1. Overview of the Board’s Quality Management Plan

2. 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

3. Quality Systems Overview

4. 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

5. 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

6. 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

7. Also in Clean Water Regulations  Section 31.45 – Quality Assurance  Section 35 – Quality assurance for 106 Grant funds

8. 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

9. Quality Management Plans

10. 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

11. 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

12. 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

13. Why Bother?  A Quality System will –Reduce cost –Increase productivity –Improve product quality –Standardize product quality –Increase customer satisfaction –Increase employee job satisfaction

14. The Boards’ Quality Management Plan

15. Our Plan Contains  Approval Page  Table of Contents  Vision Statement  Organization Responsibilities  Quality Assurance Program Components  Quality Improvement Process

16. 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

17. 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

18. 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

19. 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

20. 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

21. 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

22. 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

23. 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

24. Others at the QA Roundtable  US EPA Region 9 Quality Assurance Unit  Others may be invited as necessary

25. Planning Documents

26. Planning

27. 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).

28. 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

29. 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

30. 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

31. 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)

32. Quality Assurance Program Plans

33. 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

34. Where do They Come From?  Derived from EPA Region 9’s guidance document R9/QA03.1  Looks a lot like Quality Assurance Project Plans

35. 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

36. Quality Assurance Project Plans

37. 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

38. 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

39. Simplified Quality Assurance Project Plan

40. 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

41. 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

42. 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

43. 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

44. Monitoring and Assessment Plans

45. 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

46. 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

47. Sampling and Analysis Plans

48. 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

49. 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

50. Quality Planning Documents Who writes them and who uses them

51. 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

52. 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

53. End of Session - Questions Begin Quality Assurance Fundamentals