ASTM E1323-89(1994)e1

Standard Guide for Evaluating Laboratory Measurement Practices and the Statistical Analysis of the Resulting Data

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-Generic 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.

General Information

• Status: Historical
• Publication Date: 31-Dec-1993
• Technical Committee: E36 - Accreditation & Certification
• Drafting Committee: E36.60 - Accreditation Bodies

Relations

• Replaced By: ASTM E1323-89(2002) - Standard Guide for Evaluating Laboratory Measurement Practices and the Statistical Analysis of the Resulting Data
• Effective Date: 29-Dec-1989
• Referred By: ASTM D6792-23a - Standard Practice for Quality Management Systems in Petroleum Products, Liquid Fuels, and Lubricants Testing Laboratories
• Effective Date: 01-Jan-1994
• Referred By: ASTM G158-98(2021) - Standard Guide for Three Methods of Assessing Buried Steel Tanks
• Effective Date: 01-Jan-1994
• Referred By: ASTM C1592/C1592M-21 - Standard Guide for Making Quality Nondestructive Assay Measurements
• Effective Date: 01-Jan-1994
• Referred By: ASTM E2677-20 - Standard Test Method for Estimating Limits of Detection in Trace Detectors for Explosives and Drugs of Interest
• Effective Date: 01-Jan-1994
• Referred By: ASTM C1021-08(2023) - Standard Practice for Laboratories Engaged in Testing of Building Sealants
• Effective Date: 01-Jan-1994

Standards Content (Sample)

NOTICE: This standard has either been superceded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for the latest information.
e1
Designation: E 1323 – 89 (Reapproved 1994) An American National Standard
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.
e NOTE—Section 9 on Keywords was added editorially July 1994.
1. Scope Certification—Third Party Certification Program
2.3 ISO Standard:
1.1 This guide covers key elements of an evaluation of a
ISO 9000–9004 Quality Management and Quality Assur-
laboratory’s measurement practices and the statistical analysis
ance Standards
of the resulting data. This guide addresses an evaluation that
2.4 Other Standard:
covers a broad range of in-house quality measurements, some
ILAC/ISO Laboratory Accreditation—Principles and
of which may be directly related to accreditation requirements.
Practice—Collected Reports 1979–1983
1.2 This guide describes what to look for as documentation
in order to verify the operation of the practices, and what parts
3. Terminology
of the data to test and interpret in order to verify the quality of
3.1 Terms are defined in Terminology E 1187.
data being generated by the laboratory.
3.2 Definitions of Terms Specific to This Standard:
1.3 This guide does not specify or provide guidance for the
3.2.1 duplicate—a separate specimen, taken from the same
establishment or assessment of a quality program.
source as the first specimen, tested at the same time and in the
NOTE 1—Generic guidelines dealing with elements of a quality pro-
same manner as the first specimen. Duplicates can provide
gram may be found in ANSI, A1, A3, Q1, Q2, Z34.1; ISO9000–9004; and
pooled precision data for a homogeneous specimen, the test
ILAC/ISO Collected Reports 1979–1983.
method, and the test equipment.
3.2.2 out of control—the condition that exists when a data
2. Referenced Documents
point falls outside the control limits and when retesting and
2.1 ASTM Standards:
further evaluation indicates that a problem exists in analyst
E 548 Practice for Preparation of Criteria for Use in the
3 performance, the method, equipment, standardization, or cali-
Evaluation of Testing Laboratories and Inspection Bodies
bration.
E 994 Guide for Laboratory Accreditation Systems
3 3.2.3 replicate analysis—the same specimen tested again,
E 1187 Terminology Relating to Laboratory Accreditation
usually at a different time. Replicate data can be used to
2.2 ANSI Standards:
provide pooled precision of the test method, equipment, and
ANSI/ASQC A1 Definitions, Symbols, Formulas and
operator, providing the specimen is homogeneous in nature.
Tables for Control Charts
ANSI/ASQC A3 Quality Systems Terminology
4. Significance and Use
ANSI/ASQC Q1 Generic Guidelines for Auditing of Qual-
4.1 This guide is intended to provide guidance for an
ity Systems
assessor to evaluate measurement practices of laboratories,
ANSI/ASQC Q2 Quality Management and Quality System
their protocol for statistically analyzing the resulting data from
Elements for Laboratories—Guidelines
these practices, and their statistical results from these practices.
ANSI Z34.1 American National Standard for
4.2 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
This guide is under the jurisdiction of ASTM Committee E-36 on Criteria for
the Evaluation of Testing and Inspection Agencies and is the direct responsibility of may be used by accrediting agencies if their requirements can
Subcommittee E36.60 on Laboratory Accreditation Operations.
be satisfied through the laboratory’s existing quality data.
Current edition approved Dec. 29, 1989. Published February 1990.
4.3 It is not the intent of this guide to serve as sole criterion
ILAC/ISO Laboratory Accreditation-Principles and Practice-Collected Reports
for evaluating and accrediting laboratories. It is not intended to
1979–1983. American Association for Laboratory Accreditation, 656 Quince Or-
chard Rd. #704 Gaithersburg, MD 20878
cover the important generic guidelines for evaluating the
Annual Book of ASTM Standards, Vol 14.02.
laboratory’s quality program which can be found in Practice
Available from American National Standards Institute, 1430 Broadway, New
E 548 and Guide E 994.
York, NY 10018.
Copyright © ASTM, 100 Barr Harbor Drive, West Conshohocken, PA 19428-2959, United States.
NOTICE: This standard has either been superceded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for the latest information.
E 1323
5. Purpose of Evaluating Measurement Practices and the must include the specific statistical test, the number of data
Statistical Analysis of the Resulting Data points used for the test and the acceptable level of precision, be
it known either from other studies on this specific method or as
5.1 Data generated from the measurement practices of a
a limit determined by the laboratory itself.
laboratory is evaluated to determine its capability to obtain
6.1.2.5 The method for determining if outliers exist must
accurate and precise data and to determine if the laboratory
also be documented, stating when it is acceptable to ignore
correctly and efficiently analyzes and reacts to their own data.
such data points when computing control limits.
6.1.2.6 The method for determining if bias exists and the
6. Documentation of Measurement Practices and the
frequency for continued checks on the instrument or method
Statistical Protocol for Analyzing the Resulting Data
having a bias must be recorded, including any adjustments
6.1 The following documentation shall contain the informa-
made to test data as a result of the bias determined from these
tion necessary for someone to carry out the same steps
measurements.
involved in generating, charting, and reporting the data.
6.1.2.7 A table of actual values and the corresponding dates
6.1.1 Documentation Relative to Calibration:
must be kept.
6.1.1.1 The material to be measured must be documented
6.1.3 Documentation Relative to Operator Precision and
together with its source, expiration or shelf-life date, the
Accuracy:
accuracy and its source, and any preparations or conditions
6.1.3.1 The material, methods, and equipment used to de-
required which are specific to this material before it can be
termine levels of precision and accuracy of operators must be
utilized as a calibration material. Any additional components,
documented.
reagents, or physical sources used along with this material
6.1.3.2 The source of stated accuracy of the material, the
which could potentially alter the reliability of the material must
current precision and accuracy of the equipment, and the
also be documented.
current precision and bias of the method must be documented,
6.1.1.2 The identification of the equipment used, together
together with the exact computations used to determine the
with the date and operator responsible for the run, and any
single or group operator precision, accuracy, or both.
preparations involved with the calibration run must be docu-
6.1.3.3 The number of data points generated per operator for
mented.
this comparison test as well as the type (duplicate, replicate or
6.1.1.3 The type of data representation to be used, including
single) and description of the type of runs being made. It must
the exact number of data points to be used in the computation
be clearly st
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