Tianjin food producers’ implementation of food safety self inspection system and risk problem report management measures (Exposure Draft)
By: Date: 2022-07-18 Categories: authoritativerelease Tags: ,
 Chapter I General Provisions
 
Article one in order to implement the important instructions and requirements of the”four strictest”, further strengthen food safety management, urge food producers to implement the main responsibility of food safety, and improve the ability of risk prevention and control, these measures are formulated in accordance with the food safety law of the people’s Republic of China, the measures for the supervision and inspection of food production and operation and other laws and regulations, and in combination with the actual situation of our city.
 
Article two the measures are applicable to food (including food additives) producers (hereinafter referred to as”food producers”) who have obtained the food production license in this city to fulfill their obligations of food safety self-examination and risk problem reporting.
 
Article three Tianjin municipal market supervision and Administration Commission is responsible for formulating relevant management measures and guiding the district market supervision and Administration Bureau to carry out the food producers’ implementation of the food safety self-examination system and risk problem reporting.
 
The district market supervision department (including its local offices, hereinafter referred to as the”District Supervision Department”) is responsible for organizing food producers in its jurisdiction to implement the food safety self-examination system and the obligation of risk problem reporting; Supervise and inspect the work according to law, and urge food producers to implement the main responsibility of food safety.
 
Article four the implementation of the food safety self inspection system by food producers refers to the obligation of food producers, as the first person responsible for food safety, to establish a food safety self inspection system in accordance with the provisions of the food safety law of the people’s Republic of China, to regularly inspect and evaluate the food safety status produced, and to report to the district regulatory authority.
 
Risk problem report refers to the obligation of food producers to take corrective measures immediately, stop production and report to the district supervision department in case of changes in production conditions or potential risks of food safety accidents found in the daily production process.
 
 Chapter II self inspection of food safety
 
Article 5 food producers shall establish a food safety self inspection system and regularly inspect and evaluate the following contents:
 
(I) qualification of food producers, production environmental conditions, incoming inspection, production process control, product inspection, storage and delivery control, nonconforming product management and food recall, labels and instructions, management of employees, information recording and tracing, disposal of food safety accidents, varieties of food commissioned for production, commissioned period, and the supervision of the commissioned party on the production behavior of the commissioned party, Management of food additive producers;
 
(two) the rectification of the problems found in the self-examination by the food producers;
 
(III) other matters requiring self-examination by food producers as stipulated in laws, regulations and food safety standards.
 
Article 6 food producers should carry out self-examination at least once a year. In principle, according to the risk rating results, carry out self-examination according to the corresponding cycle and frequency, and implement the main responsibility of food safety. Seasonal food producers shall carry out self inspection of food safety at least once during the production season.
 
(one) if the risk level is A-level risk, self inspection shall be conducted at least once a year;
 
(II) if the risk level is level B, self inspection shall be conducted at least once every four months;
 
(III) if the risk level is level C, self inspection shall be conducted at least once every three months;
 
(IV) if the risk level is level D, self inspection shall be conducted at least once every two months.
 
Food producers shall submit a self inspection report to the district regulatory authority within ten working days after the self inspection.
 
Article 7 the self-examination organized by food producers shall be carried out according to the self-examination form for food safety of food producers in Tianjin (Annex one), and the self-examination shall be carried out by refining and supplementing the self-examination contents in combination with their own production conditions. The self inspection shall be recorded into the food quality and safety traceability and supervision system of Tianjin food production enterprises.
 
 Chapter III Risk Problem Report
 
Article 8 if a food producer finds any of the following circumstances, it shall deal with them according to the law and regulations, and report to the district regulatory department within three days.
 
(one) where the existing process equipment layout and process flow, main production equipment and facilities, food category and other matters have changed, and it is necessary to change the licensing matters specified in the food production license;
 
(two) the matters within the same food category specified in the duplicate of the food production license have changed;
 
(three) it is found that there are food raw materials, food additives and food related products that do not meet the food safety standards during the incoming inspection;
 
(four) purchasing or using food raw materials, food additives or food related products that do not meet food safety standards due to failure to comply with the incoming inspection system;
 
(V) problems are found in key links such as batching, feeding, workshop disinfection, main equipment, inner packaging, etc;
 
(6) failing to observe the delivery inspection record system or failing to pass the delivery inspection;
 
(7) the legal representative, the person in charge of quality, the inspector and other key personnel have changed;
 
(VIII) other potential risks of food safety accidents.
 
If major food safety risks are found, they shall be reported to the regional market supervision department in time.
 
If there are other provisions on reporting in food safety laws, regulations, rules and food safety standards, they shall be implemented at the same time.
 
Article 9 after finding the risk problems, the food producer shall fill in the report on the risk problems of food producers (Annex two). The report shall be made in two copies with the official seal, one for the food producer and the other for the district supervision department.
 
 Chapter IV Supervision and Administration
 
Article one0 after receiving the self-examination report of food producers, the district supervision department shall verify the self-examination report of food producers and deal with it in accordance with relevant regulations.
 
Article oneone the district supervision department shall include the reports of the self inspection form for food safety of food producers and the report form for food producer risk issues into the credit file management, and the retention period of the data shall not be less than one licensing cycle.
 
Article onetwo if food producers fail to regularly inspect and evaluate the food safety situation, the district regulatory department shall deal with it in accordance with the provisions of Article onetwo6 of the food safety law of the people’s Republic of China.
 
Article onethree in case of any of the following circumstances, the district regulatory department shall require the food producer to provide supplementary materials within a time limit or order it to resubmit:
 
(one) the food producer fails to submit a self-examination report within the prescribed time limit;
 
(two) the contents of the self-examination report of food producers are incomplete;
 
(three) food producers fail to find problems that should be found in the process of implementing the food safety self-examination system;
 
(four) other circumstances that do not conform to the provisions.
 
Article onefour If the production conditions of food producers change, no longer meet the food safety requirements or discover the potential risks of food safety accidents, fail to take corrective measures or stop production activities in accordance with the law, and report to the regulatory authorities, they shall be dealt with in accordance with the provisions of Article onetwo6 of the food safety law.
 
Article one5 if food producers fail to fulfill their obligations of food safety self-examination and risk reporting in accordance with the requirements of these measures, the relevant food producers shall be raised by one risk level in the next year; If the circumstances are serious, the risk level will be directly raised to level D.
 
Article one6 if the illegal act voluntarily reported by the food producer in the self-examination and problem report is minor and corrected in time, and has not caused harmful consequences, no administrative penalty shall be imposed.
 
 Chapter V supplementary provisions
 
Article one7 the safety risk level of food producers shall, in principle, be implemented in accordance with the Tianjin standard for the classified management of food production risks.
 
Article one8 these measures are not applicable to food producers of health food, formula food for special medical purposes and infant formula food.
 
Article one9 in case of any change in laws, regulations, rules, food safety standards and relevant documents of the State Administration of market supervision involving the implementation requirements of the above subject responsibilities, the latest provisions shall prevail.
 
Article two0 these Measures shall enter into force as of January one, two0twothree.
 
Attachment:one Self inspection form for food safety of food producers
 
  two. Food producer Risk Report
 
Attachment one
 
Self inspection form for food safety of food producers
Serial number Self inspection items Serial number Self inspection content Compliance remarks
one Qualification of food producers *one.one It has legal subject qualification and the production license is within the validity period.  yes  no  
*one.two The food and food additives produced are within the scope of license.  yes  no  
two Production environmental conditions (plant area, workshop, facilities, equipment) two.one There is no dust or ponding in the plant area, and the plant area and workshop are clean and tidy.  yes  no  
*two.two The plant and workshop shall keep a specified distance from toxic and harmful places and other pollution sources or have effective preventive measures.  yes  no  
two.three The equipment layout, process flow, main production equipment and facilities shall be consistent with those when the food production license is granted.  yes  no  
two.four The toilet is kept clean and not directly connected with food production, packaging or storage areas.  yes  no  
two.5 There are sanitary equipment and facilities for changing clothes, washing hands, drying hands, disinfection, etc., which meet the normal use.  yes  no  
two.6 Ventilation, dust prevention, drainage, lighting, temperature control and other equipment and facilities operate normally, and the equipment and facilities storing garbage and waste are clearly marked and effectively protected.  yes  no  
two.7 Detergents, disinfectants and other chemicals used in the workshop shall be clearly marked, stored by classification, and placed separately from food raw materials, semi-finished products, finished products, packaging materials, etc., with corresponding use records.  yes  no  
two.8 Production equipment and facilities shall be maintained regularly, and corresponding records shall be kept.  yes  no  
two.9 Monitoring equipment (such as pressure gauge and thermometer) shall be regularly verified, calibrated and maintained, and relevant records shall be kept.  yes  no  
two.one Regularly check the use of rat, fly and insect prevention devices and make corresponding inspection records. There is no sign of insect damage in the production site.  yes  no  
two.oneone The quasi cleaning operation area and cleaning operation area are reasonably and effectively divided. If there are air purification requirements, they should meet the corresponding requirements, and monitor and record the air cleanliness, differential pressure, ventilation times, temperature, humidity, etc.  yes  no  
three Incoming inspection *three.one Inspect the licenses and product qualification certificates of the suppliers of food raw materials, food additives and food related products; If the supplier cannot provide valid qualification certificates, there shall be inspection records.  yes  no  
*three.two Incoming inspection记录及证明材料真实、完整,记录和凭证保存期限符合要求。  yes  no  
three.three Establish and maintain the storage, safekeeping records, receiving, delivery and return records of food raw materials, food additives and food related products.  yes  no  
four Production process control *four.one 使用的食品原料、食品添加剂、食品相关产品的品种与索证索票、Incoming inspection记录内容一致。  yes  no  
*four.two Establish and maintain production material feeding records, including the name of the material fed, production date or batch number, quantity used, etc.  yes  no  
*four.three No non food raw materials, chemical substances other than food additives, recycled food, food raw materials and food additives that exceed the shelf life and do not meet food safety standards have been found to be put into production.  yes  no  
*four.four No use of food additives beyond the scope and limit was found.  yes  no  
*four.5 Production or使用的新食品原料,限定于国务院卫生行政部门公吿的新食品原料范围内。  yes  no  
*four.6 未发现使用药品生产食品,未发现仅用于保健食品的原料生产保健食品以外的食品。  yes  no  
four.7 生产记录中的生产工艺和参数与准予食品生产许可时保持一致。  yes  no  
four.8 建立和保存生产加工过程关键控制点的控制情况记录。  yes  no  
four.9 生产现场未发现人流、物流交叉污染。  yes  no  
four.one 未发现待加工食品与直接入口食品、原料与成品交叉污染。  yes  no  
four.oneone 有温、湿度等生产环境监测要求的,定期进行监测并记录。  yes  no  
four.onetwo 工作人员穿戴工作衣帽,洗手消毒后进入生产车间。生产车间内未发现与生产无关的个人用品或者其他与生产不相关物品。  yes  no  
four.onethree 食品生产加工用水的水质符合规定要求并有检测报告,与其他不与食品接触的用水以完全分离的管路输送。  yes  no  
four.onefour 食品添加剂生产使用的原料和生产工艺符合产品标准规定。复配食品添加剂配方发生变化的,按规定报告。  yes  no  
5 委托生产 *5.one 委托方、受托方具有有效证照,委托生产的食品、食品添加剂符合法律、法规、食品安全标准等规定。  yes  no  
5.two 签订委托生产合同,约定委托生产的食品品种、委托期限等内容。  yes  no  
5.three 有委托方对受托方生产行为进行监督的记录。  yes  no  
5.four 委托生产的食品标签清晰标注委托方、受托方的名称、地址、联系方式等信息。  yes  no  
6 产品检验 6.one 企业自检的,具备与所检项目适应的检验室和检验能力,有检验相关设备及化学试剂,检验仪器按期检定或校准。  yes  no  
6.two 不能自检的,委托有资质的检验机构进行检验。  yes  no  
*6.three 有与生产产品相应的食品安全标准文本,按照食品安全标准规定进行检验。  yes  no  
*6.four 建立和保存原始检验数据和检验报告记录,检验记录真实、完整,保存期限符合规定要求。  yes  no  
6.5 按规定时限保存检验留存样品并记录留样情况。  yes  no  
7 贮存及交付控制 7.one 食品原料、食品相关产品的贮存有专人管理,贮存条件符合要求。  yes  no  
7.two 食品添加剂专库或专区贮存,明显标示,专人管理。  yes  no  
7.three 不合格品在划定区域存放,具有明显标示。  yes  no  
7.four 根据产品特点建立和执行相适应的贮存、运输及交付控制制度和记录。  yes  no  
7.5 仓库温湿度符合要求。  yes  no  
*7.6 有出厂记录,如实记录食品的名称、规格、数量、生产日期或者生产批号、检验合格证明、销售日期以及购货者名称、地址、联系方式等内容。  yes  no  
8 不合格食品管理和食品召回 8.one 建立和保存不合格品的处置记录,不合格品的批次、数量应与记录一致。  yes  no  
*8.two 实施不安全食品的召回,召回和处理情况向所在地市场监管部门报告。  yes  no  
8.three 有召回计划、公告等相应记录;召回食品有处置记录。  yes  no  
*8.four 有召回食品无害化处理、销毁等措施,未发现召回食品再次流入市场(对因标签存在瑕疵实施召回的除外)。  yes  no  
9 标签和说明书 *9.one 预包装食品的包装有标签,标签标注的事项完整、真实。  yes  no  
*9.two 未发现标注虚假生产日期或批号的情况。  yes  no  
*9.three 未发现转基因食品、辐照食品未按规定标示。  yes  no  
*9.four 食品添加剂标签载明“食品添加剂”字样,并标明贮存条件、生产者名称和地址、食品添加剂的使用范围、用量和使用方法。  yes  no  
*9.5 未发现食品、食品添加剂的标签、说明书涉及疾病预防、治疗功能,未发现保健食品之外的食品标签、说明书涉及保健功能。  yes  no  
one0 食品安全自查 one0.one 建立食品安全自查制度,并定期对食品安全状况进行检查评价。  yes  no  
*one0.two 对自查发现食品安全问题,立即采取整改、停止生产等措施,并按规定向所在地市场监督管理部门报告。  yes  no  
oneone 从业人员管理 *oneone.one 建立企业主要负责人全面负责食品安全工作制度,配备食品安全管理人员、食品安全专业技术人员。  yes  no  
oneone.two 有食品安全管理人员、食品安全专业技术人员培训和考核记录,未发现考核不合格人员上岗。  yes  no  
*oneone.three 未发现聘用禁止从事食品安全管理的人员。  yes  no  
oneone.four 企业负责人在企业内部制度制定、过程控制、安全培训、安全检查以及食品安全事件或事故调查等环节履行了岗位职责并有记录。  yes  no  
*oneone.5 建立并执行从业人员健康管理制度,从事接触直接入口食品工作的人员具备有效健康证明,符合相关规定。  yes  no  
oneone.6 有从业人员食品安全知识培训制度,并有相关培训记录。  yes  no  
onetwo 信息记录和追溯 onetwo.one 建立并实施食品安全追溯制度,并有相应记录。  yes  no  
onetwo.two 未发现食品安全追溯信息记录不真实、不准确等情况。  yes  no  
onetwo.three 建立信息化食品安全追溯体系的,电子记录信息与纸质记录信息保持一致。  yes  no  
onethree 食品安全事故处置 onethree.one 有定期排查食品安全风险隐患的记录。  yes  no  
onethree.two 有食品安全处置方案,并定期检查食品安全防范措施落实情况,及时消除食品安全隐患。  yes  no  
*onethree.three 发生食品安全事故的,对导致或者可能导致食品安全事故的食品及原料、工具、设备、设施等,立即采取封存等控制措施,并向事故发生地市场监督管理部门报告。  yes  no  
onefour 前次监督检查发现问题整改情况 onefour.one 对前次监督检查发现的问题完成整改。  yes  no  
one5 其他事项 one5.one 按照法律法规或主体责任报告规定应当报告的其他情况。  yes  no  
自查结论
&#onethree;
(可另附页)
 
整改情况
&#onethree;
(可另附页)
 
自查人员签字:

&#onethree;
日期:年月日

法人代表或质量负责人签字:

&#onethree;
日期:年月日

  注:one.上表中打*号的为重点项,其他为一般项。
 
  two.如果检查项目存在合理缺项,该项无需勾选“是”与“否”,并在remarks中说明,不计入否项数。
 
  three.企业获得多个食品许可类别的,应当在“remarks”一栏中准确描述发现问题所属的食品类别。
 
  附件two
 
  食品生产者风险问题报告单
 
  企业名称(章):
报告事项
具体内容
问题发现时间
已采取的措施
remarks
one、现有工艺设备布局和工艺流程、主要生产设备设施、食品类别等事项发生变化的,需要变更食品生产许可证载明的许可事项
 
 
 
 
two、食品生产许可证副本载明的同一食品类别内的事项发生变化;
 
 
 
 
three、采购食品原料、食品添加剂、食品相关产品,未查验供货者的许可证和产品合格证明的;
 
 
 
 
four、未按照食品安全标准对无法提供合格证明的食品原料进行检验的
 
 
 
 
5、采购或者使用不符合食品安全标准的食品原料、食品添加剂、食品相关产品的;
 
 
 
 
 
6、未建立食品原料、食品添加剂、食品相关产品Incoming inspection记录制度或Incoming inspection记录不规范的
 
 
 
 
7、Incoming inspection记录未按规定期限保存的
 
 
 
 
8、生产工序、设备、贮存、包装等生产关键环节发现问题的
 
 
 
 
9、未建立食品出厂检验记录制度或出厂检验记录不规范的
 
 
 
 
one0出厂检验记录未按规定期限保存的
 
 
 
 
oneone、食品安全管理人员、检验人员、负责人发生变化
 
 
 
 
onetwo、其他有发生食品安全事故潜在风险的
 
 
 
 
报告人:
 
年月日
法人代表或质量负责人:
 
年月日
      注:表格可另附页。
 

&#onethree;
      相关报道:天津市食品生产者落实食品安全自查制度和风险问题报告管理办法起草说明