ASTM E2239-2012(2016) Standard Practice for Record Keeping and Record Preservation for Lead Hazard Activities《铅危害活动性用记录保持和记录保存规程》.pdf

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1、Designation: E2239 12 (Reapproved 2016)Standard Practice forRecord Keeping and Record Preservation for Lead HazardActivities1This standard is issued under the fixed designation E2239; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision,

2、 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 describes requirements for preservation ofrecords generated during lead hazard activities.1

3、.2 This standard does not purport to address all of thesafety concerns, if any, associated with its use. It is theresponsibility of the user of this standard to establish appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.2. Referenced Do

4、cuments2.1 ASTM Standards:2D4840 Guide for Sample Chain-of-Custody ProceduresE1579 Guide for Ensuring Data Integrity in Highly Comput-erized Laboratory Operations (Withdrawn 2002)3E1605 Terminology Relating to Lead in BuildingsE1864 Practice for Evaluating Quality Systems of Organi-zations Conductin

5、g Facility and Hazard Assessments forLead in Paint, Dust, Airborne Particulate, and Soil in andaround Buildings and Related Structures (Withdrawn2011)32.2 ISO Standards:4ISO 9000-3 Quality Management and Quality AssuranceStandardsPart 3: Guidelines for the Application of ISO9001:1994 to the Developm

6、ent, Supply, Installation andMaintenance of Computer SoftwareISO 9000:2005 Quality Management SystemsFundamen-tals and VocabularyISO 17000:2004 Conformity AssessmentGeneral Vocabu-lary and Principles3. Terminology3.1 Definitions:3.1.1 For definitions of terms not appearing here, refer toTerminology

7、E1605.3.2 Definitions of Terms Specific to This Standard:3.2.1 competence, n(1) demonstrated ability to applyknowledge and skills. ISO 9000:2005 (3.1.6)(2) specifically as applied to auditors, demonstrated personalattributes and demonstrated ability to apply knowledge andskills. ISO 9000:2005 (3.9.1

8、4)3.2.2 conformity, nfulfillment of a requirement. ISO9000:2005 (3.6.1)3.2.3 inspection, nexamination of a product design, prod-uct (3.3), process, or installation and determination of itsconformity with specific requirements or, on the basis ofprofessional judgement, with general requirements. ISO1

9、7000:20043.2.4 nonconformity, nnon-fulfillment of a requirement.ISO 9000:2005 (3.1.2)3.2.5 observation, na judgment that is based on what onesees while conducting lead hazard activities and that issubstantiated by objective evidence.3.2.6 objective evidence, ndata supporting the existenceor verity o

10、f something. ISO 9000:2005 (3.8.1)3.2.6.1 DiscussionObjective evidence may be obtainedthrough observation, measurement, test, or other means.3.2.7 procedure, nspecified way to carry out an activity orprocess. ISO 9000:2005 (3.4.5)3.2.7.1 DiscussionIn many cases, procedures are docu-mented (for examp

11、le, quality system procedures). When aprocedure is documented, the term “written procedure” or“documented procedure” is frequently used. A written ordocumented procedure usually contains the purposes and scopeof an activity; what shall be done and by whom; when, whereand how it shall be done; what m

12、aterials, equipment and howdocuments shall be used; and how it shall be controlled andrecorded.3.2.8 record, na document stating results achieved orproviding evidence of activities performed.ISO 9000:2005 (3.7.6)1This practice is under the jurisdiction of ASTM Committee E06 on Perfor-mance of Buildi

13、ngs and is the direct responsibility of Subcommittee E06.23 on LeadHazards Associated with Buildings.Current edition approved Oct. 1, 2016. Published October 2016. Originallyapproved in 2002. Last previous edition approved in 2012 as E223912. DOI:10.1520/E2239-12R16.2For referenced ASTM standards, v

14、isit 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.4Available

15、 from American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036, http:/www.ansi.org.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States13.2.9 requirement, nneed or expectation that is stated,generally impl

16、ied or obligatory. ISO 9000:2005 (3.1.2)4. Significance and Use4.1 This practice is intended to help reduce risks associatedwith lead hazards in buildings by providing standardizedrequirements for preserving records, findings, and recommen-dations associated with lead hazard activities.4.2 This prac

17、tice is intended for use by individuals andorganizations that develop and have need to preserve objectiveevidence when contracting for or when conducting lead hazardactivities themselves.4.2.1 This practice is intended to assist in complying withmanagement system requirements for record keeping as d

18、e-fined in Practice E1864, as well as record keeping regulatoryrequirements promulgated by authorities having jurisdictionregarding conduct of lead hazard activities.5. Records5.1 General Requirements:5.1.1 Records of original observations, evidence of confor-mity or nonconformity to requirements, a

19、nd derived data shallcontain sufficient information to provide traceability and toenable an individual having competence with lead hazardactivities to reach the same conclusion(s).5.1.2 Observations, data, and calculations shall be recordedat the time they are made and shall be identifiable to thesp

20、ecific task.5.1.2.1 In cases where written records are damaged andunusable (that is, crumpled or torn), a legible re-created record,where possible, shall be prepared and attached to the originaldamaged record.NOTE 1For additional information on the subject of data integrity, seeGuide E1579.5.1.3 Rec

21、ords shall contain the identity of the personnelgenerating them.5.1.4 Records are permitted to be in any media, such as hardcopy or electronic.5.1.5 As a minimum, records shall be preserved consistentwith requirements of regulatory authorities having jurisdiction.5.2 Summary List of Records:5.2.1 A

22、list of all records shall be prepared to serve as anindex of all individual records for a specific lead hazardactivity.5.2.2 This list shall summarize the identity of each record,the type of record, and where the records are stored.5.3 Record TypesA wide variety of record types may beused to record

23、lead hazard activities including log books,notebooks, pre-printed data forms, chain-of-custody forms,graphs and drawings, photographs, lead-hazard activityreports, test reports, and electronic media. Specific require-ments (additional to those given in Sections 5 and 6) for theserecord types are des

24、cribed as follows:5.3.1 Log Books and Notebooks:5.3.1.1 Log books and notebooks shall be bound withpre-numbered pages.5.3.1.2 All entries shall be made using water insoluble ink.5.3.1.3 Entries shall be signed or initialed, and dated eachworkday by the personnel generating the entries and by therevi

25、ewer, where possible.5.3.2 Pre-printed Data Forms:5.3.2.1 Data forms, either ASTM forms or equivalent, shallbe defined in terms of the associated ASTM standard.5.3.2.2 All entries shall be made using water insoluble ink.5.3.2.3 Data forms shall be signed or initialed, and datedeach workday by the pe

26、rson(s) generating the forms and thereviewer, where possible.5.3.2.4 Data forms shall be numbered in a “page of page”format for each activity.5.3.3 Graphs and Drawings:5.3.3.1 Graphs and drawing shall be labeled so that a personwith competence in performing lead hazard activities andunfamiliar with

27、their generation can decipher them.5.3.4 Chain-of-Custody Forms:5.3.4.1 Chain of custody forms (see Guide D4840) shall becompleted and labeled with the lead hazard activity (name,address, and other appropriate information).5.3.5 Photographs:5.3.5.1 Records shall be created and traceable to both thep

28、hotograph and to the lead hazard activity (for example, name,address, and other appropriate information), the name of theperson taking the photograph, and the date taken.NOTE 2Photographs may be taken using film or digital means (see5.3.8).5.3.6 Lead Hazard Activity Reports:5.3.6.1 Each lead hazard

29、activity report shall be maintainedin either hard copy or electronic copy, as appropriate.5.3.7 Test Reports:5.3.7.1 Each test report shall be approved, dated and signedby an authorized person to attest to the correctness of theresults.5.3.7.2 Test data records shall include calibration and trace-ab

30、ility verification checks.5.3.8 Electronic MediaThese media include electronicdata such as audio, computer, digital pictures, and videotape.5.3.8.1 Electronic records shall include reference to thespecific lead hazard activity (for example, name, address, andother appropriate information).5.3.8.2 Co

31、nsideration of the retention times and accessibil-ity of the electronic records shall take into account the rate ofdegradation of the electronic images and the availability of thedevices and software needed to access the records.5.4 Corrections to Records:5.4.1 Hard Copy RecordsWhen mistakes occur i

32、n hardcopy records of lead hazard activities, the correction proce-dures in 5.4.1.1 5.4.1.4 shall be followed:5.4.1.1 Do not erase, make illegible (for example, no whiteout or other obliteration of the original entry is to bepermitted), or delete the entry.5.4.1.2 Cross out each mistake with a singl

33、e line and enterthe correct entry alongside the each original entry corrected.5.4.1.3 Accompany correction(s) with the initials of theperson making the change(s), the date the correction was madeand, if appropriate, reason(s) for the correction.E2239 12 (2016)25.4.1.4 Maintain a completed signature

34、and initial form foreach lead hazard activity recorder as part of the record.5.4.2 Electronic MediaWhen mistakes occur in electronicrecords of lead hazard activities, the correction procedures in5.4.2.1 5.4.2.3 shall be followed:5.4.2.1 Measures equivalent to those in 5.4.1 for hard copyrecords shal

35、l be taken to avoid loss or unauthorized change oforiginal data.5.4.2.2 At a minimum, make an electronic entry to describechanges that were made in the record in a corresponding file orplace with the data file. Include an electronic signature anddate(s) that changes were made.NOTE 3Computer software

36、 is available to assist with the insertion ofelectronic signatures.5.4.2.3 For changes that affect the summary list of records,make appropriate changes in the data log, following the rulesfor changes in hard copy records above.6. Record Retention6.1 General:6.1.1 Organization(s) conducting lead haza

37、rd activities shallestablish and maintain procedures for identification, collection,indexing, access, filing, storage, maintenance and disposal oflead hazard activity records.6.1.2 As a minimum, records of original observations,derived data and sufficient information to establish an audittrail, cali

38、bration records (if appropriate), staff records, and acopy of each report issued shall be retained for a defined periodof time.6.1.3 Unless otherwise determined, the firm or individualresponsible for preparing the records shall be responsible fortheir retention.6.1.4 Record retention periods for lea

39、d hazard activitiesshall be established based on applicable regulatoryrequirements, contract requirements, or on the advice of legalcounsel.6.1.4.1 If not otherwise determined, retain records for aperiod not less than three years.6.1.5 Records shall be “permanent,” that is, they shall last atleast f

40、or the specified retention period.NOTE 4The property/facility owner or designated party and thelaboratory should also keep a complete copy of all records associated withthe lead hazard activities that were performed.6.2 Record Archiving and Control:6.2.1 Lead hazard activity records are to be legibl

41、e,controlled, and retained so that they are readily retrievable, infacilities that provide a suitable environment to prevent dam-age or deterioration and to prevent loss.6.2.2 Procedures shall be in place to protect and backuprecords stored electronically and to prevent unauthorizedaccess to or amen

42、dment of these records.6.3 Confidentiality of Records:6.3.1 All records shall be held secure and in confidence tothe client.7. Keywords7.1 buildings; hazard; lead; management; record keeping;record preservationASTM International takes no position respecting the validity of any patent rights asserted

43、 in connection with any item mentionedin this standard. Users of this standard are expressly advised that determination of the validity of any such patent rights, and the riskof infringement of such rights, are entirely their own responsibility.This standard is subject to revision at any time by the

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45、areful consideration at a meeting of theresponsible technical committee, which you may attend. If you feel that your comments have not received a fair hearing you shouldmake your views known to the ASTM Committee on Standards, at the address shown below.This standard is copyrighted by ASTM Internati

46、onal, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959,United States. Individual reprints (single or multiple copies) of this standard may be obtained by contacting ASTM at the aboveaddress or at 610-832-9585 (phone), 610-832-9555 (fax), or serviceastm.org (e-mail); or through the ASTM website(www.astm.org). Permission rights to photocopy the standard may also be secured from the Copyright Clearance Center, 222Rosewood Drive, Danvers, MA 01923, Tel: (978) 646-2600; http:/ 12 (2016)3