Costco GMP quality audit project mainly includes the following aspects:
1.Review the factory's quality manuals, program documents, operating procedures, etc., as well as the corresponding quality records.
2.The on-site inspection includes the production environment, equipment and facilities, production process, quality control, etc.
3.Product sampling mainly tests its safety, effectiveness and other indicators.
4.Employee training plans and records to ensure employees have the necessary skills and training.
5.Warehouse management of raw materials and finished products: all materials and semi-finished products that are against the wall and on the ground are removed and do not lean against the wall or on the ground; Material identification is aligned; Mosquito control lamps and rat cages are lit and in working condition; There can be no uncontrolled blades, scissors, tweezers (not **) in any area, and some PE cloth can not be placed outside in the rain; Too messy debris gets into the corner, and too messy raw materials don't look good to photo; Pay attention to the surrounding dead pests and pests, etc.
6.Mesh cutting workshop management: the fabric or sundries under the table need to be cleaned up; All raw materials can not be placed on the ground and against the wall, all raw materials are marked, and the identification must at least have an order number or can be found on the order number; There can be no uncontrolled blades in any area, scissors, tweezers (not **) and debris around the cutting table to clean up.
7.Anti-rodent measures: There can be no blades in all areas that are not controlled, scissors, tweezers (not **) rat cages are operating normally, bait is normal (no need to put bait indoors), rodent control records need to be updated, and indoor and outdoor rat cages need to be fixed.
8.Environmental sanitation of the production workshop: there can be no stagnant water on the floor of all workshops; All workshop equipment, ceilings, air conditioning slots, windows, etc. should be cleaned, and the dust and cobwebs of stairwells and toilets should also be cleaned; The trash cans in all workshops should have "trash can logo" and use trash cans with lids; All cleaning utensils should not appear in the production workshop (including mops, brooms, garbage shovels, disinfectant water), and should be placed in designated garbage cabinets or areas, and the brooms should be clearly marked; All glass that can come into contact with the product must be affixed with explosion-proof paper.
9.Employees' personal hygiene: non-designated disinfectants and hand sanitizers (e.g., soap, laundry detergent, floor cleaners, etc.) cannot be used in the production workshop, and broken handwashing devices need to be repaired or replaced; Employees are not allowed to wear jewelry (earrings, rings, watches, bracelets, necklaces, keys, etc.) when entering the workshop; The work clothes worn by employees should be clean and clean, free of oil stains, no damage, and no peculiar smell.
10.On-site material storage: The goods in the production workshop should be placed 18 inches away from the wall, and placed neatly, not directly on the ground; All sharp weapons must be issued with a record, and all sharp weapons must be numbered, and the sharp weapons must be complete (no broken corners, broken edges, etc.), and tied to the workbench; The chemicals used in each workshop (such as glue, sewage, Tianna water, alcohol, etc.) need to be labeled with chemicals and stored in special containers.
In terms of production sites, special attention needs to be paid to the following:
1.Keep the production site clean and orderly, and the materials are stacked neatly and not disorganized.
2.Make sure the equipment is well-maintained, in good condition, and trouble-free.
3.Operate in strict accordance with the production process and do not operate in violation of regulations.
4.Identify and isolate nonconforming products, and take corresponding treatment measures.
5.Ensure the effective implementation of quality inspection and control points to prevent non-conforming products from flowing into the next process.
6.Critical control points are monitored to ensure that key parameters meet requirements.
7.Detect and deal with abnormal situations on site in a timely manner to prevent problems from expanding.
8.Regularly conduct safety inspections and maintenance of production equipment to ensure that the equipment is safe and reliable.
9.Strengthen the safety training and education of employees, and improve the safety awareness and operational skills of employees.
10.Work closely with relevant departments to ensure smooth coordination in the production process.