Quality System – What’s changing?

1. Quality System – What’s changing? EPA Requirements for Quality Management Plans And Quality Assurance Project Plans Ray Terhune, QAS

2. Why do we have A Quality Assurance System?? To increase the reliability of the data we use in environmental decision making

3. What drives EPA’s Quality System?

4. What is currently built into this requirement for a Quality System?? • A quality system is the sum total of the policies and procedures that are developed and implemented to ensure that quality is built into programs and work products. • A quality system covers both policy and process.

5. Who is covered by this order? • EPA Organizations • Non-EPA organizations funded by EPA including: • Contractors (48 CFR 46 ) • Assistance agreement recipients (40 CFR 30, 31 and 35) ; and • Other mechanisms, such as consent agreements in enforcement actions.

6. Applicability to Environmental Programs • 1. Characterization of environmental or ecological systems and the health of populations • 2. Direct measurement of environmental conditions or releases, including sample collection, analysis, evaluations and reporting of environmental data

7. Applicability to Environmental Programs (cont) • 3. The use of environmental data collected from other sources (“secondary data”), including literature, industry surveys, compilation of data from computerized databases and information systems, results from computerized models… • 4. The collection and use of environmental data relating to occupational health and safety of personnel in EPA facilities..

8. The primary documents of a Quality System are: Quality Management Plan (QMP)EPA QA/R-2: QA Requirements for Quality Management Plans Quality Assurance Project Plan(s) (QAPP)EPA QA/R-5: QA Requirements for Quality Assurance Project Plans

9. Quality Management Plan • “A quality management plan (QMP) documents how an organization structures its quality system and describes its quality policies and procedures, criteria for and areas of application, and roles, responsibilities, and authorities. It also describes an organization’s policies and procedures for implementing and assessing the effectiveness of the quality system”. • EPA Requirements for Quality Management Plans – EPA QA/R-2 (March 2001).

10. Are QMPs Good Forever?? • No - An EPA approved QMP is good for 5 years. • When the five years are up, the grantee or contractor must resubmit a QMP for a new round of review and approval by EPA.

11. Quality Assurance Project Plan • A QAPP is a project-specific document that contains a detailed description of environmental data collection activities and operations, the problems associated with a site, the sampling and analysis requirements, the decisions to be made, and the necessary QA/QC activities governing this effort.

12. So What’s the Difference?? • “The QMP may be viewed as the ‘umbrella’ document under which individual projects are conducted. The QMP is then supported by project-specific QAPPs. The QAPP is the ‘blueprint’ by which individual projects involving environmental data are implemented and assessed and how specific quality assurance (QA) and quality control (QC) activities will be applied during a particular project”.

13. A robust Quality System is important • The development of a rigorous quality system enables an organization collecting environmental data to have a higher level of confidence in this data so that it will be of known and documented quality and usable for its intended purpose. • The quality system reflects the organizations commitment to quality management principles and practices, tailored, when appropriate, by senior management to meet the organization’s needs.

14. What’s Changing?

15. “The draft Quality Standard for Environmental Data Collection, Production and Use by Non-EPA (External) Organizations contains no new requirements”

16. What are the high points? • The external standard is intended to document the specific requirements for addressing the QA language found in 40 CFR 46, 40 CFR 31 and 40 CFR 35. These regulations apply to external organizations that conduct activities that are funded by EPA and include the collection, evaluation and use of environmental data. • Organizations are required to have a quality system that conforms to ANSI/ASQ E4; to submit a Quality Management Plan which describes their quality system; and to prepare a Quality Assurance Project Plan for environmental data projects. • To promote efficiencies and more consistent documentation, EPA consolidated the requirements found in CIO 2105.0, EPA QA/R-2: QA Requirements for Quality Management Plans and EPA QA/R-5: QA Requirements for Quality Assurance Project Plans in the external standard.

17. Other points • When finally implemented, the new Quality standard will replace EPA QA/R-2: QA Requirements for Quality Management Plans and EPA QA/R-5: QA Requirements for Quality Assurance Project Plans) • The draft Standards provide greater clarity about QA requirements for environmental data projects; addresses modeling activities, which were not specifically addressed in the previous EPA Order CIO 2105.0 and provides greater alignment with the EPA Quality Policy (CIO 2106.0) EPA Quality Policy CIO 2106.0 (http://www.epa.gov/irmpoli8/policies/21060.pdf)

18. When does this apply? • Scope:  When there is Environmental Data Collection, Production, or Use. • When environmental data is produced by or for EPA (funds or expectation of acceptance/use/putting Agency name on it)

19. Associated documents • Draft Quality Management Plan Handbook: • This draft Handbook document will assist organizations in the development of a Quality Management Plan (QMP) that addresses the requirements found in the draft standard and Annex A. • This draft Handbook contains a description of the QMP review and approval process, combined QMP/QA Project Plans, and the general guidelines for QMP content. • Appendix A contains a crosswalk to the draft QA standard and annex.

20. Associated documents continued • Draft QA Project Plan Handbook: • This draft Handbook will assist organizations in the development of a QA Project Plan (QAPP) that addresses the requirements found in the draft standard and Annex B. • This draft Handbook contains three distinct chapters. Chapter 2 is for projects requiring the collection of new data; Chapter 3 is for projects making use of existing data; Chapter 4 is for projects involving modeling. Each chapter is self contained and may be used in conjunction with the Internal and External Standards. • Section E1 contains a crosswalk of the draft Handbook to the draft standards. • Section E3 contains a crosswalk of the draft Handbook to the current Guidance for Quality Assurance Project Plans (EPA QA/G-5).

21. Will existing QMPs and QAPPs have to be redone to comply with this? • Grandfathering of existing quality documents is written into this.. • Whoever approves your QAPP now will continue to approve them. (OEI will not be changing that process) • The graded approach to QAPPs will still be allowed. (Simpler QAPPs for simple projects, more complex QAPPs for more complex, expensive projects)

22. Will it change the approval process? • No changes to the approval processes for either QAPPs or QMPs are anticipated.

23. Is OEI finished addressing comments? • OEI is still addressing comments. Some areas that will probably change include: • statistical or economic analyses using environmental data.. Likely will have major re-write

24. Region 4 QA Contacts • Danny France, Region 4 Quality Assurance Manager • 706-355-8738 • france.danny@epa.gov • Marilyn Maycock, Chief Quality Assurance Section • 706-355-8553 • maycock.marilyn@epa.gov • Daniel Garver, Air, Pesticide & Toxics Division, QC Coordinator • 404-652-9839 • garver.daniel@epa.gov • Ray Terhune, DMR-QA/ATP Coordinator Quality Assurance Section • 706-355-8557 • terhune.ray@epa.gov