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CEMP
Department of the Army
U.S. Army Corps of Engineers
Washington, DC 20314-1000
EM 200-1-1
Memorandum
No.
200-1-1
1 Jul 94
Environmental Quality
VALIDATION OF ANALYTICAL CHEMISTRY
Distribution Restriction Statement
Approved for public release; distribution is unlimited.
DEPARTMENT OF THE ARMY
U.S. Army Corps of Engineers
Washington, DC 20314-1000
EM 200-1-1
CEMP-RT
CECW-E
Manual
No. 200-1-1
1 July 1994
Environmental Quality
VALIDATION OF ANALYTICAL CHEMISTRY LABORATORIES
Table of Contents
Subject
Paragraph Page
CHAPTER 1.
INTRODUCTION
Purpose-------------------------
Applicability-------------------
References----------------------
Overview-----------------------
Responsibilities---------------
Expenses and, Funding------------
Effective Date and Amendments----
1-1 1-1
1-2 1-1
1-3 1-1
1-4 1-1
1-5 1-2
1-6 1-8
1-7 1-8
CHAPTER 2.
PROCEDURES FOR COMMERCIAL LABORATORIES
Validation Procedures
Initiation Procedures-----------
Implementation Procedures-------
Implementation Procedure Steps--
Approval Procedures-------------
Inspection/Evaluation Report----
2-1 2-1
2-1 2-1
2-3 2-5
2-4 2-15
2-5 2-23
Section II.
Revalidation, Termination, and Appeal
Revalidation-------------------
Termination--------------------
Appeal------------------------
2-6 2-26
2-7 2-27
2-8 2-28
Section III.
Information Management
Record Files--------------------
Database------------------------
2-9 2-31
2-10 2-31
CHAPTER 3.
PROCEDURES FOR USACE DIVISION LABORATORIES
USACE Division Laboratories-----
Contract QA Laboratories--------
3-1 3-1
3-2 3-2
i
EM 200-1-1
1 Jul 94
Appendices
Page
APPENDIX A
REFERENCE
A-1
APPENDIX B
INTRODUCTION TO THE U.S. ARMY CORPS
OF ENGINEERS VALIDATION PROGRAM FOR
COMMERCIAL ANALYTICAL CHEMISTRY
LABORATORIES
B-1
APPENDIX C
INFORMATION FOR COMMERCIAL ANALYTICAL
CHEMISTRY LABORATORIES UNDERGOING
VALIDATION BY THE U.S. ARMY CORPS OF
ENGINEERS
C-1
APPENDIX D
GUIDELINES FOR ANALYZING AND REPORTING
PERFORMANCE EVALUATION SAMPLES FROM
THE U.S. ARMY CORPS OF ENGINEERS
D-1
APPENDIX E
PRELIMINARY QUESTIONNAIRE FOR THE U.S.
ARMY CORPS OF ENGINEERS VALIDATION
PROGRAM FOR ANALYTICAL CHEMISTRY
LABORATORIES
E-1
APPENDIX F
ANALYTICAL PARAMETERS, METHODS, AND FEE
SCHEDULE FOR PERFORMANCE EVALUATION
SAMPLES FROM THE U.S. ARMY CORPS
OF ENGINEERS
F-1
APPENDIX G
GUIDANCE FOR PREPARATION, HANDLING, AND
VALIDATION OF PERFORMANCE EVALUATION
SAMPLES
G-1
APPENDIX H
GUIDELINES AND CRITERIA FOR ON-SITE
INSPECTION OF COMMERCIAL ANALYTICAL
CHEMISTRY LABORATORIES
H-1
APPENDIX I
CHECKLISTS FOR ON-SITE LABORATORY
INSPECTIONS
I-1
APPENDIX J
SHORT CHECKLISTS FOR ON-SITE LABORATORY
INSPECTIONS
J-1
APPENDIX K
SAMPLE RECORD OF THE LABORATORY
VALIDATION DATABASE
K-1
APPENDIX L
SUPPLEMENTAL QUESTIONNAIRE FOR VALIDATION
OF USACE DIVISION LABORATORIES
L-1
ii
EM 200-1-1
1 Jul 94
Appendices
Page
APPENDIX M
LIST OF ABBREVIATIONS, ACRONYMS, FORMULAS M-1
SYMBOLS, NUMBERS, AND TERMS
iii
EM 200-1-1
1 Jul 94
Figures
Page
FIGURE 1-1
FLOW DIAGRAM OF COMMERCIAL LABORATORY
VALIDATION PROCEDURES
1-3/
1-4
FIGURE 2-1
LABORATORY EVALUATION REQUEST FORMAT
2-2
FIGURE 2-2
ON-SITE LABORATORY INSPECTION SUMMARY
2-16/
2-18
FIGURE 2-3
VALIDATION REVIEW MEETING SUMMARY
2-20/
2-21
FIGURE 2-4
LABORATORY PERFORMANCE PROBLEM REPORT
2-29/
2-30
FIGURE C-1
SAMPLE LABORATORY EVALUATION REQUEST
C-3
FIGURE C-2
FLOW DIAGRAM OF COMMERCIAL LABORATORY
VALIDATION PROCEDURES
C-9/
C-10
FIGURE H-1
PRE-INSPECTION CHECKLIST
H-3/
H-4
FIGURE H-2
ENTRANCE INTERVIEW CHECKLIST
H-5/
H-6
FIGURE H-3
EXIT INTERVIEW CHECKLIST
H-9
FIGURE H-4
COOLER RECEIPT CHECKLIST
H-12
FIGURE K-1
SAMPLE RECORD OF THE LABORATORY
VALIDATION DATABASE
K-2/
K-6
iv
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