7.3. Design and development 設計和開發
7.3.1. Development of new products and processes 新產品和過程的開發
The Operator shall plan and control the design and development of products or processes related to safety.
經營者應對產品或與安全有關過程的設計和開發進行策劃和控制。
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.
在新產品的開發過程中通過HACCP原理的運用，確保FAMI-QS范圍所覆蓋產品的安全。
Ensure that: 確保
? Development plans are issued prior to relevant phases of the development process;
先于開發過程各相關階段，制定開發計劃；
? The development plan considers risks related to safety;
開發計劃考慮到與安全相關的危害；
? HACCP is considered.
HACCP被考慮。
7.3.2. Change control 設計更改的控制
Design and development changes shall be identified and corresponding records maintained.
設計與開發的更改應予以識別且相關記錄應予以保存。
All changes shall be reviewed, verified and validated, as appropriate, and approved before implementation.
適當時，應當對所有的更改進行評審、驗證和確認，并在實施前得到批準。
The review of design and development changes shall include evaluation of the effect of the changes
on product safety.
設計和開發更改的評審應包括對產品安全變化影響的評估。
Records of the results of the review and any necessary actions shall be maintained.
評審結果及任何必要措施的記錄應予以保持。
Ensure that: 確保
? A formal change control procedure exists;
建立了正式的更改控制程序；
? Changes are approved before implementation;
更改在執行前被批準；
? Changes are monitored and documented;
更改均已監控并形成文件；
? Changes are revised, verified, validated and resulting documents are archived;
更改已被修訂，查實、驗證和存檔；
? Safety, quality, legal requirements are taken into account in the change control procedure.
更改控制程序覆蓋安全、質量和法規的要求。