Standard Practice for Uncertainty Assessment in the Context of Seized-Drug Analysis (Withdrawn 2020)

SIGNIFICANCE AND USE
Application of Uncertainty—Qualitative and quantitative analyses require different approaches, refer to the references for additional information. Analysts shall understand the limitations of qualitative and quantitative determinations and have tools to estimate a value for measurement uncertainty of relevant, but not necessarily all, numerical results. In this regard, efforts should be made to use the vocabulary, symbols, and formatting expressed in documents published by international standardizing organizations such as ISO and ASTM International.
An understanding of uncertainty is fundamental to the interpretation and reporting of results.
The term “uncertainty” does not imply doubt; rather, its consideration provides assurance that results and conclusions from methods and analytical schemes are fit for purpose.  
The concept of uncertainty shall be considered for both qualitative and quantitative results.
Laboratory management shall ensure that uncertainty be addressed through the provision of training, procedures and documentation.
Laboratory management should consider customer requirements, such as a request for qualitative versus quantitative determinations, which influence the assessment of uncertainty.  
The benefits of understanding and determining uncertainty in this context include:
Enhancing confidence through increased understanding of results,
Providing a mechanism to express the reliability of results,
Enabling the laboratory management and customer to evaluate the fitness for purpose of results,
Facilitating the identification of procedural limitations and providing a basis for improvement, and
Complying with accreditation requirements.
SCOPE
1.1 This practice provides guidance on the concept of uncertainty and its application to the qualitative and quantitative analysis of seized drugs. In this context, uncertainty encompasses limitations of qualitative methods as well as numerical ranges as applied to quantitative analyses.
1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.3 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.
WITHDRAWN RATIONALE
This practice provides guidance on the concept of uncertainty and its application to the qualitative and quantitative analysis of seized drugs.
Formerly under the jurisdiction of Committee E30 on Forensic Sciences, this practice was withdrawn in July 2020 in accordance with section 10.6.3 of the Regulations Governing ASTM Technical Committees, which requires that standards shall be updated by the end of the eighth year since the last approval date.

General Information

Status
Withdrawn
Publication Date
31-May-2011
Withdrawal Date
07-Jul-2020
Technical Committee
Drafting Committee
Current Stage
Ref Project

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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: E2764 − 11
Standard Practice for
Uncertainty Assessment in the Context of Seized-Drug
1
Analysis
This standard is issued under the fixed designation E2764; 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 relevant, but not necessarily all, numerical results. In this
regard, efforts should be made to use the vocabulary, symbols,
1.1 This practice provides guidance on the concept of
and formatting expressed in documents published by interna-
uncertainty and its application to the qualitative and quantita-
tional standardizing organizations such as ISO and ASTM
tive analysis of seized drugs. In this context, uncertainty
International.
encompasses limitations of qualitative methods as well as
3.1.1 An understanding of uncertainty is fundamental to the
numerical ranges as applied to quantitative analyses.
interpretation and reporting of results.
1.2 The values stated in SI units are to be regarded as
3.1.2 The term “uncertainty” does not imply doubt; rather,
standard. No other units of measurement are included in this
its consideration provides assurance that results and conclu-
standard.
sions from methods and analytical schemes are fit for purpose.
1.3 This standard does not purport to address all of the
3.1.3 The concept of uncertainty shall be considered for
safety concerns, if any, associated with its use. It is the
both qualitative and quantitative results.
responsibility of the user of this standard to establish appro-
3.1.4 Laboratory management shall ensure that uncertainty
priate safety and health practices and determine the applica-
be addressed through the provision of training, procedures and
bility of regulatory limitations prior to use.
documentation.
3.1.5 Laboratory management should consider customer
2. Referenced Documents
requirements, such as a request for qualitative versus quanti-
2
2.1 ASTM Standards:
tative determinations, which influence the assessment of un-
E2329 Practice for Identification of Seized Drugs
certainty.
E2327 Practice for Quality Assurance of Laboratories Per-
3.2 The benefits of understanding and determining uncer-
forming Seized-Drug Analysis
tainty in this context include:
E2549 Practice for Validation of Seized-Drug Analytical
3.2.1 Enhancing confidence through increased understand-
Methods
ing of results,
3
2.2 ISO Standards:
3.2.2 Providing a mechanism to express the reliability of
ISO 3534-1:1993 Statistics—Part 1: Probability and General
results,
Statistical Terms
3.2.3 Enabling the laboratory management and customer to
evaluate the fitness for purpose of results,
3. Significance and Use
3.2.4 Facilitating the identification of procedural limitations
3.1 Application of Uncertainty—Qualitative and quantita-
and providing a basis for improvement, and
tive analyses require different approaches, refer to the refer-
3.2.5 Complying with accreditation requirements.
ences for additional information.Analysts shall understand the
limitations of qualitative and quantitative determinations and
4. Qualitative Analysis
have tools to estimate a value for measurement uncertainty of
4.1 The identification of seized drugs requires the combina-
tion of methods to form an analytical scheme (see Practice
1
This practice is under the jurisdiction of ASTM Committee E30 on Forensic
E2329).
Sciences and is the direct responsibility of Subcommittee E30.01 on Criminalistics.
Current edition approved June 1, 2011. Published June 2011. DOI: 10.1520/
4.2 Individual methods have limitations and, consequently,
E2764-11.
uncertainty. Uncertainty of qualitative methods is not typically
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
amenable to being expressed in numerical terms.
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
4.3 Understanding these limitations enables laboratory per-
the ASTM website.
3
sonnel to build an appropriate analytical scheme to correctly
Available from International Organization for Standardization (ISO), 1, ch. de
la Voie-Creuse, CP 56, CH-1211 Geneva 20, Switzerland, http://www.iso.org. identify a drug or other chemical.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

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E2764 − 11
4.3.1 It is expected that in the absence of unforeseen error, 6.2.2.6 Environmental conditions.
an appropriate analytical scheme effectively results in no
6.3 Factors Relevant to Estimation of Measurement Uncer-
un
...

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