7.3.  Design and development  设计和开发

7.3.1.  Development of new products and processes  新产品和过程的开发

The Operator shall plan and control the design and development of products or processes related to safety.

经营者应对产品或与安全有关过程的设计和开发进行策划和控制。

The safety of products covered by FAMI- QS scope shall be assured during the developmental stages of a

new product through application of HACCP principles.

在新产品的开发过程中通过HACCP原理的运用，确保FAMI-QS范围所覆盖产品的安全。

Ensure that:  确保

  Development plans are issued prior to relevant phases of the development process;

     先于开发过程各相关阶段，制定开发计划；

  The development plan considers risks related to safety;  

     开发计划考虑到与安全相关的危害；

  HACCP is considered.

     HACCP被考虑。

7.3.2.  Change control  设计更改的控制

Design and development changes shall be identified and corresponding records maintained.

设计与开发的更改应予以识别且相关记录应予以保存。

All changes shall be reviewed, verified and validated, as appropriate, and approved before implementation.

适当时，应当对所有的更改进行评审、验证和确认，并在实施前得到批准。

The review of design and development changes shall include evaluation of the effect of the changes

on product safety.

设计和开发更改的评审应包括对产品安全变化影响的评估。

Records of the results of the review and any necessary actions shall be maintained.

评审结果及任何必要措施的记录应予以保持。

Ensure that:  确保

  A formal change control procedure exists;

     建立了正式的更改控制程序；

  Changes are approved before implementation;  

     更改在执行前被批准；

  Changes are monitored and documented;  

     更改均已监控并形成文件；

  Changes are revised, verified, validated and resulting documents are archived;

     更改已被修订，查实、验证和存档；

  Safety, quality, legal requirements are taken into account in the change control procedure.

     更改控制程序覆盖安全、质量和法规的要求。