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

(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.

David

L.

Elam,

Jr.

Principal

Consultant

[email protected]

919.967.0500

(2)

Presentation

Will

Review

New

Regulatory

Requirements for Source Tests at US Power Plants

Requirements

for

Source

Tests

at

US

Power

Plants

1

Introduce Part 75 Regulations

1.

Introduce Part 75 Regulations

2.

Highlight Minimum Competency Rule Requirements

Describe Rationale for Minimum Competency Rule

3.

Describe Rationale for Minimum Competency Rule

Promulgation

4

Outline the essentials of a compliance strategy

4.

Outline the essentials of a compliance strategy

(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

ASTM

‐

(4)

Minimum

Competency

Rule

Describes

the

Essence

of

Compliance

for

the

AETB



Statement of Conformance to ASTM D7036-04

Statement of Conformance to ASTM D7036 04

–

Can be limited to only Part 75 work

Quality Manual



Quality Manual



Qualified Individual on Site

–

Proof of QI claim



Internal & External Audits



Performance Data



Effective 27 March 2012

(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

)

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:

•

Note:

– ASTM D 7036-04 is referenced in the rule – ASTM D 7036-04 is currently being revised

(6)

What

Is

Quality?

“Quality is fitness for use or purpose ”

Quality is fitness for use or purpose.

Joseph Juran

Simple definition covers it all

–

Simple definition covers it all

–

Focus is on the outcome, not necessarily the steps

B t

d fi iti

d

t h t h

h

–

But

, definition does not shortchange process when

(7)

The

Market

‐

driven

Approach

to

Quality

Standards

Permits

Methods

Agency

Oversight

Capable

AETB

Informed

Source

A

“Fit

for

Use”

Source

Test

Free Market

Tensions Drive

Quality

Services

(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 ”

lowest bidder.



But regulatory oversight has changed too.

Shrinking budgets mean:

–

Shrinking budgets mean:

•

Less observation, more electronic reporting

(9)

Society

Seeks

a

Guarantor

or

Enforcer

when

Free

Market

Forces

Fail

Standards

Permits

Methods

Agency

---

Oversight

Capable

---

AETB

Informed

---

Source

A

“Fit

for

Use”

Source

Test

---Free Market

Tensions Erode

with Loss of

Accountability

(10)

AETB

Minimum

Competency

Rule

Imposes

Federal

Law

to

Improve

Source

Test

Quality

Federal

Regulation

Seeks

to

Restore

Accountability

Standards Clear G id

Standards

Permits

Methods

Standards Censure Fines Guidance & Backup

Fit

for

Use

AETB:

Agency

Oversight

A

AETB:

ASTM

‐

D7036

Conforming

QMS

&

Informed

Source

“Fit

for

Use”

Source

Test

&

(11)

What

is

a

Qualified

Individual?



A QI must meet experience criteria.

Q

p

–

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

f

t AETB’ QM

d ASTM D 7036 i

ll

t

conform to AETB’s QM and ASTM D 7036 in all respects.



QI qualification credentials must be available for inspection

at the test location

at the test location.



The only external exam provider is the Source Evaluation

Society and issues a QSTI credential which satisfies QI

Soc ety a d ssues a QS

c ede t a

c sat s es Q

(12)

What

Does

It

Mean

to

“Conform

to

ASTM

D

7036?”



For most quality standards, conformance is demonstrated

q

y

,

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

(13)

Complying

with

Minimum

Competency

Rule:

A

Five

Step

p

Program

g

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.

y

(14)

Will

an

Imposed

Standard

Improve

Source

Test

Quality?



A standard does not have the power to improve

quality.



But people do



But people do.

–

Source testers who accept and advance the standard will.

Sources who value conformance enough to examine AETB

–

Sources who value conformance enough to examine AETB

credentials/claims will.

–

Accrediting organizations and auditors who recognize the

value of function over form 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,

th

till b

ibilit if th

t

ti

the source still bears responsibility if the source testing

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

li

f

(16)

References

&

Resources

(1/2)

1. Report of EPA’s Oversight of State Stack Testing Programs, 2000-P-0019, September 11, 2000 2. 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. 3801-21, August 12, 1994

3. ASTM D7306-04; Standard Practice for the Competence of Air Emission Testing Bodies; American ; p g ;

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;

http://www.astm.org/

4. Stack Testing Accreditation Council; http://www.betterdata.org/

5. Federal Register, Volume 71, No. 162, pp. 49253-49308. 40 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, 2006

6 Federal Register Volume 73 No 16 pp 4311-4377 40 CFR Parts 72 and 75 Revisions to the 6. Federal Register, Volume 73, No. 16, pp. 4311 4377. 40 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, 2008

7. Federal Register, Volume 76, No. 59, pp. 17288-17325. 40 CFR Parts 72 and 75, Protocol Gas

Verification Program and Minimum Competency Requirements for Air Emission Testing; Final Rule US Verification Program and Minimum Competency Requirements for Air Emission Testing; Final Rule, US

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References

&

Resources

(2/2) 8. Source Evaluation Society; http://www.sesnews.org/

9. Escoe, A. The Practical Guide to People-Friendly Documentation, Second Edition, ASQ Press, 1998 10. Robitaille, D. Document Control: A Simple Guide to Managing Documentation, Paton Press, 2005 11. EPA Requirements for Quality Management Plans, EPA/240/B-02/002, March 2001

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

13. Elam, D. Freedom through Conformity: The Value of Standard Operating Procedures, EM, July 2007,

pp. 24-25

14. Elam, D. What a Tangled Web We Weave When Accreditation We Attempt to Achieve, Presented at g p

35th Annual Stationary Source Sampling and Analysis for Pollutants (SSSAP), Session 6, March 23, 2011

15. EPA Promulgates Minimum Competency Requirements for Source Testing Firms Performing Part 75