ASTM E2327-2010 Standard Practice for Quality Assurance of Laboratories Performing Seized-Drug Analysis《进行没收药品分析的实验室的质量保证的标准操作规程》.pdf
《ASTM E2327-2010 Standard Practice for Quality Assurance of Laboratories Performing Seized-Drug Analysis《进行没收药品分析的实验室的质量保证的标准操作规程》.pdf》由会员分享,可在线阅读,更多相关《ASTM E2327-2010 Standard Practice for Quality Assurance of Laboratories Performing Seized-Drug Analysis《进行没收药品分析的实验室的质量保证的标准操作规程》.pdf(5页珍藏版)》请在麦多课文档分享上搜索。
1、Designation: E2327 10Standard Practice forQuality Assurance of Laboratories Performing Seized-DrugAnalysis1This standard is issued under the fixed designation E2327; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last
2、revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.1. Scope1.1 This practice covers quality assurance issues in forensiclaboratories performing seized-drug analysis including evi-dence h
3、andling, analytical procedures, report writing, methodvalidation, documentation, proficiency testing, audits, andhealth and safety.1.2 This practice is meant to apply only to qualitativeseized-drug analysis.2. Referenced Documents2.1 ASTM Standards:2E2328 Terminology Relating to Seized-Drug Analysis
4、32.2 Other Document:Scientific Working Group for the Analysis of Seized DrugsRecommendations for: Education and Training, QualityAssurance, Methods of Analysis3. Terminology3.1 Terms that may assist in interpreting this standard arefound in Terminology E2328.4. Significance and Use4.1 These are mini
5、mum standards of quality assuranceapplicable to laboratories where analysis of seized-drug sub-missions is performed.4.2 This practice is to be used by forensic analysts perform-ing seized-drug analysis and promoted/supported by laboratorymanagement.5. Quality Management System5.1 It is the goal of
6、a laboratorys drug analysis program toprovide customers of the laboratorys services access to qualitydrug analysis. It is the goal of this standard to provide aframework of quality in the processing of drug evidence,including evidence handling, management practices, qualita-tive analysis, and report
7、ing. A documented quality manage-ment system shall be established and maintained. Personnelresponsible for this shall be clearly designated and have directaccess to the highest level of management concerning labora-tory policy.5.2 The quality management system shall cover all proce-dures and reports
8、 associated with drug analysis.6. Personnel6.1 Job DescriptionJob descriptions for all personnelshould include responsibilities, duties, and required skills.6.2 Designated Personnel and ResponsibilitiesAn indi-vidual (however titled) may be responsible for more than oneof the following duties:6.2.1
9、Quality Assurance ManagerA designated personwho is responsible for maintaining the quality managementsystem (including an annual review of the program) and whomonitors compliance with the program.6.2.2 Health and Safety ManagerA designated personwho is responsible for maintaining the Laboratory Heal
10、th andSafety program (including an annual review of the program)and who monitors compliance with the program.6.2.3 Personnel Technical SupportA person who per-forms basic laboratory duties, but does not analyze evidence.6.2.4 Technician/Assistant AnalystA person who analyzesevidence, but does not is
11、sue reports for court purposes.6.2.5 AnalystA designated person who:6.2.5.1 Examines and analyzes seized drugs or relatedmaterials, or directs such examinations to be done;6.2.5.2 Independently has access to unsealed evidence inorder to remove samples from the evidence for examination;and6.2.5.3 As
12、a consequence of such examinations, signs re-ports for court or other purposes.6.2.6 Supervisory AnalystA designated person who hasthe overall responsibility and authority for the technical opera-tions of the drug analysis section. Technical operations include,but are not limited to protocols, analy
13、tical methodology, andtechnical review of reports.1This practice is under the jurisdiction of ASTM Committee E30 on ForensicSciences and is the direct responsibility of Subcommittee E30.01 on Criminalistics.Current edition approved Dec. 15, 2010. Published January 2010. Originallyapproved in 2004. L
14、ast previous edition approved in 2004 as E2327 04. DOI:10.1520/E2327-10.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe AS
15、TM website.3Withdrawn. The last approved version of this historical standard is referencedon www.astm.org.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.6.3 Qualifications/Education:6.3.1 Technical Support Personnel shall:6.3.1.1 Ha
16、ve education, skills, and abilities commensuratewith their responsibilities; and6.3.1.2 Have on-the-job training specific to their position.6.3.2 Technicians/Assistant Analysts shall:6.3.2.1 Have education, skills, and abilities commensuratewith their responsibilities; and6.3.2.2 Have on-the-job tra
17、ining specific to their position.6.3.3 All new analysts shall have at least a baccalaureatedegree or equivalent (generally a three to four year post-secondary degree) in a natural/physical science. Courseworkshall include lecture and associated laboratory classes ingeneral, organic and analytical ch
18、emistry.6.3.4 Supervisory Analysts shall:6.3.4.1 Meet all the requirements of analyst (6.3.3),6.3.4.2 Have a minimum of two (2) years of experience asan analyst in the forensic analysis of drug evidence, and6.3.4.3 Exhibit knowledge necessary to evaluate analyticalresults and conclusions.6.4 Trainin
19、g for New AnalystsThe laboratory shall estab-lish and document a training program and qualifying procedurefor all new technical personnel. A documented training pro-gram, approved by laboratory management, should focus onthe development of the theoretical and practical knowledge,skills and abilities
20、 necessary to examine seized-drug samplesand related materials. It shall include:6.4.1 A training syllabus providing descriptions of theknowledge and skills in which analysts are to be trained forspecific topic areas, milestones of achievement, and methods oftesting or evaluating competency;6.4.2 Do
21、cumented standards of performance and a plan forassessing theoretical and practical competency against thesestandards, for example, written and oral examinations, criticalreviews, analysis of unknown samples, mock casework, etc.per specific topic area;6.4.3 A period of documented, supervised casewor
22、k repre-sentative of the type they shall be required to perform; and6.4.4 A verification document demonstrating that traineeshave achieved the required competence level per specific topicarea.6.5 Maintaining Qualifications:6.5.1 Minimum annual training required for continuingprofessional development
23、 of laboratory analysts is twenty (20)hours.6.5.1.1 Training shall be relevant to the laboratorys ana-lytical mission. Professional development may include trainingrelated to ancillary duty assignments and supervision/management responsibilities.6.5.1.2 Training completed shall be documented.6.5.1.3
24、 Training can be face-to-face interaction with aninstructor, distance learning, self-directed, or computer-based.7. Physical Plant7.1 Physical Plant Requirements:7.1.1 Laboratories shall provide adequate safety and secu-rity for personnel and operations.7.1.2 Laboratories shall meet required health
- 1.请仔细阅读文档,确保文档完整性,对于不预览、不比对内容而直接下载带来的问题本站不予受理。
- 2.下载的文档,不会出现我们的网址水印。
- 3、该文档所得收入(下载+内容+预览)归上传者、原创作者;如果您是本文档原作者,请点此认领!既往收益都归您。
下载文档到电脑,查找使用更方便
5000 积分 0人已下载
下载 | 加入VIP,交流精品资源 |
- 配套讲稿:
如PPT文件的首页显示word图标,表示该PPT已包含配套word讲稿。双击word图标可打开word文档。
- 特殊限制:
部分文档作品中含有的国旗、国徽等图片,仅作为作品整体效果示例展示,禁止商用。设计者仅对作品中独创性部分享有著作权。
- 关 键 词:
- ASTME23272010STANDARDPRACTICEFORQUALITYASSURANCEOFLABORATORIESPERFORMINGSEIZEDDRUGANALYSIS 进行 没收 药品 分析

链接地址:http://www.mydoc123.com/p-530881.html