Amanda Rosemary

EPA documents Homework

EPA documents provide guidance on many different aspects of sampling, project, procedures and methods. The following documents are a sample of the materials developed and provided by the EPA to help us prepare our projects with accuracy and consistency. Answer the questions for each document.

QA/G-1 Developing Quality systems for Environmental Programs

1. Summarize what a quality system is, purpose and scope and what the benefits are.

A quality system is the means by which an organization manages its quality aspects in a systematic, organized manner.

The EPA Quality System is a management system that provides the necessary elements to plan, implement, document, and assess the effectiveness of QA and QC activities applied to environmental programs conducted by or for EPA. The EPA Quality System encompasses the collection, evaluation, and use of environmental data by or for EPA, and the design, construction, and operation of environmental technology by or for EPA

Benefits: Scientific Data Integrity, Reduced or Justifiable Resource Expenditures, Proper Evaluation of Internal and External Activities, Reliable and Defensible Decisions, Burden Reduction

2. Summarize the specification for EPA organizations and non-EPA organizations (summarize which codes)

EPA organizations EPA, 2000b	non-EPA organizations
1. Conform to the minimum specifications of ANSI/ASQ E4-1994	any organization or individual under a direct contract to EPA to furnish services or items or perform work (i.e., a contractor) under the authority of 48 CFR 46, (including applicable work assignments, delivery orders, and task orders);
2. Identify a QA Manager who reports on quality issues to senior executive leadership and ensure that this QA Manager functions independently of direct environmental data generation, model development, or technology development responsibility.	institutions of higher education, hospitals, and other nonprofit recipients of financial assistance (e.g., grants and cooperative agreements) under the authority of 40 CFR 30;
3. Develop a Quality Management Plan and implement this plan following Agency approval.	commercial business enterprises;
4. Provide sufficient resources to implement the quality system	state, local, and tribal governments receiving financial assistance under the authority of 40 CFR 31 and 35; and
5. Perform assessments of the effectiveness of the quality system at least annually and implement corrective actions based on assessment results in a timely manner.	other government agencies receiving assistance from EPA through extramural agreements
6. Submit a QA Annual Report and Work Plan for the organization that summarizes the previous year’s activities and outlines the work proposed for the current year.
7. Use a systematic planning approach to develop acceptance or performance criteria for all work covered by the EPA Quality System.
8. Have approved QA Project Plans, or equivalent documents, for all applicable EPA projects and tasks involving environmental data
9. Assess existing data when used to support Agency decisions or other secondary purposes to verify that they are of sufficient quantity and adequate quality for their intended use.
10. Implement Agency-wide Quality System requirements in all applicable EPA-funded extramural agreements.
11. Implement corrective actions based on assessment results.
12. Provide appropriate training for all management and staff to assure that QA and QC responsibilities and requirements are understood at every stage of implementation.

3. What are the elements for Environmental Data of the Quality System Standard?

11. Planning and Scoping

12. Design of Data Collection

13 Implementation

14. Assessment and Response Activities

15. Assessment and Data Usability

4. What are the Phases of the QS developments and provide a brief summary of each?

Phase 1: initiation	strategic direction is set and organizational resources are assigned to begin the process
Phase 2: development	the procedures, documents, and tools that form the quality system are brought together
Phase 3: implementation	system is made operational through training and execution of the quality system procedures throughout the organization
Phase 4: ongoing maintenance and improvement	system is monitored and evaluated to ensure that it continues to satisfy the organization’s needs and to identify and implement opportunities for improvement

5. What is the Shewhart cycle?

C Plan—Analyze the situation, develop solutions;

C Do—Implement the planned solutions;

C Check—Assess the results of the implementation; and

C Act—Take corrective action after assessment

QA/G-3 Assessing Quality Systems

1. Summarize the purpose of AQS.

Improve the quality system, provide valid feedback to management on the adequacy, implementation, and effectiveness of the quality system

QA/G-4 Systematic Planning Using the Data Quality Objectives Process

1. What is the purpose of the DQO process?

develop performance and acceptance criteria (or data quality objectives) that clarify study objectives, define the appropriate type of data, and specify tolerable levels of potential decision errors that will be used as the basis for establishing the quality and quantity of data needed to support decisions

2. What are the elements of systematic planning?

· Organization: Identification and involvement of the project manager, sponsoring organization and responsible official, project personnel, stakeholders, scientific experts, etc. (e.g., all customers and suppliers).

· Project Goal: Description of the project goal, objectives, and study questions and issues. Schedule: Identification of project schedule, resources (including budget), milestones, and any applicable requirements (e.g., regulatory requirements, contractual requirements).

· Data Needs: Identification of the type of data needed and how the data will be used to support the project’s objectives. Criteria: Determination of the quantity of data needed and specification of performance criteria for measuring quality.

· Data Collection: Description of how and where the data will be obtained (including existing data) and identification of any constraints on data collection.

· Quality Assurance (QA): Specification of needed QA and quality control (QC) activities to assess the quality performance criteria (e.g., QC samples for both field and laboratory, audits, technical assessments, performance evaluations, etc.).

· Analysis: Description of how the acquired data will be analyzed (either in the field or the laboratory), evaluated (i.e., QA review/verification/validation), and assessed against its intended use and the quality performance criteria.

3. Explain the 7 steps of the DQO process.

· The first five steps are primarily focused on identifying qualitative criteria

• the nature of the problem that has initiated the study and a conceptual model of the environmental hazard to be investigated;

• the decisions or estimates that need to be made and the order of priority for resolving them;

• the type of data needed; and

• an analytic approach or decision rule that defines the logic for how the data will be used to draw conclusions from the study findings.

· The sixth step establishes acceptable quantitative criteria on the quality and quantity of the data to be collected, relative to the ultimate use of the data

· In the seventh step of the DQO Process, a data collection design is developed that will generate data meeting the quantitative and qualitative criteria specified at the end of Step 6

4. Explain DQO iteration.

QA/G-5 Quality Assurance Project Plans (QAPP)

1. What is a QAPP and what is the purpose?

The QA Project Plan documents the results of a project’s technical planning process, providing in one place a clear, concise, and complete plan for the environmental data operation and its quality objectives and identifying key project personnel

2. What is the difference between a QAPP and Quality Management Plan?

A Quality Management Plan describes an organization’s quality system, i.e., its systematic approach to quality assurance, while a QA Project Plan describes the necessary QA procedures, quality control (QC) activities, and other technical activities that will be implemented for a specific project or program.

3. What are the 24 elements of a QAPP? Summarize each element.

Title and Approval Sheet	This element identifies key project officials and documents their approval of the QA Project Plan. The signature dates indicate the earliest date when the project can start (its effective date). This approval information is typically the first page of the QA Project Plan, and called a Title and Approval Sheet. It can also be a separate memorandum depending on the organization’s administrative policy
Table of Contents	The Table of Contents allows the reader of the QA Project Plan to locate the different information sections
Distribution List	This list identifies all individuals who should get a copy of the approved QA Project Plan, either in hard copy or electronic format, as well as any subsequent revisions
Project/Task Organization	This element allows you to rapidly identify the roles and responsibilities of those individuals involved in the project and their different organizations. It also quickly identifies lines of authority and reporting between these individuals and organizations.
Problem Definition/Background	This element gives the reader an overview of the problem to be solved, along with any pertinent background information for the project. It describes why the project will be done and what needs to be done.
Project/Task Description	This element is a management overview or summary of the work to be detailed in the remaining sections of the QA Project Plan. It describes the approach taken to address the project’s objectives, connecting what is needed to how it will be obtained.
Quality Objectives and Criteria for Measurement Data	This element describes quality specifications at two levels: (1) at the level of the decision or study question, and (2) at the level of the measurements used to support the decision or study question.
Special Training/Certification	This element identifies any special or non-routine training or certifications that are necessary for project personnel or the laboratory to successfully complete the project.
Documents and Records	This element includes information concerning the management of project documents and records, including this QA Project Plan. Management of project data is covered later in Element B10, Data Management
Sampling Process Design (Experimental Design)	This element describes the project’s data collection or research experimental design. Keys to this element are the assumptions made and how the data will be obtained. This element explains the “how and why” of the project’s information collection design to ensure that the appropriate data are collected for this project
Sampling Methods	This element details how samples or information will be collected consistently between locations and by all sampling teams, with no contamination being introduced during collection. If a portion of the data collection will be performed without the collection of discrete samples, as in situ or remote sensing monitoring, this element details how the instruments will be deployed and operated to ensure that the electronic data will not be corrupted or lost.
SAMPLE HANDLING AND CUSTODY	This element describes your efforts to have each collected sample retain its original physical form and chemical composition through collection to final disposal. It also identifies maintenance of custody, i.e., possession, of the sample. For in situ and remote sensing measurements, the same issues apply to the records of these measurements.
Analytical Methods	This element identifies the procedures to analyze samples and how good these have to be, i.e., their performance criteria, to support any decisions to be made with the data
Quality Control	There is potential variability in any sample collection, analysis, or measurement activity, with field variability generally contributing more than laboratory variability. In an environmental monitoring project, total study error can be divided into between-sampling-unit variability (influenced by sampling design error and inherent spatial variability) and within-sampling-unit variability (due to small-scale within unit variability, and variability due to sampling, analytical, and data manipulations). This section lists those checks that can be performed to estimate that variability
Instrument/Equipment Testing, Inspection, and Maintenance	This element describes how project personnel will know that the equipment will work properly when needed
Instrument/Equipment Calibration and Frequency	This element identifies how you will ensure continual quality performance of any equipment and instruments.
Inspection/Acceptance of Supplies and Consumables	Not all projects will need supplies or consumables considered as “critical” to the project. For those projects that do, this element documents your system for having the right critical field and laboratory supplies and consumables available.
Non-direct Measurements	This element addresses data obtained from existing data sources, not directly measured or generated in this project. In addition to listing the information to be obtained, discuss here your intended use of that information, for example, whether it is central or ancillary to the project, and your criteria for accepting and limiting use of that information
Data Management	This element gives an overview of the management of the data generated throughout the project.
Assessments and Response Actions	This element gives information concerning how a project’s activities will be assessed during the project to ensure that the QA Project Plan is being implemented as approved
Reports to Management	This element documents how management will be kept informed of project oversight and assessment activities and findings.
Data Review, Verification, and Validation	This element lists your criteria for deciding to accept, reject, or qualify project information to be obtained.
Verification and Validation Methods	This element identifies the methods or processes for verifying and then validating project information
Reconciliation with User Requirements	This element is to describe how you will evaluate the validated data to see if it answers the original questions asked, i.e., the measurement quality objectives or data quality objectives. This is the final assessment of the data quality and the culmination of the entire QA process for the project

QA/G-5M QAPP for Modeling

1. What does the QAPP for modeling document help you develop?

2. Why is this document important?

QA/G-5S Choosing a sampling design for environmental data collection

1. Why is selecting a sampling plan important?

A well-developed sampling design plays a critical role in ensuring that data are sufficient to draw the conclusions needed

2. What does a sampling plan consist of?

A complete sampling design indicates the number of samples and identifies the particular samples. Also, nclude an explanation and justification for the number and the positions/timings of the samples

3. Summarize the following sampling methods. Include when each would be appropriate to be used.

a. Judgmental Sampling

the selection of sampling units is based on knowledge of the feature or condition under investigation and on professional judgment and it is distinguished from probability-based sampling in that inferences are based on professional judgment, not statistical scientific theory

b. Simple Random Sampling

particular sampling units ) are selected using random numbers, and all possible selections of a given number of units are equally likely

c. Stratified Sampling

the target population is separated into nonoverlapping strata, or subpopulations that are known or thought to be more homogeneous so that there tends to be less variation among sampling units in the same stratum than among sampling units in different strata

d. Systematic and Grid Sampling

samples are taken at regularly spaced intervals over space or time. An initial location or time is chosen at random, and then the remaining sampling locations are defined so that all locations are at regular intervals over an area (grid) or time (systematic)

e. Ranked Set Sampling

It is an innovative design that can be highly useful and cost efficient in obtaining better estimates of mean concentration levels in soil and other environmental media by explicitly incorporating the professional judgment of a field investigator or a field screening measurement method to pick specific sampling locations in the field

f. Adaptive Cluster Sampling

n samples are taken using simple random sampling, and additional samples are taken at locations where measurements exceed some threshold value

g. Composite Sampling

volumes of material from several of the selected sampling units are physically combined and mixed in an effort to form a single homogeneous sample, which is then analyzed

QA/G-6 Preparing Standard Operating Procedures (SOPs)

1. What are SOPs? Explain thoroughly, do not just expand the acronym.

2. What are the benefits of using SOPs?

reduced work effort, along with improved comparability, credibility, and legal defensibility

3. What are the different types of SOPs?

SOP Preparation

SOP Review and Approval

Frequency of Revisions and Reviews

Checklists

Document Control

SOP Document Tracking and Archival

QA/G-8 Data Verification and Data Validation

1. What is data validation?

is an analyte- and sample-specific process that extends the evaluation of data beyond method, procedural, or contractual compliance (i.e., data verification) to determine the analytical quality of a specific data set

2. What is data verification?

is the process of evaluating the completeness, correctness, and conformance/compliance of a specific data set against the method, procedural, or contractual requirements

3. What is data integrity?

QA/G-9S DQA: Statistical Methods for Practitioners

1. By using DQA, what four questions can the user be able to answer?

2. What are the five steps included in DQA?

3. Discuss measures of association.

4. Discuss Pearson’s correlation coefficient.

5. What other types of correlations are discussed in this document.

6. Discuss the different graphical representation methods.

7. Discuss Posting plots, Symbol plots and Bubble plots and Geographic Information Systems (GIS) applications.

8. Briefly discuss and compare probability distributions. I.e. when can we use them in environmental data analysis?

9. How do we select a statistical method?

10. Discuss the different population sizes.

11. Discuss distributional assumptions.

12. Discuss testing for trends.

13. Discuss outliers.

14. Discuss dispersions.

15. Discuss transformations.

16. Discuss independence.

17. Discuss values below detection limits.

References

[1]2015. [Online]. Available: https://bblearn.nau.edu/bbcswebdav/pid-3584632-dt-content-rid-29692724_1/courses/1154-NAU00-CENE-281L-SEC001-2000.NAU-PSSIS/EPA-QA%20G1%20Guidance%20for%20developing%20QS%20for%20environmental%20programs.pdf. [Accessed: 31- July- 2015].

2]2015. [Online]. Available: https://bblearn.nau.edu/bbcswebdav/pid-3584632-dt-content-rid-29692725_1/courses/1154-NAU00-CENE-281L-SEC001-2000.NAU-PSSIS/EPA-QA%20G3%20Guidance%20on%20assesing%20quality%20systems.pdf. [Accessed: 31- July- 2015].

[3]2015. [Online]. Available: https://bblearn.nau.edu/bbcswebdav/pid-3584632-dt-content-rid-29692726_1/courses/1154-NAU00-CENE-281L-SEC001-2000.NAU-PSSIS/EPA-QA%20G4%20Guidance%20on%20the%20data%20quality%20objectives%20process.pdf. [Accessed: 31- July- 2015].

 [4]2015. [Online]. Available: https://bblearn.nau.edu/bbcswebdav/pid-3584632-dt-content-rid-29692727_1/courses/1154-NAU00-CENE-281L-SEC001-2000.NAU-PSSIS/EPA%20QA%20G5%20Guidance%20for%20quality%20assurance%20project%20plans.pdf. [Accessed: 31- July- 2015].

[5]2015. [Online]. Available: https://bblearn.nau.edu/bbcswebdav/pid-3584632-dt-content-rid-29692728_1/courses/1154-NAU00-CENE-281L-SEC001-2000.NAU-PSSIS/EPA%20QA%20G5M%20Qapp%20for%20modeling%20projects.pdf. [Accessed: 31- July- 2015].

[6]2015. [Online]. Available: https://bblearn.nau.edu/bbcswebdav/pid-3584632-dt-content-rid-29692728_1/courses/1154-NAU00-CENE-281L-SEC001-2000.NAU-PSSIS/EPA%20QA%20G5M%20Qapp%20for%20modeling%20projects.pdf. [Accessed: 31- July- 2015].

[7]2015. [Online]. Available: https://bblearn.nau.edu/bbcswebdav/pid-3584632-dt-content-rid-29692729_1/courses/1154-NAU00-CENE-281L-SEC001-2000.NAU-PSSIS/EPA%20QA%20G5S%20Sampling%20design%20for%20environmental%20data%20collection.pdf. [Accessed: 31- July- 2015].].

[8]2015. [Online]. Available: https://bblearn.nau.edu/bbcswebdav/pid-3584632-dt-content-rid-29692730_1/courses/1154-NAU00-CENE-281L-SEC001-2000.NAU-PSSIS/EPA%20QA%20G6%20Guidance%20for%20preparing%20SOPs.pdf. [Accessed: 31- July- 2015].

[9]2015. [Online]. Available: https://bblearn.nau.edu/bbcswebdav/pid-3584632-dt-content-rid-29692731_1/courses/1154-NAU00-CENE-281L-SEC001-2000.NAU-PSSIS/EPA%20QA%20G8%20Guidance%20on%20environmental%20data%20verification%20%26%20data%20validation.pdf. [Accessed: 31- July- 2015].

[10]2015. [Online]. Available: https://bblearn.nau.edu/bbcswebdav/pid-3584632-dt-content-rid-29692732_1/courses/1154-NAU00-CENE-281L-SEC001-2000.NAU-PSSIS/EPA%20QA%20G9S%20Data%20quality%20assesment%3B%20a%20statistical%20methods%20for%20practioners.pdf. [Accessed: 31- July- 2015].