Quality Management

Design and Application of Proprietary Statistical Software for Proficiency Testing Providers and Reference Material Providers

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  • (1)National Institutes for Food and Drug Control,Beijing 102629 ,China; (2)Qingdao University of Technology,Qingdao 266033 ,China

Online published: 2022-12-21

Abstract

Objective: To set up a customized statistical software of profi ciency testing evaluation and reference material assignment—PTP/RMP, in order to solve the problems in the statistical evaluation and calculation of profi ciency testing and standard substance for profi ciency testing providers (PTP) and reference material providers (RMP). Methods: The PTP/RMP is set up based on the statistical methods provided by ISO13528 and ISO Guide35 for profi ciency testing and reference material assignment respectively and on the MATLAB platform for interface design and statistical program construction. Results: (1) PTP/RMP software comprehensively and systematically provides statistical content required in profi ciency testing and reference material determination, including analyzing the uniformity, stability, determination of samples and the laboratory capability evaluation using the tested samples. (2) PTP/RMP software runs complex calculation principles and formulas in the background, makes the interface settings concise and intuitive, convenient and fast and gives full consideration to the non-statistical professional characteristics of users; (3) The accuracy and reliability of the PTP/RMP software was verified by comparing the statistical results of the PTP/RMP software with the statistical results in the regulations and the results from the professional statistical software. Conclusion: PTP/RMP software not only provides a professional statistical software that meets the requirements of domestic and foreign regulations on proficiency testing and reference material assignment, but also provides a new scientific evaluation and supervision tool for the statistical analysis of relevant content for regulatory examiners.

Cite this article

Li Na, Du Ying, Sui Silian, Tan Dejiang, Shi Ruihong . Design and Application of Proprietary Statistical Software for Proficiency Testing Providers and Reference Material Providers[J]. Chinese Pharmaceutical Affairs, 2022 , 36(12) : 1383 -1396 . DOI: 10.16153/j.1002-7777.2022.12.008

References

[1] ISO 13528 Statistical Methods for Use in Proficiency Testingby Interlaboratory Comparison[S].2015.
[2] GB/T 28043 利用实验室间比对进行能力验证的统计方法[S].2011.
[3] CNAS GL002《能力验证结果的统计处理和能力评价指南》[S].2018.
[4] ISO/IEC 17043 Conformity Assessment-GeneralRequirements for Proficiency Testing[S].2010.
[5] GB/T 27043 合格评定—能力验证的通用要求[S].2012.
[6] CNAS GL003《能力验证样品均匀性和稳定性评价指南》[S].2018.
[7] ISO Guide 35 Reference Materials-Guidance forCharacterization and Assessment of Homogeneity andStability[S].2017.
[8] JJF1343 标准物质定值的通用原则及统计学原理[S].2012.
[9] CNAS GL29《标准样品定值的一般原则和统计方法》[S].2011.
[10] 李娜,马莉,谭德讲,等.浅议我国监管科学发展中亟待加强的几个方面[J].中国食品药品监管,2021(2):24-31.
[11] 沈志军,魏朝晖,夏普,等.稳健统计技术在人员操作能力验证中的应用[J].金属制品,2017,43(3):53-56.
[12] 伍恒,陈祝康,顾颂青.国内外化学检测领域能力验证结果统计方法的探讨[J].食品安全质量检测学报,2016(7):2622-2629.
[13] JJF 1117计量比对[S].2010.
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