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歐洲FAMI-QS認證操作規范(二十七)生產過程的驗證

7.5.2  Verification of processes for production  

生產過程的驗證



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.

   經營者應對生產的任何過程實施驗證,包括僅在產品使用或交付之后問題才顯現的過程。


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.

   驗證應當證實這些過程實現預期結果的能力。驗證的頻次應在經營者的HACCP 體系框架下來考慮。

特別應注意殘留和均勻性。


The Operator shall establish arrangements for these processes including:

   經營者應對這些過程作出安排,包括:


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

     為生產過程的評審和批準所規定的準則;

b) approval of equipment; 設備的認可;

c) qualification of personnel; 人員資格的鑒定;

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. 記錄的要求。


Ensure that:  確保

?  A written verification procedure is in place;  

     書面的驗證程序是適宜的;

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

     驗證數據證實所有的生產過程實現策劃的結果;

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

     驗證生產的數據證實殘留被控制。



7.5.3.  Identification and traceability  標識和可追溯性


To ensure traceability, the Operator shall: 為確??勺匪菪?,經營者應:

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

   在產品實現的全過程中使用適宜的方法識別與記錄產品;

b) maintain a register, that contains: 保持登記,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.

   購進原料、飼料添加劑、功能性飼料成分或中間體的生產者的名稱與地址。購進原料應根據7.4.2驗證。

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

   生產的FAMI-QS范圍所覆蓋產品的性質和數量,

? 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

   各自的生產日期,適當時,在連續生產條件下的批次或生產的特定部分的數量,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范圍所覆蓋產品的中間商、生產商或使用者的名稱和地址。


Ensure that:  確保

?  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;

     一個追溯系統是適宜的,包括通過質量控制數據和批次生產記錄從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.

     交付能被追溯到顧客、包括顧客名字、日期、批次和數量。


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