ASTM D7036-2004 Standard Practice for Competence of Air Emission Testing Bodies《气体辐射测试机构的能力的标准规程》.pdf

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1、Designation: D 7036 04Standard Practice forCompetence of Air Emission Testing Bodies1This standard is issued under the fixed designation D 7036; 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

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

3、s. 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 un

4、dertakeone 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. 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 specification for c

6、ompetence. 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 17025 General

7、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 relativeaccuracy and QA/QC au

8、diting 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 approved test p

9、rotocola 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 ability to consist

10、ently 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 of 8.3.5 and a

11、dministered 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 by an independe

12、nt 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 exammeeting the requir

13、ements 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 deviations).3.1.

14、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 agencyobservers, customers, internal and external audit results, resultsfrom parti

15、cipation in proficiency testing programs and any1This practice is under the jurisdiction of ASTM Committee D22 on Samplingand Analysis of Atmospheres and is the direct responsibility of SubcommitteeD22.03 on Ambient Atmospheres and Source Emissions.Current edition approved August 1, 2004. Published

16、August 2004.2NCSL International, Wilderness Place, Suite 107, Boulder, Colorado 80301-54043Available from American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, Un

17、ited States.other 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) failureto fo

18、llow 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 sampl

19、ing 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 example, a certificatefrom a qualification exam provider).3.1.13 qualification exama test to e

20、valuate 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 content of qualificationexams meeting the requirements of this practice. A qualifica-tion exa

21、m 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 8.3.2 of this practice4. Significance and Use4.1 This practice establishes general criteria for a

22、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 shall contain or refer to additional specificcriteria and requirements where relevant and necessa

23、ry. 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 practice assesses the overall ability of an AETB todeliver data of known and documented qualit

24、y 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, the AETB has in place resources, training,and QA/QC consistent with this practice to insure d

25、ata 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 accreditationbodies may also use it in confirming or recognizing thecompetency of AETBs.NOTE 4

26、This 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 prescriptive criteria that may or may not be relevant to a particularAETB. It also focuses on

27、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 required for an effective program.5. Organization and Management5.1 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.5.2 The organization of the AETB shall be clearly definedincluding its place in any parent organization, and the r

29、elation-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 thispractice, the requirements of local, state and federal laws andregulations, and to meet the needs o

30、f 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 the resources and authorityto initiate corrective actions and to verify and document theireffec

31、tiveness.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 its facilities and resources meet the require-ments of this practice.5.4.4 Be organized so tha

32、t 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 its independence ofjudgment and integrity is maintained at all times.5.4.6 Be organized so that

33、 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 andprocedures, the purpose of the test project, and with assessmentof testing results. Only quali

34、fied 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 airemissions testing activities through education or professionalexperience, or both.5.4.9 Have a

35、 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 highest

36、 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.5.4.10 Have a qualified individual on-si

37、te for each testproject who is qualified for each test method performed.D70360425.4.11 Be able to provide documentation or otherwise dem-onstrate, on request from the persons or organizations evalu-ating its competence, that it complies with the relevant andappropriate federal, state, and local requ

38、irements 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 organizationsevaluating its competence, that it complies with applicablelocal, state, and federal requir

39、ements 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 that form part of its qualitysystem (internally generated or from external sources), such asregulation

40、s, standards, other normative documents, test, orcalibration methods, or a combination of thereof, as well asdrawings, software, specifications, instructions and manuals.These procedures shall be sufficient to preclude the use ofinvalid, or obsolete documents, or both.6.2 Quality system documents ge

41、nerated 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 signify the end ofthe document, and the issuing authority(ies).6.3 Changes to documents shall be reviewed

42、and approvedby the same organizational group that performed the originalreview unless specifically designated otherwise. Personnelconducting the review shall have access to pertinent back-ground information upon which to base their review andapproval. Where practicable, the altered or new text shall

43、 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 procedures and authorities for such amend-ments shall be defined. Amendments shall be clearly marked,initi

44、aled 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 madeand controlled.7. Quality System, Audit, and Review7.1 Quality PolicyThe AETB shall develop and diss

45、emi-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 quality manual and to this practice.7.1.1 The management of the AETB shall define and docu-ment its qualit

46、y 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 ensure that its quality policy is understood,implemented, and maintained at all levels within the AETB.7.2

47、 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 and meet the requirements of thispractice.7.2.1 The quality system shall be designed to ensure therequir

48、ed 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 project undertaken by the AETB.7.2.2 The quality system and the AETBs conformance tothe quality system sh

49、all 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 shall be docu-mented in a quality manual and supporting quality systemdocumentation. The manual shall addre