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011. Overview of Inspection and Testing 01 The meaning of inspection and testing: Understand the definitions of terms such as testing, inspection, experimentation, examination, verification, and validation. Understand the differences between these terms. ——Inspection: A review of a product, process, service, or installation, or a review of its design, to determine its compliance with specific requirements, or, based on professional judgment, its compliance with general requirements. The inspection of the process can include checks on personnel, facilities, technology, and methods ； In the process of conformity assessment, inspection is also referred to as examination or review. Inspection activities exist in various fields such as commodity import and export, special equipment, transportation, construction projects, information security, energy conservation and environmental protection, and public services – testing: a technical procedure that involves determining one or more characteristics of the object to be assessed according to established procedures, and then carrying out corresponding actions or providing services. Procedures are pre-determined processes and methods organized to ensure the smooth execution of a certain activity. They are mainly applicable to materials, products, or processes. Testing, also known as trials or tests. The test determines one or more characteristics according to a procedure. ——Inspection and testing institutions: A general term for organizations that engage in inspection and testing activities. Verification: Providing objective evidence to demonstrate that specified requirements are met; measurement uncertainty considerations may be taken into account where applicable, and it can involve processes or measurement procedures ； Materials, compounds, or measurement systems. Verification in the conformity assessment process refers to the inspection of the measurement system, its labeling, and the issuance of a verification certificate. In the field of legal metrology, verification is also known as calibration. Verification cannot be confused with calibration, and not every verification is validation. ——Confirmation: An assertion that the specified requirements have been met to fulfill certain intended uses or application requirements. Validation includes a detailed description of the requirements, the determination of method-specific quantities, a check to verify that the requirements can be met using the method, and a statement regarding its effectiveness. Confirmation is usually a balance between cost, risk, and technical feasibility. 02 Problems and Countermeasures in Inspection and Testing in Our Country — Problem: A large number of homogeneous inspection and testing institutions, with uneven distribution ； Some testing and inspection agencies are not operating properly ； Idle resource waste and redundant construction coexist ； Most testing and inspection agencies lack vitality ； Inspection and testing services are out of sync with market demands ； The development goals of testing institutions are not clear ； Insufficient professional development ； The supply-side contradictions identified cannot meet the needs of development — Solutions: Adhere to market orientation and internationalization, follow the principles of unified management, deepen reforms, standardize the market, and promote development ； What specific elements do the requirements for testing and inspection under market-oriented reform qualification assessment encompass? Inspection requirements: Inspectors ； Monitoring facilities and environmental conditions ； Detection equipment ； Detection method ； Test sample ； Detection technology records ； Measurement uncertainty ； Validity of measurement results ； Test report ； The testing activities do not meet the requirements ； Inspection requirements: Personnel ； Facilities and equipment ； Inspection method ； Inspection items and disposal of samples ； Record ； Inspection Report ； Subcontracting. 022. Testing 01 Qualification assessment requirements for testing: GB/T27025 \"General requirements for the competence of testing and calibration laboratories\" – Inspection personnel: personnel qualifications, a reasonable structure, timely training, strict evaluation, management and supervision, to form a complete personnel management system. It provides the strongest guarantee for realizing its quality policy ； It is also the most crucial element in an accreditation body’s assessment of its capabilities. The laboratory should employ permanent staff or contract workers, and ensure that all personnel involved in testing activities possess the appropriate qualifications and skills, as well as be under supervision. ——Testing facilities and environmental conditions: The basis upon which the laboratory ensures that the facilities and environmental conditions meet the requirements. It will not render the test results invalid, nor will it have an adverse effect on the required measurement quality. When relevant specifications, methods, and procedures specify requirements for environmental conditions, or when such conditions affect the validity of the results, the laboratory shall monitor, control, and record those environmental conditions. ——Testing equipment: Testing equipment refers to the general term for measuring instruments, software, measurement standards, reference materials, reference data, reagents, consumables, or auxiliary devices. The proper selection, assembly, use, and maintenance of equipment are directly related to the reliability and accuracy of the testing data. The laboratory shall be equipped with all the sampling, measuring, and testing equipment required for testing, and such equipment shall be under the permanent control of the laboratory. For equipment subcontracted from laboratories, CNAS recognizes only the laboratory’s management capabilities, not its technical capabilities. What is the difference between periodic verification and calibration of equipment? The equipment used for detection shall be verified and calibrated before being put into use or put back into use. Verification during the equipment’s usage is not recalibration. Calibration addresses the issue of accuracy in the device’s readings, while periodic verification mainly checks whether the device’s calibration status remains stable. Periodic verification of the equipment is not necessary; it is carried out only when required. When periodic calibration alone cannot ensure the reliability of the device’s calibrated state within its calibration validity period, periodic verification is necessary. ——Testing method: If international, regional, or ** standards, or other recognized regulatory documents contain concise and sufficient information on how to conduct the testing, there is no need to add anything or rewrite it as an internal procedure. The testing methods selected in the laboratory are those that correspond to international, regional, or **established standards. When the client has not established a testing method, the laboratory should recommend the above standards. When using methods developed or modified by the laboratory, the customer should be informed of the method selected. The laboratory should ensure that the latest valid version of the standard is used, unless that version is inappropriate or unusable. If the standard method contains only general requirements and no specific requirements, the general requirements are temporarily not applicable; they apply only when specific requirements exist. The old standards were used in product manufacturing; although new standards now exist, in cases of quality disputes requiring quality arbitration, the old standard methods should still be used as the basis for testing. The laboratory shall validate non-standard methods, methods developed by the laboratory, standard methods used outside the prescribed range, or other modified standard methods, and retain the validation records. Validation techniques include calibration using reference standards or reference materials ； Compare with the results obtained from other methods ； Inter-laboratory comparison ； Conduct a systematic review of the factors affecting the results ； The uncertainty of the obtained results is determined based on an understanding of the theoretical principles and practical experience of the method. ——Test samples: The laboratory should establish a labeling system for test samples, and these labels should be retained on the samples throughout the entire testing process. When the laboratory receives a sample, it shall check its suitability and record any abnormalities or deviations. When a client knows that the price has been reduced but still requests testing under specified conditions, the laboratory should include a disclaimer in the report indicating that the deviation may affect the results. ——Testing technology records: Records of laboratory activities indicate whether the testing met the specified quality standards or process parameters. Each test record should contain sufficient information to identify the factors affecting uncertainty when possible, and to reproduce the conditions as closely as possible. According to the observation rules, observations, data, and calculations must be recorded at the time they are generated; retroactive recording, organization, or re-entry is not allowed. Requests to correct errors in the records should be traceable to the previous version or the original observation records. The original data and documents, along with the date of the correction, an indication of what was modified, and the person responsible for the correction, must be retained. ——Measurement uncertainty: The quality of measurement results is assessed through measurement error, which indicates whether the short-term quality control process of measurement remains under control and whether the measurement results stay stable and consistent ； To determine whether the measurement capability meets the requirements for production profitability, measurement uncertainty is used as a measure. The greater the measurement uncertainty, the poorer the measurement capability; laboratories conducting tests should assess the measurement uncertainty ； In some cases, recognized testing methods specify limits for the values of the main sources of measurement uncertainty, as well as the format in which the calculated results should be presented. When evaluating uncertainty, all significant uncertainty components under the given conditions should be considered using appropriate analytical methods. Sources of uncertainty include the reference standards and reference materials used ； Methods and equipment used ； Environmental conditions ； The performance and condition of the item being tested, as well as the operator. ——Validity of test results: To ensure that the test results meet the required standards, the laboratory should employ appropriate techniques and procedures to monitor the testing process and eliminate any factors in each quality stage that could lead to non-conformities or unsatisfactory outcomes; this is what quality control entails. Quality control is the fundamental means of quality assurance. There are two types of quality control purposes: internal and external. Internal quality assurance is the mechanism by which a laboratory builds trust with its management, while external quality assurance is used by the laboratory to build trust with clients and other stakeholders. Test reports: Test reports represent the final output of a laboratory’s work. They generally include the information requested by the client, the data necessary to describe the tests conducted, as well as information related to the methods used. The laboratory is responsible for all information in the report, except for the information provided by the client; any data supplied by the client must be clearly identified. When the information provided by the client may affect the validity of the results, a disclaimer should be included in the report. When the laboratory is not responsible for sampling, the report should state that the results apply only to the samples received. The compliance statement should include the applicable results ； Specifications, standards that are met or not met, or parts of them ； Any modifications to the application’s decision rules or any reports that have been generated are provided solely in the form of additional files or data transmissions. When it is necessary to issue a completely new report, it should be assigned a unique identifier and indicate the original report that it replaces. ——Non-conformities in testing activities: Refer only to situations where any aspect or result of the testing process does not comply with the established procedures or the requirements agreed upon with the customer. Based on the specific conditions of the laboratory, analyze in which stages non-conformities mainly occur during the inspection and testing process When a severity assessment of non-conformities indicates that the non-conformity may occur again, or when there are doubts regarding the laboratory’s operations and their compliance with its management system, the laboratory shall take corrective actions. 033. Inspection – Basic requirements for inspection under GB/T 27020 and ISO 17020. An inspection body or checking organization acts on behalf of private clients; its parent organization or governmental authority conducts evaluations. The purpose is to provide said organizations with information regarding the compliance of the items being inspected with regulations, standards, specifications, inspection plans, or contracts. Inspection or testing parameters include quantity, quality, safety, suitability, and the ongoing safe compliance of the device or system in operation. ISO17020 can be used as a requirement document for accreditation, peer review, or other forms of evaluation; it applies to testing laboratories that are involved in the inspection of imported and exported goods ； Inspection of special equipment ； Transportation inspection ； Construction project supervision ； Information security inspection ； Energy conservation and environmental protection inspection ； Inspection systems for institutions such as public service inspections—referring to the management inspection plans that include rules, procedures, and methods for conducting inspections—use the same regulatory requirements, as well as specific rules and procedures, for certain types of inspections. 02 2) Basic requirements for testing institutions – Personnel: The personnel responsible for testing must possess the appropriate qualifications ； Training experience ； Possess the relevant work experience, be familiar with the requirements for the inspections carried out, and have the ability to make professional judgments regarding compliance with the overall requirements based on the inspection results and to issue corresponding reports. The personnel responsible for inspection should also possess knowledge of the manufacturing techniques related to the products being inspected, as well as knowledge of the ways in which those products or processes are used or intended to be used. They need to be aware of the defects that may arise during use or service, and they must understand the significance of any deviations detected for the proper functioning of the products or processes in question. As for facilities and equipment: inspection agencies should have sufficient and appropriate equipment and facilities to carry out all activities related to their inspection services, and they must ensure that such facilities and equipment remain suitable to meet the requirements for their intended use. These devices must be calibrated before being put into use to ensure that the measurements taken by the testing laboratory can be traced back to ** or international measurement standards. When traceability is not possible, the testing laboratory shall provide sufficient evidence of the relevance or accuracy of the test results. Defective devices should be isolated and clearly labeled to prevent misuse, and it should be checked whether the defects affect previous test results. ——Inspection method: The inspection body shall use the inspection methods and procedures specified in the requirements, based on the inspection activities carried out. If the inspection agency deems the inspection method proposed by the client to be inappropriate, it shall notify the client. The requirements upon which the inspection is conducted are usually specified in regulations, standards, specifications, inspection plans, or contracts. Specifications may include customer requirements or internal requirements. ——Inspection items and disposal of samples: The inspection body shall ensure the uniqueness of the identification of the samples and items to be inspected. Records: Records shall contain sufficient information to enable proper evaluation and tracing of the inspection activities. Inspection reports: When an inspection report or certificate includes results provided by a subcontractor, such sources shall be clearly identified. Subcontracting: When the inspection body subcontracts any part of the inspection work, it shall ensure and be able to prove that the subcontractor has the capability to carry out the corresponding services. The customer should be informed of the intention to subcontract a certain part of the inspection work, and the subcontractor must be accepted by the customer. When subcontracting certain specialized tasks, qualified and experienced personnel should be assigned to conduct an independent review of the results of the subcontracting. ——Classification requirements for testing agencies: Class A testing agencies must be independent of all parties involved. Their personnel shall not engage in any activities that could compromise the independence and integrity of their testing decisions. Testing agencies should not be part of a legal entity that is involved in the design, production, supply, installation, procurement, ownership, use, or maintenance of the items to be tested. Testing agencies should have no connections with such entities. Category B – Inspection services are provided only to the parent company of the inspection agency. Category C – The inspection agency must implement preventive measures within its organizational structure to ensure that responsibilities related to inspections and other activities are properly separated. For a Class C inspection body, the tasks of design, production, supply, installation, procurement, service, maintenance, and inspection carried out on the same object should not all be performed by the same person. If regulations explicitly permit one person to handle these tasks simultaneously, it is acceptable as long as such an exception does not compromise the accuracy of the inspection results. Inspections carried out by Class C inspection agencies cannot serve as third-party inspections for the same inspection activity, as they do not meet the independence requirements of Class A. 03 The internal management system requirements for inspection agencies: Management Approach A – management system documents, document control, record control, management review, internal audits, corrective actions, preventive actions; Management Approach B – management in accordance with 9001 standards. 04 Accreditation of inspection and testing agencies. 01 The role of inspection and testing: Accreditation of inspection and testing agencies is a fundamental licensing system in China for market access and the provision of inspection and testing services. The accreditation of testing and inspection agencies refers to the evaluation and authorization process carried out by the Certification and Accreditation Administration of the State Administration for Market Regulation, as well as provincial regulatory authorities, in accordance with relevant laws, regulations, standards, and technical specifications, to determine whether the basic conditions and technical capabilities of such agencies meet the requirements set forth by law. Inspection and testing institutions generally refer to product inspection and testing laboratories, as well as calibration laboratories (metrology rooms). 02 Basic requirements for the accreditation of inspection and testing institutions – Inspection and testing institutions must obtain the appropriate accreditation to carry out the following activities: · Providing data and results that serve as evidence for judicial decisions; · Working for administrative agencies, arbitration bodies, in social and economic activities, and for public welfare purposes; · Other activities for which laws and regulations require accreditation. Conditions for the accreditation of inspection and testing institutions: What criteria must inspection and testing institutions meeting the requirements for accreditation fulfill? Briefly describe the evaluation requirements for the accreditation of inspection and testing institutions from the aspects of people, machinery, materials, methods, and environment. A) Legal persons or organizations capable of assuming corresponding legal responsibilities. Legally established legal persons include institutional legal persons and public institution legal persons ； Corporate legal person ； As the primary responsible party for testing and inspection, social organization-based testing and inspection agencies must be accountable for the data results they produce and bear the corresponding legal responsibilities. These agencies operate in accordance with the principles of objectivity, independence, fairness, and integrity, and are obliged to keep confidential any information that constitutes secrets, trade secrets, or technical secrets. B) Inspection and testing technicians and management personnel suitable for carrying out inspection and testing activities – There should be standardized management regarding the qualification verification, appointment, authorization, and maintenance of capabilities of such personnel. The top management of the inspection and testing organization is responsible for its management system, bearing leadership responsibilities and fulfilling commitments; it is necessary to appoint a quality manager, a technical manager, and key management personnel. An authorized signatory of a testing and inspection agency, who has passed the assessment by the competent authority for accreditation and issues testing and inspection reports or certificates within the scope of capabilities approved by such accreditation, shall not appoint any agents to act on their behalf. All personnel involved in sampling, operating equipment, conducting inspections and tests, issuing reports and certificates, as well as providing opinions and explanations, must have their competence verified before taking on their duties. C) The fixed work location and working environment must meet the requirements for inspections and tests; when the environment has an impact on the quality of the results, necessary documents must be prepared, along with appropriate control measures. Ensure that environmental conditions do not render the test results invalid or have an adverse effect on the quality of testing and inspection. Testing and inspection agencies shall monitor, control, and record the environmental conditions required by standards or specifications. D) Necessary testing and inspection equipment and facilities: For equipment that has a significant impact on the test and inspection results, a calibration or verification plan should be established to ensure the metrological traceability of those results. When the reference standards cannot be traced back to ** or international measurement standards, the measurement results should be traced back to RM (reference materials), recognized or agreed-upon measurement methods and standards, or through means such as comparison, in order to demonstrate that the measurement results are consistent with those of similar testing and inspection institutions. After regular inspection or calibration of the equipment, it should be verified and fitted with a calibration status label; it may only be used after it is confirmed to meet the requirements for testing and inspection. When necessary, periodic checks are carried out to ensure the stability of specific equipment. Records of the equipment and its software that have a significant impact on inspection and testing should be kept. Equipment that has previously produced suspicious results due to overload or improper handling, or that has been shown to be defective and exceeds specified limits, must be taken out of use and isolated to prevent misuse. Management procedures for reference materials should be established and maintained. E) Has a management system that functions effectively. The management system of testing and inspection agencies includes a quality management system and a technical management system ； Administrative management system. Testing and inspection agencies shall establish a management system that suits their actual conditions, is appropriate for their testing and inspection activities, and ensures independence, fairness, scientificity, and integrity. Testing and inspection agencies shall articulate their quality policy, establish quality objectives, and review them during management reviews. They must exercise control over all stages related to document preparation, review, approval, issuance, identification, modification, and revocation; furthermore, they should control relevant documents within the management system in accordance with established procedures. Testing and inspection agencies must also effectively control contract reviews and any deviations from contracts by following predefined procedures for reviewing customer requirements, standards, and contracts. It is necessary to document the relevant review processes or outcomes. When a testing and inspection agency needs to subcontract testing and inspection tasks due to workload, it should subcontract them to agencies that have been accredited as testing and inspection institutions and have the capability to complete such subtasks. Unless it is a subcontract specified by the client or laws and regulations, the inspection and testing agency shall be responsible for the results of the subcontract. Testing and inspection agencies shall implement quality control over purchased items and related services to ensure the quality of the testing and inspection results. Testing and inspection agencies should communicate with clients to fully understand their needs; on the condition that confidentiality, safety, and the normal progress of testing and inspection are maintained, they may allow clients to enter the testing and inspection area to observe the activities. Non-compliance occurs when inspection and testing activities fail to meet the requirements of standards or technical specifications, the requirements agreed upon with the customer, or the requirements specified in the system documents. The customer should be notified when there are factors that may affect the test and inspection results. Testing and inspection agencies shall implement corrective and preventive measures. The records of testing and inspection agencies are divided into two categories: quality management records and technical records. Internal audits are planned, systematic, and independent inspection activities carried out by testing and inspection agencies on their own initiative, in accordance with the provisions of their management system documents, covering all aspects of the management system. Management review involves periodic and systematic evaluations conducted by top management to assess the suitability, adequacy, and effectiveness of the management system, thereby ensuring compliance with the quality policy and quality objectives. Testing and inspection agencies shall use appropriate methods for testing. Inspection and testing methods are divided into standard methods and non-standard methods. When the method established by the client is an enterprise method, it cannot be used directly as a method for qualification approval; it must first be converted into the organization’s own method and approved before it can be utilized. A deviation refers to a written permission under certain conditions, such as a specified allowable range, a certain quantity, and a particular time period. When transmitting test and inspection results by telephone, fax, or electronic means, testing and inspection agencies shall meet confidentiality requirements and take appropriate measures to ensure the security, validity, and integrity of the data and results. When establishing archives for inspection and testing reports or certificates, inspection and testing agencies shall file each inspection and testing contract, original records, as well as the inspection and testing reports or certificates together; the retention period for such archives shall be no less than 6 years. F) Meets the specific requirements of relevant laws, regulations, standards, or technical specifications.