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Agenda: Moderator: Betsy Grim, Director Quality Assurance, OPP
Agenda: Moderator: Betsy Grim, Director Quality Assurance, OPP
Agenda: Moderator: Betsy Grim, Director Quality Assurance, OPP
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
3:50 4:10 4:10 4:20 4:20 5:00
Agenda
Moderator: Betsy Grim, Director Quality Assurance, OPP 3:30 4:30 Louis Blume, GLNPO QAM 2:30 2:45 Kevin Bolger, Region 5 QAM 2:45 3:00 Marcia Damato, GLNPO QA Team Quality Basics Regulations Requiring Quality Quality Implementation for grants
3:00 3:30
Break
Relevant Accomplishments
Co-chaired EPAs 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
Plan.
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
Establishes policy and program requirements for the conduct of QA, for all environmentally-related measurements performed by or on behalf of U.S. EPA
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
Quality System
A structured, documented Management System describing an organizations Policies, Objectives, Principles, Authorities, Responsibilities, Accountabilities, and Implementation Plan to ensure Quality in its Work Processes, Products and Services Provides an organizations framework through: Planning, Implementing, Assessing, Improving, Documenting
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 http://www.epa.gov/quality/informationguidelines/
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
Quality System
Policy/Regulations
EPA Requirements for Quality Management Plans (QA/R-2) EPA/240/B-01/002 March 2001
Guidance for Quality Assurance Project Plans (QA/G-5) EPA/240/R-02/009 December 2002
QMP
QAPP QAPP QAPP QAPP
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)
http://www.epa.gov/quality/qa-docs/r2-final.pdf
Measurement/Data Acquisition
Elements B1-B10
Assessment/Oversight
Elements C1-C2
A6 Project/Task Description
A7 Data Quality Objectives for Measurement Data A8 Special Training Requirements/ Certification A9 Documentation and Record
1) Hypothesis test, 2) expected measurements, 3) ARARs or other appropriate standards, 4) assessment tools (technical audits), 5) work schedule and required reports.
Decision(s), population parameter of interest, action level, summary statistics and acceptable limits on decision errors. Also, scope of the project (domain or geographical locale). Identify special training that personnel will need. Itemize the information and records that must be included in a data report package, including report format and requirements for storage, etc. MEASUREMENT/DATA ACQUISITION
B1 Sampling Process Designs (Experimental Design) B2 Sampling Methods Requirements B3 Sample Handling and Custody Requirements B4 Analytical Methods Requirements B5 Quality Control Requirements
Outline the experimental design, including sampling design and rationale, sampling frequencies, matrices, and measurement parameter of interest. Sample collection method and approach. Describe the provisions for sample labeling, shipment, chain-of-custody forms, procedures for transferring and maintaining custody of samples. Identify analytical method(s) and equipment for the study, including method performance requirements. Describe routine (real-time) QC procedures that should be associated with each sampling and measurement technique. List required QC checks and corrective action procedures.
GLNPO Added Note: The above elements are minimum requirements for a QAPP, and therefore, should be used during the QAPP development.
Non-EPA Organizations
48 CFR 46 (FAR 46) for contractors 40 CFR 30, 31, and 35 for assistance agreement recipients ANSI/ASQC E4-1994
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
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
Federal Government
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.
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)
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
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)
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.
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
Stages of Quality
1 5 years
Denial Reluctance Compliance Acceptance Nirvana*
2
Bargaining Depression Training
4
True Value Added Cost Savings
Baby Steps
* Ideal condition of perfect harmony and peace
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, theyre world renowned!) Depression (I dont care anymore) Acceptance (Okay I see the value lets 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.
Stage 1: 0-25%
Characteristics External pressure forces development of QS One person appointed to QA No formal infrastructure for training, review, assessment and inventory Appoint additional QA personnel, through management edict, try to harness enthusiastic people showing initiative Artful Dodgers (Hide from QM) Argue that project is not technical or no data, no sampling Management views quality as outside their primary focus Minimal understanding throughout organization, seen as an insurance policy Staff have narrow view of when quality is needed Develop generic QMP (not too prescriptive) Encourage broader ownership across the office Try to document existing processes that relate to Quality (e.g., workload planning, expenditures) Avoid using top down logic for selling Quality, vs explanation of the benefits
Actions
Attitudes
Keys to Success
Stage 2: 25-50%
Characteristics QMP approved QAPPs developed for some projects Polarization of QM and POs
Actions
QA staff identify delinquencies & try to fill gaps Training initiated, typically introductory Good opportunity for external MSRs Develop inventory of projects/expenditures Emphasize value of QA
Most see QA as bureaucratic exercise Difficult exchanges between QA staff & POs Problem: How will my QM fix this? Management takes ownership Develop inventory, capture quality during award phase, build rapport with grants, contract staff Build on positive behavior & ignore nay-sayers
Attitudes
Keys to Success
QA = Quality Assistance
For Enterprise Assurance
Stage 3: 50-75%
Characteristics QMP approved and partially implemented QMs involved in management meetings Management begins to ask QA questions POs employ systematic planning for all projects QA staff involved in project planning Inventory of projects 100% implemented Most staff believe QA provides value QM feels like part of the team and not tattle-tale Problem: How will we fix this? Management becomes enlightened by Quality status (answers to questions) QA staff must stay involved at project-level Recognize and reward QA successes Orient limited QA $ to high priorities
Actions
Attitudes
Keys to Success
Stage 4: 75-100%
Characteristics Quality system is comprehensive QA is a component of daily activities for all staff Peer review & info quality key parts of QS Managers are actively involved and well-trained Office is perceived positively by external clients Use QA training & experience in hiring criteria Staff use we terms instead of you terms Continually re-evaluate, QM provides data assessments that relate to office-wide goals Staff seek out QA personnel for assistance Staff are empowered to improve quality Staff reveal QA concerns - know theyll be heard QM integral part of project development PO seen as enforcer and not QM Hire people with positive QA attitudes Quality system relates to organizational goals
Actions
Attitudes
Keys to Success
Management
Questions
Why?
When a manager asks about the state of quality in their organization, they emphasize its importance and drive the improvement.
Fear of additional resource demands Narrow view of quality (e.g. focus on lab data), not seen as their function Not realizing the management tools associated with the quality process They do not have battle scars from poor quality
Stage 2 Questions
Focus on Inventory How many active projects do we support? What percent collect environmental information? How many of these projects have approved quality documentation?
Stage 3 Questions
Focus on Implementation
How many projects have been assessed to evaluate key quality concerns and quality implementation?
Stage 4 Questions
Focus on Reflection
Have true environmental outcomes been addressed? Have we discussed how these quality issues affect the decision? Is the final product disseminated, consistent with IQG and Peer Review (reproducible)?
Use the quality system (i.e., the quality framework) to align and coordinate towards the same goals (GPRA goals)
Educate and involve all components of the office
Define how quality is part of day-to-day activities Show value added aspects of the quality system Management, budget office, funding office, clerical, administrative, and information management staff all need to be onboard
Discuss quality issues as part of National Funding Guidance Discuss quality implementation and infrastructure when Regional Program Managers conduct program reviews with States and Tribes
The environmental community needs to be able to answer baseline/inventory questions, before we can prepare a quality implementation scorecard
How many active projects are there that collect environmental information? How many of them have approved quality documentation? How many have evaluated the quality of the final decisions?
If we cannot answer these questions for all projects, we should at least answer the questions that relate to our Strategic Plan/ GPRA goals
Next Steps?????
Help our managers to answer baseline quality questions. Utilize the annual QAARWP? Utilize the baseline data to evaluate if our quality tools are contributing effectively to Agency goals Identify the gaps and orient our limited quality resources
Next Steps?????
Help our managers understand the quality framework and reduce confusion how various new initiatives fit together to achieve our mission Do whatever we can to empower stakeholders with quality tools processes and resources
1. The quality system is not optional. 2. All staff in the office should have a responsibility for the quality of their work and of the organization, and have identifiable roles in the quality system.
*acquired from OWs Ten Commandments for QA (2004 QMP)
3. There is an individual identified within each organizational unit in the Office whose quality system activities are independent of the line management structure. 4. Quality is a critical responsibility of all levels of management within the Office and all management personnel have identifiable roles in the quality system. Managers are responsible for ensuring the allocation of funding for quality management activities, including intramural, extramural, and travel funds, as well as funding for personnel and qualityrelated training.
5. Quality can only be achieved through systematic planning, assessment, and corrective action. 6. The importance of the project, the risk of a decision error, the schedule for completion, and the available resources are used to establish the level of quality management applied to a given activity. These considerations must be addressed and documented during the planning phase of the activity.
7. The quality of any environmental data or information used by the Office must be assessed (known) and documented, regardless of the source.
8. All environmental decisions made by the Office must be evaluated relative to the quality of the underlying data and information and these evaluations must be documented.
Provide quality support to states through annual funding guidance. State funding is much more dynamic and politically driven than federal funding Encourage Regions/States to negotiate Quality System resources through the Environmental Performance Partnership Agreement (ENPPA)
Discuss Implementation of our Quality System at Regional/State/Tribal levels alleviating Regional ambiguity and inflexibility of quality process Allow delegated programs to use the Quality System to provide more efficient utilization of limited resources
Discuss process for Regional and State/Tribal implementation of goals and quality issues in revision to the QMP Provide opportunities for managers to take ownership of quality system
Conclusion
A true functional value-added quality system is not driven by approved documentation, but more so, by the activities implemented on a daily basis that enhance the quality of the environmental decision.
Great Lakes National Program Offices QMP: http://www.epa.gov/glnpo/qmp/index.html
Please send all comments and questions to: Louis Blume, GLNPO QM 312-353-2317; Blume.Louis@epa. gov
CONGRATULATIONS!
You have successfully completed the EPA Quality in Contracts and Grants Training
Please complete the course review form and be sure to mention potential Toolbox items If you would like to know more about the EPA Quality System or have any questions, please contact:
Quality Assurance Manager, or Quality System Coordinator http://intranet.epa.gov/quality/documents/qa-community.doc Quality staff: quality@epa.gov or 202-564-6830 Visit the EPA QA Web site at: http://www.epa.gov/quality
Resources
EPA Quality Requirements for Solicitations and Contracts intranet.epa.gov/quality/contracts.html