REGION III QAPP Preparation Checklist

Site Name:		Preparer:		
Document Title(s):		Date of QAPP:	 	

Instructions for Use of Checklist:

Below is an explanation of the header items and instructions for each item.   The QAPP preparer is to fill in the Location of Element column and the Comments column when appropriate.  

IA = Included and Acceptable	IU = Included and Unacceptable	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	

	Reference Codes are provided on page 20.	Element description; specific		These four columns are for		Preparer enters the appropriate	Enter any relevant
	These references are to assist preparers in	Region III requirements are included	EPA use during review		section number, page number,	comment; include 
	identifying additional information concerning	when applicable			of the document and do 		table or figure reference where 	justification for
	QAPP contents								not require preparer input		the element can be located in the	omitting 
														QAPP; include references to other	an element
														documents when applicable (Work
														Plans, Sampling Analysis Plans, etc.)

Attachments:

References are provided on Page 20 of this checklist.

The Data Quality Objective Process is provided in Attachment 1.     This process is recommended to assist preparers with Elements A5 through A7.

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IA = Included and Acceptable	IU = Included and Unacceptable	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.)							
	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							
	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							
	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)							
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 data1 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.							
	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.							
	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.							
	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							
	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							
	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							
	Includes procedures/forms for recording the exact location and specific consideration associated with sample acquisition							
	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)							
	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)
[Use LQAP checklist if LQAP was submitted separately]							
	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]							
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							
	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
							
	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)							
	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)
							
	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)							
	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							
	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.							

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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   

2.	Data Quality Objectives Process for Superfund: Interim Final Guidance (EPA, 1993)

3.	EPA Guidance on the Data Quality Objectives Process, EPA QA/G-4, September 2000.  Can be downloaded from the Internet at  

4.	Data Quality Objectives Process for Hazardous Waste Site Investigations, EPA QA/G-4HW, January 2000.  Can be downloaded from the Internet at  

5.	Region III Modifications to the National Functional Guidelines for Inorganic Data Review, April 1993.  Can be obtained from May Edwards - 

6.	Region III Modifications to the National Functional Guidelines for Organic Data Review, November 1994.  Can be obtained from May Edwards - 

7.	Region III Innovative Approaches to Data Validation, June 1995.  Can be obtained from May Edwards -  

8.	Region III Dioxin/Furan Data Validation Guidance, March, 1999.   Can be obtained from May Edwards -  

ATTACHMENT 1 

Region III QAPP Preparation Checklist
DQO Process