GB/T 32464-2015 in English
VALIDInternal quality control for chemical analysis laboratories applying control graphic - Audit analytical system
- Issued on:2015-12-31
- Implemented on:2016-07-01
- File Format:PDF
- Delivery:Via email within 5 business days
$650.00
《GB/T 32464-2015化学分析实验室内部质量控制 利用控制图核查分析系统》由TC374（全国质量监管重点产品检验方法标准化技术委员会）归口，主管部门为国家标准化管理委员会。
本标准规定了化学分析实验室使用控制图核查分析系统的一般原则、控制图类型及其运用范围、设定控制限、基础数据预处理、使用控制图核查分析系统的工作程序、控制图的使用、控制图中质量控制数据的其他用途。
注：本标准中所称实验室均指化学分析实验室。
Introduction
Standard Overview
GB/T 32464-2015 provides chemical analysis laboratories with systematic guidance on the use of control chart technology for internal quality control, covering the complete process of control chart establishment, use and data application.
Control chart types and applicable scope
| Control chart types | Monitoring objectives | Applicable scenarios |
|---|---|---|
| X Control Chart | Joint effect of systematic factors and random factors | Blank value, calibration curve parameter monitoring |
| I Control Chart | Analysis system bias | When using CRM or known value samples |
| R/r% Control Chart | Method repeatability | Parallel sample detection range monitoring |
Control limit setting method
Statistical control limit: Calculate the standard deviation (s) based on the laboratory's historical data, warning limit = ±2s, action limit = ±3s.
Target control limit: Reference the reproducibility requirement (sRw) specified in the method standard, warning limit = ±2sRw, action limit = ±3sRw.
Implementation Suggestions
- The concentration of the quality control sample should cover the working range of the calibration curve (low, medium and high)
- The initial data accumulation should be ≥25, and it is recommended to evaluate the control limit every year
- When multi-component detection, the control limit can be relaxed for non-critical indicators
Appendix Application Examples
Appendix B takes the ICP-AES detection of Cu in tea as an example to demonstrate the complete process from quality control sample selection, data verification to control chart establishment, including:
- Normality test (Epps-Pulley method)
- Outlier processing (Dixon test)
- X/I/MR control chart parameter calculation and merging
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