ASTM C1156-2018 Standard Guide for Establishing Calibration for a Measurement Method Used to Analyze Nuclear Fuel Cycle Materials.pdf

1、Designation: C1156 03 (Reapproved 2011)C1156 18Standard Guide forEstablishing Calibration for a Measurement Method Used toAnalyze Nuclear Fuel Cycle Materials1This standard is issued under the fixed designation C1156; the number immediately following the designation indicates the year oforiginal ado

2、ption or, in the case of revision, the year of last revision. 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 guide provides the basis for establishing calibration for a measur

3、ement method typically used in an analytical chemistrylaboratory analyzing nuclear materials. Guidance is included for such activities as preparing a calibration procedure, selecting acalibration standard, controlling calibrated equipment, and documenting calibration. The guide is generic and any re

4、quiredtechnical information specific for a given method must be obtained from other sources.1.2 The guidance information is provided in the following sections:SectionGeneral Considerations 4General Considerations 5Calibration Procedure 5Calibration Procedure 6Calibration Standard 6Calibration Standa

5、rd 7Control of Calibrated Equipment 7Control of Calibrated Equipment 8Documentation 8Documentation 9Keywords 9Keywords 101.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibilityof the user of this standard to establish approp

6、riate safety safety, health, and healthenvironmental practices and determine theapplicability of regulatory limitations prior to use.1.4 This international standard was developed in accordance with internationally recognized principles on standardizationestablished in the Decision on Principles for

7、the Development of International Standards, Guides and Recommendations issuedby the World Trade Organization Technical Barriers to Trade (TBT) Committee.2. Referenced Documents2.1 ASTM Standards:2C859 Terminology Relating to Nuclear MaterialsC1009 Guide for Establishing and Maintaining a Quality Ass

8、urance Program for Analytical Laboratories Within the NuclearIndustryC1068 Guide for Qualification of Measurement Methods by a Laboratory Within the Nuclear IndustryC1128 Guide for Preparation of Working Reference Materials for Use in Analysis of Nuclear Fuel Cycle MaterialsC1210 GuideC1210 Guide fo

9、r Establishing a Measurement System Quality Control Program for Analytical ChemistryLaboratories Within the Nuclear IndustryC1215 GuideC1215 Guide for Preparing and Interpreting Precision and Bias Statements in Test Method Standards Used in theNuclear IndustryC1297 GuideC1297 Guide for Qualification

10、 of Laboratory Analysts for the Analysis of Nuclear Fuel Cycle Materials1 This guide is under the jurisdiction of ASTM Committee C26 on Nuclear Fuel Cycle and is the direct responsibility of Subcommittee C26.08 on Quality Assurance,Statistical Applications, and Reference MaterialsCurrent edition app

11、roved June 1, 2011Sept. 1, 2018. Published June 2011October 2018. Originally approved in 1990. Last previous edition approved in 20032011 asC1156 03.C1156 03 (2011). DOI: 10.1520/C1156-03R11.10.1520/C1156-18.2 For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer

12、 Service at serviceastm.org. For Annual Book of ASTM Standardsvolume information, refer to the standards Document Summary page on the ASTM website.This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the pr

13、evious version. Becauseit may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current versionof the standard as published by ASTM is to be considered the official document.Copyright ASTM

14、International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States12.2 ISO Standard:ISOISO/IEC 17025 General Requirements for the Competence of CalibrationTesting and TestingCalibration Laboratories33. Terminology3.1 For definitions of terms used in this guide but not

15、 defined herein, refer to Terminology C859.4. Significance and Use4.1 Calibration is a fundamental part of making measurements and its effect on the quality of measurement data is significant.Thus, sufficient attention must be given to calibration when it is established for a measurement method so t

16、hat the data producedwill be acceptable. The use of an inappropriate calibration standard, inadequate instructions for calibration, and poordocumentation of the calibration process are examples of circumstances that can adversely affect the validity of a calibration. Thus,the calibration process mus

17、t conform to criteria established to ensure the validity of calibration results. results and any associatedmeasurement data. Such criteria are given in Guide C1009, in which calibration is identified as a component of laboratory qualityassurance (see Fig. 1). This guide expands upon those criteria t

18、o provide more comprehensive guidance for establishing calibration.4.2 The manner of calibration and other technical requirements for calibrating a measurement method are usually establishedwhen a method is first introduced into a laboratory, which may be through validation and qualification as defi

19、ned by Guide C1068(see Fig. 1). However, calibration involves more than the technical aspects of the calibration process. The other dimension of theprocess is the operational requirements that are necessary to ensure that calibration results are valid and that they are documentedand verifiable shoul

20、d their integrity be questioned. The provisions of this guide provide those operational requirements and shouldbe considered whenever calibration is planned and established.5. General Considerations5.1 The degree of attention and effort given to calibration should depend on how the measurement data

21、are to be used. In theanalysis of nuclear materials, for example, measurement data produced for the control and accountability of nuclear material wouldnormally require more attention than data produced for process control during the processing of that material. The areas in whichthe level of attent

22、ion and effort could vary are: the calibration standard, number of calibration points, calibration acceptancecriteria, frequency of calibration, and frequency of calibration verification.5.2 Many of the provisions of this guide would not apply to the calibration of certain instruments when their cal

23、ibration is anintegral part of the analysis procedure involving a simple one- or two-step adjustment of a meter or gage. The pH meter is anexample when a buffer is used to adjustcalibrate the meter just before a pH reading is taken for a sample solution.3 Available from American National Standards I

24、nstitute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http:/www.ansi.org.FIG. 1 Quality Assurance of Analytical Laboratory DataC1156 1825.3 There are generally two approaches regarding frequency of calibration. In one case, the method is calibrated each time itis used. In the other, calibr

25、ation is established for a specified period of time, and the method must be recalibrated before that timeperiod elapses to retain calibration. When a calibration period is used, calibration verification should be used. A calibration periodmight be defined in terms of weeks or months, or defined as a

26、 run of a series of samples over a relatively short period of time.In the latter case, calibration verification could involve analyzing a standard periodically during the sample run, for example, afterevery fifth sample.5.4 Under no circumstances it is justifiable to use the results of a calibration

27、 verification to adjust a pre-existing calibration.More information regarding measurement control may be found in Guide C1210.5.5 When calibration is being planned and established, a statistician should be consulted regarding the treatment of calibrationdata, the frequency of calibration, the freque

28、ncy of calibration checks, and the criteria that determine when calibration has beenachieved (see Guide C1215 GuideC1215). This is to ensure that the calibration procedure is appropriate for the method and thatthe uncertainty estimate for the method (as determined during validation or qualification)

29、 remains valid.5.6 The organizational responsibility and authority for calibration should be defined and documented. Normally, responsibilityfor calibrating an individual method rests with the analyst using the method. If the responsibility for calibrating an instrument orclass of instruments is con

30、tracted to another organization, the laboratory is still responsible for ensuring that calibrationrequirements are being met by the organization doing the calibration.6. Calibration Procedure6.1 Calibration should be established as a written procedure. The procedure should provide instructions for t

31、hose doingper-forming the calibration, and it should document the basis for calibration, which can be used to substantiate the validity of thecalibration process, should that be required.6.2 PreparationThe calibration procedure can be prepared as a separate procedure from the one written for the mea

32、surementmethod or it can be a section of the methods procedure as long as the provisions given in 5.36.3 are addressed. If the formerapproach is used, the applicable measurement method should be clearly identified in the calibration procedure. The calibrationprocedure should be reviewed for technica

33、l adequacy and approved by the appropriate level of management. The provisionscontained in the Procedure section of Guide C1009 regarding the preparation, review, and approval of procedures should beconsidered.Also, calibration procedures should be revised, distributed, and controlled according to t

34、he provisions in the Proceduresection of Guide C1009.6.3 ContentThe following subjects should be addressed in the procedure:6.3.1 Identification of the equipment or portion of the measurement apparatus that requires calibration,6.3.2 IdentificationDescription of the calibration standard or standards

35、 that will be used and inclusion of instructions for thepreparation, pretreatment, and use of the standard(s) as appropriate;6.3.3 A statement of the required frequenciesfrequency of calibration and calibration verification as appropriate and adescription of any situations or conditions that would a

36、lter the frequencies;frequency;6.3.4 Instructions, in a step-by-step format, for performing the calibration, including applicable instructions for calculation ofthe slope of the calibration curve, preparation of a calibration curve, or other treatment of the calibration data (for example,corrections

37、 for environmental conditions) required to finalize the calibration process.6.3.5 Criteria that establish when the method or equipment needs recalibration.recalibration, for example, a specified period oftime elapsing.7. Calibration Standard7.1 Calibration standards are reference materials. A certif

38、ied reference material (CRM) is the highest level of standard in themetrological hierarchy of reference materials, followed by a working reference material (WRM). The level of reference materialis governed by the rigor, care, and overall effort put into the preparation and characterization of the ma

39、terial. Guide C1128 providesa definition of CRM and WRM and addresses the various factors that affect the quality of reference materials.7.2 SelectionThe level of a standard required for calibration depends on the requirements for the measurement data to beproduced. Selection should be based on thes

40、e requirements; for example, a CRM should not be selected when a lower levelstandard would suffice. Availability, stability, traceability to a national measurement base, and other are only some of theconsiderations that could affect selection (see Guide C1128).7.3 PreparationPreparation may vary fro

41、m making a simple dilution of a stock (master) solution to a major preparation andcharacterization effort as described in Guide C1128. In some situations, a pretreatment of the standard might be required beforeuse. Instructions for the preparation or pretreatment of the standard should be included i

42、n the calibration procedure, or at least areference to such instructions should be given. If the standard is a pre-prepared standard that requires simply taking a packagedunit for a one-time use, or if it is a physical standard (as opposed to a chemical standard) that is used repeatedly, then the so

43、urceand description of the standard should be included in the calibration procedure.C1156 1837.4 UseIf special storage or handling practices are required to protect the integrity of the standard, those practices should beprovided in the calibration procedure. Protecting the integrity of standards in

44、 terms of packaging and storage is addressed in GuideC1128.8. Control of Calibrated Equipment8.1 IdentificationEquipment requiring calibration should be uniquely identified. The identification should be marked on theequipment (for example, with tags, labels, or markings) and on related calibration r

45、ecords.8.2 Calibration StatusThere should be a process for keeping a current indication of calibration status. Status can be indicatedon the calibrated equipment with a label stating when calibration was done and when it expires. An alternative would be todocument status in the data record system us

46、ed to record calibration data and results. Those records should be readily availableto show current status.8.3 UseCalibration equipment should be used and handled in a manner to help ensure that calibration will remain valid duringthe calibration period. If there is a reason to believe that calibrat

47、ion has become invalid during the calibration period, the equipmentshould not be used until the situation has been evaluated and corrected (if necessary).8.4 Out-of-CalibrationIf a calibration time period expires, the equipment involved should be recalibrated or removed fromservice. It should not be

48、 used to generate measurement data. Any measurement data that may have been generated since the lastcalibration or verification of calibration must be considered as suspect and must not be used if objective evidence is not availableto corroborate that the data generated came from a measurement syste

49、m in control.8.5 Close-out Calibration VerificationIf a calibrated item is removed from service (due to being out of calibration, damage,replacement) and a verification of calibration has not been performed since the last measurements were taken, a verification ofcalibration must be performed to bracket the measurements performed since the last verification or calibration. If a verificationcannot be performed, all measurement data that may have been generated since the last calibration or verification must beconsidered as suspicious and must not be used if objectiv