Quality Management System Requirements for Source Testing Firms Performing Part 75 Test Programs

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1 Quality Management System Requirements for Source Testing Firms Performing Part 75 Test Programs PNWIS 2011 Session 7 11 November 2011 David L. Elam, Jr. Principal Consultant delam@summaconsultants.com

2011 Session 7 11 November 2011 David L. Elam, Jr.

2 Presentation Will Review New Regulatory Requirements for Source Tests at US Power Plants 1. Introduce Part 75 Regulations 2. Highlight Minimum Competency Rule Requirements 3. Describe Rationale for Minimum Competency Rule Promulgation 4. Outline the essentials of a compliance strategy 2

Highlight Minimum Competency Rule Requirements 3.

3 Location & Direction Clean Air Act & Amendments is statutory basis for Air Quality Regulation in US Title IV of Clean Air Act addresses Acid Deposition Regulations applicable to monitoring of acid deposition emission sources are found in the Title 40 of the Code of Federal Regulations in Part 75 (40 CFR Part 75) Part 75 Sources The Minimum Competency Rule applies to stack testing firms [Air Emission Testing Bodies (AETBs)] when testing Part 75 sources AETB s must conduct Part 75 test programs under an ASTMconforming Quality Management System 3

Regulations in Part 75 (40 CFR Part 75) Part 75 Sources The Minimum Competency Rule applies to stack testing firms [Air Emission Testing

4 Minimum Competency Rule Describes the Essence of Compliance for the AETB Statement of Conformance to ASTM D Can be limited to only Part 75 work Quality Manual Qualified Individual on Site Proof of QI claim Internal & External Audits Performance Data Effective 27 March

only Part 75 work Quality Manual Qualified Individual on Site Proof of

5 What is ASTM D 7036? The Short Answer: A quality management standard applicable to firms that conduct source testing (Standard Practice for the Competence of Air Emission Testing Bodies) A consensus standard based on ISO17025, General Requirements for the Competence of Testing and Calibration Laboratories A requirement for source testing firms that perform Part 75 emission testing programs beginning 3/27/2012 Note: ASTM D is referenced in the rule ASTM D is currently being revised 5

Competence of Air Emission Testing Bodies) A consensus standard based on ISO17025, General Requirements for the Competence of

6 What Is Quality? Quality is fitness for use or purpose. Joseph Juran Simple definition covers it all Focus is on the outcome, not necessarily the steps But, definition iti does not shortchange h process when process is integral to fitness for use or purpose 6

outcome, not necessarily the steps But, definition iti does not

7 The Market driven Approach to Quality Standards Permits Methods Agency Oversight Capable AETB Informed Source Free Market Tensions Drive Quality Services A Fit for Use Source Test 7

8 EPA Reports that the Market Driven Approach is Not Working for Source Testing Preamble to Final Rule for Minimum Competency Requirements for Air Emission Testing: EPA believes the evidence is strong that unqualified, under-trained and inexperienced testers are routinely deployed on testing projects. There are many reasons why voluntary compliance has not worked, including disagreement among stack test companies on a minimum competency standard, and the sources often used practice of hiring the lowest bidder. But regulatory oversight has changed too. Shrinking budgets mean: Less observation, more electronic reporting Delayed, and less critical report reviews 8

There are many reasons why voluntary compliance has not worked, including disagreement among stack test companies on a minimum competency standard, and the sources

9 Society Seeks a Guarantor or Enforcer when Free Market Forces Fail Standards Permits Methods Agency Oversight Capable AETB Informed Source Free Market Tensions Erode with Loss of Accountability A Fit for Use Source Test 9

10 AETB Minimum Competency Rule Imposes Federal Law to Improve Source Test Quality Federal Regulation Seeks to Restore Accountability Standards Censure Fines Fit for Use AETB: ASTM D7036 Conforming QMS & Onsite QI Standards Permits Methods Agency Oversight A Fit for Use Source Test Clear Guidance & Backup Informed Source 10

for Use AETB: ASTM D7036 Conforming QMS & Onsite QI Standards Permits Methods

11 What is a Qualified Individual? A QI must meet experience criteria. At least 10 tests for which they are seeking qualification or at least 1 year of general emission testing experience A QI must pass a qualification exam. A QI must sign a statement agreeing that all tests will conform to AETB s QM and ASTM D 7036 in all respects. QI qualification credentials must be available for inspection at the test location. The only external exam provider is the Source Evaluation Society and issues a QSTI credential which satisfies s QI requirements. 11

qualification exam. A QI must sign a statement agreeing that all tests will conform to AETB s QM and ASTM D 7036 in all respects.

12 What Does It Mean to Conform to ASTM D 7036? For most quality standards, conformance is demonstrated by third party audit. Conformance to the ASTM D 7036 can be demonstrated in two ways: Management certification letter (self-declaration) Certificate of accreditation (or interim accreditation) issued by recognized, national accreditation body Stack Testing Accreditation Council (STAC) 12

Conformance to the ASTM D 7036 can be demonstrated in two ways: Management certification letter

13 Complying with Minimum Competency Rule: A Five Step Program for AETBs 1. Be who you say you are. 2. Describe how you conduct yourself to meet the ASTM D7036 standard. 3. Conduct yourself as you have described. 4. Get better at what you do. 5. Be able to prove your claims. 13

Describe how you conduct yourself to meet the ASTM D7036 standard. 3.

14 Will an Imposed Standard Improve Source Test Quality? AA standard does not have the power to improve quality. But people do. Source testers who accept and advance the standard will. Sources who value conformance enough to examine AETB credentials/claims will. Accrediting organizations and auditors who recognize the value of function over form will. Regulators who follow through on their authorities will. 14

Source testers who accept and advance the standard will.

15 Summary ASTM D 7036 will change source testing in the US beginning with the power industry. Although source testing firms must adopt the standard, the source still bears responsibility if the source testing ti firm does not furnish a QI or conform to ASTM D7036 on a specific test program. AETBs are not free of responsibility. QIs for all practical purposes, QSTIs are AETBs first line of conformance. 15

source testing ti firm does not furnish a QI or conform to ASTM D7036 on a specific test program.

16 References & Resources (1/2) 1. Report of EPA s Oversight of State Stack Testing Programs, 2000-P-0019, September 11, Hosenfeld, J.H; Holt, C.F. Accreditation and Certification Criteria for Measurement of Emissions: National Accreditation/Certification Organization; U.S Environmental Protection Agency; Emission Measurement Branch; Project Report, Contract No. 68-D2-0165, Work Assignment No. 21, MRI Project No , August 12, ASTM D ; Standard Practice for the Competence of Air Emission Testing Bodies; American Society for Testing and Materials, Committee D22 on the Sampling and Analysis of Atmospheres, Subcommittee D22.03 on Ambient Atmospheres and Source Emissions, August 2004; 4. Stack Testing Accreditation Council; 5. Federal Register, Volume 71, No. 162, pp CFR Parts 72 and 75, Revisions to the Continuous Emissions Monitoring Rule for the Acid Rain Program, NO x Budget Trading Program, the Clean Air Interstate Rule, and the Clean Air Mercury Rule; Proposed Rule, US Government Printing Office, August 22, Federal Register, Volume 73, No. 16, pp CFR Parts 72 and 75, Revisions to the Continuous Emissions Monitoring Rule for the Acid Rain Program, NO x Budget Trading Program, the Clean Air Interstate Rule, and the Clean Air Mercury Rule; Final Rule, US Government Printing Office, January 24, Federal Register, Volume 76, No. 59, pp CFR Parts 72 and 75, Protocol Gas Verification Program and Minimum Competency Requirements for Air Emission Testing; Final Rule, US Government Printing Office, March 28,

S Environmental Protection Agency; Emission Measurement Branch; Project Report, Contract No. 68-D2-0165, Work Assignment No. 21, MRI Project No. 3801-21, August 12, 1994 3.

17 References & Resources (2/2) 8. Source Evaluation Society; 9. Escoe, A. The Practical Guide to People-Friendly Documentation, Second Edition, ASQ Press, Robitaille, D. Document Control: A Simple Guide to Managing Documentation, Paton Press, EPA Requirements for Quality Management Plans, EPA/240/B-02/002, March Guidance for Preparing Standard Operating Procedures (SOPs), EPA/600/B-07/ Elam, D. Freedom through Conformity: The Value of Standard Operating Procedures, EM, July 2007, pp Elam, D. What a Tangled Web We Weave When Accreditation We Attempt to Achieve, Presented at 35th Annual Stationary Source Sampling and Analysis for Pollutants (SSSAP), Session 6, March 23, EPA Promulgates Minimum Competency Requirements for Source Testing Firms Performing Part 75 Work, Source Evaluation Society Newsletter, Volume XXXV, No. 1, Quarter 1,

Guidance for Preparing Standard Operating Procedures (SOPs), EPA/600/B-07/001 13. Elam, D.

QUALITY MANAGEMENT SYSTEM REQUIREMENTS General Requirements. Documentation Requirements. General. Quality Manual. Control of Documents

Chapter j 38 Self Assessment 729 QUALITY MANAGEMENT SYSTEM REQUIREMENTS General Requirements 1. Establishing and implementing a documented quality management system 2. Implementing a documented quality