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歐洲FAMI-QS認證操作規(guī)范(二十七)生產(chǎn)過程的驗證

7.5.2  Verification of processes for production  

生產(chǎn)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(jīng)營者應對生產(chǎn)的任何過程實施驗證,包括僅在產(chǎn)品使用或交付之后問題才顯現(xiàn)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(xiàn)預期結(jié)果的能力。驗證的頻次應在經(jīng)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(jīng)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(chǎn)過程的評審和批準所規(guī)定的準則;

b) approval of equipment; 設(shè)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(shù)據(jù)證實所有的生產(chǎn)過程實現(xiàn)策劃的結(jié)果;

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

     驗證生產(chǎn)的數(shù)據(jù)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: 為確保可追溯性,經(jīng)營者應:

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

   在產(chǎn)品實現(xiàn)的全過程中使用適宜的方法識別與記錄產(chǎn)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(chǎn)者的名稱與地址。購進原料應根據(jù)7.4.2驗證。

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

   生產(chǎn)的FAMI-QS范圍所覆蓋產(chǎn)品的性質(zhì)和數(shù)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(chǎn)日期,適當時,在連續(xù)生產(chǎn)條件下的批次或生產(chǎn)的特定部分的數(shù)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(chǎn)品的中間商、生產(chǎn)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(tǒng)是適宜的,包括通過質(zhì)量控制數(shù)據(jù)和批次生產(chǎn)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(shù)量。


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