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ASTM D8428-21

(Guide)

Standard Guide for Establishing Analyst Competence to Perform a Test Method

Standard Guide for Establishing Analyst Competence to Perform a Test Method

SIGNIFICANCE AND USE
4.1 Analyst Competence is one of the largest influencing factors in whether a test method performed in a laboratory yields accurate and precise test results and thus is an important aspect in managing a laboratory.  
4.2 Some Regulations, International Management System Standards, such as ISO 9001, ISO 17025, AASHTO R-18, etc., and Quality Management Systems may require the establishment of analyst competence. This guide aims to provide general guidance in some of the possible approaches that may be taken to fulfill such requirements.
SCOPE
1.1 This guide covers general guidance on assessing the competence of an analyst to perform a specific test method for a specific product or set of products (for example, light distillates). It also provides guidance on some of the possible approaches that may be taken to perform the assessment.  
1.2 This guide is intended for the establishment of competence for the entire performance of a test method (that is, sample preparation, instrument set up, preparation of standards and reagents, performance of the test method, calculations, etc.) or the establishment of competence may be limited to a specific aspect in the performance of a test method (for example, sample preparation).  
1.3 The establishment of analyst competence should only be performed if the laboratory itself is capable of performing the test in strict conformance with the test method (that is, has the equipment, standards and reagents, materials, etc. which meet test method requirements).  
1.4 This guide does not cover training of an analyst, other than a review of training records to indicate the analyst has been trained.  
1.5 This guide does not cover the establishment of general technical competence of an analyst.  
1.6 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

General Information

Status
Published
Publication Date
30-Nov-2021
ICS
03.100.30 - Management of human resources
Technical Committee
D02 - Petroleum Products, Liquid Fuels, and Lubricants
Drafting Committee
D02.94 - Coordinating Subcommittee on Quality Assurance and Statistics
Current Stage
Ref Project

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ASTM D8428-21 - Standard Guide for Establishing Analyst Competence to Perform a Test Method
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This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation: D8428 − 21
Standard Guide for
1
Establishing Analyst Competence to Perform a Test Method
This standard is issued under the fixed designation D8428; 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 2. Referenced Documents
2
2.1 ASTM Standards:
1.1 This guide covers general guidance on assessing the
D6299 Practice for Applying Statistical Quality Assurance
competence of an analyst to perform a specific test method for
and Control Charting Techniques to Evaluate Analytical
a specific product or set of products (for example, light
Measurement System Performance
distillates). It also provides guidance on some of the possible
D6792 Practice for Quality Management Systems in Petro-
approaches that may be taken to perform the assessment.
leum Products, Liquid Fuels, and Lubricants Testing
1.2 This guide is intended for the establishment of compe-
Laboratories
tence for the entire performance of a test method (that is,
D7372 Guide for Analysis and Interpretation of Proficiency
sample preparation, instrument set up, preparation of standards
Test Program Results
and reagents, performance of the test method, calculations,
E456 Terminology Relating to Quality and Statistics
3
etc.) or the establishment of competence may be limited to a
2.2 ISO Standards:
specific aspect in the performance of a test method (for
ISO Guide 30 Reference materials - Selected terms and
example, sample preparation).
definitions
ISO/IEC 17025 General Requirements for the Competence
1.3 Theestablishmentofanalystcompetenceshouldonlybe
of Testing and Calibration Laboratories
performed if the laboratory itself is capable of performing the
ISO 17034 General Requirements for the Competence of
test in strict conformance with the test method (that is, has the
Reference Material Producers
equipment, standards and reagents, materials, etc. which meet
ANSI/ISO/ASQ Q9000 Quality Management System Stan-
test method requirements).
dards
1.4 This guide does not cover training of an analyst, other
2.3 Other Standards:
than a review of training records to indicate the analyst has
AASHTO R-18 Standard Recommended Practice for Estab-
been trained. lishing and Implementing a Quality Management System
4
for Construction Materials Testing Laboratories
1.5 This guide does not cover the establishment of general
technical competence of an analyst.
3. Terminology
1.6 This standard does not purport to address all of the
3.1 Definitions:
safety concerns, if any, associated with its use. It is the
3.1.1 accepted reference value, ARV, n—a value that serves
responsibility of the user of this standard to establish appro-
as an agreed upon reference for comparison, and which is
priate safety, health, and environmental practices and deter-
derived as: (1) a theoretical or established value, based on
mine the applicability of regulatory limitations prior to use.
scientific principles, (2) an assigned value, based on experi-
mental work of some national or international organization
1.7 This international standard was developed in accor-
such as the U.S. National Institute of Standards and Technol-
dance with internationally recognized principles on standard-
ogy (NIST), or (3) a consensus value, based on collaborative
ization established in the Decision on Principles for the
Development of International Standards, Guides and Recom-
mendations issued by the World Trade Organization Technical
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Barriers to Trade (TBT) Committee.
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
Available from International Organization for Standardization (ISO), ISO
1
This guide is under the jurisdiction of ASTM Committee D02 on Petroleum Central Secretariat, Chemin de Blandonnet 8, CP 401, 1214 Vernier, Geneva,
Products, Liquid Fuels, and Lubricants and is the direct responsibility of Subcom- Switzerland, https://www.iso.org.
4
mittee D02.94 on Coordinating Subcommittee on Quality Assurance and Statistics. Available from American Association of State Highway and Transportation
Current edition approved Dec. 1, 2021. Published January 2022. DOI: 10.1520/ Officials (AASHTO), 444 N. Capitol St., NW, Suite 249, Washington, DC 20001,
D8428-21. http://www.transportation.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Bo
...

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SCOPE
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SCOPE
1.1 Assisted defect recognition (AssistDR) describes a class of computer algorithms that assist a human operator in making a determination about nondestructive test data. This guide uses the term AssistDR to describe those computer assisted evaluation algorithms and associated software. For the purposes of this guide, the usage of the words “defect,” “evaluate,” “evaluation,” etc., in no way implies that the algorithms are dispositioning or otherwise making an unaided final disposition. Depending on the application, AssistDR computer algorithms detect and optionally classify indications of defects, flaws, discontinuities, or other anomalous signals in the acquired images. Software that does make an unaided final disposition is classified as automated defect recognition (AutoDR). While the concepts discussed in this guide are pertinent to AutoDR applications, additional validation tests or controls may be necessary when implementing AutoDR.  
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Standard Guide for Requirements for Analytical Laboratory Related Professions Within the Cannabis and Hemp Industries

SIGNIFICANCE AND USE
5.1 As the cannabis and hemp industries expand and their products become more available as consumable products, the following requirements and expectations within the industry become increasingly significant (Practice E2659, Terminology E2708), requiring:  
5.1.1 The safety, reliability, and quality of its products;  
5.1.2 Worker safety;  
5.1.3 Environmental sustainability;  
5.1.4 Regulatory compliance;  
5.1.5 The need for different levels of qualified professionals; and  
5.1.6 Development of qualified training and certificate programs.  
5.2 The primary objectives of this guide are as follows:  
5.2.1 Provide a general overview of the BoK required for the professions listed in Section 6 (Table 1); and  
5.2.2 Provide recommendations to form the foundation for training and subsequent recognition/certificate systems that enable consumers, employers, organizational management, government agencies, and others who rely upon a skilled workforce to distinguish between qualified and non-qualified workers.  
5.2.3 Recommend requirements that agencies can use to develop and document the specific criteria used for training or certificate programs.  
5.3 Users of this guide shall document deviations from the recommended requirements to inform their clients of the criteria applied in either the training or the certificate programs offered. As the cannabis and hemp industries mature, this guide will be updated to reflect current thinking and requirements.  
5.4 The Bok elements are applicable to certificate Programs, while the BoK, experiential and educational elements are applicable to certification process requirements.
SCOPE
1.1 This guide can provide certification bodies, training providers, employers, and certificate issuers, with best-practice guidance for administering their respective programs for supporting analytical laboratory-related professions within the cannabis and hemp industries.  
1.2 This guide recommends requirements for experience, training, education, and the body of knowledge (BoK) necessary for analytical laboratory related professions within the cannabis and hemp industries listed in Table 1.    
1.3 This guide provides recommendations for articulating professional requirements for training and education or earning certificates. Its content does not supersede requirements for training or earning a certificate defined by jurisdictional entities such as government or other regional regulatory bodies.  
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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

  • Guide
    6 pages
    English language
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  • Guide
    6 pages
    English language
    sale 15% off