ASTM D7036-2004(2011) 4375 Standard Practice for Competence of Air Emission Testing Bodies《气体辐射测试机构的能力的标准操作规程》.pdf

1、Designation: D7036 04 (Reapproved 2011)Standard 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 revis

2、ion. 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 specifies the general requirements forcompetence to carry out sampling and analysis for air emis-sions tests of st

3、ationary sources. 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 A

4、ETB does not undertakeone 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

5、 this practice.NOTE 1ISO/IEC 17025 has been considered when elaborating thispractice. It is to be noted that at the time of approval of this practiceISO/IEC 17025 was under revision. Several, but not all, statements of thispractice are consistent with ISO/IEC 17025:1999.NOTE 2This practice is a spec

6、ification for competence. It does notaddress accreditation or any activities specific to accreditation such ason-site inspections/audits by external assessors or proficiency testing.2. Referenced Documents2.1 Referenced Standards:NCSL RP-1 Establishment and Adjustment of CalibrationIntervals2ISO/IEC

7、 17025 General Requirements for the Competenceof Testing and Calibration Laboratories33. Terminology3.1 Definitions:3.1.1 air emission testingthe direct testing of emissions tothe atmosphere from stationary sources by sampling, measure-ment, and analysis including determination of the relativeaccura

8、cy and QA/QC auditing of continuous monitoring sys-tems. This definition excludes fuel sampling, visible emissionevaluations, and daily operation and maintenance of continu-ous monitoring systems.3.1.2 air emission testing body (AETB)a company orother entity that conducts Air Emission Testing.3.1.3

9、approved test protocola statement, approved by therelevant regulatory authority or other receiving party, of theobjectives 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 competencethe abi

10、lity to consistently produce ac-ceptable data of known and documented quality. An AETBshall be considered competent if it has in place and continuallyoperates under a quality system meeting the requirements ofthis practice.3.1.5 external qualification exama qualification exammeeting the requirements

11、 of 8.3.5 and administered by anindependent proctor. In addition, an external qualification exammust be: (1) approved with regard to content and format by aqualification exam provider. This test will be administered inaccordance with rules established by the Provider; and (2)administered and scored

12、by an independent proctor.3.1.6 independent proctora person not employed by orassociated with the AETB who oversees the administration ofthe external qualification exam in accordance with the rulesestablished by the qualification exam provider.3.1.7 internal qualification exama qualification exammee

13、ting the requirements of 8.3.5 and administered by theAETB.3.1.8 known and documented qualityfor 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 d

14、eviations).3.1.9 performance datadata generated, or collected, orboth by the AETB indicating conformance with customer andregulatory requirements and with the requirements of thispractice. Such data includes feedback from regulatory agency1This practice is under the jurisdiction of ASTM Committee D2

15、2 on Air Qualityand is the direct responsibility of Subcommittee D22.03 on Ambient Atmospheresand Source Emissions.Current edition approved Jan. 15, 2011. Published March 2011. Originallyapproved in 2004. Last previous edition approved in 2004 as D7036 - 04.DOI:10.1520/D7036-04R11.2NCSL Internationa

16、l, Wilderness Place, Suite 107, Boulder, Colorado 80301-54043Available from American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.observers, custome

17、rs, internal and external audit results, resultsfrom participation in proficiency testing programs and anyother 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: (

18、1) some aspect of a testprogram or test data failed to meet expectations; and (2) failureto 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 t

19、est, for example, maybe a blind determination of a reference sample, comparison ofpaired sampling trains, or recovery from dynamic spiking.3.1.12 qualification credentialsevidence that the qualifiedindividual meets the requirements of 8.3.2 and that clearlystates the scope of the qualification (for

20、example, a certificatefrom a qualification exam provider).3.1.13 qualification exama test to evaluate the knowledgeof the individual to become qualified.3.1.14 qualification exam providera recognized associa-tion of AETBs who oversees, maintains, or approves, or acombination the three the format and

21、 content of qualificationexams meeting the requirements of this practice. A qualifica-tion exam provider also develops policies and procedures forthe administration of the exams and issues qualification cre-dentials.3.1.15 qualified individualan individual who meets therequirements specified in 8.3.

22、2 of this practice4. Significance and Use4.1 This practice establishes general criteria for a qualitysystem 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 the AETBs qualitymanual, which sha

23、ll contain or refer to additional specificcriteria and requirements where relevant and necessary. Thequality manual and its implementation (including test proto-cols, reports, and personnel testing) shall provide the sole basisfor determining the conformance of the AETB with thisstandard.NOTE 3This

24、practice assesses the overall ability of an AETB todeliver data of known and documented quality on a consistent basisregardless of the test method used. There is no requirement to define ascope of testing. It is a requirement of this practice that prior to performinga test method for the first time,

25、 the AETB has in place resources, training,and QA/QC consistent with this practice to insure data of acceptablequality 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

26、accreditationbodies may also use it in confirming or recognizing thecompetency of AETBs.NOTE 4This practice is performance-based; that is, it focuses on theactual performance (that is, consistent generation of data of known anddocumented quality) of the AETB rather than on an extensive collectionof

27、prescriptive criteria that may or may not be relevant to a particularAETB. It also focuses on the education and qualifications 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 re

28、quired for an effective program.5. Organization and Management5.1 The AETB shall have in place 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.5.2 The organization

29、 of the AETB shall be clearly definedincluding its place in any parent organization, and the relation-ships between quality management, technical operations, andsupport services.5.3 It is the responsibility of the AETB to carry out itsactivities in such a way as to meet the requirements of thispract

30、ice, the requirements of local, state and federal laws andregulations, and to meet the needs of the client, and whenappropriate, regulatory authorities.5.4 The AETB shall:5.4.1 Have in place a system to collect and documentperformance data from all relevant sources.5.4.2 Provide its employees with t

31、he resources and authorityto initiate corrective actions and to verify and document theireffectiveness.5.4.3 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

32、its facilities and resources meet the require-ments of this practice.5.4.4 Be organized so that staff members are not subject toundue pressure or inducement that might inappropriatelyinfluence their judgment or results of their work, includingquality issues.5.4.5 Be organized so that confidence in i

33、ts independence ofjudgment and integrity is maintained at all times.5.4.6 Be organized so that staff members are aware of boththe extent and limitations of their responsibilities.5.4.7 Provide adequate supervision of technical staff, in-cluding trainees, by persons familiar with relevant methods and

34、procedures, the purpose of the test project, and with assessmentof testing results. Only qualified individuals may supervise atest.5.4.8 Have a technical manager or director (howevernamed) who has overall responsibility for the technical opera-tions of the AETB and has demonstrated competence in air

35、emissions testing activities through education or professionalexperience, or both.5.4.9 Have 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 pra

36、ctice are implementedand maintained. The quality manager must have direct accessto the highest 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 tech

37、nicalmanager positions should be filled independently.5.4.10 Have a qualified individual on-site for each testproject who is qualified for each test method performed.D7036 04 (2011)25.4.11 Be able to provide documentation or otherwise dem-onstrate, on request from the persons or organizations evalu-

38、ating its competence, that it complies with the relevant andappropriate federal, state, and local requirements for conduct-ing testing procedures under its scope, including compliancewith this practice.5.4.12 Be able to provide documentation or otherwisedemonstrate, on request from the persons or or

39、ganizationsevaluating its competence, that it complies with applicablelocal, state, and federal requirements governing health andsafety, transportation, shipping and other relevant require-ments.6. Document Control6.1 GeneralThe AETB shall establish and maintain pro-cedures to control all documents

40、that form part of its qualitysystem (internally generated or from external sources), such asregulations, standards, other normative documents, test, orcalibration methods, or a combination of thereof, as well asdrawings, software, specifications, instructions and manuals.These procedures shall be su

41、fficient to preclude the use ofinvalid, or obsolete documents, or both.6.2 Quality system documents generated by the AETB shallbe uniquely identified. Such identification shall include thedate of issue, or revision identification, or both, page number-ing, the total number of pages or a mark to sign

42、ify the end ofthe document, and the issuing authority(ies).6.3 Changes to documents shall be reviewed and approvedby the same organizational group that performed the originalreview unless specifically designated otherwise. Personnelconducting the review shall have access to pertinent back-ground inf

43、ormation upon which to base their review andapproval. Where practicable, the altered or new text shall beidentified in the document or the appropriate attachments.6.4 If the AETBs documentation control system allows forthe amendment of documents by hand pending the re-issue ofthe documents, the proc

44、edures and authorities for such amend-ments shall be defined. Amendments shall be clearly marked,initialed and dated. A revised document shall be formallyre-issued as soon as practicable.6.5 Procedures shall be established to describe how changesin documents maintained in computerized systems are ma

45、deand controlled.7. Quality System, Audit, and Review7.1 Quality PolicyThe AETB shall develop and dissemi-nate a quality policy. A quality policy is a formal statementsigned by top management that states the commitment by topmanagement and staff to conform to the requirements docu-mented in the qual

46、ity manual and to this practice.7.1.1 The management of the AETB shall define and docu-ment its quality policy, quality objectives, and commitment toquality.7.1.2 The AETB shall ensure that its quality policy includesrecognition of the needs and expectations of its customers. TheAETB shall also ensu

47、re that its quality policy is understood,implemented, and maintained at all levels within the AETB.7.2 Quality SystemThe AETB shall establish, maintain,and operate under a documented quality system as a means ofensuring that its operations are appropriate to providing airemission testing services an

48、d meet the requirements of thispractice.7.2.1 The quality system shall be designed to ensure therequired degree of completeness, representativeness, compara-bility, and uncertainty (within the limits of uncertainty docu-mented in the test method) needed to meet the data qualityobjectives of each pro

49、ject undertaken by the AETB.7.2.2 The quality system and the AETBs conformance tothe quality system shall be documented to the extent necessaryto ensure consistent achievement of data quality objectives forprojects undertaken by the AETB.NOTE 7Data quality objectives (however named) should always be apart of any test program. Sections 7.2.1 and 7.2.2 do not establish newrequirements. Data quality objectives may be defined in the testingmethod (for example, bias 90 %) or may be defined by regulation or by the client).7.3 Quality ManualThe quality system sha