Criterion on quality control of laboratories - Molecular biological testing of food
Some standard content:
1CS 03. 120. 10
National Standard of the People's Republic of China
GB/T27403—2008
Criterion on quality control of laboratories--Molecular biological testing of fooc2008-05-04 Issued
General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China Standardization Administration of China
2008-10-01 Implementation
Normative Reference Documents
Terms, Definitions and Abbreviations
Management Requirements
Management System
Document Control
Quality and Technical Records
Customer Service
Complaint Handling
Control of Nonconforming Work
Corrective Action
Preventive Measures
Internal Audit
Management Review…
Continuous Improvement:
5 Technical Requirements
5.1 Procurement services
5.2 Personnel
Facilities and environmental conditions
5.5 Handling of experimental reagents and hazardous wastes5.6 Traceability
6 Process control requirements
6.2 Contract review
Sampling,
Test sample disposal
Methods and method confirmation
6.6 Subcontracting
6.7 Result reporting
6.8 Emergency preparedness and response
7 Result quality control-
7.1 Internal quality control
7.2 External quality control.
Appendix A (Informative Appendix) Comparison table between this standard and GB/T27025-2008 clauses GB/T 27403--2008
GB/T 27403-2008
Appendix B (Informative Appendix)
Appendix C (Informative Appendix)
Appendix D (Informative Appendix)
Appendix E (Informative Appendix)
References
Zone division of molecular biology laboratories
Common equipment in molecular biology laboratories
Principles for prevention and treatment of PCR contamination in nucleic acid testing Prevention of RNasc contamination in RNA testing
This standard is one of the laboratory quality control specification standards, which currently includes the following standards:-GB/ GB/T27401 Laboratory Quality Control Specifications for Animal Quarantine;
-GB/T27402 Laboratory Quality Control Specifications for Plant Quarantine:
Food Molecular Biology Testing;
-GB/T27403 "Laboratory Quality Control Specifications GB/27404 Laboratory Quality Control Specifications for Food Physical and Chemical Testing"; Food Microbiology Testing;
-GB/T27405 Laboratory Quality Control Specifications GB/T27406 "Laboratory Quality Control Specifications for Food Toxicology Testing". GB/T27403-2008
Please note that some of the contents of this standard may involve patents. The issuing agency of this standard shall not be responsible for identifying these patents. Appendices A, B, C, D and E of this standard are informative appendices. This standard was proposed and managed by the National Technical Committee for Certification and Accreditation Standardization (SAC/TC261): This standard was drafted by the China National Accreditation Service for Conformity Assessment. The drafting organizations of this standard are: China National Accreditation Service for Conformity Assessment, Beijing Exit-Entry Inspection and Quarantine Bureau of the People's Republic of China. The main drafters of this standard are: Chen Guangquan, Liu Laifu, Zhang Huiyuan, Cao Shi, Ruifu He Zhaowei, Zeng Jing, Rao Hong, Han Qi, Zhang Xin. GB/T 27403--200E
The preparation of this standard is mainly based on GB/T27025 General requirements for the competence of testing and calibration laboratories, and absorbs the contents of GB/T19001-2000 "Quality Management System Requirements", and refers to the documents of relevant international professional organizations, domestic and foreign industry standards and professional literature. The applicable contents, and fully integrate the management experience of relevant domestic laboratories, this standard aims to standardize, guide and help relevant laboratories to meet the specific requirements of GB/T27025 and quality control in this professional field.
In addition to GB/T27025, the main documents related to this professional field that this standard refers to include SN/T1193-2003 "Technical Requirements for Genetic Testing Laboratories", GB19489-2004 "General Requirements for Laboratory Biosafety". In addition, although this standard includes some of the current laws and regulations in my country applicable to this professional field and some safety-related content, this standard is not used as a basis for judging whether the laboratory meets the relevant laws and regulations and safety requirements. Food molecular biology testing laboratories refer to laboratories that use molecular biology technology (such as nucleic acid technology, etc.) as the main means and food as the testing object. Its testing process mainly includes contract review, sampling, disposal of test samples, method and method confirmation, and subcontracting of testing. This standard is mainly applicable to laboratories engaged in food molecular biology testing, and laboratories engaged in food molecular biology testing can use this standard as a reference.
It is recommended that relevant laboratories should be familiar with and master the relevant contents of GB/T27025 before using this standard. For a comparison between this standard and the provisions of GB/T27025-2008, please refer to Appendix A. 1 Scope
Laboratory Quality Control Specification
Food Molecular Biology Testing
GB/T 27403-2008
This standard specifies the management requirements, technical requirements, testing process control requirements and quality control requirements for testing results of food molecular biology testing laboratories.
This standard is applicable to the quality control of laboratories that use molecular biology technology (nucleic acid technology, etc.) as the main means and food as the testing object. Molecular biology testing laboratories in other fields can also refer to it. 2 Normative References
The following documents become the terms of this standard through the use of this standard. For any dated referenced documents, all subsequent amendments (excluding errata) or revisions are not applicable to this standard. However, all parties involved in the development of this standard are encouraged to study whether the latest versions of these documents can be used. For any undated referenced documents, the latest versions are applicable to this standard. GB/T 15483.1 Proficiency testing using laboratory comparisons Part 1: Establishment and operation of proficiency testing schemes (GB/T 15483.11999, idt ISO/IEC Guide 13-1:1997) GB/T19000 Quality Management System Fundamentals and Vocabulary (GB/T19000-2000, IDT ISO9000:2000) GB19489 General Requirements for Laboratory Biosafety GB/T27000 Vocabulary and General Principles for Conformity Assessment (GB/T27000-2006, ISO/IEC17000:2001, IDT) VIM International General Terms of Metrology L is issued by the International Bureau of Weights and Measures (BIPM), the International Electrotechnical Commission (IEC), the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC), the International Organization for Standardization (ISO), the International Union of Theoretical and Applied Chemistry (IUPAC), the International Union of Theoretical and Applied Physics (IUPAP) and the International Organization of Legal Metrology (OIML). 3 Terms, Definitions and Abbreviations
3.1 Terms and Definitions
GB/T 19000, GB/T 27000 and VIM The terms and definitions established in and listed below apply to this standard. Note: GB/T 19C00 specifies general definitions related to quality, while GB/T 27000 specifically specifies definitions related to certification and laboratory accreditation. If there are differences between the definitions given in GB/T 19000, GB/T 27C00 and VIM, the definitions in GB/T 27000 and VIM shall prevail. 3.1.1
Molecular biological testing laboratories of food Molecular biological testing laboratories of food A laboratory that uses molecular biological techniques (such as nucleic acid technology, etc.) as the main means and uses food as the testing object. 3.1.2
Top management of laboratory A person or group of people who directs and controls the laboratory at the highest level. 3.1.3
Management personnel of laburatory Personnel responsible for managing laboratory activities under the leadership of the laboratory's top manager. 3. 1. 4
Inboratory competence The materials, environment, information resources, personnel, technology and expertise required for the laboratory to carry out corresponding tests. 1
GB/T 27403-—2008
Samplesample
One or more parts taken from a whole, intended to provide relevant information about the whole, usually as a basis for judging the whole. 3. 1. 6
Testing report
A document providing test results and other relevant test information. 3. 1. 7
Polymerase chain reaction, PCR is a molecular biology experimental method for in vitro enzymatic synthesis of specific DNA fragments. It mainly consists of three steps: high temperature denaturation, low temperature annealing and suitable temperature extension. The template DNA is first denatured into a single strand at high temperature. Under the influence of DNA synthase and suitable temperature, two primers anneal to a complementary sequence of two template DNA chains. Then, under the catalysis of DNA polymerase, four deoxyribonucleotide triphosphates (dVTP:) are used as substrates to extend the annealed primers. This process is repeated to amplify the DNA fragment between two known sequences geometrically.
nested polymerase chain reaction nested PCR; nPCR, nested PCR is a molecular biology experimental technique that uses two sets of PCR [pairs (nested primers) to perform rounds of PCR amplification reactions. In this technique, a pair of external primers are first used to perform the first round of PCR amplification, and then a pair of internal primers within the DNA sequence amplified by the first pair of primers are used to amplify again, so it is called nested PCR. Since two pairs of primers are used and two rounds of amplification reactions are performed, the sensitivity and specificity of the experiment are enhanced.
Biological safety cabinetsbiological safety cabinets, BSCsA device that can inhale air through a mechanical device, create a negative pressure environment in the working area, circulate the gas in the cabinet, and exhaust gas is discharged after filtering.
Biohazard work areabiohazard work area, BWAAn area reserved for work related to biological materials. It can be a complete room or a part of a room. 3. 1. 11
Aerosolaerosul
A suspension system composed of solid particles or droplets dispersed in a gas. 3. 1. 12
Target DNA Positive control positive DNA target control reference DNA, DNA extracted from traceable standard material or DNA sequence extracted from positive sample (or organism) containing target sequence: this control is used to prove that the analysis result of test sample contains target sequence. 3.1.13
target DNA negative control negative DNA target control DNA fragment without exogenous target nucleic acid sequence. This control is used to prove that the test sample does not contain target sequence. 3.2 Abbreviations
The following abbreviations apply to this standard.
DEPC: diethylpyrocarbonate. DNA: deoxyribonucleic acid. dVTPs: deoxyribonucleosidetriphosphate. MSDS: material safety data sheets. PCR: polymerase chain reaction. 2
RNA: ribonucleic acid. RNase.
TagDNA polymerase: TagDNApolymerase, thermostable DNA polymerase. 4 Management requirements
4.1 Organization
GB/T27403—2008
4.1.1 The food molecular biology testing laboratory (hereinafter referred to as the laboratory) or its organization should have a clear legal status. The laboratory is generally an independent legal person, and the laboratory that is not an independent legal person must be authorized by the legal person. 4.1.2 The laboratory testing services should be able to meet the work needs of customers and their institutions. 4.1.3 When the laboratory carries out work in places inside or outside its fixed institution, it should comply with the relevant provisions of this standard. 4. 1. 4
The laboratory manager shall be responsible for the design, establishment, maintenance and improvement of the organizational management system, including at least the following aspects: a) Allocate sufficient personnel to the laboratory and provide all personnel with the authority and resources necessary to perform their duties; b) Formulate policies and procedures to prevent institutions and personnel from being involved in any activities that may reduce their judgment, technical skills, honesty and impartiality; Formulate policies and procedures to ensure that customer confidential information is protected; e) Clarify the organizational structure of the laboratory and the relationship between the laboratory and other relevant institutions; d) Define the responsibilities, authority and relationships of all personnel; Establish a technical management team responsible for technical The person in charge of technical operations (the person in charge of technical management is also called the technical person in charge) and is given corresponding responsibilities and powers. A person in charge of quality is appointed, who is fully responsible for the operation of the quality system. A person in charge of safety is appointed, who is responsible for the safety management of the laboratory, including the formulation, implementation and updating of laboratory safety measures (including biosafety measures), daily safety maintenance, safety knowledge training, etc. Personnel who are familiar with the purpose, procedures, operation and result evaluation of the inspection shall provide corresponding training and supervision to other laboratory personnel according to their experience, ability and job qualifications. The top management directly appoints and manages the quality supervisor; designates agents for key personnel; in some small laboratories, one person may assume multiple responsibilities. 4.1.5 The top management, the person in charge of technology, the person in charge of quality and other key quality personnel may authorize competent personnel to exercise corresponding powers in professional laboratories.
4.1.6 The laboratory's top manager, technical director, quality director and heads of professional laboratories should have appointment documents. 4. 2 Management System
4.2.1 Policies, processes, plans, procedures, instructions and operating procedures should be documented and communicated to all relevant personnel. It should be ensured that relevant personnel are familiar with, understand and implement them.
4.2.2 The management system should include internal quality control and external quality review. 4.2.3 The top manager should organize the formulation of quality policies, goals and commitments, document them and write them into the quality manual. The top manager or quality director should publicize the quality policy and objectives to all employees. The quality policy, objectives and commitments should be concise and clear, and should be easily accessible to relevant personnel and should also be known to customers. They should include the following: a) The scope of services provided by the laboratory;
Commitment to service standards;
Clarification of the laboratory's quality management level and technical objectives; e)
Requirements for relevant personnel to be familiar with, understand and implement quality documents; The laboratory's commitment to professional behavior, inspection quality and compliance with management systems and relevant laws and regulations. e)
4.2.4 The quality manual should describe the management system and document structure, and indicate the referenced supporting procedures: The quality manual should also specify the positions of personnel in important positions. All personnel should be guided to use the quality manual and all referenced documents and implement these requirements. 4.3 Document control
4.3.1 The laboratory should formulate and implement special procedure documents to meet the requirements of document management, and should back up and archive the documents. At the same time, the retention period should be clearly specified. These controlled documents may be on paper or paperless media and should be maintained in accordance with national, regional and local regulations.
4.3.2 The implemented document control procedure should ensure: a) Management system related documents issued to laboratory personnel are approved by authorized personnel before release; establish records of the names, validity status and issuance status of documents in use, which are also called document control records6
Only current and confirmed document versions are used in corresponding places; d)
Documents should be reviewed, revised and approved by authorized personnel regularly; Invalid or obsolete documents should be immediately removed from all places of use or appropriately marked to prevent misuse; If the laboratory allows handwritten modifications to documents before they are reprinted, the modification procedures and authorities should be determined, and the modifications should be clearly marked, initialed and dated. The revised documents should be officially released as soon as possible. Procedures should be established to describe how to change and control files running in computer systems. g
All documents related to the management system should have unique identification, including: 4.3.3
Title and document number:
Revision date or revision number;
Number of pages (if applicable);
d) Issuing agency;
e) Identification of the source,Www.bzxZ.net
4.4 Quality and technical records
4.4.1 The laboratory should establish and implement a set of procedures for identifying, collecting, referencing, retrieving, storing, maintaining and safely handling quality and technical records.
4.4.2 All quality and technical records should be clear and easy to retrieve, and should comply with relevant regulations: A suitable storage environment should be provided and stored in an appropriate form to prevent damage, destruction, leakage, loss or theft. 4.4.3 The laboratory should clearly define the retention period of various quality and technical records. The retention period should be determined according to the nature of the inspection or the specific circumstances of each record, and in some cases it must also comply with the requirements of relevant laws and regulations. The quality and technical records shall at least include: a) inspection application form or sampling record; b) inspection results and reports; results printed out by the instrument; test plan; original work log book or record sheet; statistical records of test data; quality control records; complaints and measures taken; internal and external audit records; proficiency testing and (or) inter-laboratory comparison records; j) quality improvement records; instrument use and maintenance records, including internal and external calibration records; relevant records of external service provision; acceptance records of equipment and consumables; error or accident records and response measures; p) personnel training and competence records.
4.4.4 When an error occurs in a record, each error should be crossed out and the correct value filled in next to it, and the content before the change should be identifiable. All changes to the record should be signed or signed by the person making the change. The same measures should be taken for electronically stored records to avoid loss or modification of the original data.
4.5 Customer Service
4.5.1 The laboratory should appoint senior personnel to provide customers with appropriate pre-inspection professional consulting services. GB/T27403—2008
4.5.2 Authorized professionals in the laboratory can provide advice on the selection of inspections and services, including inspection items, test methods, required sample conditions, etc., at the request of the customer. The laboratory should clarify the customer's requirements and allow customers to enter the laboratory to monitor operations related to their work while ensuring the confidentiality of the laboratory and other customers. Customers can also be provided with sample preparation, packaging and delivery services. 4.5.3 The laboratory should maintain contact with customers, especially customers of large business, throughout the work process. 4.5.4 Where appropriate, authorized professional and technical personnel in the laboratory can provide explanations for the test results. 4.5.5 The laboratory should notify the customer of any delays and major deviations in the testing process. 4.5.6 The laboratory should solicit feedback from customers, whether positive or negative. These opinions should be used and analyzed and applied to improve the management system, testing activities and service levels. During the experiment, complete records of feedback and corresponding measures should be kept. The feedback and measures can be used as one of the inputs to the management review [see 4.11.2h)]. 4.6 Complaint handling
4.6.1 The laboratory should have policies and procedures for handling complaints from customers or other parties, and the methods should be diverse and multi-channel. The laboratory should keep records of complaints and investigations and corrective measures taken in response to complaints. Customer complaints and their handling should be one of the inputs to management review [see 4.11.2g)].
4.6.2 Laboratories are encouraged to survey their service customers to obtain positive and negative feedback information to improve and maintain the laboratory management system. 4.7 Control of nonconforming work
4.7.1 The laboratory should have special procedures and regulations to identify and control nonconforming work during the inspection process. These procedures and regulations should ensure that:
A designated person is responsible for handling non-conforming work issues; b)
The measures to be taken are clearly specified;
c) Consider the possible impact of non-conforming work and notify the customer if necessary; d)
Terminate the inspection if necessary and do not issue the report; Correct immediately and take corrective measures if necessary; e
If the inspection results have been released, consider whether they need to be recalled or handled in an appropriate manner; f
A designated person has the right to suspend (terminate) the inspection and approve the resumption of the inspection work; g)
Record each non-conforming work and archive it. These records should be reviewed regularly to identify trends and take preventive measures (see 4.9).
4.7.2 After the non-conforming work is controlled, the root causes of the non-conforming items should be analyzed and eliminated to prevent similar non-conforming work from occurring again.
4.7.3 The laboratory shall develop and implement relevant procedures to specify how to review and issue inspection reports on nonconforming work and keep records of these works.
4.8 Corrective Actions
After the nonconforming work found is controlled and corrected, it shall also be analyzed and considered whether corrective actions are needed. The corrective action procedure shall include an investigation process to determine the root or potential causes of the problem. Corrective actions shall be commensurate with the severity of the problem and the size of the risk it brings to avoid resource waste. b) If the corrective action taken involves a change, these changes shall be documented and issued to relevant personnel for implementation. c) The results of each corrective action shall be monitored to determine whether these measures are effective. If the investigation and analysis of the nonconforming work indicates that there may be problems with the management system, the laboratory shall conduct additional audits or management reviews of the management system aimed at solving the problems. The results of the corrective actions shall be reviewed. 4. Preventive Measures
The laboratory shall develop special procedures to detect potential nonconforming work and prevent its occurrence. 5
GB/T27403—200B
Potential nonconformities and required improvements, including technical aspects and related management system aspects, should be identified. If preventive measures are required, they should be developed, implemented and monitored to reduce the possibility of similar nonconformities and take the opportunity to improve. The preventive measures procedure should include the conditions for initiation and application. Preventive measures may also involve data analysis, trend and risk analysis, etc. All operating procedures should be reviewed regularly to identify potential nonconformities, propose quality and technical improvement suggestions, develop and implement improvement measures, and archive relevant documents and records. After the review is completed and the corresponding measures are implemented, the laboratory should evaluate the effectiveness of the above measures d)
by focusing on the relevant aspects of the review or audit.
The results of the implementation of preventive measures should be analyzed and judged, including whether the management system needs to be changed and how to change it. e)
4.10 Internal Audit
4.10.1 In order to check and verify the compliance of inspection and related work with the management system, the implementation of each element of the quality system should be checked and audited regularly (at least once a year), that is, internal audit. The internal audit should include all elements of the quality system and all relevant departments and personnel. Additional audits may be conducted when necessary [see 4.8d)]. 4.10,2 The quality manager or designated qualified personnel should be responsible for planning, organizing and implementing internal audits. As long as resources permit, the auditors should have no direct connection with the work being audited. A procedural document for internal audits should be formulated, including personnel responsibilities, audit types, frequency, basis, work flow, adopted methods and required related documents. 4.10.3 If non-conformity is found during the audit, the laboratory shall make corrections and take appropriate corrective or preventive measures when necessary, and document these measures and send them to the relevant departments for rectification and completion within the agreed time. A dedicated person shall be appointed to follow up the audit and verify the effectiveness of the rectification. If the problems found during the audit may affect the test results that have been issued, the customer shall be notified in writing. 4.10.4 The audit results shall be issued to all relevant departments and personnel in the form of documents. 4.10.5 The audit results and the follow-up verification of the rectification of problems shall be recorded and used as one of the inputs to the management review [see 4.11.2d)]. 4.11 Management Review
4.11.1 The laboratory shall review the management system and other related work, including inspection and consulting work, to ensure the suitability of the management system and the external conditions such as the resources required for effective operation, and make necessary changes or improvements in a timely manner. The management review shall be conducted at least once a year and may be conducted temporarily when necessary [see 4,8d)]. 4.11.2 The management review shall be chaired by the top management. Management review should at least consider the following aspects: a) Implementation of the last management review; b) Applicability of policies and procedures; Corrective measures, preventive measures and other quality system improvement methods and other improvement suggestions; d) Reports from management or supervisory personnel: Results of recent internal audits; Results of external reviews and participation in proficiency testing, inter-laboratory comparisons; f) Changes in the workload and type of work undertaken, financial situation h) Inspection service quality, including complaints or related information from customers, internal employees and other parties; i) Personnel training and effectiveness evaluation: j) Internal quality control results report; k) Evaluation of suppliers and service providers!
1) Appropriateness of the quality policy and analysis of quality target achievement. 4.11.3 The results of the management review should include an evaluation of the suitability of the management system, solutions to problems that affect the suitability and effectiveness of the management system, and tracking of the implementation of the solutions. 4.11.4 The results of the management review shall be communicated to the relevant personnel, and the documents and records shall be archived. 4.12 Continuous Improvement
4.12.1 The laboratory shall continuously improve the laboratory management system by meeting the requirements of the testing quality and customers. 4.12.2 The laboratory shall continuously improve the effectiveness of the laboratory management system by using channels such as quality policy, quality standards, data analysis, communication, management review, internal audit, proficiency verification, prevention and corrective action customer complaints. GB/T27403--2008
4.12.3 The laboratory shall establish a quality indicator system to monitor and evaluate the effectiveness of the inspection work. If the evaluation results of the indicator indicate that there is a possibility of improvement, it should be considered so that the quality of laboratory work can be continuously improved. 5 Technical Requirements
5.1 Purchasing Services
5.1.1 The laboratory shall establish policies and procedures for selecting and purchasing services and supplies that affect the quality of testing. Note: Services include: calibration (verification) services: design, installation, commissioning of facilities and environmental conditions, etc. Supplies include: testing equipment, auxiliary equipment, reagents, consumables, etc. See 5.4 for equipment procurement.
5.1.2 The laboratory shall regularly evaluate the suppliers of important supplies and services that affect the quality of testing. The evaluation shall take into account changes in experimental requirements, product quality, etc. The laboratory shall keep evaluation records and a list of qualified suppliers and update them in a timely manner. 5.1.3 In the procurement documents for items that affect the quality of test results, the laboratory shall describe the purchased items. The technical content of these procurement documents shall be reviewed and approved before issuance. Note: The description may include model, type, grade, concentration, specification, quality requirements and management system standards for the production of the purchased items, etc. 5.14 The laboratory shall accept the purchased services and supplies that affect the quality of testing. Only when they are inspected before use or otherwise proven to comply with the provisions and requirements of the relevant test methods can they be put into normal use. The laboratory shall keep all records of compliance inspections.
Note 1: Reagents that affect the quality of molecular biology testing include (but are not limited to): a) reagent trays (such as nucleic acid extraction kits, PCR premix master reaction solutions, reverse transcription kits, etc.); h) enzymes (such as heat-resistant DNA synthase, restriction endonucleases, lysozyme and proteinase K, etc.); primers.
Note 2: When appropriate, the supplier's management system compliance statement can also be used as verification information. 5.1.5 The laboratory shall provide appropriate storage locations and storage conditions according to the biological characteristics and safety characteristics of the supplies that affect the quality of testing to ensure their quality during storage. 5.1.6 The laboratory shall register and label the purchased supplies that affect the quality of testing. The labeling content should include the shelf life, sealing date, etc.
5.2 Personnel
5.2, 1 The laboratory shall have sufficient human resources to meet the needs of food molecular biology testing and operation management system. 5.2.2 The laboratory should stipulate the qualifications and job responsibilities of all personnel (management, technical personnel and support staff), and have the objectives and evaluation standards for each position. The work content of each position should be described in detail and documented and updated in a timely manner. 5.2.3 The laboratory should ensure the capabilities of all personnel who operate specialized equipment, engage in molecular biology testing, evaluate results and sign test reports. If laws and regulations have training and skill requirements for specific positions, they should comply with laws and regulations. Personnel engaged in specific work, such as those engaged in PCR and chip testing, should be qualified based on the corresponding education, training, experience and (or) demonstrable skills: when using employees in training, they should be properly supervised. Note: In addition to having the appropriate qualifications, training, experience and sufficient knowledge of the tests being conducted, the personnel who provide opinions and interpretations of the test reports must also have:
a) Knowledge of the materials, composition and production of the test objects, such as the foreign genes introduced into different strains of genetically modified crops;) Knowledge of the general requirements specified in laws and standards; c) Understanding of the extent of the impact of abnormal situations on the test objects and the test process. 5.2.4 The laboratory should formulate policies and procedures for personnel training. Training needs should be determined and corresponding training plans should be formulated. Appropriate consideration should be given to pregnancy, immune deficiency and physical disabilities. The plan should be adapted to the current and expected tasks of the laboratory. The effectiveness of the training (including the effectiveness of the trainees' ability to perform designated tasks) should be evaluated. If necessary, further training may be conducted and re-evaluated. The content of personnel training should include but not be limited to the following aspects (when applicable): 72 The laboratory shall continuously improve the effectiveness of the laboratory management system through the use of channels such as quality policy, quality standards, data analysis, communication, management review, internal audit, capability verification, prevention and corrective action customer complaints. GB/T27403--2008
4.12.3 The laboratory shall establish a quality indicator system to monitor and evaluate the effectiveness of the inspection work. If the evaluation results of the indicator indicate that there is a possibility of improvement, it should be considered to continuously improve the quality of laboratory work. 5 Technical requirements
5.1 Procurement services
5.1.1 The laboratory shall formulate policies and procedures for selecting and purchasing services and supplies that affect the quality of testing. Note: Services include: calibration (verification) services: design, installation, commissioning of facilities and environmental conditions, etc. Supplies include: testing equipment, auxiliary equipment, reagents, consumables, etc. See 5.4 for equipment procurement.
5.1.2 The laboratory shall regularly evaluate the suppliers of important supplies and services that affect the quality of testing, and the evaluation shall take into account changes in experimental needs, product quality, etc. The laboratory shall keep the evaluation records and the list of qualified suppliers and update them in time. 5.1.3 In the procurement documents of items that affect the quality of the test results, the laboratory shall describe the purchased items. The technical content of these procurement documents shall be reviewed and approved before being issued. Note: This description may include the model, type, grade, concentration, specification, quality requirements and management system standards for the production of the purchased items. 5.14 The laboratory shall accept the purchased services and supplies that affect the quality of the test. Only when they are inspected before use or otherwise proved to comply with the provisions and requirements of the relevant test methods can they be put into normal use. The laboratory shall keep all records of compliance checks. Note 1: Reagents that affect the quality of molecular biology tests include (but are not limited to): a) reagent disks (such as nucleic acid extraction kits, PCR premix master reaction solutions, reverse transcription kits, etc.); h) enzymes (such as heat-resistant DNA synthase, restriction endonucleases, lysozymes and proteinase K, etc.); primers. Note 2: When appropriate, the supplier's management system compliance statement can also be used as verification information. 5.1.5 The laboratory shall provide appropriate storage locations and storage conditions according to the biological characteristics and safety characteristics of the supplies that affect the quality of the test, so as to ensure their quality during storage. 5.1.6 The laboratory shall register and label the supplies that affect the quality of the test, and the labeling content should include the shelf life, sealing date, etc.
5.2 Personnel
5.2, 1 The laboratory shall have sufficient human resources to meet the needs of food molecular biology testing and operation management system. 5.2.2 The laboratory shall specify the qualifications and job responsibilities of all personnel (management, technical personnel and support personnel), and have the objectives and evaluation standards for each position responsibility. The work content of each position shall be described in detail and documented and updated in a timely manner. 5.2.3 The laboratory shall ensure the competence of all personnel who operate specialized equipment, conduct molecular biology testing, evaluate results and sign test reports. If laws and regulations have training and skill requirements for specific positions, they shall comply with the provisions of laws and regulations. Personnel engaged in specific work, such as those engaged in PCR and chip testing, should be qualified based on appropriate education, training, experience and/or demonstrable skills: When using employees in training, they should be properly supervised. Note: In addition to having appropriate qualifications, training, experience and sufficient knowledge of the tests performed, personnel who provide opinions and interpretations on test reports should also have:
a) Knowledge of the materials, composition and production of the test objects, such as foreign genes introduced into different strains of genetically modified crops;) Knowledge of the general requirements specified in regulations and standards; c) Understanding of the impact of abnormal situations on the test objects and the test process. 5.2.4 The laboratory should formulate policies and procedures for personnel training. Training needs should be determined and corresponding training plans should be formulated. It is advisable to appropriately consider pregnancy, immune deficiency and physical disabilities. The plan should be adapted to the current and expected tasks of the laboratory. The effectiveness of the training (including the effectiveness of the trainees' ability to perform the designated work) should be evaluated. If necessary, further training can be conducted and re-evaluated. The content of personnel training should include but not be limited to the following aspects (when applicable):2 The laboratory shall continuously improve the effectiveness of the laboratory management system through the use of channels such as quality policy, quality standards, data analysis, communication, management review, internal audit, capability verification, prevention and corrective action customer complaints. GB/T27403--2008
4.12.3 The laboratory shall establish a quality indicator system to monitor and evaluate the effectiveness of the inspection work. If the evaluation results of the indicator indicate that there is a possibility of improvement, it should be considered to continuously improve the quality of laboratory work. 5 Technical requirements
5.1 Procurement services
5.1.1 The laboratory shall formulate policies and procedures for selecting and purchasing services and supplies that affect the quality of testing. Note: Services include: calibration (verification) services: design, installation, commissioning of facilities and environmental conditions, etc. Supplies include: testing equipment, auxiliary equipment, reagents, consumables, etc. See 5.4 for equipment procurement.
5.1.2 The laboratory shall regularly evaluate the suppliers of important supplies and services that affect the quality of testing, and the evaluation shall take into account changes in experimental needs, product quality, etc. The laboratory shall keep the evaluation records and the list of qualified suppliers and update them in time. 5.1.3 In the procurement documents of items that affect the quality of the test results, the laboratory shall describe the purchased items. The technical content of these procurement documents shall be reviewed and approved before being issued. Note: This description may include the model, type, grade, concentration, specification, quality requirements and management system standards for the production of the purchased items. 5.14 The laboratory shall accept the purchased services and supplies that affect the quality of the test. Only when they are inspected before use or otherwise proved to comply with the provisions and requirements of the relevant test methods can they be put into normal use. The laboratory shall keep all records of compliance checks. Note 1: Reagents that affect the quality of molecular biology tests include (but are not limited to): a) reagent disks (such as nucleic acid extraction kits, PCR premix master reaction solutions, reverse transcription kits, etc.); h) enzymes (such as heat-resistant DNA synthase, restriction endonucleases, lysozymes and proteinase K, etc.); primers. Note 2: When appropriate, the supplier's management system compliance statement can also be used as verification information. 5.1.5 The laboratory shall provide appropriate storage locations and storage conditions according to the biological characteristics and safety characteristics of the supplies that affect the quality of the test, so as to ensure their quality during storage. 5.1.6 The laboratory shall register and label the supplies that affect the quality of the test, and the labeling content should include the shelf life, sealing date, etc.
5.2 Personnel
5.2, 1 The laboratory shall have sufficient human resources to meet the needs of food molecular biology testing and operation management system. 5.2.2 The laboratory shall specify the qualifications and job responsibilities of all personnel (management, technical personnel and support personnel), and have the objectives and evaluation standards for each position responsibility. The work content of each position shall be described in detail and documented and updated in a timely manner. 5.2.3 The laboratory shall ensure the competence of all personnel who operate specialized equipment, conduct molecular biology testing, evaluate results and sign test reports. If laws and regulations have training and skill requirements for specific positions, they shall comply with the provisions of laws and regulations. Personnel engaged in specific work, such as those engaged in PCR and chip testing, should be qualified based on appropriate education, training, experience and/or demonstrable skills: When using employees in training, they should be properly supervised. Note: In addition to having appropriate qualifications, training, experience and sufficient knowledge of the tests performed, personnel who provide opinions and interpretations on test reports should also have:
a) Knowledge of the materials, composition and production of the test objects, such as foreign genes introduced into different strains of genetically modified crops;) Knowledge of the general requirements specified in regulations and standards; c) Understanding of the impact of abnormal situations on the test objects and the test process. 5.2.4 The laboratory should formulate policies and procedures for personnel training. Training needs should be determined and corresponding training plans should be formulated. It is advisable to appropriately consider pregnancy, immune deficiency and physical disabilities. The plan should be adapted to the current and expected tasks of the laboratory. The effectiveness of the training (including the effectiveness of the trainees' ability to perform the designated work) should be evaluated. If necessary, further training can be conducted and re-evaluated. The content of personnel training should include but not be limited to the following aspects (when applicable):
Tip: This standard content only shows part of the intercepted content of the complete standard. If you need the complete standard, please go to the top to download the complete standard document for free.