Revised Data Validation Guidance 12/96

Overview

Part I: Data Validation Manual: The Data Quality System

Part I of this document is called the "Data Validation Manual: The Data Quality System". It explains the purpose and objectives of data validation and describes the Region I three Tier Data Validation system. Part I lists the information to be reviewed during data validation. It also specifies the format and components of the three types of data validation products and the distribution requirements for these products. Part I identifies the roles and responsibilities of the parties involved in the collection of environmental data. Part I is for the following parties:

• EPA personnel interested in data validation
• EPA contractors collecting environmental data
• State and Tribe personnel under Cooperative Agreements with EPA
• Federal Agency personnel under Interagency Agreements with EPA to collect environmental data
• Federal Agency personnel performing non-Fund lead work
• Potentially Responsible Parties collecting environmental data to meet EPA requirements
• Parties interested in gaining an overview of the data validation process.

Attachments A through Q of Part I provide additional information to support Part I.

Part I and attachments »

Part II: Volatile/Semivolatile Data Validation Functional Guidelines

Part II of this document is called "Volatile/Semivolatile Data Validation Functional Guidelines". It describes the specific technical procedures for doing data validation on volatile and semivolatile organic analyses generated by gas chromatography/mass spectrometry. This part lists the specific quality control parameters to be checked during data validation and explains the rationale for using them. The actual criteria used to evaluate the results are listed along with the actions to be taken when criteria are not met . Numerous technical examples are given to demonstrate how the process works. Part II is for the following parties:

• Data validators
• Environmental chemists
• Risk assessors
• Field samplers (for preservation requirements)
• Lead chemists for EPA contractors
• Parties interested in learning the details of the data validation process.

Appendices A through E of Part II contain information concerning four CLP Statements of Work as well as Action Tables for the volatile/semivolatile functional guidelines.

Part II and appendices »

Part III: Pesticide/PCB Data Validation Functional Guidelines

Part III of this document is called “Pesticide/PCB Data Validation Functional Guidelines”. It describes the specific technical procedures for doing data validation on pesticide/PCB organic analyses generated by gas chromatography/ECD. This part lists the specific quality control parameters to be checked during data validation and explains the rationale for using them,. The actual criteria used to evaluate the results are listed along with the actions to be taken when criterial are not met. Numerous technical examples are given to demonstrate how the process works. Part III is for the following parties:

• Data validators
• Environmental chemists
• Risk assessors
• Field samplers (for preservation requirements)
• Lead chemists for EPA contractors
• Parties interested in learning the details of the data validation process.

Appendices F through G of Part III contain information concerning two CLP Statements of Work as well as Action Tables for the pesticide/PCB functional guidelines.

Part III and appendices »

Part IV: Inorganic Data Validation Functional Guidelines

Part IV of this document is called “Inorganic Data Validation Functional Guidelines”. It describes the specific technical procedures for performing data validation on metals data generated by inductively coupled plasma (ICP)-atomic emission spectrometry, ICP-mass spectrometry, and cold vapor atomic absorption spectrometry (mercury), and on cyanide data generated by distillation/colorimetry. This part lists the specific quality control parameters to be checked during data validation and explains the rationale for using them. The actual criteria used to evaluate the results are listed along with the actions to be taken when criteria are not met. Numerous technical examples are given to demonstrate how the process works. Part IV is for the following parties:

• Data validators
• Environmental chemists
• Risk assessors
• Field samplers (for preservation requirements)
• Lead chemists for EPA contractors
• Parties interested in learning the details of the data validation process.

Appendices I, J, and K of Part IV contain information concerning a CLP Statement of Work as well as Action Tables and data validation worksheets for the inorganic functional guidelines.

Part IV and appendices »

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Part I: Data Validation Manual: The Data Quality System

Part I - Data Validation Manual: The Data Quality System (PDF) (61 pp., 530 KB)

Attachments

Attachment A (PDF) (1 p., 31 KB)		"Quality Assurance for Superfund Environmental Data Collection Activities" - Publication 9200.2-16FS, February 1993, and "EPA Order 5360.1, Draft 1995 Quality Assurance Order".
Attachment B (PDF) (15 pp., 43 KB)		"Region I Tiered Organic and Inorganic Data Validation Guidelines", July 1, 1993, DRAFT.
Attachment C (PDF) (48 pp., 291 KB)		"Region I CSF Completeness Evidence Audit Program", July 1991.
Attachment D (PDF) (1 p., 4 KB)		"Specifications and Guidance for Contaminant-Free Sample Containers" - Publication 9240.05A, EPA/540/R-93/051, December 1992.
Attachment E (PDF) (1 p., 4 KB)		"User's Guide to the Contract Laboratory Program", EPA/540/P-91/002, January 1991.
Attachment F (PDF) (67 pp., 407 KB)		Region I Short Sheets and EPA CLP Information Sheets.
Attachment G (PDF) (45 pp., 273 KB)		"Training Manual for Reviewing Laboratory Data Package Completeness", June 1994.
Attachment H (PDF) (35 pp., 100 KB)		"EPA Region I Performance Evaluation Program Guidance", July 1996, Revision.
Attachment I (PDF) (6 pp., 18 KB))		"The Standard Operating Procedures for Submitting Data for Reduced Payment/Data Rejection", September 9, 1991.
Attachment J (PDF) (43 pp., 1.07 MB)		Data Validation Report. DQO Summary Form ORDA/IRDA Form Telephone Log or Regional/Laboratory Communication Form Data Validation Worksheets Chain-of-Custody Form Traffic Report
Attachment K (PDF) (6 pp., 9 KB)		Example of Contract Compliance Screening (CCS) Report.
Attachment L (PDF) (84 pp., 785 KB)		"Guidance Document for Completing Region I Data Validation Utilizing CADRE Data Review", February 1995.
Attachment M (PDF) (1 p., 25 KB)		Example Tier I Validation Cover Letter.
Attachment N (PDF) (1 p., 25 KB)		Example Tier III Data Validation Reports.
Attachment O (PDF) (3 pp., 7 KB)		"March 7, 1995 Memorandum to Heidi Horahan, ARCS DPO re: CLP-SOW OLM03.1 - New Contract Requirements".
Attachment P (PDF) (45 pp., 399 KB)		"The Regional Sample Control Center Guidance for the Contract Laboratory Program (CLP) and Delivery of Analytical Services (DAS) Program for EPA-New England", November 1996.
Attachment Q (PDF) (1 p., 28 KB)		"Region I ARCS Delivery of Analytical Services Pilot Program, Final Report Volume II. Appendices", March 15, 1994.

Part II - Volatile/Semivolatile Data Validation Functional Guidelines

1. Sections I-VI (PDF) (54 pp., 823 KB)
2. Sections VII-XII (PDF) (59 pp., 901 KB)
3. Sections XIII-XVII (PDF) (35 pp., 408 KB)

Appendices

Appendix A (PDF) (17 pp., 63 KB)		CLP SOW OLM03.2/Volatile Organic Analysis - Method QC Criteria, Equations, and Definitions
Appendix B (PDF) (17 pp., 363 KB)		CLP SOW OLM03.2/Semivolatile Organic Analysis - Method QC Criteria, Equations, and Definitions
Appendix C (PDF) (12 pp., 53 KB)		CLP SOW OLC02.1/Low Concentration Volatile Organic Analysis - Method QC Criteria, Equations, and Definitions
Appendix D (PDF) (12 pp., 336 KB)		CLP SOW OLC02.1/Low Concentration Semivolatile Organic Analysis - Method QC Criteria, Equations, and Definitions
Appendix E (PDF) (11 pp., 43 KB)		VOA/SV Functional Guidelines Action Tables

Part III - Pesticide/PCB Data Validation Functional Guidelines

1. Table of Contents and Sections I-V (PDF) (66 pp., 449 KB)
2. Sections VI-X (PDF) (63 pp., 432 KB)
3. Sections XI-XV (PDF) (47 pp., 352 KB)

Appendices

Appendix F (PDF) (17 pp., 461 KB)		CLP SOW OLM04.3/Pesticide/PCB Analysis
Appendix G (PDF) (16 pp., 413 KB)		CLP SOW OLC03.2/Pesticide/PCB Analysis
Appendix H (PDF) (12 pp., 88 KB)		Pest/PCB Functional Guidelines Action Tables

Part IV - Inorganic Data Validation Functional Guidelines

1. Table of Contents and Sections I-IV (PDF) (50 pp., 2.74 MB)
2. Sections V-X (PDF) (51 pp., 2.94 MB)
3. Sections XI-XVI (PDF) (48 pp., 2.75 MB)

Appendices

Appendix I (PDF) (16 pp., 868 KB)		CLP SOW ILM05.4/Inorganic Analysis – Method QC Criteria, Equations, and Definitions
Appendix J (PDF) (14 pp., 805 KB)		Inorganic Functional Guidelines Action Tables
Appendix K (PDF) (28 pp., 1.55 MB)		Inorganic Data Validation Worksheets

 

Fact Sheet

Why:	The revised data validation guidance, the Region I, EPA-NE Data Validation Functional Guidelines for Evaluating Environmental Analyses, was written by the QA Unit Staff to formalize technical direction given since the original Region I Functional Guidelines were implemented in 1988. Data validation is necessary to ensure that only data of known and documented quality are used in making environmental decisions. As such, this guidance serves as a standard operating procedure that documents our Region's commitment to using only scientifically defensible data in environmental decision-making, it documents compliance with Headquarters' directives and guidance, and it ensures that data generated by or for the region are evaluated consistently.
What:	The Region I, EPA-NE Data Validation Functional Guidelines for Evaluating Environmental Analyses is a QA guidance document that describes the data generation and validation process, including project scoping, sample scheduling, data review and implementation of corrective actions. The document provides generic guidance in reviewing multi-media organic and inorganic data and is applicable to both CLP and non-CLP data. The "Data Validation Manual: The Data Quality System", Part I of the document, details: Purpose and objectives of data validation Describes the Region I three Tier Data Validation system Identifies the roles and responsibilities of each of the following regarding project scoping, DQO development, sample scheduling, data validation, data usability and corrective action: EPA personnel EPA contractors States under Cooperative Agreements Other Federal Agencies under Interagency Agreements Other Federal Agencies performing non-Fund lead work Potentially Responsible Parties Itemizes the information to be reviewed during data validation Specifies the format and components of the Tier I Validation Cover Letter and the Data Validation Report for Tier II and Tier III validations Identifies distribution requirements for the Tier I Validation Cover Letter and Tier II/III Data Validation Reports Parts II, III and IV are the specific Functional Guideline procedures for evaluating Volatile/Semivolatile organic analyses by GC/MS, Pesticide/PCB organic analyses by GC, and Inorganic analyses by ICP and AA, respectively. Parts II and III will replace the Region I Laboratory Data Validation Functional Guidelines for Evaluating Organics Analyses, 2/01/88 modified 11/01/88. Part IV will replace the Region I Laboratory Data Validation Functional Guidelines for Evaluating Inorganics Analyses, 6/13/88, modified 2/89.
Who:	This revised guidance document is intended for use by numerous stakeholders, including EPA and its contractors, States, Tribes, other Federal Agencies, PRPs, industry, and the public. It serves as a training, instruction, and guidance document for individuals involved in data generation activities for EPA-New England.
Contact:	Questions concerning this document can be directed to: Dr. Steve Stodola (stodola.steve@epa.gov) EPA New England Regional Laboratory Quality Assurance Unit 11 Technology Drive North Chelmsford, MA 01863-2431 (617) 918-8634