ASTM_E_2327_-_10.pdf

Designation:E232710Standard 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 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 handling,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analysis.2.Referenced Documents2.1 ASTM Standards:2E2328 Terminology Relating to Seized-Drug Analysis(Withdrawn 2005)32.2 Other Document:Scientific Working Group for the Analysis of Seized DrugsRecommendations for:Education and Training,QualityAssurance,Methods of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 minimum 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 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 reporting.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 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 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 Health andSafety program(including an annual review of the program)and who monitors compliance with the program.6.2.3 Personnel Technical SupportAperson who performsbasic laboratory duties,but does not analyze evidence.6.2.4 Technician/Assistant AnalystA person who analyzesevidence,but does not issue 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 a consequence of such examinations,signs re-ports for court or other purposes.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.Last 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 ASTM website.3The last approved version of this historical standard is referenced onwww.astm.org.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 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,analytical methodology,andtechnical review of reports.6.3 Qualifications/Education:6.3.1 Technical Support Personnel shall:6.3.1.1 Have 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 training 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 inge