RB/T 031-2020 English PDF

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RB/T 031-2020: Guidance on the selection, review and use of proficiency testing
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Basic data

Standard ID: RB/T 031-2020 (RB/T031-2020)
Description (Translated English): Guidance on the selection, review and use of proficiency testing
Sector / Industry: Chinese Industry Standard (Recommended)
Classification of Chinese Standard: A00
Classification of International Standard: 03.120.20
Word Count Estimation: 41,472
Date of Issue: 2020-08-26
Date of Implementation: 2020-12-01
Quoted Standard: GB/T 27043-2012; ISO 13528
Regulation (derived from): National Certification and Accreditation Administration Announcement No. 21 of 2020
Issuing agency(ies): National Certification and Accreditation Administration
Summary: This standard applies to proficiency testing participants and stakeholders (such as management departments or customers of laboratories) to select, verify and use proficiency testing results, and can also provide guidance for laboratories to carry out quality control.

RB/T 031-2020: Guidance on the selection, review and use of proficiency testing

---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.
Guidance on the selection, review and use of proficiency testing ICS 03:120:20 A00 The People's Republic of China Certification and Accreditation Industry Standard The choice of proficiency testing plan and Guidelines for the use of verification and results 2020-08-26 released 2020-12-01 implementation Issued by the National Certification and Accreditation Administration Commission

Table of contents

Preface Ⅲ Introduction Ⅳ 1 Scope 1 2 Normative references 1 3 Terms and definitions 1 4 Choice of proficiency testing plan 2 4:1 Develop a proficiency test participation plan 2 4:2 Choose Path 2 4:3 Basis for selection 3 5 Verification of proficiency testing plan 3 5:1 General requirements 3 5:2 Proficiency testing plan design scheme 4 5:3 Sample types and testing/calibration methods 5 5:4 Proficiency testing plan work instruction 5 5:5 Uniformity and stability of samples 5 5:6 Analysis of results 6 5:7 Assigned value 6 5:8 Standard deviation of ability assessment 6 5:9 Capacity statistics 7 5:10 Proficiency testing plan report 7 5:11 Verification of measurement audit 7 6 Utilization of proficiency test results 8 6:1 Utilization of single proficiency test results 8 6:2 Utilization of results of continuous proficiency testing program 9 Appendix A (informative appendix) Example 10 of a work instruction for a proficiency testing plan Appendix B (informative appendix) uniformity and stability test criteria and statistical methods 12 Appendix C (informative appendix) Participant results statistical analysis method 17 Appendix D (informative appendix) Determination of designated values 25 Appendix E (Informative Appendix) Determination of Standard Deviation of Ability Assessment 30 Appendix F (Informative Appendix) Calculation of Capacity Statistics 33 Reference 37

Foreword

This standard was drafted in accordance with the rules given in GB/T 1:1-2009: This standard was proposed and managed by the National Certification and Accreditation Administration Committee: Drafting organizations of this standard: China National Accreditation Center for Conformity Assessment, Testing and Evaluation Center of China Academy of Inspection and Quarantine, China Standard Chemical Research Institute, Chinese Center for Disease Control and Prevention: The main drafters of this standard: Wu Xiaohuai, Han Chunxu, Wang Xiujun, Cao Shi, Han Jingcheng, Zhai Peijun, Lu Xingan, Zhao Hongyang, Zhang Fan, Yang Jiaolan, Zhu Shilu:

Introduction

Proficiency testing is the use of inter-laboratory comparisons to evaluate participants' abilities in accordance with pre-established criteria: Participating in proficiency testing is a laboratory An important means of quality assurance, helps the laboratory evaluate and prove the reliability of its measurement results, discover its own problems, and improve the laboratory Technical ability and management level: The results of the proficiency test can be used as an effective proof of the laboratory's technical capabilities, for the management department, customers and Provide basis for selection, evaluation and accreditation of competent laboratories by other stakeholders: As the main body to participate in proficiency testing, laboratories should comprehensively consider internal quality control based on their own needs and external requirements for proficiency testing: Based on factors such as level, personnel capabilities, equipment conditions, risks, and operating costs, rationally plan and actively seek appropriate proficiency verification plans: In addition to the proficiency testing programs organized by recognized proficiency testing providers (PTP), there are a large number of industries Organizational operation proficiency testing plan: For the proficiency testing program carried out by the accredited PTP within its accreditation scope, the laboratory can Choose to participate and directly use the proficiency test results: For other proficiency testing programs, laboratories can refer to this standard to verify them to Confirm whether it meets the requirements: The choice of proficiency testing plan and Guidelines for the use of verification and results

1 Scope

This standard provides guidelines for the selection, verification and results utilization of proficiency testing plans: This standard applies to proficiency testing participants and stakeholders (such as management departments or laboratory customers) to select, verify, and use capabilities The verification results can also provide guidance for the laboratory to carry out quality control:

2 Normative references

The following documents are indispensable for the application of this document: For dated reference documents, only the dated version applies to this article Pieces: For undated references, the latest version (including all amendments) applies to this document: GB/T 27043-2012 General requirements for conformity assessment proficiency verification ISO 13528 uses statistical methods for proficiency testing (Statistical methodsforusein proficiencytestingbyinterlaboratorycomparison)

3 Terms and definitions

The terms and definitions defined in GB/T 27043 and ISO 13528 are applicable to this document: For ease of use, the following is repeated Certain terms and definitions in GB/T 27043: 3:1 Proficiencytesting Use inter-laboratory comparisons to evaluate participants’ abilities in accordance with pre-established guidelines: Note 1: Some proficiency testing providers in the medical field use the term "external quality assessment (EQA)" to indicate their proficiency testing plan and/or more broadly plan: Note 2: Rewrite GB/T 27043-2012, definition 3:7: 3:2 Proficiencytestingscheme Design and operate one or more rounds of proficiency testing in a specific field of testing, measurement, calibration or inspection: Note 1: A proficiency testing plan can include one or more specific types of testing, calibration or inspection of proficiency testing samples: Note 2: Rewrite GB/T 27043-2012, definition 3:11: 3:3 Assignedvalue The value assigned to the specific properties of the proficiency testing sample: Note: Rewrite GB/T 27043-2012, definition 3:1: 3:4 Outlier Observations in a set of data that are considered inconsistent with other data in the set: Note 1: Outliers may come from different populations, or the results of incorrect records or other gross errors: ......

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