ASTM D7036-2016 4020 Standard Practice for Competence of Air Emission Testing Bodies《空气排放试验机构的能力的标准实施规程》.pdf

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1、Designation: D7036 16Standard 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 17025:2005 has been considered when elaboratingthis Practice. Several, but not all, statements of this Practice are consistentwith ISO/IEC 17025:2005.NOTE 2This Practice is a specification for competence. It does notaddress accreditation or any activities specific to accreditation suc

6、h ason-site inspections/audits by external assessors or proficiency testing.2. Referenced Documents2.1 ASTM Standards:D1356 Terminology Relating to Sampling and Analysis ofAtmospheres2.2 Other DocumentsNCSL RP-1 Establishment and Adjustment of CalibrationIntervals2ISO/IEC 17025:2005 General Requirem

7、ents for the Compe-tence of Testing and Calibration Laboratories33. Terminology3.1 For air quality and other terms not defined here in,please refer to ASTM D1356-15 Standard Terminology Relat-ing to Sampling and Analysis of Atmospheres.3.2 Terms Specific to this Standard:3.2.1 air emission testingth

8、e 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 evaluations, and daily operation

9、and maintenance ofcontinuous monitoring systems.3.2.2 air emission testing body (AETB)a company orother entity that conducts Air Emission Testing.3.2.3 approved test protocola statement, approved by therelevant regulatory authority or other receiving party, of theobjectives of a specific test progra

10、m and the test methods (anddeviations) to be used to achieve those objectives. Alsoreferred to as “sampling plan” or “test plan.”3.2.4 competencefor an AETB, competence is the abilityto consistently produce acceptable data of known and docu-mented quality. An AETB shall be considered competent if it

11、has in place and continually operates under a Quality Systemmeeting the requirements of this Practice.3.2.5 contractany oral or written agreement between anAETB and a customer to provide services to that customer.3.2.6 external qualification exama Qualification Exammeeting the requirements of 6.2.3.

12、4 and administered by anIndependent Proctor. In addition, an External QualificationExam 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

13、Independent Proctor.3.2.7 independent proctora person not employed by orassociated with the AETB who oversees the administration ofthe External Qualification Exam according to the rules estab-lished by the qualification exam provider.3.2.8 internal qualification exama Qualification Exammeeting the r

14、equirements of 6.2.3.4 and administered by theAETB.3.2.9 known and documented qualityfor the purposes ofthis Practice, data will be of known and documented quality if1This Practice is under the jurisdiction of ASTM Committee D22 on Air Qualityand is the direct responsibility of Subcommittee D22.03 o

15、n Ambient Atmospheresand Source Emissions.Current edition approved June 1, 2016. Published June 2016. Originallyapproved in 2004. Last previous edition approved in 2012 as D7036 12.DOI:10.1520/D7036-16.2NCSL International, Wilderness Place, Suite 107, Boulder, Colorado 80301-5404.3Available from Ame

16、rican 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 19428-2959. United States1collected under a Quality System meeting the requirements ofthis Practice (including adherence to

17、approved test protocolsand deviations).3.2.10 performance datadata generated or collected orboth by the AETB indicating conformance with customer andregulatory requirements and with the requirements of thisPractice. Such data may include feedback from regulatoryagency observers, customers, internal

18、and external auditresults, results from participation in proficiency testing pro-grams and any other data that provides direct, objectivedocumentation of the quality of data collected by the body.3.2.11 performance issuea Performance Issue (or QualitySystem problem) may be of two types: (1) some asp

19、ect 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.3.2.12 preventive actionpreventive action is a proactiveprocess to identify opportunities for improvement rather than areaction to the identificat

20、ion of problems or complaints. Apartfrom the review of the operational procedures, the preventiveaction might involve the analysis of data, including trends andrisk analysis.3.2.13 proficiency testa means of evaluating an AETBsperformance relative to a given set of criteria.3.2.13.1 DiscussionA prof

21、iciency test, for example, maybe a blind determination of a reference sample, comparison ofpaired sampling trains, or recovery from dynamic spiking.3.2.14 qualification credentialsevidence that the QualifiedIndividual meets the requirements of 6.2.3 and that clearlystates the scope of the Qualificat

22、ion for example, a certificatefrom an AETB.3.2.15 qualification exama test to evaluate the knowledgeof the individual to become qualified.3.2.16 qualification exam providera recognized associa-tion who oversees, maintains, and approves the format andcontent of Qualification Exams meeting the require

23、ments ofthis Practice. A Qualification Exam Provider also developspolicies and procedures for the administration of the Exams.3.2.17 qualified individual (QI)an individual who meetsthe requirements specified in 6.2.3 of this Practice.3.2.18 requestany request of an AETB by a customer forservices. A

24、request may be verbal or in writing. (for example,request for proposal).3.2.19 tenderany formal or informal response to a cus-tomers request by an AETB (for example, proposal).3.2.20 test methodan externally or internally publishedprocedure for sampling or analysis or both of emissions fromstationar

25、y sources.4. 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 theAETBs QualityManual, which shall contai

26、n or refer to additional specificcriteria and requirements where relevant and necessary. TheQuality 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 as

27、sesses 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 toperforming a test method for the first time, the AETB h

28、as in placeresources, training, and QA/QC consistent with this Practice to insure dataof acceptable 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 accreditati

29、onbodies may also use it in confirming or recognizing thecompetency of AETBs.NOTE 4This Practice is performance-based; that is, it focuses on theactual performance (in other words, consistent generation of data ofknown and documented quality) of the AETB rather than on an extensivecollection of pres

30、criptive criteria that may or may not be relevant to aparticular AETB. It also focuses on the education and qualifications of theindividual tester.NOTE 5There has been an effort in the development of this Practice tokeep the paperwork and administrative burdens on affected AETBs to theminimum requir

31、ed for an effective program.5. Organization and Management5.1 Organization:5.1.1 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.5.1.2

32、 The organization of the AETB shall be clearly definedincluding its place in any parent organization, and the relation-ships between quality management, technical operations, andsupport services.5.1.3 It is the responsibility of the AETB to carry out itsactivities in such a way as to meet the requir

33、ements of thisPractice, the requirements of local, state and federal laws andregulations, and to meet the needs 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

34、with the resources and author-ity to initiate corrective actions and to verify and documenttheir effectiveness.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 shalloperat

35、e so that its facilities and resources meet the require-ments of this Practice.5.1.4.4 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.5.1.4.5 Be organized so that c

36、onfidence in its independenceof judgment and integrity is maintained at all times.5.1.4.6 Be organized so that staff members are aware of boththe extent and limitations of their responsibilities.D7036 1625.1.4.7 Provide adequate supervision of technical staff,including trainees, by persons familiar

37、with relevant methodsand procedures, the purpose of the test project, and withassessment of testing results. Only Qualified 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 dem

38、onstrated competence in airemissions testing activities through education or professionalexperience, or both.5.1.4.9 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

39、 the requirements of this Practice 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 p

40、ossible, the quality and technicalmanager positions should be filled independently.5.1.4.10 Have a Qualified Individual 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 organ

41、izationsevaluating its competence, that it complies with the relevantand appropriate federal, state, and local 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 th

42、e persons or organizationsevaluating its competence, that it complies with applicablelocal, state, and federal 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 qualit

43、y policy.Aquality 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.5.2.1.1 The management of the AETB shall define anddocument its quality policy, quality o

44、bjectives, and commit-ment to quality.5.2.1.2 The AETB shall ensure that its quality policy in-cludes recognition 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 S

45、ystemThe 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.5.2.2.1 The Quality System shall be designed to ensure therequired degre

46、e of completeness, representativeness,comparability, and uncertainty (within the limits of uncertaintydocumented 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 docu

47、mented to the extent necessaryto ensure consistent achievement of data quality objectives forprojects undertaken by the AETB.NOTE 7Data quality objectives (however named) have always been apart of any test program. Subsections 5.2.2.1 and 5.2.2.2 do not establishnew requirements. Data quality object

48、ives may be defined in the testingmethod (for example, bias 6.30%) or may be defined by regulation or by the client.)5.2.3 Quality ManualThe Quality System shall be docu-mented in a Quality Manual and supporting Quality Systemdocumentation. If an existing, Quality Manual adequatelyaddresses each of

49、these topics in the standard, it should notneed to be rewritten. Portions not relevant to the scope of theAETBs services may be eliminated. This documentation shallbe available for use by the AETB staff and for review byclients, regulatory authorities, and accreditation bodies uponrequest. The Quality System documents shall be maintainedcurrent under the responsibility of the Quality Manager.NOTE 8The following link provides one option for structuring aQuality Manual, but AETBs will be audited against this standard andshould consider addressing the