Best Practices for Managing a Clean Factory (Original Link: http://)
1. Purpose
1.1 To maintain the cleanliness and integrity of the clean factory environment, reduce operational costs, ensure product quality, and improve overall efficiency.
2. Scope of Application
2.1 These guidelines apply to all individuals entering the clean factory, including employees, vendors, and visitors, as well as materials brought into the facility.
3. Responsibilities
3.1 The Manufacturing Department is tasked with monitoring all personnel entering the clean room;
3.2 The Administrative Department is responsible for purchasing and maintaining the necessary attire and cleaning supplies for the clean factory.
4. Related Reference Documents
4.1 US Federal Standards
5. Definitions of Key Terms
No definitions provided at this time.
6. Workflows and Instructions
6.1 Preparation Before Entering the Clean Room
6.1.1 Masks worn prior to entering the clean room must fully cover the nose and mouth;
6.1.2 Personnel must don the appropriate dust-free attire, including hair covers, hats, and shoes;
6.1.3 Before entering the clean factory, IPQC must verify the functionality of clothing and electrostatic rings;
6.1.4 Avoid touching metal objects during static tests;
6.1.5 Regularly check the grounding status of testers each day;
6.1.6 All personnel must wear gloves and undergo static testing before entering the clean room.
6.2 Personnel Access Control
6.2.1 Personnel include individuals involved in clean room operations such as manufacturing, engineering, QA, administration, and security;
6.2.2 Employees directly involved in clean room activities are supervised by their respective units. For OTHERS needing access, approval from the production supervisor is required;
6.2.3 Vendors, including equipment agents and maintenance engineers, must fill out an "Entry Application Form" and be escorted by company personnel;
6.2.4 Customers require approval from business personnel and coordination from the production supervisor to tour the clean factory.
6.3 Clean Factory Access Procedures
6.3.1 Clean Factory Entry Procedure: Remove shoes in the changing area and enter barefoot;
6.3.1.1 Enter the locker room of the clean factory;
6.3.1.2 Wear a net cap ensuring no hair is visible;
6.3.1.3 Secure a mask over the nose and mouth;
6.3.1.4 Dress in clean garments and shoes;
6.3.1.5 Wear rubber gloves and fold them over the cuffs;
6.3.1.6 Adjust clothing in the mirror;
6.3.1.7 Pass through the Air Shower, allowing up to two people at a time. Inside the Air Shower, raise hands and pat clothes while turning three times for better cleaning.
6.3.2 Clean Factory Exit Procedure:
6.3.2.1 After exiting the Air Shower, remove dust-free shoes, garments, gloves, net caps, and masks;
6.3.2.2 Place dust-free clothing and shoes in a designated dust-free wardrobe.
6.3.3 Management and Restrictions of Clean Factory Facilities:
6.3.3.1 Only ballpoint pens, stainless steel rulers, and dust-free paper are permitted in the clean factory;
6.3.3.2 Cosmetics, including powders, perfumes, sprays, and wool-free clothing, are prohibited;
6.3.3.3 Individuals failing to comply with clean room management protocols and static testing are barred from entry;
6.3.3.4 Manuals printed on dust-free paper or plastic-processed documents may be brought into the clean room;
6.3.3.5 Spray cleaners and paint products are forbidden in clean workshops;
6.3.3.6 Tools brought by customers or suppliers must be inspected and cleaned if necessary before entry;
6.3.3.7 Photography and videography are prohibited in the clean factory without department-level approval;
6.3.3.8 The total number of personnel, both direct and indirect, in the clean room should not exceed 100;
6.3.3.9 In the work area, personnel must maintain a distance of at least 60 cm from the workstation and 60-120 cm between stations;
6.3.3.10 Latex gloves must be changed after each exit and re-entering the clean room;
6.3.3.11 Removing masks, gloves, or zippers in the clean room is strictly prohibited.
6.3.4 Clean Room Work Rules:
6.3.4.1 Any item contaminated with chemicals should be immediately cleaned or replaced to prevent harm to personnel or damage to products and equipment;
6.3.4.2 Upon noticing equipment malfunctions, alarms, or leaks, report to the on-site ME engineer and notify safety personnel if necessary;
6.3.4.3 Spilled chemical solvents should be cleaned immediately with a dust-free mop or cloth;
6.3.4.4 Powder spills should be cleaned using a dust-free vacuum cleaner.
6.4 Additional Notes:
6.4.1 Sitting on tables, machine tables, or the floor is strictly prohibited;
6.4.2 Materials and tools must be transferred via a transfer box and not carried directly into the clean room;
6.4.3 Items should not be stacked near security doors, and passing through them is forbidden except in emergencies;
6.4.4 Firefighting equipment in clean rooms must not be moved arbitrarily;
6.4.5 Operators未ç»è®¤è¯ä¸å¾—自行æ“作 machinery. Training must be conducted under supervision;
6.4.6 Smoking, eating, drinking, etc., are prohibited in the clean room. Individuals who have smoked must wait 30 minutes before entering.
6.5 Clean Factory Cleaning Specifications:
6.5.1 Approved cleaning products include dust-free mops, cloths, vacuums, and adhesive rollers;
6.5.2 Clean room uniforms should be laundered weekly; dust-free shoes every two weeks; cleaning logs maintained;
6.5.3 Trash bins in the clean room must be emptied daily, and immediate action is required if trash exceeds the bin's capacity;
6.5.4 Floors should be dusted twice daily, work surfaces wiped once, with cleaning records kept;
6.5.5 Equipment cleaning follows maintenance instructions, with records maintained.
6.6 Equipment and Construction Control:
6.6.1 A construction application form must be completed for access to the clean factory;
6.6.2 Construction teams must bring plastic sheets, stainless steel plates, vacuums, and dust-free cloths;
6.6.3 Construction teams must understand the company’s clean room protocols;
6.6.4 After construction, the clean room HEPA system must run for 24 hours before resuming production;
6.6.5 Tools brought into the clean room must be cleaned and free of visible dirt;
6.6.6 Drilling and cutting are prohibited during construction, with clear warning signs displayed;
6.6.7 Construction power equipment should primarily use electricity, avoiding steam or diesel.
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 | Humidity Specification | Dust Emission Specification |
CLASS 1000 | 20°C - 25°C | 40% - 65% | Particles > 0.5µm: ≤1000 |
6.8 Clothing Cleaning Specifications
6.8.1 Clean clothing and hats should be cleaned weekly; dust-free shoes every two weeks, with cleaning logs maintained.
Data References (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://
Clean Room Testing Standards: http://
Clean Factory Design Specifications: http://
Clean Room Management System: http://
Clean Room Ventilation Frequency Standard: http://
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