preparing a tribal environmental program level...

Preparing a Tribal Environmental Program Level QAPP

EPA Region 4 has approved this instructional for use by Region 4 Tribes and intertribal consortia. Information contained herein may be beneficial to Tribes outside or to non-Tribal grantees, but should not be used to guide Quality Assurance Project Plan (QAPP) development, submission or approval processes with prior approval. Please consult with your project officer prior to utilizing this guide.

PROGRAM LEVEL QAPP INSTRUCTIONAL

Table of Contents

Introduction................................................................................................................3Why consider this approach?..................................................................................4What is a QAPP?......................................................................................................4General Process......................................................................................................4

Foundation of the QAPP..............................................................................................7Component 1: Project Management.......................................................................8Component 2: Measurement and Data Generation..............................................12Component 3: Assessment and Oversight............................................................16Component 4: Data Evaluation.............................................................................17

Supplemental Information……………………………………………………….................…………..19

of 19


Introduction

This instructional is meant to provide you with a starting point to successfully develop a Tribal Environmental Program Level Quality Assurance Project Plan (Program Level QAPP) and Tribal Environmental Project/Site-Specific QAPP for EPA funded projects involving collection and use of environmental data. Region 4 is encouraging the use of a Program level QAPP and Project/Site-Specific QAPP(s) as an alternative to traditional QAPPs to eliminate redundancy, reduce costs, and accelerate the approval process. A Tribe using funds under a Performance Partnership Grant or separate EPA grants for multi-media data collection may prepare one Program Level QAPP and as many Project/Site-Specific QAPPs as required. Grantees cannot collect, analyze, or use data until Region 4 approves both the Program Level and applicable Project/Site-Specific QAPPs. An attempt has been made to follow CIO 2105.0 and the Quality Assurance Handbook, http://www.epa.gov/quality/qa_docs.html, as well as previous EPA requirements described in EPA Requirements for Quality Assurance Project Plans, EPA QA/R-5, available at http://www.epa.gov/quality/qs-docs/r5-final.pdf. In addition, the Northern Arizona University Institute for Tribal Environmental Professionals offers regular workshops for Tribes to learn more about QAPPs, http://www4.nau.edu/itep/.

The information in this document is written mainly in a directive or in a “how to” format. The information follows the same organization structure as the Templates for the Program Level QAPP (Attachment A) and the Project/Site-Specific QAPP (Attachment B) including section numbering systems and titles in EPA QA/R-5.

The concept of Program Level QAPPs and Project/Site-Specific QAPPs is an application of a graded approach. Since content and level of detail in individual QAPPs will vary according to the work being performed and the intended use of the data, the graded approach should be used when preparing QAPPs. A graded approach is the process of establishing the project requirements and level of effort according to the intended use of the results and the degree of confidence needed in the quality of results. In other words, the degree of documentation, level of effort and detail will vary based on the complexity and cost of the project. Appropriate and objective consideration should be given to the significance of the environmental problems to be investigated, the environmental decisions to be made, and the impact on human health and the environment. Documentation will consist of concise explanation whenever a particular project does not need to address a specific area. In addition, by cross referencing to approved Program Level QAPPs, Project/Site-Specific QAPPs may need less detail in certain areas.

of 19

In limited circumstances, EPA

may grant conditional approval of a QAPP to permit some work to begin while non-critical deficiencies in the QAPP are being

resolved.

http://www4.nau.edu/itep/

http://www.epa.gov/quality/qs-docs/r5-final.pdf

http://www.epa.gov/quality/qa_docs.html


Why consider this approach?

The QAPP lays out the background behind the environmental problem, the objectives for the project, the tasks to be performed, and the design concepts behind the layout of the project or field work. While QAPPs are project specific, some of the required elements apply to multiple environmental projects, especially in small environmental programs. We encourage the use of a streamlined Program Level QAPP and Project/Site-Specific QAPP(s) to eliminate redundancy, reduce costs associated with development, and accelerate the review and approval process.

What is a QAPP?

A QAPP is “a formal document describing in detail the necessary quality assurance (QA) and quality control (QC), and other technical activities that are implemented to ensure that the results of the work performed will satisfy the stated performance criteria. A QAPP captures how and why a project plan will be conducted, and assures the quality of the data for making environmental decisions for the project. EPA is required to follow internal standards for projects and entities outside of EPA are required external standards for projects to create a QAPP.

Many tribal programs undertake federally funded projects or programs that involve the collection or creation of environmental data (examples: ambient monitoring, soil and water sampling, etc.). While there is some flexibility in the EPA Regional Offices regarding how this requirement is implemented, in general, Tribes must have an EPA approved QAPP to assure the quality of data being collected or created prior to beginning the project or program that involves data collection. Funding for costs incurred to collect data without an EPA approved QAPP may be disallowed1. The development and revisions of a QAPP may be added as a task to the project workplan.

General Process

First, a Program Level QAPP must be developed. The Program Level QAPP consists of all routine processes and procedures or what some refer to as “Boiler Plate” for EPA projects. These consist of routine field, lab and criteria that you readily have available and should be presented in the Tribal Environmental Program Level QAPP.

Second, a Project/Site-Specific QAPP must be developed after the EPA approves the Program Level QAPP. A Project/Site-Specific QAPP is the project plan for the site or project work to be performed at a particular site (e.g. information similar to a site sampling plan). When a site or project is identified and approved by EPA, a Project/Site-Specific QAPP is developed and is linked to the approved Program Level QAPP.

There are two concepts for working with Project/Site-Specific QAPP on a site or project: the initial Project/Site-Specific QAPP, and any follow-up Project/Site-Specific QAPP. The initial Project/Site-Specific QAPP is the first and most comprehensive plan for the site. Follow-up Project/Site-Specific QAPPs or addenda are used to document any additional site or project work (or an update) that may be needed to complete the investigation. The Tribe should use the sequential number system for Project/Site-Specific QAPP to retain the context and flow of a site or project work. For example, the initial Project/Site-Specific QAPP for a site or project will be 1 40 CFR 31.45

of 19

Case Study: Applying the Program Level and Project/Site-Specific QAPP Process to a Tribal Environmental Program

Tribe ABC has a growing environmental program. In addition to a GAP grant for capacity building, the Tribe has water and air monitoring programs, and is assessing contamination at a former gas station for proposed reuse as a community park. The Tribe has had a CWA 106 grant for 3 years, and recently adopted new testing protocols for Memorial Lake.

Tribe ABC has an EPA approved Program Level QAPP that addresses the routine components of the Tribe’s quality assurance system. The Tribe has also developed Project/Site-Specific QAPPs for the Roaring River location and the Memorial Lake location. The Tribe has submitted a revised Project/Site-Specific QAPP providing new testing protocols for Memorial Lake.

The Tribe has air monitoring sites at the Tribal Administration Building and at Old Town. PM 2.5 and ozone is monitored at both locations. Based on EPA guidance, the Tribe has developed pollutant specific QAPPS for ozone and PM 2.5. Each pollutant-specific Project/Site-Specific QAPP includes both monitoring locations.

Program Level QAPP

Project or Site 1Project/Site-Specific QAPP 1A

Project or Site 3Project/Site-Specific QAPP 3B

Project or Site 1Project/Site-Specific QAPP 1B



Project or Site 1Project/Site-Specific QAPP 1C


1.A. Follow-up Project/Site-Specific QAPP Addenda for site 1 would continue the sequence with 1.B, 1.C, etc. As additional sites are proposed for sampling the second one (site 2) would start with 2.A and so forth. Refer to Figure 1 below.

Figure 1, Flow Chart Indicating Process for Multiple Sites or Projects

of 19


Figure 2, Case Study Program Level QAPP and Project/Site-Specific QAPP

of 19

Tribe Environmental Program Level QAPP(Water, Air and Land)

Project/Site Specific QAPP(s)CWA 106

Roaring River 1A

(site specific)

Memorial Lake 2A

(site specific)

Memorial Lake 2B

Project/Site Specific QAPP(s)

CAA 103/105

Ozone 1A(pollutant specific)

PM 2.5 2A(pollutant specific)

Project/Site Specific QAPP(s)

Brownfields

New Town Park 1A

(site specific)


Foundation of the QAPP The Program Level QAPP and Project/Site-Specific QAPP can be broken down into four parts to help you plan and document certain aspects of your site/project: 1) Project Management – how you will organize and run the project; 2) Measurement and Data Acquisition – how you will collect and report data; 3) Assessment and Oversight – how you will check that all activities are completed correctly; and 4) Data Evaluation – how you will review and interpret the data.

Figure 3 shows the four components and breakdown of all the QAPP elements that need be covered in the main body of a Program Level QAPP and Project/Site-Specific QAPP.

ELEMENT PROGRAM-LEVEL PROJECT/SITE-SPECIFIC QAPP

PROJECT MANAGEMENT

A1, 2, 3 Title and Approval Page / Table of Contents/ Distribution List In Program Level In Project/Site Specific

A4 Project /Task Organization In Program Level

A5 Problem Definition / Background In Project/Site Specific

A6 Project/Task Description In Project/Site Specific

A7 Special Training and Certification In Program LevelA8 Documentation and Records In Program Level

MEASUREMENT DATA ACQUISITION

B1 Sampling Design and Site Figures In Project/Site Specific

B2 Sampling and Analytical Methods Requirements In Project/Site Specific

B3 Sample Handling & Custody Requirements (usually in an SOP) In Program Level B4 Analytical Methods Requirements (usually in an SOP) In Program Level B5 Field Quality Control Requirements (usually in an SOP) In Program Level B6 Laboratory Quality Control Requirements (usually in an SOP) In Program Level B7 Field Equipment Calibration and Corrective Action (usually in an SOP) In Program Level B8 Laboratory Equipment Calibration and Corrective Action (usually in an SOP) In Program LevelB9 Analytical Sensitivity and Project Criteria (usually in an SOP) In Program Level B10 Data Management and Documentation In Program Level

ASSESSMENT/OVERSIGHT

C1 Assessments and Response Actions In Program Level

C2 Reports In Program Level

DATA EVALUATION

D1Data Review, Validation and Verification

In Program Level

February 2013- Barbara Caprita, EPA Region 4, RCRA Division Brownfields and Underground Storage Tank QA CoordinatorFigure 3 – The Four Components and Elements

of 19


Component 1: Project Management

This section of the QAPP answers:

How you will organize and run the project? Who will be involved with the project or site? What is the environmental problem? What is the background history of the problem? How will the data be used and what decisions will be made with the data?

A1. Title and Approval Page (In Program Level and Project/Site-Specific QAPP)

The purpose of this section is to identify the project title and name of organization conducting the project, as well as to document approval of the QAPP.

Ensure this element includes: Title of project and/or Program Level QAPP Name of organization conducting the work

(e.g., ABC Tribe Environmental Department) and their mailing address

Preparation date of QAPP and version number

Signature/date line for all key parties who must approve the QA Project Plan followed by a printed line including their name, organization, and title (Note: Approving officials may include if applicable, the Tribal Project Manager, Tribal QA Manager, the Tribal Environmental Director, the Tribal Chairperson/Chief or Tribal Council Members, consultant staff, contract laboratory director, the EPA Project Officer, the Regional EPA QA/QC Manager or project representative)

Assistance agreement(s), Cooperative Agreement(s), Grant(s) and/or contract number(s) funding the activity and knowledge of what program is funding the work (e.g., Clean Water Act 106 Program, Brownfields Program, Drinking Water Program, etc.)

of 19

Many Tribes balance QA/QC requirements with the demands of running an

environmental program, often with limited staff; therefore, a dedicated QA/QC

Manager may not be feasible. To address QA/QC oversight requirements, a Tribe may

choose to share QA/QC Manager responsibilities. For example, if a staff of two are both collecting data samples, they

may review one another's work. EPA’s definition of a QA/QC Manager is “the individual designated as the principal

manager within the organization having management oversight and responsibilities for planning, documenting, coordinating,

and assessing the effectiveness of the quality system for the organization”.


A2. Table of Contents (In Program Level and Project/Site-Specific QAPP)

The purpose of this section is to allow the reader of the QA Project Plan to locate the different information sections. Provide a list of the various QA Project Plan sections and subsections, tables, figures, references, appendices, etc. Include the section number, section title, and associated page where the information will be found. It is recommended to include a header on each page (typically, in the upper right corner) of the QA Project Plan denoting the project name, revision number and/or date of version, and page number.

A3. Distribution List (In Program Level and Project/Site-Specific QAPP)

The purpose of this section is to present a list of all individuals who should receive a copy of the EPA approved QA Project Plan, as well as any subsequent revisions/updates.

Provide a list of all key personnel that will receive original and updated copies of the QA Project Plan, along with their respective organization and contact information (i.e., telephone number, email address, and/or mailing address). These individuals may include:

Project Manager for Tribe Field team leader for Tribe QA/QC Manager for Tribe QA Project Plan preparer for Tribe Laboratory manager Data reviewers Any essential contractor personnel Project Officer for EPA QA/QC Manager for EPA

Paper copies need not be provided to individuals if equivalent electronic information systems can be used.

A4. Project/ Task Organization (In Program Level and Project/Site-Specific QAPP)

The purpose of this section is to identify the roles and responsibilities of those individuals involved in the project and their respective organizations. Identify the individuals and organizations participating in the project and discuss their specific roles and responsibilities. Depending on your Tribe, these individuals and organizations may include:

Local Community Elder(s)

of 19


Program or project manager Program or project staff conducting the various project activities Tribal person responsible for QA/QC (activities may include: ensuring sampling,

shipment, and lab analysis incorporate adequate QC components; reviewing QC results; recommending corrective action, when necessary; and evaluating data for inclusion in reports) – whenever possible, ensure this individual is independent of the staff generating the data

Point(s) of contact and associated organization for any consultants and/or contractors and their specific project responsibilities

Contract laboratory, if applicable, as well as associated name(s) of points(s) of contact and QA Manager

Any other key personnel or organizations involved in project or program activities

Include contact information (i.e., telephone numbers, email addresses, and mailing addresses) of all program or project staff, consultants and/or contractors, laboratory contacts and QA/QC Manager, etc. responsible for the project and the QA Project Plan.

Provide an organization chart showing lines of authority/communication (i.e., who reports to whom) for all referenced people or organizations.

A5. Problem Definition/Background (In Project/Site-Specific QAPP)

The purpose of this section is to describe the specific issue or problem to be investigated with the current project, along with any pertinent background information.

Data Quality Objectives (DQO) Process is EPA’s recommended planning process when environmental data are used to select between two alternatives or derive an estimate of contamination. The document, Guidance on Systematic Planning Using the Data Quality Objectives Process (EPA QA/G-4) http://www.epa.gov/quality/qs-docs/g4-final.pdf, provides a standard working tool for to develop DQO for determining the type, quantity, and quality of data needed to reach defensible decisions or make credible estimates. Use a table for your DQOs.

Provide information on why the investigation needs to take place. This might include knowledge about tribal concerns, reasons for conducting baseline monitoring, any background on why a problem exists or may exist, knowledge of any data gaps that need to be filled, or anything else that supports the need for the project effort. (NOTE: This information may have been included in your work plan submittal. If so, this information could be reiterated in this section.)

Identify the principal data users/decision makers (i.e., the individual(s) who will use the data to make decisions).

Provide a brief summary of existing information (including previously collected field and/or laboratory data related to the project or monitoring effort) to provide a historical, scientific, and/or regulatory perspective for the current project. This information may include:

of 19


Information regarding where and how historical data were obtained; Source of the data such as State, Tribe, Federal Agency, county, city, volunteer, permits,

university, or other sources; Summary of data gaps indicating what information is not known.

A6. Project/Task Description (In Project/Site-Specific QAPP)

The purpose of this section is to provide an overview or summary of the work. Demonstrate an understanding of what the project hopes to accomplish, by providing a summary of:

Work to be performed - This discussion should be as specific as possible and may include answering questions such as: What locations will be sampled for what parameters? How many samples are being collected? What analyses will take place for each measurement?

Products to be generated, including reports to be written Schedule for implementation - This information is often presented as a timeline

bracketing the targeted dates for each key project task such as: development and approval of QA Project Plan, sample collection dates, laboratory analysis and reporting, data validation/evaluation, other project milestones, project report development and due date.

Provide maps or tables to show geographic locations of field tasks.

This discussion does not have to be lengthy or overly detailed, but should give an overall picture of how it will help the issue or problem or question described in A5. A7. Special Training and Certification (In Program Level QAPP)

The purpose of this section is to describe any special or non-routine training or certifications necessary to successfully complete the project.

Identify any special training or certifications needed by personnel to conduct project activities. (This might be associated with activities such as: collecting samples, performing field measurements, handling of hazardous waste, reviewing data, drilling soil borings or installing groundwater monitoring well.). Discuss plans for providing any necessary training, as well as how training records will be documented, where this information will be stored, and how the effectiveness of the training will be determined.

A8. Documentation and Records (In Program Level QAPP)

The purpose of this section is to provide information concerning the management of project documents and records, including this QAPP.

List all the records and documents that will be created during the project and describe which ones will be kept, how long they will be kept, and where they will be kept. Itemize the contents of the laboratory report package. It should include: field samples results, QC samples results (blanks, duplicates, etc.), description of data qualifiers that laboratory applies to sample results, narrative describing issues and problem, resolution during analysis, chain-of-custody records raw

of 19


data, copies of logbook information to name a few. Note: A table may be useful. Indicate where all project documents and records will be stored and how long, including procedures for removing and destroying obsolete documents and records. Include any backup procedures for electronic data.

Describe plans or requirements for reporting data to EPA or other report recipients. Identify what final reports will be generated, what the report will include, and how the data will be stored (e.g., in a database, an Excel spreadsheet, a file cabinet, etc.).

Component 2: Measurement and Data Generation The elements in this group answer the following questions:

What are the sampling design and the rationale behind it? What sample collection methods will be used and what quality control will be used to assure that representative samples are collected? What measurement procedures, field techniques and laboratories will be used and what quality control will be used to assure accurate, precise and sensitive data are collected? How will sample data be managed? Note: A good reference is EPA Region 4, SESD, Athens, GA, “Field Branches Quality System and Technical Procedures”. Website: http://www.epa.gov/region4/sesd/fbqstp/index.html

B1. Sampling Design and Site Figures -- (In Project/Site-Specific QAPP)

The purpose of this element is to describe the overall design of the project data collection activities and the rationale supporting the design. This element should describe how you plan to collect representative samples. Statistical sampling designs can be used to help ensure representative samples are collected. However, statistically based sampling designs may be beyond the extent of the project.

Explain why the sampling locations, environmental parameters/analytical methods and matrices were chosen. Describe the sampling design for the project including: sampling locations and directions to them, frequency of sampling at each location, matrices to be sampled, environmental parameters/analytical methods of interest in each matrix, any design assumptions (e.g. storm event defined as “X” inches of rain after “Y” number of dry days). Include maps that

of 19

Some things to consider in developing your sampling design: What are the standards or action levels against which the data will be compared? Example, do you need to determine whether water quality

criteria are exceeded? Do you care about average contamination levels, hot spots, or the proportion of a site contaminated? Will composite samples or grab samples be used? Are you looking for trends over

time? Will there be a reference site? Are you collecting background samples? For guidance on selecting the appropriate design, refer to “Guidance for Choosing a Sampling Design for Environmental Data

Collection” (QA/G-5S) http://epa.gov/quality/qs.docs/g5s-final.pdf

http://epa.gov/quality/qs.docs/g5s-final.pdf

http://www.epa.gov/region4/sesd/fbqstp/index.html


detail sample locations.

It is recommended to create a table that includes sample matrix, environmental parameters and/or analytical methods, sampling collection method, analytical method reference, number of field samples, type and number of field QC samples for each matrix and parameter, and include acceptance criteria for blanks, matrix spike/matrix spike duplicates, and field duplicate samples.

B2. Sampling and Analytical Methods Requirements (In Project/Site-Specific QAPP)

Each sampling procedure should describe in detail each step of the procedure, the equipment, materials, supplies, sample preservation techniques, sample holding times, decontamination procedures, disposal of decontamination by-products, sample containers and volumes, quality control acceptance limits and corrective actions that will be used.

Describe procedures, or include written SOPs as electronic attachments, or on a CD, if preferred, to the QAPP for sample collection, including preparation of sample containers, sample volumes, preservation and holding times; sample packaging, labeling and shipping; equipment preparation; decontamination and disposal of waste by-products; Describe how problems (lost samples, broken equipment, inaccessible sampling locations, etc.) will be resolved and documented.

If written SOPs are used, create a table listing all field sampling SOPs that will be used. Include: Title of SOP, Date, Revision number and Organization that wrote the SOP.

Provide another table that includes: Parameter, sample container, sample volume, preservation, holding times for each parameter and matrix. Describe any modifications to the SOPs that are necessary for your project. Also, if there are any method or equipment options within the SOP, indicate which ones will be used. Indicate how these modifications and option choices will be relayed to the samplers.

of 19

A word about Standard Operating Procedures (SOPs): Written SOPs describe an organization’s procedure for doing a specific task. Unlike published methods, SOPs are specific to one organization. EPA R-4 Programs encourage the use of SOPs because they provide consistency from one user to the next and can be used by the organization for multiple projects. SOPs should be submitted electronically, or on a CD, if preferred, and submitted with the Program Level and Project/Site-Specific QAPP(s). You may also reference the SOP in the applicable document(s). When referencing SOPs, always cite the title, revision date and/or number, author, organization, and indicate if, and how, the SOP will be modified for the project (if necessary). In general, SOPs should include the following sections:

1. Title and Approval Page/Table of Contents

2. Scope and Applicability 3. Summary of Procedure4. Definitions5. Health and

Safety/Cautions/Interferences6. Personnel Qualifications

Equipment, materials and supplies (sample containers)

7. Sample Collection (Sequential steps and sample volumes)

8. Sample Handling, Preservation and Holding Times (shipment, chain-of-custody)

9. Sample Analysis (detailed steps including sample preparation)

10. Troubleshooting11. Decontamination procedures for both

sampling and analysis and disposal of decontamination by-products

12. Data Records and Management (field notes, calculations and data sheets)

13. QA/QC including QC acceptance limits and corrective actions that will be used when limits are exceeded.

14. References

A good reference is, “Guidance for Preparing Standard Operating Procedures (SOPs)”, EPA QA-G/6 Website: http://www.epa.gov/quality/qa_docs.html



B3. Sample Handling and Custody Requirements (In Program Level QAPP) This element describes how you will maintain sample integrity (samples will not get corrupted or mixed up). Indicate how samples will be handled, transported, and then held in the laboratory.

Describe how samples will be handled in the field, during transport and in the lab. Identify responsible persons. Specify chain-of-custody (C-O-C) procedures that will be used to ensure samples don’t get lost, mixed up, or tampered. Provide examples of a sample label, C-O-C forms and other documentation. Describe sample numbering/identification system for field samples and laboratory. Attach applicable SOPs.

B4. Analytical Methods Requirements (In Program Level QAPP)

This element identifies the analytical methods that will be used in the field and in the laboratory. These methods need to be sensitive enough to characterize the environmental conditions.

Describe sample preparation and analytical procedures for field techniques and laboratory methods. Reference standard methods and attach SOPs. Detail any project-specific modifications to analytical methods and SOPs. List laboratory quantitation limits (reporting limits) to ensure project sensitivity requirements will be met. Include the Laboratory QA Manual attached as SOP(s). Describe how problems (lost samples, quantitation limits, holding time exceedances, etc.) will be resolved and documented

B5. & B6. Field/Laboratory Quality Control Requirements (In Program Level QAPP) This element should list all the QC checks you are going to perform to characterize the quality of the data.

Quality Control – Field: This element should list all the QC checks you are going to perform to characterize the quality of the data. Provide a table listing the QC samples for each sampling matrix (e.g., water, soil) and environmental parameter (pH, phosphorus, etc.). The table should include: Type of QC sample (field

duplicates, Performance Evaluation Samples, and trip, equipment and cooler temperature blanks); Frequency; Acceptance criteria (control limits); matrix spike/matrix spike duplicate

of 19

Some things to consider when reviewing QC sample results:

What will you do if contaminants are found in a

“blank” sample? What will you do with sample

results that do not compare with previously collected data

and appear to be incorrect? What will you do with sample results if the instrument was

not calibrated correctly? What will you do when

duplicate sample results aren’t comparable?

What will you consider the range of comparable results to

be? What will you do with sample

results when a spiked compound is not recovered?

Or when the results of a performance evaluation sample

are inaccurate?


samples; and Corrective actions that will be done when acceptance criteria are exceeded. Include procedures and formulas for calculating QC data.

Quality Control - Field Measurement/Laboratory: Provide a table listing the QC samples for each analytical method, for each matrix and for each measurement parameter. The table should include:

Types of QC sample (lab duplicates, matrix spikes, method blanks, etc.) Frequency Acceptance criteria (control limits) Corrective actions that will be done when acceptance criteria are exceeded.

Describe procedures and formulas for calculating QC data.

The answers to these questions should be addressed in the discussion of how you will review and qualify your data. Remember: QC data are only worthwhile generating if they are used to review and evaluate your data.

B7. & B8. Field/Laboratory Equipment Calibration and Corrective Action (In Program Level QAPP)

The information in this element should describe how you will keep instruments and equipment properly operational during the project. Identify equipment and instrumentation (both field and laboratory) requiring calibration and periodic maintenance, inspection and testing. Describe how often the instrument needs to be calibrated and maintained, who will perform and document tasks. Describe the calibration and testing procedures and acceptance criteria (control limits) for operation. This information can be found in the equipment manual or on the manufacturer’s website. List the spare parts needed to be kept on hand to keep the instrument operational. Describe how problems (e.g., instrument doesn’t hold calibration) will be resolved and documented. All instrumentation/equipment must be calibrated according to a schedule specified by the method and instrument/equipment manual or SOPs.

B9. Analytical Sensitivity and Project Criteria (In Program Level QAPP)

Provide an analytical method sensitivity and project criteria table for the analytical methods that will be routinely performed on Tribal projects. This table is important for both planning the project and evaluating the resulting data. The table should include: Laboratory providing data; Analytical Method reference (e.g., VOCs 8260B); Matrix (soil, groundwater, air, etc.); Analyte/compound list; Method Detection Limit (MDL); and Quantitation/reporting limit (QL/RL)

of 19

SOPs should be submitted electronically, or on a CD, if preferred, and submitted with

the Program Level and Project/Site-Specific QAPP(s). You may also reference the SOP

in the applicable document(s).


B10. Data Management and Documentation (In Program Level QAPP)

The information contained in this element describes managing project data. It also describes procedures for maintaining data so that they will not be lost or corrupted. Data can be lost during data reduction, data reporting, data entry onto forms, reports, databases, and even in storage. Indicate how computerized information will be maintained and stored and how data loss will be mitigated. Any forms or checklists to be used can be attached.

Describe how data (both hard-copy and electronic) will be managed from the time they are generated in the field to final report and storage, and how long data will be retained. Describe how data (both hard-copy and electronic) will be managed from the time they are generated in the field to final report and storage. Discuss methods and equipment for detecting/correcting errors, and preventing data loss. Describe how computer outputs will be checked. Identify who is responsible for these tasks. Attach applicable SOPs. Note: Include SOPs on a CD and include in the appropriate document (either Program Level or the Project/Site-Specific). Discuss methods and equipment for detecting/correcting errors, and preventing data loss. Describe how computer outputs will be checked. Identify who’s responsible for these tasks.

Attach applicable SOPs. Include SOPs electronically or on a CD and include in the appropriate document (either the Program Level or the Project/Site-Specific QAPP).

Component 3: Assessment and Oversight

The elements in this group answer the following questions: How will you check to make sure that the project is being conducted as described in the QAPP? For example: Are field personnel collecting samples at the correct locations? Is the laboratory generating accurate data?

What interim and final reports will be generated? Assessment findings should be documented in a report with recommendations for corrective actions, if it applies.

Include a list of the document and reports required by EPA as listed in Award Programmatic Conditions.

C1. Assessments and Response Actions (In Program Level QAPP)

Discuss how you plan to ensure that the project will be conducted as described in the QAPP.Describe any oversight activities and/or assessments that will be performed, approximate timeframe, and person responsible. Identify who will receive a report of the findings and who will be responsible for corrective actions and follow up. Minimally, the Tribe’s Project Manager

of 19

For additional information refer to “Guidance on

Technical Audits and Related Assessments for

Environmental Data Operations”, G-7

Website: http://www.epa.gov/quality/q

a_docs.html




should schedule one review of field activities at the beginning of the project to ensure that all personnel are trained and the right equipment is in place. A Corrective Action Flow Chart is extremely useful.

If laboratories are required to maintain certification/accreditation, discuss this here. Most accredited / certified laboratories are routinely audited by certifying/accrediting bodies as part of the certification / accreditation process. Clients should request a copy of the laboratory’s accreditation certificate to retain on file. ISO, NELAC, A2LA are examples of accrediting / certifying bodies.

C2. Reports (In Program Level QAPP)

The QAPP should clearly state the type of information that will be included in the final project report.

The QAPP should clearly state the types of reports that will be developed and identify information to be included. This may include reports to the Tribal Government as well as reports identified in the Programmatic Conditions of the award.

Describe the type and number of reports that will be generated for the project. Identify who is responsible for preparing the reports and the recipients for each report. Minimally, a final project report should be written and provided to the EPA Project Officer. This report should analyze and interpret data, present observations, draw conclusions, identify data gaps, and describe any limitations in the way the data should be used.

Include a list of the type of information included in hardcopy and electronic analytical data reports.

Component 4: Data Evaluation

D1. Data Review, Validation and Verification (In Program Level QAPP)

This section describes how the data will be evaluated to determine whether they can be used to address project objectives. This group of elements answers the following questions: How will you check that individual data collection tasks were completed correctly? How will you determine that individual sample results are acceptable or unacceptable based on QC data? How will you assess the entire set of project data to determine whether the data are “good” enough to use in making project decisions and conclusions?

All data validation, review, verification SOPs should be included in an appendix to the QAPP. Also include a list of the data qualifier flags (along with their definitions). Specify how the data review, validation and verification process will be documented.

of 19


These elements are simplified into 3 steps for the purpose of this section.

Step 1: VerificationDescribe how data will be checked to ensure that they are complete and were generated according to the methods and procedures specified in the QAPP. Describe steps taken by the laboratory to qualify sample results. Include qualifiers that the laboratory will apply when data do not meet laboratory QC acceptance limits. Discuss how issues will be resolved, documented and reported and the personnel responsible for these tasks. Attach any forms and checklists used to perform completeness checks. For example, is there a procedure to check that the samples were correctly preserved? Is there a procedure to check that laboratory data packages are complete (contain all required information)?

Laboratories generally apply flags to reported sample results that do not meet Lab QC limits. For example, if a lab contaminant is present in a method blank, that contaminant would be flagged on the sample report form. Other items to check include: incubation temperatures, media preparation and sample holding times.

Step 2: Validation ProceduresDescribe how sample results will be accepted, rejected or estimated based on quality control

acceptance criteria. Define the data qualifiers that will be applied to the data (e.g., U=not detected, J=estimated, R=rejected). Attach or refer to written data validation procedures, if used. Identify the individuals who will review data, and resolve and document data quality problems.

Validation is a review of sample results by an individual who is independent of the generation of the data. That means that the laboratory reporting the data wouldn’t perform data validation. Instead, the laboratory generally performs an internal verification (QC check) of the data that it generates. Data validators use mathematical and/or statistical procedures to assess the overall ability of the data to meet the project-specific data quality objectives.

of 19

Also known as the reconciliation process for reconciling the data to the project specific DQOs which is normally a step wise process (rarely statistical) for determining whether the sample were collected and preserved properly, sample were collected at the appropriate sampling location, the sample were handled properly, the appropriate extraction / digestion / analytical method was employed, etc.


Step 3: Evaluating Data in Terms of User NeedsThis step describes how you intend to objectively decide whether the data you collected are good enough for the data user to use.

Describe how the results of the study will be analyzed and evaluated to determine whether the needs of your project were met and then reported. Include mathematical and statistical formulae that will be used to calculate precision, accuracy/bias, completeness, comparability of the project data. Describe what will happen if data are unusable. Remember, anything that compromises data representativeness ultimately impacts data quality.

Supplemental Information

This section is to include any additional information that is supportive of your QAPP documents, such as abbreviations, a glossary, references, etc.

Abbreviations – Provide a list of abbreviations and full name (example, QAPP - Quality Assurance Project Plan).

References - The use of references provides supporting documentation to the QAPP text. Include a list of all pertinent references.

Attachments – Figures, Tables and Appendices – These provide supporting information to the QAPP text.

Maps and Figures - Include maps and figures that don’t easily fit within the QAPP text as an appendix or attachment.

Tables - Include large tables that don’t easily fit within the QAPP text as an appendix or attachment.

Appendices – On CD - Include items such as: field equipment manuals, laboratory contracts and/or QA Manuals, field, laboratory and other SOPs, example documentation (i.e., field forms, chain-of-custody forms, sample labels), etc.

of 19

For additional guidance in

data usability assessment

refer to these EPA Documents:

“Data Quality Assessment: A

Reviewer’s Guide, (QA/G-