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GB/T 32464-2015: Internal quality control for chemical analysis laboratories applying control graphic -- Audit analytical system
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Internal quality control for chemical analysis laboratories applying control graphic -- Audit analytical system
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GB/T 32464-2015
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Basic data | Standard ID | GB/T 32464-2015 (GB/T32464-2015) | | Description (Translated English) | Internal quality control for chemical analysis laboratories applying control graphic -- Audit analytical system | | Sector / Industry | National Standard (Recommended) | | Classification of Chinese Standard | A00 | | Classification of International Standard | 03.120.10 | | Word Count Estimation | 48,427 | | Date of Issue | 2015-12-31 | | Date of Implementation | 2016-07-01 | | Quoted Standard | GB/T 3358.1-2009; GB/T 3358.2-2009; GB/T 3358.3-2009; GB/T 3361-1982; GB/T 4882-2001; GB/T 4883-2008; GB/T 6379.1-2004; GB/T 14666-2003; GB/T 15000.2-1994; GB/T 19000-2008; GB/T 27000-2006; GB/T 27407-2010; GB/T 32465-2015; GB/T 32467-2015; ISO 11843-1-2008 | | Regulation (derived from) | State Standard Announcement 2015 No.43 | | 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 the general principles, control chart types and application scope of the control chart verification analysis system used by the chemical analysis laboratory, sets the control limits, preprocessing of the basic data, working procedures of the control chart verification and analysis system, , To control the quality control data for other purposes. | GB/T 32464-2015: Internal quality control for chemical analysis laboratories applying control graphic -- Audit analytical system
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Internal quality control for chemical analysis laboratories applied control graphic.Audit analytical system
ICS 03.120.10
A00
National Standards of People's Republic of China
Chemical analysis laboratory internal quality control
Use the control chart to verify the analysis system
2015-12-31 released
2016-07-01 implementation
General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China
China National Standardization Management Committee released
Directory
Preface III
Introduction IV
1 Scope 1
2 normative reference document 1
3 Terms and definitions 1
4 acronyms and symbols
5 quality requirements of test results 2
6 General principles for using the control chart verification analysis system
7 control chart type and its scope of application 3
7.1 X Control Figure 3
7.2 I Control Figure 4
7.3 R control Figure 4
7.4 MR control Figure 4
7.5 Index Weighted Moving Average (EWMA) Control Figure 4
8 Set the control limit 4
8.1 Control limits and setting principles 4
8.2 Control limit and center line setting method of X control chart 5
8.3 Control limits and centerline of the very poor control chart (R control chart) or r% control chart
8.4 Control limit setting for multi-component detection 6
Basic Data Preprocessing 6
9.1 General requirements 6
9.2 Normality test 6
9.3 judgment and processing of outliers
Use the control chart to verify the working procedures of the analysis system
Use of Control Charts
11.1 Initial control chart
11.2 Recording Procedure 8
11.3 Control Chart Use 8
11.4 Verification Control Chart Quality 8
11.5 Control limits and centerline assessment and modification 9
11.6 record 9
11.7 Control chart parameter merging 9
12 Other uses of quality control data in the control chart 9
12.1 Uncertainty in measurement of assessment methods 9
Supplement to Method Validation and Confirmation
Method Comparison
12.4 Personnel comparison or assessment 10
12.5 Inspection of environmental parameters and similar parameters 10
Appendix A (informative) According to the EU countries to determine the reproducibility of total nitrogen in wastewater treatment, the laboratory's sRw
(Target control limit determination example) 11
Appendix B (Informative Annex) Example of Control Chart Establishment and Application
Appendix C (informative) Control limits and centerline setting examples 37
Appendix D (Informative Annex) Statistical Analysis Critical Value Table 38
Appendix E (informative) Establishment of an ICP system for the detection of Cd in fresh water.
Reference 42
Foreword
This standard is drafted in accordance with the rules given in GB/T 1.1-2009.
This standard is proposed and centralized by the National Standardization Technical Committee for Quality Supervision and Testing of Key Products (SAC/TC374).
The standard drafting unit. Sichuan Province Product Quality Supervision, Inspection and Testing Institute, in the inspection Warner (Beijing) Quality Technology Center Co., Ltd., Luzhou
(Beijing) Quality Inspection Technology Research Institute Co., Ltd., Sichuan Province Food and Drug Inspection Institute, Guangyuan City, the quality of products
Quality Supervision and Inspection Institute, Chengdu Hong billion Industrial Group Co., Ltd.
The main drafters of this standard. Zheng Weidong, Li Wei, Yin Jianjun, Hu Dan, Zhang Xi Cui, Cheng Guihong, Wang Ming, Fan Zhigang, Zhang Shanyi.
Introduction
This standard is a chemical analysis laboratory test method validation and internal quality control (InternalQualityControl, IQC) series
One of the standards. It is recommended that the Chemical Analysis Laboratory use this standard and other criteria in the standard.
One of the core elements of internal quality control in laboratory analysis is the establishment of an analytical method and working procedure for laboratory use
A review of the continuous evaluation system. This continuous evaluation system covers the entire process of entering the laboratory from the sample to report the results of the test,
To ensure that the accuracy of the data issued by the laboratory continues to meet an acceptable level, or to meet customer requirements for the quality of the test results. Make
Using the control chart to verify the analysis system is one of the most effective ways.
In addition to achieving the above objectives, the control chart can be used to supplement the method validation and validation (method of dispersion, bias, base
Quality effects, robustness), personnel comparison or assessment, environmental parameters and similar parameters of the inspection. This content is described in this standard.
The main contents of the standard include the quality requirements of the test results, the general principles of the control chart verification and analysis system, the type of control charts and their transport
With the scope, set the control limit, the basic data preprocessing, the use of control chart verification analysis system work procedures, control chart use, control chart
Other uses of quality control data, and five informative appendices.
Chemical analysis laboratory internal quality control
Use the control chart to verify the analysis system
1 Scope
This standard specifies the general principles of the use of the control chart verification analysis system for chemical analysis laboratories, the type of control charts and their application
Fixed control limit, the basic data preprocessing, the use of control chart verification and analysis system of the working procedures, the use of control charts, control the number of quality control
According to other uses.
Note. The laboratories referred to in this standard refer to chemical analysis laboratories.
2 normative reference documents
The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this article
Pieces. For undated references, the latest edition (including all modifications) applies to this document.
GB/T 3358.1-2009 Statistical terms and symbols - Part 1. General statistical terms and terms for probabilities
Statistical vocabulary and symbols - Part 2. Application statistics GB/T 3358.2
Statistical vocabulary and symbols - Part 3. Experimental design GB/T 3358.3
GB/T 3361-1982 Statistical processing and interpretation of data Comparison of two mean values in paired observations
Statistical processing and interpretation of data GB/T 4882-2001 Verification of normality
Statistical processing and interpretation of data GB/T 4883-2008 Judgment and processing of outliers of normal samples
GB/T 6379.1-2004 Accuracy (accuracy and precision) of measurement methods and results - Part 1. General and definitions
Analytical chemistry terms GB/T 14666-2003
GB/T 15000.2-1994 Working Guidelines for Standard Samples (2) Terms and Definitions for Standard Samples
Quality management systems - Fundamentals and terminology GB/T 19000-2008
Conformity assessment vocabulary and general principles GB/T 27000-2006
GB/T 27407-2010 Laboratory Quality Control Using Statistical Quality Assurance and Control Charts Technical Evaluation Analysis Measurement Systems
performance
GB/T 32465-2015 Chemical analysis methods - Validation and internal quality control requirements
GB/T 32467-2015 Chemical analysis methods Verification and internal quality control Terms and definitions
ISO 11843-1..2008 Testing Capability - Part 1. Terms and definitions
3 terms and definitions
GB/T 3358.1-2009, GB/T 3358.2-2009, GB/T 3358.3-2009, GB/T 6379.1-2004, GB/T 14666-
2003, GB/T 15000.2-1994, GB/T 19000-2008, GB/T 27000-2006, GB/T 32467-2015, ISO 11843-1.
The terms and definitions defined in.2008 apply to this document.
4 acronyms and symbols
This standard uses the abbreviations and symbols in Table 1.
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