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JJF 1645-2017: In-house Preparation of Quality Control Materials(QCMs)
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In-house Preparation of Quality Control Materials(QCMs)
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JJF 1645-2017
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Standard similar to JJF 1645-2017 JJG 1094 JJF 1441 JJF 1507 Basic data | Standard ID | JJF 1645-2017 (JJF1645-2017) | | Description (Translated English) | In-house Preparation of Quality Control Materials(QCMs) | | Sector / Industry | Metrology & Measurement Industry Standard | | Classification of Chinese Standard | A67 | | Classification of International Standard | 17.020 | | Word Count Estimation | 19,118 | | Date of Issue | 2017-09-26 | | Date of Implementation | 2017-12-26 | | Quoted Standard | JJF 1001; JJF 1005; JJF 1343; JJF 1507; GB/T 3358.1 | | Adopted Standard | ISO Guideline 80-2014, IDT | | Regulation (derived from) | General Administration of State Quality Inspection Announcement 2017 No. 78 | | Issuing agency(ies) | General Administration of Quality Supervision, Inspection and Quarantine | | Summary | This standard stipulates the basic characteristics of the quality control material, and provides the basic procedures for the internal development of the quality control material, as well as the basic principles of homogeneity assessment, stability assessment, and assignment in the development process. It is applicable to guiding the laboratory to carry out quality control. The internal development of the material. | JJF 1645-2017: In-house Preparation of Quality Control Materials(QCMs)---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.
(Technical specification for internal development of quality control substances)
People's Republic of China National Measurement Specifications
Internal Control of Quality Control Materials
In-housePreparationofQualityControlMaterials (QCMs)
2017-09-26 Posted
2017-12-26 Implementation
General Administration of Quality Supervision, Inspection and Quarantine released
Internal Control of Quality Control Materials
ControlMaterials (QCMs)
Focal point. National Standard Material Measurement Technical Committee
The main drafting unit. China Institute of Metrology
Participate in the drafting unit. Shanghai Institute of Measurement and Testing Technology
Chinese Center for Disease Control Occupational Health and Poison Control
This specification entrusts the national standard material measurement technical committee to be responsible for explaining
The main drafters of this specification.
Kan Ying (China Institute of Metrology)
Li Hongmei (China Institute of Metrology)
Guo Jing (China Institute of Metrology)
Participate in the drafters.
Wu Limin (Shanghai Institute of Measurement and Testing Technology)
Yan Huifang (China Center for Disease Control and Prevention Occupational Health and Poison Control)
table of Contents
Introduction (Ⅲ)
1 Scope (1)
2 References (1)
3 Terms and Definitions (1)
3.1 Quality Control Substance (1)
4 quality control material development steps (1)
5 material technical requirements (2)
5.1 substrate type, matching and interchangeability (2)
5.2 Characteristics and characteristic values (3)
5.3 Unit Specifications (3)
5.4 Batch (3)
Preparation of 6 quality control substances (3)
6.1 Collection of raw materials (3)
6.2 Materials Processing (4)
6.3 packaging and packaging (5)
7 Uniformity (6)
7.1 Overview (6)
7.2 Analysis Methods (7)
7.3 Statistical Analysis of Uniformity Data (7)
8 assignment (9)
9 Stability (9)
9.1 Overview (9)
9.2 Stability Assessment (10)
9.3 to determine the validity of quality control substances (10)
10 Transport (10)
11 Preparation of relevant documents for quality control substances (11)
11.1 General (11)
11.2 Information to be Provided for Quality Control Substance (11)
11.3 Labeling of quality control substance units (11)
11.4 Archive Information (11)
12 Storage (12)
12.1 General (12)
12.2 Monitoring of storage conditions (12)
13 Use of quality control substances (12)
13.1 General (12)
13.2 Minimum Sampling Quantity (12)
13.3 Mixing Procedure (12)
13.4 Dry Mass Correction (12)
13.5 Storage of quality control substances after opening (13)
Introduction
As the market demands for testing and product quality expand rapidly, the demand for quality control substances continues to grow. quality
Use of controlled substances include but are not limited to.
1) Make a quality control chart to prove that the measurement process is controllable and effective;
2) compare the results, confirm the equivalence of the measurement results or normalize the result;
3) Method development to establish consistency;
4) instrument performance check;
5) Repeatability/Reproducibility studies;
6) as a verification sample, such as the equivalence of two or more laboratory measurements confirmed;
7) operator change monitoring;
8) Monitoring of the impact of changes in environmental conditions.
The application of quality control substances is of great significance to promote the detection quality and product quality in various fields.
The quality control substance is only a supplement to the certified reference substance, not an alternative. Usually there is no suitable standard
Quality, or the need for large quantities of standard material, the cost is high, the laboratory needs to develop quality control substances.
This specification is equivalent to the ISO Guide 80.2014 "internal control of quality control materials", elaborated the quality control
Material internal research and development processes and uniformity assessment, stability assessment, assignment and other technical requirements to promote China's high water
Quality control of the development and application of substances to ensure that the laboratory developed quality control material can effectively play a "quality control
System "role.
This specification is first released.
Internal Control of Quality Control Materials
1 Scope
This Code outlines the basic characteristics of quality control of raw materials, and gives the quality control of the internal development of the material base
This procedure, as well as the development of uniformity assessment, stability assessment, the basic principles of assignment, suitable for guiding experiment
Room to carry out internal control of quality control material.
2 reference documents
JJF 1001 common measurement terms and definitions
JJF 1005 standard terms and definitions commonly used
General Principles and Statistical Principles of JJF 1343 Standard Substance Setting
Selection and Application of JJF 1507 Standard Substance
GB/T 3358.1 statistical terms and symbols - Part 1. General statistical terms and terms used in probability
(ISO 3534-1, IDT)
ISO Guide 80 Internal Development of Quality Control Materials [ISO Guide80.Guidanceforin-house
Preparation of Quality Control Materials (QCMs)]
For dated references, only the dated version applies to this specification. For undated references
The latest version (including all amendments) applies to this specification.
3 Terms and definitions
JJF 1001 "Common measurement terms and definitions", JJF 1005 "common terms and definitions of standard substances" and
GB/T 3358.1 "Glossary and symbols of statistics Part 1. General statistical terms and terms used in probability" Chinese regulations
The term applies to this specification.
3.1 Quality Control Materials QualityControlMaterials (QCMs) [ISO Guide 302.1.22]
The standard substance used to measure quality control.
Notes 1. "Quality control" refers to the use of such substances and not to another category of reference substances.
Note 2. Quality control standards do not require evaluation results have traceability and measurement uncertainty, but must have to meet the pre-
Period of use of the uniformity and stability.
Note 3. Certified Reference Materials can also be used for measurement quality control.
4 quality control material development steps
The basic use of quality control substances is to detect changes in order to measure repeatability, measure the precision during or
Recurring assessment, etc. (but not limited to). The assessment of uniformity and stability is usually based on the actual situation
Achieve the balance between R & D costs and intended use.
Figure 1 shows the key steps in a typical quality control material development process. However, not all steps
It will be done by the agency that needs the substance. Materials procurement, handling, packaging and packaging can be a matter of experience
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