Clean factory management practices (original link: http://)
1. Purpose
1.1 To ensure the environment of the clean factory, reduce the management cost of the company, ensure product quality and enhance operational efficiency.
2 Scope of application
2.1 All personnel entering the clean factory (including the company's personnel, manufacturers and visitors, etc.) and raw materials are subject to the provisions of these Management Rules.
3 duties
3.1 Manufacturing Department: responsible for supervising all personnel entering the clean room;
3.2 Administration Department: Purchasing and preparing for the dressing required to enter the clean factory, cleaning;
4 Related reference documents
4.1 US Federal Standard
5 noun definition
no
6 Work flow and instructions
6.1 Pre-preparation before entering the clean room
6.1.1 The mask on the face before entering the clean room must cover the nose and mouth;
6.1.2 Wear prescribed dust-free clothes, hair hoods, hats and shoes;
6.1.3 Before entering the clean factory, it is necessary for IPQC to supervise whether the functions of clothes and electrostatic rings are normal.
6.1.4 Do not touch other metal objects during static testing.
6.1.5 Check the grounding status of the tester regularly every day.
6.1.6 All personnel shall wear the gloves static test in accordance with the regulations before entering the clean room.
6.2 Personnel access control:
6.2.1 Personnel: All personnel involved in the clean room operation, such as manufacturing, engineering, quality assurance, general affairs, and security inspection.
6.2.2 The work has direct correlation with the unit colleagues, controlled by the production unit, and the rest of the departments need to inform the supervisor of the production unit to cooperate with the arrangement when they need to enter the clean factory.
6.2.3 Manufacturer: The manufacturer includes machine equipment agents or maintenance engineers and outsourced construction workers. In order to enter the clean factory, the above-mentioned personnel must fill in the “Vendor/Foreigner Entry Application Form†FM-HA-023 by the receptionist or accompanying person, and the company will be accompanied by the factory personnel to enter the clean workshop.
6.2.4 Customer:
The customers of the company are determined by the business personnel to let the customers visit the clean factory as needed, and the business staff informs the production unit manager to arrange for cooperation.
6.3 Clean factory access procedures
6.3.1 Clean factory entry procedure: Take off the shoes in the shoe changing area and enter barefoot.
6.3.1.1 Enter the locker room of the clean factory.
6.3.1.2 First wear an internet cap, and the hair should not be exposed inside the net cap.
6.3.1.3 Wear a mask that does cover your mouth and nose.
6.3.1.4 Wear clean clothes/shoes.
6.3.1.5 Wear rubber gloves on both hands and fold the gloves back over the cuffs.
6.3.1.6 Organize the costumes in the mirror.
6.3.1.7 Enter Air Shower, up to 2 people at a time. After entering Air Shower, lift your hands and slap your clothes and turn three turns to increase the cleaning effect. As shown below:
6.3.2 Clean factory leaving procedure:
6.3.2.1 After leaving the clean room after Air Shower, take off the dust-free shoes, dust-free clothes, rubber gloves, net caps and masks.
6.3.2.2 Put dust-free clothes and dust-free shoes into a dust-free wardrobe.
6.3.3 Management and restrictions of clean factory buildings:
6.3.3.1 Stationery In addition to ballpoint pens, stainless steel rulers and dust-free paper, other dust-cleaning stationery is not allowed to enter the clean factory.
6.3.3.2 In the clean factory or under the dust-free hood, the cosmetics should not be used, including powder, spray perfume, spray-type water, and wool-free clothing (such as wool clothes).
6.3.3.3 Personnel who fail to pass the clean room management procedures and static test (except for other persons not related to production) are not allowed to enter or exit the clean room.
6.3.3.4 Operation manuals made of dust-free paper or ordinary plastic-processed documents can be carried into the clean room.
6.3.3.5 Spray cleaners or paint products should not be used in clean workshops.
6.3.3.6 The tools carried by the customer or supplier shall be inspected by the accompanying personnel. Non-essential special tools shall not be carried into the clean factory; those that must be carried shall be cleaned before being carried.
6.3.3.7 In the clean factory, it is forbidden to take photos or video without approval from the supervisor above the department level.
6.3.3.8 The number of direct and indirect personnel in the clean room shall not exceed 100.
6.3.3.9 In the working area of ​​the clean workshop, when working in each station, no personnel shall walk or run and jump within 60cm of the working area; and the interval between different stations shall be 60cm-120cm.
6.3.3.10 Latex gloves must be removed after each departure from the clean room and new gloves must be replaced when returning to the clean room.
6.3.3.11 It is strictly forbidden to pull down the mask, gloves and dust-free zipper in the clean room.
6.3.4 Working rules in clean workshops:
6.3.4.1 Gloves or other items that are contaminated with chemicals should be washed or renewed immediately, and must not touch other objects to avoid injury to personnel or damage to products and equipment.
6.3.4.2 If there is any abnormality such as failure, alarm or liquid leakage in the production equipment, immediately notify the on-site ME engineer to deal with it when it is found, and notify the safety personnel to attend the scene if necessary.
6.3.4.3 If chemical solvents are spilled on the floor, immediately wipe them off with a dust-free mop or a dust-free cloth.
6.3.4.4 If a powdery object spills on the ground, it should be immediately cleaned with a dust-free vacuum cleaner.
6.4 Other notes:
6.4.1 It is strictly forbidden to sit on the work table, on the machine table or on the floor.
6.4.2 All materials and tools that need to be carried into the clean room shall be transferred from the transfer box and shall not be carried directly.
6.4.3 Objects shall not be piled up around the security door. Except in the case of fire and other related emergency situations, it is strictly forbidden to pass the personnel.
6.4.4 Fire-fighting equipment (such as fire hydrants, fire extinguishers, etc.) in clean workshops shall not be moved at will.
6.4.5 Before the operator is not qualified for certification, the machine should not be operated by itself. If it is necessary to operate the machine due to education and training, it must be accompanied by qualified personnel.
6.4.6 No smoking, food, food, beverages, etc. in the clean room. If you have smoke before entering the clean factory, you need to stand for 30 minutes before entering the clean room.
6.5 Clean factory cleaning specifications:
6.5.1 Cleaning products or tools that can be used are: dust-free mop, dust-free cloth, vacuum cleaner, dust-free cloth, dust-free paper, dust-free adhesive pad, sticky roller, plastic or stainless steel trash can.
6.5.2 Clean clothing or other overalls of all workers in the clean room should be cleaned and replaced once a week.
6.5.3 The garbage bins placed at each station in the clean workshop shall be dumped at least once a day in a clean workshop. If the garbage is found to exceed the surface of the trash can during the operation, it shall be immediately dumped in the clean workshop.
6.5.4 The clean floor of the clean factory should be cleaned once every half day using a dust-free mop. The work surface should be cleaned once with a dust-free cloth for half a day, and the relevant cleaning records should be made.
6.5.5 Cleaning of equipment in the clean room Clean the work according to the maintenance instructions of each equipment and make relevant cleaning records.
6.6 Equipment access and construction control:
6.6.1 Anyone who wants to enter the clean factory construction must fill in the “Application Form for Construction of the Clean Factory Control Area†and will be allowed to enter only after approval.
6.6.2 The construction unit shall prepare plastic sheets, stainless steel plates (for protection of the ground), vacuum cleaners for clean workshops, and other tools for dust-free fiber rags.
6.6.3 The construction unit and personnel should fully understand the general operating requirements of the company's clean factory.
6.6.4 After the completion of the construction, the clean plant HEPA needs to operate for 24 hours before the production operation can be resumed.
6.6.5 Construction tools and equipment should be carried into the clean workshop as little as possible. They must be cleaned and wiped clean before use. There should be no obvious oil, rust and dust.
6.6.6 There must be no drilling and cutting operations during construction, and the construction area should have obvious warning signs.
6.6.7 The power equipment for construction shall not be powered by steam or diesel. Generally, they are mainly based on electricity.
6.7 Environmental Control Procedures:
6.7.1 Temperature and relative humidity standards
Warning value | Stop line value | |
temperature | Above 25 ° C or below 18 ° C | Above 28 ° C or below 15 ° C |
Relative humidity | Above 65% or below 40% | Above 70% or below 30% |
Clean factory grade | Temperature specification value | Humidity specification | Dust emission specification value |
CLASS 1000 | 20 ° C ~ 25 ° C | 40% to 65% | Total number of particles above 0.5μm ㄑ1000 |
6.8 Clothing cleaning specifications
6.8.1 Clean clothing and hats must be cleaned at least once a week; dust-free shoes should be cleaned at least once every two weeks, and a clean clothing cleaning record should be filled out as a control.
Data reference (portal):
Air shower: http://
High efficiency air filter: http://
Clean room: http://
High efficiency filter leak detection: http://
Operating room purification project: http://
Cleanliness level standard: http://
Cleanroom testing standards: http://
Clean factory design specifications: http://
Cleanroom management system: http://
Clean room ventilation frequency standard: http://
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