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SQP驗廠-工廠現(xiàn)場和設(shè)施管理

 Site and Facilities Management SQP驗廠現(xiàn)場和設(shè)施管理

1、 Location and Perimeter 位置和周邊

1.1  Is the factory site location and perimeter allow the production of safe and legal products?
     工廠的選址和周邊是否允許生產(chǎn)安全合法的產(chǎn)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?
     在必要時，應(yīng)采取措施防止當?shù)鼗顒訉ΜF(xiàn)場環(huán)境的污染以免對最終產(chǎn)品的完整性產(chǎn)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暢或洪水造成損害的證據(jù)？


2、 Internal Site: Factory Layout, Product Flow and Segregation 內(nèi)部：工廠布局，生產(chǎn)流程和隔離
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
工廠的設(shè)計，建造和產(chǎn)品污染的風險控制是否遵守所有相關(guān)法規(guī)

2.1  Are site buildings and facilities suitable for the intended purpose and properly maintained?
     現(xiàn)場的建筑物和設(shè)施是否適合預(yù)期的目的和正確維護？
2.2  Is process flow diagram available?
     工藝流程圖是否可用？
2.3  Is the process flow and the location of machinery and equipment from intake to dispatch, well arranged to minimise product contamination risks?
     是否從攝入的工藝流程和機械設(shè)備的位置調(diào)度，精心安排，以減少產(chǎn)品污染的風險？
2.4  Is working space and storage capacity sufficient?
     工作空間和存儲容量是否足夠？
2.5  Are floors well designed to meet the following criteria?
      地板的設(shè)計是否符合以下標準？
  a)  the demands of the process;工藝過程的要求；
  b)  withstand cleaning materials and methods;承受清洗材料和方法；
  c) impervious and maintained in good repair.良好的維修防滲和維護。
2.6  Are buildings fabric and overhead walkways/structures (where foreign bodies could fall through) controlled through regular inspections, where necessary?
     建筑物和天橋/結(jié)構(gòu)（如異物可能會下降通過）必要時有控制嗎？是否通過定期檢查？
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?
     為墻壁，地板，天花板，管道和架空結(jié)構(gòu)的設(shè)計，施工，完成和維護，以防止冷凝和霉菌的生長，特別是在存儲領(lǐng)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?
     作為產(chǎn)品成分或制劑所供的水產(chǎn)品在那里可以接觸到，與產(chǎn)品直接接觸的是否滿足適用要求/標準？


3、 Staff Facilities SQP驗廠員工設(shè)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驗廠審核工廠清潔和衛(wèi)生規(guī)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/廢物處置
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驗廠-害蟲防治
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?