SQP验厂-工厂现场和设施管理

 Site and Facilities Management SQP验厂现场和设施管理

1、 Location and Perimeter 位置和周边

1.1  Is the factory site location and perimeter allow the production of safe and legal products?
     工厂的选址和周边是否允许生产安全合法的产品？
1.2  Where necessary, are measures taken to prevent contamination from local activities and the site environment which may have an adverse impact on the integrity of finished products?
     在必要时，应采取措施防止当地活动对现场环境的污染以免对最终产品的完整性产生不利？
1.3  Is there any evidence of damage due to inadequate drainage or flooding?
     是否有任何因引流不畅或洪水造成损害的证据？


2、 Internal Site: Factory Layout, Product Flow and Segregation 内部：工厂布局，生产流程和隔离
Premises and plant shall be designed, constructed and maintained so as to control the risk of product contamination and to comply with all relevant legislation
工厂的设计，建造和产品污染的风险控制是否遵守所有相关法规

2.1  Are site buildings and facilities suitable for the intended purpose and properly maintained?
     现场的建筑物和设施是否适合预期的目的和正确维护？
2.2  Is process flow diagram available?
     工艺流程图是否可用？
2.3  Is the process flow and the location of machinery and equipment from intake to dispatch, well arranged to minimise product contamination risks?
     是否从摄入的工艺流程和机械设备的位置调度，精心安排，以减少产品污染的风险？
2.4  Is working space and storage capacity sufficient?
     工作空间和存储容量是否足够？
2.5  Are floors well designed to meet the following criteria?
      地板的设计是否符合以下标准？
  a)  the demands of the process;工艺过程的要求；
  b)  withstand cleaning materials and methods;承受清洗材料和方法；
  c) impervious and maintained in good repair.良好的维修防渗和维护。
2.6  Are buildings fabric and overhead walkways/structures (where foreign bodies could fall through) controlled through regular inspections, where necessary?
     建筑物和天桥/结构（如异物可能会下降通过）必要时有控制吗？是否通过定期检查？
2.7  Are walls, floors, ceilings, pipe-work and overhead structures designed, constructed,finished and maintained to prevent condensation and mould growth, especially in the storage areas?
     为墙壁，地板，天花板，管道和架空结构的设计，施工，完成和维护，以防止冷凝和霉菌的生长，特别是在存储领域？
2.8  Does all water supplies used as ingredient of the products or preparation of the products where it may come into direct contact with the product meet the applicable requirements/standards?
     作为产品成分或制剂所供的水产品在那里可以接触到，与产品直接接触的是否满足适用要求/标准？


3、 Staff Facilities SQP验厂员工设施要求
Staff facilities shall be sufficient to accommodate the required number of personnel, and shall be designed and operated to minimise the risk of product contamination. Such facilities shall be maintained in good and clean condition.

3.1  Are staff facilities (e.g. toilet rooms, cleaning facilities, canteens,  etc) well-designed and constructed so that they can be easily cleaned and maintained in order to prevent any potential contamination (e.g. bacterial contamination) that could compromise product quality, safety and legality?
3.2  Are the location of staff facilities jeopardising the integrity of products?
3.3  Where smoking is allowed under national law, is there a designated controlled smoking areas which must be isolated from production areas?
3.4  Where necessary, does the company provide suitable and sufficient storage facilities to accommodate all reasonable personal items?
3.5  Where specific work-wear is required, does the company provide designated changing facilities for all personnel, whether staff, visitor or contractor?
3.6  Are outdoor clothing and other personal items stored separately from work-wear within the changing facilities?
3.7  Does the company provide suitable and sufficient hand-cleaning facilities at access to,and at other appropriate points within, production areas?


4、 Cleaning and Hygiene Practices SQP验厂审核工厂清洁和卫生规范
Housekeeping and cleaning systems shall be in place which ensure that adequate standards of cleanliness and tidiness are maintained at all times and the risk of contamination is minimised

4.1  Are cleaning procedures established for the building, utilities, plant and equipment?
4.2  Are cleaning procedures include the following as a minimum?
  a) responsibility for cleaning
  b) item/area to be cleaned
  c) frequency of cleaning d) method of cleaning
  e) cleaning materials to be used
  f) cleaning responsibility for verification, where appropriate
4.3  Are cleaning schedules established and maintained?
4.4  Are cleaning practices completed effectively so as to minimise risk of contamination?
4.5  When there is building or maintenance work, changes to equipment or introduction of new product types, are cleaning and disinfection procedures re-validated where necessary?
4.6  Where external cleaning service contractors are employed, is the service contract clearly defined the scope and frequency of the work ?
4.7  Are cleaning chemicals clearly labelled (Note: no chemicals are decanted unless into properly labelled and identified containers)?
4.8  Is hand cleaning performed at a suitable frequency to maintain hygienic conditions and prevent product contamination?
4.9  Where there are product contamination risks (e.g., in the final packing area), are necessary measures below taken as appropriate?
- wear suitable gloves or footwear;
- wear protective clothing;
- control the wearing of jewellery;
- prohibit eating, drinking and smoking in production/packaging area;
- head and facial hair is fully contained; and
- prohibit the false fingernails.


5、   Waste/Waste Disposal 垃圾/废物处置
There shall be adequate systems for the collection, collation and disposal of waste material.

5.1  Are measures established to prevent the accumulation of waste materials in production areas?
5.2  Where applicable, are waste materials categorised according to legislative requirements?
5.3  Are waste materials collected in suitably designed waste containers with clear label?
5.4  Products which are to be disposed of on safety grounds, as the result of a recall or withdrawal, or as substandard trademarked materials, are they disposed of securely or delegated to a specialist in secure waste disposal?
5.5  Are waste materials suitably quarantined and routed to ensure that they are not re-introduced into non-waste production flows?
5.6  Are external waste collection containers and compactors managed in such a manner as to minimise risk to the product?


6、  Pest Control SQP验厂-害虫防治
The company shall be responsible for minimising the risk of pest infestation on the site.

6.1  Is pest control necessary for the audited site?
6.2  Where no pest control is conducted, does the site have a suitable justification for its absence and review at least annually?
6.3  Are suitable pest control measures established for minimising the risk of pest infestation on the site?
6.4  Does the site either contract the services of a competent pest control contractor, or have trained personnel, for the regular inspection and treatment of remises?
6.5  Where external contractors are employed, is the service contract clearly defined and reflect the activities of the site?
6.6  Are procedures  and inspection documentation (e.g., log book of completed job/activity) for pest control maintained?
6.7  In the event of infestation, does the company take immediate action to eliminate the hazard?
6.8  Are pest control chemicals clearly labelled (Note: no chemicals are decanted unless into properly labelled and identified containers)?
6.9  Are all material safety data sheets (MSDS) for all chemical pest control chemicals and agents used available to relevant staff at point of use?
6.10  Are bait stations robustly constructed, tamper resistant, in good condition and effective in killing the target pests?
6.11  Are bait stations positioned to avoid potential contamination of production materials and products?
6.12  When a fumigation is necessary, are the operations carried out by competent staff with appropriate professional qualifications?
6.13  Are drains fitted with screens and traps to prevent pest entry?
6.14  Are fly-killing devices and/or pheromone traps correctly sited and operational? (Note: If there is a danger of insects being expelled from any extermination device and contaminating the product, alternative positions, systems and/or equipment must be used.)
6.15  Where necessary, are suitable precautions taken to prevent entry of pests if external doors are kept open?