ASTM C1210-96e1
(Guide)Standard Guide for Establishing a Measurement System Quality Control Program for Analytical Chemistry Laboratories Within the Nuclear Industry (Withdrawn 2005)
Standard Guide for Establishing a Measurement System Quality Control Program for Analytical Chemistry Laboratories Within the Nuclear Industry (Withdrawn 2005)
SCOPE
1.1 This standard provides guidance for establishing and maintaining a measurement system quality control program. Guidance is provided for general program considerations, preparation of quality control samples, analysis of quality control samples, quality control data analysis, analyst qualification, measurement system calibration, measurement method qualification, and measurement system maintenance.
WITHDRAWN RATIONALE
This standard provides guidance for establishing and maintaining a measurement system quality control program.
Formerly under the jurisdiction of ASTM Committee C26 on Nuclear Fuel Cycle, this guide was withdrawn in May 2005 in accordance with the Regulations Governing ASTM Technical Committees, which requires that standards shall be updated by the end of the eighth year since the last approval date.
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e1
Designation: C 1210 – 96
Standard Guide for
Establishing a Measurement System Quality Control
Program for Analytical Chemistry Laboratories Within the
Nuclear Industry
This standard is issued under the fixed designation C 1210; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (e) indicates an editorial change since the last revision or reapproval.
e NOTE—Editorial changes were made throughout in March 1997.
1. Scope C 1297 Guide for Laboratory Analysts for the Analysis of
Nuclear Fuel Cycle Materials
1.1 This standard provides guidance for establishing and
2.2 ISO Standard:
maintaining a measurement system quality control program.
ISO Guide 30 Terms and Definitions Used in Connection
Guidance is provided for general program considerations,
with Reference Materials
preparation of quality control samples, analysis of quality
2.3 ANSI Standards:
control samples, quality control data analysis, analyst qualifi-
ANSI/ASQC B1 Guide for Quality Control Charts
cation, measurement system calibration, measurement method
ANSI/ASQC B2 Control Chart Method of Analyzing Data
qualification, and measurement system maintenance.
ANSI/ASQC B3 Control Chart Method of Controlling
1.2 This guidance is provided in the following sections:
Quality During Production
Section
General Quality Control Program Considerations 5
3. Terminology
Quality Control Samples 6
Analysis of Quality Control Samples 7
3.1 Definitions of Terms Specific to This Standard:
Quality Control DataAnalysis 8
3.1.1 calibration—the determination of the values of the
Analyst Qualification 9
Measurement System Calibration 10
significant parameters by comparison with values indicated by
Measurement Method Qualification 11
a reference instrument or by a set of reference standards.
Measurement System Maintenance 12
3.1.2 calibration curve—the graphical or mathematical rep-
2. Referenced Documents
resentationofarelationshipbetweenameasuredparameterand
a property of the standard for the substance under consider-
2.1 ASTM Standards:
ation.
C 859 Terminology Relating to Nuclear Materials
3.1.3 calibration factor—the slope of the calibration curve,
C 986 Guide for Developing Training Programs in the
or its inverse for a linear calibration curve.
Nuclear Fuel Cycle
3.1.4 calibration standard—any of the standards of various
C 1009 Guide for Establishing a Quality Assurance Pro-
types having accepted values for parameters of interest.
gram for Analytical Chemistry Laboratories Within the
3.1.4.1 Discussion—The calibration standard may be used
Nuclear Industry
to adjust the sensitivity of test instruments at some predeter-
C 1068 Guide for Qualification of Measurement Methods
mined level and for periodic checks of the sensitivity.
by a Laboratory Within the Nuclear Industry
3.1.5 calibration verification—the action taken to verify the
C 1128 Guide for Preparation of Working Reference Mate-
continued validity of calibration during a time period between
rials for Use in the Analysis of Nuclear Fuel Cycle
calibrations.
Materials
3.1.5.1 Discussion—Verification involves less rigor and ef-
C 1156 Guide for Establishing Calibration for a Measure-
fort than full calibration and involves analyzing a standard at a
ment Method Used to Analyze Nuclear Fuel Cycle Mate-
specified frequency during the calibration period. Verification
rials
couldinvolveusingastandardthatislowerthanthecalibration
standard in the metrological hierarchy of standards.
3.1.6 certified reference material (CRM)—a reference ma-
This guide is under the jurisdiction ofASTM Committee C-26 on Nuclear Fuel
terial one or more of whose property values are certified by a
CycleandisthedirectresponsibilityofSubcommitteeC26.08onQualityAssurance
Applications.
Current edition approved Dec. 10, 1996. Published February 1997. Originally
published as C 1210 – 91. Last previous edition C 1210 – 91. Available from American National Standards Institute, 11 West 42nd Street,
Annual Book of ASTM Standards, Vol 12.01. 13th Floor, New York, NY 10036.
Copyright ©ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA19428-2959, United States.
C 1210
technically valid procedure, accompanied by or traceable to a
certificate or other documentation which is issued by a certi-
fying body (see ISO Guide 30).
3.1.6.1 Discussion—Acertifying body is a technically com-
petent body (organization or firm, public or private) that issues
a reference material certificate (see ISO Guide 30). Such an
organization could be the National Institute of Standards and
Technology (NIST) or the New Brunswick Laboratory.
3.1.6.2 Discussion—A reference material certificate is a
document certifying one or more property values for a certified
reference material, stating that the necessary procedures have
been carried out to establish their validity (see ISO Guide 30).
3.1.7 quality control sample—any sample used to verify or
monitor measurement system performance.
3.1.8 reference material (RM)—a material or substance one
or more properties of which are sufficiently well established to
be used for the calibration of an apparatus, the assessment of a
measurement method, or for assigning values to materials (see
ISO Guide 30).
3.1.8.1 Discussion—A reference material may also be re-
ferred to in this guide as a standard (for example, calibration
standard or control standard).
FIG. 1 Quality Assurance of Analytical Laboratory Data
3.1.9 working reference material (WRM)—a RM usually
prepared by a single laboratory for its own use as a calibration
(5) analyst qualification, and (6) other general program con-
standard, as a control standard, or for the qualification of a
siderations.Otherelementsoflaboratoryqualityassurancealso
measurement method (see Guide C 1068).
impact the laboratory quality control program. These elements
3.1.9.1 Discussion—Working reference material replaces
or requirements include (1) chemical analysis procedures and
the definitions for secondary standard and working standard.
procedure control, (2) records storage and retrieval require-
4. Significance and Use
ments, (3) internal audit requirements, (4) organizational con-
siderations, and (5) training/qualification requirements. To the
4.1 A laboratory quality assurance program is an essential
program for laboratories within the nuclear industry. Guide extent possible, this standard will deal primarily with quality
control requirements rather than overall quality assurance
C 1009 provides guidance for establishing a quality assurance
program for an analytical laboratory within the nuclear indus- requirements.
try. The basic elements of a laboratory quality assurance
5. General Quality Control Program Considerations
program are organization, quality assurance program, training
and qualification, procedures, laboratory records, control of 5.1 The quality control activities described in this guide are
records, control of procurement, control of measuring equip- intended for a quality control function which is internal to an
ment and materials, control of measurements, and deficiencies analytical chemistry laboratory. The quality control program
and corrective actions. This guide deals with the control of should have an administrator or manager working in concert
measurements aspect of the laboratory quality assurance pro- with laboratory managers to produce cost effective measure-
gram. Fig. 1 shows the relationship of measurement control ments of demonstrated quality. The program manager should
have the authority based on quality control sample perfor-
with other essential aspects of a laboratory quality assurance
program. mance to disqualify analysts or measurement systems, or to
request or require additional quality control sample analyses. It
4.2 The fundamental purposes of a measurement control
program are to provide the with use assurance (real-time is desirable for the quality control program to have periodic
control)thatameasurementsystemisperformingsatisfactorily internal assessments. These assessments should involve labo-
and to provide the data necessary to quantify measurement ratory managers, the quality control manager, and laboratory
system performance. The with use assurance is usually pro- customers. The quality control program should be audited for
vided through the satisfactory analysis of quality control procedure compliance at periodic intervals by the quality
samples (reference value either known or unknown to the assurance organization.
analyst). The data necessary to quantify measurement system 5.2 The analytical laboratories quality control program
performanceisusuallyprovidedthroughtheanalysisofquality should be described in laboratory procedures and all measure-
controlsamplesortheduplicateanalysisofprocesssamples,or ment system quality control activities should be documented.
both. In addition to the analyses of quality control samples, the Theretentionperiodforthedocumentationshouldbedescribed
laboratory quality control program should address (1) the in laboratory procedures and should be consistent with other
preparation and verification of standards and reagents, (2) data laboratory storage requirements.
analysis procedures and documentation, (3) calibration and 5.3 External quality control program assessment should be
calibration procedures, (4) measurement method qualification, conducted by an outside organization or agency at a frequency
C 1210
dictated by company or facility policy, contract, or other with a CRM (2) the direct use of a CRM as the quantifying
applicable regulations or requirements. When possible, labo- reactant (oxidant/reductant, acid/base, etc.), or (3) the use of a
ratory and quality control management should involve labora- quantifying reactant which is traceable to the certifying body.
tory measurement systems in external exchange programs, When required, a measurement process tested in traceability
such as: interlaboratory exchange programs, sample exchange exercises conducted by a higher level metrology laboratory
programs, sample or standard round robins, and referee analy- shall be used.
ses programs. The programs provide some degree of external 6.7 All quality control samples and stock solutions should
verification or validation of the measurement system quality be labeled with (1) the concentration, activity, abundance, etc.
control program that is desirable. of the species of interest, (2) solvent if other than water, (3)
matrix, (4) date prepared, (5) identification of preparer, and (6)
6. Quality Control Samples
storage requirements or limitations, if any, or coded in such a
6.1 Quality control samples (knowns, unknowns, blinds,
manner as to uniquely identify this same information.
blanks, etc.) are used to verify and monitor measurement
6.8 AllincomingchemicalsandRMsshouldbelabeledwith
system performance. Quality control samples should be pre-
a shelf life, acceptance date, or expiration date, if applicable.
pared or purchased over the measurement range of interest and
7. Analysis of Quality Control Samples
have an impurity content and matrix composition that approxi-
matestheprocesssamples,unlessthemeasurementmethodhas 7.1 The analysis of data from quality control samples
been shown to be free from sample matrix effects. Quality provides a demonstration of measurement system performance
control sample preparation procedures, specific requirements and provides the information necessary to quantify that perfor-
(purity of source materials and solvents; storage requirement; mance over the portion of the system covered by the quality
shelf life; etc.), and the preparation should be documented. control samples. The reference value of the quality control
Quality control samples may be prepared from the following: samples may be either known or unknown to the analyst.
CRMs, WRMs, RMs, pure elements or compounds with 7.1.1 The analysis of known quality control samples can
vendor supplied assay, reagent grade (or better) chemicals with provide a satisfactory bench demonstration of whether a
assay, and process materials. Guidance on the preparation of system is in- or out-of-control without the need for a computer
WRMs for use in the analysis of nuclear fuel cycle materials is based quality control program. In general, the data resulting
provided in Guide C 1128. from the analysis of known quality control samples is not
6.2 When quality control samples or quality control sample recommended for quantifying measurement system perfor-
stock solutions are prepared from CRMs, RMs, WRMs, pure mance.
elements or compounds with vendor supplied assay, or reagent 7.1.2 In general, the analysis of unknown quality control
grade (or better) chemicals with assay, records of the prepara- samples provides the data necessary to quantify measurement
tion procedure and sufficient data (mass, volume, etc.) should system performance. The data resulting from the analysis of
be maintained to demonstrate that the reference value of the unknown quality control samples may also be used to provide
source material was successfully transferred to the standard. the with use assurance of method performance, but some form
Further, a chemical analysis should be performed to verify that of computer based system would be required in order to
the preparation was successful. provide the real-time, at-bench determination of system per-
6.3 The solution should be characterized to establish its formance. The use of unknown quality control samples for
referencevaluewhenqualitycontrolsamplesorqualitycontrol both functions can significantly increase the amount of data
sample stock solutions are prepared from materials with available to model measurement systems.
uncertain assays, or from process material, or when a smaller 7.2 The frequency of analysis of quality control samples
uncertainty is required on the solution than can be obtained should be determined and described in laboratory procedures.
from the source materials. A record of the preparation proce- The frequency can range from once per batch, once per
dure and data should be maintained. The characterization instrument setup, or once per day per analyst to any frequency
method or procedure, complete with calibration data and the consistent with the stability of the measurement system and the
characterization analysis results, should be referenced or in- risk of performing erroneous determinations between quality
cluded in the preparation data. control sample analyses.
6.4 When quality control RMs cannot be prepared and 7.3 Quality control samples should be subjec
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