7.3. Design and development 設(shè)計(jì)和開(kāi)發(fā)
7.3.1. Development of new products and processes 新產(chǎn)品和過(guò)程的開(kāi)發(fā)
The Operator shall plan and control the design and development of products or processes related to safety.
經(jīng)營(yíng)者應(yīng)對(duì)產(chǎn)品或與安全有關(guān)過(guò)程的設(shè)計(jì)和開(kāi)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(kāi)發(fā)過(guò)程中通過(guò)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(kāi)發(fā)過(guò)程各相關(guān)階段，制定開(kāi)發(fā)計(jì)劃；
? The development plan considers risks related to safety;
開(kāi)發(fā)計(jì)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(jì)更改的控制
Design and development changes shall be identified and corresponding records maintained.
設(shè)計(jì)與開(kāi)發(fā)的更改應(yīng)予以識(shí)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(shí)，應(yīng)當(dāng)對(duì)所有的更改進(jìn)行評(píng)審、驗(yàn)證和確認(rèn)，并在實(shí)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(jì)和開(kāi)發(fā)更改的評(píng)審應(yīng)包括對(duì)產(chǎn)品安全變化影響的評(píng)估。
Records of the results of the review and any necessary actions shall be maintained.
評(píng)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(shí)、驗(yàn)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。