ASTM E2327-15
(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
4.1 These are minimum standards of quality assurance applicable to laboratories where analysis of seized-drug submissions is performed.
4.2 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.
1.3 This practice does not replace knowledge, skill, ability, experience, education, or training and should be used in conjunction with professional judgment.
1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
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Designation: E2327 − 15
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 E2764 PracticeforUncertaintyAssessmentintheContextof
Seized-Drug Analysis
1.1 This practice covers quality assurance issues in forensic
2.2 Other Documents:
laboratories performing seized-drug analysis including evi-
ISO Guide 34 General Requirements for the Competence of
dence handling, analytical procedures, report writing, method
3
Reference Material Producers
validation, documentation, proficiency testing, audits, and
ISO/IEC 17025 General Requirements for the Competence
health and safety.
3
of Testing and Calibration Laboratories
1.2 This practice is meant to apply only to qualitative
Scientific Working Group for the Analysis of Seized
seized-drug analysis.
Drugs Recommendations for: Education and Training,
4
1.3 This practice does not replace knowledge, skill, ability, Quality Assurance, Methods of Analysis
experience, education, or training and should be used in
3. Terminology
conjunction with professional judgment.
3.1 Terms that may assist in interpreting this standard are
1.4 This standard does not purport to address all of the
found in Terminology E1732.
safety concerns, if any, associated with its use. It is the
responsibility of the user of this standard to establish appro-
4. Significance and Use
priate safety and health practices and determine the applica-
bility of regulatory limitations prior to use.
4.1 These are minimum standards of quality assurance
applicable to laboratories where analysis of seized-drug sub-
2. Referenced Documents
missions is performed.
2
2.1 ASTM Standards:
4.2 This practice is to be used by forensic analysts perform-
E620 Practice for Reporting Opinions of Scientific or Tech-
ing seized-drug analysis and promoted/supported by laboratory
nical Experts
management.
E1732 Terminology Relating to Forensic Science
E1459 Guide for Physical Evidence Labeling and Related
5. Quality Management System
Documentation
5.1 It is the goal of a laboratory’s drug analysis program to
E1492 Practice for Receiving, Documenting, Storing, and
providecustomersofthelaboratory’sservicesaccesstoquality
Retrieving Evidence in a Forensic Science Laboratory
drug analysis. It is the goal of this standard to provide a
E2326 Practice for Education and Training of Seized-Drug
framework of quality in the processing of drug evidence,
Analysts
including evidence handling, management practices, qualita-
E2329 Practice for Identification of Seized Drugs
tive and quantitative analysis, and reporting. A documented
E2548 Guide for Sampling Seized Drugs for Qualitative and
quality management system shall be established and main-
Quantitative Analysis
tained. Personnel responsible for this shall be clearly desig-
E2549 Practice for Validation of Seized-Drug Analytical
nated and have direct access to the highest level of manage-
Methods
ment concerning laboratory policy.
5.2 The quality management system shall cover all proce-
1
This practice is under the jurisdiction of ASTM Committee E30 on Forensic
dures and reports associated with drug analysis.
Sciences and is the direct responsibility of Subcommittee E30.01 on Criminalistics.
Current edition approved May 1, 2015. Published June 2015. Originally
approved in 2004. Last previous edition approved in 2010 as E2327 – 10. DOI:
3
10.1520/E2327-15. Available from International Organization for Standardization (ISO), ISO
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or Central Secretariat, BIBC II, Chemin de Blandonnet 8, CP 401, 1214 Vernier,
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Geneva, Switzerland, http://www.iso.org.
4
Standards volume information, refer to the standard’s Document Summary page on Available from Scientific Working Group for the Analysis of Seized Drugs,
the ASTM website. http://www.swgdrug.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
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E2327 − 15
6. Personnel 6.5 Maintaining Qualifications—All forensic scientists have
an ongoing responsibility to remain current in their field (see
6.1 Job Description—Job descriptions for all personnel
Practice E2326).
should include responsibilities, duties, and required skills.
7. Physical Plant
6.2 Designated Personnel and Responsibilities—An indi-
vidual (however titled) may be responsible
...
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 − 10 E2327 − 15
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 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.
1.3 This practice does not replace knowledge, skill, ability, experience, education, or training and should be used in conjunction
with professional judgment.
1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility
of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory
limitations prior to use.
2. Referenced Documents
2
2.1 ASTM Standards:
E620 Practice for Reporting Opinions of Scientific or Technical Experts
E2328E1732 Terminology Relating to Seized-Drug AnalysisForensic Science (Withdrawn 2005)
E1459 Guide for Physical Evidence Labeling and Related Documentation
E1492 Practice for Receiving, Documenting, Storing, and Retrieving Evidence in a Forensic Science Laboratory
E2326 Practice for Education and Training of Seized-Drug Analysts
E2329 Practice for Identification of Seized Drugs
E2548 Guide for Sampling Seized Drugs for Qualitative and Quantitative Analysis
E2549 Practice for Validation of Seized-Drug Analytical Methods
E2764 Practice for Uncertainty Assessment in the Context of Seized-Drug Analysis
2.2 Other Document:Documents:
3
ISO Guide 34 General Requirements for the Competence of Reference Material Producers
3
ISO/IEC 17025 General Requirements for the Competence of Testing and Calibration Laboratories
Scientific Working Group for the Analysis of Seized Drugs for the Analysis of Seized Drugs Recommendations for: Education
4
and Training, Quality Assurance, Methods of Analysis
3. Terminology
3.1 Terms that may assist in interpreting this standard are found in Terminology E2328E1732.
4. Significance and Use
4.1 These are minimum standards of quality assurance applicable to laboratories where analysis of seized-drug submissions is
performed.
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 Dec. 15, 2010May 1, 2015. Published January 2010June 2015. Originally approved in 2004. Last previous edition approved in 20042010 as
E2327 – 04.E2327 – 10. DOI: 10.1520/E2327-10.10.1520/E2327-15.
2
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 Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
3
The last approved version of this historical standard is referenced on www.astm.org.Available from International Organization for Standardization (ISO), ISO Central
Secretariat, BIBC II, Chemin de Blandonnet 8, CP 401, 1214 Vernier, Geneva, Switzerland, http://www.iso.org.
4
Available from Scientific Working Group for the Analysis of Seized Drugs, http://www.swgdrug.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
E2327 − 15
4.2 This practice is to be used 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 and quantitative analysis, and reporting. A documented quality management system
shall be established and maintained. Personnel responsible for this shall be clearly designated and have direct access to the highest
level of management conce
...
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