ASTM D7036-2012 7459 Standard Practice for Competence of Air Emission Testing Bodies《空气排放试验体能力的标准实施规程》.pdf

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1、Designation: D7036 12Standard Practice forCompetence of Air Emission Testing Bodies1This standard is issued under the fixed designation D7036; 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 p

2、arentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.1. Scope1.1 This Practice specifies the general requirements for thecompetence to carry out sampling and analysis for air emis-sions tests of stationary sourc

3、es. It covers testing and calibra-tion performed using standard methods, non-standard methodsand methods developed by the AETB.1.2 This Practice is applicable to all bodies engaged in airemission testing regardless of the number of personnel or thescope of testing activities. When an AETB does not u

4、ndertakeone or more of the activities covered by the Practice such asdeveloping test methods, the requirements of those clauses donot apply.1.3 The notes given provide clarification of text, examples,and guidance. The notes do not contain requirements and donot form an integral part of this Practice

5、.NOTE 1ISO/IEC 17025 has been considered when elaborating thisPractice. Several, but not all, statements of this Practice are consistentwith ISO 17025:2005.NOTE 2This Practice is a specification for competence. It does notaddress accreditation or any activities specific to accreditation such ason-si

6、te inspections/audits by external assessors or proficiency testing.2. Referenced Documents2.1 Referenced Standards:NCSL RP-1 Establishment and Adjustment of CalibrationIntervals2ISO 17025 General Requirements for the Competence ofTesting and Calibration Laboratories33. Terminology3.1 Definitions:3.1

7、.1 air emission testingthe direct testing of emissions tothe atmosphere from stationary sources by sampling,measurement, and analysis including determination of therelative accuracy and QA/QC auditing of continuous monitor-ing systems. This definition excludes fuel sampling, visibleemission evaluati

8、ons, and daily operation and maintenance ofcontinuous monitoring systems.3.1.2 air emission testing body (AETB)a company orother entity that conducts Air Emission Testing.3.1.3 approved test protocola statement, approved by therelevant regulatory authority or other receiving party, of theobjectives

9、of a specific test program and the test methods (anddeviations) to be used to achieve those objectives. Alsoreferred to as “sampling plan” or “test plan.”3.1.4 competencefor an AETB, competence is the abilityto consistently produce acceptable data of known and docu-mented quality. An AETB shall be c

10、onsidered competent if ithas in place and continually operates under a Quality Systemmeeting the requirements of this Practice.3.1.5 external qualification exama Qualification Exammeeting the requirements of 6.2.3.6 and administered by anIndependent Proctor. In addition, an External QualificationExa

11、m must be: (1) approved with regard to content and formatby a Qualification Exam Provider. This test will be adminis-tered in accordance with rules established by the Provider; and(2) administered and scored by an Independent Proctor.3.1.6 independent proctora person not employed by orassociated wit

12、h the AETB who oversees the administration ofthe External Qualification Exam according to the the rulesestablished by the qualification exam provider.3.1.7 internal qualification exama Qualification Exammeeting the requirements of 6.2.3.4 and administered by theAETB.3.1.8 known and documented qualit

13、yfor the purposes ofthis Practice, data will be of known and documented quality ifcollected under a Quality System meeting the requirements ofthis Practice (including adherence to approved test protocolsand deviations).3.1.9 performance datadata generated and/or collected bythe AETB indicating confo

14、rmance with customer and regula-tory requirements and with the requirements of this Practice.Such data may include feedback from regulatory agencyobservers, customers, internal and external audit results, resultsfrom participation in proficiency testing programs and any1This Practice is under the ju

15、risdiction of ASTM Committee D22 on Air Qualityand is the direct responsibility of Subcommittee D22.03 on Ambient Atmospheresand Source Emissions.Current edition approved Oct. 1, 2012. Published November 2012. Originallyapproved in 2004. Last previous edition approved in 2011 as D7036 - 04 (2011).DO

16、I:10.1520/D7036-12.2NCSL International, Wilderness Place, Suite 107, Boulder, Colorado 80301-54043Available from American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-29

17、59. United States1other data that provides direct, objective documentation of thequality of data collected by the body.3.1.10 performance issuea Performance Issue (or QualitySystem problem) may be of two types: (1) some aspect of a testprogram or test data failed to meet expectations; and (2) failur

18、eto follow the Quality Manual or a required component of themanual is absent.3.1.11 proficiency testa means of evaluating an AETBsperformance relative to a given set of criteria.3.1.11.1 DiscussionA proficiency test, for example, maybe a blind determination of a reference sample, comparison ofpaired

19、 sampling trains, or recovery from dynamic spiking.3.1.12 qualification credentialsevidence that the QualifiedIndividual meets the requirements of 6.2.3.2 and that clearlystates the scope of the Qualification (for example, a certificatefrom a Qualification Exam Provider).3.1.13 qualification exama t

20、est to evaluate the knowledgeof the individual to become qualified.3.1.14 qualification exam providera recognized associa-tion of AETBs who oversees, maintains, and/or approves theformat and content of Qualification Exams meeting the require-ments of this Practice. A Qualification Exam Provider also

21、develops policies and procedures for the administration of theExams and issues Qualification Credentials.3.1.15 qualified individualan individual who meets therequirements specified in 6.2.3.2 of this Practice.4. Significance and Use4.1 This Practice establishes general criteria for a QualitySystem

22、that, when followed, helps ensure consistently accept-able data quality from an AETB. The relevant criteria con-tained in this Practice shall be addressed in theAETBs QualityManual, which shall contain or refer to additional specificcriteria and requirements where relevant and necessary. TheQuality

23、Manual and its implementation (including testprotocols, reports, and personnel testing) shall provide the solebasis for determining the conformance of the AETB with thisstandard.NOTE 3This Practice assesses the overall ability of an AETB todeliver data of known and documented quality on a consistent

24、 basisregardless of the test method used. There is no requirement to define ascope of testing. It is a requirement of this Practice that prior toperforming a test method for the first time, the AETB has in placeresources, training, and QA/QC consistent with this Practice to insure dataof acceptable

25、quality are produced.4.2 This Practice is for use by AETBs in developing thequality, administrative, and technical systems that govern theiroperations. Clients, regulatory authorities, and accreditationbodies may also use it in confirming or recognizing thecompetency of AETBs.NOTE 4This Practice is

26、performance-based; that is, it focuses on theactual performance (i.e., consistent generation of data of known anddocumented quality) of the AETB rather than on an extensive collectionof prescriptive criteria that may or may not be relevant to a particularAETB. It also focuses on the education and qu

27、alifications of the individualtester.NOTE 5There has been an effort in the development of this Practice tokeep the paperwork and administrative burdens on affected AETBs to theminimum required for an effective program.5. Organization and Management5.1 Organization:5.1.1 The AETB shall have in place

28、a structure, including aQuality System that enables it to continually monitor andimprove its ability to deliver its scope of services. This abilityshall be measured by Performance Data.5.1.2 The organization of the AETB shall be clearly definedincluding its place in any parent organization, and the

29、relation-ships between quality management, technical operations, andsupport services.5.1.3 It is the responsibility of the AETB to carry out itsactivities in such a way as to meet the requirements of thisPractice, the requirements of local, state and federal laws andregulations, and to meet the need

30、s of the client and regulatoryauthorities.5.1.4 The AETB shall:5.1.4.1 Have in place a system to collect and documentPerformance Data from all relevant sources.5.1.4.2 Provide its employees with the resources and author-ity to initiate corrective actions and to verify and documenttheir effectiveness

31、.5.1.4.3 Be legally identifiable, that is, it shall meet theapplicable legal requirements of the governmental jurisdictionin which it conducts business. It shall be organized and shalloperate so that its facilities and resources meet the require-ments of this Practice.5.1.4.4 Be organized so that st

32、aff members are not subject toundue pressure or inducement that might inappropriatelyinfluence their judgment or results of their work, includingquality issues.5.1.4.5 Be organized so that confidence in its independenceof judgment and integrity is maintained at all times.5.1.4.6 Be organized so that

33、 staff members are aware of boththe extent and limitations of their responsibilities.5.1.4.7 Provide adequate supervision of technical staff,including trainees, by persons familiar with relevant methodsand procedures, the purpose of the test project, and withassessment of testing results. Only quali

34、fied individuals maysupervise a test.5.1.4.8 Have a Technical Manager or Director (howevernamed) who has overall responsibility for the technical opera-tions of the AETB and has demonstrated competence in airemissions testing activities through education or professionalexperience, or both.5.1.4.9 Ha

35、ve a Quality Manager (however named) who hasresponsibility for the Quality System and its implementation.The quality manager shall have authority and responsibility forensuring that the requirements of this Practice are implementedand maintained. The quality manager must have direct accessto the hig

36、hest levels of management at which decision aremade on policies affecting the AETB.NOTE 6The Quality Manager may also be the Technical Manager inAETBs with limited staff. Whenever possible, the quality and technicalmanager positions should be filled independently.5.1.4.10 Have a Qualified Individual

37、 on-site for each testproject who is qualified for each test method performed.5.1.4.11 Be able to provide documentation or otherwisedemonstrate, on request from the persons or organizationsD7036 122evaluating its competence, that it complies with the relevantand appropriate federal, state, and local

38、 requirements forconducting testing procedures under its scope, including com-pliance with this Practice.5.1.4.12 Be able to provide documentation or otherwisedemonstrate, on request from the persons or organizationsevaluating its competence, that it complies with applicablelocal, state, and federal

39、 requirements governing health andsafety, transportation, shipping and other relevant require-ments.5.2 Management System:5.2.1 Quality PolicyThe AETB shall develop and dis-seminate a quality policy.Aquality policy is a formal statementsigned by top management that states the commitment by topmanage

40、ment and staff to conform to the requirements docu-mented in the Quality Manual and to this Practice.5.2.1.1 The management of the AETB shall define anddocument its quality policy, quality objectives, and commit-ment to quality.5.2.1.2 The AETB shall ensure that its quality policy in-cludes recognit

41、ion of the needs and expectations of its custom-ers. The AETB shall also ensure that its quality policy isunderstood, implemented, and maintained at all levels withinthe AETB.5.2.2 Quality SystemThe AETB shall establish, maintain,and operate under a documented Quality System as a means ofensuring th

42、at its operations are appropriate to providing airemission testing services and meet the requirements of thisPractice.5.2.2.1 The Quality System shall be designed to ensure therequired degree of completeness, representativeness,comparability, and uncertainty (within the limits of uncertaintydocument

43、ed in the test method) needed to meet the data qualityobjectives of each project undertaken by the AETB.5.2.2.2 The Quality System and theAETBs conformance tothe Quality System shall be documented to the extent necessaryto ensure consistent achievement of data quality objectives forprojects undertak

44、en by the AETB.NOTE 7Data quality objectives (however named) have always been apart of any test program. Sections 5.2.2.1 and 5.2.2.2 do not establish newrequirements. Data quality objectives may be defined in the testingmethod (e.g., bias 6.30%) or may be defined by regulation or by the client.)5.2

45、.3 Quality ManualThe Quality System shall be docu-mented in a Quality Manual and supporting Quality Systemdocumentation. The manual shall be structured according tothe outline provided in Appendix X1 of this Practice. Portionsnot relevant to the scope of the AETBs services may beeliminated. This doc

46、umentation shall be available for use bythe AETB staff. The Quality System documents shall bemaintained current under the responsibility of the QualityManager.5.3 Document Control:5.3.1 GeneralThe AETB shall establish and maintainprocedures to control all documents that form part of itsQuality Syste

47、m (internally generated or from external sources),such as regulations, standards, other normative documents, testand/or calibration methods, as well as drawings, software,specifications, instructions and manuals. These proceduresshall be sufficient to preclude the use of invalid and/or obsoletedocum

48、ents.5.3.2 Quality system documents generated by the AETBshall be uniquely identified. Such identification shall includethe date of issue and/or revision identification, pagenumbering, the total number of pages or a mark to signify theend of the document, and the issuing authority(ies).5.3.3 Changes

49、 to documents shall be reviewed and ap-proved by the same organizational group that performed theoriginal review unless specifically designated otherwise. Per-sonnel conducting the review shall have access to pertinentbackground information upon which to base their review andapproval. Where practicable, the altered or new text shall beidentified in the document or the appropriate attachments.5.3.4 If the AETBs documentation control system allowsfor the amendment of documents by hand pending the re-issueof the documents, the procedures and authorities for