ASTM E2239-2004 Standard Practice for Record Keeping and Record Preservation for Lead Hazard Activities《铅危害领域的记录保存和维护的标准实施规程》.pdf

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1、Designation: E 2239 04Standard Practice forRecord Keeping and Record Preservation for Lead HazardActivities1This standard is issued under the fixed designation E 2239; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of las

2、t revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon (e) 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.1.2 This standar

3、d 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 Documents2.1 ASTM

4、 Standards:2D 4840 Guide for Sampling Chain-of-Custody ProceduresE 1579 Guide for Ensuring Data Integrity in Highly Com-puterized Laboratory Operations3E 1605 Terminology Relating to Abatement of Hazardsfrom Lead-Based Paint in Buildings and Related StructuresE 1864 Practice for Evaluating Quality S

5、ystems of Organi-zations Conducting Facility and Hazard Assessments forLead in Paint, Dust, Airborne Particulate, and Soil In andAround Buildings and Related Structures2.2 ISO Standards:ISO 9000-3 Quality Management and Quality AssuranceStandardsPart 3: Guidelines for the Application of ISO9001:1994

6、 to the Development, Supply, Installation andMaintenance of Computer Software4ISO 9000-2000 Quality Management SystemsFundamentals and Vocabulary43. Terminology3.1 Definitions:3.1.1 For definitions of terms not appearing here, refer toTerminology E 1605.3.2 Definitions of Terms Specific to This Stan

7、dard:3.2.1 competence, ndemonstrated ability to apply knowl-edge and skills. ISO 9000-20003.2.2 conformity, nfulfillment of a requirement.ISO 9000-20003.2.3 inspection, nconformity evaluation by observationand judgment accompanied as appropriate by measurement,testing or gauging.3.2.4 nonconformity,

8、 nnon-fulfillment of a requirement.ISO 9000-20003.2.5 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 of something. ISO 9000-20003.2.6.1 Dis

9、cussionObjective evidence may be obtainedthrough observation, measurement, test, or other means.3.2.7 procedure, nspecified way to carry out an activity orprocess. ISO 9000-20003.2.7.1 DiscussionIn many cases, procedures are docu-mented (for example, quality system procedures). When aprocedure is do

10、cumented, 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 materials, equipment and howdocuments shall be used; a

11、nd how it shall be controlled andrecorded.3.2.8 record, na document stating results achieved orproviding evidence of activities performed.3.2.9 requirement, nneed or expectation that is generallyimplied or obligatory. ISO 9000-20004. Significance and Use4.1 This practice is intended to help reduce r

12、isks associatedwith lead hazards in buildings by providing standardizedrequirements for preserving records, findings, and recommen-dations associated with lead hazard activities.1This practice is under the jurisdiction of ASTM Committee E06 on Perfor-mance of Buildings and is the direct responsibili

13、ty of Subcommittee E06.23 on LeadHazards Associated With Buildings.Current edition approved April 1, 2004. Published April 2004. Originallyapproved in 2002. Last previous edition approved in 2003 as E 2239 03.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Custom

14、er Service at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.3Withdrawn.4Available from American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036.1Copyright ASTM International, 100

15、 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.4.2 This practice 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

16、 is intended to assist in complying withmanagement system requirements for record keeping as de-fined in Practice E 1864, as well as record keeping regulatoryrequirements promulgated by authorities having jurisdictionregarding conduct of lead hazard activities.5. Records5.1 General Requirements:5.1.

17、1 Records of original observations, evidence of confor-mity or nonconformity to requirements, and 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,

18、 and calculations shall be recordedat the time they are made and shall be identifiable to thespecific 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 rec

19、ord.NOTE 1For additional information on the subject of data integrity, seeGuide E 1579.5.1.3 Records 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

20、 requirements of regulatory authorities having jurisdiction.5.2 Summary List of Records:5.2.1 A 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 w

21、here the records are stored.5.3 Record TypesA wide variety of record types may beused to record lead hazard activities including log books,notebooks, pre-printed data forms, chain-of-custody forms,graphs and drawings, photographs, lead-hazard activity re-ports, test reports, and electronic media. Sp

22、ecific requirements(additional to those given in Sections 5 and 6) for these recordtypes are described 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 s

23、igned or initialed, and dated eachworkday by the personnel generating the entries and by thereviewer, 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 wate

24、r insoluble ink.5.3.2.3 Data forms shall be signed or initialed, and datedeach workday by the person(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

25、labeled so that a personwith competence in performing lead hazard activities andunfamiliar with their generation can decipher them.5.3.4 Chain-of-Custody Forms:5.3.4.1 Chain of custody forms (see Guide D 4840) shall becompleted and labeled with the lead hazard activity (name,address, and other appro

26、priate information).5.3.5 Photographs:5.3.5.1 Records shall be created and traceable to both thephotograph 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 us

27、ing film or digital means (see5.3.8).5.3.6 Lead Hazard Activity Reports:5.3.6.1 Each lead hazard 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

28、to the correctness of theresults.5.3.7.2 Test data records shall include calibration and trace-ability 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 thespecif

29、ic lead hazard activity (for example, name, address, andother appropriate information).5.3.8.2 Consideration 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 nee

30、ded to access the records.5.4 Corrections to Records:5.4.1 Hard Copy RecordsWhen mistakes occur in 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 o

31、riginal entry is to be permit-ted), or delete the entry.5.4.1.2 Cross out each mistake with a single 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, i

32、f appropriate, reason(s) for the correction.5.4.1.4 Maintain a completed signature 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

33、be followed:5.4.2.1 Measures equivalent to those in 5.4.1 for hard copyrecords shall be taken to avoid loss or unauthorized change oforiginal data.E22390425.4.2.2 At a minimum, make an electronic entry to describechanges that were made in the record in a corresponding file orplace with the data file

34、. Include an electronic signature anddate(s) that changes were made.NOTE 3Computer software 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 c

35、opy records above.6. Record Retention6.1 General:6.1.1 Organization(s) conducting lead hazard 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 ori

36、ginal observations,derived data and sufficient information to establish an audittrail, calibration 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

37、 the records shall be responsible fortheir retention.6.1.4 Record retention periods for lead hazard activitiesshall be established based on applicable regulatory require-ments, contract requirements, or on the advice of legal counsel.6.1.4.1 If not otherwise determined, retain records for aperiod no

38、t less than three years.6.1.5 Records shall be “permanent,” that is, they shall last atleast for 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

39、performed.6.2 Record Archiving and Control:6.2.1 Lead hazard activity records are to be legible, con-trolled, 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

40、 to protect and backuprecords stored electronically and to prevent unauthorizedaccess to or amendment 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 preser

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42、s, are entirely their own responsibility.This standard is subject to revision at any time by the responsible technical committee and must be reviewed every five years andif not revised, either reapproved or withdrawn. Your comments are invited either for revision of this standard or for additional s

43、tandardsand should be addressed to ASTM International Headquarters. Your comments will receive careful 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 C

44、ommittee on Standards, at the address shown below.This standard is copyrighted by ASTM International, 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).E2239043