GB/T 33464-2016 Guide to the preparation and use of standard operating procedures for chemical analysis
Some standard content:
ICS03.120.10
National Standard of the People's Republic of China
GB/T33464—2016
Guidelines for preparing and using standard operation procedures for chemical analysis forchemicalanalysis
Released on 2016-12-30
General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China Standardization Administration of China
Implementation on 2017-07-01
GB/T33464—2016
This standard is one of the series of standards for verification, validation and internal quality control (Internal Quility Control, IQC) system of test methods in chemical analysis laboratories. The following standards have been or are planned to be released in this series of standards: Terms and definitions for verification, validation and internal quality control of chemical analysis methods;
Requirements for verification, validation and internal quality control of chemical analysis methods Internal quality control of chemical analysis laboratories using control charts to verify analysis systems: Implementation guide for verification, validation and internal quality control of chemical analysis methods Metal component analysis based on sample digestion; Implementation guide for verification, validation and internal quality control of chemical analysis methods Chromatography and mass spectrometry analysis;
Implementation guide for verification, validation and internal quality control of chemical analysis methods Qualitative reporting of results. This standard was drafted in accordance with the rules given in GB/T1.12009 and GB/T20001.2-2001. This standard is under the jurisdiction of the National Technical Committee for Standardization of Key Product Inspection Methods for Quality Supervision (SAC/TC374). The main drafting units of this standard are: Sichuan Product Quality Supervision and Inspection Institute, China Inspection Alliance (Beijing) Quality Inspection Technology Research Institute Co., Ltd., Luzhou Laojiao Co., Ltd., China Inspection Warner (Beijing) Quality Technology Center Co., Ltd., Sichuan Food and Drug Inspection Institute, Guangyuan Product Quality Supervision and Inspection Institute, Chengdu Hongyi Industrial Group Co., Ltd. The main drafters of this standard are: Zheng Weidong, Wang Ming, Hu Dan, Jiang Weidong, Li Wei, Zheng Haifeng, Zhang Suyi, Fan Zhigang. 1
GB/T33464-2016
Standard Operation Procedure (SOP. The English abbreviations are used below) is a written guidance document that specifies laboratory repetitive activities. The scientific preparation and effective implementation of SOP is an integral part of laboratory quality management. Its role is to minimize differences, ensure that all operations comply with relevant requirements, and that the test results continuously issued by the laboratory are reliable and consistent in accuracy; secondly, to enable laboratory technology and experience to be passed on, and the quality of testing will not be affected by personnel changes. This standard is mainly used to guide chemical analysis laboratories to complete method verification or confirmation. After establishing a feasible internal quality control system on this basis, detailed test procedures and internal quality control system texts are compiled based on the referenced test method standards, combined with technical supplements and changes, and guidance on use is provided. 1 Scope
Guide to the Preparation and Use of Chemical Analysis Standard Operating Procedures GB/T33464—2016
This standard specifies the requirements for the preparation, review, approval, release, management and use of SOPs by chemical analysis laboratories for the test methods used, after completing method verification and confirmation and establishing an internal quality control system. This standard does not contain general or routine requirements for the safety of chemical analysis laboratories. This standard applies to the preparation and use of SOPs in chemical analysis laboratories (the term "laboratory" that appears later in this standard is the abbreviation of chemical analysis laboratories).
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only the dated version applies to this document. For undated references, the latest version (including all amendments) applies to this document. GB/T14666-2003 Analytical Chemistry Terminology
GB/T19000-2008
3 Quality Management System Fundamentals and Terminology
GB/T27000-2006 Vocabulary and General Principles for Conformity Assessment GB/T32467-2015 Validation and Internal Quality Control of Chemical Analysis Methods Terms and Definitions 3 Terms and Definitions
The terms and definitions defined in GB/T32467-2015, GB/T14666-2003, GB/T19000-2008 and GB/T27000-2006 apply to this document.
4 General requirements for SOP
4.1 The preparation of SOP should be included in the laboratory's quality assurance plan, and qualified personnel should be authorized to prepare it in the format specified in this standard. The laboratory should ensure that the SOP is detailed, specific, concise, and conveys accurate and clear information, with strict logic, and can provide practical and effective guidance for testing activities and internal quality control activities. Note: The content requirements of SOP are shown in Chapter 5, and the format requirements are shown in Chapter 6 and the references given in Appendix A. 4.2 The laboratory determines the best test procedure suitable for the laboratory during the method validation or confirmation stage, and prepares the SOP after completing the method validation or confirmation and having sufficient internal quality control plans. Note: Different laboratories may obtain different results when testing the same sample according to the same method. There are two reasons for this. One is the difference in actual operation, which is manifested in partial changes in the test conditions or partial adjustments to the content of the test procedure; the second is the difference in internal quality control measures of different laboratories. 4.3 If necessary, the laboratory should establish corresponding SOPs for different methods or different test objects of the same method. 4.4The core content of SOP should include detailed test process operation requirements for personnel, instruments, reagents, environmental conditions, sample storage and preparation involved in the test, including supplements to the method text, quality assurance plans, internal quality control measures analysis system verification, etc. The laboratory should ensure that these contents are scientific, applicable and operational. 4.5The writing staff should be familiar with the writing requirements and master all the technical contents of the object. The preparation work should include the preparation of SOP drafts, soliciting opinions, organizing discussions, and reviewing.
GB/T33464—2016
4.6This standard only requires the specific safety requirements involved in the method text based on SOP, as well as the potential safety hazards when operating according to SOP.
Note: The laboratory should have separate procedures or systems for safety and health. If the method involves specific requirements, or the laboratory management system documents are not detailed enough, they can be supplemented in detail in the SOP. 4.7The laboratory should have a statement of copyright ownership of SOP in consideration of its legal responsibilities to ensure that technical secrets will not be leaked during authorized use.
Note: The usual authorization procedure is to indicate the copyright statement and confidentiality requirements on the officially released version. 4.8 The official version of the SOP finally released by the laboratory should be accompanied by the release date, implementation date, revision number, page number and total number of pages, preparation, review, and approval records.
SOP content requirements
Management records
SOP should have records such as document number, version number, total number of pages and page numbers, preparation, review, approval, release date, and implementation date. 5.1.1
5.1.2 If the SOP document is revised, there should be a revision record. 5.2 Summary description content
Purpose of SOP preparation
5.2.2 Scope of application: the test objects applicable to the SOP, the requirements of laws and regulations, and other relevant restrictions. 5.2.3 Terms and definitions: The terms and definitions given in the standards issued by international organizations and national standards should be used as much as possible. If the procedure includes terms, abbreviations, and acronyms that are not in the existing international and national standards, they should be defined. 5.2.4 Preparation basis: including standards, published documents, summary documents of laboratory method verification and confirmation, and other relevant management documents of the laboratory.
5.2.5 Method principle: If the method principle has been clearly stated in the basis document, this content can be simplified or omitted. 5.2.6 Briefly describe the test process: Graphical description can be used when appropriate. 5.2.7 Detailed description of the supplement to the method based on the SOP. 5.3
Testing procedure requirements
5.3.1 Personnel qualifications/responsibilities. When laws and regulations or the laboratory have special requirements for personnel qualifications/responsibilities, they should be specified in detail in the SOP. 5.3.2 Requirements for environmental conditions of the test method and measures to meet the requirements. 5.3.3 When necessary, the requirements for computer hardware and software of the test 5.3.4 Detailed test process requirements, including pre-test preparation requirements, auxiliary tools, glassware, reagents and consumables, etc. 5.3.5 If the method has special requirements for the traceability and verification of instrument and equipment, they need to be described 5.3.6 Requirements for sample collection, handling and storage. 5.3.7 Sample preparation (such as extraction, digestion). 5.3.8 Instructions for setting and changing instrument conditions during the test. 5.3.9 Possible faults during the test and troubleshooting methods. 5.3.10 Requirements for data collection, calculation conversion, final expression and reporting. Note: See 8.2.10 of Appendix A for data reporting requirements. 5.3.11 Records of the evaluation process and results of measurement uncertainty, and requirements for re-evaluation of measurement uncertainty during testing. 5.3.12 Requirements for internal quality control. Precautions, indicating activities that may cause equipment damage, sample decomposition and invalid results. This content is a key item of the procedure. Safety operation requirements, in accordance with the requirements of 4.6, detailed descriptions of operations that may cause personal injury or endanger life during testing and their precautions, and explanations of what will happen if the procedures are not performed or not followed correctly. This content is a key item of the procedure. 5.3.15 Other necessary instructions.
5.4 Internal quality control requirements
5.4.1 Detailed description of the method performance indicators obtained through verification or validation, explanation of how these indicators meet the accuracy requirements, and appropriate IQC procedures that meet the internal quality control requirements during the testing process. Note: The purpose of internal quality control activities is to verify whether the quality of the work continues to meet the relevant requirements. IQC activities include three important contents: one is to describe in detail the tools and operating procedures for quality control of the testing process and verification of the analytical system; the second is the criteria for evaluating whether the quality of the test results meets the requirements; and the third is the corrective measures or preventive measures that need to be taken when the data quality does not meet the requirements of the evaluation criteria or is in the warning area. 5.4.2
Quality control requirements for the testing process are additional quality control measures in the testing process, including the following: a)
Requirements for calibration curve quality evaluation, quality control and shelf life management, if any; b)
Batch grouping requirements for batch analysis, when applicable; c)
Requirements for using standard substances for recovery control Requirements for independent repeated testing;
Requirements for inserting blank samples and quality control samples in the testing sequence: Criteria for evaluating whether the quality of the test results meets the requirements: Requirements for implementing corrections and corrective actions;
Regular summary, reporting of IQC data and results Analytical system verification, including the following: 5.4.3
Requirements for quality control samples;
Types and methods of establishing control charts;
Requirements for using control charts and evaluation methods; d)
Requirements for taking corrections and corrective actions.
6 SOP format requirements
6.1 General
The format of SOP varies depending on the type of SOP and the laboratory. The level of detail of the content varies depending on the frequency of use of the SOP, the number of people using the SOP, and the training. In general, the format that chemical analysis laboratories should follow when writing SOPs includes six elements: title, directory, document preparation, approval and modification records, procedures, records, and references. 6.2 Title page
In addition to the document title, the title page also contains the content of 5.1. 6.3 Directory
The laboratory can catalog the content of the SOP according to its actual situation. The directory should at least display the secondary title to facilitate future revisions and references.
6.4 Overview
Includes purpose, scope of application, terms and definitions, and compilation basis (i.e., the content of 5.2.15.2.4). Independent chapters can be used to describe 6.5 Procedures
Includes the contents of 5.2.5 to 5.2.7 and 5.3. 3
GB/T33464—2016
6.6 Records
When necessary, make requirements for the records used for the test process results, quality assurance, and quality control, and design sample tables as much as possible. 6.7
References
If available, list useful references for easy reference when revising. 7SOP Management
7.1 Review, Approval, and Release
7.1.1 The prepared SOP should be reviewed and approved before it can be issued to employees for use. 7.1.2 The following situations must be reviewed and approved: a) Before first use;
b) After being revised;
c) When it is cancelled.
7.1.3 Before the official version of the SOP and the subsequent revised version are released, they should be reviewed or approved by authorized personnel. The review and approval personnel should be from the laboratory's top management, quality assurance personnel or SOP compilers. The laboratory shall make appropriate division of labor and authorization for the review and approval personnel.
7.1.4 The content of SOP shall be reviewed from the following four aspects: a)
Whether it meets the requirements of this standard:
Whether the method verification or confirmation has been completed, whether the verification or confirmation results have been evaluated, and whether the verification results meet the specified requirements and the confirmation results meet the expected requirements; b)
Whether all technical procedures can ensure the realization of quality goals: whether the content of the quality control procedures is sufficient and whether it can ensure that the data continuously issued by the laboratory is accurate and reliable. d)
7.1.5The release, use and management of SOP shall meet the following requirements: a)
SOP shall be loose-leaf bound to facilitate modification and page change. The valid text of SOP shall be distributed to all relevant testing personnel for use at the testing site. b)
SOP should be controlled in accordance with the document control requirements of this standard and the laboratory. 7.2 Management in use
7.2.1 The laboratory should have procedures or documents to ensure that the testing and other activities related to the testing work are carried out in accordance with the requirements of SOP, and ensure that the testing methods and operating processes adopted by the laboratory are controllable. 7.2.2 Deviation handling. If a deviation from SOP occurs during use, it should be immediately fed back to the relevant department or relevant personnel, and the deviation should be evaluated and handled in accordance with the following requirements:
a) The evaluation shows that the deviation does not affect the accuracy of the test results , does not violate the requirements of relevant laws and regulations, and is finally confirmed as an allowable and acceptable deviation, the SOP will be revised and communicated to each tester and relevant department; if the evaluation shows that the deviation will lead to inaccurate and unreliable test results and cannot meet the performance index requirements of the method specified in the SOP, or b)
violates the requirements of relevant laws and regulations and is an unallowable deviation, then corrections will be implemented, recorded and communicated to relevant personnel and departments: If the deviation causes a deviation and is evaluated as an inappropriate deviation, corrective measures should be recorded and taken, and then clear requirements will be made in the SOP. In this case, the SOP should also be revised and the revised requirements 7.2.3 SOP implementation supervision, the laboratory's technical supervisor or quality assurance department, or both, will regularly supervise the actual operation process of the SOP. The situation of each supervision and inspection should be recorded. This supervision activity should be included in the laboratory's quality management plan Note: Ideally, the implementation of the SOP should be supervised at least once a year; the frequency and number of supervisions for the implementation of the SOP by new and in-training personnel should be more.
7.3 SOP revision, review and improvement
GB/T33464—2016
7.3.1 The published SOP should be reviewed regularly or when the test method standard changes to determine whether it needs to be revised or re-compiled to ensure its suitability.
Note: The recommended review cycle is 1 year.
7.3.2 If the test procedure changes due to different sample matrices, the established SOP should be revised. The revised SOP should be accompanied by a statement of the reasons for the revision, and the revised copy should be kept as an archive. 7.3.3 When the SOP is revised, updated or replaced, it needs to be reviewed and approved again. When the basis for preparation undergoes major substantive changes, a new version needs to be published.
7.3.4 Detailed records of review, revision and improvement should be kept. Note: Considering that analytical methods and procedures are not static, due to changes in requirements or the need to improve performance and efficiency, the laboratory should strengthen the responsibilities of relevant professionals, timely collect new technologies and new developments related to SOPs, propose improvement plans for SOPs, and improve them according to the requirements of laboratory technical operation procedures.
8 SOP use
8.1 SOP users should keep the documents well. SOPs that require confidentiality should be strictly kept confidential in accordance with the relevant requirements of the laboratory and SOPs.
The laboratory should ensure that testers can easily access SOPs, and users should ensure that valid versions are used at all times. 8.3 If the SOP allows different procedural options for different test objects, attention should be paid to the consistency of the options and the test objects when using them. If there are confirmed modifications and changes, they should be implemented in a timely manner. 8.4 When the user encounters a situation that is not clearly specified in the SOP, or there are areas that are not applicable or need to be improved, he should report it to the laboratory supervisor in a timely manner. The laboratory supervisor is responsible for organizing relevant technical personnel to discuss and study in a timely manner and make decisions. 8.5 When the laboratory needs to extend the use of methods, it should stipulate the principles of extended use, and re-compile or revise the existing SOP after completing the necessary demonstration, verification or confirmation.
9SOP file management
9.1 The laboratory should establish files to record and save the distribution of SOPs, the holders and the revision of SOPs. 9.2 The laboratory quality assurance department should keep the valid version of SOP. After the SOP is revised or replaced, the obsolete version should be collected in time. If the obsolete version needs to be archived for reference in future work, it should be sorted and marked for identification. 9.3 The laboratory can manage SOP by using electronic documents. Whether it is paper or electronic documents, the key to management is to ensure that only one valid version is in use at any time. The copies or photocopies used at the testing site should be derived from this unique version. If electronic documents are used, the laboratory shall strictly control modification and printing to prevent unauthorized printing and modification. Note: Electronic signatures are allowed in electronic documents, and the laboratory shall have effective management measures. 9.4
The laboratory shall have a special department responsible for the storage of SOP files. The SOP documents and materials kept as archives shall at least include the following:
Method verification or confirmation records;
Review, approval and issuance records;
Handling records of deviations during implementation;
Revision and version change records;
Review and supervision implementation records;
SOP texts that have been modified, changed, and invalidated for reference. f)
GB/T33464—2016
Retention period The general format of SOP shall be implemented in accordance with the relevant requirements of laboratory document management
The general format of SOP is given in Appendix A. The example provided in Appendix A is only to illustrate the general format and main structure of SOP. Contents of the cover (including the following information)
SOP name:
Document number:
Version number:
Preparation department:
Release date:
Appendix A
(Informative Appendix)
Test method standard operating procedure (SOP) format GB/T33464—2016
(Or design the number position according to the laboratory's requirements) (Or design the version number position according to the laboratory's requirements) (set) date
Implementation date:
Laboratory name
GB/T33464—2016
Revision record
File name:
Revision number
Revision page range
Revision content
Reviser
Approving person
File number:
Implementation time
4SOP body
4.1 Title
Involves the analysis object and analysis method, and may also be the laboratory test method code. 4.2 Purpose
Includes the purpose of standardizing the test process and stipulating internal quality control. 4.3 Scope of application
GB/T33464—2016
The sample matrix type and the range of analytical self-standard components suitable for the test method, as well as the appropriate internal quality control instructions. 4.4 Job requirements and responsibilities
When there are requirements in laws and regulations, or when there are special requirements in the laboratory, the professional requirements and working experience of the personnel required to complete the work shall be put forward; the responsibilities of all departments and personnel related to the testing and implementation of internal quality control shall be stipulated. 4.5
Based on documents
Published standards, or reference books and documents on relevant methods published in authoritative magazines, etc. 4.6
Terms and Definitions
List the documents using terms and definitions, as well as supplementary terms, definitions, abbreviations and symbols4.7 Method Overview
Includes the source of the method, authority, etc., changes and supplements to the method by the laboratory4.8
Test Procedure
4.8.1 Method Principle
4.8.2 Test Process and supplements to the test procedures in the standard or adopted method text, including the following contents:a) Instruments, specify the instrument performance that meets the requirements of the standard, as well as the traceability of the measurement value, storage and maintenance, repair of the equipment, preparation before testing: expected failures and methods for troubleshooting, etc. wwW.bzxz.Net
b) Glassware III and other auxiliary equipment, explain the types of glassware III and other auxiliary equipment, assembly instructions, diagrams, etc., preparation and adjustment before testing, and cleaning and preparation of glassware, etc.c)
Chemicals and reagents, explain the purity, grade, storage, disposal, shelf life requirements of the required chemicals and reagents, etc. Requirements for testing environment conditions and regulations that meet the requirements. Sample collection, handling, preparation (such as extraction, digestion) and storage. Requirements and instructions for instrument condition settings and instrument testing procedures during the test. When applicable, batch analysis requirements. Requirements for computer hardware and software.
Data collection, calculation conversion, final expression and record content, abnormal conditions during the test and their handling requirements, requirements for reporting data, including the requirements for the laboratory to report the minimum detection result based on the detection limit of the method, such as the requirement to report "not detected" with the laboratory's method detection limit; the requirement to report quantitative test results with the laboratory's quantitative limit; the requirement for the test result to be within the technical requirements 94 Job requirements and responsibilities
When there are requirements in laws and regulations, or when there are special requirements in the laboratory, the professional requirements and working experience of the personnel required to complete the work shall be put forward; the responsibilities of all departments and personnel related to the testing and implementation of internal quality control shall be stipulated. 4.5
Based on documents
References and documents on published standards or relevant methods published in authoritative magazines, etc. 4.6
Terms and Definitions
List the documents using terms and definitions, as well as supplementary terms, definitions, abbreviations and symbols4.7 Method Overview
Includes the source of the method, authority, etc., changes and supplements to the method by the laboratory4.8
Test Procedure
4.8.1 Method Principle
4.8.2 Test Process and supplements to the test procedures in the standard or adopted method text, including the following contents:a) Instruments, specify the instrument performance that meets the requirements of the standard, as well as the traceability of the measurement value, storage and maintenance, repair of the equipment, preparation before testing: expected failures and methods for troubleshooting, etc.
b) Glassware III and other auxiliary equipment, explain the types of glassware III and other auxiliary equipment, assembly instructions, diagrams, etc., preparation and adjustment before testing, and cleaning and preparation of glassware, etc.c)
Chemicals and reagents, explain the purity, grade, storage, disposal, shelf life requirements of the required chemicals and reagents, etc. Requirements for testing environment conditions and regulations that meet the requirements. Sample collection, handling, preparation (such as extraction, digestion) and storage. Requirements and instructions for instrument condition settings and instrument testing procedures during the test. When applicable, batch analysis requirements. Requirements for computer hardware and software.
Data collection, calculation conversion, final expression and record content, abnormal conditions during the test and their handling requirements, requirements for reporting data, including the requirements for the laboratory to report the minimum detection result based on the detection limit of the method, such as the requirement to report "not detected" with the laboratory's method detection limit; the requirement to report quantitative test results with the laboratory's quantitative limit; the requirement for the test result to be within the technical requirements 94 Job requirements and responsibilities
When there are requirements in laws and regulations, or when there are special requirements in the laboratory, the professional requirements and working experience of the personnel required to complete the work shall be put forward; the responsibilities of all departments and personnel related to the testing and implementation of internal quality control shall be stipulated. 4.5
Based on documents
References and documents on published standards or relevant methods published in authoritative magazines, etc. 4.6
Terms and Definitions
List the documents using terms and definitions, as well as supplementary terms, definitions, abbreviations and symbols4.7 Method Overview
Includes the source of the method, authority, etc., changes and supplements to the method by the laboratory4.8
Test Procedure
4.8.1 Method Principle
4.8.2 Test Process and supplements to the test procedures in the standard or adopted method text, including the following contents:a) Instruments, specify the instrument performance that meets the requirements of the standard, as well as the traceability of the measurement value, storage and maintenance, repair of the equipment, preparation before testing: expected failures and methods for troubleshooting, etc.
b) Glassware III and other auxiliary equipment, explain the types of glassware III and other auxiliary equipment, assembly instructions, diagrams, etc., preparation and adjustment before testing, and cleaning and preparation of glassware, etc.c)
Chemicals and reagents, explain the purity, grade, storage, disposal, shelf life requirements of the required chemicals and reagents, etc. Requirements for testing environment conditions and regulations that meet the requirements. Sample collection, handling, preparation (such as extraction, digestion) and storage. Requirements and instructions for instrument condition settings and instrument testing procedures during the test. When applicable, batch analysis requirements. Requirements for computer hardware and software.
Data collection, calculation conversion, final expression and record content, abnormal conditions during the test and their handling requirements, requirements for reporting data, including the requirements for the laboratory to report the minimum detection result based on the detection limit of the method, such as the requirement to report "not detected" with the laboratory's method detection limit; the requirement to report quantitative test results with the laboratory's quantitative limit; the requirement for the test result to be within the technical requirements 9
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