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Quality control in laboratories -- Applying statistical quality assurance and control charting techniques to evaluate analytical measurement system performance
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GB/T 27407-2010
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Basic data | Standard ID | GB/T 27407-2010 (GB/T27407-2010) | | Description (Translated English) | Quality control in laboratories -- Applying statistical quality assurance and control charting techniques to evaluate analytical measurement system performance | | Sector / Industry | National Standard (Recommended) | | Classification of Chinese Standard | A41 | | Classification of International Standard | 03.120.30 | | Word Count Estimation | 36,376 | | Date of Issue | 2011-01-14 | | Date of Implementation | 2011-07-01 | | Quoted Standard | GB/T 3358.2-2009; GB/T 4889; GB/T 15000.3-2008; GB/T 15483.1; GB/T 19000; GB/T 27025; GB/T 27408 | | Adopted Standard | ASTM D6299-2008, MOD | | Regulation (derived from) | Announcement of Newly Approved National Standards No. 2, 2011 (No. 167 overall) | | Issuing agency(ies) | General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, Standardization Administration of the People's Republic of China | | Summary | This standard specifies: Statistical quality control procedures design and operation plan, analysis for continuous monitoring of the test measurement system stability, precision and bias performance. This standard applies to measurements under homogeneous and stable materials to produce a continuous numerical results stable measurement systems, laboratory test methods measure the same characteristics by GB/T 27408 bias between the two measuring systems amended difference monitoring. The standard for measuring system performance in a controlled state statistics normality assumption model to describe and predict. |
GB/T 27407-2010: Quality control in laboratories -- Applying statistical quality assurance and control charting techniques to evaluate analytical measurement system performance ---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Quality control in laboratories. Applying statistical quality assurance and control charting techniques to evaluate analytical measurement system performance
ICS 03.120.30
A41
National Standards of People's Republic of China
Laboratory Quality Control
The use of statistical quality assurance and control chart
Performance Evaluation and Analysis Measurement System
Issued on. 2011-01-14
2011-07-01 implementation
Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China
Standardization Administration of China released
Table of Contents
Introduction Ⅲ
1 Scope 1
2 Normative references 1
3 Terms, definitions and symbols 1
4 standard sample 5
4.1 precision measurement system to establish and monitor the quality control sample using 5
4.2 Verification standard sample measurement system accuracy using 5
4.3 Measuring system verification audit confirmed using 5 samples
5 single analytical measurement systems quality assurance (QA) program 6
5.1 Overview 6
Quality control samples measuring 5.2 system stability and precision monitoring test 6
5.3 Accuracy monitor 6
5.4 The test conditions and the frequency 6
5.5 measurement system precision and bias performance evaluation 6
7 5.6 Proficiency Testing
5.7 Measurement system independent confirmation 7
6 test results pretreatment evaluation and interpretation 7
6.1 Overview 7
Pretreatment of test results 7 6.2
6.3 Control 8
The initial results of the assessment 6.4 8
9 6.5 Control Chart explanation
Figure 6.6 Control parameters --- regularly update the program 19
Figure 6.7 Control parameters --- regularly update the program 29
7 measuring system performance assessment 10 Precision and Bias
7.1 Quality control samples tested intermediate precision estimate 10
7.2 single verification standard samples of several tests measuring system biased estimate 10
More than 7.3 standard verification test sample measuring system biased estimate 10
8 measure system performance estimates Ack audit sample use 11
Appendix A (normative appendix) SQC Technology 12
Appendix B (normative) Statistical Table 28 value
References 32
Foreword
This revised standard adopts ASTMD6299.2008 "statistical quality assurance and control chart analysis evaluated the performance measurement system."
(Standardpracticeforapplyingstatisticalqualityassuranceandcontrolchartingtechniquestoevaluate
analyticalmeasurementsystemperformance).
Taking into account China's actual test and application, adopting ASTM D6299.2008, this standard and made editorial changes
Adjustment.
The Standard Annexes A and B are normative appendix.
This standard is recognized by the National Standardization Technical Committee and centralized authentication.
This standard was drafted. People's Republic of China Liaoning Province Exit Inspection and Quarantine, China Quality Certification Center, People's Republic of China Mountain
East Entry-Exit Inspection and Quarantine of Jilin People's Republic of China, People's Republic of China Guangdong Entry-Exit Inspection and Quarantine
Bureau, the Shenzhen People's Republic of China Entry-Exit Inspection and Quarantine Bureau, Dalian University of Technology School of Mathematical Sciences.
The main drafters of this standard. Wang Wen bucket, cattle Xingrong, Chen Shan, Li Jie, Zhou Xiao, Zhong Zhiguang, director husband silver, right Xing, Wang, Li, Yang Xue,
Song Lixin, Wang Hui.
Laboratory Quality Control
The use of statistical quality assurance and control chart
Performance Evaluation and Analysis Measurement System
1 Scope
This standard provides the statistical quality control program design and operation of the program for stability analysis of continuous monitoring under test measurement system, fine
Density and performance bias.
This standard applies to uniform and stable materials to produce a continuous measurement of stable numerical results measurement systems, laboratory test methods, the same special
Under the measure by GB/T 27408 bias after correction between the two measurement systems to monitor the difference.
This standard applies to measure system performance in a state of statistical control under the assumption of normality models to describe and predict.
2 Normative references
The following documents contain provisions which, through reference in this standard and become the standard terms. For dated references, subsequent
Amendments (not including errata content) or revisions do not apply to this standard, however, encourage the parties to the agreement are based on research
Whether the latest versions of these documents. For undated reference documents, the latest versions apply to this standard.
GB/T 3358.2-2009 Statistics Vocabulary and symbols - Part 2. Applied Statistics
GB/T 4889 Statistical processing and interpretation of the normal distribution with mean and variance estimation test
General principles and statistical methods GB/T 15000.3-2008 standard samples for the work (3) standard sample set value
GB/T 15483.1 ability to use inter-laboratory comparison of verification - Part 1. Development and operation of proficiency testing schemes
GB/T 19000 Quality management systems Fundamentals and vocabulary
GB/T 27025 testing and calibration laboratories General requirements
Evaluation of the effectiveness of the linear relationship between the GB/T 27408 laboratory quality control of non-standard test method
3 Terms, definitions and symbols
GB/T 3358.2, GB/T 15000.3 and GB/T 15483.1 established in the following terms, definitions and symbols apply to this
standard.
3.1 Terms
3.1.1
Accepted reference value acceptedreferencevalue; ARV
Standard values \u200b\u200bfor comparison after consultation agreed.
NOTE. Accept a reference value derived from.
a) based on scientific principles or theoretical values \u200b\u200bdetermined value;
b) certification based on the specified value or values \u200b\u200bof the experimental work of some national or international organization;
c) based on scientific or engineering organizations agree experimental work under the auspices of the value or the value of certification;
d) when a) b) c) can not be obtained, then use the expected value, which specifies the set of measurements mean.
[Quoted from GB/T 3358.2-2009]
3.1.2
Accuracy accuracy
Test results or measurement results and the degree of consistency between the true value.
Note 1. In practice, the true value with the accepted reference value instead.
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