspects in a systematic, organized manner. It provides a framework for planning, implementing, and assessing work performed by an organization and for carrying out required quality assurance (QA) and quality control (QC) activities.”

Introduction to EPA QA/G-1 Guidance for Developing Quality Systems for Environmental Programs EPA/240/R-02/008 November 2002

What is in a Quality System

It encompasses a variety of technical and administrative elements, including:– Policies and objectives,– Organizational authority,– Responsibilities,– Accountability, and– Procedures and practices

Why Do This?

EPA order 5360.A1 section 2.b requires EPA funded environmental programs have a quality system meeting American National Standard ANSI/ASQC E4-1994, Specifications and Guidelines for Quality Systems for Environmental Data Collection and Environmental Technology Programs

Also in Clean Water Regulations

Section 31.45 – Quality Assurance Section 35 – Quality assurance for 106

Grant funds

And Beyond EPA

“The State Water Resources Control Board (SWRCB) is authorized to make decisions affecting the quality of the waters of the State of California. With the knowledge that there is an inviolable trust, the US Environmental Protection Agency mandated that environmental data collected by the State be of known quality, and, as appropriate, legally defensible for the decisions to be made with them.”

Board QMP

Quality Management Plans

Where do They Come From?

Required by EPA’s order 5360.A1 which calls for a Quality System meeting ANSI/ASQC E4-1994

Details and Required Elements from EPA QA/R-2

Examples exist in the form of a model QMP and the approved QMPs of various EPA Regions

What are They?

Framework for How We will Manage our Quality System

Leans on Management, Planning, and Assessment of the Quality System Process

Assigns Duties, Authorities, and Responsibilities

Brings in All Players, Including Senior Management

Who Writes Them and Who For?

An organization’s quality management office

Apply to all programs and functions within the organization that generates, collects or receives data

Why Bother?

A Quality System will– Reduce cost– Increase productivity– Improve product quality– Standardize product quality– Increase customer satisfaction– Increase employee job satisfaction

The Boards’ Quality Management Plan

Our Plan Contains

Approval Page Table of Contents Vision Statement Organization Responsibilities Quality Assurance Program Components Quality Improvement Process

Summarizing our Plan

Quality processes assigned to persons associated with Regional Boards and State Board Programs

A Quality Assurance Roundtable as a source of quality system information and mutual problem solving

A call for the use of quality planning and documents

Who are These Persons?

The Board’s Quality Assurance Officer and any staff in the Board’s Quality Assurance Program

Designees from the Regional Boards who are identified as QA Lead Persons

Designees from State Board Programs who are identified as Program Representatives

Representatives from US EPA R9

Board Quality Assurance Officer and QA Program Staff

Implements State and Regional Water Board Quality Assurance policy

Ensures that projects and programs comply with the requirements of the QMP

Ensures that quality assurance performance standards are in place

Ensures that organizations providing data under agreements with the Boards comply with requirements in the QMP

Provides information and training Participates in the Quality Assurance Roundtable

Duties continued

Reviews and approves program level QA planning documents

Prepares annual up-dates of the QMP every 5 years

Prepares an annual Quality Assurance Report to US EPA Region 9

Maintains a database of Quality Assurance documents

And Still More Duties

Performs data validation and review Performs Management System Reviews and

Technical Systems Audits Coordinates with EPA Manages the Discharge Monitoring Report-

Quality Assurance program (DMR-QA) Manages contracts for quality assurance

related services

QA Lead Persons and Program Representatives

QA Lead Persons are individuals chosen from Regional Board staff

Program Representatives are individuals chosen from State Board programs

Each has similar duties and responsibilities which cover the quality system process within their respective Boards and programs

Are members of the QA Roundtable

Duties

Quality system policy – assure that projects and programs comply with the provisions of the QMP

Quality planning documents – assure that projects and programs develop, use and maintain quality planning documents

Quality technical review – review project and program conformance to their applicable quality planning document

The QA Roundtable

Consistent and appropriate level of planning is applied throughout Board

Discuss issues of general interest such as reviews of planning documents, training, contractor support and laboratory performance.

Meetings are held once a quarter in person or via conference call

Others at the QA Roundtable

US EPA Region 9 Quality Assurance Unit Others may be invited as necessary

Planning Documents

Planning

A Reason to Plan?

"Would you tell me which way I ought to go from here?" asked Alice.

"That depends a good deal on where you want to get," said the Cat.

"I really don't care where" replied Alice."Then it doesn't much matter which way

you go," said the Cat.

Lewis Carroll, Alice's Adventures in Wonderland (1865).

Planning is the Key

It Makes Us Think about What We are Doing

It Brings to Bear Our Knowledge of What We are Doing

It is Proactive Not Reactive Leading to a Better Product

Planning Provides a Framework for Assessment and Control

Why Write out a Plan?

Commits our demands relative to quality Provides a means of informing others Reminds us of our plans Is a training tool

Planning Document Basics

Identify sponsoring organization and personnel

Project goal, objectives, and schedule Link data to project goal Type, quality, and quantity of data needed Acceptance or performance criteria Sampling plan and QA/QC requirements How the data will be analyzed

Common Planning Documents

Quality Management Plans (QMP) Quality Assurance Program Plans (QAPrP) Quality Assurance Project Plans (QAPjP) Sampling and Analysis Plans (SAP) Monitoring and Assessment Plans (MAP)

Quality Assurance Program Plans

What are They?

Written for a single Program or Function Detailed Plans for setting, assessing and

controlling quality for data gathered, generated, or received by Program

Acts as a core for other Planning Documents

Are open-ended

Where do They Come From?

Derived from EPA Region 9’s guidance document R9/QA03.1

Looks a lot like Quality Assurance Project Plans

Who Writes Them and Who For?

A Program’s quality assurance staff – or maybe the Board’s Quality Management Office with input from Program staff

Applies to all functions within the Program that generates, collects or receives data

Quality Assurance Project Plans

What are They?

Plans relating to a single project or action Describes the Project from why we are

doing it to how we will assess our success Contains information that might be included

in other Plans, such as a Sampling and Analysis or Monitoring and Assessment Plan

Can include information found in a Program’s QAPrP

Where do They Come From?

Requirements found in EPA’s QA/R-5 with guidance found in EPA’s QA/G-5 serve as the base (developed as part of EPA’s initial Superfund and Contract Laboratory program)

Some of the contents may be required by the contents of a QAPrP

Simplified Quality Assurance Project Plan

What are They?

Like their more complex cousins are plans that cover a single project or function

The section headings are simple and straightforward

Could be a stand-alone Plan or an adjunct to a QA Program Plan

Section Headings

Identify sponsoring organization and personnel

Project goal, objectives, and schedule Link data to project goal Type, quality, and quantity of data needed Acceptance or performance criteria Sampling plan and QA/QC requirements How the data will be analyzed

Where do They Come From?

EPA has suggested these headings as a simple replacement for the more formal QA Project Plan format

There are no guides at this time

Why Replace QAPjP Requirements?

EPA developed the requirements and guides of QA-R5 and QA-G5 under the Superfund program

Formality due to the need to support litigation for cleanup costs and to defend against confusion over what “value” the data has in assessing blame, level of contamination, and cleanup efficacy

Monitoring and Assessment Plans

What are They?

Plans for monitoring and the analysis of the information so that a question can be answered

Plan How, Where, and Why You are Monitoring

Where do They Come From?

There is no EPA document relating to Monitoring and Assessment Plans

Could use those section from the requirements and guidance documents for QA Project Plans to write one

Variations have been developed, such as the Project Analysis and Evaluation Plan (PAEP) used by Financial Assistance

Sampling and Analysis Plans

What are They?

Plans relating to just sampling and analysis tasks

Could be a stand-alone Plan or an adjunct to a QA Program Plan or QA Project Plan

Where do They Come From?

EPA has written QA/G5S, a guide to Sample Design

EPA Region 9 has a guide to Sampling and Analysis Plans

As for the analytical side, much of that could come from the selected method’s quality practices, those used by the selected laboratory’s Quality Document, or from a QA Program Plan

Quality Planning Documents

Who writes them and who uses them

Who Writes and Uses These Plans

Program or Project staff writes them The same Program or Project staff follows

the contents The Program or Project Quality Assurance

organization reviews and assesses conformance

The Quality Assurance Program may also assess conformance as part of a review of Program or Project QA activities

Summary

Planning is important A written document solidifies the plan There are choices of what type of document

to write The Board has a Quality Management Plan

End of Session - Questions

Begin Quality Assurance Fundamentals