Validation of Analytical Chemistry Laboratories (Environmental Quality).pdf

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

2-3 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

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

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

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