Fillable Epa Qapp Review Checklist (Commonwealth of Massachusetts)

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Epa Qapp Review Checklist (Commonwealth of Massachusetts)

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Revision: 0
Date: January 27, 2006
1
REGION 3 QAPP Review Checklist
Document Number:
Site Name:
Document Title:
Account Number:
Print Form
Save
Revision: 0
Date: January 27, 2006
2
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Date: January 27, 2006
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IA = Included and Adequate for Data Quality IU = Included and Inadequate for Data Quality NI = Not included NA = Not Applicable
Reference
Code
(Section #)
Elements & Required Information IA IU NI NA Location of Element
in Submitted
Document
(Section #, Table #,
figure #, etc)
COMMENTS
PROJECT MANAGEMENT
1 ( A1) Title & Approval Page
Includes title of plan
Includes name of the organizations
Includes names, titles, signatures of appropriate
officials and their approval dates
1 (A2) Table of Contents
(Lists sections, figures, tables, references, and
appendices)
Effective Document Control Format
1 (A3) Distribution List
(Lists all the individuals and their organizations who
will receive copies of the approved QAPP and any
subsequent revisions.)
1 (A4) Project Organization
Identifies key individuals or organizations
participating in the project with their responsibilities
(e.g., data users, decision-makers, project QA
manager, subcontractors, etc.)
Revision: 0
Date: January 27, 2006
4
IA = Included and Adequate for Data Quality IU = Included and Inadequate for Data Quality NI = Not included NA = Not Applicable
Reference
Code
(Section #)
Elements & Required Information IA IU NI NA Location of Element
in Submitted
Document
(Section #, Table #,
figure #, etc)
COMMENTS
PROJECT MANAGEMENT
Identifies/Describes individual(s) responsible for
overall QA/AC (Project QA manager is independent
of the data generating unit)
Identifies individual(s) responsible for sampling
operations and sampling QC
Identifies individual(s) responsible for data
processing and data processing QC
Identifies organization(s) involved with data analysis
Identifies individual(s) responsible for data validation
(needs to be independent of data
generator/laboratory)
Project Organization Chart(s) [Shows lines of
authority and reporting responsibilities, includes
contractors and subcontractors]. Includes EPA’s
role and other stakeholders/decision makers.
1 (A5) Site Background
Includes a list of the known and suspected
contaminants in each medium and estimates of their
concentration, variability, distribution, and location.
Includes the site’s physical and chemical
characteristics that influence migration and
associated human, environmental and physical
targets.
Includes a conceptual site model and exposure
pathways
Revision: 0
Date: January 27, 2006
5
IA = Included and Adequate for Data Quality IU = Included and Inadequate for Data Quality NI = Not included NA = Not Applicable
Reference
Code
(Section #)
Elements & Required Information IA IU NI NA Location of Element
in Submitted
Document
(Section #, Table #,
figure #, etc)
COMMENTS
PROJECT MANAGEMENT
Includes a summary of the outcome and status of
any previous response(s) at the site, such as early
actions or previous data collection activities
Includes Site Maps (historical & present)
1 (A5)
2 (Chap.1)
3
(Chap. 1)
4
(Chap. 1)
Problem Definition
Includes statement(s) of the decision(s) that will be
made based on the outcome of the field
investigation
Includes list of actions that will be taken toward
remediation or removal of the potential
contamination problem based on the outcome of the
field investigation
Includes the types of informational inputs needed for
decision (e.g., sampling, modeling, or a combination
of these approaches). If applicable, include
collection of previous data collection (identifying
sources).
Identifies Applicable technical quality standards or
criteria (e.g., ARARS, State standards, other federal
agency standards, action levels).
Includes specific action levels and the criteria for
choosing between alternative actions
Revision: 0
Date: January 27, 2006
6
IA = Included and Adequate for Data Quality IU = Included and Inadequate for Data Quality NI = Not included NA = Not Applicable
Reference
Code
(Section #)
Elements & Required Information IA IU NI NA Location of Element
in Submitted
Document
(Section #, Table #,
figure #, etc)
COMMENTS
PROJECT MANAGEMENT
Includes a decision rule - an “if...then....” statement
that defines the conditions that would cause the
decision maker to choose among alternative
courses of action. The decision rule should include
the decision, the actions, the parameter of interest
and the action level.
1 (A6)
4
(Chap. 3)
Project Description & Schedule
Provides a description of the work to be performed;
provides sufficient information as to the project’s
goals and types of activities to be conducted
Includes special personnel and equipment
requirements that may indicate the complexity of the
project (particularly for any new or innovative
sampling or analytical technique being employed)
Includes Project Schedule Timeline (graphical or
tabular format). Includes start and completion dates
for all project activities (including quality assurance
assessments).
Includes procedure for notification of project
participants concerning schedule delays (identify job
function, org. name, personnel responsible for
providing and receiving such notification, and
personnel responsible for approving schedule
changes)
Includes discussion of resource and time
constraints, such as seasonal sampling restrictions
and considerations (if applicable)
Revision: 0
Date: January 27, 2006
7
IA = Included and Adequate for Data Quality IU = Included and Inadequate for Data Quality NI = Not included NA = Not Applicable
Reference
Code
(Section #)
Elements & Required Information IA IU NI NA Location of Element
in Submitted
Document
(Section #, Table #,
figure #, etc)
COMMENTS
PROJECT MANAGEMENT
1 (A7) Quality Objectives & Criteria
Lists measurement methods for each item of
necessary information (list chemical and/or
biological analytical methods). Specific tables may
be included here or under A7 and/or B4 of this
checklist. Tables need to include Project Action
limits, project quantitation limits and laboratory
detection limits.
Includes the range of anticipated concentrations of
the parameters of interest
Defines and evaluates the potential consequences
of decision errors (i.e., false positive error or false
negative error) near the action level.
Includes how sufficient data will be collected to
ensure that the proposed action limits are not
exceeded after remediation and/or removal of
contaminants of concern.
Describes when screening and definitive data
1
will
be used to make site decisions. Also, defines
limitations on the use of screening data. For
screening data being used for site decisions, at least
10% must be confirmed by fixed laboratory.
Provides justification when not confirming.
1
For definition of screening and definitive data see reference 2.
Revision: 0
Date: January 27, 2006
8
IA = Included and Adequate for Data Quality IU = Included and Inadequate for Data Quality NI = Not included NA = Not Applicable
Reference
Code
(Section #)
Elements & Required Information IA IU NI NA Location of Element
in Submitted
Document
(Section #, Table #,
figure #, etc)
COMMENTS
PROJECT MANAGEMENT
Addresses Precision (quantitative measurement
performance criteria, QA/QC activities, and/or QC
checks/samples being used to determine acceptable
precision for each matrix, analytical parameter and
concentration level). Includes equations to be used
to calculate precision.
Addresses Accuracy (quantitative measurement
performance criteria, QA/QC activities, and/or QC
checks/samples being used to determine acceptable
accuracy/bias for each matrix, analytical parameter
and concentration level). Includes equations to be
used to calculate accuracy.
Addresses Representativeness (quantitative
measurement performance criteria, QA/QC activities
being used to determine representativeness for
each matrix, analytical parameter and concentration
level).
Addresses Comparability (quantitative measurement
performance criteria, QA/QC activities, and/or QC
checks/samples being used to determine
comparability for each matrix, analytical parameter
and concentration level). Sampling and analytical
procedures are consistent within and between data
sets.
Provides criteria for comparing oversight split
sampling, if applicable.
Provides Comparability criteria for field
screening/confirmatory results, if applicable.
Revision: 0
Date: January 27, 2006
9
IA = Included and Adequate for Data Quality IU = Included and Inadequate for Data Quality NI = Not included NA = Not Applicable
Reference
Code
(Section #)
Elements & Required Information IA IU NI NA Location of Element
in Submitted
Document
(Section #, Table #,
figure #, etc)
COMMENTS
PROJECT MANAGEMENT
Addresses Completeness. If applicable, includes a
list of critical samples. Includes equations to be
used to calculate completeness.
Includes a table with the project’s QA objectives for
precision, accuracy and completeness. The QA
objectives should include requirements for “Total
system” variability and bias not just laboratory error
or criteria (Total system = sampling design error +
measurement error).
1 (A8) Special Training Requirements/Certification Listed
(Unique methods, Validators, Water Plans)
Lists or states how training is provided,
documented, and assured
1 (A9) Documentation and Records
Itemizes the information and records (field operation
records, laboratory records, data handling records)
that must be included in the data report package
and specifies the desired reporting format for hard
copy and electronic forms
Identifies any other records and documents
applicable to the project, such as audit reports,
interim progress reports, and final reports, that will
be produced. Includes electronic data from
instrumentation (tapes).
Specifies or references all applicable requirements
for the final disposition of records and documents,
including location and length of retention period.
Revision: 0
Date: January 27, 2006
10
IA = Included and Adequate for Data Quality IU = Included and Inadequate for Data Quality NI = Not included NA = Not Applicable
Reference
Code
(Section #)
Elements & Required Information IA IU NI NA Location of Element
in Submitted
Document
(Section #, Table #,
figure #, etc)
COMMENTS
PROJECT MANAGEMENT
States Revisions/updates to QAPP are every 3-5
years
MEASUREMENT/DATA ACQUISITION ELEMENTS
1 (B1) Sample Design
Identifies Type (composite, grab, etc.) and number
of samples required. Table format recommended.
Provides justification for type and number of
samples; MDL rationale/impact. Identifies
Background samples (if applicable)
Sampling Process Design (Experimental Design)
[Describes the experimental design or data
collection design for the project]
Sample Locations and frequency (e.g. map)
Sample & Analysis Methods (General description)
Sample matrices
Classifies each measurement parameters as either
critical or needed for information only
Provides Appropriate validation study information;
for nonstandard situations
1 (B2) Sampling Methods Requirements
Revision: 0
Date: January 27, 2006
11
IA = Included and Adequate for Data Quality IU = Included and Inadequate for Data Quality NI = Not included NA = Not Applicable
Reference
Code
(Section #)
Elements & Required Information IA IU NI NA Location of Element
in Submitted
Document
(Section #, Table #,
figure #, etc)
COMMENTS
PROJECT MANAGEMENT
Identifies sample collection procedures and
methods (if referencing sampling, SOPs may be
attached to QAPP)
Describes filtering procedures, if applicable.
Describes sequencing of samples, if applicable
Describes homogenizing of samples, if applicable
Identifies support facilities
Identifies individuals for corrective action. Describe
decision/who’s responsible and documentation
required.
Includes Sampling SOP Modifications
Provides Cleaning & Decontamination Procedures
of Equipment/Sample Containers [Decontamination
Procedures includes acid, water, and solvent rinse
(methanol is preferred solvent )]; SOPs
Provides Sampling Containers, Volumes, Holding
Times, & Preservation Table
Revision: 0
Date: January 27, 2006
12
IA = Included and Adequate for Data Quality IU = Included and Inadequate for Data Quality NI = Not included NA = Not Applicable
Reference
Code
(Section #)
Elements & Required Information IA IU NI NA Location of Element
in Submitted
Document
(Section #, Table #,
figure #, etc)
COMMENTS
PROJECT MANAGEMENT
Provides Field Sampling Equipment Calibration w/
table
Identifies Field Equipment Maintenance, Testing &
Inspection Requirements
Provides Inspection & Acceptance Requirements for
Supplies/Sample Containers
1 (B3) Sample Handling, Tracking & Custody
Requirements
Note: Laboratory QAP should included information
about laboratory sample handling and custody.
Provides Sample Handling, Tracking & Custody
SOPs with Sample Handling Flow Diagram (used for
multiple sampling events with multiple laboratories)
Provides Sample Collection Documentation
(includes form to track custody)
Provides Sample Container Label / Sample Tag
(include examples)
Identifies Field Notes (lists information to be entered
in field logbook)
Documents source of field reagents or supplies,
includes sample containers
Revision: 0
Date: January 27, 2006
13
IA = Included and Adequate for Data Quality IU = Included and Inadequate for Data Quality NI = Not included NA = Not Applicable
Reference
Code
(Section #)
Elements & Required Information IA IU NI NA Location of Element
in Submitted
Document
(Section #, Table #,
figure #, etc)
COMMENTS
PROJECT MANAGEMENT
Includes procedures/forms for recording the location
& specific consideration associated with samples
Documents specific preservation method (including
temperature upon receipt)
1 (B4) Analytical Methods Requirements
Provides SOPs and validation information for
nonstandard methods
Provides 10% offsite laboratory confirmation for
screening methods
Identifies laboratory (ies)
Includes laboratory(ies) information (QA Manual,
SOPs, PE results, certifications)
[Use LQAP checklist if LQAP submitted separately]
Identifies individuals responsible for corrective
action
Specifies needed laboratory turnaround time (if
important to the project schedule)
Provides Field Analytical Methods & SOPs (includes
modifications if applicable)
Revision: 0
Date: January 27, 2006
14
IA = Included and Adequate for Data Quality IU = Included and Inadequate for Data Quality NI = Not included NA = Not Applicable
Reference
Code
(Section #)
Elements & Required Information IA IU NI NA Location of Element
in Submitted
Document
(Section #, Table #,
figure #, etc)
COMMENTS
PROJECT MANAGEMENT
Provides Field Analytical Instrument Calibration
Provides Field Analytical Instrument/ Equipment
Maintenance Testing & Inspection Requirements
Identifies Field Analytical Inspection & Acceptance
Requirements for Supplies
Provides Fixed Lab Analytical Method Requirements
(include sub-sampling, preparation, cleanup, or
extraction methods/procedures)
Provides Fixed Lab Analytical Methods & SOPs
(includes modifications if applicable; includes
reporting limits, etc.)
[Use LQAP checklist if LQAP was submitted
separately]
Provides Fixed Lab Instrument Calibration
procedures
[Use LQAP checklist if LQAP was submitted
separately]
Identifies Fixed lab Instrument/Equipment
Maintenance, Testing & Inspection Requirements
[Use LQAP checklist if LQAP was submitted
separately]
Identifies Fixed Lab Inspection & Acceptance
Requirements for Supplies (audits)
[Use LQAP checklist if LQAP was submitted
separately]
Revision: 0
Date: January 27, 2006
15
IA = Included and Adequate for Data Quality IU = Included and Inadequate for Data Quality NI = Not included NA = Not Applicable
Reference
Code
(Section #)
Elements & Required Information IA IU NI NA Location of Element
in Submitted
Document
(Section #, Table #,
figure #, etc)
COMMENTS
PROJECT MANAGEMENT
1 (B5) Quality Control Requirements (Identifies required
measurement QC checks for both the field and the
laboratory)
Includes Trip blank (1/cooler containing volatiles)
Includes Field blank (1 blank/matrix/day or 1
blank/20 samples/matrix, whichever is more
frequent)
Includes Rinsate/Equipment Blank (1
blank/matrix/day or 1 blank/20 samples/matrix,
whichever is more frequent)
Includes Temperature Blank (1/cooler)
Includes Field Duplicate (1 duplicate/20 samples)
Includes Matrix Spike/Matrix Spike Dup (1/20
samples/matrix)
Identifies acceptance criteria and corrective action
for QC procedures
Identifies Field Analytical QC (calibration check
samples), includes frequency and limits
Provides Fixed Laboratory QC procedures,
frequency and limits
[Use LQAP checklist if LQAP was submitted
separately]
1 (B6) Instrument/Equipment Testing, Inspection, and
Maintenance Requirements
Revision: 0
Date: January 27, 2006
16
IA = Included and Adequate for Data Quality IU = Included and Inadequate for Data Quality NI = Not included NA = Not Applicable
Reference
Code
(Section #)
Elements & Required Information IA IU NI NA Location of Element
in Submitted
Document
(Section #, Table #,
figure #, etc)
COMMENTS
PROJECT MANAGEMENT
Identifies acceptance testing of sampling and
measurement systems
Describes equipment preventative and corrective
maintenance
Notes availability and location of spare parts
1 (B7) Instrument Calibration and Frequency
Identifies equipment needing calibration and
frequency for such calibration
Identifies frequency of calibration verification or
continuing calibration
Notes required calibration standards and/or
equipment
Cites calibration records and manner traceable to
equipment
1 (B8) Inspection/Acceptance Requirements for Supplies
and Consumables
Revision: 0
Date: January 27, 2006
17
IA = Included and Adequate for Data Quality IU = Included and Inadequate for Data Quality NI = Not included NA = Not Applicable
Reference
Code
(Section #)
Elements & Required Information IA IU NI NA Location of Element
in Submitted
Document
(Section #, Table #,
figure #, etc)
COMMENTS
PROJECT MANAGEMENT
States acceptance criteria for supplies and
consumables
Notes responsible individuals
1 (B9) Data Acquisition Requirements for Non-Direct
Measurements (Historical/Databases/Modeling)
Identifies types of data needed for non-
measurement sources (e.g., computer databases
and literature files), along with acceptance criteria
for their use
Describes any limitations of such data
Documents rationale for original collection of data
and its relevance to this project
1 (A9,
B10)
Data Management
Can be included in separate Data Management Plan
Describes Data Recording (Describes standard
record-keeping and data storage and retrieval
requirements)
Revision: 0
Date: January 27, 2006
18
IA = Included and Adequate for Data Quality IU = Included and Inadequate for Data Quality NI = Not included NA = Not Applicable
Reference
Code
(Section #)
Elements & Required Information IA IU NI NA Location of Element
in Submitted
Document
(Section #, Table #,
figure #, etc)
COMMENTS
PROJECT MANAGEMENT
Describes Data Validation (Details the process of
data validation; should address how the method,
instrument, or system preforms the function it is
intended to -consistently, reliably, and accurately
when generating the data)
Note: Part D addresses the overall project data
validation
Describes Data Transformation (Documents
Procedures)
Data transformation is the conversion of individual
data point values into related values or possibly
symbols using conversion formulas or a system for
replacement)
Note: Transformation and aberration of data for
statistical analysis should be outlined in element D3.
Describes Data Transmittal (Describes each data
transfer step and the procedures used to
characterize data transmittal error rates and to
minimize information loss in transmittal)
Describes Data Reduction - involves irreversible
reduction in the size of the data set and an
associated loss of detail. (For manual calculation,
includes an example of how raw data is reduced; for
automated data process, indicates how the raw data
are to be reduced with a well-defined audit trail, and
references specific software documentation)
Revision: 0
Date: January 27, 2006
19
IA = Included and Adequate for Data Quality IU = Included and Inadequate for Data Quality NI = Not included NA = Not Applicable
Reference
Code
(Section #)
Elements & Required Information IA IU NI NA Location of Element
in Submitted
Document
(Section #, Table #,
figure #, etc)
COMMENTS
PROJECT MANAGEMENT
Describes Data Analysis (includes an outline of the
proposed methodology with a more detailed
discussion included in final report)
Describes Data Tracking (describes procedures for
tracking the flow of data through the data processing
system)
Describes Data Storage and Retrieval (describes
procedures for data storage and retrieval including
security and time of retention included; includes
documentation of the complete control system;
discusses performance requirements of the data
processing system, including provisions for the
batch processing schedule and the data storage
facilities). Includes storage and retrieval of electronic
data (needs to be available upon EPA request)
ASSESSMENT/OVERSIGHT ELEMENTS
1 (C1) Assessments and Response Actions
Lists required number, frequency and type of
assessments, with approximate dates and names of
responsible personnel (assessments include but are
not limited to peer reviews, management systems
reviews, technical systems audits, performance
evaluations, and audits of data quality)
Revision: 0
Date: January 27, 2006
20
IA = Included and Adequate for Data Quality IU = Included and Inadequate for Data Quality NI = Not included NA = Not Applicable
Reference
Code
(Section #)
Elements & Required Information IA IU NI NA Location of Element
in Submitted
Document
(Section #, Table #,
figure #, etc)
COMMENTS
PROJECT MANAGEMENT
Identifies individual(s) responsible for corrective
actions
Provides Feedback from performance audits (field
and laboratory)
Includes Schedule of audits
1 (C2) Reports to management
Identifies frequency and distribution of reports for
project status
Identifies frequency and distribution of reports for
results of performance evaluations and audits
Identifies frequency and distribution of reports for
results of periodic data quality assessments
Identifies frequency and distribution of reports for
changes in the QAPP
Identifies frequency and distribution of reports for
any significant QA problems indicating EPA is
notified immediately
Identifies frequency and distribution of reports for
preparers and recipients of reports
DATA VALIDATION AND USABILITY ELEMENTS
1 (D1) Data Review
Revision: 0
Date: January 27, 2006
21
IA = Included and Adequate for Data Quality IU = Included and Inadequate for Data Quality NI = Not included NA = Not Applicable
Reference
Code
(Section #)
Elements & Required Information IA IU NI NA Location of Element
in Submitted
Document
(Section #, Table #,
figure #, etc)
COMMENTS
PROJECT MANAGEMENT
Describes the procedures being used to review field
and laboratory data to ensure that it meets
requirements specified in field and analytical SOPs.
Includes project-specific calculations or algorithms
Identifies issue resolution procedure and title(s) of
individual(s) responsible for issue resolution
1 (D2)
5
6
7
Data Verification and Validation Methods
Describes process for data validation and
verification (provide SOPs or reference Region III
Modifications to National Functional Guidelines for
Data Review)
Identifies issue resolution procedure and title(s) of
individual(s) responsible for issue resolution
Identifies method for conveying these results to data
users
1 (D3) Data Quality Assessment
Describe the procedures used to evaluate the
uncertainty of data acquired during sampling and
analytical procedures.
Describes the procedures that will be used to
reconcile project results with DQOs.
Describes how the limitation on use of the data will
be reported.
Revision: 0
Date: January 27, 2006
22
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References
1. EPA Requirements for Quality Assurance Project Plans, EPA QA/R5, March 2001. Can be downloaded from the Internet at
http://www.epa.gov/QUALITY/qa_docs.html
2. Data Quality Objectives Process for Superfund: Interim Final Guidance (EPA, 1993)
3. Guidance on Systematic Planning using the Data Quality Objectives Process. EPA /240/B06?001, February 2006. Can be downloaded from the Internet
at http://www.epa.gov/QUALITY/qa_docs.html
4. Data Quality Objectives Process for Hazardous Waste Site Investigations, EPA QA/G-4HW, January 2000. Can be downloaded from the Internet at
http://www.epa.gov/QUALITY/qa_docs.html
5. Region III Modifications to the National Functional Guidelines for Inorganic Data Review, April 1993. http://www.epa.gov/region03/esc/qa/dataval.htm
6. Region III Modifications to the National Functional Guidelines for Organic Data Review, November 1994.
http://www.epa.gov/region03/esc/qa/dataval.htm
7. Region III Innovative Approaches to Data Validation, June 1995. http://www.epa.gov/region03/esc/qa/dataval.htm
8. Region III Dioxin/Furan Data Validation Guidance, March, 1999. http://www.epa.gov/region03/esc/qa/dataval.htm
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Epa Qapp Review Checklist (Commonwealth of Massachusetts)

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Completed 26 July 2020

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