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湖北福星生物科技有限公司文件

文件编号

FX-15-01-005

异物管理规程

版本

02

文件类型

制度

编写

审核

批准

生效日期

页数

15 / 15

状态

一、目的
1. Purpose

为了制定食品生产过程中防止异物污染管理的有关规定确保食品生产过程中交叉污染得到控制产品质量处于受控状态。依据GB 14881《食品生产通用卫生规范》相关标准及本企业的实际情况,制定本规程。
In order to formulate relevant regulations on the prevention and management of foreign matter contamination during the food production process , ensure that cross-contamination during the food production process is controlled and product quality is under control. This procedure is formulated based on the relevant standards of GB 14881 " General Hygienic Specifications for Food Production " and the actual situation of the enterprise .

二、范围
2. Scope

适用于食品生产过程中防止异物污染的管理。
Suitable for the management of preventing foreign matter contamination during food production.

三、管理职责
3. Management responsibilities

1、质量管理部:组织制定相关异物管理规程,定期进行异物相关防控措施落实情况的检查并督促整改,对客户相关异物投诉组织调查分析和回复。
1. Quality Management Department: Organize the formulation of relevant foreign matter management procedures, regularly inspect the implementation of foreign matter-related prevention and control measures and supervise rectifications, and organize investigations, analysis and responses to customer-related foreign matter complaints.

2、生产运营中心:根据异物管理规程,制定车间相关操作规程并进行落实。对相关进入车间的人员、原辅材料、生产工艺和加工操作方法、设备设施和环境进行相关管控。
2. Production Operation Center: According to the foreign matter management regulations, formulate relevant operating procedures for the workshop and implement them. Carry out relevant control over personnel entering the workshop, raw and auxiliary materials, production technology and processing operation methods, equipment, facilities and environment.

3、设备动力部:对新工艺设备的设计及现有工艺设备改造和设备维护过程避免异物的引入。
3. Equipment Power Department: avoid the introduction of foreign matter during the design of new process equipment, modification of existing process equipment, and equipment maintenance.

4、采购部:配合质量管理部门对供应商审核,对反馈的原辅材料异物问题联络供应商调查分析和落实纠正措施。
4. Purchasing Department: Cooperate with the quality management department to audit suppliers, and contact suppliers to investigate and analyze reported foreign matter problems in raw and auxiliary materials and implement corrective measures.

5、计划物流部:负责仓库贮存及发货车辆防止异物污染的管理。
5. Planning and Logistics Department: Responsible for the management of warehouse storage and delivery vehicles to prevent foreign matter contamination.

四、内容
4. Content

1 异物来源
1 Source of foreign matter

异物的来源从以下人、机、料、法、环五个方面分析
The sources of foreign matter are analyzed from the following five aspects: people, machines, materials, methods and environment:

1.1 主要包括车间工人、管理人员、机修工、参观者等进入车间的人员。作为生产企业人员管理不善会造成严重的异物混入毛发的混入、手套头套混入、创可贴混入、纽扣、钥匙、饰物、烟蒂等的混入。
1.1 people : Mainly including workshop workers, managers, mechanics, visitors and other people entering the workshop. As a production enterprise , poor personnel management will cause serious foreign matter mixing , such as : hair mixing, gloves and headgear mixing, band-aid mixing, buttons, keys, accessories, cigarette butts, etc.

1.2 :指食品生产和加工过程所用的设备、管道阀门和加工工器具等。也包括生产用垫圈、O型圈、软连接等易耗品,破损、脱落很容易造成异物的混入。如筐具、刀具的破损灯泡、玻璃破裂,焊接维修时的焊豆、焊渣等,会造成塑料、玻璃、金属混入加热器等维修时振动导致浮尘脱落。
1.2 Machine : refers to the equipment, pipes, valves, processing tools, etc. used in food production and processing. It also includes production gaskets, O -rings, soft connections and other consumable items. Damage or falling off can easily lead to the mixing of foreign matter. For example, broken baskets and knives , broken light bulbs and glass , and welding beans and slag during welding and repair can cause the mixing of plastic, glass , and metal . Vibration during maintenance of heaters, etc. may cause floating dust to fall off.

1.3 :指食品生产和加工过程所用的原材料,包括原材料、包装材料,也包括质量相关的低值易耗品。当原辅料本身或其包装物含有一些石子、金属、灰尘等异物,加工时清洗不干净、不彻底或成品用的包材上有浮灰泥土各种异物,都会造成异物的混入。
1.3 Materials : refers to raw materials used in food production and processing, including raw materials, packaging materials, and quality-related low-value consumables. When the raw and auxiliary materials themselves or their packaging contain foreign matter such as stones, metal, dust, etc., if the cleaning is not clean or thorough during processing, or there is floating dust, mud and other foreign matter on the packaging materials for the finished product , foreign matter will be mixed in.

1.4 :生产工艺或加工方法不正确原料本身异物较多而工艺中没有过滤、过筛、过磁等去除异物的工序。车间用的和食品接触的加热空气和氮气等没有经过过滤。
Method 1.4 : The production process or processing method is incorrect , the raw material itself has a lot of foreign matter, and there is no filtering, sieving, magnetization and other processes to remove foreign matter in the process. The heated air and nitrogen used in the workshop and in contact with food are not filtered.

1.5 :食品生产与加工环境不良造成的异物混入卫生情况不好导致蟑螂、苍蝇等昆虫的混入墙壁水泥块破碎、脱落的混入水质的不洁 (水中杂质) 等皆可造成异物的混入而影响产品的品质。
Ring 1.5 : Foreign matter mixed in due to poor food production and processing environment . For example, poor hygiene can lead to the mixing of cockroaches , flies and other insects ; the mixing of broken and falling cement blocks on the walls ; the unclean water quality (impurities in the water), etc. can cause the mixing of foreign matter and affect the quality of the product.

2 防止异物混入的对策
2. Countermeasures to prevent foreign matter from entering

防止异物混入具有常见性和多发性控制异物的混入首先要坚持预防为主的原则,同时加强成品放行前的检测;对于内外部发现的异物问题进行原因分析采取坚决有效的措施预防异物混入的可能。
Preventing the mixing of foreign matter is common and frequent . To control the mixing of foreign matter, we must first adhere to the principle of prevention first, and at the same time strengthen the detection of finished products before release; analyze the causes of foreign matter problems found internally and externally , and take resolute and effective measures to prevent the mixing of foreign matter. possible.

原则方
Principle direction :

a. 现场管理为基础:加强车间异物管理,包括不限于现场清洁及基础设施维护、5S管理、废弃物控制、昆虫的捕杀、毛发的控制、橡胶手套的控制、破损工器具的控制、车间报表纸张的控制、车间墙上张贴纸张的控制、对玻璃制品、塑料制品、木制品的控制等。及时进行检查发现不安全的卫生隐患及时消除。
a . Based on on-site management: Strengthen foreign matter management in the workshop , including but not limited to on-site cleaning and infrastructure maintenance, 5S management, waste control, insect killing, hair control, rubber gloves control, damaged tools and equipment, and workshop reports Control of paper, control of paper posted on workshop walls, control of glass products, plastic products, wood products , etc. Conduct timely inspections and eliminate unsafe health hazards promptly.

b. 全过程管理,预防为主:加强供应商管理,加强到货验收及进入车间原辅料状况的检测,避免进入下一道工序。
b. Whole-process management, focusing on prevention: Strengthen supplier management, strengthen arrival acceptance and detection of the status of raw and auxiliary materials entering the workshop to avoid entering the next process.

c. 各部门及全员参与:提高相关部门的异物防控方面职责的认识,并积极参与;加强员工对异物控制重要性和知识培训,进行异物的管控
c. Participation of all departments and all employees: Improve the awareness of relevant departments’ responsibilities in foreign matter prevention and control and actively participate; strengthen employee training on the importance and knowledge of foreign matter control , and conduct foreign matter control .

3 对异物控制的具体管理
3. Specific management of foreign matter control

3.1 进入车间人员带入异物的控制:
3.1 Control of foreign objects brought in by persons entering the workshop:

车间人员进入生产区,可能将身上毛发、衣服脱落物、佩戴物等带入,本过程预防措施见《人员出入管理区标准操作规程》、《人员卫生管理制度》。
When workshop personnel enter the production area, they may bring hair, clothes off, and other items worn. Please refer to the "Standard Operating Procedures for Personnel Entry and Exit Management Areas" and "Personnel Hygiene Management System" for preventive measures during this process.

3.2 生产流程设备、工器具等易损部件造成的异物混入控制
3.2 Control of foreign matter mixing caused by production process equipment, tools and other vulnerable parts

3.2.1 设备上的易损部件,如垫片、软连接等,设备上的易脱落部件,如贴的目视化标识、设备维修后的胶布等,每次清场检查一次,如有破损,立即查找残缺部分。
3.2.1 Wearable parts on the equipment, such as gaskets, soft connections, etc., and easy-to-fall off parts on the equipment, such as visual signs, tapes after equipment maintenance, etc., shall be inspected once every time the site is cleared. If there is any damage, Find the missing parts now.

3.2.2 设备设施、工器具上有焊接的部分,使用前必须先去除表面的焊豆确保生产加工过程中无开焊裂口现象加工过程中有破损破损工器具停止使用该时间段内产品单独存放评估后处理。
3.2.2 For the welded parts of equipment, facilities and tools, the welding beans on the surface must be removed before use to ensure that there are no welding cracks during the production and processing process ; if there is any damage during the processing , the damaged tools and tools must be stopped for this period of time . The products inside are stored separately and processed after evaluation.

3.3 车间环境带来异物的控制
3.3 Control of foreign matter brought about by workshop environment

3.3.1 虫鼠害控制管理
3.3.1 Pest and rodent control management

车间开启门导致蚊虫等的进入,按《虫害、鼠害控制程序》执行。
If the workshop door opens and mosquitoes enter, follow the "Pest and Rodent Control Procedures".

3.3.2 车间设施破损带来异物
3.3.2 Foreign objects caused by damaged workshop facilities

车间主管和班长负责定期巡视车间各种设施的完好性,包括天花板、墙面地面、门、踢脚线、定位线等,有破损情况立即处理。
The workshop supervisor and squad leader are responsible for regularly inspecting the integrity of various facilities in the workshop, including ceilings, walls, floors, doors, skirting lines, positioning lines, etc., and handling any damage immediately.

3.3.3 易碎品管理
3.3.3 Fragile goods management

玻璃、灯具等玻璃制品及塑料制品按《易碎品管理规定》执行。
Glass, lamps and other glass products and plastic products are subject to the "Fragile Products Management Regulations".

3.3.4 木制品管理
3.3.4 Wood product management

各类带有质材料的工具、办公桌、椅及办公用品等按《木制品使用管理规定》执行。
All types of tools, desks, chairs and office supplies containing wooden materials shall be subject to the "Regulations on the Management of the Use of Wooden Products".

3.3.5 金属制品管理
3.3.5 Metal products management

3.3.5.1 加工过程中的控制
3. 3.5.1 Control during processing

a. 原料方面通过目视检查(及磁铁吸附)保证原辅料中没有金属的混入。
a. In terms of raw materials : Ensure that there is no metal mixed in raw and auxiliary materials through visual inspection (and magnet adsorption).

b. 工器具、设备设施方面
b. Tools, equipment and facilities

• 使用的器具无破损残缺。每班进行检查破损的器具严禁使用。如加工过程中有破损破损工器具停止使用该时间段内产品单独存放评估后处理。
• The utensils used are not damaged or defective. Inspections are conducted every shift , and damaged equipment is strictly prohibited from use. If there is any damage during the processing , the damaged tool and equipment will be stopped from use , and the products will be stored separately during this period and processed after evaluation.

• 器具、设备设施等有进行焊接的地方使用前必须先去除表面的焊豆确保生产加工过程中无开焊裂口现象。
Where welding is performed on appliances, equipment and facilities , the welding beans on the surface must be removed before use to ensure that there are no welding cracks during production and processing.

• 设备安全卫生控制如有些机器中使用的小螺丝更换时必须检查个数 确认有无缺失及时上报。
• Equipment safety and health control . For example, when replacing small screws used in some machines , the number must be checked to confirm whether they are missing and reported in a timely manner.

c. 成品方面:包装时加设X光机进行探测监控。
c. In terms of finished products: an X-ray machine is added for detection and monitoring during packaging.

3.3.6 纸制品管理
3.3.6 Paper product management

3.3.6.1 每天班前对进车间的工人进行检查不准工作时带废纸进车间。
3. 3.6.1 Workers entering the workshop should be inspected before work every day , and waste paper is not allowed to be brought into the workshop during work.

3.3.6.2 生产过程用的报表实行数量管理不得带多余的报表进车间并保证带入车间的报表无破损。
3. 3.6.2 Implement quantity management on the reports used in the production process , do not bring excess reports into the workshop , and ensure that the reports brought into the workshop are not damaged.

3.3.6.3 生产过程中定时对填写的报表进行检查发现破损立即寻找若找不到则该时间段内生产的产品单独存放评估后处理。
3. 3.6 .3 During the production process, the filled-in reports will be checked regularly . If any damage is found, look for it immediately . If it cannot be found, the products produced during that time period will be stored separately and processed after evaluation.

3.3.6.4 严禁工作中私自在墙上张贴纸张应加塑处理或用PE袋装起来。班中加工人员有事出车间时使用公司统一的请假条严禁私自乱涂乱画造成不必要的废纸产生。
3. 3.6 .4 It is strictly prohibited to post paper on the wall without permission during work . It should be plasticized or packed in PE bags. When the processing personnel in the class leave the workshop for business , they should use the company's unified leave request form . It is strictly forbidden to scribble without permission , causing unnecessary waste paper.

3.3.6.5 报表记录人员离加工设备一定距离
3. 3.6 .5 The person recording the report should be at a certain distance from the processing equipment .

3.4 原辅料带来异物的控制
3.4 Control of foreign matter brought by raw and auxiliary materials

3.4.1 原辅料暂存间
3.4.1 Temporary storage room for raw and auxiliary materials

a. 所有原辅物料在使用前必须将外包装清理干净。
a. The outer packaging of all raw and auxiliary materials must be cleaned before use.

b. 所有分内外包装的原辅物料外包装不准带入加工车间。
b. All raw and auxiliary materials in external and internal packaging are not allowed to be brought into the processing workshop.

c. 使用时采用先进先出的原则。
c. Adopt the first-in-first-out principle when using.

d. 任何原辅料使用前要开口整齐避免异物混入。
d . Any raw materials and auxiliary materials must be opened neatly before use to avoid foreign matter being mixed in.

3.4.2 原辅材料管理
3.4.2 Raw and auxiliary materials management

3.4.2.1 进厂
3.4.2.1 Entering the factory

a. 运输车辆必须清洁无异物无污染保持干燥。
a. Transportation : The vehicle must be clean, free of foreign matter , pollution-free , and kept dry.

b. 生产厂家必须为合格供应方有厂家证明、卫生合格证、注册证书、出厂检验合格单等。
b. Manufacturer : must be a qualified supplier with manufacturer's certificate , health certificate, registration certificate, factory inspection certificate, etc.

c. 检验
c. Inspection :

• 包装物料接收时要对其强度、版面、有无污染、有无异物等进行检验合格入库不合格退货。
• When receiving packaging materials, their strength, layout, contamination, foreign matter, etc. must be inspected . If qualified, they will be put into storage and if not, they will be returned.

• 内包装袋每进一批由化验人员进行微生物涂抹检测合格使用不合格退货。
• Each batch of inner packaging bags will be tested for microbial smear by laboratory personnel. If it is qualified , it will be used , and if it is not qualified, it will be returned.

3.4.2.2 放置
3.4.2.2 Placement

a. 内、外包装物料按客户、产品规格等分开放置如有必要可挂牌标识。
a. Inner and outer packaging materials should be placed separately according to customer and product specifications , and can be labeled if necessary.

b. 物料要用垫板垫起离地、离墙放置严禁直接放在地面上。
b. Materials should be placed on pads and away from the ground and walls . It is strictly forbidden to place them directly on the ground.

c. 所有物料上加遮盖物防止灰尘污染。
c. Cover all materials to prevent dust contamination.

d. 夏季因多雨原因造成的潮湿、发霉要及时晾晒控制微生物的繁殖污染保证纸箱的强度不受影响以免纸箱破损混入产品中。
d. Moisture and mildew caused by rainy weather in summer must be dried in time to control the breeding and contamination of microorganisms and ensure that the strength of the carton is not affected to prevent the carton from being damaged and mixed into the product.

e. 物料间严禁存放化学药品、竹木制品、玻璃制品等。
e . It is strictly prohibited to store chemicals, bamboo products, glass products, etc. in the material room.

f. 破损、烂裂的器械、物品严禁存放在物料间。
f . Broken or rotten equipment and items are strictly prohibited from being stored in the material room.

3.4.2.3包材使用
3.4.2.3 Use of packaging materials

a. 确认
a. Confirm

• 提前确认包装物料和版面、印记位置等合格后方可使用。
• Confirm the packaging materials, layout, marking position , etc. in advance and use them only after they are qualified.

• 包装前检查产品品名规格与包装物料上的品名规格是否一致。
• Before packaging, check whether the product name and specifications are consistent with those on the packaging materials.

b. 产品更换时
b. When product is replaced

• 产品清理上一种产品彻底清理、全部入库存放。
• Product cleaning : The previous product is thoroughly cleaned and stored in inventory.

• 物清理上一种产品所用物料彻底清理全部入物料库内标识清楚防止不同物料混用。
Material cleaning : The materials used in the previous product are thoroughly cleaned , and all are clearly marked in the material warehouse to prevent the mixing of different materials.

3.5 车间废弃带来异物的控制
3.5 Control of foreign matter caused by waste in the workshop

3.5.1 生产现场使用的垃圾桶必须有桶盖,并且出于常闭状态。
3.5.1 Trash cans used at production sites must have lids and be in a normally closed state.

3.5.2 生产中产生的废弃物随时放到垃圾桶中,垃圾桶套内袋,每班必须清理一次,洁净区用垃圾桶洗完后75%酒精消毒。
3.5.2 Waste generated during production should be placed in the trash can at any time. The trash can is covered with an inner bag and must be cleaned once every shift. The clean area should be disinfected with 75% alcohol after washing the trash can.

3.5.3 废弃物通道
3.5.3 Waste channel

3.5.3.1 前处理用完的废包材及空油桶,批清场时由物料中转间出车间,送至厂区指定位置。
3.5.3.1 The waste packaging materials and empty oil drums that have been used up for pre-processing will leave the workshop from the material transfer room and be sent to the designated location in the factory during batch clearance.

3.5.3.2 普通区垃圾桶中垃圾每班结束统一清理,送到厂区垃圾桶中。
3.5.3.2 The garbage in the trash cans in the general area will be cleaned up at the end of each shift and sent to the trash cans in the factory area.

3.5.3.3 洁净区废弃物在本批次生产结束后,清场时装到洁净的PE袋中,由缓冲间送至外包间,最后再送到垃圾桶中,PE袋必须是洁净、消毒过的,袋口扎紧。
3.5.3.3 After the production of this batch, the waste in the clean area is cleared and put into clean PE bags, sent from the buffer room to the outsourcing room, and finally sent to the trash can. The PE bags must be clean and disinfected. Tie the mouth tightly.

3.6 车间设备设施维修带来异物的控制
3.6 Control of foreign objects brought about by maintenance of workshop equipment and facilities

3.5.1 维修人员自带工具数量清点,进出车间遵守车间卫生管理制度。
3.5.1 Maintenance personnel shall count the number of tools they bring and comply with the workshop hygiene management system when entering and exiting the workshop.

3.5.2 维修人员工作服保持卫生清洁。
3.5. 2 Maintenance personnel’s work clothes should be kept hygienic and clean.

3.5.3 非必须使用的工具禁止带入车间车间准备的专用工具箱时刻保持清洁卫生。
3.5. 3. Tools that are not necessary for use are prohibited from being brought into the workshop . The special tool box prepared in the workshop should be kept clean and hygienic at all times.

如果当班中机械设备损坏需动用电焊机、拉结电线或挖凿地面、更换灯管等造成产品安全隐患较大的维修项目正常生产中严禁进行必须全部清理结束在班后实施,维修完成后做好清洁卫生检查
Note : If the mechanical equipment is damaged during the shift , it is necessary to use electric welding machines, tie wires , or dig the ground, replace light tubes, etc. Maintenance projects that cause greater product safety hazards are strictly prohibited during normal production and must be cleaned up . After the shift Implement and perform cleaning and sanitation inspections after the repairs are completed .

3.6 发货管理:对于将要发货的产品进行外观检查。运输车辆必须清洁无异物无污染,符合相关运输的要求
3.6 Delivery management: Conduct visual inspection of products to be shipped. Transport vehicles must be clean, free of foreign matter and pollution , and comply with relevant transport requirements .

3.7 生产过程中糊粉导致的异物控制:按《糊粉控制操作规程》执行,生产部门及研发及时调整参数,减少糊粉问题。
3.7 Control of foreign matter caused by aleurone during the production process: According to the "Aleurone Control Operating Procedures", the production department and R&D adjust parameters in a timely manner to reduce aleurone problems.

4 内部检查:对于人员、设备、原材料、环境和工艺中异物检测方法(如X光机,过滤,磁力棒,筛网等)进行定期检查,包括各部门内部检查和质量管理部组织的定期检查,对发现的问题制定纠正预防措施进行整改。
4 Internal inspections: Conduct regular inspections on personnel, equipment, raw materials, environment and foreign matter detection methods (such as X-ray machines, filtration, magnetic rods, screens, etc.) in the process, including internal inspections of each department and regular inspections organized by the quality management department, Develop corrective and preventive measures to rectify discovered problems.

5 产品发现异物管理:生产产品出现异物按《不合格品处理操作规程》执行;对于客户的异物投诉或内部产品异物发现必须进行原因分析,制定纠正预防措施并进行跟踪落实。
5 Management of foreign matter found in products: Foreign matter found in production products shall be implemented in accordance with the "Operation Procedures for Handling of Non-Conforming Products"; for customer complaints of foreign matter or the discovery of foreign matter in internal products, the cause must be analyzed, corrective and preventive measures must be formulated and tracked and implemented.

六、支持性文件
6. Supporting documents

序号
serial number

类别
category

编号
serial number

名称
name

1

制度
system

FX-07-00-004

人员卫生管理制度
Personnel hygiene management system

2

流程
process

FX-15-01-001

人员出入管理区工作流程
Work flow of personnel entry and exit management area

3

SOP

SOP02-1-020-02

虫害、鼠害控制程序
Pest and rodent control procedures

4

制度
system

SOP02-1-022-01

易碎品管理规定
Fragile goods management regulations

5

制度
system

SOP02-1-023-01

木制品使用管理规定
Management regulations on the use of wood products

6

流程
process

FX-20-01

不合格品处理操作规程
Operational procedures for handling unqualified products

7

SOP

SOP02-1-026-01

糊粉控制操作规程
Aleurone control operating procedures

七、文件变更理由
7. Reasons for document changes

修订理由
Reason for revision

根据质量、食品安全、环境管理体系要求,参考《GMP》要求、《食品安全法》2015年修订版、婴幼儿配方乳粉生产许可审查细则,对公司文件编码原则、文件编制的申请与起草、文件的复印、文件的受控、文件的颁发项内容等进行更新修订。
According to the requirements of quality, food safety, and environmental management systems, with reference to the requirements of "GMP", the 2015 revised version of the "Food Safety Law", and the review rules for infant formula milk powder production license, the application and drafting of company document coding principles and document preparation, The copying of documents, the control of documents, and the content of issuance items of documents are updated and revised.

01

食品安全法2018版修订
Food Safety Law 2018 Revision

02

全面修订,包括职责、原则及增加木制品及塑料制品、车间废弃物等的控制管理。
Comprehensive revision, including responsibilities, principles and added control and management of wood products, plastic products, workshop waste, etc.