质量管理问题的关键性失误点是：

1. Necessary specifications and requirements are not communicated to and/or agreed with the factory's component/raw material suppliers.

没有与工厂的零件/原料供应商就所有必需的规格和要求进行过沟通和/或认可。

2. The incoming goods area is not clean, dry, and with appropriate illumination and temperature.   Materials are not suitably handled.

收货区域不干净、潮湿，光线和温度不适宜。货物搬运不恰当。

3. In the incoming goods area, defective items are not suitably segregated from items to be used.

在收货区域，有问题的产品没有与将要使用的产品进行适当地隔离。

4 In the production area, rejected products and components are not suitably segregated. Their re-use/disposal are not suitably controlled / authorised.

在生产区域，不合格的产品和零部件没有被恰当的隔离存放，它们的重新使用/处理方式没有得到恰当的控制/认可。

5. During production, products are not stored in suitably clean, tidy, safe, dry areas with appropriate illumination and temperature. They are not handled appropriately when moved from one area to another.

   在生产过程中，产品没有被恰当地存放在干净、整洁、安全、干燥并且光线和温度都适宜的环境中。　当产品被从一个地方移到另一个地方去的时候没有进行恰当的搬运。

6.In the final inspection, packing and storage area, rejected items are not suitably segregated.

在产品的最终检验阶段，不合格产品没有被恰当的隔离开来。

7. The storage areas for finished goods are not big enough, suitably clean, dry, with appropriate illumination and temperature.  Goods are not suitably handled.

   成品的存放区域不够大、环境肮脏、潮湿，光线和温度不适宜。货物的搬运不恰当。

8. No effective positive release process before goods leave the factory.

   在货物离开工厂以前，没有建立有效确定的出货程序。