1.0 Guidence on Production Process
5.0 Non-conformity Management
1., Abstract
Strictly control and manage on non-conformity to prevent the problems coming up again.
2., Duty
2.1, The QC Department and Administration Department are responsible for non-conformity management;
2.1, Relevant responsible departments should be responsible for correction of non-conformity or take corrective measures; laboratory is responsible for tracking and verification,
3., Non-conformity scope:
3.1, Non-conforming products includes non-conformed raw materials, packing materials, semi-finished products and finished products;
3.2, Non-conforming work includes non-conformed management, technical work, process and system.
4., Find the existed non-conformity through inspection, examination, verification,visiting clients, feedback, and complaints.
5., Treatment on non-conforming products
5.1, Non-conforming products should be identified, marked and recorded by laboratory, and then inform the responsible departments and report to company management.
5.2, Responsible departments should be segregated and marked with an obvious sign.
5.3, Administration Department should organize relevant persons of QA, QC, Technical Department, Production Department, and Supply Department to review on the non-conforming products, analyze the reasons, clarify the responsibilities, determine the treatment measures and then report to company management for approval.
5.4, Treatment on non-conforming semi-finished products:
(1).,Scraping (2)., Recovery processing (3)., Downgrading treatment
5.5, Treatment on non-conforming excipient and packing materials
(1)., Return to suppliers (2)., Downgrading treatment (3)., Scraping
5.6, Disuse the non-conforming production water.
5.7, Scrap or recover-process on non-conforming finished products.
5.8, Responsible department take corrective measures according to non-conformity reasons and the Administration Department track and verify on the process.
6. Treatment on non-conforming work
6.1, Non-conforming work includes non-conformed management, technical work, process and system.
6.2, Production workers violating the rules and regulations of the enterprise and production operation process, administrative staffs failing to fulfil the duties and neglecting the management, and inspection personnel failing to fulfil the duties all belong to non-conforming work.
6.2.1, Relevant department should report the non-conforming work to the Administration Department and fill out an non-conforming notice form to responsible department after noticing the non-conformity through inspection, examination, verification,visiting clients, feedback, and complaints.
6.2.2, Administration Department should organize a review on the non-conforming work, responsible department analyzes on the reasons and propose corrective measures. Administration Department should record and summarize on all non-conforming work regularly so as to verify the effectiveness of corrective measures and prevent the occurrence of similar non-conformity in the future.
6.2.3, Responsible department should research and analyze on the reason of non-conforming work, clarify responsibilities, determine corrective measures and report to company management. Administrative Department should track and verify on the implementation of corrective measures and track its effectiveness.
6.3, Treatment on non-conforming work
(1)., Non-conforming work could be corrected based on the seriousness of the circumstances, and the involved workers could be imposed a penalty of RMB50 or even dismissed.
(2)., General manger educate or demote the relevant personnel per actual situation.
(3)., Call a meeting in the whole company to announce the non-conforming work and study on the corrective measures to ensure it will not happen in the future.
7. Record and file
6.0 Management of environmental sanitation and disposal of waste
1. Objective
Regulate the production environment, strengthen the control on relevant production activities, ensure the environmental sanitation objective and standard could be obtained.
2. Application scope
This system applies to the control of the operation process of the company’s environmental sanitation management system.
3. Duty
3.1, The administrative department is responsible for the setting up the management posts for production waste, waste packaging materials and other wastes, as well as for making and implementing the corresponding disposal control procedures.
3.2, The workshop is responsible for cleaning and collection of production wastes.
3.3, The day shift is responsible for the loading, disposal and dumping of production wastes (waste packing materials and other wastes).
3.4, The administrative department also is responsible for the approval and records on disposal of pollutants(garbage is included).
4. Operational control system
4.1, The environmental sanitation factors of our company include waste water, waste residue, waste oil, waste materials, garbage and so on. The important environmental sanitation factors are mainly controlled by the administrative department according to the important environmental factors.
4.1.1, Control and management of water pollution
The production waste water should be discharged in a centralized way. The outer drain should be in line with the government standards for waste water discharge and the administrative department is responsible for the supervision and management on this work. And control the water consumption by cycling use of water and save in production process. Workshop should strictly follow the operation regulation to reduce the amount of waste water.
4.1.2, Control and management of solid waste
1), The impurities, waste and waste packing materials in production should be collected for for centralized treatment by the workshop, and need to be stacked in a designated location and then disposed by the day shift.
2), The domestic garbage is disposed by the day shift under the instruction of the administrative department.
4.1.4, Maintenance measures should be adopted immediately for oil leakage of packaging equipment to prevent the spread of contamination.
4.1.5, The Non-recyclable waste is disposed by the day shift under the instruction of the administrative department.
4.1.6, The administrative department is responsible for planning and managing the company’s water, electricity and other energy resources, so as to ensure the full and effective utilization of energy and reduce consumption.
4.2, The place where raw materials, packaging materials and finished products are placed should be neat, hygienic and well ventilated, so as to prevent mildew, dampness, deterioration, insects, rats and so on. Chemical raw materials should be sealed and stored. And all articles should be classified and stored clearly.
4.3, The workshop should strictly carry out environmental sanitation management according to the above requirements and make corresponding records. When non-conformity occurs, it is dealt with according to the rules of the factory. The management representative shall be responsible for checking the execution of the workshop at all times.
4.4, The company should maintain a good hygienic environment and greening work. Garbage and all kinds of waste raw materials and packaging should be cleaned at any time.
9.0, Management on the Workshop
1. Abstract
Production and packing workshop are important conditions to affect the quality of the finished products. The company establishes a workshop that meets the requirements of production and maintains normal maintenance to ensure that it is in good condition.
2. Duty
2.1, The quality inspection department is responsible for the management of production facilities and workplaces.
2.2, The production department is responsible for the maintenance of production facilities and workplaces.
3, The production facilities and workplaces shall be designed and constructed by qualified units that selected by the manager.
4, The quality inspection department shall supervise on the construction process of production facilities and workplaces, and organize inspection after they are completed.
5, Reasonable design the workshop according to the requirements of food production technology. The flow of people and materials should be reasonable. And each workshop should be able to meet their own requirements for production.
6, The workshop should have enough space for storage and transportation of equipment, materials, for sanitation and pass-through of personnel. The workshop should be clean and bright, and facilities to prevent dust, rat and flies should be established to ensure no invasion and concealment of rats, flies and other pests.
7, The workshop shall establish facilities for washing hands, disinfecting and changing clothes.
8, All kinds of harmful substances used in the production process should be placed and disposed reasonably.
9, The workshop floor should be paved with non-toxic, anti-slippery and hard materials to ensure there is no crack and in good drainage condition. The walls should be covered with light colored nontoxic materials and the roof should be clean with no dust.
10, The temperature and humidity of the workshop should meet the production requirements of the processed products.
11, The production process should be reasonable, each process should be linked up successively to reduce roundabout procedures and cross contamination.
12, The workshop should keep sufficient light, and illumination should meet the requirements of production and processing. Lighting equipment above the workstation and open-produced raw materials should equipped with protection device.
10.0 Management on Warehouse
1., Abstract
Warehouse is a necessary condition for production, so the company should establish a warehouse that meets with the production requirements and carry on strict management on it to ensure it works in good condition.
2. Duty
2.1, The quality inspection department is responsible for supervising on the construction process of the warehouse as well as checking and accepting after completion.
2.2, The warehouse keeper is responsible for daily management of the warehouse as well as the checking, accepting, keeping and using of materials.
3., The warehouse should be neat and smooth without cracks on floors. It should have facilities for moistureproof, fire prevention, rodent control, pest control and dustproof.
4., The temperature and humidity in the warehouse should conform to the storage requirements of raw materials, finished products and other articles.
5., The goods stored in the warehouse should be kept well and shouldn’t be placed directly on the ground or against the wall. “First-in, first-out” principle should be followed to ensure the stock is always the latest. And the keeper should counting the inventory regularly to make sure the inventory meets with the records.
6., The keepers should notify the quality inspectors to inspect on the raw materials and outsourced materials according to company’ acceptance criteria before they are put into warehouse. Once they are inspected to be conformed, the keepers should count the quantity, classify and attach the “Conform” mark to each material. Warehouse for raw materials, finished products, semi-finished products and packaging materials shall not store articles that are toxic, harmful, inflammable and explosive.
7., The raw materials and outsourced materials that are inspected to be unconformed should be attached with obvious mark and segregated in a designated place. Based on inspection report from the warehouse keeper, the unconformed materials should be returned to the suppliers by sales department.
8., Warehouse keepers should timely report the unconformtiy to the company manager including the category, quantity, reason so the unconformed materials could be dealt with timely.
