ASTM E1212-2012 Standard Practice for Quality Management Systems for Nondestructive Testing Agencies 《无损检测机构质量管理系统的标准实施规程》.pdf

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1、Designation: E1212 12Standard Practice forQuality Management Systems for Nondestructive TestingAgencies1This standard is issued under the fixed designation E1212; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last rev

2、ision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.1. Scope*1.1 This practice covers general requirements for the estab-lishment and maintenance of a quality management system foragencies e

3、ngaged in nondestructive testing (NDT).1.2 This practice utilizes criteria contained in Practice E543.1.3 This practice utilizes criteria contained in AmericanNational Standard ANSI/ISO/ASQ Q90012008, Quality man-agement systemsRequirements.1.4 This practice recognizes the importance of establishing

4、minimum safety criteria.1.5 The use of SI or inch-pound units, or combinationsthereof, will be the responsibility of the technical committeewhose standards are referred to in this standard.1.6 This practice does not purport to address all of thesafety concerns, if any, associated with its use. It is

5、 theresponsibility of the user of this practice to establish appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.2. Referenced Documents2.1 ASTM Standards:2E543 Specification for Agencies Performing NondestructiveTestingE1359 Guide for Eva

6、luating Capabilities of NondestructiveTesting Agencies2.2 ASNT/ANSI Standards:3ASNT Recommended Practice No. SNT-TC-1A PersonnelQualification and Certification in Nondestructive TestingANSI/ASNT CP 189 Qualification and Certification of Non-destructive Testing Personnel2.3 ANSI/ASQ Standards:A8402 M

7、anagement and Quality Assurance-Vocabulary4Q9000 Series of Quality Management and Quality Assur-ance (Q9000 through Q9004 inclusive) Standards (Theseare exact equivalents to the ISO 9000 through ISO 9004series)2.4 AIA Standard:NAS 410 NAS Certification and Qualification of Nonde-structive Testing Pe

8、rsonnel53. Terminology3.1 Definitions of Terms Specific to This Standard:3.1.1 agency, nthe public, independent, or in-house non-destructive testing organization selected by the authority toperform the examination(s) required by the purchase order orspecification.3.1.2 authority, nthe owner, prime c

9、ontractor, engineer,architect, or purchasing agent in responsible charge of thework, or duly recognized or designated representative.3.1.3 continual quality improvement, n an ongoing qualityimprovement activity for achieving results. Improvement maybe directed at individual processes, finished produ

10、cts, oradministrative processes. The continual quality improvementprogram utilizes statistical methods, team projects, and othertools as appropriate to obtain and sustain improvements.3.1.4 customer, ncustomer is used with the same meaningas “authority.”3.1.5 process capability, nthe degree to which

11、 a processcan produce the same results without variation, that is, repro-ducibility.3.1.6 process control, nmanaging a process to ensure thatit is performing to its designed capability.1This practice is under the jurisdiction of ASTM Committee E07 on Nonde-structive Testing and is the direct respons

12、ibility of Subcommittee E07.09 onNondestructive Testing Agencies.Current edition approved Nov. 1, 2012. Published November 2012. Originallyapproved in 1987. Last previous edition approved in 2009 as E1212 - 09. DOI:10.1520/E1212-12.2For referenced ASTM standards, visit the ASTM website, www.astm.org

13、, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.3Available fromAmerican Society for Nondestructive Testing (ASNT), P.O. Box28518, 1711 Arlingate Ln., Columbus, OH 43228-0518, ht

14、tp:/www.asnt.org.4Available from American Society for Quality (ASQ), 600 N. Plankinton Ave.,Milwaukee, WI 53203, http:/www.asq.org.5Available from Aerospace Industries Association of America, Inc. (AIA), 1000Wilson Blvd., Suite 1700,Arlington, VA22209-3928, http:/www.aia-aerospace.org.*A Summary of

15、Changes section appears at the end of this standardCopyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States13.1.7 quality management system, nthe organizationalstructure, responsibilities, practices, procedures, processes, andresources for imp

16、lementing and maintaining the quality pro-gram.3.1.8 quality manual, na comprehensive document statingthe quality policy and specifying organizational structure,practices, and procedures necessary to empower the qualitypolicy and quality management system.3.1.9 quality objectives, nspecific obtainab

17、le improve-ment goals supporting the quality program.3.1.10 quality policy, nthe overall intentions and directionof an organization regarding quality as formally expressed bytop management.3.1.11 quality records, nformal documentation of exami-nation results or data supporting the quality management

18、system.3.1.11.1 DiscussionExamples are: audit reports, calibra-tion data, NDT records, process qualification results, qualifi-cation data, and test data.4. Significance and Use4.1 This practice covers procedures for establishing andmaintaining a quality system for nondestructive testing agen-cies.4.

19、2 Controlling the quality of service rendered is a continu-ing process. This practice provides guidelines for establishinga quality management system that provides for: calibration,standardization, reference samples, examination plans, andprocedures.4.3 The basic requirements for a quality managemen

20、t sys-tem encompass the following areas, all of which shall bedocumented.4.3.1 Quality policy statement, planning, andadministration,4.3.2 Organization,4.3.3 Human resources,4.3.4 Physical resources, and4.3.5 Quality management.5. Quality Policy Statement, Planning, andAdministration5.1 Policy State

21、mentA policy statement shall describemanagements specific intention and policy with respect toquality. The policy statement should specify an organizedapproach for carrying out those intentions and should addressitself to all major quality parameters. It should be approved bythe chief executive offi

22、cer for company-wide policies or bysubordinate officers for specialized policies. Periodic auditsshould be required to ensure adherence to quality policies.5.2 Quality ObjectivesObjectives should be establishedfor appropriate key elements of performance such as safetyrequirements, internal performan

23、ce levels, vendorperformance, training, and qualification of personnel.5.3 Quality Management SystemA quality managementsystem shall be established that will carry out the statedpolicies and objectives.5.4 Quality PlanningPlanning for each new or modifiedprocess or test method should define those ch

24、aracteristics to becontrolled. Quality planning also includes providing for ad-ministrative processes needed to implement compliance withthis practice.5.5 Quality ManualThe quality policy and system shall bedocumented and be in accessible form, such as a qualitymanual or series of manuals. Key eleme

25、nts should include, asnecessary:5.5.1 The general quality statement,5.5.2 A description of the quality system,5.5.3 Ageneral description of quality planning requirementswith specifics for each product category where appropriate,5.5.4 The requirements of Practice E543 pertaining to thelaboratory proc

26、edure manual, and5.5.5 Typically used examination procedures.5.6 AdministrationClear lines of authority shall be estab-lished to administer the quality management system.5.6.1 Quality ResponsibilityThe quality responsibility ofeach unit within the organization shall be approved by the chiefoperation

27、 officer of each unit.5.6.2 Quality Performance ReportingResponsibility forreporting performance against stated quality objectives tohigher management should rest with functions independent ofthose responsible for the attainment of those objectives. Pro-cedures for documentation and record retention

28、 should beestablished.5.6.3 Quality System AuditsTo provide assurance, a peri-odic audit of the quality management system should be madeby an organizational element independent of the unit beingaudited or by a qualified third party to monitor the effectivenessof various quality management system pro

29、cesses. It mayinclude, as appropriate:5.6.3.1 Management audits to determine how well qualitypolicy and objectives are being met,5.6.3.2 System audits, including examination process auditsto determine how well quality planning has been implementedand to identify areas where changes would be benefici

30、al to thequality services performed, and5.6.3.3 Records documenting findings and corrective andpreventive actions taken.6. Organization6.1 The following information concerning the organizationof the agency shall be documented.6.1.1 A description of the organization including:6.1.1.1 The complete leg

31、al name and address of the mainoffice,6.1.1.2 The names and positions of the principal officers anddirectors,6.1.1.3 The agencys ownership, managerial structure, andprincipal members,6.1.1.4 The functional description of the agencys organiza-tional structure, operational departments, and support dep

32、art-ments and services. This may be demonstrated in the form ofcharts that depict all the divisions, departments, sections andunits, and their relationships,E1212 1226.1.1.5 All relevant organizational affiliates of the agencyand principal officers of affiliates and directors of affiliateswhere appl

33、icable,6.1.1.6 External organizations and organizational compo-nents and their functions that are utilized for significanttechnical support services, and6.1.1.7 A brief history of the agency including its relation-ship with its organizational component affiliations and othersupporting information.6.

34、1.2 A listing of the relevant technical services offered.6.1.3 A list giving applicable dates of qualifications andaccreditations.7. Human Resources7.1 GeneralThose aspects of the quality system where thework of the employees will affect the quality of products shallbe identified, and specific actio

35、n taken to control them.7.2 Management ResponsibilitiesThe quality-relatedrequirements, duties, and responsibilities of all personnel shallbe identified. Job criteria that are quality-related should bespecified in job descriptions to permit proper employee selec-tion.7.3 Employee Selection and Train

36、ingEmployees shall beselected on the basis of capability and experience or thepotential to fully qualify for the job. A training program shallbe maintained to ensure employees develop and retain skillcompetence. Nondestructive testing (NDT) personnel shall bequalified in accordance with a nationally

37、 recognized NDTpersonnel qualification practice or standard such as ANSI/ASNT-CP-189, ASNT/SNT-TC-1A, AIA/NAS 410, or a simi-lar document. The practice or standard used and the applicablerevision shall be specified in the contractual agreement be-tween the using parties.7.4 The agency shall provide

38、the following documentation:7.4.1 Awritten outline or chart giving operational personnelpositions and their lines of responsibility and authority, and7.4.2 A summary job description for each professional,scientific, supervisory, and technical position category includ-ing the required education, trai

39、ning and experience,certification, or professional licenses.7.5 The agency shall provide a description of its methods ofmaintaining personnel records to document the qualifications,work experience, and training history of each person in thepositions described in 7.4.2. The agency shall also provide

40、adescription of its means of ensuring confidence in its humanresources including the maintenance of records.8. Physical Resources8.1 The agency shall provide an inventory of its relevantphysical resources including:8.1.1 A general description of the agencys facilities forNDT related activities.8.1.2

41、 An inventory of equipment used to perform NDTincluding the following for each item of equipment:8.1.2.1 Type of equipment and use,8.1.2.2 Name of manufacturer,8.1.2.3 The equipment model and serial number,8.1.2.4 Properties of the equipment subject to standardiza-tion or calibration,8.1.2.5 The ran

42、ge of operation and range of calibration,8.1.2.6 Reference to a recognized calibration procedure,8.1.2.7 Frequency of calibration, and8.1.2.8 Allowable tolerances or maximum sensitivity.8.1.3 A system of written procedures for each NDT serviceperformed by the agency. The procedures shall include ade

43、scription of the methods used for NDT and the methods usedfor data recording, data processing, data reporting, and forcertification of the results. When required, customer approvalshall be obtained.8.1.4 An inventory of reference material including a libraryof standards, applicable technical publica

44、tions, and pertinentspecifications and amendments.9. Quality Management9.1 Purchased NDT Equipment, Materials, and Services:9.1.1 GeneralThe quality management system shall in-clude procedures to ensure effective supplier quality manage-ment for all purchased materials and services. Controls shall b

45、eprovided for materials, equipment, and any subcontractedservices.9.1.2 Supplier Quality Program and Selection MethodsProcedures shall be established for the selection and qualifica-tion of suppliers, such as supplier surveys, past quality history,and industry history. Each suppliers quality capabil

46、ity shall beperiodically evaluated, including audit visits whereappropriate, based upon performance. The requirements forquality management shall be established in the purchaseagreement. The purchase agreement should include the ele-ments of the quality management system that are to beperformed by t

47、he supplier in assuring quality.9.1.3 Receiving InspectionFor those purchased itemswhere inspection upon receipt is acceptable, inspection ofsubmitted items shall be performed to the degree and extentneeded to determine acceptability. Receiving inspection shallinclude well-maintained records so that

48、 past supplier perfor-mance is available. Adequate facilities and procedures forstorage, handling, protection, and controlled release of pur-chased materials shall be established. Materials inspected,tested, and approved shall be separated from withheld orrejected materials.9.1.4 Nonconforming Mater

49、ial ControlControl of non-conforming purchased supplies or equipment shall be main-tained to ensure that such items are not used.9.1.5 Subcontracted ServicesWhen the agency utilizes theservices of another agency to perform all or part of its services,provisions shall be made to ensure that the activities areperformed in accordance with the purchasers requirements.Actions to be taken shall be included in the agencys qualityassurance manual. The requirements of Guide E1359 shall beused as a guide in evaluating the quality system of thesubcontract