overview of the board’s quality management plan
DESCRIPTION
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?. - PowerPoint PPT PresentationTRANSCRIPT
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Overview of the Board’s Quality Management Plan
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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
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Quality Systems Overview
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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
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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
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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
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Also in Clean Water Regulations
Section 31.45 – Quality Assurance Section 35 – Quality assurance for 106
Grant funds
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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
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Quality Management Plans
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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
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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
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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
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Why Bother?
A Quality System will– Reduce cost– Increase productivity– Improve product quality– Standardize product quality– Increase customer satisfaction– Increase employee job satisfaction
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The Boards’ Quality Management Plan
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Our Plan Contains
Approval Page Table of Contents Vision Statement Organization Responsibilities Quality Assurance Program Components Quality Improvement Process
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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
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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
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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
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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
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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
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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
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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
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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
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Others at the QA Roundtable
US EPA Region 9 Quality Assurance Unit Others may be invited as necessary
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Planning Documents
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Planning
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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).
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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
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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
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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
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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)
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Quality Assurance Program Plans
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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
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Where do They Come From?
Derived from EPA Region 9’s guidance document R9/QA03.1
Looks a lot like Quality Assurance Project Plans
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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
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Quality Assurance Project Plans
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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
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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
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Simplified Quality Assurance Project Plan
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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
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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
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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
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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
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Monitoring and Assessment Plans
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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
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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
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Sampling and Analysis Plans
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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
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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
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Quality Planning Documents
Who writes them and who uses them
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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
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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
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End of Session - Questions
Begin Quality Assurance Fundamentals