7.3. Design and development 設(shè)計和開發(fā)
7.3.1. Development of new products and processes 新產(chǎn)品和過程的開發(fā)
The Operator shall plan and control the design and development of products or processes related to safety.
經(jīng)營者應(yīng)對產(chǎn)品或與安全有關(guān)過程的設(shè)計和開發(fā)進(jìn)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(chǎn)品的開發(fā)過程中通過HACCP原理的運(yùn)用，確保FAMI-QS范圍所覆蓋產(chǎn)品的安全。
Ensure that: 確保
? Development plans are issued prior to relevant phases of the development process;
先于開發(fā)過程各相關(guān)階段，制定開發(fā)計劃；
? The development plan considers risks related to safety;
開發(fā)計劃考慮到與安全相關(guān)的危害；
? HACCP is considered.
HACCP被考慮。
7.3.2. Change control 設(shè)計更改的控制
Design and development changes shall be identified and corresponding records maintained.
設(shè)計與開發(fā)的更改應(yīng)予以識別且相關(guān)記錄應(yīng)予以保存。
All changes shall be reviewed, verified and validated, as appropriate, and approved before implementation.
適當(dāng)時，應(yīng)當(dāng)對所有的更改進(jìn)行評審、驗證和確認(rèn)，并在實施前得到批準(zhǔn)。
The review of design and development changes shall include evaluation of the effect of the changes
on product safety.
設(shè)計和開發(fā)更改的評審應(yīng)包括對產(chǎn)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(jié)果及任何必要措施的記錄應(yīng)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(zhí)行前被批準(zhǔn)；
? Changes are monitored and documented;
更改均已監(jiān)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(zhì)量和法規(guī)的要求。