ECOS Information Session

Draft EPA Quality Documents

February 13, 2013

Presented by

EPA Quality Staff,

Office of Environmental Information

For meeting purposes only
Agenda

• Welcome 

• Purpose of Information Session

• Overview

• Next Steps

• Questions

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Purpose of Information Session

• To share the proposal to issue a Quality Standard for 

external organizations

• To provide general information about the proposed 

Quality documents and the rationale for the change

• To clarify the process for submitting questions and 

comments 

• To provide the next steps in the process

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Why the concern about “quality”?

“[Quality Assurance] ensures that the data relied upon 

for decision making is of known and documented quality 

and is based on sound scientific principles.”

EPA Administrator Lisa Jackson, May 2009 

“Quality Assurance refers to the ... systematic 

measurement, comparison with a standard, monitoring 

of processes and an associated feedback loop that 

confers error prevention.”

Wikipedia, January 2013

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Benefits of documenting QA

Documentation of processes and procedures reduces 

vulnerabilities and increases data reliability and 

defensible decisions:

• scientific data integrity 

• justifiable resource expenditures

• transparent activities

• reliable and defensible decisions

• often results in burden reduction

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The Graded Approach

Excessive implementation of QA procedures and extensive 

documentation of protocols is not needed. QA activities 

and documentation should be proportionate with the:

• importance of the project or study

• resources available

• organizational management and structure

• intended use of the data

• potential risks of making wrong decisions

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Good documentation 

• Sound QA activities and good documentation are 

achieved through the use of Quality Management Plans 

(QMPs) and Quality Assurance Project Plans (QAPPs).

• A QMP reflects the activities and policies common to the 

organization. It is the ‘umbrella’ under which individual 

projects are conducted.

• A QAPP contains the instructions by which individual 

projects are implemented. It documents exactly what 

needs to be done, how to do it, and when it will be done.

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The Standards

Proposed Quality Standards :

 Quality Standard for Environmental Data 

Collection, Production and Use by EPA 

Organizations CIO Standard 2106-S-01 

 Quality Standard for Environmental Data 

Collection, Production and Use by non-EPA 

Organizations CIO Standard 2106-S-02 

They are similar but tailored to meet the needs of specific 

users. The correlation between them is very high and cover the 

same technical areas. The only difference between them 

is in internal procedural matters and EPA responsibilities.

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Rationale for the Change

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• Standards were developed to support the EPA Quality 

Policy (CIO 2106.0) issued in 2008

• Standards are intended to incorporate and clarify the 

QA requirements for EPA organizations that are found 

in the EPA Order (CIO 2105.0)

• Standards are intended to incorporate and clarify the 

QA requirements for non EPA organizations found in 

external agreements
Replaces existing requirements

When CIO Standard 2106-S-02 (External Standard) is 

issued, it will replace:

• QA/R-2 for Quality Management Plans (QMPs)

• QA/R-5 for QA Project Plans (QAPPs) 

Organizations continue to develop: 

• QMPs 

• QAPPs 

The External Standard continues the requirement 

for these Plans to be approved before environmental

data are collected, produced or used. 

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How do they differ from existing?

Compared with the existing requirements, these Standards are:

• reflective of current practices in quality

• more explicit in what is required 

• consistent with EPA Quality Policy CIO 2106

• better organized 

There will be very little change in practical application 

and will result in stronger QMPs and QAPPs

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Coverage of the Standards

Main document:

• Content of Quality Management Systems and Quality 

documentation

• Planning, implementation, and assessment processes

• Roles and responsibilities of management and staff

Three Annexes:

• A. Requirements for QMPs (normative)

• B. Requirements for QAPPs (normative)

• C. Guidelines on Project Planning (informative) 

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Accompanying Handbooks

Handbooks have been made for use with the Standards:

• Preparing Quality Management Plans

• Developing Quality Assurance Project Plans

These non-mandatory advisory documents will: 

• Address QA requirements found in the Standards

• Replace previous related guidance documents

• Provide greater clarity on relevant QA practices

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Rationale for the Change

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• EPA plans to issue a Guidance document to support 

the EPA Quality Policy (CIO 2106.0). 

• QA Handbooks are intended to provide detailed 

practical advice on how to prepare the QA 

documents described in the Quality Standards 
What do the Handbooks replace?

These Handbooks replace:

• Unofficial advice on QMPs

• Guidance for QA Project Plans (EPA QA/G-5)

These Handbooks are not “stand-alone” documents 

but intended to be used together with the Standards.

References to specific parts of the Standards are 

included in each section of the Handbooks.

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Are there large differences between 

Handbooks and the old Guidance?

No.

The QAPP Handbook incorporates all the material in the old

Guidance (QA/G-5) and adds some more advice.

QA/G-5 QAPP Handbook

2A. Project Management 2.2 Project Management

2B. Data Generation & Acquisition 2.3 Data Acquisition

2C. Assessment & Oversight 2.4 Assessments

2D. Data Validation & Usability 2.5 Evaluation of Usability

3.1 Projects Using Existing Data 3.1 – 3.5 Evaluation of

Existing Data

...but there are differences

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Differences for example?

The QAPP Handbook adds the following topics: 

• qualitative comparisons to acceptance criteria

• evaluation of unconventional measurements

• qualitative and quantitative evaluations of usability

• use of existing data

• qualitative comparisons 

• information on modeling

• use of data quality indicators

• use of quality control samples

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How to submit questions and 

comments to EPA

• Go to www.regulations.gov 

• Enter EPA–HQ–OEI–2012–0774 in the search line 

• Add a check in the box “Supporting & Related Material“

• When leaving comments, go back to the results page 

click on “Comment Now!”

• Submit comments in the text box or by uploading a file

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Next Steps

• Comments are due by February 28, 2012

• EPA plans to post this presentation in the docket

• EPA plans to address all comments and questions 

received in the docket

• EPA response to questions and comments will be 

placed in the docket by April 15, 2013

• EPA plans to issue the Quality Standards and QA 

Handbooks in April 2013.

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QUESTIONS

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