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  1. Agenda Moderator: Betsy Grim, Director Quality Assurance, OPP Part 1: Quality Basics 1:30 – 2:30 Louis Blume, GLNPO QAM Quality Basics and Stages of Quality 2:30 – 2:45 Kevin Bolger, Region 5 QAM Regulations Requiring Quality 2:45 – 3:00 Marcia Damato, GLNPO QA Team Quality Implementation for grants 3:00 – 3:30 Break

  2. Agenda Moderator: Betsy Grim, Director Quality Assurance, OPP Part 2: Integrating and Documenting Quality in Project Management Tom Huges, QAO, NHEERL and Cheryl Itkin, QAO, NCEA 3:30 – 3:50 Overview of “other” data 3:50 – 4:10 Documenting “other” data 4:10 – 4:20 Break 4:20 – 5:00 Hands on exercise

  3. Agenda Moderator: Betsy Grim, Director Quality Assurance, OPP 3:30 – 4:30 Louis Blume, GLNPO QAM Quality Basics 2:30 – 2:45 Kevin Bolger, Region 5 QAM Regulations Requiring Quality 2:45 – 3:00 Marcia Damato, GLNPO QA Team Quality Implementation for grants 3:00 – 3:30 Break

  4. Quality Management Basics and Advanced Stages of Quality Systems Louis Blume, U.S. EPA, Great Lakes National Program Office, Project Level QA Training for EPA QA Managers May 14, 2009 San Antonio, Texas

  5. Louis Blume’s QA Background • QA Manager, US EPA – GLNPO, 1995 – present • Chief of Planning, US EPA, Region 5, 1990 – 1992 • ORD Regional Scientist, US EPA, Chicago, IL, 1989 – 1990 • Soil Scientist, US EPA Office of Research and Development, Las Vegas, Nevada. 1985-1989 Relevant Accomplishments • Co-chaired EPA’s National Workshop on Graded Approaches for QA • Presented QA Symposia in Canada and Russia • QA Manager: National Acid Deposition Soil Survey, Direct/Delayed Response Project, US EPA • M.S. Soil Science,Taxonomy / Morphology – University of Georgia • B.S. Forestry – Michigan Tech University

  6. We are here today to talk about the advantages of a Quality System, Versus a Quality Management Plan.

  7. Benefits of a Quality System • Provides an effective management process that assures fact based environmental decisions • Applies Quality principles to non-laboratory oriented data collection activities • policy making, modeling, pollution prevention, economic assessments • Allows flexibility on how you implement data collection activities • can result in significant cost savings! • Provides your organization a management structure that promotes continuous improvement

  8. EPA Order CIO 2105.0: Major Points • Defines requirements and implementation for quality systems which support U.S. EPA environmental programs directly or through extramural agreements • Defines and broadens the scope of “environmental data” to include all input information to decision processes. • Identifies QA roles and responsibilities for agency managers and staff

  9. U.S. EPA Order CIO 2105.0:Policy and Program Requirements for the mandatory Agency-Wide Quality System • Establishes policy and program requirements for the conduct of QA, for all environmentally-related measurements performed by or on behalf of U.S. EPA

  10. Definition of Environmental Data • “Any measurements or information that describe environmental processes, location, or conditions; ecological or health effects and consequences; or the performance of environmental technology. For EPA, environmental data include information collected directly from measurements, produced from models, and compiled from other sources such as data bases or the literature.” EPA Order 5360.1 A2, May 2000

  11. Quality System • A structured, documented Management System describing an organization’s Policies, Objectives, Principles, Authorities, Responsibilities, Accountabilities, and Implementation Plan to ensure Quality in its Work Processes, Products and Services • Provides an organization’s framework through: Planning, Implementing, Assessing, Improving, Documenting

  12. Quality Management Systems can/should be based on a Graded Approach Quality system requirements are commensurate with: • Importance of work • Availability of resources • Unique needs of organization • Consequences of potential decision errors

  13. GLNPO’s Graded Approach toQuality System Documentation Replaced four-tiered category approach with new project categories: • State agencies • Tribal grants • Consortium grants • Cluster grants • Existing data/modeling • Habitat/ecosystem restoration • Ambient monitoring and research demonstration • Volunteer monitoring • Sediment assessment • Pollution prevention and environmental education • Repeating projects of similar scope 1 to 4: QMP usually required 5 to 11: QAPP usually required

  14. Quality Review vs. Peer Review • Quality Reviews of QAPPs focus on: • the process • the chance for success • technical details and validity of results, from a reproducibility standpoint • Peer Reviews are primarily driven by the discipline

  15. Peer Review and Information Quality Guidelines GLNPO believes that an effective quality system ensures • Implementation of Agency peer review policy (EPA document #100-B-00-001) • • Adherence to OMB’s federal Information Quality Guidelines or IQGs (67 FR 8451) • •

  16. What Does OMB Direct Agencies Do to comply with the IQGs? • Adopt a basic standard of quality for disseminated information • Apply the principles ofinformation qualityto each step of EPA’s development of information • creation, collection, maintenance & dissemination • Enable affected persons to seek and obtain corrections to "Information* disseminated” to the public by filing a Request for Correction (RFC) *Information, dissemination, distribution, and influential information are further defined at

  17. What is Quality? • Objectivity • Presentation: is accurate, clear, complete and unbiased (transparency) • Substance: accurate, reliable, and unbiased ..based on sound statistical and research methods • Utility • Usefulness of the information to its intended users, including the public • Integrity • Protection from unauthorized access or revision

  18. Quality SystemPolicy/Regulations QMP Organization/Program Quality System QMP Quality Assurance QAPP, SPP (DQO) Project Quality Control QAPP, SOP Project

  19. Specifications for Non-EPA Organizations • EPA Requirements for Quality Management Plans (QA/R-2) EPA/240/B-01/002 March 2001 • Guidance for Developing Quality Systems for Environmental Programs (QA/G-1)EPA/240/R-02/008 November 2002 • EPA Requirements for QA Project Plans (QA/R5) EPA/240/B-01/003 March 2001 • Guidance for Quality Assurance Project Plans (QA/G-5) EPA/240/R-02/009 December 2002

  20. QMPs vs. QAPPs • Quality Management Plans reflect activities and policies common to all projects. • Quality Assurance Project Plans reflect specific projects. QMP QAPP QAPP QAPP QAPP

  21. Quality Management Plan (QMP) The QMP describes quality requirements and procedures for activities that support the collection, use, and communication of environmental data and information, including: • Project Planning • Grants, contracts and interagency agreements • Documents and records • Technical Tasks • Information Technology • QA Assessments/Audits and corrective action responses See EPA Requirements for Quality Management Plans (EPA QA/R-2)

  22. Quality Assurance Project Plans (QAPPs) • Mandatory document for any data collection activity • Describes how data and information will be collected, analyzed and assessed • Describes the technical details and procedures to be used in the collection of data SeeEPA Requirements for Quality Assurance Project Plans (EPA QA/R-5)

  23. Required Elements in a QMP • Management and Organization • Quality System and Description • Personnel Qualifications and Training • Procurement of Items and Services • Documentation and Records • Computer Hardware and Software • Planning • Implementation of Work Processes • Assessment and Response • Quality Improvement

  24. Required Elements in a QAPP Guidance Assurance for Project Plans, EPA QA/G-5 • Project Management • Elements A1-A9 • Measurement/Data Acquisition • Elements B1-B10 • Assessment/Oversight • Elements C1-C2 • Data Validation and Usability • Elements D1-D3

  25. Required Elements in a QAPP

  26. Required Elements in a QAPP GLNPO Added Note: The above elements are minimum requirements for a QAPP, and therefore, should be used during the QAPP development.

  27. Comparison of Required Elements in a QAPP versus a QMP

  28. EPA’s Quality System EPA Organizations • EPA Order 5360.1 • EPA Order 5360 (Quality Manual) • Contracts Management Manual (EPA Order 1900) • ANSI/ASQC E4-1994 Non-EPA Organizations • 48 CFR 46 (FAR 46) for contractors • 40 CFR 30, 31, and 35 for assistance agreement recipients • ANSI/ASQC E4-1994

  29. Authorizing Requirements • ANSI/ASQC E4-1994/2004 is a national consensus standard designed specifically for quality systems applied to environmental data collection and environmental technology programs. • Relates directly to ISO 9000 certification and over 14000 approved organizations

  30. Quality System Requirements for Extramural Agreements • Conformance to ANSI/ASQC E4-1994/2004 requires: Documentation must be sufficient to describe the quality system

  31. American National Consensus Standard • ANSI/ASQC E4, Specifications and Guidelines for Quality Systems for Environmental Data Collection and Environmental Technology Programs • Provides the basis for planning, implementing, documenting, and assessing a quality system • Standard divided into 3 parts • Part A: Management Systems • Part B: Environmental Data • Part C: Environmental Technology • Standard available from ASQ (

  32. Basic Quality System Requirements for Solicitations and Contracts • Conform with ANSI/ASQC E4-1994/2004 • Document the organization's quality system (QMP) which should be approved prior to initiating environmental work • Document the application of QA and QC activities to activity-specific efforts (QAPP) which should be approved prior to initiating environmental data collection • Verify that products/services meet specifications

  33. Is it Acquisition or Assistance? Acquisition vs. Assistance EPA Order 5700.1 The basic difference between acquisition and assistance is the relationship between the parties. • If an activity is funded to meet an internal EPA need, e.g., prepare a specific report to Congress or purchase furnishings for EPA staff, then an acquisition (contractual) relationship exists and EPA's direct procurement requirements (e.g., the Federal Acquisition Regulations) apply. • If the activity is funded to primarily benefit someone other than the Federal government

  34. Contract-Specific Quality System Procedures QA Review Form: • Required for all solicitations and contracts, work assignments, delivery orders, task orders, and for modifications that involve a significant change to the Statement of Work. • Documents the necessary quality-related activities to be performed by the contractor. • May document the quality-related activities to be performed by EPA. • Standardizes how EPA Contracting Officer's Representatives and QA Managers communicate quality specifications to EPA Contracting Officers to ensure inclusion of the specifications in standard contract clauses.

  35. Quality Requirements for Solicitations and Contracts Objectives: • Identify Authorizing Requirements - where to find specifics and updates • Describe requirements and responsibilities that ensure QA in Contracts

  36. Federal Government Federal Acquisition Requirements (FAR) • Regulation - FAR 46.202-4 (February 1999) • Applies to all Federal Agencies • Allows Federal Agencies to: • Select a higher-level quality standard and • Tailor this standard to meet Agency-specific needs

  37. Contract Quality Requirements • The type and content of the contract quality requirements depends on the nature of the work. It can range from inspection at the time of acceptance to requiring that the contractor implement a comprehensive program (quality system) for controlling quality. • Contract quality requirements fall into four general categories, depending on the extent of quality assurance needed by the Government.

  38. Contract Quality Requirements • Higher-level contract quality requirements. For complex or critical items or when the technical requirements of the contract require -- • (1) Control of such things as work operations, • in-process controls, and inspection; or • (2) Attention to such factors as organization, • planning, work instructions, documentation control, • and advanced metrology. • (FAR 46.202-4)

  39. EPA’s Adoption of FAR 46.202-4 • EPA's higher-level quality standard is usually American National Standard ANSI/ASQC E4-1994, "Specifications and Guidelines for Quality Systems for Environmental Data Collection and Environmental Technology Programs." • Chapters 7 and 46 of EPA's Contracts Management Manual (CMM) contains EPA-specific policy and procedures: • Contract Clause • Step-by-Step Directions for COs and CORs • QA Review Form

  40. Application of Contract Requirements • Not based on cost but on the type of work to be performed • Covered activities are the same as the activities covered by the EPA Quality System • Applies to simplified acquisitions except those under a purchase order (which should not be used for covered activities)

  41. The QA Review Form The QARF provides information: • From the Contracting Officer's Representative to inform the Contracting Officer what quality requirements should be included in a solicitation • Enhance QA Manager oversight of the quality-related activities QARF must be completed for: • Solicitations • Contract Statements of Work (SOW) • SOW for work assignments/delivery orders/task orders • Modifications to existing work assignments/delivery orders/task orders that change the SOW • Technical directives and actions that do not affect the work performed by the contractor (for example, incremental funding or time extensions) do not require a QARF.

  42. Complete the QARF • Check "Yes" and complete the rest of the QARF if project involves: • collection, generation, use, and/or reporting of environmental data; • design, construction, and/or operation of environmental technologies; • development and/or use of models; or • other activities that need QA or QC requirements as identified in your organization's QMP. • If the work does not involve any of these activities, check "No," skip Quality Related Requirements and complete Signatures. • Estimate the percentage of costs or level-of-effort allocated to the activities identified.

  43. Stages of Quality System Implementation • Quality programs are not implemented with the stroke of a pen upon the approval of a Quality Management Plan • Functional quality programs do not just happen - they evolve, typically after QMP approval

  44. Value of Defining Stages of Implementation • Provides a metric to measure success • Emphasizes the fact that good programs take time and continuously improve • Illustrates a quality continuum • Establishes realistic expectations Quality Infrastructure • 1 2 3 4

  45. Stages of Quality System Implementation Matrix • Columns = Degree of Implementation • Stage 1: 0-25% • Stage 2: 25-50% • Stage 3: 50-75% • Stage 4: 75-100% • Rows = Characteristics, Actions, Attitudes, and Keys to Success See handout or

  46. Stages of Quality 1 – 5 years Denial Reluctance Compliance Nirvana* Acceptance 1 2 3 4 Bargaining True Value Added Depression Cost Savings Training Baby Steps * Ideal condition of perfect harmony and peace

  47. Kubler-Ross1 Stages of grief: • Denial (No lab analysis in my project!) • Anger (I can not afford to write a QA plan, you write the plan for me) • Bargaining (Not much guidance! They will publish the report!, They have a QMP!, They did a QA plan a year ago, they’re world renowned!) • Depression (I don’t care anymore) • Acceptance (Okay I see the value let’s get together and talk about the key parts!) 1. Kubler-Ross, Elisabeth. 1969. On Death and Dying. ISBN 0-684-83938-5, Reprinted 1997, Simon & Schuster, Inc.

  48. Stage 1: 0-25%

  49. Stage 2: 25-50%

  50. QA = Quality Assistance For Enterprise Assurance We succeed as a team, or we fail as a team.