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欧洲FAMI-QS认证操作规范(二十七)生产过程的验证

7.5.2  Verification of processes for production  

生产过程的验证



The Operator shall verify any processes for production. This includes any processes where deficiencies become apparent only after the product is in use or has been delivered.

   经营者应对生产的任何过程实施验证,包括仅在产品使用或交付之后问题才显现的过程。


Verification shall demonstrate the ability of these processes to achieve expected results. Frequency of verifications shall be considered under the Operator’s HACCP system. Particular attention shall be given to carry-over and homogeneity.

   验证应当证实这些过程实现预期结果的能力。验证的频次应在经营者的HACCP 体系框架下来考虑。

特别应注意残留和均匀性。


The Operator shall establish arrangements for these processes including:

   经营者应对这些过程作出安排,包括:


a) defined criteria for review and approval of the manufacturing processes;

     为生产过程的评审和批准所规定的准则;

b) approval of equipment; 设备的认可;

c) qualification of personnel; 人员资格的鉴定;

d) use of specific methods and procedures; and 特定的方法和程序的使用;以及

e) requirements for records. 记录的要求。


Ensure that:  确保

  A written verification procedure is in place;  

     书面的验证程序是适宜的;

  Verification data demonstrates that all production processes achieve planned results;  

     验证数据证实所有的生产过程实现策划的结果;

  Verification data of production demonstrates that carry-over is controlled.

     验证生产的数据证实残留被控制。



7.5.3.  Identification and traceability  标识和可追溯性


To ensure traceability, the Operator shall: 为确保可追溯性,经营者应:

a) identify and record the product by suitable means throughout product realisation; and

   在产品实现的全过程中使用适宜的方法识别与记录产品;

b) maintain a register, that contains: 保持登记,包括:

 the names and addresses of manufacturers of incoming materials, feed additives, functional feed ingredients or of intermediates. Incoming materials shall be verified according to section 7.4.2.

   购进原料、饲料添加剂、功能性饲料成分或中间体的生产者的名称与地址。购进原料应根据7.4.2验证。

 the nature and quantity of the products produced covered by FAMI-QS scope,

   生产的FAMI-QS范围所覆盖产品的性质和数量,

 the respective dates of manufacture and, where appropriate, the number of the batch or of the specific portion of production in the case of continuous manufacturing,and

   各自的生产日期,适当时,在连续生产条件下的批次或生产的特定部分的数量,以及

 the names and addresses of the intermediaries, manufacturers or users to whom the products covered by FAMI- QS scope have been delivered.

   已交付的FAMI-QS范围所覆盖产品的中间商、生产商或使用者的名称和地址。


Ensure that:  确保

  A traceability system is in place, including tracing back from the final product through quality control data and batch records to the raw materials used and the suppliers;

     一个追溯系统是适宜的,包括通过质量控制数据和批次生产记录从成品追溯到使用的原材料及其供方;

  Deliveries can be traced to customers, including customer name, date, batch and amount.

     交付能被追溯到顾客、包括顾客名字、日期、批次和数量。


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