ASTM E2327-10
(Practice)Standard Practice for Quality Assurance of Laboratories Performing Seized-Drug Analysis
Standard Practice for Quality Assurance of Laboratories Performing Seized-Drug Analysis
SIGNIFICANCE AND USE
These are minimum standards of quality assurance applicable to laboratories where analysis of seized-drug submissions is performed.
This practice is to be used by forensic analysts performing seized-drug analysis and promoted/supported by laboratory management.
SCOPE
1.1 This practice covers quality assurance issues in forensic laboratories performing seized-drug analysis including evidence handling, analytical procedures, report writing, method validation, documentation, proficiency testing, audits, and health and safety.
1.2 This practice is meant to apply only to qualitative seized-drug analysis.
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Designation: E2327 − 10
StandardPractice for
Quality Assurance of Laboratories Performing Seized-Drug
1
Analysis
This standard is issued under the fixed designation E2327; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope 5. Quality Management System
1.1 This practice covers quality assurance issues in forensic
5.1 It is the goal of a laboratory’s drug analysis program to
laboratories performing seized-drug analysis including evi-
providecustomersofthelaboratory’sservicesaccesstoquality
dence handling, analytical procedures, report writing, method
drug analysis. It is the goal of this standard to provide a
validation, documentation, proficiency testing, audits, and
framework of quality in the processing of drug evidence,
health and safety.
including evidence handling, management practices, qualita-
tive analysis, and reporting. A documented quality manage-
1.2 This practice is meant to apply only to qualitative
ment system shall be established and maintained. Personnel
seized-drug analysis.
responsible for this shall be clearly designated and have direct
access to the highest level of management concerning labora-
2. Referenced Documents
tory policy.
2
2.1 ASTM Standards:
5.2 The quality management system shall cover all proce-
E2328 Terminology Relating to Seized-Drug Analysis
3
dures and reports associated with drug analysis.
(Withdrawn 2005)
2.2 Other Document:
6. Personnel
Scientific Working Group for the Analysis of Seized Drugs
Recommendations for: Education and Training, Quality 6.1 Job Description—Job descriptions for all personnel
should include responsibilities, duties, and required skills.
Assurance, Methods of Analysis
6.2 Designated Personnel and Responsibilities—An indi-
3. Terminology
vidual (however titled) may be responsible for more than one
3.1 Terms that may assist in interpreting this standard are of the following duties:
found in Terminology E2328.
6.2.1 Quality Assurance Manager—A designated person
who is responsible for maintaining the quality management
4. Significance and Use
system (including an annual review of the program) and who
monitors compliance with the program.
4.1 These are minimum standards of quality assurance
6.2.2 Health and Safety Manager—A designated person
applicable to laboratories where analysis of seized-drug sub-
who is responsible for maintaining the Laboratory Health and
missions is performed.
Safety program (including an annual review of the program)
4.2 This practice is to be used by forensic analysts perform-
and who monitors compliance with the program.
ing seized-drug analysis and promoted/supported by laboratory
6.2.3 Personnel Technical Support—Apersonwhoperforms
management.
basic laboratory duties, but does not analyze evidence.
6.2.4 Technician/Assistant Analyst—Aperson who analyzes
evidence, but does not issue reports for court purposes.
1
This practice is under the jurisdiction of ASTM Committee E30 on Forensic
6.2.5 Analyst—A designated person who:
Sciences and is the direct responsibility of Subcommittee E30.01 on Criminalistics.
Current edition approved Dec. 15, 2010. Published January 2010. Originally 6.2.5.1 Examines and analyzes seized drugs or related
approved in 2004. Last previous edition approved in 2004 as E2327 – 04. DOI:
materials, or directs such examinations to be done;
10.1520/E2327-10.
2 6.2.5.2 Independently has access to unsealed evidence in
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM order to remove samples from the evidence for examination;
Standards volume information, refer to the standard’s Document Summary page on
and
the ASTM website.
3
6.2.5.3 As a consequence of such examinations, signs re-
The last approved version of this historical standard is referenced on
www.astm.org. ports for court or other purposes.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
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E2327 − 10
6.2.6 Supervisory Analyst—A designated person who has 7. Physical Plant
the overall responsibility and authority for the technical opera-
7.1 Physical Plant Requirements:
tionsofthedruganalysissection.Technicaloperationsinclude,
7.1.1 Laboratories shall provide adequate safety and secu-
but are not limited to protocols, analytical methodology, and
rity for personnel and operations.
technical review of reports.
7.1.2 Laboratories shall meet required health and safety
6.3 Qualifications/Education: building codes.
7.1.3 La
...
This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation:E2327–04 Designation: E2327 – 10
Standard Practice for
Quality Assurance of Laboratories Performing Seized-Drug
1
Analysis
This standard is issued under the fixed designation E2327; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope
1.1 This standardpractice covers quality assurance issues in forensic laboratories performing seized-drug analysis including
evidence handling, analytical procedures, report writing, method validation, documentation, proficiency testing, audits, and health
and safety.
1.2Standards are 1.2 This practice is meant to apply only to the practice of qualitative seized-drug analysis.
2. Referenced Documents
2
2.1 ASTM Standards:
E2328 Terminology Relating to Seized-Drug Analysis
2.2 Other Document:
ScientificWorking Group for theAnalysis of Seized Drugs Recommendations for: Education andTraining, QualityAssurance,
Methods of Analysis
3. Terminology
3.1 Terms that may assist in interpreting this standard are found in Terminology E2328.
4. Significance and Use
4.1 These are minimum standards of quality assurance applicable to laboratories where analysis of seized-drug submissions is
performed.
4.2The standards are4.2 This practice is to be practicedused by forensic analysts performing seized-drug analysis and
promoted/supported by laboratory management.
5. Quality Management System
5.1 It is the goal of a laboratory’s drug analysis program to provide customers of the laboratory’s services access to quality drug
analysis. It is the goal of this standard to provide a framework of quality in the processing of drug evidence, including evidence
handling, management practices, qualitative analysis, and reporting. A documented quality management system mustshall be
established and maintained. Personnel responsible for this mustshall be clearly designated and have direct access to the highest
level of management concerning laboratory policy.
5.2 The quality management system mustshall cover all procedures and reports associated with drug analysis.
6. Personnel
6.1 Job Description—Job descriptions for all personnel should include responsibilities, duties, and required skills.
6.2 Designated Personnel and Responsibilities —An individual (however titled) may be responsible for more than one of the
following duties:
6.2.1 Quality Assurance Manager—A designated person who is responsible for maintaining the quality management system
(including an annual review of the program) and who monitors compliance with the program.
6.2.2 Health and Safety Manager—A designated person who is responsible for maintaining the Laboratory Health and Safety
program (including an annual review of the program) and who monitors compliance with the program.
1
This practice is under the jurisdiction of ASTM Committee E30 on Forensic Sciences and is the direct responsibility of Subcommittee E30.01 on Criminalistics.
Current edition approved Oct. 1, 2004. Published January 2005. DOI: 10.1520/E2327-04.
Current edition approved Dec. 15, 2010. Published January 2010. Originally approved in 2004. Last previous edition approved in 2004 as E2327 – 04. DOI:
10.1520/E2327-10.
2
For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at service@astm.org. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1
---------------------- Page: 1 ----------------------
E2327 – 10
6.2.3 Personnel Technical Support—A person who performs basic laboratory duties, but does not analyze evidence.
6.2.4 Technician/Assistant Analyst—A person who analyzes evidence, but does not issue reports for court purposes.
6.2.5 Analyst—A designated person who:
6.2.5.1 Examines and analyzes seized drugs or related materials, or directs such examinations to be done,done;
6.2.5.2 Independently has access to unsealed evidence in order to remove samples from the evidence for examination,; and
6.2.5.3 As a consequence of such examinations, signs reports for court or other purposes.
6.2.6 Supervisory Analyst—Adesignated person who has the overall responsibility and authority for the technical operations of
the drug analysis section. Technical ope
...
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