Notice of Chongqing agricultural and Rural Committee on printing and distributing the implementation rules for the assessment of Chongqing agricultural product quality and safety testing institutions
By: Date: 2022-07-18 Categories: authoritativerelease Tags: ,
Agricultural and rural committees, animal husbandry (Veterinary) development centers, fruit industry development centers of all districts and counties (autonomous counties), Chongqing high tech Zone reform and Development Bureau of Western Science City, agriculture and Forestry Bureau of Wansheng Economic Development Zone, Chongqing agricultural product quality and safety inspection institutions, and relevant units:
 
The”detailed rules for the implementation of the assessment of Chongqing agricultural product quality and safety testing institutions” is hereby printed and distributed to you, please comply with it.
 
Chongqing agricultural and Rural Committee
 
July 14th, 2022
 
Implementation rules for the assessment of Chongqing agricultural product quality and safety testing institutions
 
 Chapter I General Provisions
 
Article 1 in order to comprehensively strengthen the management of the municipal agricultural product quality and safety inspection institutions (hereinafter referred to as the quality inspection institutions) and standardize the assessment of the municipal agricultural product quality and safety inspection institutions (hereinafter referred to as the assessment), the detailed rules for the implementation of the assessment are formulated in accordance with the requirements of the law of the people’s Republic of China on the quality and safety of agricultural products and other relevant laws, administrative regulations and work specifications, and in combination with the actual situation of the supervision of the quality and safety of agricultural products in our city.
 
Article 2 quality inspection institutions can only engage in external inspection of agricultural products, agricultural inputs and the environment of origin after being assessed and qualified by inspection and testing institutions.
 
Article 3 Chongqing Municipal Agricultural and rural commission is responsible for the supervision and administration of the examination of quality inspection institutions within the scope of this Municipality. Chongqing agricultural and rural commission entrusted Chongqing agricultural products quality and Safety Center (hereinafter referred to as the technical examination institution) to be responsible for the technical examination of the assessment of quality inspection institutions.
 
Article 4 these rules are applicable to the assessment of quality inspection institutions in Chongqing.
 
 Chapter II basic conditions and capability requirements
 
Article 5 a quality inspection institution applying for examination shall be established according to law and meet the following basic conditions:
 
(1) having the qualification of an independent legal person or the certificate of authorization of a legal entity, and being able to bear corresponding legal liabilities;
 
(2) to ensure that the testing activities are carried out objectively, impartially and independently;
 
(III) have the personnel, quality system, instruments and equipment, facilities and environment required to carry out the quality and safety inspection of agricultural products.
 
Article 6 a quality inspection institution shall have management and technical personnel suitable for the quality and safety testing activities of agricultural products it is engaged in.
 
Technical personnel engaged in the quality and safety inspection of agricultural products should have a technical secondary school degree or above in relevant majors, and be qualified after the examination of their institutions, and take up their posts with certificates.
 
Article 7 the number of technical personnel of a quality inspection institution shall not be less than 5, of which the proportion of personnel with intermediate or above technical titles or equivalent capabilities shall not be less than 40%.
 
(I) the person in charge of technology, the person in charge of quality and the authorized signatory shall have an intermediate or above technical title or equivalent ability, and have been engaged in work related to the quality and safety of agricultural products for more than 5 years. Graduated from doctor’s degree, engaged in inspection and testing of related majors for 1 year or more; Graduate from master’s degree, and have been engaged in relevant professional inspection and testing for 3 years or more; Bachelor degree, engaged in relevant professional inspection and testing work for 5 years or more; Graduated from college and engaged in inspection and testing of related majors for 8 years or more, which can be regarded as the same ability.
 
(II) all personnel of the quality inspection institution shall be trained in professional knowledge and relevant laws and regulations, familiar with the quality system, pass the examination, and work with certificates.
 
(III) the quality inspection institution shall have short-term, medium-term and long-term training plans for all kinds of personnel, and have implementation records.
 
Article 8 the quality inspection institution shall establish a quality management and quality assurance system suitable for its testing work and ensure the effective operation of the system.
 
(I) quality system documents such as”quality manual”,”procedure documents and management system”,”operation instructions” shall be available.
 
(II)”quality manual” shall describe all elements of the quality system, including institutions and personnel, quality system, instruments and equipment, testing work, records and reports, facilities and environment. It should also include:
 
  1. Overview of quality inspection organization;
 
  2. The legal status, nature and tasks of the institution;
 
  3. Quality policy and objectives;
 
  4. The impartiality statement of the institution and its competent unit (when applicable);
 
  5. Post responsibilities of all departments and personnel;
 
  6. Organizational structure block diagram;
 
  7. Laboratory distribution plan;
 
  8. A list of the organization’s personnel composition (indicating the date of birth, educational background, major, office, position or position, professional title) and a resume of personnel with intermediate professional titles or above;
 
  9. List of main testing instruments and equipment (indicating instrument and equipment name, model and specification, instrument number, precision or other performance indicators, manufacturer, purchase date, unit price, measured items, management personnel, operators, etc.);
 
  10. Business scope of the institution, testing product (parameter) catalogue and its standard code and name;
 
  11. Periodic table for verification and calibration of measuring instruments, self inspection and self calibration measurement value traceability or transmission block diagram;
 
  12. Environmental technical parameters and control measures;
 
  13. Inspection work flow chart;
 
  14. Block diagram of quality assurance measures, including element composition, relationship of various measures, responsible departments or personnel, etc;
 
  15. Contents and schedules of procedure documents and management systems;
 
  16. Catalogue and attached table of operating procedures for main instruments and equipment.
 
(III)”procedure documents and management system” shall include:
 
  1. Document control and maintenance procedures;
 
  2. Quality system audit procedures;
 
  3. Management review procedures;
 
  4. Metrological verification procedures of instruments and equipment;
 
  5. Instrument operation inspection procedure;
 
  6. Instrument and equipment management procedures (including purchase, acceptance, commissioning, use, maintenance, management, fault repair, degradation and scrap);
 
  7. Use and management procedures of measurement standards, reference materials and standard solutions;
 
  8. Sample extraction, transmission, storage and disposal procedures;
 
  9. Inspection work control procedure;
 
  10. Re inspection and determination procedures;
 
  11. Review procedure of entrusted inspection agreement (contract);
 
  12. Adopt non-standard methods and procedures;
 
  13. Carry out the working procedure of testing new projects;
 
  14. Filling and verification procedures of original records;
 
  15. Record management control procedure;
 
16. Preparation, review and approval procedures of inspection reports;
 
  17. File management procedures for original data and other technical materials;
 
  18. Report, analysis and handling procedures of detection accidents;
 
  19. On site inspection procedures (if applicable);
 
  20. Inspection subcontracting procedures (if necessary);
 
  21. Complaint handling procedures;
 
  22. Procurement and management procedures for external support services and supplies;
 
  23. Toxic and dangerous goods management procedures;
 
  24. Testing quality assurance and control procedures (including capability verification and comparison procedures);
 
  25. Control procedures for corrective and preventive measures;
 
  26. Allowable deviation from the control procedure;
 
  27. Measurement uncertainty evaluation procedure (if applicable);
 
  28. Facility and environmental control procedures;
 
  29. Personnel training and assessment system;
 
  30. Validation system of technical documents;
 
  31. Annual work plan, inspection and summary system;
 
  32. Laboratory safety and health and other internal affairs management system;
 
  33. Confidentiality system of technical data and information;
 
  34. Charging management system;
 
  35. Document management system;
 
  36. Laboratory waste disposal system, etc.
 
(IV)”operation instructions” shall include:instrument and equipment calibration procedures, operation inspection procedures, instrument operation procedures, inspection implementation rules, various quality record formats, etc.
 
(V) there are quality control procedures for testing results to ensure the quality of testing. The following methods can be adopted:reviewing the results with statistical techniques, participating in the ability verification test, comparing between laboratories, using certified reference materials, repeated inspection with the same or different methods, and re inspection of retained samples.
 
(VI) the quality supervisor shall effectively supervise the inspection, and record the problems found in the supervision process and the treatment.
 
(VII) special personnel shall be responsible for the inquiry and collection of technical standards; The technical director is responsible for confirming the effectiveness of the standard.
 
(VIII) internal audit including all elements of the quality system shall be carried out at least once a year; Auditors shall have no direct responsibility relationship with the audited department, track the implementation and effectiveness of corrective measures and record them.
 
Management review shall be carried out at least once a year on the basis of internal audit.
 
Article 9 quality inspection institutions should have testing instruments and equipment and reference materials that are suitable for the quality and safety testing activities of agricultural products they are engaged in, and the allocation rate of instruments and equipment should reach more than 98%; The intact rate of instruments and equipment in use should reach 100%. At the same time, the following requirements shall be met:
 
(I) instruments and equipment shall be provided with unique identification and attached with status identification;
 
(II) there should be a list of instruments and equipment and use records; The use record shall meet the requirements of test reproducibility and traceability;
 
(III) measuring instruments shall have valid certificates of metrological verification (or calibration) and periodic tables of verification (or calibration);
 
Self calibrated instruments and equipment shall have calibration procedures, calibration plans and quantity value traceability diagrams to ensure that the quantity value can be traced to the national standard;
 
(IV) instruments with high frequency of use, poor stability and out of the direct control of the laboratory should be checked for operation;
 
(V) instruments and equipment shall be filed independently; There should be special personnel for management and maintenance; There are operating procedures for instruments and equipment, which are convenient for operators to compare and use;
 
(VI) certified reference materials are managed by special personnel, with a list of certified reference materials, and purchase and use records.
 
Article 10 the quality inspection institution shall establish a scientific and reasonable testing workflow and corresponding working procedures, which can be operated effectively.
 
(I) the testing work flow chart shall include all links from sampling, sample circulation, testing, testing report to complaint.
 
(II) prepare implementation plans for mandatory testing tasks issued by the government;
 
For entrusted inspection, a sample entrustment form should be filled in. In addition to recording the information of the entrusting party and the sample, it should also include the inspection basis, detection method, sample status, and other contents agreed by both parties, with appropriate confirmation methods.
 
(III) sampling shall meet the requirements of relevant procedures and regulations. The sampling records are complete and accurate. There are measures to ensure the authenticity and representativeness of the samples taken and the safe arrival of the samples in the laboratory.
 
The samples should be kept by a specially assigned person with unique number and detection status identification, and measures should be taken to ensure that the samples are not confused, lost or damaged during detection and storage. There are sample handling records. During the circulation of samples, the condition of samples should be checked during handover to avoid deterioration, loss or damage. In case of damage and loss, emergency measures shall be taken in time.
 
(IV) the testing methods specified in national standards, industrial standards, relevant testing technical specifications or documents shall be adopted to carry out the work. If it is necessary to use non-standard testing methods, the method shall be confirmed according to the procedure for using non-standard methods.
 
(V) the external support services and supplies required for the testing work shall be managed according to the procedures, the suppliers shall be evaluated, and the list of qualified suppliers and relevant information shall be kept.
 
  (六)分包项目应控制在仪器设备使用频次低且价格昂贵的范围内,并在检验报告中注明;应保存分包方的资质证明,并有对分包方的评审记录。
 
  第十一条 质检机构应对所有的记录实行分类管理,包括质量记录和技术记录,明确其保存期限;质检机构应做好相关资料的保密工作。
 
  (一)检验报告和相应的原始记录应独立归档,保存期不少于六年,包括:检验报告、抽样单、样品委托单、检测任务单、原始记录及其相关联的图谱或仪器测试数据。
 
  (二)检测原始记录内容真实,应包含足够的信息,以保证其能够再现。至少包括:样品名称、编号、检测方法、检测日期、检测地点、环境因素(必要时)、检测过程与量值计算有关的读数、计算公式和允差要求等信息。
 
  (三)检验报告格式和内容应符合有关法律法规规定;应准确、客观地报告检测结果,应与原始记录及委托方要求相符合。检验报告的结论用语应符合有关规定或标准的要求,并在体系文件中规定。检验报告应有批准、审核、制表人的签字和签发日期;检验报告封面加盖机构公章和机构考核标识(经机构考核合格的质检机构);检验结论加盖机构检验专用印章,并加盖骑缝章。
 
  (四)对已发出的检验报告如需修改或补充,应另发一份题为《对编号××检验报告的补充(或更正)》的检验报告。
 
  第十二条 质检机构应当具有与检测活动相适应的固定工作场所,并具备保证检测数据准确的环境条件。
 
  (一)从事相关田间试验和饲养实验动物试验检测的,还应当符合检疫、防疫和环保的要求。从事农业转基因生物及其产品检测的,还应当具备防范对人体、动植物和环境产生危害的条件。
 
  (二)有专用的检测工作场所,仪器设备应相对集中放置,相互影响的检测区域应有效隔离,互不干扰。
 
  (三)实验室的仪器设备、电气线路和管道布局合理,符合安全要求,便于检测工作的进行。
 
  (四)实验场所内外环境的粉尘、烟雾、噪声、振动、电磁干扰、基因转移等应确保不影响检测结果。
 
  检测环境条件应符合检测方法和所使用食品设备的规定,对检测结果有明显影响的环境因素应监测、控制和记录。
 
  (五)样品的贮存环境应保证其在保存期内不变质;不能保存的样品应有委托方不进行复检的确认记录。化学试剂的保存条件应符合有关规定,有机试剂的贮存场所应有通风设施。有毒物品和易燃易爆品应有符合要求的保存场地,有专人管理,有领用、批准与登记手续。有毒物品的使用应有监督措施。
 
  (六)应采取措施保证检测作业对环境不产生污染。应制定处理污染发生的应急预案。
 
  (七)废气、废水、废渣等废弃物的处理应符合国家有关规定。
 
  第十三条 质检机构应当具有相对稳定的工作经费。
 
  第三章 申请与评审
 
  第十四条 除国务院有关部门依法设立或者授权的质检机构,可经有关部门审核同意后向农业农村部提出申请外,重庆市范围内其他申请考核的质检机构(以下简称申请人),应当向重庆市农业农村委员会(以下简称考核机关)提出书面申请。
 
  第十五条 考核机关对申请材料完整性进行初审,申请材料齐全或经补正材料后齐全,初审合格的,应当自收到申请材料之日起5个工作日内向申请人送达申请予以受理的《申请初审意见书》,并将申请材料送技术审查机构进行技术审查;申请材料存在可以当场更正错误的,应当告知并允许申请人当场更正;申请材料不齐全,经补正仍不符合规定的,应当自收到补正材料之日起5个工作日内向申请人送达申请不予以受理的《申请初审意见书》。
 
  第十六条 技术审查机构应当自收到申请材料之日起5个工作日内完成对申请材料的技术审查。
 
  对技术审查合格或经补充材料后审查合格的,向考核机关提交技术审查意见书。
 
  第十七条 技术审查合格的,考核机关自收到技术审查意见书之日起5个工作日内安排现场评审;技术审查不合格的,技术审查机构应当出具技术审查不合格通知书。
 
  第十八条 现场评审实行评审专家组负责制。专家组由3~5名评审员组成,必要时可聘请其他技术专家参加。
 
  (一)评审员应当具有高级以上技术职称、从事农产品质量安全检测或相关工作5年以上,并经农业农村部考核合格。
 
  (二)现场评审前考核机关应将评审有关事项通知申请人和评审组成员。
 
  评审专家组应当在3个工作日内完成评审工作,并向考核机关提交评审结果。
 
  (三)现场评审工作必须坚持“科学、客观、公正”的原则。现场评审应当包括以下内容:
 
  1.质量体系运行情况;
 
  2.检测仪器设备和设施条件;
 
  3.检测能力。
 
  (四)现场评审结论为:通过、基本通过和不通过。
 
  1.通过:按《评审细则》要求评审,所有条款全部为“符合”(不适用项除外)。
 
  《评审报告》的评审结论表述为:评审组认为该质检机构在机构与人员、质量体系、仪器设备、检测工作、记录与报告、设施与环境六个方面,符合《重庆市农产品质量安全检测机构考核评审细则》的要求。在申请检测的项目范围内,具备按相关标准进行检测的能力,同意现场评审“通过”,报请重庆市农业农村委员会审批。
 
  2.基本通过:分为整改后报材料确认和整改后现场确认两种情况。
 
  基本通过,整改后报材料确认的判定标准为:按《评审细则》要求评审,15项及以下评审条款为“基本符合”和“不符合”,其中关键项“基本符合”少于6项,非关键项“不符合”不超过1项。
 
  基本通过,整改后现场确认的判定标准为:按《评审细则》要求评审,25项及以下评审条款为“基本符合”和“不符合”,其中关键项“基本符合”少于10项,非关键项“不符合”不超过2项。
 
  《评审报告》的评审结论表述为:评审组认为该质检机构在机构与人员、质量体系、仪器设备、检测工作、记录与报告、设施与环境六个方面,基本符合《重庆市农产品质量安全检测机构考核评审细则》要求。在申请检测的项目范围内,具备按相关标准进行检测的能力,同意现场评审“基本通过”。对于评审过程中发现的问题,质检机构应在和评审组商定的时间内进行整改,整改时间不超过30个工作日,整改结果经报材料确认或现场确认,评审组长签署意见后,报请重庆市农业农村委员会审批。
 
  3.不通过:按《评审细则》要求评审,25个以上条款“基本符合”和“不符合”,其中10项以上关键项“基本符合”,或3项及以上非关键项“不符合”,或1项及以上关键项“不符合”。
 
  评审结论为“不通过”的,要在《评审报告》的评审结论中明确不通过的事实依据,并提出限期改进的建议。待改进后,质检机构可重新提出考核申请。
 
  第四章 审批与颁证
 
  第十九条 考核机关自收到评审结果的5个工作日内,作出申请人是否通过考核的决定。
 
  通过考核的,颁发《重庆市农产品质量安全检测机构考核合格证书》(以下简称《考核合格证书》),准许使用农产品质量安全检测考核标志,并予以公告。
 
  未通过考核的,书面通知申请人并说明理由。
 
  第二十条 考核机关应定期将《考核合格证书》颁发情况向农业农村部备案。
 
  第五章 延续与变更
 
  第二十一条 《考核合格证书》有效期为6年。证书期满继续从事农产品质量安全检测工作的,应当在有效期届满3个月前提出申请,重新办理《考核合格证书》。
 
  第二十二条 在证书有效期内,质检机构法定代表人、名称或者地址变更的,应当及时向原考核机关办理变更手续。
 
  第二十三条 在证书有效期内,质检机构有下列情形之一的,应当向原考核机关重新申请考核:
 
  (一)检测机构分设或者合并的;
 
  (二)检测仪器设备和设施条件发生重大变化的;
 
  (三)检测场所变更的;
 
  (四)检测项目增加的。
 
  第六章 监督管理
 
  第二十四条 考核机关通过年度报告、能力验证、现场检查等方式,对质检机构进行监督管理。
 
  质检机构应当按照考核机关的要求,参加其组织开展的能力验证或者比对,以保证持续符合机构考核条件和要求。
 
  第二十五条 对于机构考核工作中的违法行为,任何单位和个人均可以向考核机关举报。考核机关应当对举报内容进行调查核实,并为举报人保密。
 
  第二十六条 质检机构在考核中隐瞒有关情况或者弄虚作假的,考核机关应当予以警告,取消考核资格,一年内不再受理其考核申请;采取欺骗、贿赂等不正当手段取得考核证书的,撤销考核证书,三年内不再受理其考核申请。
 
  质检机构伪造检测结果或者出具虚假证明的,或擅自发布检测数据和结果,并造成不良后果的,依照《中华人民共和国农产品质量安全法》相关规定处罚,三年内不受理其机构考核申请。
 
  第二十七条 质检机构有下列情形之一的,由考核机关责令其1个月内改正;逾期未改正或改正后仍不符合要求的,由考核机关暂停其检测工作:
 
  (一)未按规定对人员、仪器设备、设施条件、质量管理体系、检测工作等实施有效管理的;
 
  (二)未按规定办理变更手续的;
 
  (三)检验报告、原始记录及其他档案管理不规范的。
 
  第二十八条 质检机构有下列情形之一的,由考核机关责令其3个月内整改,整改期间不得向社会出具具有证明作用的检验检测数据、结果;逾期未整改或整改后仍不符合要求的,由考核机关撤销其《考核合格证书》:
 
  (一)超出批准的检测能力范围,擅自向社会出具检验数据、结果的;
 
  (二)非授权签字人签发检验报告的;
 
  (三)检测工作存在较大风险隐患的。
 
  第二十九条 质检机构有下列行为之一的,考核机关应当视情况注销其《考核合格证书》:
 
  (一)自愿申请注销的;
 
  (二)所在单位撤销或者法人资格终结的;
 
  (三)检测仪器设备和设施条件发生重大变化,不具备相应检测能力,未按本细则规定重新申请考核的;
 
  (四)《考核合格证书》有效期届满,未申请延续或者依法不予延续批准的;
 
  (五)无正当理由未按照考核机关要求参加能力验证的;
 
  (六)无正当理由不接受、不配合监督检查的;
 
  (七)依法可注销检测机构资格的其他情形。
 
  第三十条 质检机构伪造检测结果或者出具虚假证明的,依照《中华人民共和国农产品质量安全法》第四十四条的规定处罚。
 
  第三十一条 从事考核工作的人员不履行职责或者滥用职权的,依法给予处分。
 
  第七章 附 则
 
  第三十二条 法律、行政法规和农业农村部规章对农业投入品质检机构考核另有规定的,从其规定。
 
  第三十三条 本细则自公布之日起施行。原《重庆市农业委员会关于重庆市农产品质量安全检测机构考核实施细则》(渝农发﹝2011﹞89号)同时废止。