ASTM E1323-89(2002)
(Guide)Standard Guide for Evaluating Laboratory Measurement Practices and the Statistical Analysis of the Resulting Data
Standard Guide for Evaluating Laboratory Measurement Practices and the Statistical Analysis of the Resulting Data
SIGNIFICANCE AND USE
This guide is intended to provide guidance for an assessor to evaluate measurement practices of laboratories, their protocol for statistically analyzing the resulting data from these practices, and their statistical results from these practices.
This guide is generic in the sense that it covers the entire range of in-house quality measurement practices found in a testing laboratory, but the results of the described evaluation may be used by accrediting agencies if their requirements can be satisfied through the laboratory’existing quality data.
It is not the intent of this guide to serve as sole criterion for evaluating and accrediting laboratories. It is not intended to cover the important generic guidelines for evaluating the laboratory’ quality program which can be found in Practice E 548 and Guide E 994.
SCOPE
1.1 This guide covers key elements of an evaluation of a laboratory's measurement practices and the statistical analysis of the resulting data. This guide addresses an evaluation that covers a broad range of in-house quality measurements, some of which may be directly related to accreditation requirements.
1.2 This guide describes what to look for as documentation in order to verify the operation of the practices, and what parts of the data to test and interpret in order to verify the quality of data being generated by the laboratory.
1.3 This guide does not specify or provide guidance for the establishment or assessment of a quality program. Note 1Generic guidelines dealing with elements of a quality program may be found in ANSI, A1, A3, Q1, Q2, Z34.1; ISO9000-9004; and ILAC/ISO Collected Reports 1979-1983.
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An American National Standard
Designation:E1323–89(Reapproved 2002)
Standard Guide for
Evaluating Laboratory Measurement Practices and the
Statistical Analysis of the Resulting Data
This standard is issued under the fixed designation E 1323; 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.
1. Scope ANSI Z34.1 American National Standard for
Certification—Third Party Certification Program
1.1 This guide covers key elements of an evaluation of a
2.3 ISO Standard:
laboratory’s measurement practices and the statistical analysis
ISO 9000–9004 Quality Management and Quality Assur-
of the resulting data. This guide addresses an evaluation that
ance Standards
covers a broad range of in-house quality measurements, some
2.4 Other Standard:
of which may be directly related to accreditation requirements.
ILAC/ISO Laboratory Accreditation—Principles and
1.2 This guide describes what to look for as documentation
Practice—Collected Reports 1979–1983
in order to verify the operation of the practices, and what parts
of the data to test and interpret in order to verify the quality of
3. Terminology
data being generated by the laboratory.
3.1 Terms are defined in Terminology E 1187.
1.3 This guide does not specify or provide guidance for the
3.2 Definitions of Terms Specific to This Standard:
establishment or assessment of a quality program.
3.2.1 duplicate—a separate specimen, taken from the same
NOTE 1—Generic guidelines dealing with elements of a quality pro-
source as the first specimen, tested at the same time and in the
gram may be found inANSI,A1,A3, Q1, Q2, Z34.1; ISO9000–9004; and
same manner as the first specimen. Duplicates can provide
ILAC/ISO Collected Reports 1979–1983.
pooled precision data for a homogeneous specimen, the test
method, and the test equipment.
2. Referenced Documents
3.2.2 out of control—the condition that exists when a data
2.1 ASTM Standards:
point falls outside the control limits and when retesting and
E 548 Practice for Preparation of Criteria for Use in the
3 further evaluation indicates that a problem exists in analyst
Evaluation of Testing Laboratories and Inspection Bodies
performance, the method, equipment, standardization, or cali-
E 994 Guide for Laboratory Accreditation Systems
bration.
E 1187 Terminology Relating to Laboratory Accreditation
3.2.3 replicate analysis—the same specimen tested again,
2.2 ANSI Standards:
usually at a different time. Replicate data can be used to
ANSI/ASQC A1 Definitions, Symbols, Formulas and
provide pooled precision of the test method, equipment, and
Tables for Control Charts
operator, providing the specimen is homogeneous in nature.
ANSI/ASQC A3 Quality Systems Terminology
ANSI/ASQC Q1 Generic Guidelines for Auditing of Qual-
4. Significance and Use
ity Systems
4.1 This guide is intended to provide guidance for an
ANSI/ASQC Q2 Quality Management and Quality System
assessor to evaluate measurement practices of laboratories,
Elements for Laboratories—Guidelines
their protocol for statistically analyzing the resulting data from
these practices, and their statistical results from these practices.
This guide is under the jurisdiction of ASTM Committee E11 on Quality and 4.2 This guide is generic in the sense that it covers the entire
Statistics and is the direct responsibility of Subcommittee E11.20 on Test Method
range of in-house quality measurement practices found in a
Evaluation adn Quality Control.
testing laboratory, but the results of the described evaluation
Current edition approved Dec. 29, 1989. Published February 1990.
may be used by accrediting agencies if their requirements can
ILAC/ISO LaboratoryAccreditation-Principles and Practice-Collected Reports
1979–1983. American Association for Laboratory Accreditation, 656 Quince Or-
be satisfied through the laboratory’s existing quality data.
chard Rd. #704 Gaithersburg, MD 20878
4.3 It is not the intent of this guide to serve as sole criterion
Annual Book of ASTM Standards, Vol 14.02.
4 for evaluating and accrediting laboratories. It is not intended to
Available from American National Standards Institute, 1430 Broadway, New
York, NY 10018.
cover the important generic guidelines for evaluating the
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
E1323–89 (2002)
laboratory’s quality program which can be found in Practice 6.1.2.3 The time interval for testing, or a date for each data
E 548 and Guide E 994. point if a time interval is not practical, must be noted.
6.1.2.4 Directions on how to statistically compare the labo-
5. Purpose of Evaluating Measurement Practices and the
ratory results of precision with a known statement of precision
Statistical Analysis of the Resulting Data
for that method must be clearly documented. These directions
5.1 Data generated from the measurement practices of a
must include the specific statistical test, the number of data
laboratory is evaluated to determine its capability to obtain
points used for the test and the acceptable level of precision, be
accurate and precise data and to determine if the laboratory
it known either from other studies on this specific method or as
correctly and efficiently analyzes and reacts to their own data.
a limit determined by the laboratory itself.
6.1.2.5 The method for determining if outliers exist must
6. Documentation of Measurement Practices and the
also be documented, stating when it is acceptable to ignore
Statistical Protocol for Analyzing the Resulting Data
such data points when computing control limits.
6.1 The following documentation shall contain the informa-
6.1.2.6 The method for determining if bias exists and the
tion necessary for someone to carry out the same steps
frequency for continued checks on the instrument or method
involved in generating, charting, and reporting the data.
having a bias must be recorded, including any adjustments
6.1.1 Documentation Relative to Calibration:
made to test data as a result of the bias determined from these
6.1.1.1 The material to be measured must be documented
measurements.
together with its source, expiration or shelf-life date, the
6.1.2.7 Atable of actual values and the corresponding dates
accuracy and its source, and any preparations or conditions
must be kept.
required which are specific to this material before it can be
6.1.3 Documentation Relative to Operator Precision and
utilized as a calibration material. Any additional components,
Accuracy:
reagents, or physical sources used along with this material
6.1.3.1 The material, methods, and equipment used to de-
which could potentially alter the reliability of the material must
termine levels of precision and accuracy of operators must be
also be documented.
documented.
6.1.1.2 The identification of the equipment used, together
6.1.3.2 The source of stated accuracy of the material, the
with the date and operator responsible for the run, and any
current precision and accuracy of the equipment, and the
preparations involved with the calibration run must be docu-
current precision and bias of the method must be documented,
mented.
together with the exact computations used to determine the
6.1.1.3 The type of data representation to be used, including
single or group operator prec
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