ASTM E2239-2012 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的标准实施规程》.pdf

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1、Designation:E223904 Designation: E2239 12Standard 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 revisio

2、n, 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 of records generated during lead hazard activitie

3、s.1.2 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibilityof the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatorylimitations prior to use.2. Referenced D

4、ocuments2.1 ASTM Standards:2D4840 Guide for Sample Chain-of-Custody Procedures3E1579 Guide for Ensuring Data Integrity in Highly Computerized Laboratory OperationsE1605 Terminology Relating to Lead in BuildingsE1864 Practice for Evaluating Quality Systems of Organizations Conducting Facility and Haz

5、ard Assessments for Lead inPaint, Dust, Airborne Particulate, and Soil in and around Buildings and Related Structures2.2 ISO Standards:ISO 9000-3Quality Management and Quality Assurance StandardsPart 3: Guidelines for the Application of ISO 9001:1994to the Development, Supply, Installation and Maint

6、enance of Computer Software3ISO 9000-2000Quality Management SystemsFundamentals and Vocabulary3ISO 9000-3 Quality Management and Quality Assurance StandardsPart 3: Guidelines for the Application of ISO 9001:1994to the Development, Supply, Installation and Maintenance of Computer SoftwareISO 9000:200

7、5 Quality Management SystemsFundamentals and VocabularyISO 17000:2004 Conformity AssessmentGeneral Vocabulary and Principles3. Terminology3.1 Definitions:3.1.1 For definitions of terms not appearing here, refer to Terminology E1605.3.2 Definitions of Terms Specific to This Standard:3.2.1 competence,

8、 ndemonstrated ability to apply knowledge and skills. ISO9000-2000 ( 1) demonstrated ability toapply knowledge and skills. ISO 9000:2005 (3.1.6)(2) specifically as applied to auditors, demonstrated personal attributes and demonstrated ability to apply knowledge and skills.ISO 9000:2005 (3.9.14)3.2.2

9、 conformity, nfulfillment of a requirement. ISO9000-2000ISO 9000:2005 (3.6.1)3.2.3 inspection, nconformity evaluation by observation and judgment accompanied as appropriate by measurement, testingor gauging. examination of a product design, product (3.3), process, or installation and determination o

10、f its conformity withspecific requirements or, on the basis of professional judgement, with general requirements. ISO 17000:20043.2.4 nonconformity, nnon-fulfillment of a requirement. ISO9000-2000 ISO 9000:2005 (3.1.2)1This practice is under the jurisdiction of ASTM Committee E06 on Performance of B

11、uildings and is the direct responsibility of Subcommittee E06.23 on Lead HazardsAssociated with Buildings.Current edition approvedApril 1, 2004. PublishedApril 2004. Originally approved in 2002. Last previous edition approved in 2003 as E223903. DOI: 10.1520/E2239-04.Current edition approved July 15

12、, 2012. Published August 2012. Originally approved in 2002. Last previous edition approved in 2004 as E2239 04. DOI:10.1520/E2239-12.2For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at serviceastm.org. For Annual Book of ASTM Standardsvolume info

13、rmation, refer to the standards Document Summary page on the ASTM website.3Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http:/www.ansi.org.1This document is not an ASTM standard and is intended only to provide the user of an ASTM standar

14、d an indication of what changes have been made to the previous version. Becauseit may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current versionof the standard as published by ASTM i

15、s to be considered the official document.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.3.2.5 observation, na judgment that is based on what one sees while conducting lead hazard activities and that is substantiatedby objective evide

16、nce.3.2.6 objective evidence, ndata supporting the existence or verity of something. ISO 9000-2000 ISO 9000:2005 (3.8.1)3.2.6.1 DiscussionObjective evidence may be obtained through observation, measurement, test, or other means.3.2.7 procedure, nspecified way to carry out an activity or process. ISO

17、9000-2000 ISO 9000:2005 (3.4.5)3.2.7.1 DiscussionIn many cases, procedures are documented (for example, quality system procedures). When a procedureis documented, the term “written procedure” or “documented procedure” is frequently used. A written or documented procedureusually contains the purposes

18、 and scope of an activity; what shall be done and by whom; when, where and how it shall be done;what materials, equipment and how documents shall be used; and how it shall be controlled and recorded.3.2.8 record, na document stating results achieved or providing evidence of activities performed.ISO

19、9000:2005 (3.7.6)3.2.9 requirement, nneed or expectation that is stated, generally implied or obligatory. ISO9000-2000 ISO 9000:2005(3.1.2)4. Significance and Use4.1 This practice is intended to help reduce risks associated with lead hazards in buildings by providing standardizedrequirements for pre

20、serving records, findings, and recommendations associated with lead hazard activities.4.2 This practice is intended for use by individuals and organizations that develop and have need to preserve objective evidencewhen contracting for or when conducting lead hazard activities themselves.4.2.1 This p

21、ractice is intended to assist in complying with management system requirements for record keeping as defined inPractice E1864, as well as record keeping regulatory requirements promulgated by authorities having jurisdiction regardingconduct of lead hazard activities.5. Records5.1 General Requirement

22、s:5.1.1 Records of original observations, evidence of conformity or nonconformity to requirements, and derived data shall containsufficient information to provide traceability and to enable an individual having competence with lead hazard activities to reachthe same conclusion(s).5.1.2 Observations,

23、 data, and calculations shall be recorded at the time they are made and shall be identifiable to the specifictask.5.1.2.1 In cases where written records are damaged and unusable (that is, crumpled or torn), a legible re-created record, wherepossible, shall be prepared and attached to the original da

24、maged record.NOTE 1For additional information on the subject of data integrity, see Guide E1579.5.1.3 Records shall contain the identity of the personnel generating them.5.1.4 Records are permitted to be in any media, such as hard copy or electronic.5.1.5 As a minimum, records shall be preserved con

25、sistent with 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 an index of all individual records for a specific lead hazard activity.5.2.2 This list shall summarize the identity of each record, the type o

26、f record, and where the records are stored.5.3 Record TypesA wide variety of record types may be used to record lead hazard activities including log books, notebooks,pre-printed data forms, chain-of-custody forms, graphs and drawings, photographs, lead-hazard activity reports, test reports, andelect

27、ronic media. Specific requirements (additional to those given in Sections 5 and 6) for these record types are described asfollows:5.3.1 Log Books and Notebooks:5.3.1.1 Log books and notebooks shall be bound with pre-numbered pages.5.3.1.2 All entries shall be made using water insoluble ink.5.3.1.3 E

28、ntries shall be signed or initialed, and dated each workday by the personnel generating the entries and by the reviewer,where possible.5.3.2 Pre-printed Data Forms:5.3.2.1 Data forms, either ASTM forms or equivalent, shall be defined in terms of the associated ASTM standard.5.3.2.2 All entries shall

29、 be made using water insoluble ink.5.3.2.3 Data forms shall be signed or initialed, and dated each workday by the person(s) generating the forms and the reviewer,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

30、and drawing shall be labeled so that a person with competence in performing lead hazard activities andunfamiliar with their generation can decipher them.5.3.4 Chain-of-Custody Forms:E2239 1225.3.4.1 Chain of custody forms (see Guide D4840) shall be completed and labeled with the lead hazard activity

31、 (name, address,and other appropriate information).5.3.5 Photographs:5.3.5.1 Records shall be created and traceable to both the photograph and to the lead hazard activity (for example, name,address, and other appropriate information), the name of the person taking the photograph, and the date taken.

32、NOTE 2Photographs may be taken using film or digital means (see 5.3.8).5.3.6 Lead Hazard Activity Reports:5.3.6.1 Each lead hazard activity report shall be maintained in 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 signe

33、d by an authorized person to attest to the correctness of the results.5.3.7.2 Test data records shall include calibration and traceability verification checks.5.3.8 Electronic MediaThese media include electronic data such as audio, computer, digital pictures, and videotape.5.3.8.1 Electronic records

34、 shall include reference to the specific lead hazard activity (for example, name, address, and otherappropriate information).5.3.8.2 Consideration of the retention times and accessibility of the electronic records shall take into account the rate ofdegradation of the electronic images and the availa

35、bility of the devices and software needed to access the records.5.4 Corrections to Records:5.4.1 Hard Copy RecordsWhen mistakes occur in hard copy records of lead hazard activities, the correction procedures in5.4.1.1-5.4.1.4 shall be followed:5.4.1.1 Do not erase, make illegible (for example, no wh

36、ite out or other obliteration of the original entry is to be permitted),or delete the entry.5.4.1.2 Cross out each mistake with a single line and enter the correct entry alongside the each original entry corrected.5.4.1.3 Accompany correction(s) with the initials of the person making the change(s),

37、the date the correction was made and, ifappropriate, reason(s) for the correction.5.4.1.4 Maintain a completed signature and initial form for each lead hazard activity recorder as part of the record.5.4.2 Electronic MediaWhen mistakes occur in electronic records of lead hazard activities, the correc

38、tion 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 copy records shall be taken to avoid loss or unauthorized change oforiginal data.5.4.2.2 At a minimum, make an electronic entry to describe changes that were made in the record in a correspondi

39、ng file or placewith the data file. Include an electronic signature and date(s) that changes were made.NOTE 3Computer software is available to assist with the insertion of electronic signatures.5.4.2.3 For changes that affect the summary list of records, make appropriate changes in the data log, fol

40、lowing the rules forchanges in hard copy records above.6. Record Retention6.1 General:6.1.1 Organization(s) conducting lead hazard activities shall establish and maintain procedures for identification, collection,indexing, access, filing, storage, maintenance and disposal of lead hazard activity rec

41、ords.6.1.2 As a minimum, records of original observations, derived data and sufficient information to establish an audit trail,calibration records (if appropriate), staff records, and a copy of each report issued shall be retained for a defined period of time.6.1.3 Unless otherwise determined, the f

42、irm or individual responsible for preparing the records shall be responsible for theirretention.6.1.4 Record retention periods for lead hazard activities shall be established based on applicable regulatory requirements,contract requirements, or on the advice of legal counsel.6.1.4.1 If not otherwise

43、 determined, retain records for a period not less than three years.6.1.5 Records shall be “permanent,” that is, they shall last at least for the specified retention period.NOTE 4The property/facility owner or designated party and the laboratory should also keep a complete copy of all records associa

44、ted with the leadhazard activities that were performed.6.2 Record Archiving and Control:6.2.1 Lead hazard activity records are to be legible, controlled, and retained so that they are readily retrievable, in facilities thatprovide a suitable environment to prevent damage or deterioration and to prev

45、ent loss.6.2.2 Procedures shall be in place to protect and backup records stored electronically and to prevent unauthorized access to oramendment of these records.6.3 Confidentiality of Records:6.3.1 All records shall be held secure and in confidence to the client.E2239 1237. Keywords7.1 buildings;

46、hazard; lead; management; record keeping; record preservationASTM International takes no position respecting the validity of any patent rights asserted in connection with any item mentionedin this standard. Users of this standard are expressly advised that determination of the validity of any such p

47、atent rights, and the riskof infringement of such rights, 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 e

48、ither for revision of this standard or for additional standardsand 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 fai

49、r hearing you shouldmake your views known to the ASTM Committee 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). Permission rights to photocopy the standard may also be secured from the AST