名    称Name
设备的设计、选型与前期管理规程 Instructions for Design, Model Selection and Early management of Equipment
编    号 Number
SMP-SHB-003-01SMP-SHB-003-01
起 草 人 Draftsman
 审 核 人 Assessor
 批 准 人 Ratifier
起草日期 Date of draft
 审核日期 Examination date
 批准日期 Ratify date
分 发 至 Distribute to
 执行日期 Execution date
1.
目的：加强设备的设计、选型工作，为满足生产和工艺要求，制定从设备规划到投产这Objective: to strengthen design and selection of equipment, meet the requirements of manufacture and technics, and regulate the early management of the phase from programming to putting into production.
一阶段的前期管理工作。
2.
范围：所有新购置设备固定资产。Application: all newly-purchased equipment and fixed capital.

3．
责任人：公司设备部门负责人、使用部门负责人、QA负责人及管理人员。Responsible Person: responsible persons for equipment departments, using departments and QA and administrative staff.
4．
内容： Content:
4.1
设备前期管理是指企业在设备的规划、设计、选型、购置及安装调试直至投产转固等方Early management of equipment refers to the management of equipment programming, design, model selection, purchase, installation and debugging before putting into production.
面的管理工作。
4.2
公司设备管理部门应设专人负责前期工作，如有重大技术改进与改造，应填写设备改造变更申请表，并配有原有设计图纸和设备变更设计图纸（及图纸版本编号），经QA确认后，将变更图纸（及图纸版本编号）存于原设计院或资料室备案。Department of equipment of the company is responsible for the early management. If is important technical improvement and alternation, application form of equipment alternation should be filled out and handed into QA along with the original and alternated design drawing (and number of drawing edition). After affirmation, alternated drawing (and number of drawing edition) should be stored and put on records in former design institute or in data room.并成立专门的技术工作管理小组负责组织技术准备工作。Also, special design management team should be established to take charge of the preparation of organizing technique.施工中严格遵守开工手续，积极协助公司领导和有关部门进行决策，为投产和设备后期管理创造条件。Work-starting procedure should be strictly followed in construction. Department of equipment should also actively assist company leader and related departments in making decisions in order to create favorable conditions for production and later management.

华译网北京翻译公司翻译过大量有关设备的设计、选型与前期管理规程的文件资料,Beijing Chinese Translation Service Company has translated many technical documents about Instructions for Design, Model Selection and Early management of Equipment
4.3
设备管理部门负责人必须参与设计阶段的方案论证，必须做到设备的设计、选型、安装Responsible persons in the department of equipment must participate in the argumentation of project in design phase, and must ensure that the design, model selection and installation of equipment
应符合生产要求，易于清洗、消毒或灭菌，便于生产操作和维修、保养，并能防止差错meet the requirements of manufacture and the equipment is easy to wash, disinfect or sterilize, and also easy to handle and maintain. The equipment should also be able to prevent error and reduce pollution.
和减少污染。与药品直接接触的设备表面需选用304不锈钢材质为好，应光洁、平整， 304 stainless steel should be used in the contact interface, and the interface should be smooth and flat,
易清洗或消毒、耐腐蚀，不与药品发生化学变化或吸附药品。easy to wash or disinfect, erode-resistant. It should not interact with drugs or absorb drugs. 设备所用的润滑剂、冷却剂等不得对药品或容器造成污染。Lube and refrigerant applied to equipment should not pollute drugs or containers. 对设备的先进性（技术、安全、节能、环保）、经济性、可靠性、可维修性、兼容性（设备相互之间的统一配合性）进行综合分析，择优确定，把好选型关。 Responsible persons in the department of equipment are responsible for the general analysis of the advancement (on technique, safety, energy sources economization and environment protection), economy, reliability, maintainability, compatibility (cooperation among all equipment) of the equipment. They will choose the best to ensure perfect model selection.
4.4
接到使用部门填报的“设备购置立项申请表”，经公司级设备主管批准后，即可办理立项手续。Project proposal and confirmation procedure can be carried out when equipment purchase project proposal and confirmation application form is handed in and ratified by equipment managers.设备管理部门应做好设备订购、监制工作，应优先选用通过质量认证企业生产的设备，最好有检测报告。Department of equipment should complete the order and manufacture-supervision of the equipment, chose the enterprises that have passed quality certification first, and supply monitoring report if needed.特种设备必须购自国家认定有资质证明的企业，如有必要应先考查。Special equipment has to be purchased from enterprises that has the certification confirmed by central government. Check of the enterprise should be applied if needed. 协调安装调试中的问题，并搞好现场服务。They should coordinate the problems occurring over the installation and debugging, and serve in site.在订购设备时，设备管理部门应向设备制造公司提出供给必要的备件和资料；引进设备订货时，要根据具体情况同时订购必须的备品备件和引进部分汉字的图纸资料。When equipment is ordered, department of equipment should provide equipment manufacture factory with necessary spare parts and information. When the equipment is introduced overseas, they should order necessary spare parts and Chinese drawing data at the same time according to the situation.
4.5
设备到货后，设备管理部门应组织使用部门、档案管理员三方到场开箱验收，认真检查After the its arrival, department of equipment, accompanied by using department and file clerks, should check and accept the equipment,
设备质量和数量。examine its quality and quantity carefully.检验、计量仪器开箱，还应有计量人员参加。If it should be measured, staff in charge of measurement should appear, too. 进口设备的验收，设备When checking and accepting of the imported equipment.
部门应会同商检部门和参与订货的有关人员，共同进行检验。besides department of equipment, commodity inspection authorities and person that ordered this equipment should also participate.验收时，设备部门对随箱During checking and accepting,
文件、图纸、说明书、装箱单等资料进行清点登记。department of equipment should count and record all drawing, instruction books and packing lists.Original files should be handed over to technique archives.